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Let’s start with the good news first. A report issued by the National Capital Association and PricewaterhouseCoopers found that venture capital investment in biotechnology grew 22 percent in 2011. And, now the bad news; initial funding for biotechnology startups seeking investment hit a 16 year low last year. The consensus among financial analysts is that life science investors are increasingly focusing on later stage companies because they carry less clinical and regulatory risks as compared with early stage ones. Put simply, VCs, like everyone else, have become much more risk adverse and do not want to invest in companies that don’t have a minimum history of success.

According to the report, venture firms spent $4.73 billion on 446 biotechnology companies in 2011, the highest dollar amount since 2007. Approximately, 153 biotechnology and medical devices companies received their first round of funding last year.

Finally, the US Food and Drug Administration approved 30 drugs in 2011; 13 of which were developed in part by venture funding.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!!

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From 2001 to present, roughly 300,000 pharmaceutical employees have lost their jobs. That is a massive number; second only to the job losses in the automotive and financial services industries. The main reasons for the layoffs have been a lack of return on investment on R&D activities and impending patent cliffs in 2013 for as many as 15 blockbuster drugs. 

Ed Silverman who runs the Pharmalot blog speculated in a post yesterday that the number of pharma layoffs may be dwindling. His assertions are based on an analysis of the annual number of pharma layoffs provided by the outplacement firm of Challenger, Gray and Christmas. Ed’s wrote:

 “So far this year, pharma layoffs have totaled 19,076, and this includes the 13,000 job cuts planned by Merck, which is actually eyeing many foreign positions, therefore, swelling the latest tally. Last year, pharma eliminated 53,636 jobs, down from 61,109 in 2009, when annual layoffs peaked. In fact, the 2009 bloodletting was outsized compared with every other year - the next highest annual layoff tally occurred in 2008, when 43,014 industry cuts were announced. Between 2003 and 2007, the number of jobs that were eliminated ranged from about 15,000 to 31,000 annually, according to the firm.”

This led Ed to posit that the worst may be over and those pharma employees who still have jobs may be able to relax a bit. However, it is important to note (as Ed also points out) that many big companies are still purchasing or opening new  R&D and manufacturing facilities in emerging markets like India and China and more and more R&D jobs are being outsourced. Further, while many US pharma reps have lost their jobs hiring reps in emerging markets continues to explode. Interestingly jobs that are in demand and still available to Americans include those in regulatory affairs, compliance, IT, clinical operations and marketing. Unfortunately, these are very specialized jobs and many of those pharma employees who have been layed off lack the requisite skills to compete for those jobs!

While I think we may have seen the last of massive layoff in big pharma, smaller and less publicized layoffs will likely continue at many US life sciences companies. The downsizing trend taking place in America will likely continue until drug pipelines are populated with new candidates and life science executive realize that outsourcing R&D job is not a viable solution for their productivity problems.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Interest in the diagnostic sector of the life sciences industry began to wane shortly after development of a test for HIV in the 1980s. However, the emergence of molecular diagnostics and personalized medicine coupled with the 2001 anthrax attacks and the SARS outbreak have helped to reinvigorate this sector. In fact, the diagnostic industry is one of the fastest growing segments of today’s life sciences industry. 

For those of you who may not know, diagnostics tests are regulated in the US as medical devices not therapeutic entities. And, for the most part, the regulatory approval process for diagnostic tests is less stringent and quicker than that required for FDA approval of new therapeutic agents.

Unlike most pharmaceutical and biotechnology companies, companies focused on developing new diagnostic products are hiring. Boston-based Immunetics, a diagnostic company that focuses on developing tests to detect viral and bacterial pathogens including HIV, anthrax and others, is currently looking to hire a regulatory affairs and sales and marketing professional (Product Manager). 

The requirements for the regulatory affairs position can be found here whereas the qualifications for the sales and marketing opportunity can be found here. Neither of the two positions requires a PhD degree. However, persons with PhD degree who possess a strong background in regulatory affairs or pharmaceutical sales and marketing experience will be considered.

For those of you PhD degree holders out there, getting additional training in regulatory affairs or sales and marketing (for those with a business bent) would be extremely useful for those of you seeking employment in the life sciences or medical devices industries.

Until next time...

Good Luck and Good Job Hunting!!!

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Late last week, Janet Woodcock, head of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation (CDER) made public comments which suggested that the long awaited guidance for approval of biosimilar products in the US was complete and likely to be issued by the end of this year. According to the Pharmalot Blog, another agency official suggested that the guidance may be “as early as the next few weeks, maybe even days.” Conventional wisdom suggests that the end of the year scenario may be more likely!

As widely anticipated, the guidance will resemble that already in place in Europe and will rely heavily upon analytical similarity of the biosimilar to the innovator product to determine the clinical testing requirement for approval of the molecule. Interestingly, Woodcock went out on a limb and suggested that the FDA approval process may make interchangeability feasible for biosimilars. For those who may not know, interchangeability or substitution allows pharmacists to substitute generic small molecules drugs for brand names when filling a prescription. This practice is legally allowed by the Hatch Waxman Act because FDA approval of a generic indicates that it biologically equivalent or identical to the branded molecule.

For those of you who have not close paid attention to the biosimilar brouhaha, a regulatory approval pathway for these molecules was implemented in Europe in 2004. Since that time, at least 10 biosimilar products have reached European markets. At present, biosimilars are still not legal in the US. While Woodcock and other FDA officials may be proud of their progress, why has it taken over 12 years for the agency to divine regulatory guidance for this class of molecules? 

Until next time...

Good Luck and Good Job Hunting!!!!!!

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For the past few years, I along with many others have advocated the use of social media platforms (mainly Facebook, Twitter and YouTube) by life sciences companies. Despite a very positive beginning by companies like Novo Nordisk, Johnson and Johnson and others, the implementation of social media in the life sciences industry has been stymied by a lack of regulatory guidance by the US Food and Drug Administration (FDA) and legal and commercialization concerns. While many believe that FDA guidance on the topic will be the panacea that they were waiting for, I personally don’t believe that it will make one bit of difference. That said, Steve Woodruff, the author of the IMPACTIVITI Blog, provides one of the best analyses that I have encountered that explains why social media and pharma don’t work well.

In a post entitled “Time to Give Up on Pharma and Social Media,” Steve cogently provides four compelling reasons why it will be difficult for pharma to ever embrace social media for commercial purposes. They include 1) the lack of regulatory guidance; 2) pharma does not communicate or interact in real time; 3) personnel turnover, short term thinking, lack of innovation and too much focus on quarterly profits; and 4) pharma’s addiction to centralized, one-way controlled communications. His bottom line:

“Public, interactive, real-time social media platforms and commercial pharma communications simply don’t mesh well” 

While I agree with Steve that social media may not be ideal for commercial purposes in the prescription life sciences industry, it may be perfectly well suited for pharmacovigilance and adverse event reporting, clinical trial recruitment and management, education, community outreach and employee recruitment and retention. These are not new ideas. But, because they cost money to implement and don’t contribute the most company’s revenue-driven bottom lines, life sciences companies have not actively explored or embraced them for these purposes. 

Whether big pharma and biotech companies like it or not, social media is here to stay. And, if these companies fail to act soon, they eventually will begin to lose their competitive edges and perhaps more importantly, market share. 

Until next time.. 

Good Luck and Good Job Hunting!!!!!!!!

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US Food and Drug Administration (FDA) inspections of drug and devices manufacturing facilities are typically anxiety ridden exercises that can strike fear into even the most seasoned quality and regulatory affairs professionals. And, most manufacturing facilities do not escape these inspections unscathed and are routinely cited, in many cases, for minor infractions.

For those of you who may not be familiar with FDA inspections, manufacturing facilities that produce approved drugs and devices must be inspected every two years for insure regulatory compliance with Current Good Manufacturing Practices (CGMPs). During the inspection, FDA inspectors document “significant objectionable conditions, relating to products and/or processes or other violations of the Food Drug and Cosmetic Act” that they observe. These are known in the industry as Form FDA 483 Inspectional Observations or simply 483. Companies that receive 483s must correct the so-called objections conditions to remain CGMP compliant.

While receiving 483s during an inspection may be routine, it can be overwhelming to inexperienced companies and their representatives. With this in mind, I found a great blog post by Bruce McDuffee, Global Marketing Manager, Veriteq that provides insights on interacting with the agency to manage 483s. He offers the following advice:

“One thing that you should be clear about is that this is not a ‘warning letter’; it is an offer to help you resolve issues and improve your quality system. The FDA may or may not issue a warning letter next if you have not addressed the conditions of the 483 to its satisfaction. Receiving a 483 does not necessarily mean you are out of compliance.

In responding to a 483, your objectives should include these three things; establish credibility, demonstrate acknowledgement and understanding of the observations and the associated requirements and show commitment to corrective actions."

Bruce recommends that you take the following actions when dealing with 483s:

1. Get your response in on time or even early if possible. The FDA wants to see the response within 15 days, so plan your review and internal processes accordingly.
2. In the first paragraph, demonstrate your understanding of and desire to comply with FDA regulations.
3. Respond individually to each item addressed on the form. Give a corrective action and time-frame for implementing.
4. Prioritize by first addressing the conditions that will most likely affect product quality.
5. Outline how and when each deficiency will be corrected.
6. Avoid talking about whose fault the issue is or how it came to be. For example, keep a positive tone and indicate how the quality system will be improved.
7. Include any reference documents, such as purchase agreements for a new monitoring system or employment agreement for a new quality manager.
8. Keep in mind that there is a formal process available for you to dispute the findings.
9. Be proactive in addressing the conditions. For example, address why the deficiencies were not detected internally and what will be done to correct this condition.
10. Seek clarification with the inspector when you receive the 483 on the spot. Be sure you understand each objectionable condition before the inspector leaves the site. It may behoove you and your firm to seek out an industry expert if the matters seem complex or if the issues are not able to be resolved by your own personnel.”

While CGMP and regulatory compliance may seem like arcane concepts, they are vitally important and must be clearly understood by companies that are manufacturing FDA-approved drugs and devices. Failure to comply can result in penalties, monetary fines and revocation of a license to manufacture a drug or device.

Until next time....

Good Luck and Good Job Hunting (try regulatory affairs or quality assurance and control)

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There has been some buzz on LinkedIn and Facebook about an article that appeared in the March 3, 2011 issue of Nature Magazine. The article entitled “Traditional Drug-Discovery Model Ripe for Reform” and basically chronicles the decline in emphasis being placed by most companies on traditional in-house drug discovery as a source for new candidate molecules. Also, it points out that most big pharma companies now agree that they are not good at drug discovery but excel in clinical development and marketing of new medicines. Industry’s new view of itself is supported by the fact that over 200,000 pharmaceutical and biotechnology workers—roughly 50% were discovery scientists—have their lost jobs in the past three years or so. This begs the question “who is going to discover the new molecular entities that large drug companies are going clinically evaluate and ultimately market? According to the article, academic researchers are likely to play a pivotal role in this newly emerging drug discovery paradigm. 

The new model proposed in the article goes something like this. First, all intellectual property rights for certain compounds will be lifted or removed. Compounds of interest would subsequently be evaluated in small clinical trials for safety and possible efficacy. And, interested drug makers would only compete with one another on specific molecules after they were deemed safe and potentially effective. Up until this point, all data on prospective drug candidates would be openly published and freely available to interested parties.

Proponents of the model contend that the approach would allow drug targets to be more quickly validated and developed less expensively because there would less duplication of research activities. Further, it would reduce the exposure of patients to experimental molecules that have already deemed to be ineffective. Interestingly, the new model would rely exclusively on academic scientists who would be supported by a global initiative that cost about $325 million per years— with half coming from the pharmaceutical industry and half from the public. Finally, drug candidates identified in the initial screening process would be available to companies that participate in the initiative (presumably to the company that invested the most?)

While the proposed model is clearly “wishful thinking” on behalf of academics who are struggling to win grant support, it is deeply flaw and was obviously proposed by academic scientists who lack a clear understanding of the industrial drug development process. First, intellectual property (IP) and patents are the life blood of the industry and are in fact what allows drug companies to prevent competition in certain therapeutic areas maximize their return on investment on the drugs that they develop. Therefore, it is highly  unlikely that any drug maker would agree to lift or suspend IP around a novel new molecule. Second, must academic scientists are not qualified nor trained to engage in industrial drug development. Unlike academic science, industrial research is highly regulated and must be performed according the regulations and guidelines established by various regulatory agencies like the US Food and Drug Administration. If the research is not conducted in a regulatory compliant manner, then the prospective new drug will not be able to win regulatory approval. Third, eliminating IP would prevent university tech transfer offices—which exist almost entirely to manage a university’s IP—from negotiating lucrative licensing deals with interested companies or other parties. This, in turn, would reduce the contribution of funds by technology transfer offices that is used to run many academic research centers. Finally, the model is based upon the assumption that academic scientists (unlike drug companies) willfully and freely share information with one another for the “common good.” However, based on my experiences as an academic for over 20 years, most scientists don’t subscribe to the level of altruism and philanthropy attributed to them in the article. In fact the ego-involvement and competition amongst academics is so fierce, that  many academic refuse to share important new information or breakthroughs with their colleagues until grants are funded or the data are published in peer reviewed journals. Put simply, most academics are trained to work by themselves in their own laboratories and are neither interactive nor collaborative by nature.

There is no question that the old industrial drug discovery model is in transition and a new one will ultimately emerge. However, the role of academics in the new model is likely going to be less than proposed in present article. Too many systemic changes would be required for this model to be effective. That said, providing graduate students and postdocs with training in regulatory affairs and new drug development could be a step in the right direction! Nevertheless, a better solution to the problem may be a greater role for government in new drug discovery and development. To that end, the UK Medical Research Council has established the Developmental Pathway Funding Scheme that supports the development of promising basic science research into new drugs and medical devices. Also, Francis Collins, the current head of the National Institutes of Health has proposed the creation of a National Center for Advancing Translational Sciences to transform basic science into prospective new drugs and treatments.

Despite the good intentions of the article, the path forward for academic scientists is not going to be easy. To make matters worse, it is becoming increasingly difficult for PhD-trained scientists to find jobs. That said, if you are truly interested in industrial drug discovery and development I highly recommend that you take some regulatory affairs course or enroll in a certificate or MS degree program in biotechnology that teaches the business side of the life sciences industry.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

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About a month ago, BioJobBlog in association with the JobJob Health Job Board launched the BioJobCenter; an automated job board designed to help persons looking for employment in the life sciences industry. While the site has been well received, we decided to create a widget for BioJobBlog that features the types of job openings that exist @ the BioJobCenter. The widget will allow readers to apply and search for jobs directly from the BioJobBlog website.

The widget is located in the upper left hand side of the BioJobBlog sidebar (in case you haven’t noticed). Job seekers who click on a job title are taken to the BioJobCenter where they can directly apply for the job (after you join the site). Refreshing the BioJobBlog page will display a new list of job openings! If you are looking for specific jobs in specific locations you can search for more jobs by surfing over to the BioJobCenter and conducting a formal job search there. 

In other news, JobJobHealth recently released an iPhone app that allows users to conduct job searches on their phones. The app (JobJobHealth) is available in the iTunes store!

Check it out!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!!

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Last week, the US House of Representatives voted to cut FDA funding by $220 million. The House vote was not surprising given the prevailing attitude among many pharmaceutical and biotechnology company executives that FDA approval of new drugs and devices has become increasingly difficult. While there is no question that the current approval process for new drugs and devices has become more rigorous as compared with the incredibly lax process (and in some cases, the almost non-existent process) used during the Bush Administration, the FDA is simply fulfilling the mandate for the agency when it was created in 1938. That is: to provide the American public with SAFE and efficacious drugs to treat unmet medical need. 

Until recently, the FDA had been chronically under funded. And, because of this, the American public was forced to suffer through the Vioxx scandal, the heparin scare and the appearance on the market of many unapproved medical devices. These and other events that occurred over the past decade beg the question: “Should the American public’s safety be placed in jeopardy again simply because the Republican-controlled House is looking for ways to cut deficit spending?”

Unfortunately, the activity of anti-FDA lobbyists (funded mainly by US pharmaceutical and biotechnology companies) has been ramped up ever since the Democrats lost control of the House. And, since most Republicans believe that any government regulation whatsoever is too much regulation, it is easy to understand the House would vote to cut FDA funding. Nevertheless, insufficient funding will not allow the agency to hire the number of inspectors required to insure that drug manufacturing is conducted according to FDA-mandated regulatory guidelines. These activities are essential to insure the safety of the prescription drugs and medical devices sold on the US market.

According to FDA Current Good Manufacturing Practice (CGMP) guidelines, drug manufacturing plants for all approved drugs and devices are to be inspected every two years. Inspections are required for all manufacturing plants in the US as well as FDA-approved manufacturing facilities overseas. Because of ongoing shortages of FDA inspectors (and the emergence of numerous overseas manufacturing facilities), these inspections are typically conducted every three to five years rather than every two years! Clearly, this is not in the best safety interests of the American public.

A report published by the General Accounting Organization about the heparin scare of three years ago nicely sums up the issues.

“In its response to the heparin crisis, FDA took several actions related to its responsibility to protect the public health by ensuring the safety and security of the nation’s drug and medical device supplies. FDA increased its activities related to oversight of heparin firms by conducting inspections and investigations and monitoring heparin imports, and worked with drug and device manufacturers to recall contaminated products while ensuring that an adequate supply of uncontaminated heparin was available. With the help of external entities, FDA identified the unknown contaminant and developed tests to screen all heparin products. Additionally, the agency reached out to its international regulatory partners during the crisis. However, FDA faced some limitations in its efforts to inspect heparin firms in China and collaborate internationally, and the agency was unable to determine the original source of contamination.”

Interestingly, as today reported by the EyeonFDA blog, the U.S. House of Representatives Energy and Commerce Committee announced today that it was re-opening examination of the heparin contamination issue.  A letter was sent by the Chair of the Committee, Rep. Fred Upton (R-MI) as well as other members to FDA Commissioner Margaret Hamburg requesting that the agency supply all documents in connection with the heparin investigation from January 1, 2008 until present.  In its announcement, the Committee stated:

“It has been almost three years since the FDA linked deaths and serious allergic-type reactions of patients in the United States to supplies of heparin that came from the People’s Republic of China which was adulterated with overly sulfated chondroitin sulfate (OSCS). FDA officials believe this was an instance of economically motivated adulteration,” the members wrote. “However, neither the Chinese government nor the FDA has identified those responsible for the contamination or described how the heparin actually came to be contaminated.”

Mark Senak, author of  EyeonFDA blog aptly noted:

"It is certainly important in that any public health crisis involving the contamination of food or drugs be thoroughly investigated. But the investigating body can’t have it both ways. You can’t criticize an agency for not conducting inspections that are not funded by the same members of the same investigative body."

Is this any way to run a country?

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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Many life sciences company executives will tell you that getting US Food and Drug Administration (FDA) approval for their products has gotten tougher than it has been in the past 10 years or so. This shouldn’t come as a surprise to most BioJobBlog readers because there was almost know regulation of pharmaceutical, biotechnology and medical devices products during the eight years that Bush was in power. Seemingly, many life sciences companies have forgotten that FDA’s mission is to provide the American public with SAFE and efficacious drugs and devices; not to quickly approve products to bolster a company’s stock share price. That said, some medical devices companies, like their pharmaceutical and biotechnology cousins, have begun to complain about the FDA regulatory process for medical devices.

Historically, the regulatory challenges for getting medical devices approved have always been much lower than those for garnering approval of prescription drugs, vaccines and other biological products. Since 2000, the regulations guiding regulatory approval for medical devices had grown extremely lax.  For example, there has recently been a spate of recalls for certain previously-approved devices including cardiovascular stents, implantable cardiac devices and hip replacements.

The Obama administration is attempting to restore the rigor of the approval process and some medical devices companies are extremely unhappy about it. This renewed effort has forced some devices companies to eschew the lucrative US devices market entirely in favor of European and Asian markets; mainly because they were unable to garner FDA approval for their devices. Interestingly, the companies that are complaining the loudest are start ups rather than established medical devices companies. Their main complaints are the ever-increasing size of the clinical trials and length of time it takes to win regulatory approval for their products. Not surprisingly, these complaints are mostly driven by financial pressures at the start ups. Because of the recession, many of the venture capitalists who backed these companies have less money to invest and demand quicker and higher returns on their investments. Consequently, many of the star tups are under capitalized and simply don’t have the financial resources to stay in business and wait for FDA approval. While I understand their business pressures and urgency, winning FDA approval is suppose to be about safety and efficacy not about ROI. Maybe start up devices companies experiencing these difficulties ought to retool or reinvent their business plans!

To be clear, FDA approval rates for medical devices are down; 19 premarket approvals (PMA) were granted in 2010 as compared with 48 in 2000. Also, the average time to win 510(k) clearance (less stringent than PMA and used for most devices) rose to 116 days in 2008 from 97 days in 2002. There is no question that winning regulatory approval for new medical devices may seem to be getting tougher than in the recent past. But, if that helps to improve efficacy and patient safety than I don’t necessarily think that it is such a bad thing. And as Stephen Oesterle, MD senior vice president for medicine and technology at Medtronic (one of the world’s largest medical devices companies) aptly said in a recent NY Times article “The FDA is asking for larger trials, more thoughtful trials, all in the interest of the American public.”

Until next time...

Good Luck and Good Job Hunting!!!!

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According to a post on the Pharmalot Blog, Abbott Laboratories today announced that it will eliminate 1,900 jobs or six percent of its workforce. The company cited its thinning pipeline and the current challenging regulatory environment for the corporate reorganization and downsizing. In other words, we are having trouble getting our new drugs approved and we can’t afford to continue to pay people’s salaries and benefits who aren’t delivering for us. The Pharmalot post didn’t provide specifics on the layoffs.  However, Lisa Madden a Delta  Pharma Recruiter and BioCrowd member  sent me a message and told me that 1,000 of the layed off workers were onsite employees and the remaining 900 were sales reps

Like it or not, this is the new reality for life sciences R&D types, So, if I were a  graduate student or postdoc considering a career in the life sciences industry, I highly recommend a well developed and carefully thought out “Plan B.”

Until next time,

Good Luck and Good Job Hunting!!!!!

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The US Food and Drug Administration (FDA) is one of those federal agencies that everyone loves to hate. Sometimes I think the FDA is more vilified than the Internal Revenue Service! Nevertheless, FDA’s mission is to provide the American public with safe and efficacious foods, medicines and cosmetics. And, despite some highly publicized missteps like Vioxx and Avandia in recent years, the agency has done a great job since it was created in 1930.

Mark Senak, who writes the always interesting and incisive EyeonFDA blog, published a piece outlining what consumer may expect from FDA this year. The highlights on his list include:

• Draft guidance regarding the Internet and the use of social media
• Increased enforcement of social media in the life sciences industry
• Renewed interest on divining a legal, regulatory approval pathway for biosimilars

While none of these items is new, one can only hope that the agency can finally deliver on implementing these policies.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Biocon, one of India’s leading biopharmaceutical companies today announced that they have entered into a strategic global agreement for the worldwide commercialization of Biocon's biosimilar versions of Insulin and Insulin analog products:  Recombinant Human Insulin, Glargine, Aspart and Lispro.  

As part of the deal, Pfizer will have exclusive rights to commercialize these products globally, with certain exceptions, including co-exclusive rights for all of the products with Biocon in Germany, India and Malaysia.  

Biocon will continue to assume responsibility of clinical development, manufacture and regulatory approval of these products in various geographical regions and countries. Biocon's recombinant human insulin formulations are approved in 27 countries in developing markets, and commercialized in 23. Glargine’s first market was India where it was recently launched.  

Under the terms of the agreement, Pfizer will make upfront payments totaling $200 million.  Biocon is also eligible to receive additional development and regulatory milestone payments of up to $150 million and will receive additional payments linked to Pfizer's sales of its four Insulin biosimilar products across global markets.

While both Biocon and Pfizer are pushing the biosimilar aspect of the deal, it is important to point out that recombinant insulin are approved as “drugs” not biologics in the US. Consequently, these products are not true biosimilars and qualify for ANDA approval in the US. That said, it is intriguing that Pfizer is willing to be portrayed as a company that endorses the use of biosimilar medicines. Interestingly, however, there is still no regulatory approval for biosimilars in the US. And, despite public assertions to the contrary, most major pharmaceutical and big biotech companies are fiercely opposed to the introduction of biosimilars to the US. To that end, the current biosimilar legislation recently approved by Congress will prohibit the US introduction of biosimilars until approximately 2020.  

To date, more than 10 biosimilars have received marketing authorization in the EU and other Western markets. Europe approved a regulatory pathway for approval of biosimilars in 2004. Biosimilars have been sold in the so-call gray, unregulated markets in Asia, South America and elsewhere for the past decade.

Until next time...

Good Luck and Good Job Hunting (try India, they are hiring)

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Mark Senak, author of the EyeonFDA blog and a feisty social media advocate and enthusiast today reported that the long awaited FDA guidelines for the use of social media by life sciences companies might not be completed until 2012. 

Mark, who is attending the Food and Drug Law Institute Advertising and Promotion Conference being held in Washington, D.C. (#FDLIAP), based his timeline on remarks made by during presentations by a couple of FDA employees from the Division of Drug Marketing, Advertising and Communications (DDMAC). According to Mark:

“A process begun in 2009 may see a milestone in 2010 with issuance of draft guidance, followed by commentary and revision and the issuance of a final of what will be much guidance, apparently.  A three year "event.”

Further, Mark offered this assessment:

“The Internet and social media landscape moves at the speed of light.  Consider that Twitter only came into existence three years ago.  The development of each new platform introduces new questions into the equation.  Consider the frequency and with what depth and breadth consumers consult the Internet and social media for health care information, and we have a priority that demands something faster than a three year event.”

While I agree with Mark that FDA should act faster to develop guidelines for the use of social media for promotional and non-promotional purposes, the existing guidelines for print and broadcast media are sufficient for companies (which abide by DDMAC regulations) to launch successful social media campaigns. A great example of this is Novo Nordisk’s novel Twitter campaign entitled “Race with Insulin” in which professional race car driver Charlie Kimball tweets about his use of Novo’s insulin products.  Novo contends that the campaign helps to dispel the notion that persons with type I diabetes are limited in what they can do personally and professionally (it also helps to sell more insulin!)

Some industry insiders and bloggers think that Novo’s Twitter campaign may be inappropriate and ill-advised. Like it or not, the Race with Insulin Twitter campaign is compliant with existing DDMAC regulations and no different than many other direct-to-consumer advertising campaigns that use paid company spokespersons. Personally, I think that criticism of the campaign is nothing more than “sour grapes,” i.e. Novo figured it out before other pharma marketers did!

The lack of FDA guidance on the use of social media will certainly hinder and perhaps deter other pharma companies from leveraging the true power of social media. However, the old adage “where there is a will, there is way” is particularly apt for those companies that are seriously considering social media in the absence of any notable regulatory guidance on the subject.

Until next time....

Good Luck and Good Tweeting!!!!!!!!!!!!!

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Regulatory affairs professionals (RAP) are by far some of the most important employees at pharmaceutical, biotechnology and medical devices companies. Without RAPs, the requisite regulatory documents would not be filed and new drugs and devices would not be approved for marketing and sale.

Unlike other life sciences disciplines, a career in regulatory affairs is highly industry- specific and rarely taught at most academic institutions. In other words, if you are considering a career in regulatory affairs, don’t expect to get the training that you need in a PhD or postdoctoral training program; you will have to get it elsewhere!

A recent report compiled by the Regulatory Affairs Professionals Society (RAPS) entitled the “2010 Scope of Practice & Compensation Report for the Regulatory Profession” highlights the growing value and importance of regulatory affairs personnel in the life science industry. The report was compiled from the results of a survey of over 3000 regulatory affairs employees in 55 different countries.

The results show regulatory professionals are taking on a wider range of responsibilities, including becoming increasingly involved in critical business functions. Despite the economic downturn since the previous survey in 2008, overall compensation continued on an upward trend, although it grew at a slightly slower pace. The report also points to the continuing globalization of the profession, increased involvement with multiple product types and 6% higher compensation for professionals with Regulatory Affairs Certification (RAC).

Other important findings included in RAPS’ report include:

• US respondents with the RAC credential reported average total compensation that was 6% higher than their peers without the RAC. Forty-four percent of all survey respondents are RAC certified.
• The percentage of RACs is especially high in Canada (54%) and the US (47.2%). A little more than 21% of European-based respondents reported having the RAC.
• Overall, about 34% of respondents said they were involved in comparative effectiveness research and reimbursement, up from 23% in 2008.
• Half of all senior-level respondents reported being involved in government affairs.
• About 70% of respondents said their work is either global in nature or focused on multiple regions of the world.
• More than 68% reported involvement with multiple product types, a 6.3% increase from 2008.
• Overall, just 5.7% reported working with biosimilars, a product category that was added to the survey for the first time, but 22% of respondents from Asia and Latin America reported involvement with biosimilars.
• Nearly all respondents have a university degree; many have advanced degrees. The percentage of respondents whose highest degree earned is a master’s is up to 37.5%, a 17.2% increase from 2008. The percentage of respondents with MBAs and postgraduate certificates also increased.
• Respondents reported significant professional experience outside regulatory, an indication that many have transitioned into regulatory from another, related field. Most have educational backgrounds in life sciences, clinical sciences or engineering.

If this sounds like a career option for you, I highly recommend that you visit the RAPS website. If you already have a PhD, masters’ degree or even a bachelor’s degree, getting RAC certification will certainly increase the likelihood of landing a regulatory affairs job in the life sciences industry. One caveat: the RAPS courses are not inexpensive and may require a substantial amount of time in order to pass the RAC examination.

If the RAC route doesn’t seem realistic or reasonable, try getting an entry-level job with the US Food and Drug Administration. Being an ex-agency employee will guarantee employment in the life sciences industry until you retire!

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

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After weeks of bad press regarding manufacturing problems and a narrowly-averted proxy contest, Genzyme today announced that its experimental drug for multiple sclerosis, alemtuzumab, received fast track approval status from the US Food and Drug Administration (FDA).

Alemtuzumab (marketed as Campath, MabCampath or Campath-1H) is a monoclonal antibody used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma. Alemtuzumab targets CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes are derived.

For those of you who may not know, FDA grants fast track status to experimental drug candidates that are designed to treat serious diseases, and may be superior to current treatments. Fast track status includes an expedited review and additional collaboration between Genzyme and the and the agency and allows Genzyme to submit portions of the alemtuzumab BLA as they are completed, rather than waiting to submit the completed application when testing is finished.

Until next time..

Good Luck and Good Job Hunting!!!

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The conversation about follow-on biologics became extremely muted after passage of the US Healthcare Reform Act which included a 12 year period of data exclusivity for innovator company products. This provision inhibits biosimilar manufacturers from introducing generic versions of branded biologics for 12 years from the date the US Food and Drug Administration granted a license for the branded product. While this may effectively limit activity in the follow-on biologics space in the US, it didn’t stop Merck from launching its BioVentures Division (dedicated to follow-on biologics development) almost two years ago.

At the time of the announcement Merck executives in charge of the BioVentures Division divulged that its first product would be a PEGylated version of Amgen’s anemia drug Epogen (EPO). Unfortunately, a PEGylated version of EPO doesn’t qualify as a follow-on biologics because PEGylated proteins are considered new molecular entities (NMEs) by regulatory agencies. Nevertheless, Merck also said it would develop other follow-on products and that its efforts would be based primarily on the proprietary humanized yeast biomanufacturing platform it acquired after purchasing Glycofi, a New Hampshire-based biopharmaceutical company that developed the technology. Interestingly, two weeks ago Merck announced that it was abandoning the PEGylated-EPO product that it mentioned two years ago at the BioVentures kick off press conference.

It isn’t clear whether or not Merck jettisoned the project because of patent infringement litigation, regulatory concerns or possibly because of the increasingly fierce competition in the EPO space. Another possibility is that pharmaceutical companies have finally realized that biologically-active proteins are costly to manufacture and have limited therapeutic applicability as compared with monoclonal antibodies (MAbs) which are taking the biopharmaceutical industry by storm. At last count, there were over 300 MAbs in various phases of pre-clinical development with and about 125 in late stage clinical development. Last week, Teva and Lonza announced plans to develop a biosimilar version of Roche’s anti-inflammatory and cancer MAb Rituxan (rituximab)—kicking off a new era in the biosimilar industry.

For those of you who are unfamiliar with or remain interested in the follow-on biologics debate, I came across a nice PowerPoint presentation given by Teruhide Yamaguchi at the Division of Biological Chemistry and Biologicals at the National Institutes of Health.

Quality Safety and Efficacy of Follow-on Biologics

Until next time...

Good Luck and Good Job Hunting!!!!!!

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Mark Senak, author of the incisive EyeonFDA blog and de facto watchdog of all things social media in the life sciences, has assiduously been tracking company and trade organization input to the docket for the Part 15 meeting on medical product promotion and the internet and social media. To date, according to Mark, the following companies and trade groups have officially submitted their comments and viewpoints to the docket                                                                                              

1. Covidien
2. Johnson & Johnson
3. Bayer Healthcare
4. Sanofi Aventis
5. AstraZeneca
6. Eli Lilly
7. Medtronic
8. Pfizer
9. Abbott
10. Novartis
11. Genentech
12. Sepracor
13. Merck
14. Medtronic
15. Biotechnology Industry Organization (BIO)
16. PhRMA
17. National Organization for Rare Disorders (NORD)

As you may recall, industry input was lacking and surprisingly absent from the public hearings held by FDA on the topic earlier this year. While news analysts and bloggers were incredulous that companies didn’t actively participate in the earlier public hearings, this behavior is typical of life sciences companies that like to do things quietly and, when possible, behind closed doors. Ironically, this lack of transparency and inclination to secrecy is the antithesis of social media. Is it any wonder then, that life sciences companies are suspicious and wary of the impact that social media may have on their ability to conduct business?

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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For the past decade or more multiple drug resistant strains of bacteria such as methicillin resistant Staphylococcus aureus (MRSA), enterococci and other Gram positive cocci have been highlighted and showcased in the medical and lay press. While the incidence of infections caused by MRSA and other Gram positive cocci has steadily risen, antibacterial drug discovery experts have long known that the greatest disease threat in the future will be from emerging multiple antibiotic resistant strains of Gram negative bacteria including Acinetobacter baumannii, Klebsiella pneumoniae, Serratia marcescens and Pseudomonas aeruginosa.

Last Spring, in an interview that I conducted with Barry Eisenstein, MD, Senior Vice President of Scientific Affairs at Cubist Pharmaceuticals and an antibacterial drug discovery expert, he indicated that there are currently no drugs in development to treat infections caused by antibiotic resistant Gram negative bacteria. He warned that this, coupled with the loss of interest in antibiotic development by large pharmaceutical companies, will cause infections caused by multiple drug resistant Gram negative bacteria to become a serious unmet medical need in the not so distant future. The appearance of an article in the New York Times this past Saturday chronicling the rise of infections caused by antibiotic resistant Gram negative bacterial suggests that the not so distant future may have already arrived! For the record: would newspaper and television reporters please refrain from identifying bacteria as “germs.” It is an anachronistic term which was coined in the 19^th century before bacteria and viruses were conclusively identified as the cause of most infectious diseases.

Despite the media hype about antibiotic resistant Gram positive bacteria, a variety of new drugs have been developed to treat infections caused by these bacteria. Interestingly, because of greater public awareness about MRSA infections and improved hospital infection control and surveillance programs, the incidence of disease caused by MRSA and other Gram positive bacteria is finally beginning to wane. Unfortunately, the same is not true for infections caused by antibiotic resistance Gram negative bacteria.

For those of you who may not know, the cell wall architecture of Gram negative bacteria (and a multitude of antibiotic resistance mechanisms) makes it much more difficult and costly to develop new antibiotics to treat Gram negative infections. Consequently, research in this area has been largely ignored for the past 15 years or so. This means that in the future the morbidity and mortality associated with infections caused by antibiotic resistant Gram negative bacteria is certain to rise. With this in mind, persons at the greatest risk of developing these infections include patients in hospitals and long term care facilities and individuals receiving implantable medical devices.

Because most large pharmaceutical companies abandoned antibiotic drug discovery in the mid to late 1990s, it is unlikely that new Gram negative antibiotics will come from the pharmaceutical sector. While there are several small biopharmaceutical start ups working on antibiotics for Gram negative bacteria (KaloBios Pharmaceuticals, Calixa Therapeutics and Novexel) the increasing regulatory scrutiny and rising development costs suggests that these companies may have trouble bringing new antibiotics to market. Sadly, this places the onus of new Gram negative antibiotic discovery squarely on the shoulders of the US government. To that end, as much as it pains me to say this, it will likely take the death of government official or family member before sufficient resources are allocated to address this rapidly growing unmet medical need. Maybe the Obama Administration ought to think about allocating stimulus monies to begin to address the problem!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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Mark Senak, social media enthusiast and author of the EyeonFDA blog, raised the question on his blog today as to whether or not the US Food and Drug Administration (FDA) ought to have a fan page on Facebook: the ever expanding, ubiquitous social media platform. He aptly points out that FDA has already created a channel on YouTube and has a twitter account. So, why not a fan page on Facebook, he asked.

While Mark and I agree on most things, I am not convinced that having an FDA fan page on Facebook would make a difference in the way in which FDA communicates with the American public. FDA is already behind on the social media curve and, as the FDA public hearings held late last year suggest, the agency is struggling with formulating regulatory guidelines for its use by drug and devices manufacturers. Might not creating a FDA fan page on Facebook be the proverbial straw that broke the camel’s (agency) back? 

Perhaps I am overreacting to the whole Facebook phenomenon and grossly under estimating the agency’s capabilities. But I simply don’t get Facebook!  At best, it is overwhelming, difficult to navigate and seemingly cluttered mindless chatter and people engaging in Mafia wars. There is no question that a fan page would increase FDA’s exposure and its “hipness quotient” but to what end? The agency already has trouble maintaining and managing its existing web assets (have you ever tried finding information at FDA.gov?). Adding a new website would simply mean more work for overworked and underpaid government employee who seemingly play by different rules than the outside world.

Don’t get me wrong. I am an avid social media enthusiast who believes that persons who engage in social media must be “all in” to be effective. Having said that, I believe that the agency would be better served if it works to improve the navigability and accessibility to information on its existing web assets. There is no question that building an agency fan page on Facebook may convince Americans that FDA gets “the whole social media thing.” But if the fan page doesn’t provide Americans with relevant and useful scientific, medical and regulatory information, then adding a FDA fan page to Facebook will do little more than increasing the heft of an already bloated social media platform whose utility and effectiveness is already beginning to wane.

In my experience, building a website or fan page is the easy part; continuing to populate the pages and sites with useful, meaningful and temporally-relevant content is the difficult part!

Hat tip to Mark for starting the conversation!

Until next time...

Good Luck and Good Job Hunting!!!!!

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As many of you already know, I talk to a lot of graduate students and postdoctoral fellows who are disillusioned with the prospect of remaining in the laboratory for the rest of their lives. Frequently, students mention regulatory affairs as an alternate career option and ask me what type of training and skills are required to transit into a regulatory career. Unfortunately, regulatory affairs is an industry specific career and regulatory affairs training programs with the possible exceptions of the courses offered by the Regulatory Affairs Professionals Society (RAPS) and the Drug Information Association (DIA) (which can be costly) are not readily accessible to graduate students and postdoctoral fellows. Consequently, I recommend that PhD-trained scientists who are interested in regulatory affairs check out employment opportunities at the US Food and Drug Administration (FDA). This is because there is no better place than FDA to learn the “ins and outs” of regulatory affairs!

Until recently, jobs, fellowships and training programs at the agency were scarce. However, while reading an industry trade magazine I came across an ad (posted below) announcing fellowship opportunities for PhD level life scientists, healthcare professionals, pharmacists and even engineers(although they only need a bachelors degree to be eligible.

This is an opportunity for those interested in a regulatory affairs career to give it a shot! For more info visiting the agency’s website

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Theravance Inc. announced Thursday US Food and Drug Administration (FDA) regulators are not satisfied with new data on its infection drug candidate telavancin (Vibativ), and indicated that further clinical studies may be required to win marketing approval.

Approval of Vibativ has been held up for three years, as the Food and Drug Administration asked the company for more data about the drug, and about studies Theravance has conducted in support of its application to the FDA. Theravance said Thursday the FDA told it the data so far is not enough to prove Vibativ works.

The agency will not begin a formal review of the drug until it says it is satisfied with the data.

Vibativ, or telavancin, is an injection intended to treat complicated or drug-resistant infections like methicillin-resistant Staphylococcus aureus (MRSA). Theravance submitted an NDA to FDA for review in December 2006.

According to Theravance, the FDA did not say Theravance would have to run a new clinical trial to gain approval, but it suggested a design for such a study. Company representative said that they do not know what the FDA wants and said the agency did not provide any suggestions about the goals of the proposed study, how many patients should be included, or even how many studies might be required ( I guess it may be time for a meeting to discuss these issues?).

In response to the FDA’s previous requests for more data on telavancin, Theravance said it combined data from two late stage trials of Vibativ, with the goal of making the data more comparable. It said the FDA told it that the data is equal to only one study. Two late-stage trials are often required to win approval.

Theravance said it has tested Vibativ on about 1,500 patients and said its studies are the largest that have been submitted in support of a new drug of its type.

Regulatory concerns about Vibativ include a risk of birth defects when it is used in pregnant women, manufacturing issues, and questions about data comparing the drug to vancomycin, which is the most powerful antibiotic currently on the market.

While getting new antibiotics are the market are important, clinical studies must be carefully designed with appropriate endpoint to address potential safety and efficacy issues. Although Theravance believes that it has done that, the agency, as always, will be the final arbiter of a decision on telavancin.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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As Jonathan Richman, author of the Dose of Digital blog focused on pharmaceutical marketing aptly put it, its time to “stop talking about social media.” “To recap, in 2009 we demanded the FDA call a hearing to discuss social media…and they did! We wrote and read hundreds, if not thousands, of articles on social media. We transformed (read: hijacked) every digital marketing conference into a social media conference. We launched a ton of social media programs even if they represent a conservative start.”

While I am still an ardent social media enthusiast and supporter, I agree with Jonathan that it may be time to sit back, relax and reflect a little bit until FDA enlightens us with their first round of guidance on social media and the life sciences industry. Having said that, I am certain that the agency’s first iteration will provide us bloggers with sufficient fodder to write about and ignite round 2 of the discussion. In the meantime, @Skypen of Ignite Health graciously created a website called Everything About the FDA, Internet & Social Media that provides updates, commentary and even tweets (#FDASM) about FDA progress or lack thereof.

I think that social media has a role to play in the life sciences industry. However, the role has yet to be defined mostly because of the lack of regulatory guidance in the area.

Until next time...

Good Luck and Good Tweeting!!!!!!!!!

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Jonathan Richman, author of the Dose of Digital Blog, got it exactly right in today’s post  entitled “Patients WILL Have the Final Say on Pharma Social Media” He was spot on with his conclusion that while social media pundits and patient advocacy groups can push FDA to attempt to provide guidance on the use of social media, in the end, it will be patients (customers) not regulators who determine whether or not pharma will incorporate social media into future business models. Recently, it has been pointed out (on Twitter of course) that patient advocacy groups were under represented at the recent public FDA hearings on social media. While this is true, it likely will have little bearing on the regulatory guidance ultimately issued by the agency. This is because public input is generally not used to fundamentally shape regulatory guidance or policies but to fine tune them! The agency generally has a regulatory framework in mind before it conducts public hearing to collect stakeholder input and comments.

As I mentioned in previous posts, FDA intentionally crafts regulations and guidelines that are subject to interpretation because they are meant to serve as the minimum regulatory requirements and standards that must be met to insure drug and device safety and efficacy. While this is not ideal for many corporate regulatory affairs professionals, it is necessary because the agency simply cannot provide specific or custom-designed guidance to the plethora of drug and device manufactures that it oversees.  In other words, the regulations that FDA crafts are meant to serve as general regulatory frameworks not clearly defined, company-specific rules and regulations. Companies that struggle with interpretation of FDA regulations are encouraged to meet with FDA regulators for guidance and clarification. More importantly, while FDA is charged with insuring the safety and efficacy of drugs and devices, the agency has very little control over how companies choose to interact with patients, customers and stakeholders. For example, companies ARE NOT required to submit direct-to-consumer (DTC) ads, marketing and advertising campaigns or other promotional materials for FDA review. This means that drug and device manufacturers have enormous flexibility in choosing how to market, advertise and promote approved products. FDA regulators only get involved when the agency is alerted to the possibility that certain ads or promotional materials may contain inappropriate, misleading or inaccurate medical information or claims. When a company is “snagged” by FDA for suspect marketing practices, the agency generally imposes mandatory regulatory review (for a defined period of time) of all subsequent DTC and promotional campaigns developed by the transgressor. To that end, the lack of patient advocacy testimony at the recent FDA hearings on social media should have little or no impact on the guidance that FDA ultimately issues.

While the much anticipated guidance ought to provide a regulatory framework for companies that choose to use social media, it can not “force” drug and device manufacturers to adopt or use it. This will be a corporate decision that will likely be made by legal, regulatory and marketing pharmaceutical executives. Finally, as Jonathan rightly points out, the needs and demands of patients will ultimately determine whether or not a drug or device manufacturer implements a social media strategy. And, not surprisingly, this decision will likely be based on drug sales and business outcomes rather than a need for patient education or public safety. Because—at the end of the day—business is business!

Hat tip to Jonathan!

Until next time...

Good Luck and Good Tweeting!!!!!!!!!

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Earlier this week, Mark Senak who writes the EyeonFDA blog, offered his insights and analysis of pharma’s relationship with Twitter. Today, he tackled YouTube and Pharma. While YouTube has been around a lot longer than Twitter, pharma’s use (with the exception of Johnson and Johnson, Sanofi-Aventis and Tibotec) of the popular video-sharing site has been extremely limited despite the ability of the entity that posts the video to eliminate or regulate the ability of users to leave and share comments after viewing it. 

I suspect that the industry’s reluctance to use YouTube may be related to the lack of regulatory guidance for this medium. Nevertheless, I don’t completely understand why drug makers have chosen not to use the widely popular video site to increase patient awareness about certain medical conditions or to promote patient wellness. These types of videos would likely be appreciated by the public and quite possibly help to repair tarnished image of the pharmaceutical industry held by many consumers and stakeholders.

Hat tip to Mark!

Until next time....

Good Luck and Good Viewing!!!!!

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Mark Senak who writes the EyeonFDA blog has compiled a list of the life sciences companies that presently have a Twitter account and use it. While there are only 12 companies on the list, he provides a nice commentary on their use and makes some recommendations for improvement.

Although I am a staunch supporter of the use of social media in the life sciences, it appears to me that the discussion about its use has been somewhat muted since the FDA convened a public hearing on the topic last month. I suspect that many of the companies and stakeholders who participated in the discussion prior to the FDA meeting are presently in “wait and see” mode. However, don’t be surprised if the social media guidance issued by FDA is lacking and excruciatingly wanting!!!! For those of you who may not be familiar with the ways in which the agency operates, its regulators tend to craft guidance and regulation that are broad, loosely defined and open to interpretation. The agency intentionally crafts its guidance and regulations this way because it doesn’t want its rules and regulations to be “literally interpreted” by companies and other stakeholders. Generally speaking, its regulations represent the “minimum” requirements that must be met in order to insure regulatory compliance. In other words, there is no upper limit on what companies can do to insure compliance but there certainly is a minimum requirement that must be met to avoid regulatory sanctions and penalties. As one lawyer who used to work for the agency shared with me recently, “FDA crafts the regulations but it is left to the companies and courts to interpret them.”

Most of the current discussions about social media and the life sciences industry primarily focus on its use as marketing and promotional vehicle. And, as many of you may already know, FDA isn’t exactly keen or pleased with the current marketing and advertising strategies and practices utilized by a sizeable number of life sciences companies. Perhaps a shift away from marketing and advertising discussions to more regulatory-friendly and practical applications like clinical trials recruitment and public outreach may lead to a more rapid uptake of social media by FDA and life sciences companies? Just sayin’

Until next time...

Good Luck and Good Tweeting!!!!

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Mark Senak, social media advocate and author of the EyeonFDA blog, has been spot on with his commentary on the recent public hearings held by FDA to unravel the social media conundrum facing the life sciences industry. Despite its good intentions, the agency is intent on applying an anachronistic method of developing guidance (designed for processes that undergo incremental changes) for a technology that changes rapidly and is ill-defined. In other words, they are trying to force a square peg into a round hole—it simply won't work!

As duly noted by Mark, FDA seems focused on inconsequential and banal issues like fair balance. The whole concept of fair balance has never been clearly defined and companies continually do everything possible to test the agency's resolve on the issue by finding new ways to push the envelope.Therefore, it makes no sense to me that the agency would choose to focus on the question of fair balance and social media when more pressing issues like adverse event reporting, responsibility for site content(when tools like Google Sidewiki are available to Internet users ) and off-label promotion of approved drugs and devices. As Mark rightly points out, is anybody really going to read the fine print about side effects and adverse events associated with a drug when they click through on an ad that promotes a medicine that might help them? Do people really read the product insert forms that accompany all prescription drugs?

Don't get me wrong. I am not trying to play down the importance of fair balance but DTC advertising is old hat and most experts agree that it really doesn't work well to sell prescription drugs. To that end, I think FDA needs to throw out the old play book and create a new one for social media. Unlike previous regulations, the ones that will guide social media need to be flexible and adaptive enough to accommodate the rapidly changing social media landscape. Nobody said it was going to be easy but that is why FDA employees get paid the big bucks!

Until next time....

Good luck and Happy Thanksgiving!!!!!!!!

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Unlike many of my social media colleagues, I’m not attending the FDA public hearing taking place in Washington, D.C today (Friday the 13^th oh my). I wanted to attend and actually testify but I didn’t understand how the process works and blew my opportunity. However, I will be prepared for rounds 2 and 3 and beyond. I can assure you that this will not be the last public meeting organized by the agency to develop guidance for the use of social media in pharmaceutical marketing and advertising. 

The brouhaha over social media and its use in the life sciences industry is purportedly taking place because of the lack of regulatory guidance on the topic. While I agree that FDA needs to craft a reasonable regulatory policy for the use of social media for promotional purposes, the discussion taking place has little to do with the medium and everything to do with the fair balance of ads that are used to promote drug sales. For those of you who may not know, fair balance (in regulatory parlance) means that drug manufacturers are required to fully disclose in print, television, radio and internet ads the benefits as well as the side effects and risks associated with a specific product. Unfortunately, too often, drug makers tend to promote the therapeutic benefits of a drug but downplay its side effects and risks. This isn’t surprising because drug makers, like other for-profit companies, must sell as much product as possible to generate sufficient revenues to remain profitable.  And, as we all know, consumers and physicians are more likely to use or prescribe drugs that have therapeutic benefits without many side effects or risks.

Since the inception of direct-to-consumer advertising, FDA and drug makers have been playing a cat-and mouse-game with the fair balance issue. Most drug makers understand the “balance” that FDA requires for traditional promotional ads, but rather than abide by the rules, many choose to determine how far they can bend the rules before they appear on FDA’s radar. Therefore, it should come as no surprise that drug companies have adopted the same strategy when it comes to Internet advertising and search result ads. To be fair, FDA hasn’t crafted any definitive guidance on Internet advertising or search ad fair balance requirements. However, rather than apply what they have learned over the years about fair balance in print and television advertising, many drug makers chose to ignore fair balance requirements for Internet advertising simply because there are no written regulations or rules. To that end, 14 pharmaceutical and biotechnology companies recently received warning letters about their misuse of promotional drug ads that appeared with Google search results. FDA cited the lack of fair balance in the search ads as reasons for the warning letters. By issuing identical warning letters to 14 different drug companies, the agency was essentially saying “c’mon guys, who are you trying to kid—you ought to know better by now!”

Unfortunately, even when there are regulations, many companies spend hundreds of millions of dollars to look for deficiencies and loopholes that can be exploited to increase and improve drug sales. Therefore, I contend, that regardless of the social media guidance that FDA ultimately issues, drug and device manufacturers will continue to look for work arounds to regulations that they perceive hinder product sales.  

Social media is all about transparency, accessibility and communications between participants. The guidance that FDA issues about the use of social media in the life sciences industry will likely be circumspect and open to interpretation as it usually is. As one FDA legal expert explained to me, “FDA crafts the laws but it is up to the judiciary  to interpret how they ought to be applied.”

I suspect little will change until drug manufacturers realize that full disclosure and transparency, not half-truths and opaqueness, will ultimately lead to improved drug sales in the future.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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It is amazing the things you learn if you pay attention from time to time.  While attending a meeting on e-healthcare last week in Philadelphia I learned that according to the American public the pharmaceutical industry is less popular than the banking industry. This was startling to me given that the recent financial collapse was caused almost entirely by the banking industry.  That the pharmaceutical industry is more reviled than the banking industry suggests that life sciences company have a bit of PR work to do.  But, not to worry, people still hate the oil industry more than the pharmaceutical industry.

On another note, the US FDA decided to raise the cost of regulatory filings for fiscal year 2010.  The cost of filing an application with clinical data is $1.4 million (up from $ 1.2 million in FY 2009); $702, 750 for an application not requiring clinical data or a supplement requiring clinical data (up from $623,600 in 2009) and 457,200 as compared with $425,000 in FY 2009 for an establishment fee (for facilities where drugs are made).* 

I guess the agency figures that pharma can handle the increases despite poor public image and an ongoing recession.

* AAPS News Magazine, Oct-Nov '09

Until next time...

Good Luck and Good Job Hunting

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For the past several weeks, the EyeonFDA blog has been reporting on the possible regulatory impact of Google’s Sidewiki on life sciences companies. For those of you who may not be familiar with Sidewiki  (released in late September) it is a new feature of the Google toolbar which can turn a static web 1.0 website into an interactive web 2.0 experience by allowing website visitors to leave comments behind.

When you use side-wiki, you have the ability to leave your comments and associate them with a website whether or not the website owner has enabled commenting.  Since the comments are maintained by Google, there is no direct relationship with the website.  Basically, anybody who visits a website that has Sidewiki enabled can say or comment on whatever they like and immortalize it (until Google removes it) for the entire world to see. Apparently, this doesn’t sit well with many website owners and Google purportedly recently release code to disable Sidewiki at websites that don’t want to support it. However, it isn’t clear how robust the anti-sidewiki code is!

While I haven’t formulated an opinion on Side Wiki yet (mostly because it isn’t that interesting to me), it does represent a regulatory dilemma for life sciences companies with marketed drugs and devices. According to today’s EyeonFDA post “If someone writes of an adverse event on a Sidewiki, or promotes an off-label use, it is now on the company's home page.  Is the company under a duty to monitor and correct such misinformation or if they do, do they incur liability for doing so?  It is a conundrum - and there is no insight apparent from the FDA on the matter.” Further, most life sciences companies have yet to craft a legal or regulatory policy for Sidewiki usage. 

EyeonFDA has been assiduously monitoring life sciences company websites for the appearance of Sidewiki. To date EyeonFDA has found it on the following company websites:

1. Abbott
2. Amgen
3. AstraZeneca
4. Bayer
5. Baxter
6. Bristol-Myers Squibb
7. GSK
8. Johnson & Johnson
9. Lilly
10. Novartis
11. Novo Nordisk
12. Pfizer
13. Roche
14. Sanofi-Aventis
15. Takeda

While Google would like everyone to believe that Sidewiki is taking the Internet by storm and spreading like the H1N1 virus, a show of hands at yesterdays e-Patient Connections 2009 meeting in Philly, which was attended by many computer geeks and social media enthusiasts, revealed that about4 out of about 150 had heard of it! Nevertheless, it is out there and life sciences companies would be well advised to formulate internal legal and regulatory guidelines despite the fact that FDA hasn’t issued any guidance on its use.

P.S. Shortly after I posted this, @pharmaguy alerted me to an article that appeared on the today's online PharmaExec.com entitled "SideWiki: What's Pharma To Do"?

Until next time...

Good Luck and Good Commenting

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The answer to this question is not yet! However, the The Wall Street Journal recently reported that 64% of U.S. physicians are using smart phones (up 50% from two years ago) and increasingly are relying on them to find medical information, manage patients and transmitting clinical data. To that end, a post at the Medical Translation Insights blog discusses the changing role of smart phones in healthcare and the regulatory challenges they may face if classified as medical devices.

 When Cell Phones Become Medical Devices

The definition of "medical device" is shifting, quickly and dramatically.  The revised MDD now includes stand-alone software in the definition. In other words,if software has a medical purpose, it probably can/must be CE marked. And smart phones are quickly becoming the conduit of choice for collecting and researching, disseminating, and evaluating clinical data.

As Bob on Medical Device Software points out, its unique user interface, display, and broadband capabilities make the Apple iPhone a particularly attractive platform for medical applications. For example, the AirStrip OBSERVER suite of applications is custom-designed for the iPhone, makes some components available for download at the Apple App Store, and received FDA clearance for some modalities.

While most medical apps fall into the reference category, applications are getting more sophisticated and are taking advantage of the devices networking abilities. A trio of applications developed by researchers at the University of Utah aptly demonstrate these advances. Another factor is the appeal and widespread use of these devices. The Wall Street Journal reports [login required] today that 64% of U.S. physicians are using smart phones.

There are several big questions and unknowns hanging over these developments: First and foremost, there is the question of data security. As quoted in the same WSJ article, Deborah Peel of Patient Privacy Rights worries that "the vast majority of health information technology has not been designed to ensure that patients control access to that data and use of that data". So, paradoxically, the more ways that doctors can access patients' records, the more their confidentiality is threatened.

Second, what is the quality threshold for smart phone applications? Just because something is on the iPhone doesn't mean it's necessarily a quality application

Regulators around the world are bound to tackle these questions. FDA, for instance, is already looking at this issue and sooner or later will regulate certain phones. It's certainly not the end of the world to be classified as a medical device, but verification and validation of these applications won't be easy.

 As these applications get developed and become part of a networked medical device, language will also become an issue again. Translation service providers will need to become familiar with smart phone development and localization issues and support consistently translated content across multiple platforms and media.

Until next time...

Good Luck and Good Job Hunting

ForeignExchange Translations provides specialized language services to pharmaceutical and medical device companies

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My son, who is a 9^th grader, was recently asked to write an essay for his social studies class about the application of Machiavellian principles to modern day rulers and governments. One of Machiavelli’s ideas that he chose to write about was the notion that a good ruler or government must do it’s very best to insure the safety and health of its subjects or constituents. While this may seem altruistic or philanthropic don’t be fooled—workers who are afraid, unhealthy or regularly ill aren’t productive and can threaten the economic well-being and stability of a society. In any event, he asked me to help with a modern day example of how safety can be reconciled with the Machiavellian principle; “the end justifies the means.” As an infectious disease professional, I quickly realized that mandatory vaccination of newborns and school-aged children against viral and bacterial diseases is a great example.

Prior to the development and subsequent worldwide use of childhood vaccines, epidemics and pandemics of smallpox, measles, polio, diphtheria and other serious diseases routinely ravaged the planet with impunity. During the recurring outbreaks, large numbers of people became ill, and while some sustained life-long debilitating injuries, many others suffered long, painful and excruciating deaths. The recognition that often devastating and regularly occurring outbreaks and epidemics could threaten the well being— and possibly destabilize monarchies and democratically elected governments—  led to the development of  20^th century vaccines against many bacterial and viral childhood diseases. However, it is important to note, while most vaccines are safe and offer protection for many individuals (typically 90% or higher), a small percentage (usually 1% to 5%) of those vaccinated, may experience side effects ranging from mild to severe and possibly life threatening. I believe that vaccination is a polemic for the “ends justify the means” principle because while some vaccinated individual may suffer serious side effects or death greater numbers will benefit from the protection and safety afforded by most vaccines. In other words, governments must be willing to risk harm and possibly death to some of its citizens to insure the productivity, well being and ultimately the safety of the majority.

Despite the medical and health benefits of vaccines, the anti-vaccine movement in the US has steadily been gaining strength of late. Vaccine opponents’ fears have been stoked and promulgated by bogus clinical data offered by fraudulent scientists (which have subsequently been discredited and refuted) and media outlets seeking sensational stories to sell magazines and newspapers. Last week, a 14 year old British girl died shortly after being vaccinated with Cervarix, GlaxoSmithKline’s (GSK) cervical cancer vaccine. This story was quickly pounced upon by the British tabloids and widely circulated.  In the end, the safety of the Cervarix—a vaccine administered to 1.8 million girls without a single death similar to the one that had occurred—became suspect. Almost immediately, anti-vaccine advocates publicized this unfortunate incident as another other reason why parents shouldn’t vaccinate their children. The girl’s death prompted UK officials to immediately suspend all nationwide Cervarix vaccinations; even though an autopsy hadn’t been performed to determine the actual cause of the girl’s death. After an autopsy was finally performed, British health officials announced that the girl had a large cardiac tumor that had infiltrated one of her lungs and that it was likely cancer not Cervarix that caused her death. Unfortunately, the media’s feeding frenzy fanned by the anti-vaccine lobby’s loud voice may have cost GSK US FDA approval of  Cervarix—a product approved and safely used in over 100 countries! 

About three weeks prior to the British girl’s death, an FDA advisory committee unanimously recommended approval of Cervarix. Generally, the agency follows recommendations of its advisory committees. Ironically, the girl’s death occurred several day’s prior to an FDA decision on whether or not to approve Cervarix. Much to the surprise of many industry experts, this past Tuesday, FDA delayed its decision on Cervarix’s approval. FDA spokespeople claimed that the girl’s death had no bearing on its decision to delay Cervarix’s approval (if you believe that, would any of you be interested in some land in Florida?).

It is no secret that GSK has struggled to get Cervarix approved in the US —a decision on its approval has been delayed three times over the past several years. In the interim, the company has managed to successfully address all of the agency’s concerns over Cervarix’s safety and efficacy.

FDA’s decision to delay Cervarix’s approval is great news and something of a victory for Merck, the manufacturer of Gardasil— the ONLY cervical cancer vaccine approved in the US and Cervarix’s main competitor. Failure of Cervarix to win FDA approval will undoubtedly help Merck to bolster Gardasil sales and help it maintain its stranglehold on the US anti-cervical cancer market for the foreseeable future!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

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A spokesperson at the US Food and Drug Administration (FDA) announced today that it decided to delay its decision whether or not to approve GlaxoSmithKline’s (GSK) anti-cervical cancer vaccine Cervarix. The agency was scheduled to announce its ruling Tuesday on whether to approve Cervarix, but a GSK spokeswoman said the review will continue. An agency spokesperson failed to disclose any reasons for the delay because FDA doesn’t comment on ongoing product reviews. This is the second regulatory delay for Cervarix in the past two years.

The delay comes as something of a surprise because earlier this Earlier this month, an outside panel of health experts voted that Cervarix appears safe and effective for girls and women ages 10 to 25. The FDA is not required to follow the group's advice, though it usually does. Cervarix already is approved in nearly 100 other countries, but has been delayed in the U.S. since 2007, when the FDA said it needed additional safety data.

An approval from FDA would allow London-based GSK to compete against Merck's blockbuster vaccine Gardasil, which has been on the US market following its approval in 2006. Based on all available published reports, Cervarix has a similar safety profile and efficacy profile as compared with Gardasil.

One of the issues with Cervarix may be the adjuvant use to formulate the vaccine to bolster anti-HPV immunity. While Merck's Gardasil uses an aluminum salt adjuvant, Cervarix uses a novel adjuvant known as AS04. The agency’s lack of familiarity with AS04 and possible concerns about its safety may be what is delaying the Cervarix decision. 

Stay tuned for further details!

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Pharmaceutical,biotechnology and other companies that sell prescription drugs and devices are deathly afraid of adverse events (AEs) associated with their products. For those of you who may not know, companies with approved prescription drugs and medical devices are required to track and report any adverse events associated with their products to regulatory agencies like the US Food and Drug Administration (FDA). If FDA receives enough AE complaints about a product, the agency will investigate to determine whether or not there may be efficacy, safety or tolerability issues with it. And, if FDA thinks that the AEs are legitimate, it may ask a company to conduct Phase IV clinical trials with the product in question or require that changes be made to the product’s label. Not surprisingly, these outcomes can be time consuming and perhaps more importantly, costly. Label changes—especially for blockbuster products—frequently lead to changes in physician prescribing habits which can translate into a loss of revenue. Despite the fact that ALL drugs exhibit AEs, many companies falsely cling to the hope that there will be few, if any, AEs reported for their products.

While drug makers are very familiar with the range of possible AEs associated with their drugs—all AEs for a drug are identified and reported during clinical trials—pharmaceutical executives are concerned about social media activities, because they fear that than the number and frequency of AEs reported for their products will increase. This, in turn, would prompt FDA and other regulatory agencies to investigate and more closely scrutinize their marketed products. As Jonathan Richman, author of the Dose of Digital Blog points out in an excellent post entitled the “Myth of Adverse Event Reporting” AEs are a fact of life for prescription drugs. And, that social media may help to improve adverse reporting. Like Jonathan, I contend that social media might allow drug makers to more effectively identify potential safety issues with a product earlier in its lifecycle and thereby minimize possible deleterious effects of the drug on certain patient populations. I think that drug manufacturers ought to begin to consider how they might effectively use social media to improve AE reporting rather than ignore the potential upside of this new medium.

The Myth of Adverse Event Reporting

Adverse Events are nothing more than negative reviews. If you want people to genuinely talk about your brand, they are going to say negative things. But how often do posts include adverse events? Nielsen decided to take a look at this rather than simply assume it was ” a lot,” which of course is a difficult number to manage. Nielsen looked at Yahoo Health boards and took 500 postings. Of these, only 1 contained enough information to qualify as an adverse event that needed to be reported. That’s 0.2%. Why so low? Turns out that someone simply saying that your drug caused them to have a headache isn’t enough to qualify as an adverse event. Nielsen summed up the pieces of information required to report an adverse event and there are four pieces: “(i) an identifiable patient; (ii) an identifiable reporter; (iii) a specific drug or biologic involved in the event; and (iv) an adverse event or fatal outcome.” (Hat tip to Pharma 2.0 for the summary). The study showed that one or two of these pieces were often available, but not all four. In addition, they found that it would be impossible to get all four even with some effort. In fact, the FDA says, “[Without these pieces] a report on the incident should not be submitted to the FDA because reports without such information make interpretation of their significance difficult, at best, and impossible, in most instances.”

This is because people often don’t register or leave their personal information in a post, so there is no way for a company to follow up and fill in the blanks. Naturally, if there is something significant, every effort should be made, but on the often anonymous Internet, this is usually difficult. Suppose for a moment there were several adverse events that need to be reported. How often do they need to be reported? The FDA is pretty clear on this. For new drugs, reports need to be filed quarterly for three years. After that, it’s annually. For “serious and unexpected” events, these have to be reported within 15 days. However, there’s a pretty high threshold for an adverse event to be considered “serious and unexpected.” Every company already has these reporting channels in place, so it is simply a matter of including adverse events received from social media into the workstream. 

Yes, it’s a balance. The fact is adverse events should not be the reason why healthcare shies away from social media. These risks can easily be mitigated and, if done right, can actually be used in a positive way. So, don’t use adverse events as an excuse anymore. You’ve got the data. 1 in 500 posts include a reportable event. You report quarterly at most (which you’re doing anyway). How much ongoing effort do your other marketing programs require? Probably quite a bit more than this. Next time you hear this excuse, you’ve got the data to dispel the myth of adverse event reporting.

Until next time...

Good Luck and Good Job Hunting!!!!!!

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BioJobBlog and BioCrowd along with the Business Development Institute, the Journal of Communication in Healthcare and others are co-sponsoring a meeting entitled “Social Media and Healthcare” that will be held on July 23, 2009 in NYC at the Graduate Center of The City University of NY (365 Fifth Avenue at 34th Street). Topics that will be covered include:  

1. Managing regulatory and legal issues when planning and implementing social media strategies
2. Is there a role for social media in President Obama’s healthcare reform plans?
3. Why real-time social media tools like Twitter are gaining momentum and when it makes sense to use them
4. How social media has affected crisis communications in the healthcare industry
   
5. Selling social communications projects and proving ROI to senior management
   
6. Creating and participating in communities to achieve communication, educational and branding objectives
7. Planning and executing a social communications plan with little or no budget
8. Building relationships and partnerships with new healthcare media leaders beyond advertising
9. Best practices for using social communications to connect internally with employees and stakeholders
   
10. Tools, technologies, and best practices for monitoring and measuring social communications

The meeting’s agenda features case study presentations and a series of roundtable discussions on social media topics. I will be leading a roundtable discussion called “How to Build a Social Networking Site for Bioscientists.” Approximately 300 senior marketing, communications and media professionals from Fortune 1000, middle market and emerging growth companies are expected to attend from leading pharmaceuticals, medical technology/device companies, managed care providers, hospitals, healthcare media companies, government and nonprofit organizations.  

BioCrowd members can register for the meeting at a discounted rate of $155. Check it out—it will be money well spent!

Hat tip to Steve Etzler at the BDI and Mario R. Nacinovich Jr., Editor-in-Chief, Journal of Communication in Healthcare for organizing this topical and important meeting.

I hope to see you at the meeting next Thursday!!!!

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Mark Senak, who writes the outstanding Eye on FDA blog, posted an interesting article today that tracks the number of warning letters issued by DDMAC (the center that oversees life sciences marketing and advertising) over the past 12 years. Not surprisingly, the number of warning letters issued by DDMAC fell precipitously during the Bush Administration, after reaching a high during the waning years of Bill Clinton’s presidency. In fact, the number of warning letters issued by DDMAC during the first two quarters of 2009 exceeds the yearly total of warning letters issued in the past 4 of five years. However, as Mark clearly points out, the 2009 year to date number of warning letters may be artificially inflated because of 14 identical ones issued on the same day (April 2) to 14 different companies regarding internet search engine advertising. Nevertheless, it is becoming increasingly apparent that the agency is beginning to emerge from a long slumber and that US regulatory oversight may be entering a new, more scrutinizing era. 

While increasing regulatory scrutiny may be appropriate after 8 years of no regulation at all, it is important that FDA doesn’t overreact and unnecessarily stifle new drug and product development. To that end, I believe that the agency needs to be reorganized, revamped and revitalized to replace its traditionally “reactive” way of doing business with a more “proactive” one.  For example, there is a burgeoning need for regulatory guidance on the use of social media by companies in the pharmaceutical, biotechnology and medical devices and diagnostics industries. Unfortunately, FDA has been unwilling or unable to enunciate a cogent regulatory strategy or any meaningful guidance on this topic. Consequently, many life sciences companies have refrained from using social media because they simply don’t know how to implement it in the current regulatory environment. I believe that FDA, not the companies it regulates, should take the lead on this issue.

Finally, it is becoming increasingly apparent that many companies will continue to refrain from using social media and other Web 2.0 tools until FDA crafts some useful guidance on these topics. Sadly, Web 3.0 is just around the corner and the agency is still struggling with regulatory guidance for corporate websites. Maybe Congress needs to craft some new FDA modernization legislation—it has been 12 years since the last modernization bill was passed!

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

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The debate, if you can call it that, over whether or not interactive social media platforms like Facebook and Twitter can be used in the life science industry is moving forward at glacial speed. I decided that it was time to propose some ideas rather than continue to admonish the US Food and Drug Administration (FDA) for a lack of guidance.

There are several reasons which may explain the inertia surrounding the adoption of social media by pharmaceutical, biotechnology and medical devices and diagnostics companies. First, and perhaps foremost, FDA has been consistently reluctant to craft any useful guidance on the use of Web 2.0 technologies for research, clinical or promotional purposes. The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) is still trying to figure out how to regulate website content. Is it any wonder that FDA is reluctant to tackle the regulatory implications and issues associated with social media platforms like Facebook and Twitter? Second, a majority of social media advocates— who are leading the charge at many life sciences companies—are marketing and advertising executives who tend to look at social media strictly as a promotional tool. Finally, much of what takes place at life sciences companies is proprietary and confidential—information flow between the company and its employees and the public is fastidiously monitored and tightly regulated. Because of this, the life sciences industry’s “process” is intentionally opaque—which is contrary to the goals of social media which is to promote transparency (or the illusion of it).

There is no doubt that the life sciences industry is the most highly regulated industry on the planet. While this represents a formidable challenge for adoption of social media, it is by no means insurmountable—especially if social media is used for purposes other than branding, marketing and advertising. For example, the most straight forward application of social media at life sciences companies would be in the areas of corporate recruitment and employee retention. Many Fortune 500 companies outside of the life sciences industry have been using Facebook, MySpace and LinkedIn for years for recruiting purposes. While not commonly acknowledged, life sciences companies have quietly begun to use Facebook, LinkedIn and MySpace to recruit prospective employees. Interestingly, the new kid on the block—Twitter—looks to potentially be a more powerful recruiting tool than any of its predecessors. Unfortunately, employee retention is no longer a priority at many companies. However, before the economic meltdown a number of companies, most notably Best Buy, were experimenting with social media to retain talented employees.

Another potential use of social media is for pharmacovigilance and adverse events reporting. Companies with approved products on the market are required by FDA (and other regulatory agencies that approved their products) to set up post marketing surveillance programs for adverse events reporting. By law, companies that receive adverse events reports from consumers, physicians or other entities must report them to the regulatory agencies that approved the product. Regulatory agencies maintain adverse events databases for all approved drugs and devices to monitor drug safety.  If designed and implemented correctly, interactive social media platforms like Facebook and Twitter (which operates in real-time) would make excellent pharmacovigilance and adverse reporting tools. Quite coincidentally, John Mack, who runs the Pharma Marketing Blog, reported a partnership between UCB and PatientsLikeMe.com to create a pharmacovigilance reporting platform for UCB products.

Recruiting patients for participation in clinical trials (to assess efficacy and safety of prospective new drugs) has become extremely challenging over the past few years.Traditional patient recruitment strategies include print, television and radio ads and in some instances, websites. All of these recruitment methods are costly, labor intensive and limited in their effectiveness because they only reach small number of prospective clinical trial participants. I contend that Facebook with over 200 million users, LinkedIn with members in over 140 different countries and Twitter which is growing rapidly would be ideal for clinical trial recruitment and retention purposes. Others have also proposed this idea.

Finally, while the use of social media to promote approved drugs and devices may be difficult because of regulatory constraints, it can be utilized to keep the public informed about prospective new medicines and promote a company’s image or brand. There is no question that the public perception of the pharmaceutical industry has been severely tarnished over the last few years.  The industry’s continued lack of transparency and failure to adequately disclose potential safety risks about some approved products continues perpetuate a negative image. One way to restore public trust and confidence is to use social media to actively engage the public in conversation on wellness, addressing unmet medical needs and prospective new medicines and treatments that are being developed. Also, social media platforms could be employed to showcase community outreach programs and discuss educational initiatives to improve science education and training.

Social media is no longer a new phenomenon or technology. It is a legitimate form of communication which has become an integral part of the Web 2.0 experience. I suspect that the life sciences industry will have to make a decision about social media in the not so distant future—or possibly miss a potentially game-changing business opportunity. And, as Ken Kesey aptly said in Tom Wolfe’s ‘The Electric Kool-Aid Acid Test’—“You’re either on the bus…or off the bus.”

 Until next time...

 Good Luck and Good Job Hunting!!!!!!!!

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Twitter, which is currently de rigueur in social media circles, is emerging as one of the most powerful branding and marketing social media tool that has been developed to date.   While other industries are already exploiting Twitter’s powerful marketing reach (to hawk their wares), drug makers have been reluctant to adopt Twitter and most other forms of social media. Industry analysts and company insiders contend that pharma’s reluctance to adopt social media can be attributed to the US Food and Drug Administration’s (FDA) lack of guidance on its use for promotional purposes. At present, it is anybody’s guess when this guidance may be issued, if ever.

Nevertheless, as always, there are a few daring companies willing to “boldly go where no pharma company has gone before”—in this case—Twitter! These companies include Boehringer Ingelheim (BI), Astra Zeneca, Novartis and Pfizer. According to a post on the Advance Market WoRx blog, BI is leading the way among pharma company Twitterers, with 679 following, 745 followers and 47 tweets. AstraZenecaUS has 136 following, 440 followers and 22 tweets. Pfizer has 351 following, 462 followers and 48 tweets.  Novartis has 0 following, 681 followers and 40 tweets (I guess Novartis has a thing” against following people).

Unlike its fellow pharma Twitters, BI—which began using Twitter in November 2008—actually uses it as an interactive and conversational microblogging platform (as it was intended). The other pharma company Twitters use it almost exclusively “as a one-way PR feed” says Ellen Hoenig Carlson at Advance Market WoRx. According to a post on the Pharmafocus website, "Boehringer has incorporated Twitter into its wider communications strategy and is using the site regularly to engage its stakeholders. In addition to posting press releases, BI uses Twitter to recommend web-based information about therapeutic areas and articles that its followers might find interesting or useful. To keep its finger on the pulse of the Twitterverse, BI uses media scanning programs to help monitor online conversations and responds quickly to join in or start up Twitter conversations.”

Kudos to Boehringer for recognizing Twitter’s potential to communicate with patients, physicians and other interested parties. I hope that more pharmaceutical companies begin to use Twitter and other forms of social media to engage and improve communications with their stakeholders.

Until next time...

Good Luck and Good Twittering (or should it be Tweeting?) 

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The US economy has lost about 7.1 million jobs since December 2007 and nationwide unemployment is hovering around 8.5 percent. Despite the lost of  about 80,000 pharmaceutical jobs over the past three years and unprecedented consolidation taking place in the life sciences sector—Merck-Schering Plough, Pfizer-Wyeth and Roche-Genentech—the job prospects for scientists at biotech companies, medical devices and diagnostics, and government appear to be stronger than anticipated. While drug discovery and sales jobs may be scare, there are rapidly emerging opportunities in the fields of medical communications, regulatory affairs, biomanufacturing, clinical trials management , bioengineering, medical devices/diagnostics and website development and management.

President Obama’s promise to restore science to its rightful place, his reversal of the ban on federal funding for embryonic stem cell research and an unwavering commitment to alternate energy technologies suggest that the future may be very bright for bioscientists. For example, there are massive hiring initiatives at federal agencies like the US Food and Drug Administration (FDA) and the Unites States Department of Agriculture (UDSA) — as the Obama administration attempts to overall these agencies— and funding levels at the National Institutes of Health are on the rise (aided in part by a $200 million Challenge Grant stimulus program).

While the road to economic recovery may be a long one, graduate students and postdoctoral fellows who are currently engaged in life sciences research should “stay the course and not jump ship just yet.” The life sciences industry is more recession proof than others and it will be one of the first to experience an economic turn around. And, when it does it is best to prepared to find a job!

Until next time…

Good Luck and Good Job Hunting!!!!!!

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Tainted pistachio nuts are the culprit for this week’s Salmonella outbreak.  Fortunately, Kraft Foods’ quality unit was doing its job and was able to alert consumers about the problem before the outbreak reached epidemic proportions. At present, there are only two suspected cases of Salmonella gastroenteritis that may be linked to tainted pistachios. The contamination has been traced back to a California company which, according to reports, is the second leading producer of pistachios in the US.

As I have mentioned several times before, Salmonella outbreaks are nothing new and not out of the ordinary in the food industry. However, what is new is the growing lack of regulatory compliance that seems to be pervasive at American food manufactures. Many blame declining food safety on the US FDA’s lack of trained inspectors. While this may play a role, I believe that the real problem lies with the failure of many food industry executives to make a commitment to quality outlined in FDA’s Current Good Manufacturing Practices (cGMPs). 

I have been teaching cGMP to biotechnology students for the past six years or so.  I always tell them that the regulations are meaningless unless management makes a commitment to quality. And, the only way to accomplish this is by insisting that all manufacturing taking place at a company stringently adheres to all GMP regulations and guidelines. For those you who may not be familiar with cGMPs, they are the minimum regulatory standards that must be met to insure US product (food, drugs and cosmetics) quality and safety.

Over the past decade or so, Americans have grown accustomed to a wide variety of choices when it comes to raw and processed foods. To meet demand, US food manufacturers must source and import fruits, vegetables, spices and other foodstuffs from all over the world. Regardless of the origin of a food source, cGMPs clearly state the onus is on the manufacturer (not the supplier) to perform the necessary tests to insure food safety and quality. The recent spate of Salmonella outbreaks suggests that some food manufacturers are either cutting corners or don’t fully understand what testing is necessary to guarantee food safety. Unless something changes, Americans confidence in the safety of US food supply will continue to wane.

Until next time...

Good Luck and Good Easting (avoid pistachios)

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As many of you know, the life sciences industry, one of the most highly regulated industries of the economy has been hesitant and reluctant to embrace social media to reach out to patients, physicians and the lay public. This is because the US Food and Drug Administration, specifically Division for Drug Marketing, Advertising and Communications (DDMAC), has been mute on the subject and hasn’t issue one iota of guidance on the use of social media in the pharmaceutical, biotechnology or medical devices/diagnostic industries.

Mark Senak, a regulatory affairs lawyer and owner of the blog eyeonfda.com, invited Dr. Jean Ah Kang, Special Assistant at DDMAC in charge of Web 2.0 policy development to talk about FDA’s views and ideas about social media and its use in the life sciences industry. Listening to the 15 min podcast would be, according to Mark, “time well spent” for social media advocates in the pharmaceutical, biotechnology and medical devices/diagnostics sectors.

Hat tip and much “love” to Mark who wrote “BTW, I absolutely expect waves of love for this (the podcast)."

Until next time....

Good Luck and Good Listening!!!!!!!!!! 

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According to a report on NPR’s All Things Considered program, the Obama Administration has nominated Margaret Hamburg, MD to head the US Food and Drug Administration. Dr. Hamburg is a former health commissioner in New York City who has worked on issues surrounding infectious diseases and bioterrorism. In New York, she instituted a needle-exchange program to help prevent the spread of HIV. She also set up a program, in which health workers went to tuberculosis patients’ homes to help them manage their drug regimens.

A Harvard Med School graduate, Dr. Hamburg was an assistant secretary of health and human services during the Clinton administration and now works at the Nuclear Threat Initiative, which tries to cut the threat from nuclear, chemical, and biological weapons. She opposes abstinence-based sex education in public schools and has been a critic of the marketing practices of the pharmaceutical industry. Further, Dr. Hamburg is a leading advocate for changes in the nation’s public health policies and infrastructure, from local health departments to the highest levels of government. Finally, after eight years of mismanagement and poor leadership, the agency has somebody at the helm with intelligence, experience and is an advocate for change. 

Kudos to Team Obama!

Until next time...

Good Luck and Good Job Hunting (FDA is hiring)!!!!!

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The Eye on FDA blog reported today that AstraZeneca and Sanofi-Aventis have joined the ranks of Abbott, GSK, J&J and SanofiPasteur on YouTube. Pharmaceutical companies are taking advantage of the power of YouTube and other social media sites because regulatory guidance hasn’t been issued on its use to promote products or brand awareness. In other words, this is uncharted territory and companies can essentially 'test the waters' to see how far regulatory agencies will let them go.  I suspect that early life sciences company adopters of social media will garner substantial ROI before regulatory guidance is issued.

A lack of regulatory oversight, the ability to manage and control content and the low costs associated with creating Internet videos make YouTube and other social media sites attractive to pharmaceutical and biotechnology companies. The life sciences sector is just beginning to recognize the power of social media and the role that it may play in promoting products and brand awareness to consumers.  Expect many more life sciences companies to experiment with social media in the near future--its a veritable goldmine!

Until next time…

Good Luck and Good Video Watching!!!!!!! 

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About a year ago, I was eating lunch and bunch of pharma executives were at the table next to me. I inadvertently overhead bits of their conversation and I heard the words, Facebook, MySpace and YouTube mentioned. This suggested to me that pharma was more aware of social media (and its business implications) than pharma publicly cared to admit. Pharma has been reluctant to embrace social media because of possible legal and regulatory ramifications. Nevertheless, a few companies have decided to boldly go where no pharma company has gone before—to YouTube.

The Eye on FDA blog, which is very bullish on social media, has been keeping aof pharma companies that have created channels on YouTube, the video site owned by Google. To date, Sanofi Pasteur, GSK, Abbot and JNJ have taken the YouTube plunge (see SanofiPasteurTV , GSKVision, AbbottChannel, andJNJHealth).  I suspect that pharma companies are willing to take a risk on YouTube, because unlike other social media platforms, they can disable the functionality that allows viewer to leave comments, kudos or kvetches after viewing videos. This shields the companies from unwarranted claims, misinformation about its products and negative publicity.

At present, the US Food and Drug Administration, has issued little or no guidance on the use of social media by drug makers. This means that drug makers are in uncharted territory and can experiment with social media without fear of much regulatory oversight or scrutiny.  Now that pharma has broken the social media barrier, I wonder whether MySpace, Facebook and Twitter (the hottest new social media tool at the moment) will be next. Interestingly, I learned yesterday that Novartis uses twitter and can be followed @Novartis.

Off the record conversations with MySpace representatives suggest that a number of pharmaceuticals have quietly created branded product pages on MySpace for years.  As the MySpace rep put it, how can you ignore an audience of 60 million people?  Further, Facebook’s fan pages are growing in popularity and don’t be surprise to see pharma pages begin to appear there. It will be interesting to see how pharma will incorporate social media into its business and marketing models in the future.

Until next time…

Good Luck and Good Video Watching!!!!!!!!

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The Pharmalot blog reported today that this coming Friday, the US Federal Trade Commission (FTC) will conduct a workshop on the issue of follow-on biologics. The roundtable will apparently be organized into five panels to discuss: 1) the price and market share effect of entry by both biosimilar and biogeneric drugs, 2) the likely competitive effects of reference product regulatory exclusivity, 3) biotechnology patent issues, 4) the likely competitive effects of follow-on biologic regulatory incentives, and 5) the patent resolution process.

The first thing that comes to mind is “beating a dead horse” (euphemistically of course). Call me crazy but these very issues have been bandied about and discussed ad nauseum and  for the past decade or so. I am not sure what new revelations will come to light at this Friday’s FTC roundtable meeting. 

Here’s a thought. Maybe industry representatives, FDA regulators and the insurance companies ought to ask the European Union how they were able to craft their version of a regulatory pathway for approval of these products way back in 2004. Nah…let’s let the lobbyist duke it out and see which side wins!

Until next time…

Good Luck and Good Job Hunting

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Just when I thought the absurdities surrounding the American follow-on biologics debate couldn’t get any sillier, the US Federal Trade Commission (FTC) announced today that it would sponsor public workshops and round table discussion to learn more about the impact of follow-on biologics on American competitiveness, regulatory policies and healthcare costs.

I am not certain what role the FTC has in the follow-on biologics debate (as far as I am concerned, it shouldn’t have much of one) but what new information does the FTC think that it is going to get that other more relevant government agencies like FDA or the US Congress don’t already have about follow-on biologics? After all, the debate to formulate an approval pathway for follow-on biologics in the US has gone on for almost 10 years now. How ineffectual and ineffective can the US government and its agencies be (rhetorical question)?

As far as I can ascertain, the main reason why follow-on biologics are not already being sold in the US are the never-ending efforts of power, well-funded lobby organizations like BIO and PhRMA. The data are incontrovertible: 1) the cost of branded drugs is out of reach for many Americans, 2) access to potentially life-saving drugs and treatments is hindered by restrictive drug formularies and onerous insurance co-pays and 3) many local and state governments and large, multi-national corporations can no longer provide adequate healthcare coverage for their employees because of out-of-control medical costs and expenditures.

In my opinion, the irony of the US follow-on biologics brouhaha is that it is putting American companies at a competitive disadvantage in the biosimilar/follow-on biologics space. Selling profitable, cheaper generic versions of blockbuster drugs is no longer a dream but a reality in countries like China and India whose middle class has finally come of age. True, the American pharmaceutical/biotech market is still the largest in the world—but will it still be the largest 10 years from now? Only time (and Asia) will tell.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!

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FDA approvals of biopharmaceutical products have decreased in recent years. This includes recombinant proteins and monoclonal antibodies and cancer therapeutics. In the decade from 1996-2005, an average of 16.6 new drugs were approved each year. In marked contrast, there were only 11 and 12 new medications approved in 2006 and 2007, respectively.

Last year was an unusually unproductive year for the pharmaceutical and biotechnology industry. The combined sales for products approved in 2007 are projected to be less than $1.0 billion dollars–the benchmark for drugs that receives blockbuster status. Further, most or the approved drugs were similar to ones that were previously approved (so called “me too” drugs) and none will significantly improve healthcare for large numbers of patients.  Finally, only two recombinant protein drugs were approved in 2007–a level more representative of the 1980s.

Most analysts agree that it is unclear why FDA approval of new drugs has decreased over the past few years and who, if anybody (FDA and/or industry), deserves the blame for the approval drop-off. Regulatory filings for a number of new products are either expected or currently pending. To that end, it is likely that there will be more new approvals in 2008 and 2009 as compared with previous years. To learn more about the drug approval conundrum please read this article recently written by Ronald A Radar.

The rate of new approvals must increase in order for the biopharmaceutical and pharmaceutical industries to remain economically healthy and viable. Industry and the FDA must work more closely with one another to continue to insure that the American public has ready access to innovative, safe and efficacious, new biopharmaceutical and pharmaceutical products. 

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The Bush administration's proposed 2009 fiscal year budget for the FDA includes not only a 5.7 percent increase but a plan to seek authority to allow the agency to approve abbreviated applications for follow-on biologics.

As part of the budget package, the administration said it is seeking regulatory authority for the FDA to approve follow-on biologics, also called biosimilars or biogenerics, which would be financed through user fees.

The House and the Senate both introduced follow-on biologics legislation in 2007, with the Senate's bill moving the furthest by achieving passage by the Health, Education, Labor and Pensions Committee. Lawmakers have pledged to move the legislation forward in 2008.

Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), said "BIO strongly believes that the FDA should have a pathway for the approval of follow-on biologics, which protects patient safety and promotes continued innovation," Greenwood added that "The creation of a pathway for follow-on biologics is a top legislative priority for BIO, and we are meeting with members of the House and Senate to encourage them to consider and pass follow-on biologics legislation this session." This is quite a policy turnaround for BIO which over the past 8 years has spent tens of millions or more lobbying against allowing follow-on biologics in the US.

Even more shocking than the BIO turn around, was the first ever plea last week by the Whitehouse to pass legislation to craft legislation to create a regulatory approval pathway for follow-on biologics-what’s up with that? I guess Bush and his big biotech buddies finally realized that large sums of money can be made in the follow-on biologics/biogenerics business. This possibility was not lost on the Europeans, who created a regulatory pathway for approval of biosimilars (what follow-on biologics are called in Europe) several years ago! Biosimilars are already on the European market–who said that Europeans were less entrepreneurial than Americans?

Contrary to statements made by FDA officials last week, which suggested that FDA would craft the follow-on biologics legislation, it now appears that FDA will  work closely with Congress to draft a legislative proposal for approval of  follow-on biologics. I don’t think that Congress’s involvement is a good idea given the political wrangling, deal-making and concessions that must be made in order to get legislation passed. As the old adage goes, something is better than nothing.

It looks as though follow-on biologics may become a reality in the US. As I mentioned in previous posts, I don’t think Americans will see follow-on biologics on the market before 2010 or 2011. That said, it gives us Americans something to look forward to!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

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Although industry and academia share a common bond (no pun intended), which is obviously science, the lexicons of these two seemingly similar but parallel worlds are markedly different. For example, do you know what the acronyms IND, NDA, cGMP, cGLP, BLA, CTD, PK or PD stand for? If you cannot decipher any of them, you ought to forget about getting a job in industry and stay in academia. If you know what 95 % or less of them mean, I highly recommend that you get some additional training before applying for your first industrial position. If you are one of the lucky few who recognized and correctly interpreted 100% of the acronyms, you are either working in industry or recently completed some postgraduate training in drug development and regulatory affairs. The point that I am trying to make is that you cannot possibly expect to get a job in industry if can’t speak the language that you need to know in order to succeed! As the old saying goes “You need to learn how to walk before you can run”.

So, take the test and your score will determine whether you are ready to apply for that long sought after job in the pharmaceutical or biotechnology industries.

Footnote: For those of you who are interested, you can decipher all of the acronyms that I listed by visiting and rooting around the FDA website.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

Find information on Diversity recruiting at DiversityJobs.com.

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