Update: Chinese Researchers Finish Sequencing the Giant Panda Genome

China's Beijing Genomics Institute in Shenzhen announced that it has mapped the entire genetic code for the giant panda using DNA sequencing and analysis equipment from San Diego-based Illumina. The project began in mid 2008 and was completed by Jan.2009.

The panda at the center of this discovery is Jingjing, who lives in China's Chengdu Panda Breeding Research Center and was the mascot for the 2008 Beijing Olympics. The genetic information from Jingjing is expected to be complemented in the future with genetic information from other pandas.

Scientists hope to use the data from the sequencing project to better understand panda biology and reproduction. Giant pandas are difficult to breed in captivity and are currently on the endangered species list.

In China, the panda's genome sequencing was ranked by the Chinese government as one of the top 10 technology achievements of the year, right up there with the nation's space shuttle and the completion of the Tibetan railway.

Until next time...

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

 

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Another Sign That Pharma Companies Will Rely Less on Internal R&D Programs

The drug maker Eli Lilly and Co quietly launched a new website today for a program dubbed Lilly Phenotypic Drug Discovery Initiative or PD2. According to the company, “The PD2 initiative is a unique opportunity for investigators from external institutions to submit proprietary compounds for potential screening in Lilly's phenotypic assay panel. This highly collaborative process is enabled by a web-based application that facilitates efficient transfer of information between Lilly and the investigator. The PD2 screening panel is currently comprised of five modules which are relevant to therapeutic areas of long-term strategic interest, including oncology, neurological disorders, and metabolic diseases. This panel may change over time to reflect additional research interests.”

Company officials believe that program will allow it to evaluate and possibly license treatments from biotech companies and academic institutions "that are never fully evaluated as potential drug candidates." The launch of the PD2 website—perhaps the first of its kind—clearly sends a signal that pharmaceutical companies are reducing their reliance on internal discovery programs to identify prospective new molecular entities and are eager to enter into licensing deals to find and acquire them. 

Membership in the PD2 requires that a legal representative from the investigator's academic institution or biotech company executes a Material Transfer Agreement (MTA). Once the MTA is reviewed and approved by Lilly officials, the institution can create an account. Until that time, use of the site is limited to browsing only. I have no doubt that technology transfer offices at most major universities will be signing up for membership in short order.

I think the PD2 initiative is an innovative and timely one given the massive reductions in R&D jobs that have taken place at many pharma companies over the past two years. Expect other pharma companies to follow Lilly’s lead.

Until next time....

Good Luck and Good Job Hunting!!!!!

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Celebrate National DNA Day Tomorrow!

National DNA Day is a unique day when students, teachers and the public can learn more about genetics and genomics! The day commemorates the completion of the Human Genome Project in April 2003, and the discovery of DNA's double helix by Watson, Crick and Rosalind Franklin.

National DNA Day is usually observed on April 25 (it was created by the US Congress seven years ago), but this year the National Human Genome Research Institute (NHGRI) will hold most of its activities on Friday, April 24 to accommodate classroom schedules. Building upon the popularity of the online chatroom and ambassador programs, NHGRI and its DNA Day partners this year have expanded their outreach efforts even further by creating National DNA Day social networking pages on Facebook and Twitter.

National DNA Day is much more than a time to honor historical achievements. It's a day filled with opportunities for students, teachers and the public to learn how the exciting field of genome research affects our lives. NHGRI researchers, called DNA Day Ambassadors, are visiting dozens of high schools throughout the nation during April to give presentations and field questions from students. This year, NHGRI is particularly focusing on the southwest region of the United States, sending DNA Day ambassadors to high schools in Utah, Colorado, Arizona, New Mexico and Texas.

No matter where they live, students and teachers can participate in National DNA Day through a live, moderated online chat with NHGRI researchers, which will be open for questions Friday, April 24, from 8 a.m. to 6 p.m. Eastern. NHGRI experts will be available to answer questions on a wide range of topics, including basic science, clinical research, genomics careers and the ethical, legal and social implications of genome research. For those unable to participate in the live event, a transcript of the chat will be available on the DNA Day Web site at National DNA Day Online Chatroom.

You can also participate online on Facebook and @dnaday on Twitter

Happy Birthday DNA!

 

Another Antibiotic Discovery And Development Company Is Downsizing

Targanta Therapeutics, a Cambridge, MA-based biopharmaceutical company, announced that it will lay off 85 of its 115 employees or almost 75% of its workforce. The news follows the FDA’s rejection of its application for oritavancin, an antibiotic it is developing to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and other antibiotic resistant bacteria. The agency wants Targanta to conduct another Phase III clinical trial to further assess of oritavancin’s safety and efficacy.

The company estimates that the new clinical trial will cost about $20 million. Targanta CEO Mark Leuchtenberger said “We are no longer a pre-commercial company. We are back to being a Phase three company, and that requires us to right-size and to streamline our operations.”

Things are not going well for companies in the antibacterial drug discovery and development space. Late last month, FDA rejected Swiss-based Arpida’s NDA for iclaprim an antibiotic it was developing to treat complicated skin and soft infections caused by MRSA. Shortly after receiving the news, Arpida layed off roughly 72% of its employees and is down to about 30 employees like Targanta.

It is unfortunate that big pharma decided to abandon antibacterial discovery and development research about eight years ago. Consequently, development of  new, much-needed antibiotics has been relegated to financially-strapped, small biopharmaceutical companies whose likelihood of success is questionable.

Until next time…

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

The End of an Era: Ligand Pharmaceuticals to Buy Pharmacopeia for $70 Million in a Stock Deal

New Jersey-based Pharmacopeia, the first-ever combinatorial chemistry company, announced that it had agreed to be purchased by Ligand Pharmaceuticals in a stock deal worth about $70 million. Onetime a leader in combinatorial chemistry and high throughput screening, Pharmacopeia has struggled of late after it jettisoned its profitable molecular modeling division several years ago. While the company was able to advance several of its lead compounds into early phase clinical testing, its  longtime business model, predicated on multiple, small discovery deals with large pharmaceutical companies, was unable to provide enough capital to continue to sustain operations.

Pharmacopeia was established in 1993 after its founders licensed from Columbia University several of the first issued combinatorial chemistry patents. The company was a pioneer in combinatorial chemistry (and subsequently high throughput screening) and was the first to publicly tout the virtues of combinatorial chemistry in drug discovery. By the mid-1990s, many pharmaceutical companies had embraced combinatorial chemistry as the “next big thing” and began eliminating traditional natural product and medicinal chemistry jobs. The industry’s love affair with combinatorial chemistry grew so strong that many companies (most notably Merck), completely eliminated their natural products discovery departments in the late 1990s. Unfortunately, the role of combinatorial chemistry in drug discovery never lived up to its promised potential and was largely abandoned in the early 2000s. Although combinatorial chemistry is now part of the modern day drug discovery paradigm, this onetime “shining star” has largely been relegated to a minor supporting role.

I first became acquainted with Pharmacopeia in 1994 after I took a job with Transcell Technologies, a now-defunct biotechnology company that was co-located with Pharmacopeia in a research facility in Monmouth Junction, NJ. While Transcell and Pharmacopeia shared a cafeteria and some common laboratory equipment, Pharmacopeia employees were strictly forbidden to talk with Transcell employees— lest they inadvertently divulge proprietary combinatorial chemistry concepts that might jeopardize the company’s future. Coincidentally, a guy who lived two doors down from my family and me turned out to be Pharmacopeia’s in-house intellectual property attorney. Although, Ron and I became good friends, he was also extremely tight-lipped about the “goings-on” at Pharmacopeia. Privately-held Pharmacopeia went public in 1995 and at one time, its market capitalization was almost $1.0 billion.

By any reckoning, a 15-year run is outstanding for a biopharmaceutical company. However, as the old adage goes, “All good things must come to an end.” At present, it is not clear, whether or not California-based Ligand will relocate the company or cut jobs. Nevertheless, Pharmacopeia’s impending demise sends a clear signal that the golden age of combinatorial chemistry has ended!

Until next time….

Good Luck and Good Job Hunting!!!

 

FDA Jobs?

In the January 2007 issue of Drug Discovery & Development, Ted Agres authored an informative article called "FDA's Sweeping Changes" that outlined reforms that are slated to occur at the agency. One of these is an amendment to the Prescription Drug User Fee Act (PDUFA; which is up for renewal) to increase user fees for regulatory reviews. For those of you who are not familiar with PDUFA, it was passed in 1992 and it authorized FDA to collect fees from industry to hire additional staff to meet faster approval goals for Investigational New Drug (IND), New Drug (NDA) and Biological License Applications (BLA). Under PDUFA, user fees have grown from $9 million or 7% of FDA's drug review costs in FY1993 to ca. $ $280 million or more than 59% in FY 2007 which began on Oct. 1, 2007.  

In addition to being used to speed drug review, the new fees will support post-market surveillance and post-market evaluation of drug safety. Further, for the first time, drug manufacturerers have agreed to provide user fees to support FDA review of direct to consumer advertising (DTC). At present, FDA has no authority over DTC ads prior to drug launch; companies submit copies of broadcast and print ads when they begin running. FDA is seeking the authority to review DTC ads before they can be aired or printed.

Increases in user fees suggest that the agency ought to be looking for a few "good women and men" to review regulatory submissions and institute its new focus on drug safety and surveillance.

Until next time......

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