The Future of Pharmaceutical R&D

Did you know that the top ten pharmaceutical companies in the world spent close to $50 billion dollars last year on R&D? That sum could be used to purchase the entire US biotechnology industry except for the five largest companies—Genentech, Amgen, Gilead Genzyme and Celgene. Further, pharma’s R&D budget is about 4 times the R&D budget of all of the US biotechnology companies combined. According to a blurb in breakingviews.com, Pfizer alone spent $8 billion last year which was greater than the sum spent by biotech’s top five companies. What this tells us is that pharmaceutical companies are grossly unproductive when it comes to drug discovery and development. This would explain why nearly three-quarters of all new medicines approved for sale in the US last year originated at biotechnology companies.

It is becoming increasingly apparent that biotechnology companies are much more efficient at R&D than pharmaceutical companies. More importantly this suggests that something must change so that pharma can continue receive adequate ROI on internal discovery programs. Perhaps big pharma ought to spend a greater portion of its R&D budget on biotech mergers and acquisitions rather than continuing to invest in inefficient and failing internal R&D programs. While biotechnologynology companies are exceptional in drug discovery, they are severely lacking when it comes to clinical development of new drugs. This is largely due the high costs of conducting human clinical trials (which are required for regulatory approval of all new medicines). Most biotechnology companies are strapped for cash and don’t have sufficient funds to conduct clinical trials on their own.

Not surprisingly, given the recent financial downturn, there has been a recent spate of deals in which pharma has been willing to pay large sums of money for clinical development rights to promising new biotechnology drugs. Moreover, a majority of the almost 160,000 employees layed off by pharma companies in the past few years have been R&D scientists. This suggests that pharma is beginning to realize that its money may be better spent doing deals or buying biotech companies rather than continuing to invest large sums of money into it’s own unproductive R&D programs. Unfortunately, this paradigm shift doesn’t bode well for doctoral students and post-doctoral fellows who are training in the life sciences. This is because many entry-level biotech positions, traditionally filled by newly-minted PhDs and postdoctoral fellows will likely be filled by experienced, pharmaceutical employees who lost their jobs in the recent rounds of layoffs. As much as I hate to say this, if I were a life sciences graduate student or postdoctoral fellow considering an R&D career in industry, I would begin to explore alternative career options.

Until next time….

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

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It Had to Happen Sooner or Later: Health Canada Adopts Draft Guidance for Subsequent Entry aka Follow-On Biologics aka Biogenerics

Ed Silverman over at Pharmalot reported today that Health Canada, the Canadian equivalent of the FDA has beaten the FDA to the punch and issued draft guidance for follow-on biologics known in Canada as subsequent entry biologics. The Canadian regulatory agency recently posted on its website requirements for manufacturers and says it could approve products under existing regulations until laws are amended to include the new approval pathway.

If approved, a subsequent-entry biologic would have to be similar to a previously approved biologic, relying in part on publicly- available safety and efficacy data. Product interchangeability and substitutability would not be automatic, but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A meeting to review the draft document is scheduled for May. The proposed Canadian legislation is very similar to that adopted by the European Union for biosimilar products (what they are called in Europe). Not surprisingly the recently proposed US legislation is markedly different than the Canadian and European legislation. Go figure!