Tired of the biopharma pessimism? Before writing this month’s Editor’s Note, I reflected on what had been written in this column over the past 10 months. While I’ve delved into a wide variety of topics (e.g., activist investors, breakthroughs, Brexit), 40 percent of the columns touched on drug pricing (a rather polarizing subject). When thinking about all the hostility heaped on our industry — especially now during a U.S. presidential campaign — I couldn’t bear entering November on note of negativity. So, I started thinking about some of the “bright spots” that have occurred in this industry recently.
First, consider the fact that, as of this writing, we have seen 58 FDA drug approvals this year, with 17 being for novel compounds. Of course, this drug-approvals bright spot isn’t free of controversy, as was evident by the recent approval of Sarepta’s Exondys 51 (eteplirsen), indicated for Duchenne muscular dystrophy. Janet Woodcock, M.D., director for the FDA’s CDER, pushed for the drug’s approval despite heated internal opposition. Dr. Luciana Borio, acting agency chief scientist, argued that its approval would lower agency standards, while Ellis Unger, M.D., director of the office of drug evaluation, called the compound a “scientifically elegant placebo.” Time will tell who’s right. But I admire Woodcock for her willingness to take a risk, which in my opinion is another bright spot. After all, wouldn’t it have been significantly easier for her and FDA Commissioner Robert Califf to just “go along to get along?”
I came across another industry bright spot while attending The Economist’s 2016 War On Cancer event. One of the speakers, Kelvin Lee, M.D., of the Roswell Park Cancer Institute, shared his organization’s experience in working with Cuba. When learning that the country’s Center of Molecular Immunology (CMI) had developed a lung cancer vaccine (CIMAvax), he and colleagues didn’t let a 54-year-old trade embargo stand in the way of bringing this innovation to patients in the states. Roswell anticipates beginning U.S. clinical trials soon, perhaps before the end of next year.
It was on the last day of the 2016 International Society for Pharmaceutical Engineering (ISPE) annual meeting that I identified my next bright spot. Presenter Dr. Frank Gupton, Ph.D., a professor at Virginia Commonwealth University (VCU), spent 30 years in industry before embarking on his second career. Since “retiring” he has given a TEDx talk, published numerous articles, and received grants totaling nearly $10 million from the Bill & Melinda Gates Foundation. One of his teaching projects seeks cheaper and more efficient ways to manufacture medicines. The first drug tackled, nevirapine, is an HIV/AIDS compound for which Gupton (while in industry) developed the commercial process. By making a few simple changes, the Medicines for All Initiative team reduced:
They did all of this while increasing the yield from 59 to 92 percent. But most telling is the increased number of patients who can now be treated more cost-effectively. It is estimated that just a 10 percent improvement would achieve a savings of $75 million and allow the Gates initiative to treat 150,000 more patients. Following this success, Gupton’s team received another $5 million to investigate improving two additional HIV/AIDS drugs (i.e., tenofovir, darunavir).
Know of a biopharma bright spot? If so, rather than assume we are already aware, please send us an email (rob.wright@ lifescienceconnect.com) and let us know. For couldn’t we all benefit from focusing a little more on the positive?