Genetic Engineering & Biotechnology News

DEC 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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6 | DECEMBER 2017 | GENengnews.com | Genetic Engineering & Biotechnology News Christina Bennett Behind the glow of a computer screen, pri- mary care physician and policy researcher Walid Gellad, M.D., drafts emails, grant proposals, journal articles—and tweets. Earlier this year he wrote an op-ed for the Wall Street Journal in which he drew read- ers closer to his world: The Veterans Affairs (VA) hospital system, where he is a part-time primary care physician. The fact that he spends so much time at the VA gives him a different vantage point than most as it relates to the drug pricing issue—a quality made clear in the aforementioned article as well as throughout much of his work. He also penned a controversial perspective for the New England Journal of Medicine, explain- ing the nuances of accelerated approval of expensive drugs. And he reminded others in a post on the Health Affairs Blog that health reform is needed for long-term care too. All the while, he keeps pace in the tradi- tional publishing sphere. He authored about a dozen research studies this year alone on various healthcare policy issues, the latest aimed at informing policy surrounding the opioid epidemic. And this physician-aca- demic hybrid has a knack for tweeting. "Most of my week is spent sitting at a desk in front of a computer typing," Dr. Gel- lad tells GEN, chuckling softly. He works at the University of Pittsburgh, where he has been a faculty member for nearly a de- cade. Currently, he is associate professor of medicine and the director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. Another generous portion of his time is spent in meetings. "That's what occupies my day. It's a lot about writing and talking to peo- ple." He jokes, "Does that sound exciting?" All joking aside, Dr. Gellad says he en- joys how he spends the majority of his time. "That's how you do the research—in meet- ings and at your computer." The remaining time—one day a week— he spends seeing patients at the VA Pitts- burgh Healthcare System. Music and Medicine Rewind two decades, and you'd find a young Gellad composing music, not research articles, emails, or smart, 280-character sum- maries. Having grown up playing piano and being around music all his life, he chose to study music during his undergraduate years at Swarthmore College, a private liberal arts college in Pennsylvania. "You didn't have to be a biology major to go to medical school, so I studied music and did all of the pre-med requirements at the same time," he says. He saw it as his chance to do something different, before medical school. He says he was "hooked" when he took a music theory class at the start of college. "There's this amazing structure to music, this underlying almost mathematical explanation for why the music sounds the way it does." "During this whole time it was absolutely clear what I was going do after college, and that was go to medical school," he says. "I was never going to be a musician. I knew I wasn't at the level where I could be a mu- sician professionally, but the issues around music theory just fascinated me." "Where I went to college, I think at least half of the music majors ended up going to medical school, so for me it was not that unusual. But it certainly is not typical, and something I'm really happy I did," he says. During medical school at the University of Maryland School of Medicine, he devi- ated slightly: He took a year off to serve as an AmeriCorps volunteer in Brooklyn. "I'd always been interested in public health in general, but that was a firsthand experience," he says about his time as an AmeriCorps volunteer. He recalls doing a lot of health education work in a Brooklyn community and being face-to-face with the ways health is affected by forces outside of the healthcare system. "That was pretty im- pactful. That really solidified my interest in wanting to do something related to public health, or policy in general." After medical school, he trained at Brigham and Women's hospital in Boston, where he found role models who showed him how he could be both a primary care physi- cian and be involved in research and policy. He also completed a master's in public health and a fellowship in health research services. Stuck in the Middle "I've been interested in this issue of pre- scription drug costs since I started," Dr. Gel- lad says. During his residency, the first paper he published as lead author examined how the new prescription drug benefit for seniors (Medicare Part D) could affect vulnerable se- niors. When the article was published, Medi- care Part D had just gone into effect. He says the issue of prescription drug costs has been pervasive throughout his research. However, interjecting his voice into the drug pricing de- bate has been a challenge. "The middle-of-the-road people, they get no air time," he says. "Everyone is compet- ing for airtime, and it's not necessarily that exciting to just be in the middle sometimes. That's a challenge for people who want to solve the problem." He adds, "That's part of why Twitter is ac- tually very useful. It evens the playing field a little bit." A Voice on Twitter Dr. Gellad joined Twitter in April of 2014 and says the social media site has served as a way to meet people, develop ideas, learn each side of an issue, keep up with the latest news—and have your opinion heard. "He has a very important voice that reaches a different audience because of his activity on Twitter," says colleague Chester Good, M.D., chair of the Medical Advisory Panel for Pharmacy Benefits Management for the Department of Veterans Affairs. Dr. Good and Dr. Gellad coauthor articles to- gether often. Dr. Good adds, "I'm an older guy, and I stick to traditional means of pub- lishing, but [Dr. Gellad has] figured out the social media angle." One relationship Dr. Gellad has fostered through social media is that with Twitter sensation Vinay Prasad, M.D., hematologist- oncologist and assistant professor of medicine at the Oregon Health and Sciences Univer- sity. Dr. Prasad is known among tweeps for his snappy, fearless remarks on hot-button healthcare issues. Dr. Prasad recalls virtually connecting with Dr. Gellad a few years ago through Twitter. Since then, they have met in person and collaborated at times. (In 2016, Prasad, Gellad, and Topol were all named in a list of people—dubbed #biotwitter—who were found to be quickest to share biotech-re- lated links on trending topics in the industry.) A Pharmaceutical Pricing Primer, Presented via a Series of Well-Crafted Tweets Walid Gellad Walid Gellad: A Unique Voice in the Drug Pricing Debate Thoughts from a Thought Leader Insights Industry Watch Days after the founder and majority owner of Insys Therapeutics was indicted on federal racketeering and conspiracy charges, the company continued to reel. John N. Kapoor, Ph.D., 74, of Phoenix, was arrested October 26 on felony charges stemming from what federal prosecutors alleged was a nationwide conspira- cy to profit by bribing doctors and pharmacists to pre- scribe the opioid agonist Subsys (fentanyl sublingual spray), indicated for patients with cancer pain. Insys, however, is already preparing for the worst. Three days after Dr. Kapoor's arrest (October 29), the company disclosed a $150-million "best estimate" of the minimum liability exposure it is willing to pay over five years, following talks with the U.S. Department of Justice (DOJ) that were unresolved at deadline. "From a negotiating standpoint, we still don't know what the DOJ's settlement number is, though clearly it must be higher than this," said Oppenheimer analyst Derek Archila. "We continue to remain cautious on the shares." And with good reason: From a high of $14.70 on May 31, Insys shares have cratered, falling 65% to $5.09 on November 1. A day later, Insys reported deeper-than-expected red ink. The company finished the third quarter with a loss of $166.32 million and net revenue of only $30.670 million, down from $57.773 million in Q3 2016. Insys blames the loss on declining prescription volume for Subsys. The company's marketing practices for Subsys sparked the federal investigation that led to the arrest of Dr. Kapoor and six other former executives, includ- ing ex-CEO and President Michael L. Babich. Through his lawyer, Dr. Kapoor insisted he would fight the charges—which could, if he is convicted, send him to prison for decades. Dr. Kapoor—a former executive chairman and CEO of Insys who resigned October 31 as chairman of drug developer Akorn—has been charged with conspiracy under the Racketeer Influenced and Corrupt Organiza- tions (RICO) Act, and other felonies that include con- spiracy to commit mail and wire fraud, and conspiracy to violate the Anti-Kickback Law. n Insys Continues to Reel after Founder's Arrest

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