2014's 9 biggest biopharma game-changers, according to industry experts
2014 was chock full of game-changing approvals, research advances, and dramatic mergers and acquisitions that fostered increasing biotech and pharmaceutical industry consolidation.
But much of the "drama" in the biopharma industry centered on product approvals and medical breakthroughs that addressed longstanding unmet medical needs.
BioPharma Dive asked its team of experts to weigh in on seminal events and trends in the biotech and pharma sectors in 2014. Here’s what they had to say (note: you can click on each individual's name to see his or her picture):
Osnat Benshoshan, Vice President of Marketing at SERMO
"By the end of 2104, over 50% of doctors had joined social networks and realize the benefits of sharing wisdom, knowledge, and feelings with one another."
Sean Dalziel, Co-Founder and Managing Partner, Actera Pharmaceuticals
"I think a major game-changer in 2014 was Genentech/Roche complementing their outstanding discovery capabilities with a solid M&A strategy, focused around Seragon, InterMune, and NewLink."
Venkat Gullapalli, MD, CEO, Medikly
"For years, the pharmaceutical industry has relied on sales reps as one of the primary sources of intelligence for tracking physician behavior, but in the last several years the trend has moved towards a more data-driven approach to understanding and interacting with physicians.
With 99% of physicians online and the proliferation of 'no-see' policies, using big-data analytics makes sense. Yet, although the industry has been moving towards a big data-based model in which multi-channel marketing efforts are informed by various types of digital data, traditional approaches to customer segmentation (traditional market research, etc.) are still the norm. However, 2014 was a turning point—a point where the early adapters started to benefit from an approach in which capturing and organizing large amounts of fragmented data allowed them to create a singular view of their physician audience and to interact with them in a much more targeted, and effective, manner."
Robert Jackson, Experienced Pharmaceutical Sales Representative, Midwest
"In 2014, the pool of pharmaceutical sales representatives continued to shrink as companies focused on cost-cutting and greater reliance on non-personal promotion. When you consider the impact of the proliferation of ‘no-see’ policies and the Sunshine Act, it seems that pharmaceutical sales reps are at risk of becoming extinct."
Barry Mennen, MD, a Washington, DC-based physician, with 30 years of experience in the pharmaceutical industry
"My choice has to be Gilead's Harvoni (ledipasvir and sofosbuvir).This fixed-dose combination that cures chronic hepatitis C with the most common genotype (genotype 1) has changed everything for patients with this disease—whether they've been treated previously or are naive to therapy. Administered orally once per day for 8 or 12 weeks, HCV is cured—in some studies 100% of the time!
No agent introduced in 2014 has the potential to affect as many patients so dramatically.
By targeting two key proteins that the virus needs for replication (NS5A and NS5B), Harvoni blocks the virus' main defense mechanism: mutation. In order to defeat Harvoni, the virus would need to produce two distinct and viable mutations in these proteins simultaneously. The brilliance of this combination has been shown in its clinical efficacy."
Disclaimer: Dr. Mennen has no relationship with Gilead of any kind.
Mark Menning, Co-Founder and Managing Partner, Actera Pharmaceuticals
"2014 was no doubt the year of a hot biotech market as reflected by the large number of IPOs and acquisitions. However, it was refreshing to see the market provide some filtering and not allow just anyone to go public. There were a lot of withdrawn or rescheduled offerings, too. Of note in the acquisitions was Roche/Genentech finally opening the check book with major small-molecule grabs like InterMune and Seragon over the summer."
Leigh Purvis, Director, Health Services Research, AARP Public Policy Institute
"PCSK9 inhibitors were the big game-changer in 2014. I’ve heard estimates that these new cholesterol-reducing drugs will have a price tag of at least $10,000 per year, with a patient population of roughly 10 million Americans. Assuming that’s true, the spending associated with PCSK9 inhibitors is going to be astronomical. And unlike Sovaldi, the costs will not be relatively short-term. High cholesterol is a chronic condition, meaning the costs will be incurred year after year—and that’s before we take manufacturers’ regular price increases into account."
Cornelia Reininger, MD, PhD, Chief Medical Officer, Navidea Biopharmaceuticals
"2014 was quite the year for precision and companion diagnostics, led by recent FDA biomarker & companion diagnostic guidance. Delivering a successful biomarker therapeutic strategy alongside developing a complementary precision diagnostic is becoming the norm with clinical advancements being made daily.
In oncology, for example, precision diagnostics are emerging as a method to improve patient outcomes and their chances of treatment response. Precision diagnostics also provide novel tools that ensure that surgical and drug costs are spent on the patients who actually need them. This saves the healthcare system time and money as well as protecting the patient from detrimental side effects. Through the adoption of biomarker-based, precision diagnostics as standards of care, physicians will have the potential to effectively diagnose patients, assess disease stage and/or progression, inform treatment decisions, and reliably predict response to therapy."
Richard Wasserman, MD, Clinical Professor of Pediatrics at the University of Texas Southwestern Medical School
"The approval of HyQvia was a game-changer in 2014. This therapy will dramatically alter the immunoglobulin market because it combines the advantage of intravenous, IGIV therapy, which is infrequent dosing, with the most important attributes of subcutaneous, IGSC therapy, which supports patient self-administration and has fewer systemic side effects."