"Hyper-Innovation" In Pharma: FDA Approvals Are Just The Start
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
The big news coming into 2015 was the FDA’s 2014 approval record. The agency approved a total of 41 new drugs in 2014 — its highest record in 18 years since it churned out 53 in 1996.
AstraZeneca saw the highest number of approvals for the year, winning an FDA nod for four drugs targeting diabetes, generalized lipodystrophy, OIC, and ovarian cancer. Biogen Idec and Eli Lilly followed closely behind, each with 3 drugs approved in 2014.
The approved drugs covered 10 therapeutic areas. Infectious diseases garnered 12 treatment approvals. Oncology came in second with eight approvals, followed by rare diseases with five approvals. Forbes has compiled a complete list of the approved treatments that can be found here.
It’s clear, after this surge in approvals, that the industry has increased its productivity. Pharma is slowly clawing its way out of what Forbes has labeled the “painful trough” of 2005-2010. But what do these recent approvals tell us about where we are headed — or where we need to be headed — as an industry?
Forbes expects that this approval rate signifies we are entering an age of “hyper-innovation.” While we haven’t reached the same high number of drug approvals we had in 1996-97, what is being approved boasts much higher cure and remission ratings. There are also new technology initiatives being launched that promise to make drug R&D a cheaper and more efficient endeavor. Just this week, in fact, Amgen and Kite pharma announced a new collaboration to develop and commercialize Chimeric Antigen Receptor (CAR) T-cell immunotherapies. Novartis joined forces with Intellia Therapeutics for its gene-editing tools. Forbes also calls attention to the industry’s growing interest in biochips and bioprinting technologies.
But we also are in the age of R&D restructuring as companies face patent expirations. According to Global Data, pharma companies are poised to lose $65 billion by 2019 after patent expirations. In fact, 2014 drug approval winners Eli Lilly and AstraZeneca are two of the companies GlobalData singles out that will particularly feel the pinch.
To bolster pipelines, there are a number of companies entering into mergers and acquisitions — a trend expected to continue through 2015, Bloomberg reports.
A large number of new drug approvals might not necessarily be the answer, however, says Fierce Biotech’s John Carroll. Instead, industry will continue to reorganize, change, and/ or “hatchet down storied research complexes,” all of which he considers to be “more the norm than the exception.”
But to me, these changes in R&D signify that the industry is adapting itself to the age of open innovation. Companies like AstraZeneca, GSK, and Pfizer are regularly entering headlines for their newest initiatives to keep research alive — even if that research is not being carried out solely in-house.
Last summer, AstraZeneca embraced open innovation with its plans for a new “see-through” lab in Cambridge. The company also just jumped on board with GSK and five other big names — Janssen, Lilly, Pfizer, Takeda, and UCB — to create a “virtual” library of failed molecules in the hopes that the partners will be able to find new and exciting uses for them.
Even Pfizer, which has been the topic of much discussion because it sliced-and-diced its R&D, was the feature of an article in The Boston Globe this summer after launching its newest research lab for its rare diseases, inflammation, neuroscience, and cardiovascular pipelines. Like AstraZeneca’s see-through lab, Pfizer has shunned office spaces in favor of open workstations that create a collaborative atmosphere that is “a cross between serious science and move-in-day at a college dormitory,” writes The Boston Globe.
It seems to me that the industry’s continued forays into open innovation will be the real key to “hyper-innovation.” While patent expirations and the creation of new blockbusters to support business are real pressures for companies as large as Pfizer, we’re continuing to see a refreshing change in point of view on innovation. No longer a singular task, teamwork is proving necessary to achieve “hyper-innovation.”
As Guierrez-Ramos told The Boston Globe, “There are a few things — the chemical structure of a drug or the protein sequence of a therapeutic antibody — where we need to take precautions [and protect from others],” he said. “However, those are only 10 percent of our activity. The other 90 percent can be shared.” This is a viewpoint I certainly hope to continue seeing pervading the industry long into the future.