After months of delay and suspense, in a Rose Garden ceremony, President Trump and HHS Secretary Alex Azar announced a comprehensive approach to prescription drugs, which they claimed would address major challenges.
I imagine George Yancopoulos, profiled on this month’s cover, to have gained some of his life’s wisdom in a similar fashion to most people — by trying new things.
Tawni Koutchesfahani, director of manufacturing strategy at Relypsa, says pharmaceutical manufacturing must diversify if it is to thrive. That means the recruitment and retention of more women and more millennials.
Biopharma startups are enjoying a window of opportunity for successful IPOs that opened in mid-2017. CEOs share their experiences of going public, what is fueling IPOs, and tips for others thinking about making this important next step.
It takes more to enter the biosimilar business than simply being a leading innovator in the biologics space. As several Pfizer experts shared, there are some integral transitions, both in mindset and in terms of practice, that need to occur to fully embrace biosimilars.
Sage Therapeutics’ CEO Jeff Jonas, M.D., discusses what he means by a “return to the basics of science” at his company.
Summary: Jeff Jonas, M.D., CEO of Sage Therapeutics, discusses some of the challenges of launching a product that could change the paradigm of treating postpartum depression (PPD).
Three manufacturing executives from three different companies (i.e., Allergan, Biogen, and GSK) tackle questions on trends, regions, and the future of biopharmaceutical manufacturing.
Four biopharma manufacturing executives disclose what they are doing at their organization that will have a big impact on manufacturing operations in 2018 and beyond.
In slowing down long enough to be deliberate, thoughtful, and proactive in your approach, you lay the necessary foundation to go faster where it counts.
I’ve heard it said that innovation in the biosimilar world extends beyond the actual scientific and technical development of the product; innovation also applies to the act of changing and shaping regulations and perspectives. This year’s conference really emphasized the specific tasks being carried out by members of biosimilar companies, patient advocacy groups, payers, and research organizations to change and advance perspectives.
Much of the focus these days, especially after the release of ICH E6(R2), has been on how Sponsors can better monitor and oversee the performance of their CRO partners. This discussion, and resulting effort, around CRO oversight is worthwhile and useful, but too often it is narrowly focused on metrics. A holistic approach to successfully partnering with CROs is needed, starting with the initial assessment of outsourcing drivers all the way through to trial completion.
Sponsor companies are increasingly examining ways to integrate the payer community’s point of view into clinical development activities, a trend that could improve the chances a drug will gain market access, achieve faster adoption once launched, and better meet patient needs. With payers increasingly demanding evidence of a drug’s value before they will cover a marketed product, demonstrating both better clinical and economic benefits of a treatment takes on greater significance.
I spent the first two decades of my medical device career with startups and larger OEMs, working with or hiring consultants, as needed, for support. I then became a consultant for seven years, and I saw outsourced support from the other side. Now, I want to share some perspective on outsourced support. These important relationships can make or break your business.
To come out on top, some medical device companies are dedicating more attention to the workplace as a competitive differentiator. Investing in smart real estate and facilities strategies can pay dividends in helping companies win and retain the best talent. What’s working?
As the divorce date approaches for the U.K. and the EU, one would be forgiven for thinking there would be a plan in place to deal with an event that will have such a profound global impact on the pharma industry. However, manufacturers have to prepare for any possibly scenario, while continuing to wait for clarity.
The challenge to recruit and retain numbers of patients for Phase 3 industry-sponsored trials is not new to the industry. In fact, 48 percent of sites miss their enrollment targets and 80 percent of trials are delayed due to recruitment, but there are new opportunities to achieve recruitment goals while also minimizing dropout.