Here’s to Looking Ahead

The traditional holiday season is upon us, in the most untraditional of times. While December usually offers “best of” articles or a round-up of the year, this year is more about looking forward to 2021 and what that will bring. And we are lucky to have science on our side, with the vaccines rounding the corner. Nowhere in recent memory has the biopharma industry been more a part of the daily conversation than the past nine months. And behind the scenes, companies quickly pivoted, collaborated, partnered, and shifted gears to address COVID-19 itself, or keep its business running on the therapeutic interest at hand. We will see more next year what COVID has meant to prescriptions, diagnoses, clinical trials or changes in commercialization, and we will be right there detailing that in the coming months, as we have during the past year.

Our January magazine is our milestone Industry Outlook issue, which features the near-term trends contributed to us by our esteemed Editorial Advisory Board. We usually have such a long list, that we choose a final 8-10 on which to focus. But the outlying trends still weigh in on the overall industry, so let’s take a look at what we won’t be taking a deeper dive on.

Lisa Henderson, Editor-in-Chief

• Distribution pathways, access, and affordability. Market access and patient access continue to take center stage, even enlightening those not familiar with this timeless issue under the light of COVID-19. These topics and updates appear on our pages online and in print in a timely fashion.
• Regulatory perception shifts. Some have suggested—between some unfortunate communications from FDA and data questioning from other quarters—that the agency is losing its luster among industry watchers. While individual instances make noise, they don’t necessarily denote a trend or an accurate reflection of all of FDA. With CBER Director Peter Marks, MD, PhD, and Patrizia Cavazzoni, MD, Acting Director of CDER, the full scope of what the drug development industry and its science can accomplish will be well communicated.
• All pharma companies are subject to global requirements. Consider what GDPR has meant to data and privacy in pharma and the amendments made here to adopt to EU stands. The global requirements of, for example, a carbon-footprint, could easily extend outward as overlay effect to all companies. Keep a watchful eye on those developments.
• Also, the overlay effect of biologics. While not all pharma develops biologics, clearly some of the effects could impact the small molecule sector. Quality manufacturing is tied to the delivery of a therapeutic at the outset of development. But also packaging, transportation, and storage; cybersecurity; and public health surveillance brings an aura extending to all companies. Surveillance in the form of the safety surveillance currently conducted or through real-world data capture will be front and center as therapies move more quickly through the process into populations, e.g., COVID.
• The high-priced controversy of therapies. How does industry continue to bring the narrative of the long-term business value of therapies? How is it possible to establish market value for drugs where there is no known value/no market comparison? Hints for the incoming administration that changes are coming, which would have been true regardless of administration; however, rational changes need to be discussed on policy levels.

Then there are other trends that were discussed and will be fleshed out in much more detail in the coming months. Those include sales force structure changes in regard to HCP engagement/environment; diversity in clinical trials; IP sharing and pre-competitive collaborations; pharma’s interaction with PBMs and payers; and our regularly scheduled appearances of the HBA Woman of the Year, Emerging Pharma Leaders, our Pharma 50, and more.

This time last year, we surely didn’t know what was coming our way. But watching the industry respond and pivot and bring its best to bear on multiple levels has been an inspiration.

All of us at Pharmaceutical Executive wish you a safe and happy new year.

Lisa Henderson is Pharm Exec’s Editor-in-Chief. She can be reached at lhenderson@mjhlifesciences.com.