Investment and innovation are booming, but…

We heard directly from Dr. Patrizia Cavazzoni, Acting Director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). Below, find highlights from her conversation with Dr. Cartier Esham, BIO’s VP for Emerging Companies.

How are things at FDA? Following a period of adaptation, FDA has reached "a steady state when it comes to reacting to the virtual environment," and continues leveraging virtual platforms to conduct meetings with sponsors.

When it comes to inspections, FDA has made "substantial adaptations," including using information shared by trusted regulatory partners, requesting records directly from facilities in lieu of on-site drug inspections, and actively exploring alternatives for remote/live interactions.

How will we know treatments being developed so quickly will be safe and effective? FDA requires "substantial evidence of effectiveness" with results from "adequate and well-controlled trials," she said. "This substantial evidence standard underpins the decision for approval."

FDA has a "robust and well-proven system" for monitoring post-market safety of drugs, she added, including through the Sentinel System and using reviews of adverse event reports. (Read the live blog for her explanation of the difference between “approval” and an “Emergency Use Authorization.”)

Long term, Dr. Cavazzoni hopes the use of digital technologies and decentralized trials will help facilitate clinical trial enrollment and retention, while "optimizing or promoting clinical trial diversity." One challenge to clinical trial diversity has been limitations on having clinical trial sites in areas where they can reach diverse populations.

Biotech investment is booming and we’re getting closer every day to new vaccines and therapeutics for COVID-19. But, it’s important to heed the warnings of experts about the impact of policy on biotech’s bright future.

2020 has been the strongest on record for biotech—with record IPOs, record follow-on offerings (or FPOs), a significant uptick in private investment, significant new fund formation, and strong capital formation, said experts in the market outlook session.

But drug pricing proposals could affect investment and innovation. During the election outlook session, Mike Mattoon, BIO’s VP of Federal Government Relations, said President Trump’s “most-favored nation” drug pricing scheme is similar to H.R. 3, Speaker Pelosi's drug pricing bill, which the president’s own economic advisers said would lead to fewer drugs due to less investment in R&D.

"Basing pricing and reimbursement on, in some cases, the lowest price paid in certain countries" could lead to what Mattoon called a "downward spiral" as it would create added risk for investors trying to fund research that’s already risky.

Learn more about the dangers of foreign price setting here.

"Price controls don’t work to incentivize innovation," said Rachel King, CEO of BIO member GlycoMimetics. Watch:

There’s a lot of work to do to improve diversity and inclusion in the biotech industry. How do we get there? Yesterday, experts provided practical advice.

"There’s a disparity between the U.S. population and what it looks like for the pipeline," said Brady Huggett, Senior Editor at Nature Publishing Group, who moderated the session. "That disparity is increased when you look at who works in this industry and then it’s increased again when you look at venture."

Change has to come from the top. "It’s our responsibility as leaders in the field to ensure that we are promoting diversity from the highest levels across all of those segments of the ecosystem in order to bring people in and train them," said Sonia Gupta, Managing Director at Goldman Sachs & Co.

"What matters more than the size of the company is whether people at the top view it as a priority," agreed Susan Angele, Senior Adviser for Board Governance at KPMG.

Both large and small companies can take steps to tackle the problem. Grace Colón, President and CEO of InCarda Therapeutics, explained how her small biotech is broadening their pool of potential candidates and creating a culture of inclusion. Watch:

Broadening networks is a good place to start, especially if you work in venture capital, explained Jackie Grant, Principal at Abingworth, who recently wrote an op-ed, Investing in racial diversity: a call to action to the venture capital community.

For more concrete actions your company can take, read BIO’s report, Measuring Diversity in the Biotech Industry: Building an Inclusive Workforce.

More News:

Delaware Business Times: Viewpoint: Delaware’s bioscience sector is critical to its future
"The extraordinarily successful initial public offering by Prelude Therapeutics (PRLD) last month made clear investors’ immense confidence in prospects for the Wilmington biopharmaceutical company," writes Michael Fleming, President of the Delaware Bioscience Association.

President Trump’s Thursday: Campaign rally in Greenville, NC, then meeting with fundraisers in Doral, FL. President Trump will participate in a live town hall on NBC News at 8:00 PM ET, while VP Biden will participate in a live town hall on ABC News, also at 8:00 PM ET. 

What’s Happening on Capitol Hill: The chances of Congress passing a coronavirus stimulus package before the election are "almost gone," reports Bloomberg. Senate Judiciary continues consideration of Judge Amy Coney Barrett, who yesterday said she does not have "firm views" on climate change and, as expected, continued to decline to opine on the Affordable Care Act.