Good Day BIO: What happened at yesterday's hearing on the COVID-19 response

Recapping yesterday’s hearing on the federal COVID-19 response as well as what we learned about the future of clinical trials at the BIO CEO and Investor Conference. (742 words, 3 minutes, 42 seconds)

Admin officials return to Congress to discuss COVID-19 response

Partisan differences were on display as Republicans took the lead in criticizing federal health agency leaders for the COVID-19 response at a joint hearing of the Health and Oversight & Investigations subcommittees of the House Energy & Commerce Committee.

The key takeaway: “It is critical that we understand in detail the federal response,” said Oversight & Investigations Chair Morgan Griffith (R-VA). Both Democrats and Republicans emphasized the need for preparedness; Democrats praised vaccine development (though the role of biotech companies was not highlighted).

We need to reauthorize the Pandemics and All-Hazards Preparedness Act (PAHPA), which “could make a difference between life and death for millions of Americans,” said Health Chair Brett Guthrie (R-KY). (BIO agrees.)

Criticisms were wide-ranging: poor public health data and communication, problems with CDC testing kits, an inadequate national stockpile of protective equipment, inadequate oversight of NIH grants for COVID-19 research, and poor inspection of foreign sites by the FDA.

Trust was a common theme. Republicans said missteps eroded trust; CDC Director Rochelle Walensky and FDA Commissioner Robert Califf cited misinformation. Rep. Frank Pallone (D-N.J.) decried dangerous misinformation from “extremists on the right.”

Lessons learned: “sharing our scientific data faster, enhancing our laboratory quality, translating that science into clear, concise communications,” said Walensky. She and Acting NIH Director Lawrence Tabak emphasized the value of reaching people through community-based organizations.

Equity is driven by local outreach and other factors, said participants:

• Rep. Robin Kelly (D-IL.) said free vaccines improved equity and asked NIH’s Tabak about clinical trial diversity.
• NIH is using lessons learned on community outreach to improve diversity in all clinical trials, said Tabak.
• Rep. Raul Ruiz (D-CA) urged reducing barriers to care and efforts to distribute vaccines to all communities.
• Rep. Tony Cardenas (D-CA) recommended wider translation of messaging into Spanish.

The next steps: The process will continue at upcoming House hearings. Expect both needed discussions on pandemic preparedness as well as political posturing.

5 things to know about clinical trials

During the BIO CEO and Investor Conference, the future of clinical trials came up in several conversations—here are five themes.

1. ‘It’s not an if but how to prioritize CROs.’
Even in a volatile economy, biopharmaceutical companies must continue R&D—especially small and pre-clinical companies. CROs, or contract research organizations, can help. 

In 2023, “it’s not an if but how to prioritize CROs,” said Arda Ural, Ph.D., Americas Industry Market Leader for Life Sciences and Healthcare at Ernst & Young.

2. Trials can be decentralized, but patients should remain at the center.
COVID-19 accelerated the decentralization of clinical trials because we had to “move and sustain trials with urgency,” said Craig Lipset, Founder of Clinical Innovations Partners and Co-Chair of the Decentralized Trials and Research Alliance (DTRA).

But while decentralization may stick around, you still must engage with patients and “have your patient at the center,” said Michelle Keefe, CEO of Syneos Health.

3. AI can improve trials when used correctly.
Everyone’s talking about the roles AI and automation will play in clinical trial design and implementation. This technology can help on the front end, such as determining feasibility, finding the right patients, and onboarding sites.

“You don’t need humans to onboard a site,” said Simon Burns, CEO & Co-Founder of Vial. What’s problematic, he said, is when you have “unstructured” processes like emails, regulatory document capture, and budgeting, which can make it difficult to digitize and automate.

“If you structure, you can digitize and get better data,” he said.

The key is to “marry AI and machine learning with human expertise,” said Keefe.

4. Relationships with regulators matter.
This is especially true in the initial trial design, said Evan Loh, CEO of Paratek Pharmaceuticals, which is developing solutions for antimicrobial resistance. 

“Don’t just listen to your board and make your trial sample size smaller,” he said. “You have to have a discussion with your regulators.” Otherwise, you might compromise the trial.

5. Clinical trial diversity matters.
The omnibus passed last year mandates diversity in clinical trials, and companies “have to have plans in place to show how we will enroll a diverse population,” said Lipset. However, we also need to consider “what will drive sustained commitment to representation in clinical trials. 

Read the whole thing.

President Biden’s Thursday: Speaking about his administration’s economic accomplishments in Tampa, FL. Biden will seek to contrast his policies with Republicans’, including Florida Gov. Ron DeSantis, a potential opponent in 2024 elections, Tampa Bay Times reports. 

What’s Happening on Capitol Hill: The Senate Agriculture Committee will hold a Farm Bill hearing focused on “Commodity Programs, Crop Insurance, and Credit.” The Senate HELP Committee will meet to discuss committee rules and funding.