BIO CEO's letter: 'The next 50 years'

BIO CEO John Crowley’s annual letter to members: ‘The next 50 years’

BIO President & CEO John F. Crowley noted the 50th anniversary of biotech in his annual letter to BIO’s members, sent April 8. Some excerpts:

Why it matters: “As we embark upon the next 50 years, a stark question confronts us: America invented modern biotechnology, but will we author its next chapter or watch it be written somewhere else?”

International challenge: “China is now investing at unprecedented speed and scale, with a coordinated national strategy to dominate biotechnology and biomanufacturing. At the same time, here in America, our system for research and development of newer and better medicines has grown overly complex and costly.”

Policy challenges include price controls and “efforts to undermine vaccine confidence, restrict mRNA and advanced technologies, and weaken intellectual property protections.”

Most favored nation (MFN): “Perhaps the greatest threat facing our industry is the push to codify MFN policies into law by importing socialist price controls. … BIO is actively advocating against these proposals, which would impose international reference pricing schemes that undermine America’s leadership as the world’s most innovative market.”

Food and Drug Administration (FDA): “One of BIO’s top priorities is pushing for bold reform of the FDA and our clinical trial system. … It is imperative that FDA keep pace if we want to maintain America’s lead in the biotechnology revolution.”

BIO’s Board set long-term priorities in March:

• Access: “Advance proposals to ensure real access and affordability to medicines.”
• Innovation: “Protect and strengthen America’s biomedical leadership by continuing to advance policies that aid innovation and company growth.”
• Storytelling: “Let’s humanize who we are, what we do, and why we do it.”
• Institutional strength: “A stronger BIO is able to deepen member value, expand investor tools, and operate more effectively.”

Read the full letter.

BIO patient advocacy Coffee Chat: Venture philanthropy and risks of MFN

The BIO Coffee Chat, where patient advocates share ideas and discuss challenges and trends, covered venture philanthropy and the threat of Most Favored Nation (MFN) pricing in March.

Price controls like MFN and the Inflation Reduction Act limit access while often actually driving up costs for patients, advocates said.

Access is harmed through reduced innovation and drug availability according to panelists, who spoke of the challenges of obtaining medicines in European and Asian markets.

Why this matters: “Affordability and timely access remain a persistent challenge, both in the United States and abroad,” said Karin Hoelzer, Senior Director of Patient Advocacy at BIO. “Recent efforts by policymakers to implement arbitrary drug price controls are exacerbating these barriers while, paradoxically, increasing out-of-pocket costs for many patients.”

Read more in Bio.News.

Venture philanthropy sees patient advocacy organizations acting as investors, partners, and strategic guides, alongside biotech firms, to help derisk early-stage assets. Deploying patient-driven capital, disease expertise—and the power of patient-generated data—these organizations enable development of potentially transformative therapies.

Why this matters: “In many cases, patient advocates are helping the entire innovation ecosystem work most effectively—from drug discovery through market access and beyond,” said Hoelzer.

Read more in Bio.News.

What Else to Read

BIO welcomes proposals from FDA to expedite clinical trials. The Food and Drug Administration (FDA) outlines a plan in its 2017 spending proposal to create a New Clinical Trial Notification Pathway to expedite first-in-human trials by eliminating duplicative requirements. “There is resounding agreement that we need to make drug development and the FDA’s regulatory process more efficient, transparent, and predictable, and we welcome proposals that will increase domestic efficiency and lower cost in early drug development,” said a statement from Annetta Beauregard, BIO SVP for Science & Regulatory Affairs. “That includes reducing the time, cost, and complexity of early-stage research and advancing modern trial approaches. We look forward to learning more about the legislative proposal.” Read more here.

Delaware’s life science firms excel, but continued success requires investment, writes Michael Fleming, president and CEO of the Delaware Bioscience Association in Delaware Business Times. For example, BioCurie, a small Delaware biotech “using AI to transform how life-changing cell and gene therapies are manufactured,” recently won “a highly competitive $9.3 million ARPA-H grant to advance its novel AI platform for scalable biopharmaceutical manufacturing.” Delaware Bioscience seeks to keep talented graduates of Delaware universities in the state by paying down student loans through the state-backed STAR Fund, which should be continued, Fleming writes. “The full potential of our early-stage science and technology companies can only be realized through continued investment,” he says. Read more here.

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