What should be in PAHPA?

What happened on the Hill yesterday with PAHPA and R&D amortization—plus, three tips from an expert on making a biotech partnership a success. (717 words, 3 minutes, 35 seconds)

What should be included in PAHPA?

BIO’s Phyllis Arthur testified on Capitol Hill yesterday expressing BIO's views on how the U.S. Government can better prepare for the next pandemic.

The hearing: During yesterday’s House Energy & Commerce Health Subcommittee hearing, Members of Congress and witnesses—including Phyllis Arthur, BIO’s SVP for Infectious Disease and Emerging Science Policy—discussed the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). 

Why it matters: “This is an important moment for our nation as we emerge from a, hopefully, once-in-a-generation pandemic allowing us to take stock of lessons learned. The important question to ask is, are we more prepared today than we were in 2019? Unfortunately, it is not evident that we are,” said Arthur in prepared testimony.

On AMR: Not including the PASTEUR Act in PAHPA reauthorization would be a “missed opportunity,” said Rep. Nanette Barragan (D-CA). “Having antibiotics and antifungals to treat people in a rapid way is really important in a lot of disasters,” agreed Arthur.

On DiseaseX: Rep. Lori Trahan (D-MA) noted bipartisan support for preparing for unknown viral threats but expressed disappointment with flat/static funding. Arthur highlighted the need to advance monoclonal antibodies, platform technologies and oral antivirals to replicate what we did preemptively with smallpox and apply during the MPOX outbreak.

On march-in rights: “Policies on reasonable pricing and march-in rights have been tried elsewhere and have shown many negative impacts,” said Arthur in response to a question from Rep. Larry Bucshon, M.D. (R-IN). This would present an “even greater threat” to medical countermeasures. 

On learning from COVID: “That kind of partnership where the expertise and experience of industry—for manufacturing, clinical trial development, knowing how to manufacture products well—was really coupled well with the government’s leadership and facilitating that process. This is the kind of partnership that we need in the interpandemic period so that we’re actually ready to go in less time than one year,” she said.

The bottom line: “Congress must continue to send a strong signal that it is committed to prioritizing national health security and health defense by providing the resources and authorities needed to fully prepare for and defend against biological threats,” concluded Arthur.

3 keys to a successful biotech collaboration

“Partnership has been the key to developing and delivering many of today’s most important medicines to patients,” says Genmab EVP and COO (and BIO Board member) Anthony Mancini, who has two decades of experience in biotech partnerships. In a Bio.News exclusive, he explains how to make partnerships a success.

1. Put a stake in the ground together.

“In the most successful partnerships, both companies have determined early on that, despite their uniqueness, they share the same end goal, whether that be launching a new medicine or developing a new investigational asset,” Mancini says.

2. Invest your time and your best people…and build trust.

Partnerships take work. But: “With strong culture and clear governance in place, the alliance team will have the tools they need to more efficiently make decisions together, ultimately building trust and effectiveness over time.”

3. Don’t fear evolving your partnership—for the right reasons.

Sometimes, the partnership needs to change—but if you’ve built trust, you can change together.

“In my experience, the best things in partnerships happen when leaders come together and have honest conversations about their company’s goals, the performance of the alliance, and new or different resources that could further enhance the alliance,” says Mancini.

Why it matters: There were over 57,000 partnering meetings at the 2023 BIO International Convention—meaning 57,000+ potential biotech partnerships coming soon to bring innovations to patients. 

Read the whole thing at Bio.News.

President Biden’s Wednesday: This evening, he’ll deliver remarks at the League of Conservation Voters dinner at The Anthem in D.C.

What’s Happening on Capitol Hill: Yesterday, House Ways and Means reported out three tax bills and one trade bill, including one to retroactively restore the deduction of R&D expenses and delay amortization until 2025. While both Republicans and Democrats expressed support for repealing the newly enacted R&D amortization, the parties continue to disagree over the scope of an overall tax package. Of note, Rep. Greg Murphy, M.D. (R-NC) discussed the impact of R&D amortization on small molecules research companies—watch the full (and long) markup. Today, the House Energy and Commerce Health Subcommittee will hold a hearing on legislative proposals to support rare disease patients and research, while House Appropriations will mark up Agriculture-FDA spending bills.