Tune in as Glenn Hunzinger, PwC’s Health Industries Leader, connects with Matt Rich, PwC’s Pharma and Life Sciences R&D Leader, to unpack the recent disruption at the FDA and what it means for the pharmaceutical and biotech sectors. They discuss how companies can stay agile in the face of regulatory uncertainty, avoid preventable delays, and take practical steps to move programs forward with clarity.

Discussion highlights:

• Ongoing restructuring at the FDA is creating uncertainty and delays in drug and device approvals, with wide-ranging impacts across the pharma, biotech and medtech landscape.
• While companies can’t control the regulatory environment, they can focus on improving internal speed, efficiency, and submission quality to keep programs moving forward
• Avoiding preventable missteps, or “foot faults,” in data, endpoints, and submission packages is critical to reducing review delays and regulatory pushback
• Diversifying risk by pursuing parallel regulatory pathways in other regions such as Europe and Japan can help accelerate access and reduce dependency on a single agency
• In the absence of a clear playbook, companies should focus on what they can control by applying past lessons, staying disciplined, and collaborating across the industry to support more efficient FDA review processes

Speakers:

Matt Rich, PwC’s Pharmaceutical and Life Sciences R&D Leader
Glenn Hunzinger, Partner, Health Industries Leader, PwC

Linked materials:

Navigating the FDA disruption: 4 key actions for pharma

For more information, please visit us at: https://www.pwc.com/us/en/industries/health-industries/health-research-institute/next-in-health-podcast.html.

Tune in as Glenn Hunzinger, PwC’s Health Industries Leader and Roel van den Akker, PwC’s Pharma and Life Sciences Deals Leader discuss the rapid rise of China’s biotech industry and what it means for U.S. pharmaceutical companies. They discuss the evolving role of Chinese biotech in the global innovation landscape and share perspectives on how U.S. pharmaceutical companies can thoughtfully assess opportunities, manage cross-border complexities, and build effective partnering and diligence strategies.

Discussion highlights:

• China’s biotech industry is growing fast and becoming a global player, with U.S. companies increasingly looking to partner with Chinese firms on cutting-edge science
• U.S. pharma leaders are encouraged to move beyond skepticism and stay curious by building relationships, learning from local innovation, and exploring new partnership opportunities
• Successfully partnering with Chinese biotech firms requires a careful and well-structured approach that accounts for global complexity, protects data and IP, and uses creative deal structures like new company formations to manage risk and stay flexible
• U.S. companies need to be proactive in order to stay competitive by actively exploring global innovation, understanding the risks, and having a clear strategy to bring high-potential science to U.S. patients

Speakers:

Roel Van den Akker, Pharmaceutical and Life Sciences Deals Leader
Glenn Hunzinger, Partner, Health Industries Leader, PwC

Linked materials:

China's rise as a biotech innovation hub: 4 key strategic questions for US biopharma executives

For more information, please visit us at: https://www.pwc.com/us/en/industries/health-industries/health-research-institute/next-in-health-podcast.html.

Disclaimer: This episode was recorded on April 11th, 2025, and reflects the information available at the time of recording. As we know, America is in motion here, and so subsequent updates may not be reflected in this discussion as things continue to evolve and change.

Tune in as PwC specialists from across the health industry share their insights on how recent policy shifts under the Trump administration could shape healthcare in the years to come. In this episode, Glenn Hunzinger, Jenny Colapietro, and guests Kelly Griffin, Phil Sclafani, and Ruchita Kewalramani break down the potential implications of proposed government healthcare cuts, tariff policy and agency workforce reductions, along with the growing role of AI in the industry. They also discuss how pharma, medtech, payers and providers can stay ahead amidst the uncertainty.

Discussion highlights:

• Proposed funding cuts to major government healthcare programs like Medicare, Medicaid, and NIH could significantly disrupt access, affordability, and service delivery across the healthcare landscape.
• Workforce reductions at federal agencies like the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and Health and Human Services (HHS) may slow drug approvals, diminish oversight, and impact public health standards.
• New and evolving tariff policies are creating cost pressures across pharmaceutical and medtech supply chains, with potential downstream impacts on pricing, R&D, and patient access.
• The rapid adoption of AI in healthcare is creating new opportunities across diagnostics, R&D, and operations, while also raising concerns around governance and data privacy.
• To stay ahead, industry leaders must assess risks, strengthen agility, and uncover opportunities to innovate in today’s dynamic environment.

Speakers:

Kelly Griffin, Director, Health Policy Intelligence Institute, PwC
Ruchita Kewalramani, Partner, Health Services PwC
Phil Sclafani, Partner, Pharma & Life Sciences, PwC
Glenn Hunzinger, Partner, Health Industries Leader, PwC
Jenny Colapietro, Principal, Consulting Commercial Leader, PwC

Linked materials:

Health Policy and Intelligence Institute

For more information, please visit us at: https://www.pwc.com/us/en/industries/health-industries/health-research-institute/next-in-health-podcast.html.