Series - Policy

The biopharmaceutical ecosystem is facing heightened uncertainty, driven by funding constraints, regulatory shifts, and policy reforms—including pricing pressures and the potential expansion of international reference pricing. These dynamics are reshaping dealmaking and raising critical questions for companies pursuing global out‑licensing strategies.

Join experts from Covington for a timely discussion on how these trends are influencing licensing decisions, with insights on:

• Structuring Out‑Licensing Agreements and Territory Splits – strategic and practical considerations
• Policy Impacts on Licensing – Key developments in the U.S. and EU
• Executing Near‑Term Deals – practical guidance in an evolving market

This program is currently under review for Continuing Legal Education (CLE) credit. A determination is pending, and participants will be notified once an accreditation decision has been made.

In September 2025, the U.S. FDA launched a major enforcement campaign targeting direct-to-consumer (DTC) pharmaceutical advertising that misleads patients or downplays risks. Following a September 2025 presidential directive, the agency announced hundreds of enforcement actions—including over 100 cease-and-desist letters—signaling a zero-tolerance stance toward unbalanced or deceptive ads. While most of the letters focused on DTC content, FDA also sent letters for health care provider (HCP) promotion. The message: Government scrutiny and enforcement will significantly increase for biopharma as well as medical device promotion. This webinar includes regulatory compliance and drug advertising compliance experts who dissect the FDA’s mindset and ways to proactively mitigate concerns.

In this webinar, panelists:
– Drill down into FDA’s renewed enforcement areas
– Dissect the implications of increased enforcement on the industry
– Identify specific cases that are clear examples for company concern
– Isolate the key principles for avoiding violations and demonstrating good faith

Is this the first time you’re attending BIO International Convention? This webinar is for you! We’ll cover all the basics of where to go and what to do - plus, you’ll get some insider tips from the BIO team on this year’s exciting event. 

If you haven't already registered, please learn more and register at convention.bio.org

The FDA has established the Split Real-Time Application Review (STAR) pilot program. The purpose of this program is to shorten the time from the date of a complete submission to the action date, in allowing earlier patient access to therapies that address an unmet medical need.

In this webinar, FDA staff will give an overview of the program, including the eligibility criteria for the pilot, and will answer your questions about participating in the program.

View this conversation highlighting how BIO member companies are strengthening food security and addressing climate change through biotechnology innovations in crop protection and efficient food production. Learn how regulation and policy can support agricultural innovation to protect our environment and our food supply.

View this conversation highlighting how BIO member companies are leveraging biotechnology innovations to enable advances in climate adaptation, mitigation, and resilience. Hear how diverse feedstocks and manufacturing processes are targeting emission reduction breakthroughs in hard-to-reach sectors. Learn how regulation and policy can better incentivize innovation and be structured to support new and emerging technologies throughout research, development, demonstration, and deployment.

​It's been one year since the passage of the IRA. The Centers for Medicare & Medicaid Services has moved forward implementing the law's various provisions, including the new Medicare negotiation program and the redesign of the Medicare Part D benefit. Learn the latest developments from our panel of experts, including how the IRA is impacting biopharmaceutical companies today. Panelists delve into other important issues beyond the IRA, including new developments in Medicaid, 340B, and the emergence of Prescription Drug Affordability Boards in a number of states.  

Following reauthorization by Congress of the SBIR/STTR Programs in 2022, there are new rules companies should familiarize themselves with concerning required disclosures of foreign affiliations or relationships with foreign countries. In addition to mandating disclosures prior to receiving SBIR awards, companies must also regularly update NIH following any changes to a disclosure. View this webinar organized by the Biotechnology Innovation Organization (BIO) for a comprehensive discussion on how to effectively navigate these new rules as you apply for SBIR awards.

This webinar is co-hosted by the National Institutes of Health (NIH) Seed Office.

View this important webinar for those invested in the broader biotech industry, "Understanding the Business Implications of Global Access and Benefit Sharing Policies." Tailored for members of BIO and a diverse community of stakeholders, this high-level session focuses on understanding the impact of recent developments in the global policy arena that will affect industry’s access to vital biologic materials and information. These policies have implications for the way industry will need to share the potential benefits that flow from their use of these physical and digital resources worldwide. Through interactive discussions led by seasoned experts across the Biotech ecosystem, explore the intricate relationship between national and global concerns, while uncovering the potential implications for your company. This webinar will equip you with the knowledge and insights essential to thriving in an ever-evolving global biotech landscape for an empowering dialogue that promises to shape the future of biotechnology.