Series - Early Stage Issues

View this webinar for an in-depth exploration of today's complex global market landscape. This panel will address the challenges of launching new therapies in multiple countries, focusing on early decision points for risk mitigation and maximizing supply chain resiliency. Discover how Cencora's global capabilities and flexible solutions can strengthen supply chain resilience amidst evolving challenges.
 

Moderator: Sandra Anderson, Senior Vice President Commercialization, Cencora

Panelists:

• Glenn Pauly, Chief Commercial Officer, Alzheon
• Graham Goodrich, Chief Commercial Officer, Apnimed
• Leigh Shultz, PhD, Associate Vice President & International Head of Trade Channel Strategy & Enablement, Merck & Co.
• Kevin McDermott, Vice President International Commercialization, Cencora
• Tom Doyle, Head of U.S. Commercial Solutions, Cencora

Through 2027, the FDA is conducting a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program to facilitate CMC development of selected products under investigational new drug applications with potential expedited clinical development timeframes. The pilot is a joint effort by both FDA's Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Selected drug development programs receive extra opportunities to discuss product-specific CMC concerns with the FDA reviewers through CMC-focused Type B meetings to help product development keep pace with their clinical development.

In combination with PhRMA and the FDA, BIO hosted a webinar to inform BIO and PhRMA's memberships about the CDRP: What sorts of products are eligible, what is needed to apply, and why an IND sponsor of a promising product with an expedited clinical development timeframe would want to enlist in this pilot. This webinar will provide additional insights into the CDRP application process, and the planned public workshop designed to promote innovation and understanding in product development.

More than $4B of deals between biopharma companies and AI specialists were announced last year. Similar to the massive quality leap from GPT-2 to GPT-4 and the record-breaking consumer adoption rates of AI tools, that same exponential progress and uptake is coming to biotech AI. 2024 may bring the first one-trillion-parameter protein language model. Companies are already using AI to program, as opposed to discover, antibodies. This level of opportunity and change brings with it urgency—— companies need to rethink from the ground up how their R&D should work to compete in a new era defined by the intersection of biology, data, and AI.

In this webinar, learn how companies are updating their approach to R&D, with a focus on:

1. AI-Ready Data: Improving generation of high-quality biomedical data to support AI model building and model tuning
2. AI-Enabled Scientists: Integrating the right models directly into scientists’ workflows for everyday use
3. Scalability: Making performance, speed, privacy, and cost tradeoffs for deployment of AI, and connecting the wet and dry labs

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.

With the majority of biological studies conducted in academic settings but nearly all innovative new drug clinical trials sponsored by industry, improving translational research success rates for commercialization is critical to bringing new treatments to patients. Surveys of academic tech transfer offices and the biopharma industry executives working on such alliances cite as obstacles two highly controllable factors: disagreement about alliance performance metrics and misalignment of deal terms priorities. This panel discusses best practices for removing such obstacles to accelerate more promising ideas into clinical development for patients.

BIO's updated 2023 report, "U.S. Biotechnology Translational Research: Partnership Models, Management Principles, and Best Practices," is available for download at the link below.  The webinar also summarizes major findings from that BIO report as context for the panel discussion and audience Q&A.