Series - Early Stage Issues

BIO's new and improved partnering system — BIO Partnering™ — will open for the 2025 BIO International convention in early April. Join BIO's VP of Partnering, Mackensie Vernetti, for a webinar showcasing the new platform, complete with an in-depth live demo, as well as partnering tips and best practices. This webinar will provide the tools and guidance to maximize your experience at the event.

Key Takeaways:

• In-Depth Look at the Partnering System: Learn about features that streamline partnering discovery and make easy work of meeting management.
• What's New: See the newest system enhancements in action.
• Best Practices: Advice on how to search and find partners, send quality meeting requests and triage your messages.
• Quick Tips: Discover shortcuts and helpful tools to save you time.

Learn more about the BIO International Convention at

https://convention.bio.org/

The BIO International Convention is the largest and most comprehensive event for biotechnology, representing the full ecosystem of biotech with 20,000 industry leaders from across the globe.

In a time of remarkable discovery and progress, the biotechnology industry stands at the forefront of a revolution changing how we live, heal, and care.  View this webinar for a tour of the program's featured sessions, super sessions, and notable expert speakers, across the more than 140 sessions planned for BIO 2025 in Boston, June 16-19.   Also, this webinar will be your first look at several new program session types and event surprises in progress, including a BIO Storytelling Stage, new evening reception venues, and an expanded main stage experience that will debut this year.  The webinar includes advice on planning your calendar to maximize the value of attending.

Join Sydney Williams, BIO Senior Manager, Exhibit Sales & Systems, for a webinar to walk exhibitors through the tools needed to plan for the 2025 BIO International Convention. 

This webinar gives our exhibitors the resources to have an impactful presence in Boston. 

The following topics are discussed: 

• Exhibitor resource center
• Exhibitor tools and resources
• Tips to maximize your event experience in Boston

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.