Series - Scientific Developments

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.

This webinar will help BIO 2024 attendees/exhibitors better prepare for their on-site experience at the event. We will provide important and practical on-site information, including programming and interactive event opportunities, as well as further instruction on how to more effectively use advanced features of the BIO One-on-One Partnering™ and Exhibitor platforms.

Gain valuable insights to make the most out of your participation at the upcoming BIO International Convention in San Diego this June!

To learn more about attending BIO 2024, visit http://convention.bio.org

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 BIO International Convention attracts 15,000+ biotechnology and pharma leaders for one week of intensive networking to discover new opportunities and promising partnerships. Position yourself for success at this year's event, June 3-6, in San Diego! BIO is where business and breakthroughs converge – and the BIO One-on-One Partnering™ system facilitates the connections that fuel our industry.

Attend this webinar to learn more about what’s happening at BIO 2024 and what the BIO One-on-One Partnering™ system can do for your business goals. Explore the program, networking opportunities, partnering system fundamentals, gain insight to best practices for partnering, and much more! For more information and to register for BIO 2024, please visit: convention.bio.org

Join BIO staff as they walk exhibitors through the tools needed to plan for BIO International 2024!

The goal of this webinar is to provide our exhibitors with the resources to have an impactful presence in San Diego as well as provide additional details.

The following topics will be discussed:

• Exhibitor Dashboard
• Exhibitor Resources
• Exhibitor Partnering
• Important Dates and Deadlines
• Frequently Asked Questions (FAQs)

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.

Announcements around and during JPM Week each January often create waves throughout the biotechnology ecosystem. View this Biotechnology Innovation Organization (BIO) webinar to learn what experienced dealmakers and market analysts found most relevant and influential from JPM Week to consider when planning your own capital formation and partnering priorities for 2024. The discussion covers developments affecting M&A trends, the IPO window, licensing trends, biotech AI, and investor sentiment.

This webinar will also preview the program for the BIO CEO & Investor Conference, February 26-27, and explain how BIO’s One-on-One Partnering during the event can help you make progress against your 2024 priorities.

Want to learn more about events happening during JPM Week 2024 and how you can better navigate (and survive) it all?
 
View this webinar to get a grasp of all your options for networking and educational opportunities, hear from two panelists on how they approach this busy week, and start planning with BIO & Novateur's Event Guide to JPM 2024, a free mobile app. This webinar covers:
 
—Tips & tricks to make the most of JPM Week
—Receptions and other networking opportunities
—Conferences, presentations and other educational events
—Overview of BIO and Novateur Ventures’ JPM Week Events Guide mobile app
—BIO’s onsite meeting space in San Francisco and BIO Partnering at JPM Week

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.