Series - Early Stage Issues

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.

On May 15, 2024, in combination with PhRMA and the FDA, BIO will host 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.

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.

Big4Bio has heard your concerns loud and clear, and their pre-JPM Week/BioWeekSF online webinar, sponsored by BIO (Biotechnology Innovation Organization), is here to provide solutions and insights that will transform your JPM2024 experience. 

The panelists are industry experts who understand your pain points and provided actionable solutions:
– Dawn Bell, PharmD, Founder/Director, Myracle Therapeutics
– Kimberly Ha, Founder & CEO, KKH Advisors
– Chris Garabedian, Chairman & CEO, Xontogeny
– Lindy Fishburne, Managing Partner, Breakout Ventures

and BIO Partnering at JPM Week context from
– Mackensie Vernetti, Vice President, Partnering, Biotechnology Innovation Organization (BIO)

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.