Series - Early Stage Issues

Join Thermo Fisher Scientific for an exclusive webinar introducing a transformative approach to biologics development and clinical scale-up. Their "Path to IND for Biologics" method accelerates the journey from DNA to IND/IMPD submission and first-in-human clinical trials in as few as 9 months. Dr. Elena Gontarz, a leading expert in the biologics industry, will guide you through this innovative process, leveraging AI/ML, transposase technology, and integrated solutions during the session: "Path to IND for Biologics: From DNA to First-in-Human in 9 Months." Following the presentation, Dr. Gontarz will answer audience questions and discuss how these novel strategies can streamline the development of complex biologics, such as Fc-fusion proteins and bispecific antibodies, driving them swiftly from development to commercialization.

Get a sneak peek on this novel platform 

Terms and Conditions: Titer levels provided are estimates based on third party results and may vary depending on molecule type or other factors. Timeline from DNA to drug product and start of clinical trials for all path to IND for biologics options may vary depending on molecule type or other factors and are estimates to be finalized after third party cell line development dates are available and confirmed. 9-month timeline will incur additional risk.

Learn more about Dr. Elena Gontarz's expertise and background:

https://www.patheon.com/us/en/insights-resources/blog/navigating-the-complexities-of-process-performance-qualification.html

https://www.patheon.com/us/en/insights-resources/blog/choosing-a-cdmo-who-is-a-true-bioproduction-expert.html

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

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

So far, 2024 biotech markets and funding are trending better than last year, but volatility is on the upswing. Join this webinar to hear experienced perspectives on what investment signals to be watching to position yourself for a strong springboard into closing out the year before JPM Week restarts the cycle. This webinar will also preview the panel topics and speakers for the upcoming BIO Investor Forum as well as demonstrate how best to utilize the event’s BIO One-on-One Partnering System to connect with investors and more.

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.

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.