Series - Early Stage Issues

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.

Looking for an efficient and effective way to source new partnerships and manage your meetings for JPM Week? This webinar explains how BIO One-on-One Partnering™ can help. Learn about BIO’s onsite meeting space in San Francisco, tips and tricks for using the system, and how to schedule your meetings with different location options. Also, get a look at how you can stay in-the-know about networking and other opportunities during JPM Week.

For more information about BIO Partnering at JPM Week, please visit: https://www.bio.org/events/bio-partnering-jpm

This webinar covers the following: 
- Preview of BIO’s onsite meeting space in San Francisco 
-Partnering best practices & how to schedule your meetings
- Live demo of the partnering system & advanced features
- Intro to BIO and Novateur Ventures’ JPM Week Events Guide mobile app
- Q&A with the host

Quick Links:

1. Copy of today’s slides: PowerPoint Presentation (bio.org)
2. Registration rates & where to register: https://bpjw.bio.org/registration
3. 2024 Participating companies: https://bpjw.bio.org/participating-companies
4. 2024 Participating investors: https://bpjw.bio.org/bio-one-one-partnering/participating-investors
5. Guide to JPM’24 mobile app for iPhone: https://apps.apple.com/mu/app/guide-to-jpm23/id1494244381
6. Guide to JPM’24 mobile app for Android: https://play.google.com/store/apps/details?id=org.novateur.ConferenceGuide
7. Submit your JPM Week event for our mobile app & Dec 12 webinar event list: https://forms.office.com/pages/responsepage.aspx?id=FmEqTcAdB0iptW1DmWAlb-7aiIadk1dGqhpdctNwLzRUM0pDVkYzQVlDTFJTQUJJMVpWTUVPSFUzSi4u
8. Register for the Dec 12^th JPM Networking Webinar: https://www.bio.org/webinars/raising-capital/bios-jpm-week-events-networking-preview

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.

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)

​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.