BIO Early-Stage Resources Hub
February 15, 2024
1:00 PM - 2:00 PM EST
Zoom
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.
Speakers:
- Cartier Esham, PhD, Chief Science Officer, BIO
- Lashawn Schnupps, PharmD, Senior Regulatory Project Manager, FDA
- Kristy Lupejkis, Deputy Vice President and Chief of Staff, PhRMA
February 26, 2024
7:00 AM - 7:00 PM EST
The New York Marriott Marquis - New York, NY
Participate in the BIO CEO & Investor Conference, one of the largest investor conferences in our industry where institutional investors, industry analysts, and senior executives are shaping the future investment landscape of biotechnology.
Don't miss your opportunity to:
- Find and request meetings with potential partners using the BIO One-on-One Partnering™ system
- Discover the latest innovations in biotech during Company Presentations
- Hear from thought-leaders during sessions on therapeutic advancements, market outlook, and policy priorities
Past speakers include MDs, CSOs and industry analysts discussing the latest information on pipeline innovation along with industry executives and analysts who delve into timely and relevant business models, deal-making, and investment trends.
Download the 2023 Program Guide to see the caliber of sessions you can expect at the event.
February 27, 2024
7:00 AM - 7:00 PM EST
The New York Marriott Marquis - New York, NY
Participate in the BIO CEO & Investor Conference, one of the largest investor conferences in our industry where institutional investors, industry analysts, and senior executives are shaping the future investment landscape of biotechnology.
Don't miss your opportunity to:
- Find and request meetings with potential partners using the BIO One-on-One Partnering™ system
- Discover the latest innovations in biotech during Company Presentations
- Hear from thought-leaders during sessions on therapeutic advancements, market outlook, and policy priorities
Past speakers include MDs, CSOs and industry analysts discussing the latest information on pipeline innovation along with industry executives and analysts who delve into timely and relevant business models, deal-making, and investment trends.
Download the 2023 Program Guide to see the caliber of sessions you can expect at the event.
BIO is re-launching a streamlined version of our FDA communications survey to gauge the effectiveness of FDA-sponsor interactions during drug development. This brief survey asks about topics such as communications channels, special designations, and clinical holds.
The survey is pivotal for BIO’s ongoing efforts to ensure the FDA review process is working as well as it can. In the past, a similar survey has been critical in our continuous efforts to work with FDA on best practices and to reauthorize PDUFA. The results will be incorporated into BIO’s advocacy agenda to ensure a science-driven, innovative, well-resourced FDA.
To participate, simply click here to go to the survey. After you access the survey, you will receive a personalized link via email. If you don’t see the email, please check your spam folder. Once you receive the link, you can begin the survey, which takes about 5 minutes to complete.
Participating companies will receive exclusive access to survey data during a webinar in 2024. All data and feedback will be anonymized.
If you have questions about the survey you may reach out to fdasurveysupport@bio.org.
Thank you in advance for your participation in this important effort!
BIO Office Hours is a resource for BIO members to meet one-on-one with subject matter experts on business services. Every month, BIO invites an expert to provide an overview of business critical topics followed by the opportunity for BIO Members to meet with the expert, ask questions, and learn more.
We hosted several key topics during BIO Office Hours this year, like R&D tax credits, grant writing, and regulatory inspections. If you missed one, BIO members can now schedule an appointment with a subject matter expert on a previously featured topic. Fill out this form to select your interested topic and availability.