New Horizons in Value-Added Medicines
The open access VAM Week conference is a live fully online conference composed of two main tracks, Commercialization/Business & Development, as well as several satellite symposia. Each year the main sessions feature expert presenters from the FDA, commercialization, legal and product development fields. Registrants receive free access to all sessions including satellite symposia. But attendees must register to receive their free seat. Click the registration button below and secure your seat today!
Planned Agenda
Commercialization Track Session 1 Commercialization Success Stories |
Commercialization Track Session 2 Combination Products: Using Combos to Your Advantage |
Commercialization Track Session 3 Commercialization: The B2 Marketing Challenge |
Commercialization Track Session 4 Regulatory: Gathering Evidence for Value-added Medicine |
Commercialization Track Session 5 Commercialization: Value-added Medicines Beyond the U.S |
Moderator: Ed Allera (The 505(b)(2) Platform) Speakers: Vincente Anido, Former CEO of Aerie Pharmaceuticals |
Moderator: Matt Fedowitz (Buchanan Ingersoll & Rooney) |
Moderator: Steve Casey (Managing Partner, Omni-HC) Speakers: Mark Aikman, PharmD (former Head of US Operations, Xspray Pharma) |
Moderator: Ed Allera (The 505(b)(2) Platform) Speakers: Dr. Kevin Bugin, (FDA) and Dr. Paul Aliu, (Novartis) |
Moderator: Barbara Binzak Blumenfeld Speakers: Le Tong (China), Viswaprasad (India), Fernando Braune |
Session will be a discussion with several legendary CEO’s/C-level executives who have successfully built and sold value-added medicines companies. We will discuss their investment and development strategies as well as their considerations for when to financially exit their investments/companies. |
Session will focus on the use of devices, digital health, and AI assets to add value to drug products. Measuring clinical improvement, optimizing reimbursement, access to formularies and proper distribution models are evolving. Patenting and Orange Book listing strategies are now interrelated and under scrutiny. The panel of investors, reimbursement specialists, and lawyers will discuss this dynamic market. |
Session will cover the challenges of commercializing a 505(b)(2) in todays market. The discussion will focus on the hidden differences between a b2 and b1 products and how best to avoid mediocrity in your 505(b)(2) commercial efforts. |
This session will be a panel discussion with FDA and industry experts. The focus will be on new methods for gathering clinical data to support new indications . Momentum is growing for the use of decentralized clinical trials and other types of new technologies to gather evidence from real world patients. FDA will discuss new approaches they have seen and where problems are arising. An industry representative will discus the problems that have arisen in gathering the information and gaining acceptance by regulators. |
Session will cover value-added medicines outside the US. We will review specific countries including China, India and Brazil to learn how these countries are participating in the VAM market. The discussion will focus on any regulatory pathways that promote VAMs and how the countries pharmaceutical industry participates in the VAM market. |
