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!
Development Track Session 1 Snatching a 505(b)(2) Victory from the Jaws of an ANDA Defeat |
Development Track Session 2 Combination Products and Digital Health – Technical Challenges and Opportunities: |
Development Track Session 3 The Crucial Impact that a 505(b)(2)’s Clinical Development Program Has on its Commercial Potential: |
Development Track Session 4 Effective Collection and Use of Post-Approval Safety/Efficacy Data |
Development Track Session 5 Parlaying Drug Approvals to and from the US – Focus on 505(b)(2)s |
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Moderator: Alicia Baker McDowell, DRSc, MS (Fortrea) Speakers: David Rosen, BS Pharm, JD (Foley & Lardner LLP), Abie Ekangaki, PhD (Premier Consulting), Siva Vaithiyalingam, PhD (Cipla) |
Moderator: Janet Vaughn, BSc Speakers: Mary T. Thanh Hai, MD (OND, FDA), Delphine Saragoussi (PPD) Panelist: Aysha Amman, PharmD (Teva) |
Moderator: Raluca Radu (Medicines for Europe) Speakers: Kaitlyn Huff. PhD (PPD), Simion Oros from (Cipla EU) |
Session will focus on repurposing generics, with emphasis on developing ophthalmic products, for 505(b)(2) NDA submission. Examples of where a repurposed generic may have a clinical advantage such as supra bioavailability, lower dose, less food effect, or fewer adverse events will be presented. |
Session will cover the nuances of the regulatory and commercial aspects of combination product development, including the 505(b)(2) NDA pathway, and how to leverage existing information for the drug and/or device constituent components to streamline overall combination product development, including combination products that incorporate a digital device component. A case study of the development journey of the Digihaler System, its technical and regulatory challenges, and the potential benefits that the technology will bring to asthma and COPD treatment will be presented. |
Session will cover the connection between clinical study design, labeling, and commercial viability/success. |
Session will discuss collection and evaluation of post-marketing surveillance and Phase IV study safety and efficacy data. Areas such as lifecycle management, shared REMS program, mining post-approval data such as adverse events, and commitment for post-approval studies will be emphasized |
Session will present strategies to minimize duplication of clinical trials to support submission to US (505(b)(2) NDA), EU, India and China. |
