Webinar: Minimize and eliminate Common Pitfalls Typically Found in Preparing a Product Development Plan
Sponsored by: Batavia Biosciences
- Therapeutic Protein
- Product Development Plan
- Biopharmaceutical Development
- Manufacturing Strategy
Date: 26 October
Days to go: 32
Time: 3PM London/10AM New York
How Starting With the End-in-Mind Improves Your CMC Strategy for a Therapeutic Protein
It is very exciting when you find out that your therapeutic product idea is a game changer. The discovery of a new medicine with the potential of saving or changing many people’s lives is very exhilarating. But then reality kicks in. The transition of your idea into a product requires not only hard work and enthusiasm, but also a clear business plan, to include funding needs, a clinical and regulatory approval strategy, a development, manufacturing, and product supply strategy that fits with the principle of Quality by Design. One of the main challenges of this complex process is deciding on the appropriate manufacturing strategy from Phase-I clinical studies up to commercial manufacturing.
In this webinar, we will focus on the Product Development Plan for a typical therapeutic protein. The objective of this plan is to provide the roadmap to successfully execute the key steps in the supply of the product during the clinical development and commercialization phases. The Product Development Plan is important for investors and pharmaceutical partners. It provides a clear overview of the funding needs per phase and the risks involved. In the Product Development Plan go/no-go decision points are clearly indicated to guide the timing of the key decisions that need to be made by the executive team.
This webinar is an in-depth tutorial on how to prepare a Product Development Plan illustrated with examples of past experiences in the field. If you want to learn how you can optimally transition your novel product idea to a successful commercial product, register now!
Head of Operations at Batavia Biosciences
Dr. Cacciuttolo is Head of Operations at Batavia Biosciences Inc in the USA. He has extensive experience in leading biopharmaceutical development from the start-up stage to registraton and commercial operations, introducing innovative approaches to process development. Dr. Cacciuttolo worked as an Executive at leading companies like MedImmune, Medarex, Percivia, Tetragenetics, Algenis, myTomorrows, and PathoVax.
Key Learning Objectives
- How to prepare a Product Development Plan
- How to minimize and eliminate common pitfalls typically found through the product development cycle
- How to increase your translational success rate
- Biopharmaceutical Heads of R&D
- Head of Technical Operations
- R&D Project Managers
- CSO in Biopharmaceutical Start-up Organisations
- CEO in Biopharmaceutical Start Up Organisation
- Academics working in Biopharmaceutical grants
- Consultants in Biopharmaceutical Process Development