fast track to the market

Webinar - Overcoming CMC challenges in Rare Disease Drug Development and registration


Are you ready to meet the Chemistry, Manufacturing & Controls (CMC) Challenges in Rare Disease Drug Development and Registration? This webinar will take you through some specific features of Rare Diseases programs and will focus on the typical challenges associated with CMC activities in the development and registration of Rare Disease and Orphan Drug candidates, as well as providing you with some guidance on overcoming these challenges. Understanding your product, your manufacturing process and being prepared with the required Quality data pack is a critical step in the commercial launch of your innovative product and will help you live by your commitments to Rare Disease patients.

Our latest webinar, 'Overcoming CMC challenges in Rare Disease Drug Development and registration' presented by EVP, Global API Chemistry, Process Development and Manufacturing, Jerome Dauvergne, discusses how:

  • Rare Diseases are not unusual and tackling them matters a great deal to society;
  • Developing and commercialising new Rare Disease treatments represents a paradigm shift;
  • Overcoming the unique CMC challenges associated with Rare Disease development and registration requires agility and interdisciplinary collaboration;
  • Strong, passionate commitment from all partners involved is critical to success.

About the speaker

Jerome DauvergneJerome Dauvergne
EVP, Head of Global API Chemistry, Development & Manufacturing

Jerome has over 20 years’ experience in discovery, development and manufacture of active pharmaceutical ingredients (API) and medicinal products (MP).

He has managed both in-house and external Chemical Development & Manufacturing operations within several pharmaceutical and biotech companies, including large pharma (Pfizer), mid-sized pharma (Ipsen Pharma) and small biotechs (Novexel, Mereo BioPharma).

Jerome has also held Quality and CMC Regulatory management responsibilities, leading numerous projects at various stages of the product development and commercialization lifecycle. In his previous role as Head of Pharmaceutical Development at the London-based small biotech company Mereo BioPharma he led the design and execution of the CMC strategy for a portfolio of mid-to-late stage development assets, including small molecules and biologics.

Jerome holds Master’s degrees in Chemical Engineering and Organic Chemistry as well as a PhD in Organic Chemistry from the University of Strasbourg, France, and an MBA from Warwick Business School, UK.