Webinar Webinar

Webinar: Advancing mRNA-based Drug Development and Vaccine Manufacturing

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Informa Connect is delighted to host this webinar, Advancing mRNA-based Drug Development and Vaccine Manufacturing, brought to you by Parexel.

About the webinar:
The mRNA technology platform holds immense potential to revolutionize the process of drug and vaccine development. Learn from Parexel experts to gain valuable insights about navigating regulatory challenges and conducting clinical research for mRNA therapies, accelerating your product development, approval, and improving patient outcomes.

Webinar Agenda:
Section 1 – Accelerating Approval for Oncology Drug Development

  • Best practices for mRNA-based drug study design, dose optimization, and endpoint selection to ensure successful development and evaluation
  • Leveraging accelerated approval pathways and incorporating RWE/RWD to provide valuable support for study results
  • Clinical considerations on application of oncology product development of mRNA vaccines

Section 2 – Optimizing the Path to Regulatory Approval for Novel Vaccine 

  • Critical points to consider in order to gain regulatory approval and approaches to streamlining clinical development for mRNA vaccines
  • Streamlining vaccine development through novel trial design is essential for expediting the process

Section 3 – Overview of mRNA Product Manufacturing Challenges

  • Quality considerations for the application of mRNA technology in the development of mRNA vaccines
  • Navigating raw and starting material control practices
  • Effective management and implementation of Phase-appropriate CMC requirements

Q+A session and discussion

Sinan Sarac, M.D., Ph.D., M.Sc. 

Vice President, Technical - Regulatory Strategy

Sinan has worked in the EU regulatory system for more than a decade. At the EMA, he has served as a member of the Committee for Medicinal Products for Human Use (CMP), the Committee for Advanced Therapies (CAT), and the Scientific Advice Working Party (SAWP), and as a member and chair of CHMP’s Oncology Working Party (ONCWP). He also served as chief medical officer at the Danish Medicines Agency. He was responsible for the scientific evaluation of new cancer products, extension of indications, and national scientific advice. His experience covers oncology, hematology, rare diseases, advanced therapies, small molecules, monoclonal antibodies, and other protein-based products.

Cecil Nick

Vice President, Technical, Regulatory Consulting

Cecil has amassed over 30 years of experience in regulatory affairs and clinical development, with a focus on biological medicines for the past 25 years. His expertise lies in monoclonals and biosimilars, spanning various therapeutic areas including oncology, inflammatory disease, diabetes, growth factors, multiple sclerosis, neurology, antivirals, blood products, and vaccines. Since joining Parexel in 2001, he has been instrumental in clinical development, regulatory submissions, biosimilars, orphan drugs, and training. He crafts efficient and effective clinical development plans, collaborating with pharmacologists, statisticians, therapeutic experts and conducting feasibility analyses.

Christiane Niederlaender

Vice President, Technical, Regulatory Consulting

Christiane has over 12 years of regulatory agency experience in biological medicines, specializing CMC development plans and regulatory strategies for the EU and FDA. Her experience is vast, spanning all types of regulatory submissions and agency interactions as well as advising on strategic considerations for product development. Her expertise lies in cell and gene therapies, viral vectors, RNA products, and novel vaccines, including vectored vaccines. As an ex-regulator, she served as a senior quality assessor and manager at the MHRA and was a member of the Committee for Advanced Therapies (CAT) at the EMA.