Informa Australia is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Choose Location

Register Your Interest


Webinar: Advancing mRNA-based Drug Development and Vaccine Manufacturing

Wednesday 19 June 2024 | 5pm AEST (Sydney) | 3pm CST (Shanghai) | 12:30pm IST (New Delhi) | 4pm JST (Tokyo) | 8am BST (London) | 9am CEST (Copenhagen)



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

Registration is now open – click here to reserve your spot (free of charge)

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


Expert Speakers

Jeffrey Blum Charterparty Negotiation | Advanced Laytime & Demurrage

Sinan Sarac
Vice President, Technical, Regulatory Strategy,
Parexel International

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.

Jeffrey Blum Charterparty Negotiation | Advanced Laytime & Demurrage

Cecil Nick
Vice President, Technical, Regulatory Consulting,
Parexel International

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.

Jeffrey Blum Charterparty Negotiation | Advanced Laytime & Demurrage

Christiane Niederlaender
Vice President, Technical, Regulatory Consulting,
Parexel International

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.

Who should Attend this webinar

Organisation type:
Pharmaceutical, Biotechnology, Biopharmaceutical, Vaccine Manufacturers, Academic Institutions & Universities, CMO’s, CRO,s Manufacturing companies, Pharma Supply Chain Companies.

Job functions:

Clinical Operations,
Clinical Research
General Management
Health Economics & Outcomes Research
Market Access
Market Research
Medical Affairs
Medical Communications
Medical Operations
Portfolio Management
Product Development
Project Management
Regulatory Affairs Manager
Vaccine Development Specialist
Quality Control Manager
Chief Scientific Officer (CSO)
Chief Medical Officer (CMO)
Research Scientist

when & where

19 Jun 2024

Free Live Webinar

5pm AEST (Sydney)
3pm CST (Shanghai)
12:30pm IST (New Delhi)
4pm JST (Tokyo)
8am BST (London)
9am CEST (Copenhagen)

Get all the latest on Informa news and events

Informa Connect Australia is the nation's leading event organiser. Our events comprise of large scale exhibitions, industry conferences and highly specialised corporate training.

Find out more