The Future of

Bio/Pharmaceutical Analysis

Online Summit 2024

Now On-Demand

Speakers

20 June

Speakers

Robert Scott

Robert Scott BSc, MSc

QP and GMP Compliance Consultant

eXmoor Pharma Concepts Ltd

eXmoor logo

Rob has dedicated his working career to supporting the transfer of new progressive therapies from non-clinical research through to early phase clinical trials. It has always been his passion to assist with the translation of promising drug candidates and turn them into real treatments for patients. Rob started his career at Cancer Research UK as a QC officer and progressed to the position of QC and QA  anager. In that time Rob was responsible for the setup of the new laboratories within the Biotherapeutics Development Unit at CR-UK and implemented a new QMS within the department. Rob gained experience in a wide range of manufacturing and GMP processes from validation of equipment and utilities, such as autoclave and purified water system to aseptic fill and finish. Robs experience makes him extremely knowledgeable in all aspects of running a GMP operation and an ability to understand the risks associated with such operations and how best to mitigate them.

Rob also achieved status of QP during 2015 and widened his experience by becoming named on the licence at GSK, Ware for release of OSD products. Rob provided quality support to the set up and operation of GSKs first continuous tabletting line. Rob is able to apply all this experience along with effective problem solving and communication skills to ensure delivery of project goals to meet the requirements of the users and regulators ensuring the correct quality of product is delivered.

Panel

12.30 – 2.00 pm CET

CMC considerations for cell and gene therapies

Discover the latest recommendations for chemistry and manufacturing controls required to identify the potency, purity and safety of advanced therapeutic medicinal products (ATMPs). This session will cover:

  • Standards and regulatory expectations for cell-based therapies
  • CMC strategies from early through to late-stage development
  • Final product testing and characterisation, including sterility, mycoplasma and bacterial endotoxin testing.
Adiano Leuzzi with ReiThera logo

Adriano Leuzzi

Head of Process Development
ReiThera

Doli Patel

Doli Patel

Senior Director of CMC, for a major Advanced Therapy Developer and manufacturer in Europe

Daniel Pearce with Adaptimmune logo

Daniel Pearce

VP European Manufacturing and Technical Operations
Adaptimmune

Robert Scott with eXmoor logo

Robert Scott

QP and GMP Compliance Consultant
eXmoor

Scott R. Burger with Advanced Cell & Gene Therapy logo

Moderator: Scott R. Burger

Principal
Advanced Cell & Gene Therapy, LLC