[vc_row][vc_column][vc_column_text]Quality implications are crucial for the success of cell and gene therapy development. Targeted at technical and quality personnel, the 2020 Quality and Operations Track will share key learnings in manufacturing process validation, regulatory CMC considerations, starting and raw material selection, analytical tools and methods and GMP manufacturing challenges.  Experts from around the world will discuss regional nuances and global implications for harmonization of the cell and gene therapy industry across academia, industry and regulatory agencies.[/vc_column_text][vc_empty_space][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]

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Q&O Session 1 – Qualification, Regulation of Gene Editing Tools in Cell & Gene Therapy

[/vc_column_text][vc_empty_space][vc_column_text]Recent advances in genome editing technologies have substantially improved our ability to make changes in the genomes of eukaryotic cells. Viral vectors and programmable nucleases are already revolutionizing our ability to interrogate the function of the genome. This session provides an overview of current progress in qualifying and regulating targeted genome editing technologies as they are being used clinically to correct or introduce genetic mutations to treat diseases that are refractory to traditional therapies. Preclinical assessment and GMP manufacturing of these technologies as well as the regulatory requirements for FIH clinical trials utilizing these technologies will be discussed.

Shirley Bartido, PhD, MBA, Cellectis, United States

Christopher Ballas, PhD, Innovative Cellular Therapeutics, United States

David Jones, MSc, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Stephan Reynier, MSc, Cellectis, France
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Q&O Session 2: Manufacturing Process Validation – considerations for validation of autologous products

[/vc_column_text][vc_empty_space][vc_column_text]Process Validation – it has to happen! Join us to hear regulatory perspectives and real-world examples of considerations specific to autologous products, including both cells and tissues. Are normal donor cells ok to use? What risks are associated with validating your process using cells or tissues from healthy donors?

Emily Hopewell, PhD, Indiana University School of Medicine, United States

Antonio Ruiz-Garcia, MPharm, Hospital Universitario Virgen de las Nieves, Spain

Corey Smith, PhD, QIMR Berghofer, Australia

Aisha Khan, MSc, MBA, University of Miami, United States
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Q&O Session 3: Regulatory CMC Considerations of ATMPs

[/vc_column_text][vc_empty_space][vc_column_text]The Q&O track regulatory session will address the hot CMC topics of 2020. For many ATMP products identification of critical quality attributes (CQAs) that can predict clinical outcome is not easy, especially due to inherent variability of the starting materials. Product characterization and selection of most useful assays will be discussed in this session, as well as the GMP constraints across the US and the EU. In the panel discussion regulatory experts from US, EU and Japan will address the CMC readiness of companies and regulatory authorities in the context of the expedited regulatory programs of ATMPs.

Paula Salmikangas, PhD, NDA Advisory Services Ltd., Finland

Christopher Bravery, PhD, Consulting on Advanced Biologicals, United Kingdom

Shinichi Noda, PhD, Pharmaceuticals and Medical Devices Agency(PMDA), Japan

Rocio Salvador-Roldan, European Commission, Belgium[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”QO4″]

Q&O Session 4: Starting & Raw Material Selection for ATMP Manufacturing

[/vc_column_text][vc_empty_space][vc_column_text]Starting and raw material selection is an essential aspect that need to be considered for ATMP manufacturing in order to guarantee quality of medicinal products to be used in patients. During this session the most important aspects regarding starting and raw material selection for ATMP manufacturing are going to be reviewed such as:

  • Differences in donor eligibility requirements, regulatory aspects to comply during donor selection and ethical considerations
  • Critical aspects to consider when using biological raw materials for ATMP manufacturing
  • Challenges to consider during vector production and control
  • Appropriate conditions to establish and test when using seed lots and cell banks

[/vc_column_text][vc_empty_space height=”15″][vc_column_text]Chair:
Gloria Carmona, MPharm, Andalusian Network for Design and Translation of Advanced Therapies, Spain

Craig Spalding, MBA, Scottish National Blood Transfusion Service, United Kingdom

Rosaria Giordano, MD, Fondazione IRCCS Ca’ Granda – Ospedale Maggiore Policlinico, Italy

Daniela Bischof, PhD, Indiana University School of Medicine, United States

Gerhard Bauer, PhD, University of California Davis Institute for Regenerative Cures, United States[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”QO5″]

Q&O Session 5: Characterization of Active Substance and Comparability

Rosemarie Bell, B.App.Sc Micro/Biochem MASM, Q-Gen Cell Therapeutics QIMR Berghofer Medical Research Institute, Australia

Mehrshid Alai-Safer, PhD, Kite Pharmaceuticals, United States

Mohamed Heidaran, PhD, Parexel International, United States

Krishnendu Roy, PhD, Georgia Institute of Technology, United States[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”QO6″]

Q&O Session 6: Analytical Tools and Method Development 

Gerry McKiernan, Cell Therapies Pty Ltd, Australia

Sophie Paczensy, MD, PhD, Indiana University School of Medicine, United States

David M. Barrett, MD, PhD, Children’s Hospital of Philadelphia, United States[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”QO7″]

Q&O Session 7: GMP Manufacturing Challenges

Shiraz Ziya, PhD, Sartorius Stedim Biotech Ltd, United Kingdom

Angela Osborne, PhD, eXmoor pharma concepts ltd, United Kingdom

Linda Kelley, PhD, Moffitt Cancer Center, United States[/vc_column_text][/vc_column][/vc_row]