Workforce Development in Biomanufacturing

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Workforce Development in Biomanufacturing

A Global Partnership with ISCT and CMaT

Developed by field experts from academic, regulatory, clinical, and commercial domains, this training program will focus on introducing key topics in cell and gene therapy manufacturing and development. Over the coming years, ISCT and CMaT will work together to offer hands-on practical training with specific focus on manufacturing, business development, licensing, and regulatory pathways. 


WELCOMING THE FIRST COHORT OF TRAINEES IN APRIL 2022

The program aims to address key topics in CGT manufacturing and development and will include asynchronous lectures (comprised of a Theory and an Application component) as well as live instructor office hours/ expert panel Q&A sessions. There will be 4 modules:

  • Module 1: Stem Cell and Immune Cell Engineering and Therapies
  • Module 2: Quality Assurance and Regulatory Framework
  • Module 3: Cell Bioprocessing and Manufacturing 
  • Module 4: Cell Product Characterization and Importance of Standards


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Registration


Registration Deadline: May 11, 2022 

Key Program Dates

Program Opens - April 25
Module 1 LIVE Session - May 16 at 11:00-12:00 EDT
Module 2 LIVE Session - May 20 at 11:00-12:00 EDT
Module 3 LIVE Session - May 31 at 11:00-12:00 EDT
Module 4 LIVE Session - June 8 at 11:00-12:00 EDT
Program Closes - June 22

Program Format

  • Asynchronous lectures composed of Theory and Application components
  • 1 LIVE Expert Panel Discussion and Q&A session per module 
  • A certificate of completion is attainable for each module upon completion of the module assessment
“ISCT has long identified and taken measures to alleviate the skills shortages across the cell and gene therapy sector. ISCT has run a range of courses across the CGT sector, including forming our ISCT Early-Stage Professionals (ESP) Committee, responsible for our extensive Mentoring Program. Despite these efforts, growth in the CGT sector continues to outpace the professionals entering. This is a major issue for the sector that could become critical in the near future."
-Bruce Levine, President, ISCT
“A well-trained, readily available, diverse workforce is crucial to the success of the emerging cell and gene therapy industry, especially given its highly specialized skill sets, GMP and regulatory requirements, and complex manufacturing and supply chain infrastructure.

Our partnership with ISCT brings the largest cell manufacturing research and education consortium together with the largest global cell & gene therapy society to deliver critically needed workforce training for CGT. Together, we hope to develop a robust, on-demand, client-centric training platform for industry and clinical manufacturers.”
-Krishnendu Roy, Robert A. Milton Chair, CMaT

Module Descriptions:



This module will focus on providing a broad overview of stem cell and immune cell therapies. More specifically, it will cover different types of therapeutic cells that are being investigated in the cell and gene-modified cell therapy space, strategies to engineer them and associated challenges, and their manufacturing process.


THEORY
Johnna Temenoff, PhD, Professor, Georgia Tech and Emory University, USA

APPLICATION
Fabien Moncaubeig, Chief Development Officer, TreeFrog Therapeutics, France 


THEORY
Edward Botchwey, PhD, Associate Professor, Georgia Tech, USA

APPLICATION
David Kugler, PhD, Scientific Director, Engineered T Cell Biology, Bristol Myers Squibb, USA 


THEORY
Krishanu Saha, PhD, Associate Professor, University of Wisconsin, USA

APPLICATION
Robert Deans, PhD, Chief Scientific Officer, Synthego Corp., USA



This LIVE session provides the opportunity for program participants to ask questions directly to the speakers of Module 1.

MODERATOR
Krishnendu Roy, PhD, Director, NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT), USA



This module will begin with the discussion of key Quality by Design (QbD) concepts for therapeutic cell manufacturing including critical quality attributes (CQAs), critical process parameters (CPPs), critical material attributes (CMAs), design space, and process analytical technology (PAT). Emphasis will also be put on importance of cGMP practices and guidelines, and quality control in cell manufacturing space. In addition, participants will also develop an understanding of ethics and policy guidelines, and global regulatory framework for cell therapy and the cell manufacturing industry.

THEORY
Krishnendu Roy, PhD, Director, NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT), USA

APPLICATION
Gregory Russotti, PhD, Chief Technology Officer, Century Therapeutics, USA

THEORY
Aaron Levine, PhD, Associate Professor, Georgia Tech, USA

APPLICATION
Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research & Early Product Development, Center for Cell & Gene Therapy, Baylor College of Medicine, USA





THEORY & APPLICATION
Donald Singer, Senior Microbiology Technical Consultant, North America, Ecolab, USA






This LIVE session provides the opportunity for program participants to ask questions directly to the speakers of Module 2.

MODERATOR
Krishnendu Roy, PhD, Director, NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT), USA

Kaitlin Morrison, PhD, Director of UNC Lineberger Sponsored Clinical Research, UNC Lineberger Comprehensive Cancer Center, USA will participate in the Expert Panel Discussion Session in place of Bambi Grilley. 


This module will cover various bioprocessing approaches for the effective translation of cell therapies from bench-scale to industrial scale products. More specifically, various technologies used for therapeutic cell expansion will be discussed. Emphasis will also be put on the discussion of biomaterials and 3D microcarriers employed for adherent cells expansion, and downstream processing approaches including fill and finish, storage of cells, and cryopreservation techniques. Participants will also learn about the importance of supply chain management and distribution strategies in the cell therapy industry.


THEORY
Carolyn Yeago, PhD, Associate Director – Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Tech, USA

APPLICATION
Eytan Abraham, PhD, Vice-President, Head of Cell Therapy Franchise, Resilience, USA


THEORY
Allison Hubel, PhD, Director, Technological Leadership Institute, University of Minnesota , USA

APPLICATION
Sean Werner, PhD, President, Sexton Biotechnologies, USA


 




This LIVE session provides the opportunity for program participants to ask questions directly to the speakers of Module 3.

MODERATORS
David DiGiusto, PhD, SVP, Stem Cells and Regenerative Medicine, Resilience, USA
Krishnendu Roy, PhD, Director, NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT), USA


THEORY
Shalu Suri, PhD, Associate Director, NSF ERC Diversity & Inclusion and Engineering Workforce Development, Georgia Tech, USA

APPLICATION
Jon Rowley, PhD, Founder and Chief Technology Officer, RoosterBio, USA



THEORY
Ben Wang, PhD, Professor and Executive Director, Georgia Tech Manufacturing Institute, USA
Kan Wang, PhD, Senior Research Engineer, Georgia Tech Manufacturing Institute, USA
Chip White, PhD, Professor, Georgia Tech Manufacturing Institute, USA

APPLICATION
Chris McClain, MBA, Senior Vice President, Business Development, Be the Match BioTherapies, USA
Adrian McKemey, PhD, Managing Director, IQVIA, USA


In this module, participants will learn about the importance of analytical tools for quality assessment and batch release. Emphasis will also be put on identifying assays for cell characterization to ensure cells potency, viability, and purity, among other attributes. This module will also cover various automation approaches that are being developed and integrated in the overall manufacturing workflow to increase efficiency and reduce cost.


THEORY
Carolyn Yeago, PhD, Associate Director – Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Tech, USA

APPLICATION
Kara Levine, PhD, Head of Systems and Tools, Cell Therapy Bioprocessing, MilliporeSigma, USA


This LIVE session provides the opportunity for program participants to ask questions directly to the speakers of Module 4.

MODERATOR
Krishnendu Roy, PhD, Director, NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT), USA


THEORY
Stephen Balakirsky, PhD, Principal Research Scientist, Georgia Tech Research Institute, USA

APPLICATION
Ian Johnston, PhD, Senior Project Manager Research and Development, Miltenyi Biotec, Germany