The Bioprocessing Summit 2019

Boston, MA

August 12 - August 16, 2019

Boston, MA |

The Bioprocessing Summit convenes more than 1,500 international bioprocess professionals to share practical solutions for today's bioprocess challenges. Now in its eleventh year, the event has grown to include 16 distinct meetings with weeklong programming on upstream and downstream processing, analytical development and quality, formulation and stability, cell and gene therapy production, and manufacturing. Along with the impressive array of conferences, the Summit also includes short courses and training seminars that provide in-depth coverage of critical bioprocess topics.


August 12:
1:10 PM
Roadmap to Successful Commercialization of Cell and Gene Therapy Products Bridging the GAP
Speaker: Mo Heidaran, PhD, Vice President, Technical, PAREXEL Consulting, Former FDA Reviewer

Cell and gene therapy products include a diverse array of very complex products which are intended to treat, modify or even cure many life threatening conditions. The opportunities are tremendous, but the challenges are equally complex. Ultimately successful commercialization of cell and gene therapy products requires a multi-disciplinary approach, one that fully integrates patient needs and product knowledge with the capability to commercially manufacture these complex products consistently.

August 14:
8:15 AM KEYNOTE PRESENTATION
Regulation and Challenges in Developing Vector-Based Gene Therapies
Speaker: Mo Heidaran, PhD, Vice President, Technical, PAREXEL Consulting, PAREXEL International

While it is assumed that regulatory approval often leads to commercial success, this may not become an overwhelming trend in the field of gene therapy. The major reasons for this disconnect will be discussed in my presentation but full understanding of how these products work (knowledge of the product) and how these products could be consistently manufactured must be an essential part of the product development cycle

MO1.pngMo Heidaran, PhD, Vice President, Technical, PAREXEL Consulting, PAREXEL International

 

 

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