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7:00am - 7:55am

Registration

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Showing of Streams
9:30am - 10:15am

Morning Coffee & Networking

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Showing of Streams
12:15pm - 1:30pm

Networking Luncheon in the Poster & Exhibition Hall

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Showing of Streams
3:00pm - 3:10pm

Chairperson's Closing Remarks

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3:10pm - 3:15pm
End of Conference

End of Conference

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7:00am - 7:55am 55 mins
Registration
7:55am - 8:00am 5 mins
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Chairperson's Opening Remarks
7:55am - 8:00am 5 mins
Cell and Gene Therapy Connect – Partnering Track
Chairperson's Opening Remarks
8:00am - 8:30am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Sigilon Case Study: Creating a phase appropriate supply chain
  • Devyn Smith - Chief Strategy Officer and Head of Operations, Sigilon Therapeutics, USA
  • Supply Chain
  • Cryo
  • Delivery
  • Identifying when to invest
8:00am - 8:45am 45 mins
Info
Cell and Gene Therapy Connect – Partnering Track
Evolving landscape of cell and gene therapies, a year in review
  • Janet Lynch Lambert - Chief Executive Officer, Alliance for Regenerative Medicine, USA

With the industry moving at an incredible rate, changes are frequent, and updates happen daily. 2018 and the first half of 2019 have brought both exciting news as well as challenges. Points to be discussed on this panel include (but are not limited to):

-Policy environment 2019
-Sector Technology 2019
-Clinical progress H1 2019
-Anticipated clinical data events 2019-2020
-Looking ahead: 2019 and beyond

8:30am - 9:00am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Challenges for adoption of advanced therapies – experience from the UK
  • Anna Outhwaite - Head of ATTC Network Coordination, Cell and Gene Therapy Catapult, UK



8:45am - 9:30am 45 mins
Info
Cell and Gene Therapy Connect – Partnering Track
Partnership and collaboration: Can more collaboration solve a multitude of problems?
  • Timothy Herpin - Chief Business Officer, Caribou Biosciences
  • Loic Vincent - Head Oncology & Immunology Research Partnerships, Head of Cell Therapy Discovery, Takeda, USA
  • John Hewes - Senior Specialist, Invention Development, DHHS/NIH/NCI Technology Transfer Center, USA
  • Devyn Smith - Chief Strategy Officer and Head of Operations, Sigilon Therapeutics, USA
  • Traditional models for development, R&D, manufacturing and commercialization may not produce the best results in the ever-evolving world of cell and gene therapies. Can collaboration between companies, academic institutions, patient advocacy groups and public (government and non-profit) organisations help solve the problem?
9:00am - 9:30am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Spotlight Presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Kristin Skahan; Email: kristin.skahan@knect365.com

 

9:30am - 10:15am 45 mins
Morning Coffee & Networking
10:15am - 10:45am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
The Impact of Gene and Cell Therapy on the Supply Chain
  • Chad Presher - Associate Director, Clinical Drug Supply, Biogen, USA
  • Meridith Hyres - Senior Specialist, Clinical Supply Management, Biogen, USA



10:30am - 11:20am 50 mins
Info
Cell and Gene Therapy Connect – Partnering Track
CMO landscapes for new product initiatives: Novel outsourcing models
  • Moderator Amanda Micklus - Principal Analyst, Datamonitor Healthcare
  • Panellist Wouter Van t’Hof - Cord Blood Bank Director, Cleveland Cord Blood Centre, USA
  • Panellist Steve Oh - Director Stem Cell Bioprocessing & Institute Professor,, A*Star, Singapore
  • When looking forward to the successful manufacture and commercialization of cell and gene therapies, there is the age-old debate of what model is best when it comes to success. This panel will discuss what the most cost-effective models are, and how target therapeutic companies can form meaningful and engaging partnerships with CMO’s to produce commercial grade products.
10:45am - 11:15am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Avoiding even more bottlenecks – strategies for apheresis
  • Patrick Hanley - Immunotherapy GMP & Research Assistant Professor & Director, Children's National Health System, USA
  • How are companies currently handling apheresis
  • Is everyone using apheresis, or do some use large blood draws?
  • What is the best strategy?
  • Possible centralised auditing systems?
11:15am - 11:45am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Cell tracking and labeling for Autologous T-Cell products across the supply chain
  • Chris Baldwin - Supply Chain Director, GSK, USA

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11:20am - 12:10pm 50 mins
Info
Cell and Gene Therapy Connect – Partnering Track
Next generation therapies
  • Panellist David Smith - Chief Commercial Officer, Healios
  • Panellist Felicia Pagliuca - VP Cell Biology R&D, Semma Therapeutics, USA
  • With all the exciting clinical results and new candidates rising up through product pipelines, CAR-T, gene therapies and CRISPR are seeing real advancements. What are some of the new advances in the field? And what will the ‘next generation’ or ‘CART 3.0’ therapies be?
11:45am - 12:15pm 30 mins
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Patient Centric Supply Chain
  • David Kim - Director, Supply Chain, Kite, A Gilead Company, USA
12:15pm - 1:30pm 75 mins
Networking Luncheon in the Poster & Exhibition Hall
1:30pm - 2:00pm 30 mins
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
A Risk Assessment Strategy For Microbiological Controls
  • Donald Singer - GSK Senior Fellow, Microbiology, Biopharmaceutical GMP Operations, GSK, USA
1:30pm - 3:00pm 90 mins
Cell and Gene Therapy Connect – Partnering Track
The rest of the day is set aside for partnering meetings
2:00pm - 3:00pm 60 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Panel Discussion: Rapid Microbial Methods for Final Release of Cell Therapy Products
  • Moderator Brandy Sargent - Editor, Cell Culture Dish, USA

Cell Therapy products have unique manufacturing requirements that necessitate the development of new processes and technologies to support manufacturing. Like other biologics, most cell therapies require microbial testing including, mycoplasma, sterility, and endotoxin analysis prior to final product release and as part of meeting regulatory requirements for Cell Therapy products. Traditional microbial testing methods can take several weeks to over a month, which doesn’t fit the needs of the quick turnaround time for cell therapies. This is why rapid microbial methods provide an important solution to a significant challenge in Cell Therapy manufacturing.

In this panel we will discuss:

  • Current rapid microbial testing methods available
  • Rapid microbial testing benefits
  • Qualification of these methods with regulatory bodies
  • How rapid microbial testing enables in-process analytics and quality by design initiatives.
3:00pm - 3:10pm 10 mins
Chairperson's Closing Remarks
3:10pm - 3:15pm 5 mins
End of Conference