2018

Boston, MA

 

2017 Speakers

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Tara Clark
VP Commercial Business, Corporate Officer
Draper Laboratories

Day One

June 26th, 2017

14.50 | Discover: Cell Therapy Manufacturing: Challenges and Opportunities in CMC Management

16.40 | Discuss: Tackling Variability in Patient Starting Material and Considerations from a Manufacturing Perspective

Zorina Pitkin
SVP, Quality Systems
Organogensis

Dr. Zorina Pitkin is Senior Vice President of Quality Systems at Organogenesis Inc., a leading regenerative medicine and advanced wound care company focused on development and commercialization of both cellular and acellular therapies. She has over 20 years of experience in the field of biotechnology including the development of Quality System programs for autologous and allogeneic cellular therapies, biologic/device combination products, and for xenotransplantation.  Dr. Pitkin holds a Ph.D. in Biological Sciences from the Research Institute of Influenza, Russian Academy of Medical Sciences, and is Regulatory Affairs certified.

Day One

June 26th, 2017

15.30 | Discover: Rapid sterility test method for an allogeneic cell-based therapy product

13.00 | Discuss: Can we Make Autologous Therapies Economically Competitive?

Molly McCormick
VP, Case Management and Operations Services
Be The Match

Molly McCormick is the Vice President of Case Management and Operations Services for the National Marrow Donor Program® (NMDP)/Be The Match®, the national registry for the United States. She leads teams dedicated to providing highly personalized case management services ensuring the fulfillment of the best-matched donor and cord blood unit for searching patients. Key achievements include growth of NMDP/Be The Match’s apheresis center network to support peripheral blood stem cell collection activity, implementation of a performance management system for the supplier network, development of related donor services, as well as business leadership for technology projects that enable core operations and guide donors through search and donation activities. Prior to joining the NMDP/Be The Match in 2000, her work focused on public health care access and delivery, as well as working with insurers with an emphasis on building care networks to serve publicly-insured members throughout Minnesota. McCormick holds a Bachelors of Arts from the University of Minnesota and a Masters of Arts in Political Science from Rutgers University, where she was awarded the Harold Martin Fellowship.

Day Two

June 27th, 2017

09.30 | Discover: The Importance of Patient Case Management to Reduce Variability in Cell Therapy Supply Chains

Kimberly Freeman
Vice President, Commercial Strategy & Planning
Adaptimmune

Day Two

June 27th, 2017

14.20 | Discover: Commercial Implications for the Cell Journey

14.40 | Discuss: Designing a Global Pricing and Reimbursement Strategy

09.50 | Discuss: Incorporating a Cellular Orchestration Platform (COP) and Other Systems

Knut Niss
VP, Program Management
Mustang Bio

Day One

June 26th, 2017

13.00 | Discuss: Can we Make Autologous Therapies Economically Competitive?

12.40 | Discover: Considerations for Allogeneic Therapies Beyond COGS

09.00 | Chairman’s Opening Remarks

Day Two

June 27th, 2017

09.00 | Chairman’s Opening Remarks

Biren Mistry
Senior Bioengineer
Celgene

Shirley Bartido
Director of Regulatory Affairs
Cellectis

Day Two

June 27th, 2017

14.00 | Discover: Regulatory Perspectives on CAR-T Cells

14.40 | Discuss: Designing a Global Pricing and Reimbursement Strategy

Donna Rill
VP Manufacturing
Cell Medica

Day One

June 26th, 2017

10.10 | Discuss: What are the Biggest Bottlenecks when Scaling Up Manufacturing Procedures?

09.10 | Discover: Planning for Success: A Path to Commercialization

Day Two

June 27th, 2017

09.50 | Discuss: Incorporating a Cellular Orchestration Platform (COP) and Other Systems

Jeremy Cress
Director of Operations
Fibrocell Science

Day Two

June 27th, 2017

09.50 | Discuss: Incorporating a Cellular Orchestration Platform (COP) and Other Systems

09.10 | Discover: Understanding and Overcoming the Complexities of the Personalized Medicine Supply Chain

Steve Buckanavage
President
Mentoris Advisors LLC

Steve has extensive experience in delivering global large scale and complex projects in all aspects of strategy, team leadership, and operational planning easily moving from vision to hands-on implementation. He has successfully designed and established global commercial teams to set strategy and commercialize new therapies. He was previously VP Global Commercial Strategy, Immunotherapeutics and has held several related roles in AstraZeneca. Steve has extensive experience in delivering global large scale and complex projects in all aspects of strategy, team leadership, and operational planning easily moving from vision to hands-on implementation. He has successfully designed and established global commercial teams to set strategy and commercialize new therapies. He was previously VP Global Commercial Strategy,Immunotherapeutics and has held several related roles in AstraZeneca.

Workshop A

28th June 2017

09.00 |
Can a Disruptive Therapy Be Administered without Disruption?

Day Two

June 27th, 2017

15.10 | Discover: An Essential Guide to Enable Providers to Adopt and Use New Cell Therapies

John McMannis
EVP Manufacturing
Mesoblast

Day One

June 26th, 2017

16.40 | Discuss: Tackling Variability in Patient Starting Material and Considerations from a Manufacturing Perspective

13.00 | Discuss: Can we Make Autologous Therapies Economically Competitive?

12.20 | Discover: Autologous vs. Allogeneic: How Do We Create the Most Economically Viable Product?

Ron Fedechko
Associate Research Fellow
Pfizer

Day One

June 26th, 2017

16.40 | Discuss: Tackling Variability in Patient Starting Material and Considerations from a Manufacturing Perspective

15.10 | Discover: Developing a Raw Material Sourcing Strategy to Ensure Product Quality and Supply

Laurence Cooper
CEO
ZIOPHARM Oncology

Day One

June 26th, 2017

10.10 | Discuss: What are the Biggest Bottlenecks when Scaling Up Manufacturing Procedures?

09.50 | Discover: Reducing the COGs with Novel Genetic Engineering

Sagi Moran
VP Operations & Manufacturing
Pluristem

Day Two

June 27th, 2017

12.30 | Discuss: What are the Various Manufacturing Business Models that can be Applied to Successfully Meet Patient Demand?

12.10 | Discover: A Novel Approach to Commercial Production of Cell- Based Therapeutics

John Davies
President
Tissue Regeneration Therapeutics

Day One

June 26th, 2017

15.50 | Discover: Effective Processes for the Harvesting, Expansion, and Characterization of Cells from Human Umbilical Cord Tissue

Stefano Baila
Product Development Manager
Celyad

Day Two

June 27th, 2017

11.30 | Discover: Use of Target Product Profile during Cell Therapy Development

Tom Isett
CEO
Commence Bio

Day Two

June 27th, 2017

12.30 | Discuss: What are the Various Manufacturing Business Models that can be Applied to Successfully Meet Patient Demand?

11.50 | Discover: Establishing a Long-Range Manufacturing Strategy for Early-Stage Companies

Rob Margolin
VP, Corporate Development & Strategy
TrakCel

Day Two

June 27th, 2017

09.50 | Discuss: Incorporating a Cellular Orchestration Platform (COP) and Other Systems

Aaron Dulgar-Tulloch
Director, BridGE
GE Healthcare

Day One

June 26th, 2017

09.30 | Discover: Balancing Cost and Risk to be Smart, Closed & Connected

10.10 | Discuss: What are the Biggest Bottlenecks when Scaling Up Manufacturing Procedures?