R. Lee Buckler, BEd, LLB
Founder. Managing Director. Director, Cell Therapy Business
Lee is Managing Director of and a consultant the Cell Therapy Group.

Lee has worked in the cell therapy - regenmed industry in various capacities since April 2000. 

Lee is driven, task-oriented, creative, and focused.  He has worked well in management positions, thrives in collaborative environments requiring multiple inputs, and is self-disciplined to execute and deliver as required.

His experience has honed his ability to contribute both critically at a high-level and while paying attention to and performing the detailed tasks required to ensure all components of a project are successfully executed.

Lee has significant experience in both revenue-focused for-profit companies and  mission-based non-profit organizations.

Expertise:  Lee has a broad range of experience and expertise of the cell therapy industry largely in executive and project management, business development, marketing, market research and analysis, communications, fundraising, and inter-organizational collaborations. 

He has broad expertise is in the

• commercial (market, sales, business development),
  
• corporate (business planning, SWOT, budgeting, operations), and
  
• financial (reimbursement, financing, M&A, etc)
  

with a comprehensive base of the

• scientific (product characterization, mechanism of action, etc),
  
• clinical (trial design, enrollment, etc), and
  
• regulatory (cGTP vs cGMP, etc)
  

aspects in the development of cell therapy or regenmed products.  

The core value Lee brings to CTG and its clients is a rare breadth of understanding of the entire spectrum of the cell therapy and regenmed industries primarily around who is doing what with whom.  This knowledge of the industry players, what they have, and with whom they are working is both driven by and drives his proprietary industry database which he vigilantly maintains.  Additionally, Lee leverages for his clients the relationships he has with executives in many of those companies.   

Experience: By way of background, Lee has previous years experience in law (as a judicial law clerk, articling student, and commercial attorney).  Most recently, he has 9+ years in the cell therapy industry in various roles including executive management (non-profit and for-profit), project management, business development, sales, marketing, communications, and consulting.

During his tenure with ISCT, he was instrumental in coordinating ISCT’s efforts to establish a bi-annual liaison meeting between the U.S. FDA CBER and industry stakeholders that focuses on issues related to the cell therapy sector.  This cell therapy liaison meeting has become a significant part of FDA’s strategy in the cell therapy sector.

With Dr. Stephen Noga, (then of Johns Hopkins Medical University) he worked to establish an annual meeting on the regulatory framework for cell therapies (Somatic Cell Therapy Symposium) that is now in its 9^th year and has been co-sponsored by ISCT, AABB, and the FDA.

Lee has worked closely on projects with the National Institutes of Health (NIH), National Marrow Donor Program (NMDP), Food and Drug Administration Center for Biologics Education and Research (FDA CBER), the Foundation for the Accreditation of Cellular Therapy (FACT), American Society of Blood and Marrow Transplantation (ASBMT), American Association of Blood Banks (AABB), Pediatric Blood and Marrow Transplant Consortium (PBMTC), Canadian Blood and Marrow Transplant Group (CBMTG),  Production Assistance for Cellular Therapy (PACT - an NIH-funded program), Canadian Stem Cell Network of Excellence, and others.

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