Cell & Gene Therapy
New cell and gene therapies are now available for patients, some after decades of research. The culmination of these efforts will be novel treatments, and perhaps ultimately cures, for devastating and intractable illnesses. Greenleaf assists sponsors by optimizing FDA interactions and submissions to support development, manufacturing, quality, compliance, and regulatory review.
Cell & Gene Therapy Team
Greenleaf experts specializing in biologics and product quality, manufacturing, and compliance combine their deep knowledge to ensure that clients have integrated regulatory advice on cell and gene therapies — guided by decades of experience in senior FDA positions, global public health organizations, academia, and industry.
John TaylorPresident and Principal, Compliance and Regulatory Affairs
Karen Midthun, M.D.Principal, Drug and Biological Products
Cynthia SchnedarPrincipal, Regulatory Compliance
Julia Barrett, M.D., M.P.H.Executive Vice President, Drug and Biological Products
John K. Jenkins, M.D.Principal, Drug and Biological Products
Robert J. Meyer, M.D.Principal, Drug and Biological Products
Madeleine Giaquinto, J.D.Director, Regulatory Affairs
Our Cell & Gene Therapy Services
Product Development & Review
Members of Greenleaf’s Drug and Biological Products Team specialize in strategic communications with the FDA at every stage of product development ⎯ early INTERACT meetings, pre-IND and meetings throughout development, correspondence, clinical trial design, submissions, FDA review communications and labeling discussions, and postmarket requirements. The team also assists clients in preparing for milestone meetings.
Quality, Manufacturing & Compliance
For companies striving to introduce cell and gene therapy products to the market, establishing manufacturing and quality controls is one of the primary challenges.
Greenleaf’s Product Quality, Manufacturing, and Compliance Team, along with its network of independent compliance experts, offers credible, informed guidance to help manufacturers of cell and gene therapies comply with the FDA’s multiple current GXP regulations. The team also assists clients with pre- and postapproval inspection readiness and FDA communications and facilitates engagement with CBER’s Advanced Technologies Team.
Greenleaf understands the complex environment within which life science transactions take place and advises investors on potential issues and regulatory risks that may be identified during such transactions.
Evaluation & Development of a Cell and Gene Therapy Quality Management System
A biopharmaceutical company well-versed in small molecule manufacturing processes requested Greenleaf’s support in building out its cell and gene therapy (CGT) manufacturing facility processes. Specifically, Greenleaf was asked to assist in developing the company’s Quality Management System (QMS) for new modalities in order to understand its positioning for sustainability and expansion of operations. Greenleaf experts …