Cell & Gene Therapy
After decades of research, cell and gene therapies offer new hope to patients with diseases and conditions previously considered untreatable. While there have been tremendous advances, companies must navigate a rapidly evolving regulatory environment. Greenleaf assists sponsors by optimizing FDA interactions, submissions, manufacturing technology, and quality systems to support regulatory compliance and review.
Cell & Gene Therapy Team
Greenleaf’s team is comprised of former leaders in the FDA’s offices overseeing cell and gene therapies, drugs and biologics, drug product quality, and compliance, working in close collaboration to ensure that clients have integrated regulatory advice guided by decades of experience.
John TaylorPresident and Principal, Compliance and Regulatory Affairs
Karen Midthun, M.D.Principal, Drug and Biological Products
Wilson W. Bryan, M.D.Executive Vice President, Drug and Biological Products
Cynthia SchnedarPrincipal, Regulatory Compliance
Sandra L. Kweder, M.D.Principal, 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
Greenleaf’s Drug and Biological Products Team helps sponsors understand and respond to the FDA requirements applicable to cell and gene therapy products and optimize FDA interactions and submissions to support development and regulatory review.
As development of cell and gene therapies often involves consideration of aspects of medical device and combination product regulation — another area of deep FDA experience and expertise at Greenleaf — experts from the Medical Device and Combination Products Team and the Drug and Biological Products Team collaborate regularly on such matters.
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. Manufacturers of cell and gene therapies are responsible for complying with multiple current GXP regulations, including: good manufacturing practice regulations (GMPs) and/or quality system regulations (QSRs); good laboratory practice regulations (GLPs); good clinical practice regulations (GCPs); and good tissue practice regulations (GTPs).
Greenleaf’s Product Quality, Manufacturing, and Compliance Team, along with its network of independent compliance experts, provide clients with the strategic and technical support needed to meet FDA requirements, including pre- and postapproval inspection readiness and compliance assessments. The team offers credible, informed guidance on FDA communications and meeting preparation, provides regulatory benchmarking services, and assists clients with evaluating and responding to FDA Form 483s, warning letters, untitled letters, and other FDA regulatory correspondence.
Additionally, Greenleaf works with the FDA to support client development and implementation of cell and gene therapy manufacturing technology. Greenleaf has effectively engaged with the FDA on behalf of clients to discuss, identify, and resolve potential technical and regulatory challenges related to emerging manufacturing technologies prior to regulatory submissions.
Regulatory Landscape Analysis & Diligence
Greenleaf monitors and analyzes the regulatory environment for emerging trends in cell and gene therapy regulation that could potentially impact current development programs ⎯ including orphan drug designation and exclusivity, long-term follow-up requirements, companion diagnostics, and the development and use of real-world evidence ⎯ as well as changes to the competitive landscape for cell and gene therapies.
Our Advisory Services Team also offers focused due diligence and regulatory risk assessment in this space.
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 …
Connect With an Expert
Greenleaf’s Cell & Gene Therapy Team is ready to help you achieve your regulatory goals. Please provide the information below and a team member will be in contact.