Drug & Biological Products
In the challenging world of biopharmaceutical development, companies need a trusted regulatory partner to help them make timely, informed decisions. Greenleaf’s respected FDA experts provide a vital perspective to clients on the complex process of bringing new therapeutics to market.
Drug & Biological Products Team
Greenleaf’s Drug and Biological Products Team has a robust blend of regulatory and policy expertise and FDA institutional knowledge. The team’s approach is guided by decades of regulatory experience in drug and biological product development, spanning all therapeutic areas.
John K. Jenkins, M.D.Principal, Drug and Biological Products
Robert J. Meyer, M.D.Principal, Drug and Biological Products
Karen Midthun, M.D.Principal, Drug and Biological Products
Sandra L. Kweder, M.D.Principal, Drug and Biological Products
Joseph GriffinExecutive Vice President, Drug and Biological Products
Brian CorriganExecutive Vice President, Regulatory Policy
Stephen MasonExecutive Vice President, Regulatory Policy
Chris Leptak, M.D., Ph.D.Executive Vice President, Drug and Biological Products
Wilson W. Bryan, M.D.Executive Vice President, Drug and Biological Products
Sarah McGarry, M.D.Senior Vice President, Drug and Biological Products
Sean HilscherVice President, Regulatory Policy
Rhona BaniquedExecutive Director of Operations, Drug and Biological Products
Tanvi MehtaManager, Regulatory Affairs and Policy
Stephen PowerAssociate Director of Operations, Drug and Biological Products
Becca HuntAssociate Director of Operations, Drug and Biological Products
Our Drug & Biological Products Services
Strategic Regulatory Guidance
Greenleaf experts specialize in providing strategic and technical guidance on medical product development, regulatory review, and postmarket requirements. Our strategic consultation encompasses:
- FDA regulatory programs and procedures
- Product development
- Endpoint and biomarker selection, development, and regulatory review
- Use of real-world evidence in regulatory submissions
- Product classification and jurisdiction
- Premarket review processes
- Postmarket safety requirements
- Labeling requirements
- Direct-to-consumer advertising review processes
- Promotional materials and use of social media
- Remediation of untitled and warning letters
- Pipeline decisions and optimization
Premarket Review Process
Drawing on deep knowledge cultivated during their careers as FDA leaders and senior officials, Greenleaf’s advisors deliver analysis and guidance on an array of issues companies face throughout the premarket review process, including:
- Scientific and regulatory practices for clinical programs and regulatory submissions
- Identification of and eligibility for special designations, such as breakthrough therapy designation, RMAT, fast track, and accelerated approval
- Determination of classification as a drug, biological product, or combination product and preparation of Requests for Designation (RFDs) and pre-RFDs to determine regulatory identity and responsible FDA Center
- Preparation for FDA milestone meetings, including EOP2, pre-filing, mid-cycle review, and end-of-review meetings
- Advisory committee meetings and decisions
- FDA communications, including formal, in-person, and regulatory correspondence
Drug Development Tool Services
Greenleaf’s experts provide strategic regulatory support for the development and regulatory use of drug development tools (DDTs), including biomarkers and novel technologies. In addition to critical assessment of a client’s goals, Greenleaf identifies regulatory and/or scientific gaps and recommends potential paths to address those gaps.
Combination Product Support Services
Greenleaf provides strategic advice throughout the combination product lifecycle, including all potential premarket pathways (NDA, ANDA, BLA, PMA, 510(k), De Novo). Our experts have extensive experience with drug-coated devices and a wide range of drug delivery systems including subcutaneous, inhaled, injected, topical, intrathecal, and closed loop. We also have knowledge and experience with designation and development of companion diagnostics.
Greenleaf has expertise to help sponsors determine the regulatory identity (classification) of their product as a drug, device, biological product, or combination product. For drugs and biological products, Greenleaf can prepare Requests for Designation (RFDs) and pre-RFDs to determine the regulatory identity and responsible FDA Center.
Pipeline Review Services
Our team’s multidisciplinary expertise helps companies evaluating and prioritizing their drug development pipeline to understand and effectively manage regulatory risk. We provide pipeline evaluations, gap analyses, and customized strategies for:
- Managing regulatory risk and reducing regulatory uncertainties
- Planning and decision-making related to clinical programs and regulatory approval
- Prioritizing and addressing programmatic needs for individual candidates and across the portfolio, based on systematic gap analysis
- Drug development options, opportunities, and benchmarks
Regulatory Policy Services
Greenleaf’s team includes regulatory policy experts with extensive experience providing insight and recommendations to small and large companies, trade associations, patient organizations, and other stakeholders on:
- FDA regulatory policy, including novel programs
- Product designations and access to expedited programs
- Regulatory issues arising both pre and post market
- Regulatory intelligence and scientific policy
- Building client capacity and understanding of regulatory policy issues
Cell and Gene Therapy
The Drug and Biological Products Team assists sponsors of cell and gene therapies with FDA interactions and submissions — including early INTERACT and pre-IND meetings; requests for orphan drug, RMAT, and rare pediatric disease designations; and data comparability questions — and helps to clarify FDA requirements for specific types of cellular products. The team also provides guidance on how to maximize clinical trial design for cell and gene therapies to treat rare and ultra-rare diseases.
Digital Health Services
Greenleaf experts provide guidance to clients developing, commercializing, utilizing, and investing in innovative digital health technologies as they navigate the evolving landscape of FDA digital health requirements.
Experts from the Drug and Biological Products Team provide advisory services that include extensive research and due diligence for investors engaged in potential deals that require regulatory risk analyses before and after decisions and transactions.
Restarting a Stalled Development Program
Greenleaf Health worked with a multinational biopharmaceutical manufacturer to reinitiate their phase 3 program for a women’s health product, which had stalled after the FDA had voiced concerns with the design of the pivotal trial. The client needed a way to fulfill the Agency’s request for additional long-term outcomes data, which would require an expansion …
Leading a Client Through Dispute Resolution to Product Approval
Upon receiving a Complete Response Letter (CRL) for their lead product to manage mild to moderate pain, a mid-sized specialty pharmaceutical company engaged Greenleaf Health to assist them in addressing the deficiencies cited in the CRL and developing a strategy for resubmitting the new drug application (NDA). Greenleaf’s regulatory experts, in conjunction with a partner …
Developing a Regulatory Strategy to Successfully Manage Assessment and Conduct of a Large Phase 3 Program
Greenleaf Health assisted a mid-sized pharmaceutical company in developing a regulatory strategy to address safety and trial conduct issues in the phase 3 program for their lead compound for cardiovascular disease. During phase 3 trials, the client identified a consequential safety event and sought Greenleaf’s guidance on both addressing the safety event in the context …
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