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Rebecca focuses her practice on FDA regulatory matters and advises life sciences and health care clients on a broad range of regulatory and compliance issues under the Food, Drug and Cosmetics Act and related laws. Rebecca routinely provides regulatory counsel for corporate transactions, license and collaboration agreements, manufacturing and supply arrangements, and public and private securities offerings involving drug, device, cosmetic, food, and dietary supplement companies. Rebecca also regularly provides legal and strategic advice to pharmaceutical and biotech clients on advertising and promotion issues. Rebecca maintains an active pro bono practice with a focus on immigration, health care, and child welfare issues.
Experience
Transactions and Offerings
- Routinely provide regulatory counsel for corporate transactions involving drug, medical device, cosmetic, food, and dietary supplement companies. Representative transactions:
- Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, in its sale to Sanofi for approximately $2.9 billion.
- Pfizer in its $6.7 billion acquisition of Arena Pharmaceuticals, a biotechnology company developing potential therapies for the treatment of several immuno-inflammatory diseases.
- TPG Capital and Clayton, Dubilier & Rice on regulatory matters in their acquisition of Covetrus, a global leader in animal health technology and services.
- Blackstone Life Sciences in its $2 billion strategic collaboration to support Alnylam’s advancement of innovative RNA interference (RNAi) medicines.
- GHO Capital Partners LLP in its investment in Biocare, a leading developer of world-class immunohistochemistry and in situ hybridization reagents for cancer diagnosis and chromosomal profiling.
- Prevail Therapeutics in its sale to Eli Lilly and Company to establish a gene therapy program at Lilly anchored by Prevail’s portfolio of neuroscience therapeutics to address fatal genetic forms of neurodegenerative diseases including Parkinson’s disease and neuronopathic Gaucher disease, among other disorders.
- Avista Capital Partners in its acquisition of G&W Laboratories, Inc.’s extended topicals and dermatology business unit.
- Blackstone Life Sciences in its acquisition of Clarus, a leading global life sciences investment firm that closed its inaugural fund with $4.6 billion in capital commitments.
- Routinely perform FDA regulatory advice for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotech companies. Representative matters:
- Sigilon Therapeutics, Inc. in its $145 million initial public offering
- Underwriters in the $82.5 million initial public offering of Codiak BioSciences, Inc., a clinical-stage company focused on pioneering the development of exosome-based therapeutics as a new class of medicines
- Lead underwriters in the follow-on offering of Fulcrum Therapeutics, Inc.
- Underwriters in several debt and equity offerings for Rhythm Pharmaceuticals, Provention Bio and Seres Therapeutics
- Frequently advise pharmaceutical and medical device clients in connection with collaboration, licensing, manufacturing, and quality agreements.
Advertising and Promotion
- Routinely assess regulatory compliance of advertising and promotional materials for pharmaceutical, biotech, medical device, cosmetic, and food companies.
- Routinely assist pharmaceutical and medical device clients in developing policies and procedures governing the review, approval, and use of promotional and non-promotional materials.
- Frequently serve as the legal and compliance reviewer on pharmaceutical and biotech clients’ promotional review committees.
- Seconded for four months to global biopharmaceutical company as an associate general counsel responsible for endocrinology and fertility therapeutic areas, leading legal issues relating to advertising and promotional review committees, as well as supported and advised brand teams and senior leadership and drafted commercial agreements, among other corporate responsibilities.
- Performed an assessment of a pharmaceutical client’s promotional review committee, which involved employee interviews, reviewing SOPs and other internal documents, evaluating a sampling of promotional materials used by the company, and providing recommendations for improvement.
Regulatory Strategy
- Regularly advise on policies and procedures for pharmaceutical, medical device, cosmetic, and food clients, including policies governing GxP and quality activities, internal and third party audits, vendor selection, qualification and management, complaint handling, recalls and adverse event reporting.
- Drafted a successful request for a priority review voucher on behalf of a biotechnology firm.
- Advised a pharmaceutical client regarding compliance with cGMP requirements and responding to FDA inspections and warning letters.
- Advised medical device client regarding issues related to recall and regulatory reporting decisions.
- Advised pharmaceutical clients on issues related to Hatch-Waxman, orphan drug exclusivity, and new chemical entity exclusivity.
- Advised a compounding pharmacy on compliance matters associated with the Drug Quality and Security Act and implementing FDA regulations and guidance.