Jessica Band is as an associate in Ropes & Gray’s life sciences and regulatory compliance group, where she advises life sciences companies on a broad range of transactional, regulatory, and compliance matters and leads the group’s knowledge management and artificial intelligence adoption initiatives. Jessica has significant experience counseling life sciences companies regulated under the Federal Food, Drug, and Cosmetic Act and related laws. Her practice focuses on clinical trials, product development, regulatory strategy, advertising and promotional compliance, the regulation of digital health and artificial intelligence tools, drug and biologic exclusivity, quality system issues, and post-approval compliance. Jessica also assists clients in assessing FDA regulatory risks and negotiating key regulatory deal terms in complex transactions involving life sciences companies, including mergers, acquisitions, equity investments, collaborations, and security offerings.
Jessica plays a central role in developing, maintaining, and growing the practice group’s legal knowledge base. She designs and curates the group’s know-how resources, precedents, and practice guidance, and she leads efforts to evaluate and integrate artificial intelligence tools into the group’s workflows – helping the team deliver regulatory advice more efficiently.
Prior to joining Ropes & Gray, Jessica worked for Kaiser Permanente and the Advisory Board Company. Jessica attended the Georgetown University Law Center and completed a Master in Public Administration (MPA) at the Harvard Kennedy School.
Experience
- Routinely performs FDA regulatory diligence and negotiates key regulatory deal terms in corporate transactions involving pharmaceutical, medical device, compounding pharmacy, clinical research organization (CROs), dietary supplement and cosmetics companies on behalf of both private equity firms and strategic buyers. Representative transactions:
- Advent International and Warburg Pincus in their $4.25 billion investment in Baxter International Inc.’s BioPharma Solutions (BPS) business, a leading provider of sterile contract manufacturing solutions, parenteral delivery systems, and customized support services to the pharma and biotech industries.
- Pfizer in its $ 11.6 billion acquisition of Biohaven Pharmaceuticals, the maker of NURTEC ODT, a dual-acting migraine therapy approved for both acute treatment and episodic prevention of migraine in adults.
- TPG Capital and Clayton, Dubilier & Rice on regulatory matters in their acquisition of Covetrus, a global leader in animal health technology and services.
- Routinely performs FDA regulatory diligence for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotech companies.
- Routinely advises pharmaceutical and biotech clients in connection with license and collaboration agreements, supply agreements, and quality agreements.
- Routinely provide strategic advice and analysis to digital health clients on FDA’s evolving regulatory framework for software products, including mobile medical applications, clinical decisions support tools, and electronic health records.
- Routinely reviews advertising and promotional materials for pharmaceutical and medical deice companies for compliance with FDA and FTC requirements.
- Drafted and reviewed policies and procedures for a range of pharmaceutical and medical device clients, including policies governing promotional activities, interactions with healthcare providers, scientific communications, GxP and quality activities.
- Drafted trade complaints to FDA on behalf of pharmaceutical and medical device clients.
- Advised pharmaceutical companies on issues related to Hatch-Waxman, orphan drug exclusivity, and pediatric exclusivity.
- Counseled a medical device company related to responses to FDA inspections, field actions, and internal initiatives relating to regulatory compliance and quality.
- Advised pharmaceutical manufacturers, medical device companies, and compounding pharmacies during regulatory inspections and in responding to FDA 483s.
Knowledge Management & AI Adoption. Leads the development and maintenance of the group’s legal knowledge base, precedent library, and practice guidance, and spearheads the evaluation, piloting, and rollout of artificial intelligence tools to enhance the delivery of regulatory legal services, including designing and deploying custom AI workflows tailored to the group’s recurring regulatory tasks.
Pro Bono. Maintains active pro bono practicing, including building a case library for The Habeas Project of New England and evaluating case files from the Innocence Project’s Intake Department to identify incarcerated persons who may qualify for Innocence Project representation.