Jesselyn C. Pe is an associate in the FDA Regulatory and Enforcement practice of Paul Hastings and is based in the firm’s New York office.
Her practice focuses on advising life sciences companies on a broad range of regulatory and enforcement matters related to the U.S. FDA, including on Good Manufacturing Practices (GMPs) and Quality System Regulation (QSR) compliance, clinical trials, and product security. She has conducted significant proactive reviews for drug and medical device companies relating to quality and compliance controls, supplier management, clinical operations and product diversion / falsification. She has assisted U.S. and international companies in responding to FDA Warning Letters, FDA Form 483s, and other enforcement actions. She has conducted data integrity investigations and other internal investigations related to GMP violations. Her practice also focuses on counseling life sciences companies on developing and implementing effective compliance programs, and preparing them for FDA inspections, including through on-site guidance and support.
Ms. Pe regularly prepares and negotiates a wide array of supply, services, and quality agreements with contract manufacturers, research organizations, and clinical investigators. She advises clients on manufacturing, clinical, and regulatory issues in connection with due diligence pre- and post-acquisition reviews and mergers and acquisitions involving life sciences companies.
She was a legal secondee for more than a year with the rare disease affiliate of a global pharmaceutical company, where she provided day-to-day legal support for the Global Quality, Global Operations, Supply Chain, and Product Security functions. She counseled stakeholders on regulatory and legal risks related to GMPs, Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), and Good Distribution Practices (GDPs).
She started her law career as an Intellectual Property litigation associate in another global law firm, where her practice focused on Hatch-Waxman and patent infringement litigation of pharmaceutical and medical device patents. She has both bench and jury trial experience, including direct examination of corporate and expert witnesses, arguing motions, preparing briefs and other Court filings, and participating in hearings for summary judgment, discovery, pre- and post-trial, and injunctive motions.
Ms. Pe has extensive experience with the pharmaceutical industry, having worked for 11 years in various capacities in-house in global pharmaceutical companies prior to law school, including as a Drug Regulatory Affairs manager at Novartis. Her responsibilities included: preparing, managing, and filing New Drug Applications (NDAs), 505(b)(2) applications, Abbreviated New Drug Applications (ANDAs), and Investigational New Drug Applications (INDs); ensuring compliance of marketed prescription and OTC drugs with NDA and FDA regulations, and serving as the company contact person in the event of product recalls and FDA inspections; interpreting current and proposed FDA regulations, including their impact on the company’s products and operations; and reviewing and approving drug product labeling, advertising, and scientific papers to ensure compliance with approved NDAs and FDA regulations, as well as the goals of the business.
In addition, Ms. Pe has extensive bench chemistry and laboratory experience, and has held positions as an analytical research chemist in R&D and Quality Control chemist at Boehringer Ingelheim, where she developed and validated analytical methods for investigational and marketed drugs, designed and performed stability studies, and performed QC release testing of finished drug products, raw materials, and packaging components.
During law school, she held a judicial externship with The Honorable John J. Hughes, U.S. Magistrate Judge, with the U.S. District Court for the District of New Jersey.
- Pro Bono Service Awards (Sidley Austin, 2016, 2018-2019)
- Rutgers University School of Law – Newark, J.D., 2007
- New York University, Stern School of Business, M.B.A., 1993
- University of the Philippines, B.S. (magna cum laude), 1984
Foreign language capabilities
- Ms. Pe is a native Tagalog (Filipino) speaker
- Conducted proactive review of the clinical operations processes in the US and OUS of a major pharmaceutical company
- Prepared and negotiated a variety of supply, services, and quality agreements with third-party manufacturers of commercial and clinical supplies, contract organizations, laboratories, and clinical investigators
- Conducted FDA-related due diligence for various corporate transactions involving pharmaceutical, biological, and medical device companies, including early stage companies as well as larger companies with well-established portfolios
- Assisted state licensing team of pharmaceutical company in state licensing submissions and renewals, including in responding to states’ inquiries related to the licenses
- Counseled Asia-based API manufacturer in responding to 483 observations and Warning Letter, and assisted company in developing and implementing effective remediation of its Quality Systems
- Assisted pharmaceutical manufacturer in developing and implementing comprehensive remediation program, and preparing company’s multiple Asia-based manufacturing sites for successful FDA re-inspections
- Conducted significant data integrity investigation and remediation in response to FDA Warning Letter for Asia-based pharmaceutical manufacturer
- Conducted comprehensive review of supplier management processes and regulatory purchasing controls at multinational device manufacturer
- Assisted global pharmaceutical company in investigating and responding to an FDA Warning Letter for GMP issues in its Asia-based subsidiary
Engagement & Publications
- Going Up the Chain: Escalation of Significant Issues in Life Sciences Companies, Peter Lindsay, Nathan Sheers, and Jesselyn Pe, FDLI Update Magazine, Spring 2021
- Admitted to the U.S. Court of Appeals for Veterans Claims and is an accredited attorney with the Department of Veterans Affairs
- Has devoted significant time to pro bono efforts, primarily assisting veterans in applying for Combat-Related Special Compensation (CRSC) and seeking disability benefits