Mesoblast’s CEO appointed Tom to serve on the Operating Committee, comprised of the company’s most senior executives and tasked with providing strategic direction and support on financial, commercial, clinical, personnel, and other critical matters confronting the company.

Tom is the Head of U.S. Legal for Mesoblast (NASDAQ: MESO, ASX: MSB), a multinational, cutting-edge biotech company bringing life-saving therapies to critically underserved patient populations. In this executive role, Tom serves as a strategic partner to Mesoblast‘s C-Suite, Board of Directors, and other executives as the company strives for the approval, manufacturing, and commercialization of its first-in-kind pipeline products. Tom is responsible for all legal matters in the U.S. and has a… Show more Tom is the Head of U.S. Legal for Mesoblast (NASDAQ: MESO, ASX: MSB), a multinational, cutting-edge biotech company bringing life-saving therapies to critically underserved patient populations. In this executive role, Tom serves as a strategic partner to Mesoblast‘s C-Suite, Board of Directors, and other executives as the company strives for the approval, manufacturing, and commercialization of its first-in-kind pipeline products. Tom is responsible for all legal matters in the U.S. and has a range of international responsibilities, including negotiating a range of complex agreements and strategic partnerships (e.g., CDMO agreements, distribution/speciality distribution agreements, license agreements, clinical-trial agreements / R&D contracting), building out a commercial infrastructure and supply chain, establishing a Patient Support Program, leading the legal support for numerous business units and other functions (e.g., Commercial, Marketing and Market Access, Supply Chain, Compliance, Public Relations, Regulatory, Quality, Manufacturing, Medical Affairs, Clinical/R&D, Human Resources), overseeing complex litigation, investigations, and other disputes in the U.S. and abroad, serving as the legal representative on Mesoblast’s promotional review committee, and ensuring that Mesoblast’s U.S.- and Singapore-based manufacturing comports with U.S Food and Drug Administration (FDA) Current Good Manufacturing Practices (cGMP).Boasting a global footprint and commercial partnerships with industry standard-bearers, Mesoblast and its innovative platform technology have been recognized with the Fierce Innovation Awards - Life Sciences Edition 2020 for Biotech Innovation, Frost & Sullivan 2017 Global Technology Leader — Cell Therapy Industry Award, and Key Innovation Award 2013 from the Pontifical Council for Culture and The Stem for Life Foundation, among other honors. Show less

Tom was the Global Chief FDA Compliance Counsel, Head of Corporate Litigation and Investigations, and a member of the Quality / cGMP Steering Committee at Lupin, a multinational generic and speciality pharmaceuticals company with 20,000+ employees, 15 manufacturing plants, and 5 research facilities world-wide. He successfully guided multiple plants in the U.S. and abroad through cGMP remediations, resulting in FDA declining to take any further action. Tom directly supported C-Suite executives… Show more Tom was the Global Chief FDA Compliance Counsel, Head of Corporate Litigation and Investigations, and a member of the Quality / cGMP Steering Committee at Lupin, a multinational generic and speciality pharmaceuticals company with 20,000+ employees, 15 manufacturing plants, and 5 research facilities world-wide. He successfully guided multiple plants in the U.S. and abroad through cGMP remediations, resulting in FDA declining to take any further action. Tom directly supported C-Suite executives (CEO, President, EVPs), the Board of Directors, and the General Counsel from Lupin’s global corporate headquarters in Naples, FL. Show less

Lupin’s CEO appointed Tom to serve as one of three members of Lupin’s Quality / cGMP Executive Steering Committee, the executive body tasked with ensuring continuous cGMP compliance across the company’s manufacturing network and reporting directly to the CEO. As a key member of the Committee, Tom successfully guided multiple Lupin manufacturing sites through FDA inspections and cGMP remediation… Show more Lupin’s CEO appointed Tom to serve as one of three members of Lupin’s Quality / cGMP Executive Steering Committee, the executive body tasked with ensuring continuous cGMP compliance across the company’s manufacturing network and reporting directly to the CEO. As a key member of the Committee, Tom successfully guided multiple Lupin manufacturing sites through FDA inspections and cGMP remediation plans:https://www.lupin.com/lupins-somerset-manufacturing-plant-receives-eir-from-us-fda/https://www.lupin.com/lupins-goa-manufacturing-plant-receives-eir-from-us-fda/ Show less

Charter member of CPB task force responsible for reviewing all actions arising under the FDCA proposed by U.S. Attorneys’ Offices nationwide and determining whether (1) such actions would proceed and (2) CPB would monitor or intervene in the actions. This task force was formed after DOJ amended Section 4-8.200 of the Justice Manual to require USAOs, “[u]pon opening any criminal investigation involving a possible violation of the FDCA . . . [to] notify and consult with [the Consumer Protection… Show more Charter member of CPB task force responsible for reviewing all actions arising under the FDCA proposed by U.S. Attorneys’ Offices nationwide and determining whether (1) such actions would proceed and (2) CPB would monitor or intervene in the actions. This task force was formed after DOJ amended Section 4-8.200 of the Justice Manual to require USAOs, “[u]pon opening any criminal investigation involving a possible violation of the FDCA . . . [to] notify and consult with [the Consumer Protection Branch].” The change responded to concerns about inconsistent enforcement of the FDCA. Show less

Tom was a federal prosecutor at the U.S. Department of Justice’s Consumer Protection Branch located in Washington, D.C. The Consumer Protection Branch, a small branch of only 30 prosecutors, has exclusive authority to enforce the Federal Food, Drug, and Cosmetic Act (FDCA) and U.S. Food and Drug Administration (FDA) regulations (including cGMP regulations) against the medical-device, pharmaceutical, food, and cosmetic industries in civil actions and must be consulted on (and has the authority… Show more Tom was a federal prosecutor at the U.S. Department of Justice’s Consumer Protection Branch located in Washington, D.C. The Consumer Protection Branch, a small branch of only 30 prosecutors, has exclusive authority to enforce the Federal Food, Drug, and Cosmetic Act (FDCA) and U.S. Food and Drug Administration (FDA) regulations (including cGMP regulations) against the medical-device, pharmaceutical, food, and cosmetic industries in civil actions and must be consulted on (and has the authority to intervene in) all criminal actions filed under those laws. The Consumer Protection Branch also litigates enforcement actions on behalf of the Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), and other government agencies.While at the Consumer Protection Branch, Tom spearheaded major civil and criminal investigations into multimillion- and multibillion-dollar fraudulent schemes, conducted False Claims Act criminal investigations, served as first-chair counsel on precedent-setting enforcement actions, represented FDA in court in affirmative and defensive litigation, was a charter member of the Branch's FDCA Consultation Action Team tasked with reviewing all proposed FDCA criminal actions nationwide, and drafted FDA industry guidance, among many other responsibilities. Tom also prevailed in enforcement actions on behalf of the FTC and CPSC. The CPSC action resulted in a resounding government victory and established the most important case law under the Consumer Product Safety Act in decades.The Consumer Protection Branch’s guiding principle is the protection of the health, safety, and economic security of the American consumer, and in that connection Tom worked to enforce consumer-protection statutes in close coordination with federal agencies such as FDA, the FTC, the CPSC, the National Highway Traffic Safety Administration, and the Consumer Financial Protection Bureau, as well as U.S. Attorneys’ Offices across the United States. Show less

Tom was a litigation, FDA compliance, and government-enforcement attorney in the firm’s Washington, D.C. office, working extensively with both the firm's Litigation and FDA Enforcement groups. His litigation practice focused on complex lawsuits and white-collar investigations in the U.S. and abroad. Tom conducted sensitive and wide-ranging investigations in matters arising under, among other laws, the Federal Food, Drug, and Cosmetic Act, FDA regulations (including cGMP regulations), the False… Show more Tom was a litigation, FDA compliance, and government-enforcement attorney in the firm’s Washington, D.C. office, working extensively with both the firm's Litigation and FDA Enforcement groups. His litigation practice focused on complex lawsuits and white-collar investigations in the U.S. and abroad. Tom conducted sensitive and wide-ranging investigations in matters arising under, among other laws, the Federal Food, Drug, and Cosmetic Act, FDA regulations (including cGMP regulations), the False Claims Act, the Anti-Kickback Statute, the Foreign Corrupt Practices Act, and other laws. Tom also built clients' FDA compliance programs, embedding himself in clients' operations and working closely with stakeholders to identify areas needing improvement and create policies and procedures which managed risk without overburdening the businesses. For example, Tom worked closely with life-sciences clients to ensure cGMP compliance in response to Form-483s and Warning Letters issued after FDA inspections. Tom’s clients ranged from Fortune 100 corporations to charitable associations, the latter of which formed part of Tom’s award-winning pro bono practice. Tom has special expertise in e-discovery matters and was a longtime member of the firm’s E-Discovery Task Force. Show less