Orrick Grows Life Sciences & HealthTech Platform with 7-Lawyer FDA and Healthcare Regulatory Team

6 minute read | July.11.2024

Orrick has added a trio of regulatory partners to the firm’s Life Sciences & HealthTech platform, including: Georgia Ravitz, who focuses on matters before the FDA, and Amy Joseph and Jeremy Sherer, who advise digital health innovators and other healthcare providers on healthcare regulatory and transactional matters nationwide. Together, they will support the firm’s clients as they innovate across the Life Sciences & HealthTech sector.
Most recently head of the FDA regulatory practice at Wilson Sonsini, Georgia joins in Washington, D.C. She counsels U.S. and international clients through all phases of the corporate lifecycle, focusing on food and drug law and regulatory policy.
Amy and Jeremy join Orrick from national healthcare boutique Hooper, Lundy & Bookman in Boston. They counsel healthcare industry stakeholders, from digital health startups to publicly traded companies and investors, on issues involving regulatory compliance, digital health, and the utilization of artificial intelligence and machine learning in healthcare delivery.
With these additions, Orrick continues the rapid growth of the firm’s Life Sciences & HealthTech platform, which has more than quadrupled in size to 53 partners over five years. The firm today acts for more than 600 life sciences, healthtech and digital health clients, including 12 of the top 20 biopharma companies in the U.S. and 350+ growth companies and leading investors.

"Regulatory uncertainty is a top concern of both high-growth disruptors and global leaders in Life Sciences & HealthTech, as in all of the sectors on which Orrick focuses – and AI-driven innovation is only heightening this focus,” said Orrick Chair Mitch Zuklie. “Combining this 7-lawyer team with our privacy practice, we now offer destination-quality regulatory solutions for our growing portfolio of clients innovating in Life Sciences & HealthTech. We’re also excited to build our healthcare platform, a core piece of the puzzle in delivering innovative patient care.”

“The growth of our Life Sciences & HealthTech platform has outpaced even our most ambitious goals, with the sector now comprising 20% of our corporate, IP litigation and commercial/products liability litigation practices,” said Thora Johnson, a privacy advisor and co-leader of Orrick’s Life Sciences & HealthTech initiative. “We’re excited to build out a world-class regulatory practice, covering FDA, healthcare, privacy, antitrust and strategic partnerships, to deliver holistic solutions for the most innovative clients.”

“The convergence of technology and life sciences is generating tremendous opportunities for the discovery and delivery of therapies to treat life-changing disease,” said Stephen Thau, a member of Orrick’s Tech Companies practice and co-leader, with Thora, of the Life Sciences & HealthTech initiative. “Our clients are responding with innovation in all types of therapies and in the delivery of care. At the same time, we’re entering a period of uncharted regulatory developments. With the additions of Georgia, Amy and Jeremy, we are even better positioned to help disruptors scale, develop strategic partnerships, protect IP and navigate a plethora of new regulation.”

“There’s a transformation underway in life sciences and tech-enabled healthcare delivery like nothing we have seen in our lifetimes,” said Orrick Life Sciences Sector Leader David Gindler. “These additions enable Orrick’s clients across the corporate lifecycle to meet the moment.”

American Lawyer covered the team’s move in this feature.

About the Team

Georgia Ravitz

453876 Georgia guides healthcare and consumer products clients, including high-growth companies, investors and public companies, through the FDA’s regulation of medical devices, pharmaceuticals, cosmetics, food and agribusiness and emerging healthtech innovations. She advises U.S. and foreign companies through all phases of their product lifecycle.

“I’m excited to join Orrick’s thriving Life Sciences & HealthTech platform and look forward to collaborating with Amy, Jeremy, Thora and Orrick’s outstanding emerging companies practice to offer something truly special at this incredible moment in the market,” Georgia said.

Amy Joseph

453686 Amy, a Chambers-ranked attorney, counsels healthcare companies on a wide range of regulatory and transactional matters. Her areas of expertise include compliance with federal and state anti-kickback and self-referral laws, patient privacy laws, and otherwise establishing compliant frameworks for companies as they scale. She regularly counsels on strategic affiliations, value-based care arrangements and other innovative business models.

“We’ve collaborated over the past several years with the tremendous Orrick team – and now we are thrilled to join forces with them, and with Georgia, to advise clients on the most cutting edge issues facing today’s healthcare industry,” Amy said.

Jeremy Sherer

453705 Jeremy, most recently the co-chair of Hooper, Lundy & Bookman’s digital health practice, is a Chambers-ranked healthcare advisor. He regularly counsels healthcare clients on establishing and scaling multi-state virtual care delivery models, and navigating the myriad regulatory issues that arise in digital health ventures. His expertise includes corporate practice of medicine issues, the full range of telehealth scope of practice issues, and establishing business arrangements between medical practices and investor-backed management services organizations (also known as “PC-MSO” arrangements).

“We are truly inspired by the array of talent and portfolio of clients that Orrick has assembled,” Jeremy said. “Orrick is developing the regulatory team that digital health and healthtech companies need to navigate them through the industry’s complex regulatory landscape. Combined with the firm’s industry-leading technology and innovation, artificial intelligence and data privacy capabilities, to name a few, this platform is intentionally designed to meet the needs of scaling healthcare companies – and we’re thrilled to be a part of that effort.”

About Shari Fleishman Esfahani

Shari, who joins as counsel, focuses on regulatory and compliance advice, litigation and dispute resolution in the fields of life sciences, healthcare and consumer products. She advises companies with FDA-regulated products as well as healthcare companies and has substantial experience in complex advertising/promotion issues. Shari conducts regulatory due diligence for private equity funds, acquirers, sellers and underwriters in corporate transactions regarding FDA and FDA-adjacent regulatory issues. Her litigation work includes healthcare False Claims Act (qui tam) cases, false advertising, product liability, commercial disputes (breach of contract, business torts), antitrust (including Orange Book delisting challenges) and regulatory enforcement actions.

About Scott Cohn

Scott, who joins as counsel, advises life sciences and consumer product companies on all aspects of product regulation, safety and compliance, including labeling, advertising and import/export requirements. He has guided hundreds of innovative companies in effectively navigating the ever-evolving federal, state and international regulatory landscape.

Orrick Life Sciences & HealthTech

In 2023, Orrick’s life sciences team advised on $3.8 billion in M&A transactions across 12 countries, and $2.5 billion in venture financings globally, acting for high-growth life sciences, healthtech and digital health companies and strategics. Our litigation and IP team, which includes 57 lawyers with technical degrees in life sciences and engineering including, 7 PhDs, represents some of the largest life sciences companies in the world, including Gilead, Genentech and others. Twenty percent of our corporate, litigation and IP work focuses on Life Sciences & HealthTech.

Related Lawyers

Georgia C. Ravitz Partner, FDA & Healthcare Regulation, Life Sciences & HealthTech

Washington, D.C.

See my bio

D:+1 202 339 8651
E: [email protected]

Practice:

FDA & Healthcare Regulation
Life Sciences & HealthTech
Strategic Advisory & Government Enforcement (SAGE)
Technology Companies Group
Technology & Innovation

vCard

See full bio

Georgia C. Ravitz Partner

Washington, D.C.

Georgia also has extensive experience in assisting clients with product recalls, crisis management and government enforcement. Her practice in this sector includes assisting manufacturers, distributors, retailers and importers on all types of FDA regulated products including pharmaceuticals, medical devices and software, wearables, health and wellness products, cosmetics, cell and plant based foods, conventional foods, ag tech, compounded drugs, and dietary supplements.

Georgia’s deep experience and ability to provide practical guidance in FDA and FDA-adjacent regulatory matters allows her to work closely with innovative companies looking to minimize regulatory burdens and maximize U.S. marketing opportunities in the life science and health tech industry verticals. She also conducts regulatory due diligence for private equity and public company transactions involving life science, medtech and innovative companies.

Georgia is a frequent speaker at conferences and events who contributes regularly to leading trade and consumer media outlets.

Amy M. Joseph Partner, FDA & Healthcare Regulation, Life Sciences & HealthTech

Boston

See my bio

D:+1 617 880 2230
E: [email protected]

Practice:

FDA & Healthcare Regulation
Life Sciences & HealthTech
Strategic Advisory & Government Enforcement (SAGE)
Technology Companies Group
Technology & Innovation

vCard

See full bio

Amy M. Joseph Partner

Boston

Amy works with digital health companies, health systems and other public and private companies—from new entrants to seasoned organizations—to address regulatory compliance and transactional needs. She also advises investors and collaborates with clients to understand their business goals and tailor practical solutions to help them achieve those objectives. Amy is well-versed in the corporate governance, data privacy, and security and scope-of-practice considerations facing the healthcare industry as it incorporates artificial intelligence (AI) and machine-learning (ML) solutions into clinical workflows. Her practice includes structuring and scaling national telehealth practices across a range of clinical disciplines, including complex collaborative arrangements involving labs, medical device manufacturers, remote patient monitoring solutions and pharmacies.

Amy spends much of her time working with clients on vetting and developing strategic affiliations, joint venture transactions and other novel business arrangements, including developing value-based enterprises and otherwise identifying means to achieve further alignment among stakeholders. She advises on reimbursement issues with respect to federal healthcare programs, private payors and self-pay business models. She also helps develop compliance programs and advises on related protocols and best practices.

In particular, Amy advises on physician self-referral, anti-kickback and other fraud and abuse law matters as well as on patient privacy matters, including HIPAA, 42 CFR Part 2 and corresponding state-level compliance. Amy also assists with internal investigations and assessing and responding to the results, including developing corrective action recommendations and self-disclosures.

A sought-after speaker and prolific writer on some of the most complex and critical issues in healthcare law, Amy shares her insights in publications and presentations across the country. She co-authored chapters in numerous publications, including the telemedicine chapter of the American Bar Association’s Physician Law: Evolving Trends & Hot Topics and a chapter addressing telehealth in the MCLE Massachusetts Health and Hospital Law Manual.

Chambers USA notes that Amy has “deep expertise in matters that impact healthcare providers and healthcare transactions,” “is a terrific resource on a range of regulatory issues” and “an expert in the Stark Law.”

Amy graduated first in her class at UCLA Law and was elected to the Order of the Coif. Prior to law school, Amy served in the U.S. Air Force.

Jeremy D. Sherer Partner, FDA & Healthcare Regulation, Life Sciences & HealthTech

Boston

See my bio

D:+1 617 880 2254
E: [email protected]

Practice:

FDA & Healthcare Regulation
Life Sciences & HealthTech
Strategic Advisory & Government Enforcement (SAGE)
Technology Companies Group
Technology & Innovation

vCard

See full bio

Jeremy D. Sherer Partner

Boston

Jeremy advises clients on the full range of regulatory health care issues facing digital health stakeholders. His depth and breadth of experience enables him to help established and early-stage companies navigate a complex and ever-changing business and regulatory landscape. As one client’s CEO explained, “Jeremy is one of the best thought partners, and hands down the best legal navigator, I’ve found in the digital health space.”

His telehealth experience includes advising on compliance with state licensure requirements for physicians and non-physician practitioners, corporate practice of medicine issues, remote prescribing (including controlled substances), patient consent and Medicare, Medicaid and commercial reimbursement. He advises clients on compliance with laws against fraud and abuse, including federal and state anti-kickback and self-referral laws, as well as privacy issues arising under HIPAA and its state-level counterparts.

Jeremy has substantial experience pertaining to structuring, operationalizing and scaling “PC-MSO” arrangements across all 50 states. He also advises venture capital and private equity firms conducting regulatory diligence associated with investments in digital health and health care technology ventures, from seed stage funding to nine-figure raises.