Heidi Gertner works at the forefront of the drug regulatory industry. She provides insight to large and small pharmaceutical companies and research institutions in dealing with government regulators to maximize business potential.

With her wealth of drug regulatory knowledge and creative thinking skills, Heidi finds solutions to client problems and is a tireless advocate. She helps clients resolve their enforcement differences with the FDA and facilitates positive relationships with the agency. Heidi anticipates and helps clients dealing with cutting-edge issues, both by assessing policy initiatives and finding new business opportunities.

Heidi began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships, one at the Cleveland Clinic Foundation, and another at the National Institutes of Health. At the National Institutes of Health, Heidi's work focused primarily on human subject protection and research ethics issues.

Heidi honed her legal skills at the FDA's Office of Chief Counsel, where she advised government regulators on almost all aspects of drug regulation for 13 years. At the FDA, Heidi's portfolio focused on drug advertising and promotion, combination products, drug safety, clinical trials and human subject protection, Rx-OTC switches, and over-the-counter drug regulation. While at the agency, she oversaw numerous rulemaking and enforcement actions. As one of a handful of senior lawyers, Heidi worked closely with the Center for Drugs, HHS officials, and congressional staff.

Heidi joined Hogan Lovells in 2014 and calls the D.C. office her home base. She is plugged into the D.C. regulatory scene and works closely with companies and research institutions on developing regulatory and business strategy. She is an integral part of the skilled team of drug regulatory lawyers and works across numerous groups within the firm to provide clients with comprehensive legal and business advice. She is also an adjunct professor of law at American University's Washington College of Law, where she has challenged students in her Health Law Bioethics class for the past 15 years.

Positioned at the forefront of FDA compliance and regulatory issues critical to the business of life science companies, Jim Johnson excels at knowing what's ahead.

He works with life science clients on U.S. Food and Drug Administration (FDA) compliance and enforcement matters, focusing on FDA inspections, current good manufacturing practice (GMP) requirements, data integrity responsibilities, import and export issues, and pharmacovigilance obligations. He helps clients around the world identify compliance risks early, prevent problems from happening, efficiently resolve issues with minimal corporate pain, and improve agency relationships.

Jim knows the FDA well. Prior to joining Hogan Lovells, he served as Associate Chief Counsel for Enforcement in the FDA's Office of the Chief Counsel. He handled GMP enforcement and provided legal counsel on a range of inspectional and compliance issues to agency components, particularly the FDA's Office of Regulatory Affairs (ORA) and Center for Drug Evaluation and Research's (CDER) Office of Compliance.

Whether preparing an international manufacturing site for an FDA inspection, or working with a U.S.-based facility in response to FDA inspectional observations (a Form FDA 483), Jim uses his extensive agency and private practice experience to assist pharmaceutical, biotechnology, and cosmetic companies worldwide. He regularly conducts GMP assessments and investigations, resolves warning letters and import alerts, and appears in front of the FDA on behalf of companies to resolve enforcement actions.

Jim also advises life science companies on drug approval and life-cycle management strategies, and represents clients in related litigation against the FDA and U.S. Patent and Trademark Office. Jim honed these skills at the FDA, where he defended the agency in Hatch-Waxman cases involving agency exclusivity and patent-term extension determinations.

Whether describing complex science in straightforward terms to lawyers or translating premarket and compliance regulatory requirements to scientists, Randy Prebula focuses on practical industry experience and a deep understanding of Food and Drug Administration (FDA) regulations to help clients navigate the intersections of science, policy, and law.

As a key resource for medical device, drug, human tissue, and combination product manufacturers, Randy works seamlessly across borders with clients and internal teams to help bring innovative medical products to market and meet patient needs throughout each product's unique life cycle.

As co-director of the firm's FDA Medical Devices and Technology practice area, Randy helps develop and integrate legal and non-legal professionals into our practice to leverage technical and legal knowledge that provides clients with practical, implementable solutions to meet their regulatory needs. He also helps companies with cutting-edge technologies navigate and optimize the FDA approval process.

He brings a wealth of experience in immunology, biochemistry, and new product development and provides real-world experience in developing, implementing, and maintaining compliant regulatory systems and procedures.

As Global Head of our Life Sciences industry group, Asher Rubin has spent the past several years working with clients on some of the most exciting new technologies in the life sciences industry, such as CAR-T therapies, checkpoint inhibitors, co-stimulatory proteins, companion diagnostics, digital health technologies, ultra-orphan drugs, and gene therapies.

Asher developed his extensive industry knowledge over a period of more than 15 years, beginning with his role as in-house counsel and ultimately general counsel of a publicly traded, fully integrated pharmaceutical company.

Currently, Asher represents both private and publicly traded businesses, academic medical centers, inventors, and venture capital and private equity funds in a wide variety of transactions. He has comprehensive knowledge of the full spectrum of the life sciences sector: pharmaceuticals, biotechnology, medical devices, medical technology, digital health, and health services.

Asher has successfully negotiated and completed a range of life sciences transactions, with a particular focus on complex collaborative arrangements. Additionally, he regularly advises clients on venture capital financing, initial public offerings, follow-on financing, mergers and acquisitions, licensing transactions, joint ventures, co-promotion agreements, manufacturing arrangements, royalty acquisitions and divestitures, structured-finance arrangements, and sponsored research.

With six years of service as in-house counsel, he provides practical guidance to CEOs, CFOs, GCs, and other executives on their everyday legal matters, which include board governance, compensation, and employment matters. He regularly serves as a senior advisor to in-house counsel and as an outside general counsel for clients with limited in-house resources.

As co-head of the firm's global Fund Formation Practice Group, David Winter represents sponsors and investors across the fund formation spectrum. David was nearly eight years into his career as a tax lawyer when the firm asked him to take an expanded role in fund formation. He readily accepted and has never looked back.

David's clients include multi-billion dollar private equity firms, first-time fund managers, university endowments, pension plans, banks, and SBICs, many of whom he has represented for more than 10 years.

Funds are partnerships in the truest sense of the word and this principle guides David's practice. His experience advising both sponsors and investors arms him with the perspectives needed to craft creative and effective solutions. He believes in market neutral terms as a starting point for all funds, but when an off-market term is justified, David is adept at developing a solution that will satisfy all stakeholders. He particularly enjoys the civility and mutual respect that define the fund formation bar.

David's sponsor practice is broad. He represents the sponsors of private equity, venture capital, energy, real estate, and debt funds. His clients include sponsors of sector-focused funds and opportunistic funds, domestic and foreign funds, complex parallel and co-invest structures, funds-of-funds, and funds-of-one.

David's institutional investor clients include lead and anchor investors, strategic investors, passive term-takers, and everything in between. He tailors his advice and the scope of his work to match the needs of each client.

Brooke Bumpers has spent her entire legal career working with health care and life sciences organizations, helping them understand federal and state regulatory and legislative issues to resolve their problems. She has comprehensive knowledge of the regulation of clinical laboratories and medical device companies, including Clinical Laboratory Improvement Amendments (CLIA) and state regulation, as well as in the areas of hospice and palliative care and end-of-life issues.

Brooke enjoys variety in her practice, with a background in the regulation of human tissue, including organ donation, reproductive medicine, telemedicine and digital health, and healthcare reform, including Medicare's initiatives to transition from fee for service to performance-based payment systems.

Brooke especially enjoys learning about her clients' business and policy goals and helping them achieve them. Whether that involves advising on compliance with existing laws and regulations, working to change them through legislation, or advocating with government agencies, she is up for the challenge. Brooke takes pride in maintaining long-term relationships with clients and helping them with a wide range of issues affecting their industry, including obtaining coding, coverage, and reimbursement for a new lab test; developing and implementing a legislative strategy; or drafting comments on regulatory changes.

Her interest in all things health-related runs deep. Before joining Hogan Lovells in 1994, Brooke worked in the health practice group of a California-based law firm. Prior to attending law school, she worked on health policy issues for a state regulatory agency and a statewide health care provider. She chose to attend Georgetown Law School for the wide variety of health-related and regulatory courses offered, and because it was located in Washington, D.C., where she could get a close-up view of the laws and policies being made.