Greenleaf Health provided strategic and tactical advice to an early-stage software as a service (SaaS) start-up developing and commercializing a software product intended for mental health providers and patients. The Greenleaf team reviewed various proposed claims for the client’s product to ensure that the claims would not cause the software to be an FDA-regulated medical …
Greenleaf Health helped a digital therapeutic company developing cognitive treatments as it navigated the de novo classification request regulatory pathway. Greenleaf experts worked closely with the client to address FDA concerns and requests regarding the digital therapeutic device, helping to clarify the FDA’s questions and recommendations and assisting with drafting written correspondence to the Agency. With Greenleaf’s …
Vice President, Regulatory Compliance and Deputy General Counsel
Maria is a Vice President in Greenleaf’s regulatory compliance group, where she provides strategic and regulatory advice to clients. Maria also serves as Greenleaf’s in-house Deputy General Counsel.
Prior to joining Greenleaf, Maria gained policy and legal experience in both the private and public sectors. She formerly served at the White House in several roles. She served on the Domestic Policy Council as Deputy Director and Special Assistant to the President. Maria also served as the Deputy Associate Counsel in the Office of the Vice President.
Maria’s previous private sector experience included consulting and legal roles. Maria was at Greenleaf in the regulatory compliance group.
She formerly was at a global law firm in the litigation and international arbitration group. Before pursuing her law degree, Maria was an Analyst at an international business and economic public policy consultancy. She worked principally with the Managing Directors, former administration alumni including a President’s Chief of Staff, in providing key policy advice to clients.
Maria earned her J.D. from Georgetown University Law Center and her B.A. from Georgetown University, graduating summa cum laude and Phi Beta Kappa.
Chris Leptak, M.D., Ph.D.
Executive Vice President, Drug and Biological Products
Chris joined Greenleaf in 2021, bringing 14 years of FDA regulatory experience to his role as Executive Vice President of Drug and Biological Products. He specializes in the regulatory use of novel clinical endpoints, including surrogates for both traditional and accelerated marketing approval.
While at the FDA, Chris began as a medical officer in the gastroenterology division. With his immunology expertise, his primary focus was on immunomodulator drug and biologic product development. After joining OND’s Guidance and Policy team, he became OND’s first biomarker and companion diagnostic lead, responsible for developing guidance and evidence requirements to support regulatory acceptance. As CDER’s lead for implementation of the 21st Century Cures legislation for Section 3011 Drug Development Tools, he supervised staff responsible for Clinical Outcomes Assessments, biomarkers, and innovative drug development tools and approaches. As part of OND’s modernization effort, he led the creation of ODES, served on OND’s Senior Management Council, and supervised groups responsible for safety analytics as well as regulatory research in addition to the qualification programs. Chris served as the Chair of CDER’s Drug Development Tools Committee, the group of senior staff responsible for advice for novel surrogate endpoints and acceptance of DDT qualification submissions. He worked closely with all OND offices and divisions as well as CDER, CBER, and CDRH and founded and chaired an FDA-wide biomarker working group. Chris is frequently invited to speak and serve as a panelist at scientific conferences.
At Greenleaf, Chris draws on his expertise as a recognized expert on biomarkers and regulatory science to provide authoritative scientific advice and technical direction on critical aspects of drug development, particularly those that involve the broadest and most complex topics. His familiarity with regulatory precedent and policy enables him to formulate options and alternatives for novel ideas and approaches.
Chris completed a combined B.S./M.S. in Molecular Biophysics and Biochemistry from Yale University in 1990. His graduate work included an M.D. and Ph.D. in Microbiology/Immunology at the University of California, San Francisco in 1999. He completed his residency in Emergency Medicine at Harvard’s Brigham and Women’s Hospital and Massachusetts General Hospital in 2003.
In addition, Chris brings scientific and collaborative leadership experience from his roles on the Foundation for the National Institutes of Health Biomarkers Consortium Executive Committee and European Innovative Medicines Initiative TransBioLine Biomarker Development Scientific Advisory Board.
Vice President, Regulatory Policy
As Vice President of Regulatory Policy at Greenleaf Health, Sean Hilscher brings 15+ years of experience in health care, having worked with a broad array of stakeholders including life science companies, data companies, providers, and international health organizations. Sean helps Greenleaf clients navigate the evolving regulatory policy landscape, conducting in-depth analyses of legislation, regulations, and regulatory initiatives and their impact on clients’ products.
Previously, Sean served as a Director at the American College of Cardiology (ACC), where he managed a suite of real-world evidence platforms marketed to providers, payers, and life science companies. Sean has experience in strategy and operation consulting from his time at the Advisory Board Company. As a manger in the sourcing and operations practice, Sean led data analysis efforts for operational and supply chain consulting engagements with provider organizations across the country.
Sean earned his MBA from the Georgetown University McDonough School of Business and an MA in Politics, Philosophy, and Economics from the University of Oxford.
Kalah Auchincloss, J.D., M.P.H.
Executive Vice President, Regulatory Compliance & Deputy General Counsel
Kalah Auchincloss has more than 15 years of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector. Kalah spent six years at the FDA, including as Deputy Chief of Staff for two FDA Commissioners, Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office.
Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in the FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues.
Before joining the FDA, Kalah was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group.
As an Executive Vice President at Greenleaf, Kalah is continuing her commitment to public health by providing strategic counsel to clients on compliance, enforcement, and policy matters. Kalah counsels clients across a range of product sectors and is knowledgeable about multiple areas of FDA regulation, including drugs, compounding, unapproved drugs, diagnostics, digital health, cosmetics, and cell and gene therapy.
Kalah holds a B.A. with honors from Williams College, a J.D. with honors from Georgetown University Law Center, and an M.P.H. from Harvard University.
Daniel Schultz, M.D., F.A.C.S.
Principal, Medical Devices and Combination Products
Dr. Daniel Schultz joined Greenleaf following a distinguished 35-year career devoted to supporting and advancing Americans’ public health as a physician, teacher, Food and Drug Administration (FDA) official, and member of the US Public Health Service (USPHS). He has been recognized many times for his contributions and dedication to public health.
Dan continues his commitment to public health at Greenleaf as Principal of Medical Devices & Combination Products, where he provides strategic consulting services and works with Greenleaf clients to bring safe and innovative devices to patients.
As Director of the Center for Devices and Radiological Health (CDRH) at FDA from 2004–2009, Dan was responsible for seven FDA offices and more than 1,000 agency employees. He led the development, implementation, and evaluation of regulatory policies concerning medical devices and radiation-emitting products.
Dan began his 15-year FDA career in 1994 as a Medical Officer in the General Surgery Devices branch of the CDRH’s Office of Device Evaluation. In 1995, he advanced to Chief Medical Officer in the Office of Device Evaluation in the division of Reproductive, Abdominal, ENT, and Radiological Devices. He served as Division Director from 1998–2001. Dan became Deputy Director for Clinical and Review Policy in the Office of Device Evaluation in 2001 and Director of the Office of Device Evaluation the following year.
During his time at FDA, Dan took advantage of his medical knowledge and experience as Assistant Professor of Surgery at the Uniformed Services University of the Health Sciences and as a member of the Surgical Staff at the National Naval Medical Center in Bethesda, MD.
Before joining FDA, Dan served as a member of USPHS. During postings at Indian Health Service hospitals in Arizona and New Mexico, he provided medical care for people living in the Navajo Nation and Indian Pueblos. Dan received multiple awards for his service, including the Public Health Service Outstanding Medal.
A New York City native, Dan is a graduate of the City College of New York. He received his M.D. from the University of Pittsburgh and is board certified in Surgery and Family Practice.
Maura M. Norden, J.D.
Executive Vice President, Medical Devices and Combination Products & General Counsel
Maura Norden joined Greenleaf from the law firm Sidley Austin LLP in January 2015, following nearly a decade advising leading medical device and drug companies and investors on a broad range of FDA regulatory matters.
Maura uses her comprehensive and in-depth understanding of the FDA’s statutory jurisdiction, regulatory requirements, and regulatory processes to provide strategic advice to FDA-regulated companies throughout the product lifecycle, from development to FDA premarket review and postmarket regulation. Maura advises a broad range of clients, including early-stage companies, large, multinational industry leaders, trade associations, and public health groups.
More specifically, Maura’s experience includes advising:
- Digital health companies on the FDA’s evolving approach to digital health products;
- Consumer technology companies with respect to potential FDA regulation under the medical device provisions of the Federal Food, Drug, and Cosmetic Act;
- Clinical laboratory clients regarding the FDA’s historical and current policies related to laboratory-developed tests (LDTs);
- FDA-regulated firms on compliance with FDA promotional requirements, drawing on experience gained during temporary assignments to multinational pharmaceutical companies, where she sat on copy review committees;
- Cosmetics companies with respect to permissible claims for cosmetic products;
- Investors by providing strategic advice and conducting regulatory assessments in connection with due diligence for transactions and working with investors post acquisition on integration activities;
- Trade associations and other public-health-focused organizations developing positions on various FDA policies, reports, proposed rules, and guidance documents;
- In vitro diagnostic (IVD) companies on product development, regulatory pathway questions, and premarket review issues; and
- A range of life sciences companies regarding regulation by and engagement with the FDA during the COVID-19 pandemic.
Maura received her J.D., with honors, from the George Washington University Law School where she was an associate of The George Washington International Law Review. She received her B.A. from the University of Virginia where she was a Jefferson Scholar.
Executive Vice President, Regulatory Policy
Brian Corrigan joined Greenleaf in August 2014, following more than a decade of professional experience in the biopharmaceutical industry. Brian uses his in-depth understanding of the U.S. healthcare system and the Food and Drug Administration (FDA) regulatory process to provide strategic and technical guidance to Greenleaf clients.
At Greenleaf, Brian has advised numerous clients in the drug and biologics space on interpreting FDA clinical expectations, navigating regulatory hurdles, and executing formal meetings with the FDA, while providing strategic support through the application review process toward product approval.
Brian also leads Greenleaf’s Advisory Services practice area, working with life science investors to evaluate potential issues and regulatory risks during the due diligence stage of transactions.
Before joining Greenleaf, Brian was a key member of the Government Affairs and Public Policy team at Vertex Pharmaceuticals. Brian led the development of Vertex’s regulatory policy strategies and worked closely with the company’s leadership to incorporate these strategies into business planning and clinical development initiatives. Brian also represented the company on industry trade association committees.
Brian joined Vertex Pharmaceuticals from Astellas Pharma U.S., where he worked on federal policy and governmental affairs issues.
Brian graduated magna cum laude from the George Mason University School of Law. He received his B.A. from Boston College, where he graduated magna cum laude and Phi Beta Kappa.