Advisory Services Team - Greenleaf Health

Maura M. Norden, J.D.

Executive Vice President, Medical Devices and Combination Products & General Counsel

Background:
- More than 15 years advising FDA-regulated entities, investors, and public health organizations on a broad range of FDA regulatory matters
Specialty:
- FDA statutes, regulations, and policy | Development, clearance and approval, and marketing of FDA-regulated products | FDA regulation of in vitro diagnostics and laboratory-developed tests | FDA regulatory due diligence | FDA regulation of digital health
Experience:
- Joined Greenleaf after almost a decade of professional experience in the food, drug, and medical device practice group at a large, multinational law firm

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.

Brian Corrigan

Executive Vice President, Regulatory Policy

Background:
- 15-plus years in the pharmaceutical industry
Specialty:
- Strategic regulatory guidance and advisory services support for life science transactions
Experience:
- Previous industry experience in regulatory policy development

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.