FDA and IP Lifecycle Lawyer for Healthcare or Life Sciences Practice

Brian J. Malkin

Bethesda, MD ***** ***- ***-**** ************@*****.*** linkedin.com/in/brianmalkin HEALTH COUNSEL

Seasoned healthcare attorney with extensive experience in product lifecycle for Food and Drug Administration (FDA) and Intellectual Property (IP) life sciences, including negotiating and drafting agreements, advertising and promotion, and risk management. Adept at analyzing procedures and business needs, leveraging industry knowledge, compliance, and strategic thinking to implement process improvements that enhance efficiency and comply with regulatory requirements. 30+ years FDA Regulatory Compliance/Diligence for all FDA-Regulated Products from Preclinical to Commercial Inspections and Adverse Event/Recall Management including 483s Quality Agreements Contract Manufacturing Litigation Support for FDA/IP FDA-Related FTC/USDA Compliance State Board of Pharmacy Regulations and Licensure

Telemedicine DSHEA Life Science IPOs and Product/Company Diligence Cannabis Licensure/Regulation EXPERIENCE

Teva Pharmaceuticals, Washington, DC July 2023 – July 2025 Associate General Counsel - Regulatory

Supported Research and Development (R&D), Regulatory Affairs (RA), Medical Affairs (MA), Compliance & Ethics, Litigation, Commercial, Quality, and other client groups by counseling on FDA regulatory law and strategy including expedited development pathways, labeling and safety issues, pre-and post-approval development challenges, advertising and promotion reviews including nonpromotional pipeline and medical/legal/regulatory (MLR) reviews, and pharmacovigilance, including risk management programs such as Risk Evaluation and Mitigation Strategies (REMS).

• Served as a Center of Excellence in regulatory law, including on issues arising under the FDCA, PHSA, BPCIA, PREA, BPCA, the Hatch-Waxman Act, the Orphan Drug Act, the User Fee Acts, and other laws.

• Represented Teva in informal and formal dispute resolution and litigation and developed advocacy strategies, submissions, appeals, and correspondence.

• Championed Teva’s patient-centric market access with rare/unmet need diseases, advisory boards, clinical study recruitment and patient-friendly design, advertising/promotion, and compassionate use/expanded access.

• Demonstrated internal/external policy development including drafting operating procedures and compliance guidelines, comments to proposed rulemakings, and persuasive interactions with legislative/regulatory staff.

• Participated in R&D project teams across therapeutic areas to advise on legal and regulatory issues and post- approval developments for innovative and biosimilar pharmaceutical products.

• Developed and maintained relationships with health authorities, external facing organizations, trade associations, and pharmaceutical industry counterparts.

• Provided training for R&D, RA, MA, and commercial functions on FDA legal and regulatory issues. McDermott Will & Emery LLP, Washington, DC July 2020 – July 2023 Partner

Counseled pharmaceutical and biologic clients including drug manufacturers, pharmacies (compounding and retail), biotechnology, medical device, and cannabis companies on FDA regulatory matters and IP law as they developed new products and protected their innovations though lifecycle management and pursued transactional opportunities. Developed regulatory strategies, REMS, and patent portfolios with a focus on innovator products (including orphan and DEA-scheduled products), biosimilar and complex generic or 505(b)(2) NDA products, and combination drug products, including new and emerging areas such as regenerative medicine and cannabis-based products.

• Conducted lifecycle company audits resulting in follow-on products, new patents, and regulatory strategies.

• Drafted FDA meeting requests and associated documents and participate in FDA meetings for new product development and to resolve stalled product development or compliance issues.

• Reviewed and advised on compliance risks for FDA-regulated product labeling and promotional material.

• Worked with biotechnology companies to form partnerships and participated in resultant joint development committees for coordinating new product development and advised on ongoing regulatory and patent strategies.

• Participated in company- and venture-fund FDA and IP diligence and compliance with securities filings, corporate presentations, and public statements to critically evaluate new FDA-regulated companies or products.

• Managed patent portfolio dockets, including international associates, resulting in new patents and settlements.

• Drafted comments to FDA guidance on bioequivalence and therapeutic equivalence related to generic and 505(b)(2) NDAs for multinational generic drug company and proposed rulemakings on orphan products.

• Developed regulatory/legislative strategies with lobbyists regarding orphan products for 505(b)(2) NDA company. Brian J. Malkin ************@*****.*** Page 2

ArentFox Schiff LLP (formerly Arent Fox LLP), Washington, DC January 2017 – July 2020 Counsel

Lead lifecycle attorney for the firm’s biotechnology diligence team for regulatory and IP matters and supported drug, biologic, and medical device clients obtain and maintain regulatory approvals, including navigating exclusivities.

• Conducted FDA and IP stock offering/investment bank due diligence for start-up drug, biotechnology, and medical device companies, in addition to reviewing prospectus documents, press releases, and roadshows.

• Drafted citizen petitions related to orphan drugs, biosimilar products, and complex generic drugs including persuasive scientific and bioequivalence arguments and expert declarations.

• Drafted orphan drug designations and related documents, resulting in new orphan drug opportunities.

• Drafted comments to FDA guidance/rulemakings regarding FDA’s listings in the Orange Book and bioequivalence- related proposals, as well as other bills to enhance drug competition for large, multinational generic drug company.

• Worked with regulatory authorities to permit marketing of gray-area consumer products, including cannabis-derived and psychedelic products with federal and state regulatory implications.

• Negotiated/drafted supply agreements for pharmaceutical/biotechnology clients, including CREATES Act samples. McGuireWoods LLP, Washington, DC March 2014 – January 2017 Senior Counsel

Led the firm’s FDA regulatory industry teams handling matters impacted by FDA-regulated products: drugs (including animal drugs and compounded products), biologics, medical devices, foods and dietary supplements, tobacco products, cannabis-derived products, and cosmetics.

• Conducted FDA and intellectual property due diligence for lenders related to debt financing and mergers and acquisitions for primarily mid-cap level product manufacturers in the drug, biologic, and medical device areas.

• Developed product development and lifecycle management strategies for new products including patents.

• Drafted client comments to FDA guidance regarding bioequivalence and clinical trials and proposed rulemakings and developed legislative strategies for large, multinational generic drug company.

• Drafted patent term extension/restoration applications and handled inter-related regulatory issues regarding determining which patent to seek extension and how to maximize regulatory exclusivities.

• Drafted clinical trial audit agreements and managed clinical trial audits and responses to FDA deficiency letters. Haug Partners LLP (formerly Frommer, Lawrence & Haug LLP), NYC; Washington, DC August 2004 – March 2014 Partner

Litigated Hatch-Waxman Act cases and conducted due diligence for new products and companies, including reviewing and analyzing patent portfolios, in addition to assessing regulatory strength and potential for generic or follow-on competition, developed regulatory approval or patent prosecution strategies, and drafted licensing agreements.

• Litigated Hatch-Waxman cases for both branded/innovator and generic pharmaceutical and biotechnology clients including prelitigation strategies and settlements (including antitrust considerations).

• Drafted and reviewed various contractual rights, including pharmaceutical ingredient/product supply agreements.

• Reviewed trademarks, copyrights, and trade secret information for potential for infringement and developed strategies to protect new products in development.

• Developed, drafted, and implemented regulatory strategies for biotechnology and pharmaceutical products including new product development, lifecycle management, and generic, biosimilar, or 505(b)(2) NDAs. EDUCATION

Bachelor of Science, Biochemistry, May 2004 University of Maryland, College Park Juris Doctor, June 1991 The George Washington University Law School Bachelor of Arts, Economics with Special Honors, February 1988 The George Washington University Brian J. Malkin ************@*****.*** Page 3

ADDITIONAL RELEVANT EXPERIENCE

Hyman, Phelps & McNamara, P.C., Washington, DC

Associate

Developed and drafted strategies for pharmaceutical and biotechnology companies regarding regulatory requirements and clinical development, resulting in product approvals or removal of clinical holds. Drafted and reviewed companies’ petitions and correspondence with the FDA, resulting in situations where agreement was reached with minimum regulatory requirements for product approval. Advocated clients' positions with Congress, agencies, and other counsel resulting in new or modified legislation, e.g., bioterrorism legislation, or meetings to resolve potential litigation issues. U.S. Food and Drug Administration (FDA), Rockville, MD Regulatory Counsel

Implemented and directed the Patent Term Restoration Program under the Hatch-Waxman Act, answered queries regarding the application process and precedent, and developed and executed new policies. Developed and executed new regulatory policies for human subject protection, resulting in new legislation, FDA regulations, or public health recommendations, including emergency-use medical products for national stockpile and animal efficacy trials. TEACHING EXPERIENCE

Yeshiva Katz Biotech IP and FDA, New York, NY September 2018 – Present Adjunct Professor

Developed and teach course covering intellectual property and regulatory considerations and topics for biotechnology entrepreneurs involving case studies and projects. Georgetown University Law School, Washington, DC September 2018 – Present Guest Professor

Served as guest lecturer for health law LLM courses covering topics including clinical trials, pharmacovigilance, FDA regulatory reviews, and cannabis law.

American University Washington College of Law, Washington, DC September 2020 – Present Guest Professor

Served as guest lecturer for FDA regulatory law class covering topics including generic and biosimilar drug approvals. PROFESSIONAL AFFILIATIONS

DC Bar Intellectual Property Community, Washington, DC September 2019 – Present Co-Chair

Developed new Intellectual Property Community engagement with over 30 new active members as committee chairs or members, fostering partnership with the International Trade Commission Trial Lawyers Association and new programs such as IP for FDA Lawyers, International IP Litigation, and Cannabis IP, and programs for young IP attorneys. NY State Bar Association (NYSBA) Food, Drug and Cosmetic Law Section, New York, NY June 2015 – Present Executive Committee Member (former Chair 6 years)

Developed new Section initiatives including legislative comments and cross-sectional programming featuring intellectual property, antitrust law, and entertainment, arts, and sports law, and programming for young FDA attorneys. NYSBA Cannabis Law Section (formerly Committee on Cannabis Law), New York, NY June 2015 – Present Member (former initial Co-Chair and founder)

Developed thought leadership for the developing area of cannabis law involving related disciplines such as FDA and health law, intellectual property, corporate and business law, banking law, labor law, and environmental law in continuing legal education programs and opinions, including drafting legislative comments and reports as NYSBA’s official positions.

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