Sarah Spurgeon Email & Phone Number

Foster City, Ca, Us

Thousand Oaks, Ca, Us

As Senior Counsel, I advise executives and product teams on legal matters for commercial and investigational biologics, biosimilars and small molecule drugs, including:- Interactions with regulatory authorities, including filing marketing applications, supplements, and RTQs; product label negotiations; advisory board preparations, REMS development; pharmacovigilance matters (including health authority inspections and AE reporting); and clinical trial related filings- Global medical and commercial communications, annual communication plans, press releases and standby statements, and medical FAQs and information letters- Strategic matters such as managing product liability, life cycle planning (including exclusivities), and clinical trial recruitment and retention - Digital tool and device development, such as combination products, in vitro diagnostics, wearables and smart phone apps- Healthcare compliance issues requiring False Claims Act, Anti-Kickback Statute, PhRMA Code, pre-approval and off-label promotion, or other health care laws analysis -Drafting, negotiating and interpreting transactions, including strategic collaboration agreements; research alliances, co-development arrangements, data sharing and clinical trial contracting- Clinical trial registration and reporting, data transparency and privacy compliance, and the appropriate use and storage of blood and tissue samples - Development and company-wide deployment of internal policies and guidance

Washington, District Of Columbia, Us

As Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), I serve as one of the principle food and drug law regulatory attorneys for the association and regularly advise clients on state and federal legislation as well as regulatory compliance matters across the biopharmaceutical life cycle.Substantive areas of interest include: clinical trial regulation and pre-approval matters (e.g., e-informed consent and expanded access); the regulation of communicating information related to prescription medicines (e.g., REMS, PhRMA Code, and FDAMA 114); and matters related the safety, security and quality of the global pharmaceutical supply chain (e.g., implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Drug Quality and Security Act (DQSA)).

PWR is a boutique law and health care consultancy specializing in developing unique strategies to address complex pharmaceutical, biotechnology and public health challenges. Selected as part of the founding associate class for PWR, I advised life science companies on strategic and regulatory issues related to REMS compliance, life cycle management, Hatch-Waxman litigation, and federal legislation.

Washington, D.C., Us

As an associate at Covington & Burling, I belonged to one of the largest and most well-respected life sciences law practices in the world. My practice focused on: pharmaceutical life cycle strategy and compliance; Hatch-Waxman litigation; and corporate transactions involving life science companies.

Boston, Massachusetts, Us

NEHI (Network for Excellence in Health Innovation) is a non-profit, non-partisan think tank dedicated to identifying innovations that improve the quality and costs of health care in the United States. As one of the founding team members of NEHI, I led key research projects for NEHI’s groundbreaking Innovation report series, which focused on determining the federal and state policy changes needed to promote the widespread adoption of lifesaving new medical technologies.

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B.A., Economics And American Studies