July 21, 2019

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Driving the Deal: FDA Considerations [PODCAST]

The Food and Drug Administration (FDA) has recently publicly recognized that collaboration is a key priority as they work to safely bring cutting-edge devices and treatments to market. On this episode of the Collaborative Transformation podcast series, Life Sciences lawyers Vernessa Pollard, Veleka Peeples-Dyer and Khelin Aiken discuss trends and opportunities in the market as they relate to deals involving FDA-regulated products, including:

  • Leadership transitions at the FDA, the push toward modernization of products and product development, and what that means for the life sciences and digital health dealmaking environment.

  • Benefits of the FDA's new approach to transparency and collaboration with the life sciences industry for both companies and investors.

  • Industry collaboration opportunities emerging from FDA's rare disease product development priorities, product-specific guidance and fast-tracked designations. 

  • The increased involvement of contract manufacturing organizations and contract research organizations in life sciences and what that means for collaborations and dealmaking.

  • The role of FDA programs like the Digital Health Software Precertification Program and rules like the 21st Century Cures Act in driving innovation in life sciences. 

© 2019 McDermott Will & Emery

TRENDING LEGAL ANALYSIS


About this Author

Vernessa Pollard Pharmaceutical Attorney McDermott
Partner

    Vernessa T. Pollard is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C., office. Vernessa serves as co-head of the Firm’s Food and Drug Administration (FDA) practice.

    Vernessa advises companies on regulatory, compliance, enforcement and legislative matters involving pharmaceuticals, medical devices, digital and mobile health, health IT solutions and services, and emerging technologies and software. She also advises national and international food and cosmetic producers and retailers on...

    202-756-8181
    Veleka Peeples-Dyer, McDermott Will Emery, life sciences industry, FDA attorney, drug safety lawyer, health care fraud counsel,
    Partner

    Veleka Peeples-Dyer is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm's Washington, D.C., office. She is an experienced attorney with an extensive background in the Life Sciences Industry, including Food and Drug Administration (FDA) regulation, clinical trials, manufacturing and supply, drug safety, licensing, product acquisition due diligence, health care fraud and abuse and compliance matters. Additionally, Veleka’s experience includes conducting internal investigations, developing and implementing legal and compliance training programs and advising on federal and state transparency, lobbyist and disclosure issues, including the Federal Physician Payments (Sunshine) Act.

    Veleka previously worked as in-house counsel to publicly-traded biotechnology and pharmaceutical companies. She served as a strategic business and legal advisor, counseling on the full range of research, development, regulatory, compliance and commercialization issues that biotechnology and pharmaceutical companies face. Veleka’s earlier corporate counsel experience includes working in the government contracts and utilities industries. Veleka understands the challenges clients face in this industry by providing strategic and practical counsel on the challenges and business complexities that life sciences companies face.

    202-756-8639