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Jodi Stanfield

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Partner
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Areas of Focus

Overview

Jodi Stanfield is the leader of the firm’s Life Sciences Clinical Development Group. In addition to her client work, she provides training and oversight for attorneys’ and contract specialists’ handling of contract matters within the Clinical Development Group.

Jodi began her life sciences career as in-house counsel for an international contract research firm. She has and continues to cultivate deep knowledge and skill, which she uses to help clients navigate complex contract matters including pre-clinical and clinical services agreements, such as sponsor-CRO engagements, and manufacturing and development agreements involving intricate supply chains.

Jodi regularly helps clients with planning and implementation of clinical trial related agreements, including those associated with large and/or international studies.

Career & Education

    • Senior Legal Counsel, PSI CRO AG, a global contract research organization
        • Worked with internal teams and pharmaceutical and medical device clients to conclude clinical trial and related agreements in countries all over the world.
        • Managed internal compliance issues, training and advised on general legal issues.
    • Commercial litigation associate, AmLaw 50 firm
        • Represented clients on a number of complex commercial matters.
    • Senior Legal Counsel, PSI CRO AG, a global contract research organization
        • Worked with internal teams and pharmaceutical and medical device clients to conclude clinical trial and related agreements in countries all over the world.
        • Managed internal compliance issues, training and advised on general legal issues.
    • Commercial litigation associate, AmLaw 50 firm
        • Represented clients on a number of complex commercial matters.

    • University of California, Davis School of Law, J.D.
    • San Jose State University, B.S., summa cum laude
    • University of California, Davis School of Law, J.D.
    • San Jose State University, B.S., summa cum laude

    • California
    • California

Jodi's Insights

Client Alert | 6 min read | 05.11.26

FDA’s AI in Early Phase Clinical Trials RFI: An Opportunity to Help Set the Rules of the Road

Consistent with recent FDA initiatives directed at leveraging AI technologies and improving early-phase clinical trial conduct, the FDA has issued a Request for Information (RFI) for input on a proposed AI-enabled optimization pilot program for early-phase clinical trials. The issues for which FDA is requesting information fall into two categories:  (A) Pilot program design and implementation and (B) Program evaluation metrics and success criteria....

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Representative Matters

  • Advises clients on contracting issues and strategies for clinical trial matters, including for large multinational studies. Oversees drafting and negotiation of clinical trial related agreements and documentation, such as CRO engagements, CTAs, ICFs, and investigator-initiated study agreements.
  • Manages complex projects such as the development of several bespoke services agreement templates for use across shared-platform companies, as well as the negotiation of those agreements.
  • Drafts and negotiates development and manufacturing services agreements, both on behalf of biopharmaceutical companies as well as on behalf of CDMOs, including for small molecule, biologic, and cellular products, as well as for starting/ancillary materials and excipients. Also assists clients in ensuring consistency between manufacturing agreements and associated quality agreements.

Jodi's Insights

Client Alert | 6 min read | 05.11.26

FDA’s AI in Early Phase Clinical Trials RFI: An Opportunity to Help Set the Rules of the Road

Consistent with recent FDA initiatives directed at leveraging AI technologies and improving early-phase clinical trial conduct, the FDA has issued a Request for Information (RFI) for input on a proposed AI-enabled optimization pilot program for early-phase clinical trials. The issues for which FDA is requesting information fall into two categories:  (A) Pilot program design and implementation and (B) Program evaluation metrics and success criteria....

View All Insights

Practices

Industries

Jodi's Insights

Client Alert | 6 min read | 05.11.26

FDA’s AI in Early Phase Clinical Trials RFI: An Opportunity to Help Set the Rules of the Road

Consistent with recent FDA initiatives directed at leveraging AI technologies and improving early-phase clinical trial conduct, the FDA has issued a Request for Information (RFI) for input on a proposed AI-enabled optimization pilot program for early-phase clinical trials. The issues for which FDA is requesting information fall into two categories:  (A) Pilot program design and implementation and (B) Program evaluation metrics and success criteria....

View All Insights