Launching a drug development company with novel technology from academia
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Jodi Stanfield
Principal
Jodi is the leader of Faber’s clinical development practice 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 joined Faber after beginning 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 Faber 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.
Jodi joined Faber after beginning 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 Faber 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.
More about Jodi
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 Association
Morgan Lewis & Bockius LLP
- Represented clients on a number of complex commercial matters
- Actively leads firm’s clinical development practice group of over 15 lawyers and contract specialists
- Advises clients on contracting issues and strategies for clinical trial matters, including for large multi-national 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; assists clients in ensuring consistency between manufacturing agreements and associated quality agreements
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 Association
Morgan Lewis & Bockius LLP
- Represented clients on a number of complex commercial matters
- Actively leads firm’s clinical development practice group of over 15 lawyers and contract specialists
- Advises clients on contracting issues and strategies for clinical trial matters, including for large multi-national 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; assists clients in ensuring consistency between manufacturing agreements and associated quality agreements
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