Attorney at Law
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Lisa A. Mammel
Lisa A. Mammel, Attorney at Law
2003–present
Lisa advises public and private biotechnology, pharmaceutical and medical device companies on legal and business issues relating to health care product research and development, clinical trials, regulatory approval, and intellectual property protection.
Lisa drafts and negotiates clinical trial agreements, investigator agreements, CRO service agreements and ancillary documents for the conduct of clinical trials in the U.S. and overseas. She also drafts and negotiates non-disclosure agreements and legal representative agreements.
Lisa also advises clients on compliance with U.S. and foreign legislation pertaining to personal data protection (including the General Data Protection Regulation), clinical trial registration, physician payment, and clinical data reporting.
Cooley Godward LLP
1996-2003
As a senior associate in Cooley Godward’s Corporate Life Sciences Practice (now Cooley LLP), Lisa advised public and private biotechnology companies on legal, business and ethical issues pertaining to corporate partnering, compliance, licensing, clinical trials and regulatory approval of health care products.
Lisa counseled clients on U.S. and foreign clinical legal matters ranging from animal tox studies, to Phase I, II and III clinical trials, to expanded access trials.
Further, Lisa advised clients on legal and business issues relating to U.S. government initiatives in the areas of vaccine stockpiles and national health emergency preparedness.
Education
Lisa earned a Juris Doctor of Law degree from the Berkeley School of Law (formerly Boalt Hall School of Law) at the University of California at Berkeley. Upon graduation Lisa was awarded a federal clerkship in the Chambers of Honorable Oliver W. Wanger: U.S. District Court, E.D. of CA.
Lisa also received a Master’s degree from the Johns Hopkins University (School of Advanced International Studies), and a Bachelor of Arts degree from Kalamazoo College where she graduated Phi Beta Kappa.
Language Skills
Lisa’s language skills are invaluable in negotiating agreements in the international realm. Developed both through formal study and through working in Europe and Africa, Lisa’s language skills include fluency in French and Italian, and basic conversational Arabic and Lingala.
Representative National Presentations in the Life Sciences Field
"Intellectual Property Provisions in Clinical Trial Agreements." 2017.
Presentation at MAGI, Clinical Research Conference, San Francisco, CA.
"Dissecting a Clinical Trial Agreement." 2016.
Presentation at MAGI, Clinical Research Conference, Las Vegas, NV.
“The Nuts and Bolts of Running Large-Scale Clinical Trials Across Multiple Jurisdictions.” 2011.
Presentation to the American Clinical Conference Institute, Clinical Trials Conference, Philadelphia, PA.
"Drafting Comprehensive Clinical Trial Agreements – Boilerplate and Beyond." 2007.
Presentation to the American Conference Institute, Clinical Trials Conference, Boston, MA.
Outside Interests
Formerly serving as an Africa Analyst for the United States Information Agency, Lisa remains passionate about foreign policy and international law. She has served as a United Nations Elections Observer to South Africa, and as an International Monitor of the Truth and Reconciliation Commission. For the past fifteen years she has served on the Executive Committee of the International Law Section of the State Bar of California (currently, as Advisor Emeritus), and has taught semester courses on International Negotiation and Mediation at Santa Clara University.
2003–present
Lisa advises public and private biotechnology, pharmaceutical and medical device companies on legal and business issues relating to health care product research and development, clinical trials, regulatory approval, and intellectual property protection.
Lisa drafts and negotiates clinical trial agreements, investigator agreements, CRO service agreements and ancillary documents for the conduct of clinical trials in the U.S. and overseas. She also drafts and negotiates non-disclosure agreements and legal representative agreements.
Lisa also advises clients on compliance with U.S. and foreign legislation pertaining to personal data protection (including the General Data Protection Regulation), clinical trial registration, physician payment, and clinical data reporting.
Cooley Godward LLP
1996-2003
As a senior associate in Cooley Godward’s Corporate Life Sciences Practice (now Cooley LLP), Lisa advised public and private biotechnology companies on legal, business and ethical issues pertaining to corporate partnering, compliance, licensing, clinical trials and regulatory approval of health care products.
Lisa counseled clients on U.S. and foreign clinical legal matters ranging from animal tox studies, to Phase I, II and III clinical trials, to expanded access trials.
Further, Lisa advised clients on legal and business issues relating to U.S. government initiatives in the areas of vaccine stockpiles and national health emergency preparedness.
Education
Lisa earned a Juris Doctor of Law degree from the Berkeley School of Law (formerly Boalt Hall School of Law) at the University of California at Berkeley. Upon graduation Lisa was awarded a federal clerkship in the Chambers of Honorable Oliver W. Wanger: U.S. District Court, E.D. of CA.
Lisa also received a Master’s degree from the Johns Hopkins University (School of Advanced International Studies), and a Bachelor of Arts degree from Kalamazoo College where she graduated Phi Beta Kappa.
Language Skills
Lisa’s language skills are invaluable in negotiating agreements in the international realm. Developed both through formal study and through working in Europe and Africa, Lisa’s language skills include fluency in French and Italian, and basic conversational Arabic and Lingala.
Representative National Presentations in the Life Sciences Field
"Intellectual Property Provisions in Clinical Trial Agreements." 2017.
Presentation at MAGI, Clinical Research Conference, San Francisco, CA.
"Dissecting a Clinical Trial Agreement." 2016.
Presentation at MAGI, Clinical Research Conference, Las Vegas, NV.
“The Nuts and Bolts of Running Large-Scale Clinical Trials Across Multiple Jurisdictions.” 2011.
Presentation to the American Clinical Conference Institute, Clinical Trials Conference, Philadelphia, PA.
"Drafting Comprehensive Clinical Trial Agreements – Boilerplate and Beyond." 2007.
Presentation to the American Conference Institute, Clinical Trials Conference, Boston, MA.
Outside Interests
Formerly serving as an Africa Analyst for the United States Information Agency, Lisa remains passionate about foreign policy and international law. She has served as a United Nations Elections Observer to South Africa, and as an International Monitor of the Truth and Reconciliation Commission. For the past fifteen years she has served on the Executive Committee of the International Law Section of the State Bar of California (currently, as Advisor Emeritus), and has taught semester courses on International Negotiation and Mediation at Santa Clara University.
Curriculum Vitae