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Tuesday, June 25 • 8:00am - 9:15am
#215: Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-589-L04-P; CME 1.25; IACET 1.25; RN 1.25

Global clinical trials conducted with GMOs pose unique regulatory, logistical and strategic challenges. This session will presents case studies addressing lessons learned and perspectives from regulatory authorities, investigators and patients.

Learning Objectives

Describe strategies to optimize the conduct of clinical trials with GMOs, in order to facilitate approval across multiple layers and regulatory bodies; Discuss efforts among different stakeholders (Sponsor, CRO, vendors) to enable adequate IP management; Identify how to implement educational plans to overcome cultural barriers (patients, families and site staff) and facilitate enrolment completion.


Esther Mahillo, PhD


Clinical Research with GMOs: Regulatory, Ethical, and Biosafety Challenges
Daniel Kavanagh, PhD

Operational and Logistical Aspects of Working with GMOs
Esther Mahillo, PhD

Patient Perspective
Kathleen Higgins

avatar for Daniel Kavanagh

Daniel Kavanagh

Senior Scientific Advisor, Gene Therapy, WCG
Dr. Kavanagh is Senior Scientific Advisor, Gene Therapy at WIRB-Copernicus Group (WCG). Prior to joining WCG, he was Assistant Professor of Medicine and Institutional Biosafety Committee Vice Chair at Harvard Medical School, Assistant Immunologist at the Massachusetts General Hospital... Read More →
avatar for Esther Mahillo

Esther Mahillo

Customer Relationship Executive, Oncology and Hematology, Syneos Health
I have been working for 24 years in the clinical research arena. Over the past 20 years, I have conducted 47 phase I-III clinical trials enrolling more than 13,000 patients at over 1,000 sites in 50 countries.I obtained my PhD with a research on the role of multicatalytic proteinase... Read More →
avatar for Kathleen Higgins

Kathleen Higgins

Director of Community Outreach, Li Fraumeni Syndrome Association

Tuesday June 25, 2019 8:00am - 9:15am PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum
  • Level Intermediate
  • Featured Topics What's Next,Patient Focused,Advanced Therapies
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum