Experience

Editas Medicine

• United States
• Biotechnology Research
• 100 - 200 Employee

• Chief Medical Officer

  • Jul 2022 - Present

  Cambridge, Massachusetts, United States



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Global Project Head, Rare Diseases and Rare Blood Disorder Clinical Development

  • Jan 2017 - Jul 2022

  Cambridge, MA, USA • Accountable for end to end Clinical Development • Leading a group of Sr. medical directors and medical directors for Phase 1 to Phase 3 studies • Responsible for a strategy partnership for clinical development of multiple rare diseases • Lead fitusiran program (siRNA for hemophilia A and B, with and w/o inhibitors) currently in Phase 3 development, including adult and pediatric studies, and completed 3 Phase 3 studies, all with positive results • Oversaw collaboration of Onpattro… Show more • Accountable for end to end Clinical Development • Leading a group of Sr. medical directors and medical directors for Phase 1 to Phase 3 studies • Responsible for a strategy partnership for clinical development of multiple rare diseases • Lead fitusiran program (siRNA for hemophilia A and B, with and w/o inhibitors) currently in Phase 3 development, including adult and pediatric studies, and completed 3 Phase 3 studies, all with positive results • Oversaw collaboration of Onpattro clinical development (siRNA for Transthyretin Amyloidosis) which was approved 2018 • Lead early stage programs in Rare Disease Therapeutic Area, include SCD, hemophilia, multiple complement-mediated diseases and kidney diseases • Engagement with US FDA, EMA (incl. PDCO), Japan PMDA and China NMPA, including pre-IND, end of Phase 2 meetings, revision of Phase 3 clinical program • Participating due diligence and in licensing activities, including acquisition of a public company • Working closely with Research, Commercial, Market Access and Medical Affair on program/franchise strategies Show less



Biogen

• South Africa
• Wellness and Fitness Services
• 1 - 100 Employee

• Therapeutic Area Head, Hematology, Clinical Development

  • Jan 2013 - Jan 2017

  Cambridge, MA • Therapeutic area head for non-malignant hematology clinical development, including molecules in early and late stage clinical development programs on hemophilia and hemoglobinopathy (sickle cell disease and thalassemia) • Therapies under development included biologics, gene therapies, and small molecules; Clinical studies in adult and pediatric populations • Critical leadership for global approvals of Alprolix®and Eloctate®, and design of first in human study for Altuviiio® • Led a… Show more • Therapeutic area head for non-malignant hematology clinical development, including molecules in early and late stage clinical development programs on hemophilia and hemoglobinopathy (sickle cell disease and thalassemia) • Therapies under development included biologics, gene therapies, and small molecules; Clinical studies in adult and pediatric populations • Critical leadership for global approvals of Alprolix®and Eloctate®, and design of first in human study for Altuviiio® • Led a group of medical directors from establishing clinical development plans to preparation of study protocols, medical monitoring, clinical study reports and regulatory filings • Led medical monitoring partnership with CRO Medical directors for clinical studies • Led clinical development programs by working with a matrix team including clinical operation, statistics, regulatory, medical affair, commercial and market access • Extensive experience in BLA/NDA filings and approvals in US, EU, Japan, Canada and other regions • Worked closely with Research, Medical Affair and Commercial on pipeline development • Developed and coached medical directors and other colleagues within and outside the group • Clinical lead for external partnership on joint clinical development program

• Director, Discovery Research

  • Apr 2010 - Dec 2012

  Waltham, MA • Founding director for the department, responsible for molecular discovery, cell line development, protein expression, purification and analytics for hematology research projects • Leading research collaboration with external partner, which resulted in programs in clinical and preclinical development • Co-inventor of Altuviiio® approved by FDA in 2023 • Reviewing/preparing CMC sections of IND/IMPD and BLA filings (US, EU and Asia) • Reviewing/preparing clinical documents for BLA… Show more • Founding director for the department, responsible for molecular discovery, cell line development, protein expression, purification and analytics for hematology research projects • Leading research collaboration with external partner, which resulted in programs in clinical and preclinical development • Co-inventor of Altuviiio® approved by FDA in 2023 • Reviewing/preparing CMC sections of IND/IMPD and BLA filings (US, EU and Asia) • Reviewing/preparing clinical documents for BLA filing • Participating due diligence and in licensing activities



Bayer

• Chemical Manufacturing
• 700 & Above Employee

• Head, Expression Technologies

  • 2000 - 2010

  Berkeley, CA • Directed the department responsible for protein expression system, cGMP and research cell line development, cell line evaluation and protein production in bioreactor, cGMP cell banking and support of production of marketed products • Led a hemophilia drug discovery program and delivered program from concept design, CMC development to IND • Co-inventor of Jivi, a PEGylated FVIII, approved in US, EU and globally • Led global CMC process development teams for Phase I and Phase III… Show more • Directed the department responsible for protein expression system, cGMP and research cell line development, cell line evaluation and protein production in bioreactor, cGMP cell banking and support of production of marketed products • Led a hemophilia drug discovery program and delivered program from concept design, CMC development to IND • Co-inventor of Jivi, a PEGylated FVIII, approved in US, EU and globally • Led global CMC process development teams for Phase I and Phase III clinical manufacture processes, completed Phase I clinical manufacture (DS and DP) at in-house cGMP pilot facilities Show less