Experience

Pulmocide

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• President, US Operations

  • Aug 2019 - Present

  Greater Boston Area



C after D Inc.

• Principal

  • Jan 2004 - Present

  Greater Boston Area Consultant on drug development, regulatory strategy, product diligence etc. for select clients in the pharmaceutical industry (large and small companies) and the investment community (e.g. venture capitalists, bankers). Projects have included business plans, Series A fund-raising, exclusivity extensions, product development, FDA and international regulatory interactions, as well as operational activities (e.g. submission development and writing). Expertise in CMC, biologics, pre-clinical… Show more Consultant on drug development, regulatory strategy, product diligence etc. for select clients in the pharmaceutical industry (large and small companies) and the investment community (e.g. venture capitalists, bankers). Projects have included business plans, Series A fund-raising, exclusivity extensions, product development, FDA and international regulatory interactions, as well as operational activities (e.g. submission development and writing). Expertise in CMC, biologics, pre-clinical, post-approval, and IND activities. Show less



Arsanis

• United States
• Biotechnology Research

• Chief Development Officer, Managing Director, Arsanis Biosciences GmbH

  • Oct 2006 - Jun 2019

  Greater Boston Area and Vienna, Austria Responsible for global regulatory affairs, quality, clinical operations, manufacturing and research. Head of our Vienna research site as it transitioned through a reverse merger with X4 Pharmaceuticals. Successfully led clinical development of ASN100 through global Phase 2 study, managed CMC through Phase 3/commercial process, and directed research group through transition, guiding them to new goals and long-term programs for X4.



BIND Therapeutics

• United States
• Biotechnology
• 1 - 100 Employee

• Vice President, Regulatory Affairs & Quality Assurance

  • Dec 2014 - Oct 2015

  Cambridge, MA Head of RA&QA, responsible for all regulatory interactions and compliance.



Cubist Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Vice President, Regulatory Affairs

  • May 2005 - Apr 2011

  Responsible all regulatory activities for the Company, with one licensed product (CUBICIN), and an active pipeline. Oversaw growth from one approved indication in the US to multiple indications in over 60 countries. Part of leadership team that guided unprecedented corporate growth, led diligence efforts for pipeline-building, and provided interim leadership for such groups as Clinical Operations, Safety, Project Management, and Quality.



Sention

• Software Development

• Vice President

  • 2002 - 2005

  Responsible for all regulatory and quality issues for a small, CNS-focused start-up. Helped develop proof-of-concept studies, understand product exclusivity issues, craft development plans, and in-license new products. As part of the senior management team also worked to secure funding.



Biochem Pharma/Shire Biologics

• Director, Regulatory Affairs

  • 1999 - 2003

  Responsible for regulatory and quality at a vaccine development company that also provided ~1/2 of Canada's influenza vaccine supplied. Secured the approval of the live biologic, BCG Live, managed a group of 12 at 3 locations, and filed multiple INDs.



PAREXEL

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Consultant

  • 1998 - 1999

  Consultant to a variety of clients, with a focus on regulatory meetings with FDA, GMP compliance for biologics, and non-clinical requirements in the EU.



Procter and Gamble

• Packaging and Containers Manufacturing
• 1 - 100 Employee

• Scientist

  • 1993 - 1997

  Led clinical trial endpoint design and execution for the pivotal Phase 3 studies for Actonel.



University of Washington

• United States
• Higher Education
• 700 & Above Employee

• Post Doc

  • 1991 - 1992

  Post doctoral research on surface analysis of biomaterials using secondary ion mass spectrometry.



Cornell University

• United States
• Higher Education
• 700 & Above Employee

• Grad Student

  • 1985 - 1990

  Ithaca, NY Ph.D. research on imaging methods using secondary ion mass spectrometry (SIMS).