Breakout Sessions: Preparing for New Product Introduction

10:00 AM - 11:00 AM
Room 156

Following panel 1, there will be three separate breakout sessions. Each of these will explore strategies for the introduction of new interventions to developing world markets - one focusing on drugs, one on vaccines, and one on diagnostics. Panelists with on-the-ground experience will discuss key barriers to effective product introduction and key interventions at both the global and local levels to overcome these hurdles.

Focus: Diagnostics

Panelists:

  • Moderator: Maurine Murtagh, CEO, The Murtagh Group
  • Gonzalo Domingo, Senior Scientist, PATH
  • Andy Fish, Executive Director, AdvaMed Dx
  • Lauren Mikulski, Strategic Project Manager, Global Health, BD
  • Trevor Peter, Senior Laboratory Specialist, Clinton Foundation

Who's Who


 

Domingo Gonzalo Domingo - Gonzalo Domingo currently serves as the senior technical lead for several diagnostics development projects at PATH including the development of point-of-care rapid diagnostic tests . He manages complex collaborations involving public-sector organizations, diagnostic technology companies, reagent suppliers, contract manufacturing facilities, and other research institutions. Gonzalo has extensive expertise in parasitology research and field-based experience using diagnostic technologies in low-resource settings. Gonzalo is co-principal investigator of the GHDx Center, where he leads activities aimed at encouraging early exploratory research into innovative approaches in the development of diagnostics for low-resource settings. He established a rigorous review process to identify and evaluate emerging technologies, and he manages a grant-making mechanism with a total budget of $1 million. He is also involved in designing, coordinating, performing, and managing evaluations and studies of diagnostic tests to assess their performance in the lab and field. He is skilled at clinical sample processing, diagnostic test development and parasitology research. Dr. Domingo’s previous experience includes supervision of a clinical laboratory and teaching undergraduate and graduate programs.
   
Fish Andy Fish -  Andy Fish is Executive Director of AdvaMedDx, representing leading manufacturers of in vitro diagnostic tests.  Functioning as an association within AdvaMed, the medical device trade association, AdvaMedDx advocates for health care policies that support robust innovation, ensure timely approval, and promote rapid adoption of new, safe and effective in vitro diagnostic tests. 

Andy has extensive government relations, legal, regulatory, and policy background in food, drug, health, and agriculture issues.  Andy was previously Senior Vice President of Legal and Government Affairs, General Counsel, and Secretary for the Consumer Healthcare Products Association (CHPA), representing manufacturers of nonprescription medicines and dietary supplements.  Andy also worked for the American Cancer Society as Senior Director of Federal Government Relations. 

Earlier in his career, Andy served as Assistant Secretary of Agriculture for Congressional and Intergovernmental Affairs, after twice working for the U.S. Senate Agriculture Committee, first as a professional staff member and later as deputy chief counsel.  Andy’s work in private practice focused on biotech regulation, as well as on a wide range of food, drug and agriculture issues.  Andy is a graduate of Yale University and Stanford Law School.
   
Mikulski Lauren Mikulski - Lauren Mikulski joined BD (Becton, Dickinson & Co.) in 2009, and serves as Strategic Manager for Global Health. In this role she is responsible for evaluating new technologies for resource-limited settings that will increase access to quality healthcare for patients in developing countries and emerging markets. She develops Global Health’s long-term strategy and manages BD’s global public-private partnerships to identify new opportunities to advance global health around the world.

In her current role based in Nairobi, Kenya, she leads BD’s future efforts for go-to-market strategies and sustainability for diagnostics in developing countries.  Her role allows her to work across BD’s three business segments and travel to locations worldwide to determine which technologies and programs can help advance BD’s strategic innovation initiatives.

Prior to her current role at BD, Lauren worked at Johnson & Johnson, (Tibotec Therapeutics), Dell Inc., Cayuga Medical Center, Rockefeller University, and Africare where she lived and worked in Uganda. Lauren has been involved in the fight against HIV/AIDS for over 10 years and has been dedicated to helping expand access to healthcare and medical technology. Lauren holds an M.B.A. with majors in Health Enterprise Management, Marketing, International Business, Management & Strategy, and Social Enterprise from Kellogg School of Management at Northwestern University in Evanston, IL. She also holds a Bachelor of Science degree in Industrial & Labor Relations with a concentration in Law & Society from Cornell University in Ithaca, NY.

   
Murtagh Maurine Murtagh - Maurine Murtagh is currently a consultant on diagnostics in resource-limited settings in which capacity she is working with the Bill & Melinda Gates Foundation and UNITAID.  Until recently, Maurine was the Director of Diagnostic Services for the Clinton Health Access Initiative (CHAI), a position she held for about five years.  Prior to joining CHAI, Maurine was a corporate partner at the law firm of Howard Rice Nemerovski Canady Falk & Rabkin in San Francisco, California, where her focus was on mergers and acquisitions and securities law.  Maurine began her career in investment banking, where she worked for both Smith Barney and Morgan Stanley.  She graduated from Georgetown University and holds an M.B.A. from the University of Texas at Austin, an M.Phil. in finance from Columbia University and a J.D. from Duke University.
   
Trevor Trevor Peter - Trevor Peter PhD MPH, Scientific Director for Laboratory Services at the Clinton Health Access Initiative (CHAI), has spent the past 15 years in diagnostics, research and public health. He presently leads a team providing technical assistance on the cost-effective development and deployment of diagnostics capacity, particularly for HIV, TB and malaria. He has advised governments of over 30 countries across Africa, Asia, and the Caribbean on scaling up diagnostics, introducing new technology and strengthening laboratory systems.

Before joining CHAI, he was laboratory director at Botswana-Harvard HIV Reference Laboratory, and before this led a USAID-supported vector-borne disease epidemiology research program in Zimbabwe. Dr. Peter sits on the boards of directors of the African Society for Laboratory Medicine, which is based in Addis Ababa, and the African Center for International Laboratory Training in Johannesburg, South Africa. He is also on the Steering Committee of the WHO-AFRO Laboratory Accreditation program.