Ashley Birkett, PhD
Ashley Birkett’s appointment as Director of the PATH Malaria Vaccine Initiative (MVI), one of eight global programs at PATH, took effect in October 2013. Ashley was most recently MVI’s deputy director, serving simultaneously as director of research and development (R&D)—the latter a position he has held since joining PATH in 2008.
In his position as director of R&D at MVI, Ashley has led MVI’s efforts to support the development of transmission-blocking vaccines. He also has guided MVI’s portfolio of evaluation technology projects, which are developing and refining ways to assess vaccine efficacy prior to large-scale field trials, and provided technical support across the range of MVI’s vaccine development programs, including the RTS,S program.
Ashley has more than 15 years of vaccine development experience, primarily with biotechnology companies, where he successfully advanced novel influenza and malaria vaccine candidates from research through first-in-human clinical studies. Prior to joining MVI, he was senior director of preclinical research at Acambis (now Sanofi Pasteur Biologics Co.), where he had responsibility for the company's global preclinical vaccine research portfolio, with a special focus on influenza and adjuvant technology identification. Prior to Acambis, he served in a similar role at Apovia Inc. Between 1997 and 2004, he led the Malaria Vaccine Program housed first at Immune Complex Corporation and then at Apovia. This program was the first corporate partnership for MVI after its founding as a program of PATH in 1999.
Ashley earned a PhD in biochemistry and molecular biophysics from Virginia Commonwealth University; he has a BSc (Honors) in applied biological sciences from the University of the West of England in the United Kingdom.
Cindy supports various projects within the Product Development and Access unit.
Prior to joining PATH, Cindy planned educational conferences and events in Washington, DC and Latin America for the Department of Defense.
Cindy received her BA in International Studies and Spanish from Centre College in Danville, Kentucky. She spent semesters abroad in Mexico and China. Cindy is currently pursuing a Master’s in Public Administration at George Mason University.
Director, Product Development and Access
Carla Botting serves as head of the RTS,S Program and directs the Product Development and Access Unit. The unit works to integrate the needs of developing-country health systems into MVI's product development activities, and to ensure that vaccines, once developed, will be available and accessible to those in need.
Carla has more than a dozen years of industry experience in business development and in the development and approval of biologics. Prior to joining MVI, Carla was the director of government business development at Cangene Corporation, where she oversaw program management, business development, and government relations with regard to the United States and other industrialized countries. At Cangene, Carla also served as project director for Vaccinia Immune Globulin, taking it from research and development to Food and Drug Administration (FDA) approval. Over the last seven years, Carla has worked on joint biological development programs with such partners as the Centers for Disease Control, the National Institutes of Health, the Department of Defense, and the Biomedical Advanced Research and Development Authority. Carla serves on the board of the International Center for Infectious Diseases and has served on the board of the Alliance for BioSecurity and as a member of the Board of Regents at the University of Winnipeg in Canada.
Carla has an honors degree in commerce from the University of Manitoba and has studied French at the University of Caen in France. She has worked in Russia, Ecuador, and the United Kingdom.
Alicja Dabrowska Brown, PhD
Senior Project Manager
Alicja Dabrowska Brown serves as a senior project manager in the Portfolio Management and Translational Projects Unit. She works with external partners to coordinate malaria vaccine projects in early clinical testing.
Most recently, Alicja served as a project leader at Xcellerex, where she was involved in the development of the inactivated yellow fever vaccine. Prior to joining Xcellerex, she was a postdoctoral fellow at Children’s Hospital Boston/Harvard Medical School, where she worked on HIV pathogenesis and AIDS vaccine.
She holds a PhD in molecular, cellular, and systemic physiology from Southern Illinois University School of Medicine and a BS in biology from University of Bridgeport.
Elfrida Cline-Cole, MA
Project Administrative Officer
Elfrida Cline-Cole serves as the finance and administrative officer for several units and program areas at MVI. She has more than ten years of experience in finance, contract administration, and project coordination.
Most recently, Elfrida worked as a senior finance and contract administrator for Abt Associates, Inc. in Bethesda. Prior to Abt, Elfrida served as project coordinator for the International Business Ethics Institute in Washington, DC.
Elfrida holds an MA in public policy from Howard University, a graduate diploma in institutional administration from Concordia University, and a BA in commerce and economics from Concordia University in Montreal, Quebec. Elfrida has traveled extensively and is fluent in French.
Yvette Collymore, MA
Senior Communications Officer
Yvette Collymore brings global health communication and media experience to the MVI team. She is responsible for developing communication and advocacy strategies, managing MVI's publications and website, and leading communications activities for a number of vaccine projects. Yvette has written extensively on global population and health issues, including HIV/AIDS, maternal and child health, and cervical cancer. She has also worked as a print and radio journalist in developed and developing countries.
Yvette holds an MA in journalism from the Philip Merrill College of Journalism at the University of Maryland.
Ann-Marie Cruz, PhD
Ann-Marie Cruz serves as a program officer within MVI's Research and Development Unit.
Prior to joining MVI, Ann-Marie completed three years of post-doctoral training in the Laboratory of Infectious Diseases at NIAID/NIH under the direction of Dr. Brian Murphy. There, her work focused on the development of live, attenuated vaccine candidates against parainfluenza virus type 1 (PIV1), a leading cause of lower respiratory disease and croup in infants and young children in the United States. Specifically, she studied the function of PIV1 accessory C proteins in order to determine whether mutating these proteins could contribute to the development of suitable vaccine candidates. Potential candidates were evaluated in vitro, in rodents, and in non-human primate models. Previously, Ann-Marie had carried out graduate work at the Gladstone Institute of Virology and Immunology in San Francisco, California, studying the immunology and pathogenesis of HIV-1, specifically focusing on co-receptor tropism in peripheral lymphoid tissues.
Ann-Marie holds a BS in biology from Cornell University and a PhD in biomedical sciences from the University of California, San Francisco.
Diadier Diallo, PhD, MSc
As a program advisor for the Research and Development Unit, Diadier works primarily on malaria transmission-blocking vaccine approaches, with a focus on assays validation, measurement of malaria transmission intensity, and on epidemiological studies. He also works on field site assessment and support.
Diadier has more than 18 years of experience in malaria epidemiology and control, with more than 10 years spent studying the impact of vector control measures on malaria morbidity and mortality, transmission intensity, immune response to malaria, and the spread of drug-resistant malaria parasites. He was a key member of the team that studied the relationship between malaria transmission intensity and all-cause and malaria-specific mortality across Africa.
Before joining MVI, Diadier was a senior research fellow at the Malaria Capacity Development Consortium, London School of Hygiene and Tropical Medicine (LSHTM), conducting research on malaria transmission reduction using drugs with gametocytocidal activity. Prior to that, he worked at LSHTM, coordinating a trial on the effect of seasonal malaria chemoprevention on the incidence of clinical malaria in children in Mali and Burkina Faso. He has also worked at the Malaria Clinical Trial Alliance of the INDEPTH Network in Ghana and at the ministry of health of Burkina Faso.
Diadier holds a PhD in epidemiology and master’s degree in communicable disease epidemiology from LSHTM, and a Masters in biochemistry and microbiology from the University of Ouagadougou, Burkina Faso.
Sally Ethelston, MA
Director, Communications and Advocacy
Sally Ethelston oversees the development and implementation of MVI's communications and advocacy strategy.
Prior to joining MVI, Sally worked in international reproductive health for more than 15 years, with an emphasis on communications, policy analysis, and advocacy. She directed the communications program at Population Action International for more than 10 years, followed by three years leading the group’s financing project, focused on tracking the policies, programs, and funding of the international donor community. She also has worked as a consultant to the World Bank and International Planned Parenthood Federation.
Sally has an interdisciplinary MA in Arab studies from Georgetown University, where she focused on economic and social development in the region and wrote on such issues as women and work in the Arab world and Egypt's agricultural development. Following graduate school, she worked for five years on Middle East peace and related issues. She speaks Spanish and Arabic.
Alex Golden, MBA
Alex Golden leads and supports MVI's business negotiations for the development of collaborative commercial relationships with pharmaceutical and biotechnology companies, academic institutions, and government entities. His other roles include market research and demand forecasting.
Alex has more than 14 years of biotechnology industry experience, predominantly in the area of research and development. He has held positions in research, preclinical project management, and business development. Prior to joining MVI, Alex worked as a senior consultant at Wood Mackenzie, a firm that produces strategic consulting services for large pharmaceutical companies. Alex has also held a number of business development positions in small- and mid-sized biotechnology companies.
Alex holds a BS in biotechnology from the University of Rhode Island and an MBA from F.W. Olin Graduate School of Business at Babson College.
Maria Gomez, MSc
Maria Gomez serves as project manager in the Portfolio Management and Translational Projects Unit. She works with external partners and with other units within MVI to coordinate malaria vaccine projects in early clinical testing.
Before joining MVI, Maria worked for Meso Scale Discovery in Gaithersburg, MD, where she served from 2008 to 2013 as senior process development engineer and project manager. In this role, she gained experience in the development and manufacturing of immunoassays. Prior to that, she held process engineering positions in Virginia, New York, and Florida. She has also served as statistical process control engineer in Madrid, Spain.
Maria received her BS in chemistry and MS in biochemistry at Universidad Complutense de Madrid and has additional training in statistics and quantitative research methodology from the Consejo Superior de Investigaciones Cientificas in Madrid.
Scott Gregory provides organizational and technical support to the Research and Development Unit.
Scott has more than 12 years of experience in molecular and cell-based assay development, implementation, and data management. Previously, he was at the NIAID Vaccine Immune T-Cell and Antibody Laboratory (NVITAL) where he was responsible for supervising and coordinating the ELISPOT testing activities. While working at NVITAL, he gained extensive experience performing vaccine immunogenicity studies, developing laboratory protocols, and validating testing methods for use in vaccine clinical trials. He has also served as a laboratory manager with SeraCare BioServices, where he was assigned the task of providing logistical support and coordinating activities for NIAID-supported clinical trial laboratories, in addition to performing assay development studies.
Scott holds a BS in chemistry from Oakland University in Rochester, Michigan.
Clinical Research Associate, International Program Manager
Karen Ivinson serves as a program officer within the Clinical Unit. She provides project management and technical support to clinical trials for the RTS,S vaccine program and is the MVI project manager for the safety study in HIV-infected infants and children. Karen is also assisting and supporting the preparation and implementation of RTS,S Phase 4 pharmacovigilance and effectiveness studies.
Karen joined MVI from the Meningitis Vaccine Project at PATH, where she was responsible for the management and coordination of a Phase 3 infant clinical study in Ghana. She has a background in infectious diseases, immunology and vaccine research, and preclinical therapeutic vaccine development. In clinical research, she has worked on many multi-center international Phase 2/3 studies (including HIV and other infectious diseases, pediatric vaccine, renal, and neurological studies) in Australia and the United Kingdom.
Karen received her BSc and BSc (Hons) in microbiology and immunology from the University of Melbourne in Australia. She is based at PATH's office in Ferney, France.
Sanjay Jain, PhD
Sanjay Jain serves as program advisor for vaccine development at MVI. His focus is on chemistry, manufacturing, and controls activities related to transmission-blocking malaria vaccine approaches. He is also the technical lead for process development, formulation development, and good manufacturing practices (GMP) production of recombinant-protein malaria vaccines.
Sanjay has more than 20 years of experience in process development and scale-up for GMP production of protein therapeutics and human vaccines, using a variety of production expression systems. He has supported several investigational new drugs applications and one biologics license application for approval of recombinant protein products by the US Food and Drug Administration.
Sanjay has worked for several biopharmaceutical companies, including Astra-Zeneca, Cephalon (now TEVA), and Shire Biologics (now GSK). Most recently, Sanjay managed the Bio-Process Center at the Worcester Polytechnic Institute in Worcester, MA. Sanjay received his PhD in microbiology from Paul Sabatier University in Toulouse, France.
Danielle Keeby provides support to the Clinical Unit and Finance and Administration Unit.
Her previous experience includes working as an operations assistant at Biotechnology Industry Organization, and before that providing administrative support to Representative Franklin Sands within the Florida House of Representatives.
Danielle received her BA in international affairs and history from Florida State University, with a particular concentration on development studies in sub-Saharan Africa.
Amy Lange provides support to the Portfolio Management and Translational Projects Unit and the Research and Development Unit.
Prior to joining MVI, Amy served as an executive assistant and office manager at WTS International, a wellness and leisure consulting firm. Her experience includes coordinating corporate travel, planning events and meetings, reviewing and editing sales collateral and internal publications, and providing general administrative support.
Amy holds a BA in international affairs from the University of Mary Washington.
Leander Lauffer, MS, PhD
Head of Business Development
Leander Lauffer leads and supports MVI's business negotiations for the development of collaborative commercial relationships with pharmaceutical and biotechnology companies, academic institutions, and governmental entities. He also focuses on development and implementation of intellectual-property and commercialization strategies for MVI’s complex vaccine development projects.
Prior to joining MVI, Leander led the business development function at Trubion Pharmaceuticals, successfully negotiating a major strategic partnership with a global pharmaceutical company. Leander also brings to MVI extensive experience in the business development and commercialization of vaccines. He was formerly vice-president of business development at Chiron and served as head of business development for the Vaccine Business Unit at Behringwerke AG in Germany.
Leander received a PhD in biology from Freie Universität Berlin, Germany, and a Master of Science degree in biology from Universität Konstanz, Germany.
Didier Leboulleux, MD
Didier Leboulleux serves as director of the Clinical Unit. Didier has extensive experience in vaccine and drug development, including clinical trials, vaccine policy, regulatory affairs, and licensure.
During 15 years in the global pharmaceutical industry, Didier held various leadership positions, most notably as senior medical director in the Access to Medicines Division at Sanofi Aventis, where he led the coordination of the tuberculosis, Buruli ulcer disease, and leishmaniasis global projects. While working at Sanofi Pasteur, the vaccines division of Sanofi Aventis, Didier led the medical affairs function in France, China, and Japan. In this capacity, he also managed processes for vaccine licensure, advocacy, and marketing. Most recently, he served as director of medical affairs at Laboratoires Genevrier in France. Prior to joining the pharmaceutical industry, he managed a medical research program in Senegal.
Didier holds an MD from the University of Tours, France; a degree in public health from the School of Public Health, Nancy, France; and a degree in epidemiology also from the University of Tours, France. He has published more than two dozen articles. Didier is based at PATH's office in Ferney, France.
Cynthia Lee, PhD
Director, Portfolio Management and Translational Projects
Cynthia Lee directs the Portfolio Management and Translational Projects Unit, which is responsible for the monitoring and evaluation of MVI's portfolio projects and the management of translational projects in early clinical testing. She is chair of MVI's Portfolio Management Committee and serves on the MVI Leadership Team.
Cynthia has more than 20 years of experience in the vaccine industry and brings to MVI extensive experience in multiple aspects of vaccine development. Her breadth of experience includes taking several bacterial and viral vaccines from early-stage research through development and manufacturing to clinical testing and process validation. Prior to joining MVI, she served as vice president of vaccine and drug development at Xcellerex, where she led the efforts on developing an inactivated yellow fever vaccine. She previously held various positions at Acambis, including senior director of vaccine research and director of clinical research. While at Acambis, she served as project leader for multiple projects, including Vibrio cholera, Helicobacter pylori, herpes simplex virus, and Modified Vaccinia Ankara, and she was the principal investigator of several Small Business Innovation Research grants and biodefense contracts with the NIH. Prior to joining Acambis, she headed the bacterial genetics laboratory at the Massachusetts Biologics Laboratory, where she was first introduced to vaccine development.
Cynthia conducted her postdoctoral work at the Harvard Medical School on herpes simplex virus. She holds a PhD in microbiology from the University of Chicago as well as an MS in epidemiology and BS in microbiology from the University of Washington.
Franck Lemiale, PharmD, PhD
Senior Program Officer
Franck Lemiale is a Senior Program Officer in the Research and Development Unit. As an immunologist, his main responsibilities are to serve as the project lead for the B cell target validation team and to provide R&D expertise to the RTS,S Phase 3 immunology study. His other assignments include leading the evaluation of new vaccine technologies, acting as the principal program manager for pre-clinical vaccine development projects, and more generally providing scientific expertise in immunology to preclinical, translational, and clinical vaccine projects in MVI’s portfolio.
Franck has over 15 years of experience in the field of infectious diseases, mostly focused on the treatment and prevention of HIV/AIDS. He has worked on developing innovative vaccine and gene therapy approaches in academic and pharmaceutical industry settings. Prior to joining MVI, he served as Senior Director, Vaccines and Immunology at VIRxSYS Corporation, where he led the HIV Vaccine Program from early discovery to initiation of clinical studies. While there, he also led the immunology laboratory where his team of scientists evaluated immune responses to HIV in patients treated in several gene therapy trials for treating HIV infection. His previous professional experience includes developing and characterizing new HIV vaccine candidates at the University of Tours, France, and at the NIH Vaccine Research Center in Bethesda.
Franck holds a PhD in virology/immunology and a PharmD from the University of Tours, France, and a Masters in fundamental virology from the Pasteur Institute in Paris, France.
Emily Locke, PhD, MPH
Senior Program Officer
Emily Locke focuses on preclinical development of malaria vaccine candidates, with a particular interest in identifying assays that are predictive of protection in the field.
Prior to joining MVI, Emily spent two years as a project manager for the Biomedical Center in St. Petersburg, Russia, where she managed Johns Hopkins University’s involvement in an international effort to engage Russia in global HIV research and prevention. She also worked for five years as a structural biologist and yeast geneticist for the NIH.
She received an MPH and a PhD in biology from Johns Hopkins University.
Trevor Lutzenhiser works as an administrator for MVI's Finance and Administration Unit and Research and Development Unit.
Prior to joining MVI, Trevor held the position of legal assistant at PATH. He has more than 12 years of experience providing support for legal and finance teams. Prior to that, Trevor worked at a national nonprofit health care corporation and a nonprofit legal rights organization.
Trevor holds a BA in history and philosophy from the University of Washington and has pursued graduate studies at Portland State University.
Senior Finance Officer
Gretchen MacLeod supports the RTS,S and AMA1 vaccine project teams, bringing to MVI more than ten years of financial experience working in the nonprofit environment, including extensive experience training finance staff in Africa and Asia.
Most recently, Gretchen served as a project administrator for the HIV, AIDS, and Malaria Strategic Program in PATH's Washington, DC, office. Prior to that assignment, Gretchen served as a finance officer/team leader for PATH in Seattle, where she managed and trained a team in donor financial reporting and USAID compliance. In addition to her role at PATH, Gretchen served as a trainer with the Association for PVO Financial Managers, where she developed curricula and provided workshops on USAID compliance to nongovernmental organizations in developing countries.
Gretchen holds a BA in accounting and business management from Seattle Pacific University.
Kelsey Mertes, MPA
Senior Communications Associate
Kelsey Mertes provides media relations, event planning, and project support to the Communications and Advocacy team at MVI.
Prior to joining MVI, Kelsey worked at GMMB—a strategic communication and issues advocacy firm—on account teams for the Bill & Melinda Gates Foundation and the Washington State Department of Health. At GMMB, she gained experience in social marketing, public relations, and policy research. She also worked as a research assistant on a study of state-funded early-childhood-education programs, conducted jointly by the University of North Carolina at Chapel Hill, University of Virginia, and UCLA.
Kelsey holds a BA, with honors, in sociology and editorial journalism from the University of Washington, and a master's degree in public administration with an international development emphasis from Syracuse University's Maxwell School of Citizenship and Public Affairs.
Sara Mian-McCarthy provides administrative and programmatic support for the Communications and Advocacy Unit.
Prior to joining the MVI team, Sara worked with Global Health Education Training Services in Boston, MA, and at the West African AIDS Foundation (WAAF) in Accra, Ghana. While working at WAAF, Sara helped to implement the Healthy Mother Equals Healthy Baby Initiative, which provided food and counseling to HIV-positive pregnant women. Sara has also worked at Global Health Corps (GHC) where she helped plan and coordinate GHC’s annual training institute at Yale University.
Sara received her BA from the Gallatin School of Individualized Study at New York University, with a concentration in international public health.
Merribeth Morin, PhD, MBA
Merribeth Morin serves as a program advisor to MVI's Research and Development Unit. In this role, she reviews assays used for assessing immune responses to malaria and assists in refining and improving them to ensure consistency among the various laboratories that perform the work. Consistency in assay results is imperative to ensure the best possible assessment of malaria-vaccine candidates.
Merribeth has a number of years of experience in the biotechnology industry, many of them spent developing and validating assays used for biosafety and product release testing. She has assisted many companies and organizations with the design of safety testing strategies for regulatory submissions, both to US and European agencies.
She holds a PhD in virology from Harvard University, under the mentorship of Bernie Fields, as well as an MS in microbiology from Cornell University and a BS in biology from Rensselaer Polytechnic Institute. Merribeth was also awarded an MBA from Northeastern University.
Farzana Muhib, MA, MPH
Project Manager, Product Development
Farzana Muhib leads MVI's monitoring and evaluation efforts through the development of program-wide indicators of success that provide both short- and long-term strategic milestones used to measure program progress in achieving its mission. She also leads efforts to develop a credible demand forecast for MVI's vaccine candidate, RTS,S.
Prior to joining MVI, Farzana worked at Results for Development Institute (R4D), where she was responsible for the management of project activities for the aids2031 Costs and Financing Working Group. Before joining R4D, she worked at Johns Hopkins University on the Pneumococcal Vaccine Accelerated Development and Introduction Project (PneumoADIP) as the research project manager, in charge of coordinating more than 40 research and surveillance projects. She also served as the PneumoADIP's focal point for the EMRO region and helped to set up surveillance for pneumococcal disease in several countries, including Mongolia and Pakistan.
Farzana holds an MPH from the Rollins School of Public Health at Emory University, where she concentrated in international health and epidemiology. She also obtained her MA in law and diplomacy from the Fletcher School of Law and Diplomacy at Tufts University.
Christian (Chris) Ockenhouse, PhD, MD, MS
Senior Clinical Research Scientist and Medical Officer
Chris Ockenhouse provides scientific and clinical guidance to translational project teams in charge of early clinical development, working closely with MVI staff, partners, and academic investigators. He also provides medical and scientific expertise on clinical malaria, clinical immunology, and trial design. He serves on MVI’s Portfolio Management Committee and on the MVI Leadership Team.
Chris has 25 years of experience leading R&D programs focused on discovery, process development, manufacture, and early clinical testing of multiple vaccine candidates against Plasmodium falciparum and P. vivax malaria. Prior to joining MVI, Chris was Director of the Malaria Vaccine Program at the Walter Reed Army Institute of Research (WRAIR), where he directed the formation and operations of the first joint US Army-Navy Military Malaria Vaccine Program dedicated to developing malaria vaccines within the Department of Defense. He recently retired from active duty as a Colonel in the US Army.
Chris received his medical degree from the Medical College of Pennsylvania in Philadelphia, a PhD in immunology & parasitology from the Sackler Institute for Biomedical Sciences at New York University, an MS in parasitology from the Tulane University School of Tropical Medicine and Hygiene in New Orleans, and a BS (honors) from Wheaton College. Chris has also published more than 100 articles in scientific and medical literature.
Richard Okwanyo is the finance officer in charge of monitoring the financial activities of partner organizations at 13 clinical research centers in Africa.
Before joining MVI, Richard worked as the finance manager at Mildmay International, based in Kenya, where he oversaw financial management and administration, including the management of sub-agreements and capacity building within partner organizations related to financial management and internal controls. Prior to that, Richard worked with VETAID as the regional finance and internal audit manager for Africa. He brings to MVI more than 15 years of hands-on experience and a wealth of financial-management experience, working with projects funded by a range of donors, including USAID, US Centers for Disease Control, UK Department for International Development, and the European Community.
Richard holds a postgraduate certificate in business and finance from the London School of Business and Finance and a BA in commerce (accounting option) from the University of Dar es Salaam, and he is an Association of Chartered Certified Accountants (ACCA) finalist.
Jennifer O'Reilly, MA
Senior Program Associate
Jennifer O'Reilly is a senior program associate currently working on the RTS,S malaria vaccine trial. In this role, she focuses on foreign technical assistance, partnership development, and organization of designated activities at 11 African field sites in support of developing and implementing work plans for a clinical trial network. Jennifer coordinates a number of RTS,S-specific activities at African clinical trial sites and works to implement new technologies, strategies, and logistical systems in support of the Phase 3 vaccine trial.
Prior to joining PATH, Jennifer worked as a production coordinator at the Boston Consulting Group.
Jennifer holds a BA from the University of Maryland and an MA in international affairs from Georgetown University. She specialized in development and has since received training in immunization solutions, logistics for health commodities, monitoring and evaluation fundamentals, and malaria.
David Poland, MPS
Senior Communications Officer
David Poland's focus with MVI is on communication activities related to the RTS,S vaccine.
He has worked in science communication for development—ranging from hands-on community outreach to mass media—since the mid-1980s, primarily in agriculture and biotechnology, notably in the arena of transgenic crops. David has worked as a newspaper reporter and photographer, as well as a videographer.
David holds a Master of Professional Studies in communications (with a concentration in intercultural communication) from Cornell University.
Clinical Research Program Officer
Afiya Radford provides project management and technical assistance to the Clinical Unit working on the RTS,S Phase 3 trial. She is the MVI project manager of the RTS,S Phase 3 immunology ancillary study and provides operational and financial oversight in this capacity. In addition, Afiya oversees the clinical, operational, and financial aspects of the Lilongwe trial site and also coordinates microbiology training at RTS,S trial sites.
Prior to joining the MVI team, Afiya was a molecular biology research technologist in the Division of Malaria Vaccine Development at Walter Reed Army Institute of Research (WRAIR). In this role, she gained experience in standard operating procedure development, immunoassays, and malaria microscopy, and she coordinated preclinical safety/immunogenicity studies. She also has experience in scientific data management and budgeting.
Afiya holds a BS in anthropology and biology from Howard University.
Theresa Raphael, MPH
Theresa Raphael brings more than 20 years of health-policy and communications experience to the MVI team. She plays a key role in developing content for MVI publications, reports, and proposals for current and prospective donors.
Prior to joining MVI, she worked at Northrop Grumman Health Solutions, where she served as the senior writer, responsible for the development of a wide range of materials—from fact sheets and talking points, to reports and proposals for funders. She also served as executive director of the National Coalition of STD Directors (NCSD), where she managed all aspects of the organization's work, including communications, resource development, and external relations.
Theresa holds a BA in political science from Rutgers University and an MPH from Yale University.
Senior Financial Officer
Heather Richards serves as senior financial officer working with MVI's Research and Development Unit and translational programs, responsible for contracts management, financial management, and project administration. In addition, Heather works closely with the director of finance on financial matters relating to the overall MVI portfolio, including compliance and headquarters relations.
With PATH since 2001, Heather spent six years in PATH's Finance Division as finance officer in charge of donor financial reporting before joining MVI in 2007.
Heather holds a BA in business administration from Andrews University in Michigan, where she majored in accounting.
Amanda Sanchez is the executive assistant to the MVI director.
Prior to joining MVI, Amanda worked at FHI360 in the portfolio management unit. She has more than ten years of experience providing administrative support to executive level staff and personnel in both the non-profit and for-profit sectors, most significantly within the realms of public health, portfolio management, and real estate.
Amanda is currently pursuing a degree in public health and is studying at NOVA College in Virginia.
Barbara Savarese, RN
Program Advisor and Head of Clinical Operations Unit
Barbara Savarese joined MVI in early 2006 after a 19-year career at NIH. At MVI, Barbara leads a multidisciplinary team in the clinical development of the RTS,S malaria vaccine in partnership with GlaxoSmithKline Vaccines. She is passionate about the work, supporting the development of 11 African clinical research centers that are conducting a pivotal Phase 3 efficacy trial on RTS,S and carrying out research on other MVI vaccine candidates as they enter the field.
Initially, Barbara worked in the NIH wards and clinic as a study coordinator on trials related to HIV, oncology, and sexually transmitted infections. Subsequently, she was appointed project officer and assisted in the development and administration of clinical trial networks, including the AIDS Vaccine Evaluation Unit and the Sexually Transmitted Infections Group. These activities involved setting up trial sites internationally.
Her background and training is in nursing and clinical research. She received a BS in nursing from Emory University and completed advanced training in clinical research at the NIH Clinical Center.
Callie Scott serves as a technical officer in the Product Development and Access Unit. She leads MVI’s health economics activities.
Callie has more than 10 years of experience conducting health economics research studies. Most recently, Callie worked at Boston University’s Center for Global Health and Development where she was a co-investigator and technical lead on studies focused on evaluating the costs and outcomes of HIV treatment and prevention programs in Zambia. Prior to joining Boston University, she worked at Massachusetts General Hospital where she used simulation modeling methods to estimate the clinical impact and cost-effectiveness of HIV testing, treatment, and prevention policies in the United States, South Africa, India, and Côte d’Ivoire. She has also worked at the Abdul Latif Jameel Poverty Action Lab where she coordinated a study on health care delivery, health seeking behavior, and health and socioeconomic status in India.
She holds an MSc in health policy and management from the Harvard School of Public Health and a BA in economics and political science from the University of Michigan.
Deborah Scott, MS
Clinical Research Program Officer
Deborah Scott is a program officer within MVI’s Clinical Unit. Focusing on early clinical trials, she manages clinical aspects of Phase 1/2 vaccine trials with MVI partners. Along with the MVI IRB coordinator, Deborah ensures timely submission of protocols and protocol amendments to Institutional Review Boards. Her other responsibilities include participation in maintaining internal tracking tools, conducting on-site assessments of clinical trial sites, reviewing technical documents from key partners, assisting with the annual budgeting and negotiations for clinical trial activities, and authoring clinical portions of progress reports.
Deborah’s prior experience includes working directly with clinical trial participants on several trials as a study coordinator; managing the day-to-day operations of a trial as project coordinator; and coordinating the writing, development, and implementation of protocols as a clinical trials specialist. Palliative care, oncology, emphysema, ophthalmology, and HIV served as the focuses of the trials Deborah worked on prior to joining MVI.
Deborah holds a master's degree in education from Johns Hopkins University.
Shannon Shanahan, JD
Associate General Counsel
Shannon Shanahan is responsible for managing MVI's legal matters, including providing legal, business, and strategic counsel. Shannon brings 17 years of legal experience, having worked for multinational, public, and private companies in the biotechnology and technology sectors. Shannon’s legal experience includes taking a drug candidate from preclinical to market, developing and implementing compliance plans, risk management, and negotiating complex agreements with an intellectual property emphasis.
Prior to joining PATH, Shannon was director of corporate legal affairs at Cell Therapeutics, Inc. (CTI), a multinational, public biotechnology company, where she managed the corporate legal department and all legal work for CTI and its six subsidiaries. Shannon supported CTI’s international Phase 3 clinical programs including US and European regulatory filings and product launch for Trisenox™. Prior to CTI, Shannon worked as a corporate attorney for Chiroscience/Celltech, a UK multinational, public biopharmaceutical company, where she provided legal counsel to senior management, subsidiaries, and department heads. Shannon also worked as legal counsel for technology companies in the internet and software fields. Shannon has lectured and presented on various legal topics including: legal risks in international clinical trials, contract drafting and negotiations, and litigation of intellectual property.
Shannon holds a JD from Gonzaga Law School and a BA in political science from California Polytechnic State University. Prior to obtaining her JD, Shannon worked in the nonprofit sector in San Luis Obispo, CA.
Shannon A. Simpson, MS, CCRP
Institutional Review Board (IRB) Coordinator
Shannon Simpson is the IRB coordinator responsible for managing IRB efforts within the Clinical Unit at MVI. Shannon acts as the key liaison for communicating PATH IRB requests and requirements to MVI's global partners. She corresponds daily with clinical research sites in Africa to facilitate efficient IRB reporting and submissions.
Shannon''s experience in clinical science includes pre-clinical work, serving as co-investigator, marketing of a pivotal Phase 3 trial, and international guideline awareness, as well as international travel for a selection of study sites. She has worked in the areas of women's health, infectious diseases, and oncology.
Shannon holds a BS in biology from Tuskegee University and an MS in clinical laboratory science, with a concentration in population health, from the University of Wisconsin-Milwaukee. Shannon is also a Certified Clinical Research Professional (CCRP), a certification she received through the Society of Clinical Research Associates (SoCRA).
Katya Spielberg, MBA
Director, Finance and Administration
Serving as MVI's chief financial officer, Katya Spielberg is responsible for overseeing MVI’s financial and administrative functions, including the oversight of MVI's grant funds.
With PATH since 1989, Katya Spielberg has more than 20 years of nonprofit accounting and financial-management experience, including serving as PATH’s financial controller for four years. She also served as a personnel supervisor for the United States Information Agency at the 1988 World’s Fair in Brisbane, Australia, and as a program coordinator for the University of Washington's Executive MBA program.
Katya holds an MBA from the University of Washington, with an emphasis on nonprofit management, and a BA in business administration from James Madison University in Virginia, where she majored in international business and Spanish.
Matthew Strausbaugh coordinates international and domestic travel for MVI staff.
Matthew has 15 years of international travel-agency experience focusing primarily on the intricacies and needs of travelers from nongovernmental organizations. His experience includes airfare construction, flight routing, and USAID travel regulations. In addition, he has extensive personal travel experience.
Matthew was born and raised in Maryland and attended Loyola College in Baltimore.
Gina Noe Todorovich
Noe Todorovich is a communications associate within MVI’s Communications and Advocacy Unit, working predominantly on MVI’s websites, social media outreach, and contacts database.
Prior to joining MVI, Noe worked as a senior web and new media specialist at the National Association of County and City Health Officials. Her duties included providing staff with training, assistance, and guidance in web statistics, the use of social media, electronic communications, and website maintenance. She has also worked at EEI Communications, reviewing and editing printed materials and content for various websites.
Noe received her BS in communication from Pacific Union College.
Richard Weltzin, PhD
Richard Weltzin works in the Portfolio Management and Translational Projects Unit and is responsible for managing vaccine projects in early clinical testing.
Richard has more than 20 years of experience in vaccine research, development, clinical testing, and project management. Prior to joining MVI, he was director, immunology and vaccinology at Variation Biotechnologies, Inc., where he led development of a novel hepatitis A vaccine. Before that, he served in various capacities over 17 years at Acambis Inc., most recently as senior director for viral immunology and cell biology. At Acambis, he was involved in research and development of vaccines and monoclonal antibodies against a variety of targets, including respiratory syncytial virus, Helicobacter pylori, Japanese encephalitis, dengue, and smallpox. For the ACAM2000 smallpox vaccine, he oversaw research and process development and was involved in all aspects of vaccine development through FDA licensure.
Richard received a BS in biology from the University of Illinois, an MS in neurophysiology from the University of Wyoming, and a PhD in immunology from the University of Illinois. He did postdoctoral training in cell biology and immunology at the Swiss Cancer Research Institute and Harvard Medical School.
Ulrike Wille-Reece, PhD
Ulrike (Ulli) Wille-Reece brings to MVI extensive experience in the design and immunological assessment of novel vaccine candidates. She has particular expertise in prime-boost immunization strategies using an array of delivery technologies, including adjuvanted recombinant proteins, viral vectors, and plasmid DNA. Her strong cellular immunology background is instrumental to critically evaluating novel vaccine candidates and immunization regimens in MVI's vaccine portfolio.
Prior to joining MVI, Ulli served six years as a research fellow in Dr. Robert Seder's group at the Vaccine Research Center at NIAID/NIH, where she worked on the development and preclinical evaluation of various novel HIV vaccine platforms. While working with Dr. Seder, she gained extensive knowledge in dendritic cell targeting, vaccine delivery, and evaluation of vaccine candidates in rodent and non-human primate models.
Ulli holds a PhD in biochemistry from the Universität Tübingen in Germany, and received post-doctoral training in Dr. Christopher Hunter's lab at the University of Pennsylvania. She is a 1997 graduate of the Marine Biological Laboratories course "Biology of Parasitism: Modern Approaches."
Colleen Woods, PhD
Senior Program Officer
Colleen Woods serves as a senior program officer in MVI's Research and Development Unit.
Prior to joining MVI, Colleen served on active duty for three years in the US Navy Medical Service Corps. As a Navy microbiologist, she headed the enterotoxigenic Escherichia coli (ETEC) Immunology Laboratory at the Naval Medical Research Center. In this position, she served as principal investigator for the Military Infectious Disease Research Program protocol, as associate investigator for a protocol funded by the National Institute of Allergy and Infectious Diseases (NIAID), and as associate investigator for several Phase 1 and 2 human clinical trials for ETEC vaccines. Colleen was previously employed at the Johns Hopkins Bloomberg School of Public Health, Center for Immunization Research, Department of International Health, where she managed laboratory activities, study planning, and implementation in support of Phase 1, 2, and 3 human clinical vaccine trials for various infectious disease agents, including ETEC, Shigella, anthrax, and HIV.
Colleen received her PhD in international health from the Johns Hopkins Bloomberg School of Public Health and also holds a Master of Interdisciplinary Studies in environmental health from Virginia Commonwealth University.
Bebi Yassin-Rajkumar, MMSc
Bebi Yassin-Rajkumar serves as a project manager in the Portfolio Management and Translational Projects Unit of MVI. She works with external partners and with other units within MVI to coordinate malaria vaccine projects in early clinical testing.
Before joining MVI, Bebi worked for Variation Biotechnologies Inc. in Ottawa, Canada, where she served for seven years as operations manager and project manager in the development of vaccines against influenza, hepatitis A, and other disease targets. Prior to that, she served as laboratory manager at Georgetown Public Hospital and at Guyana Medical Laboratories in Guyana, South America.
Bebi holds a BSc in biology from the University of Guyana and an MMSc in management of science from the University of Waterloo.
Edward Wu, PhD
Edward Wu serves as a project manager in the Research and Development Unit. He works within MVI units and programs to coordinate transmission-blocking vaccine development and monitor milestones used to measure program progress towards achieving strategic goals.
Before joining MVI, Edward worked for the Science Applications International Corporation (SAIC) malaria vaccine program contracted by the National Institute of Allergy and Infectious Diseases/National Institutes of Health (NIH). He served here from 2009 to 2013 as a senior scientist and as a project manager, managing malaria vaccine development projects that focused on virus-like particle/nanoparticle and conjugate delivery platforms. He also served as a liaison for inter-government agency vaccine projects. Prior to working at SAIC, he was a senior scientist with Synergy America, Inc., managing vaccine production and assay development activities. He also previously held a research fellow position at the HIV Drug Resistance Program of the National Cancer Institute/NIH.
Edward received his PhD in crystallography from the University of Pittsburgh and also holds a master’s degree in physics from the National Tsing-Hua University in Taiwan.