
External Advisory Board
Brian Bradbury
BRIAN BRADBURY
Brian D. Bradbury, DSc, is an Executive Director and Head of the Data & Analytic Center (DAC) within the Center for Observational Research (CfOR) at Amgen, Inc. As the Head of the DAC, he leads a team of epidemiologists, biostatisticians, and programmers who provide strategic and tactical support across the drug development lifecycle. The DAC has the responsibility of developing and maintaining Amgen’s RWD platform, conducting epidemiologic research on the incidence and prevalence of target clinical indications, using RWD to support RCT design, conducting feasibility analysis for post-marketing commitments, and developing Amgen’s Sentinel program, which can be used for comparative effectiveness and safety research, as well as quality of care evaluation. Brian received his DSc in Epidemiology from Boston University in 2004 and a MA in Education & Psychology from Pepperdine University in 1998. He has authored or co-authored over 65 peer-reviewed publications in the areas of pharmacoepidemiology, cancer and kidney disease epidemiology and methods for controlling confounding-by-indication in drug safety studies.
Lauren Celano
LAUREN CELANO
Lauren Celano is the co-founder and CEO of Propel Careers, a life science search and career development firm focused on connecting talented individuals with entrepreneurial life sciences companies. Propel works with current leaders and actively cultivates future leaders through full time placement, internships, mentoring, career coaching, and networking. Propel Careers is engaged across all areas of life sciences, including therapeutics, medical devices, healthcare IT, diagnostics, consulting, venture capital, and investment banking. Prior to Propel Careers, Lauren was a senior account manager for SNBL USA where she worked with emerging biotech companies in Europe, Asia, and the US to help characterize and advance their drug molecules. Prior to SNBL USA, she held business development positions with Aptuit and Quintiles, where she focused on IND enabling studies to advance therapeutics from discovery into the clinic.
Earlier in her career, Lauren held positions as a marketing manager and account manager at Absorption Systems, where she was responsible for managing life sciences companies in the northeastern United States. She has a B.S. in Biochemistry and Molecular Biology from Gettysburg College and an MBA with a focus in the health sector and entrepreneurship from Boston University. Lauren is on the membership committee of the Boston Chapter of the Healthcare Businesswomen’s Association and she also serves on the programming committee of the Capital Network.
Ms. Colatrella is Executive Director, Office of Corporate Responsibility (CR) within Global Public Policy & Corporate Responsibility at Merck & Co., Inc., a central function that coordinates the development, implementation and reporting of Merck’s global corporate responsibility approach on environmental, social, ethical and governance issues in support of the company’s business strategy. She is also responsible for Merck’s global health partnerships and policies that help to expand access to medicines, vaccines and quality health care particularly in the developing world and emerging markets. Prior to assuming this position, Ms. Colatrella was Executive Director, Global Health Partnerships, within the Office of Corporate Responsibility, responsible for key global health and access partnerships and Merck’s relationships with a wide range of stakeholders in the global health arena. Previously she was Executive Director, HIV Policy and External Affairs for the Europe, Middle East, Africa, Canada region, with a primary focus on driving Merck and industry initiatives to improve access to HIV/AIDS care and treatment in the developing world. Ms. Colatrella also served as Senior Vice-President, The Merck Company Foundation, and Senior Director, Office of Contributions, responsible for all Foundation and corporate cash grant making activities, product donations programs (e.g., the Merck Mectizan Donation Program), relationship management with key partners involved in Merck’s CR activities and representation of Merck’s CR portfolio and policy positions on issues related to CR and public-private partnership. Ms. Colatrella received her B.A. from Muhlenberg College, summa cum laude, Phi Beta Kappa, and her M.B.A. from New York University’s Stern School of Business where she was the recipient of the Dean’s Award. For seven years, two of which as Chairperson, Ms. Colatrella has served on the Partnership for Quality Medical Donations (PQMD), a coalition of pharmaceutical companies and private voluntary organizations dedicated to raising the standards for product donations globally.
Brenda D. Colatrella
BRENDA D. COLATRELLA
Lindsey Frenkel-Rorden is a Manager of Government Affairs and Public Policy (GAPP) at Vertex Pharmaceuticals, a Boston-based biotech focusing on developing transformative medicines to treat serious diseases like cystic fibrosis. Within this role, Lindsey leads a cross-functional task force on patient access, which strives to ensure patients are able to appropriately access medicines. Lindsey also supports discussions with key state and federal government officials through the collection, analysis and dissemination of health policy information. Prior to her work at Vertex, Lindsey worked in South Africa as a research for Médecins Sans Frontières (MSF) on their Access Campaign. Through various research on drug patents and regulatory drug review, it was here that Lindsey cultivated the connection between government health policies and patient access. Prior to MSF, Lindsey held several positions at ECOG-ACRIN Cancer Research Group in Boston, where she worked with leading oncologist nationally to develop cutting-edge clinical trials within the adult oncology space. She holds a MPH from Boston University of Public Health (BUSPH) with a focus on global health. She is also a graduate of the Pharmaceuticals Program at BUSPH.Lindsey Frenkel-Rorden
Mary-Lynn Fulton has more than 25 years of experience in clinical trials operations/management in the biopharmaceutical industry. She joined Vertex Pharmaceuticals Inc. in January 2016 as the Head of Study Management (Clinical Operations). Prior to this, Ms. Fulton had a 23 year career at PAREXEL (top global Contract Research Organization) in positions of increasing responsibility within Clinical Operations and Project Management. Prior to joining Vertex, she was Corporate Vice President and Head of PAREXEL’s Clinical Operations department in the Americas region, with responsibility for 1400 employees located throughout North and South America. During the course of her career, Ms. Fulton has successfully led large regional and global operational departments to achieve strategic and business goals. She has extensive experience with personnel management, optimizing organizational effectiveness and change management. Ms. Fulton is a driven and passionate leader with excellent communication and interpersonal skills, strong decision making skills and a global mindset. Ms. Fulton holds a Bachelor of Science degree from the University of Toronto and a Masters of Public Health degree from Boston University. She is a member of the Alumni Leadership Council at the Boston University School of Public Health. She is based in Vertex’s corporate headquarters in Boston, MA.Mary Lynn Fulton
Laurie founded Halloran Consulting Group in 1998. Her vision in forming the company was Life Science that Works: Product, Process and People. She realized through working with early stage biotechnology companies that senior level expertise is critical at early stages of navigation through the regulatory and operational challenges of product development. She has built a successful consultancy of likeminded experts who are dedicated to the idea that every company deserves the best practices and know-how in the life science world, regardless of its size, its name or its financial situation. She is recognized as an industry expert in improving the organizational effectiveness of those companies. Laurie worked in the outsourcing services realm during PAREXEL International’s rapid growth phase from 1988-98, where she developed competency based programs for several departments within the organization, and led the integration of the companies European operating units acquired during her tenure. She later led clinical development at OXiGENE and Antigenics, before growing the company she founded in 1998. In 2015, Laurie was honored by the Boston Business Journal as a Woman of Influence, and the company has received a ranking in the INC 500 fastest growing companies for the past 2 years. In 2010, Laurie was selected as one of the 100 Most Inspiring People in Life Science by PharmaVoice and in 2009, she was awarded Clinical Researcher of the Year by the New England Chapter of the Associate of Clinical Research Professionals. She lectures at Boston University Medical School and the Tufts Center for Drug Development Post-Graduate program. She has previously taught at George Washington University and Harvard University. Laurie earned a Bachelor of Science in Nursing from Russell Sage College and a Master of Science in Management from Leslie University. She is also a Prosci certified change management consultant.Laurie Halloran
GILBERT J. L’ITALIEN Gil L’Italien (BUSPH ’97) has over 20 years of experience in the HEOR and pharmacoepidemiology field, with an extensive track record as an industry executive, manager of people, and as an academic leader. Gil has held roles of increasing responsibility previously at Bristol Myers Squibb, Biogen, currently at Alexion, and Yale University School of Medicine as Adjunct Assistant Professor. Gil is also an affiliated faculty member to the Yale Robert Wood Johnson Clinical Scholars Program. Prior to his current professional roles, Gil was Director of Vascular Research at Massachusetts General Hospital and held a faculty appointment at Harvard Medical School. Gil has further participated in advisory committees for several government institutions such as the Agency for Health Care Research and Quality (AHRQ), the CDC Foundation Viral Hepatitis Action Coalition (VHAC), the Multiple Sclerosis Outcome Assessments Consortium (MSOAC), the Alzheimer’s Disease Technical Working Group, Green Park Collaborative, and the Merit Review Committee for the Patient Centered Outcomes Research Institute (PCORI). Gil was also a member of the User Advisory Group for IBM Watson Health Sciences, and is currently a task force member of the Personalized Medicine Connective. Gil recently joined PhRMA’s Real World Evidence Working Group (WG). The WG seeks to develop quality standards and use cases for comparative effectiveness studies submitted to regulatory agencies. Gil’s research interests have focused on the application of large scale databases for the conduct of observational comparative effectiveness studies. These include natural history studies, predictive and prognostic models, and biomarker validation.Gilbert J. L'Italien
Esprit Ma
ESPRIT MA
Esprit Ma (BUSPH ’12) currently works in Global Medical Affairs (Health Economics & Outcomes Research) as an Associate at Millennium Pharmaceuticals, Inc.. She graduated with a concentration in Health Policy and Management and a certificate in the Pharmaceuticals Program. Ms. Ma found Introduction to Health Policy & Management, Cost-Effectiveness Analysis, Introduction to Pharmaceuticals, Strategic Managmenet of Healthcare Organizations, and Global Issues in Pharmaceutical Policy to be the most relevant courses for her current job in the field of global medical affairs.
For her practicum, Ms. Ma completed two research internships; one at the World Health Organization in Geneva and the other at the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts Medical Center. Where does she see herself going in the future? Ms. Ma would like to engage in multidisciplinary health services research to strategically manage and improve the safety, effectiveness, and access to pharmaceutical innovations and health care services at the global level.
Elizabeth Olek, D.O. is a Drug Development Consultant to the biotechnology and pharmacuetical industries. She is working on specific projects that focus on the clinical development of leading edge compounds that address unmet medical needs in infectious disease. Previously, Dr. Olek was the Senior Vice President and Chief Medical Officer in Achillion. Dr. Elizabeth Olek joined Achillion in December 2007 from Novartis Pharmaceuticals Corporation where she most recently served as Global Brand Medical Director and Principal Medical Science Expert in the Infectious Disease, Transplant and Immunology Group. Prior to joining Novartis in 2005, she held Director of Clinical Research positions with InterMune Inc. and with Genetics Institute/Wyeth Research. In her roles, she was responsible for clinical research and advancement of various infectious disease drug candidates. She holds a B.S. degree in pharmacy from the University of the Sciences Philadelphia, a D.O. degree from the Philadelphia College of Osteopathic Medicine, and an M.P.H. degree in Epidemiology and Biostatistics from Boston University.Elizabeth Olek
ELIZABETH OLEK
Jamie Ring (BUSPH ’04) is the Head of Patient Advocacy at Spark Therapeutics, a leader in the field of gene therapy, seeking to transform the lives of patients by developing one-time, life-altering treatments for debilitating genetic diseases. In her role, Jamie is responsible for patient advocacy activities related to Spark’s disease areas of interest, particularly the Inherited Retinal Disorder space. Prior to joining Spark, Jamie spent 10 years at Genzyme, a Sanofi company where she most recently served as the Vice President of Patient Advocacy and Humanitarian Programs – Rare Diseases. In that role, Jamie provided strategic oversight of all advocacy programming and managed external partnerships related to Genzyme’s global humanitarian programs which provide free therapy to hundreds of patients around the globe. Prior to Genzyme, Jamie worked at Biogen supporting patient programs for both the Multiple Sclerosis and Non-Hodgkin’s Lymphoma disease communities. Additionally, Jamie worked at the ALS Therapy Development Institute as the Associate Director of Programs, responsible for ALS disease awareness initiatives and fundraising campaigns. In 2013, Jamie was voted by PharmaVoice magazine as one of the 100 most inspiring leaders in the pharmaceutical industry. Jamie holds a B.A. in Sociology from Union College, Schenectady, NY and a M.P.H. in Social & Behavioral Sciences from Boston University.Jamie Ring
JAMIE RING
Vishal Patel is Senior Director for Global Institutional Affairs at EMD Serono—the biopharmaceutical division of Merck KGaA, Darmstadt, Germany. He is charged with shaping industry practice and government policy through advocacy, dialogues, and multi-stakeholder initiatives that improve global health and support strategic business objectives. Vishal was previously adviser to the Under Secretary for Economics, Energy, and the Environment (then Robert D. Hormats) at the U.S. Department of State and healthcare adviser to U.S. Senator Jeff Bingaman (D-NM) during debate and passage of the Affordable Care Act. Before shifting to public policy, Vishal was a National Science Foundation Graduate Research Fellow at Harvard Medical School, where he identified and evaluated new antimalarial therapies and studied the spread of antimalarial drug resistance in West Africa. Vishal has authored or co-authored more than a dozen scientific articles and holds two U.S. patents. He earned a B.S. in bioengineering from the University of Illinois and a Ph.D. in biological chemistry and molecular pharmacology from Harvard University, and he is completing a M.B.A. from the Sloan School of Management at the Massachusetts Institute of Technology. Vishal is a Term Member of the Council on Foreign Relations, a recipient of the AAAS Science and Technology Policy Fellowship, and an intelligence officer in the U.S. Navy Reserve.Vishal Patel
VISHAL PATEL