MASC 2018 - Speakers Corner

Kevin Appareti

Senior Director, Global Medical Science Liaison
Royal Philips, United States

Kevin Appareti is Senior Director, Global Medical Science Liaison in the Chief Medical Office at Royal Philips. He leads the Key Opinion Leader Program and Medical Education Program. He works across Philips’ businesses, markets, and research to build strong internal and external relationships with Key Opinion Leaders (KOLs) and influencers. Kevin partners with internal business, market, and research leaders and external KOLs to develop Strategic KOL Engagement Programs to deliver strategic guidance, leverage clinical and scientific knowledge, foster peer-to-peer relationships, and support clinical and marketing evidence development and medical education in support of Philips development of meaningful innovations.

Anne Arvizu, PharmD

Chief Executive Officer and Medical Affairs Advisor
RxER Communications Corp, United States

Dr. Anne Arvizu is founder and CEO of RxER Communications Corp (www.rxercommunications.com). With 22 years of executive leadership experience in the pharma/biotech industry, she has served in key roles such as Head of Global Med Info, Knowledge Mgmt. and Literature Surveillance for Baxter, Baxalta & Shire; Member Executive, PhactMI; International Regional Head & Director of Med Comm/Med Info for GSK, LATAM; DIA MASC Program Committee & Track Chair; Podcast Host for ACMA (#V3Podcast); Board Member of AMWA and serves as Chair, South Florida YMCA Board of Directors. She currently engages biotech C-Suite and VP Level executive clients as an expert consultant for Medical Affairs Capabilities build, renovation, and value-based business expansion.

J. Lynn Bass, PharmD, RPh

Senior Director, Medical Science Liaisons
BridgeBio, United States

In her 25+ years of industry experience, Lynn has served in both individual and leadership positions within Medical Affairs at both large and start-up companies. She is currently Sr. Director, Medical Science Liaisons at BridgeBio, where she is building and leading a field medical team in the rare cardiovascular therapeutic area. Lynn is a transformative leader with proven excellence in building & developing high performing teams. Along with her leadership positions, Lynn is very active in growing/expanding the MSL profession across the industry and is a frequent invited speaker. She has also authored/ co-authored several MSL surveys highlighting and assessing the MSL role.

Peter Baumeister, PhD

Director, Global Medical and Scientific Affairs
Merck Sharp & Dohme LLC , United States

Dr. Peter Baumeister is currently a Medical Affairs professional with a career history that includes clinical and emergency medicine, basic science research, active duty enlistment in the Air Force and a short stint in art school that continues to supply him with entertaining anecdotes. He currently lives in Southern California, where he enjoys challenging the laws of physics with his eternally patient wife and 3 kids, all of whom are well-versed in basic first aid and trauma care. Professionally, he is interested in the sweet spot at the intersection of people, process, and technology in Medical Affairs and works to bring teams together that experience success greater than the sum of its individuals.

Poonam Bordoloi, PharmD

Executive Director, Head of Global Medical Affairs Capabilities
Organon & Co., United States

Poonam is currently a Team Lead within the Global Scientific Content group at Merck based in Kenilworth, NJ. She has global responsibility across the entire General Medicines portfolio with a large team covering key products. Most recently, Poonam was at Celgene in the Strategic Medical Communications and Innovation group. Prior to this, Poonam worked at Sanofi in the Medical Information Department for 12 years, at JNJ in the Global Competitive Intelligence group for 3 years, and at Parke-Davis in the MI Department for 3 years. She has 25 years of experience in Pharma and has 2 publications regarding Social Media and Medical Information Trends. Poonam chaired the 2019 DIA MASC meeting is now involved with DIA Annual.

David Bowers, PharmD

Senior Director, Operations
PPD, United States

David Bowers has 20+ years of experience managing pharmaceutical contact center programs at PPD. As Senior Director of Operations, David supports global medical information for pharmaceutical, biotechnology and medical device clients. He has a background in pharmacy, with a Doctorate of Pharmacy from the University of North Carolina in the United States. During his time at PPD, David has worked with over 30 client contact center programs providing medical information, pharmacovigilance and product complaint processing, patient adherence programs, REMS support and other services. David’s recent experience includes implementing contact center operations in the US, Europe, Latin America and Asia.

Kathryn Bucci, PharmD

Medical Governance Lead
Pfizer, Inc., United States

Senior Director, Medical Governance Lead, Pfizer, Inc. Prior to assuming this role three years ago, Kathy was in a field Medical role for 15 years with Pfizer. Kathy holds a B.S.Pharm and PharmD from St. John’s University; a Residency in Hospital Pharmacy Practice, Medical College of Virginia Hospitals; and a Fellowship in Clinical Pharmacy Practice in Family Medicine, Medical University of South Carolina. Prior to joining Pfizer, Kathy was faculty in the Department of Family Medicine, Duke University and the Medical University of South Carolina. She is a Board Certified Pharmacotherapy Specialist and Fellow, American Society of Health-System Pharmacists.

Stephanie L. Byrdé, BSN, MS, RN

Advisor, Scientific Communications, Clinical Pharmacology
Eli Lilly & Company, United States

Stephanie Byrdé is an Advisor in Clinical Pharmacology for Eli Lilly and Company. During her tenure with Lilly, she has held various roles in clinical development, project management, and scientific communications, spanning early phase through late phase submissions and launches.

Ivy Chang, PharmD

Medical Information and Communications
n/a, United States

Ivy has 20+ years of experience in the pharmaceutical industry. She is a Principal Medical Information Lead at Genentech with experience across diverse therapeutic areas including Oncology, Rheumatology, Respiratory, Ophthalmology, Endocrinology, Neurology, Cardiovascular Disease, and various clinical conditions with an immunologic basis in pathophysiology. Prior to joining Genentech, she was a Clinical Pharmacist in General Surgery, Surgical Subspecialties, and Solid Organ Transplant at the University of California San Francisco (UCSF) Medical Center, and an Assistant Clinical Professor with the UCSF School of Pharmacy. Ivy received her PharmD from University of Tennessee Health Science Center.

Michael Church, MA

Senior Director, Medical Writing
Syneos Health, United States

Michael Church has been with Syneos Health for 15 years and working in the area of scientific communications for 19 years. Having started his career as a medical editor, Michael was a founding member of Syneos's clinical group and oversees a medical writing partnership that began with 5 associates in 2005 and has grown to its current state of 110 medical writers, editors, technical writers, and regulatory publishers. He is currently a Senior Director and leads the Syneos Strategic Resourcing Medical Writing Department.

David B. Clemow, PhD

Advisor, Scientific Communications Information Strategy
Eli Lilly and Company, United States

David is an Advisor Scientific Communications at Eli Lilly and Company with over 20 years of regulatory, publication, and promotional scientific communications experience in the pharmaceutical industry. His work has included document authoring, team management, operations consulting, clinical research, and medical affairs. David is Chair of the American Medical Writers Association Medical Writing Certification Commission.

Rebecca Falcone, PharmD

Global Medical Information Systems, Insights and Omnichannel Lead
Sanofi, United States

Rebecca Falcone, PharmD has over 20 years of pharmaceutical industry experience and is currently the Global Medical Information Systems, Insights & Omnichannel Lead at Sanofi. Rebecca is responsible for the implementation and management of a global medical information system for inquiry and content management utilized in more than 175 countries, along with managing medical information insight generation and data analytics, and supporting innovative medical information digital projects. Rebecca has been a speaker at both the DIA Annual and MASC meetings and participated as a past MASC program committee member.

Maureen Feeney, PharmD, MBA, RPh

Vice President Scientific Communications and Strategic Alliances
Takeda, United States

Maureen has over 20 years of experience in Medical Affairs, including leadership roles in Medical Information, Medical Communications, and Field Medical. Maureen has been with Takeda for 9 years. She is currently Vice President Medical and Scientific Communications at Takeda. Previously, Maureen was Head of Global Medical Communications at Shire. Maureen has served on various DIA program committees. Prior to Takeda, Maureen held various positions of increasing responsibility including, Director of Medical Information at GlaxoSmithKline and Head of Medical Services at Incyte. Maureen has 10 years of clinical practice and teaching experience at Thomas Jefferson University Hospital and the University of the Sciences in Philadelphia.

Eileen Girten, MS

Director, Medical Writing
Pfizer Inc, United States

Eileen M. Girten is Director of Medical Writing at Pfizer and is experienced in regulatory and publications writing, submissions, and mentoring. She is an Adjunct Assistant Professor at the University of the Sciences in Philadelphia and has taught Regulatory Documentation Processes for the Biomedical Writing program. Eileen earned a BA in Chemistry from Rosemont College, an MS in Psychology from Saint Joseph’s University, and an MS in Biomedical Writing from the University of the Sciences in Philadelphia.

Kathleen M Guindon, PhD, MS, RN

Senior Director, Medical Science Liaison
Kronos Bio, United States

Kathleen Guindon, Director, Medical Science Liaison team at Puma Biotechnology is responsible for supervision of a team of six United States Based MSL’s. Kathy also maintains a territory within the US with her MSL team. Kathleen is a qualified registered nurse and holds the a Master’s degree from State University of New York at Buffalo in Oncology Clinical Nurse Specialist, and a doctoral degree from the University of Phoenix in Management and Organizational Leadership. She holds current memberships in NAPW, DIA, ASCO, ASH, & AACR. Kathleen’s varied background includes oncology nursing, oncology medical affairs, oncology clinical R&D, organizational management, public speaking, and publication in peer reviewed medical journals.

Jennie G Jacobson, PhD

President
Jacobson Medical Writing, Inc., United States

Jennie G. Jacobson is President of Jacobson Medical Writing. She earned her BA from Swarthmore College, and PhD from Harvard University. Jennie was a post-doc at Upjohn Laboratories and the University of Michigan before realizing being a medical writer would allow her all the fun of interpreting data without having to generate it. She rounded out her education with two AMWA certificates, a certificate in Medical Writing from U Chicago, and CMPP certification. In her 24 years as a medical writer, Jennie has written publications in a wide array of therapeutic areas including oncology, neurology, health outcomes research, gene therapy, endocrinology, respiratory disease, autoimmune disease, ophthalmology, and gastrointestinal disease.

Darryl L'Heureux, PhD, MPharm, MSc

Director, Clinical Science, Medical Writing, and Publications
Ambrx, Inc, United States

Darryl Z. L’Heureux is an active and engaged member of the medical writing community. Dr. L’Heureux received his PhD in Cancer Biology and Masters in Pharmacy, Quality Assurance and Regulatory Affairs from Temple University. He has worked within the NCI cooperative group structure and across small biotech to large pharmaceutical companies. Returning to his early research interest in immuno-oncology/tumor biology, he leads Integrated Oncology Lung Development at Bristol-Myers Squibb. Combining his interest in science and education, Dr. L’Heureux continues to present lectures/roundtables at professional and educational events. He teaches scientific writing in the Professional Master’s Scientific Writing Program at Temple University.

Jeff Mathews, MPH

Director, Medical Information
Gilead Sciences, United States

Jeff is the Director of US Medical Information at Gilead Sciences, where he is responsibility for developing and executing strategies to deliver medical information services across all Gilead products in the US. He has nearly 14 years of Medical Communications experience with roles in Scientific Communications, Publication Planning, and Medical Information at Eli Lilly, Sunovion Pharmaceuticals, and Vertex Pharmaceuticals. He holds a Masters of Public Health in Epidemiology from Indiana University and is a Certified Medical Publication Professional (CMPP).

David Meats

Director, Regulatory Services Management
Certara, United States

David Meats is a Director of Regulatory Services and Medical Affairs at Certara. He has been a medical writer and manager for 23 years working in oncology, immuno-oncology, endocrinology, musculoskeletal, cardiac, hepatic, renal, and infectious disease therapeutic areas on nearly every available clinical document type. He specializes in leading and writing FDA and EMA regulatory submissions and an expert in technology development in regulatory services. David is also a co-chair for the Medical Writing track of the DIA 2024 conference, and has been a member of DIA for 8 years.

Robert Paarlberg, MS

Principal
Paarlberg & Associates LLC, United States

Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB. Bob is former Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 40 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs. Bob has been active in the clinical trial disclosure and transparency space since 2005.

David Price, PhD

Advisor, US Field Medical, Bio-Medicines Medical Sciences Liaisons
Lilly USA, LLC, United States

David Price, PhD has been employed with Eli Lilly and Company since 2011. David began as a Psychiatry Medical Science Liaison. David took the opportunity to diversify his MSL experience by transitioning to MSL roles supporting Urology as well as Musculoskeletal therapeutic areas. In 2014, David shifted to US Field Medical Operations and capability development across numerous therapeutic areas and MSL teams. Prior to his current role, David was a Global MSL Trainer in Lilly’s Office of Medical Professional Development. In 2018, David started his current position as a Field Medical Advisor providing operational leadership, strategic oversight and chief of staff responsibilities for Lilly’s US Bio-Medicines MSL program.

Robin Whitsell

President
Whitsell Innovations, Inc., United States

Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior to founding WI, Ms. Whitsell was the assistant director of preclinical & clinical development at Inspire Pharmaceuticals and a team lead at GlaxoWellcome. She has degrees in biophysics and physics from Miami University and interned at Los Alamos National Laboratory.

Robin Winter-Sperry, MD

Field Medical Excellence, International / Oncology Lead
Pfizer, United States

Dr. Robin Winter-Sperry is currently the Field Medical Excellence, International / Oncology Lead at Pfizer. With roles of increasing responsibility, she was the Global MSL Lead at Ipsen. Prior to joining Ipsen, she was Head, Global Field Based Medical Excellence and Insights at Sanofi Genzyme after joining as VP, Strategy, MS. With extensive consulting experience as President of Scientific Advantage, she’s been instrumental in Medical Affairs strategy, operations including mergers, transitions and organizational design. She has pioneered the recognition of MSLs as a specialty in the biopharmaceutical and device industry, responsible for creating and developing many of the industry’s leading Medical Affairs and Field Medical teams.

Ann Winter-Vann, PhD

Senior Writer and Manager
Whitsell Innovations, Inc., United States

Ann Winter-Vann earned her PhD in Molecular Cancer Biology from Duke University, where she was a predoctoral fellow of the Howard Hughes Medical Institute. Following a postdoctoral position in the Pharmacology Department at UNC-Chapel Hill, Ann joined Whitsell Innovations, Inc., where she is now a senior writer and manager. She has extensive experience in clinical regulatory writing and also provides consultations and training in medical writing. Ann has co-taught a science writing course for first-year biomedical graduate students at UNC-Chapel Hill. Ann is a past president of the Carolinas chapter and the current President of the American Medical Writers Association (AMWA).

Alicia Alexander Cadogan, PharmD, RPh

Director, Oncology Medical Information
Pfizer Inc, United States

Alicia is Director and Team Lead for North America Oncology Medical Information at Pfizer Inc. Alicia has participated in the DIA Core Curriculum both as faculty and Chairperson, and in 2010 served as Chairperson for the DIA Annual March Med Comm Meeting. She has led the Fellow program for the DIA Med Comm Meeting from 2012 thru 2021. Alicia received her BS in Pharmacy from St. John’s University, and her PharmD from Albany College of Pharmacy. She spent 4 years at The University of Pittsburgh School of Pharmacy as a Nephrology Fellow and then as Assistant Professor of Pharmacy and Therapeutics. Alicia also worked in Medical Communications at Wyeth Pharmaceuticals and as Medical Director at CoMed Communications.

Pamela Cyrus, MD, PhD

Vice President and Head of Medical Governance, Pharmaceuticals
Bayer Healthcare Pharmaceuticals, Inc., United States

Dr. Pamela Cyrus is Vice President and Head, Medical Governance at Bayer Pharmaceuticals Division since 2014. In this position, Dr. Cyrus oversees Medical Governance systems and processes worldwide that enable country-personnel to quickly and efficiently move through compliant processes. This position is accountable for the global medical affairs standards. This role has oversight responsibility to protect the interests of patients in accordance with all relevant legislation and guidelines including EU, FDA and country directives, Medicines Law, the Pharmaceutical Industry Code of Practice (CoP), regulatory guidelines for the advertising and promotion of medicines and other relevant agencies and company standard operating procedures.

Paul Grant

Director Communications, My Health Record
Australian Digital Health Agency, Australia

Paul Grant has been involved in digital media since the inception of the public Internet. For much of the past 11 years, he has been based in London U.K., where he produced digital engagement strategies and social media insights for the leading health and pharmaceutical organizations in the world. Until his return to Australia, he was faculty lecturer in social media for the European Center of Pharmaceutical Medicine, an advisor in pharmaceutical guidance for digital communications, and Chief Innovation Officer for a global health consultancy. Paul is passionate about inspiring and motivating organizations towards an empowered and sustainable future capability.

Craig Klinger, RPh

Director - Global MSL Trainer, The Office of Medical Professional Development
Eli Lilly and Company, United States

In Craig’s more than 30 years working at Lilly, he has successfully worked in various positions in multiple therapeutic areas including neuroscience, diabetes and osteoporosis. Craig is a founding member of the Medical Science Liaison (MSL) program at Lilly where he worked in the New York City Metropolitan area for over 13 years in this field role. Craig spent 6 years as the MSL Trainer for Lilly USA and in 2017 became part of the Office of Medical Professional Development where is he assumed the role of the Global MSL trainer. Craig has been very active in developing benchmarking survey data on MSL standards across the pharmaceutical industry. Craig received the DIA Excellence in Service award in 2021.

Arlene Kray, PharmD, PhD

Associate Director, Medical Writing
PRA Health Sciences, United States

Arlene Kray has over 10 years of industry experience with increasing levels of responsibility. She received her PhD in Pharmacology from Vanderbilt University. She completed Post-doctoral Training at Carnegie Mellon University and then pursued a PharmD at Duquesne University while working as a clinical scientist and medical writer. She has been with PRA since 2016 and currently leads a team of medical writers and managers supporting Oncology. She also teaches Pharmacology to Nursing Students at the local community college.

Ed Cunningham, PharmD

Sunovion Pharmaceuticals, Inc., United States

Ed Cunningham, PharmD is Senior Director, Neurology Medical Science Liaison (MSL) Team Lead at Sunovion Pharmaceuticals Inc. Ed is based in Milwaukee, WI, and is responsible for overseeing the US Neurology MSL team. Prior to joining Sunovion, Ed was the Director of Specialty Care MSLs at Eisai Inc., leading the company’s Neuroscience and Metabolic MSL teams. Ed obtained his PharmD degree from Philadelphia College of Pharmacy and completed a 1-year Drug Information Residency with Janssen Pharmaceutica. Ed has been in the pharmaceutical industry for 17 years, working as a team leader in a variety of Medical Affairs functions, including Medical Information, Medical Education, Investigator Initiated Studies, and MSLs.

Rebecca A. Vermeulen, RPh

Vice President, Global Patient Networks | PD Medical Affairs
Genentech, A Member of the Roche Group, United States

Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science Liaisons, Patient Partnership, Digital Health, and Six Sigma, in her 29 years of healthcare industry experience, and has been responsible for creating global standards for information exchange with healthcare professionals and patients. Rebecca is currently a board member for Patient Focused Medicines Development, Past Chair Board of Directors for the DIA, Chair Emeritus Corporate Board of Directors for the Healthcare Businesswomen’s Association.

Jim Wilkinson, PhD

U.S. Medical Affairs Lead, Medical Affairs & Evidence Generation
Argenx, United States

Jim Wilkinson, PhD is an executive leader in global and US Medical Affairs, with over 22 years in the biopharma industry. His experience includes leading Global/US Medical Information, Global Publications, Global/US Medical Communications, Global Field-Based Medical, and US Medical Science Liaison (MSL) teams. Jim has worked in multiple therapeutic areas while also launching multiple products throughout the course of his career. He has extensive working knowledge of the commercialization process, compliance, product launches, company/product acquisition and integration, legal and regulatory guidelines, operations, omnichannel communications, and promotional review. Jim received his B.S. from UW-Madison and his Ph.D. from UM-Minneapolis.

Paul Berg, MS

Principal Research Scientist
Eli Lilly & Company, United States

Paul has been a statistician at Eli Lilly for 19 years and worked across a variety of therapeutic areas, in both management and individual contributor roles. Besides working on clinical trials, he has also worked in leadership development and quality systems within the statistics organization. Paul earned his B.S. in mathematics from the University of Notre Dame and his M.S. in biometry and epidemiology from the Medical University of South Carolina.

Kendra Bolt, PhD

Senior Manager of Scientific Communications
Audentes Therapeutics, United States

In 2015, Kendra Bolt joined Audentes Therapeutics as the second member of it's Scientific Communications and Medical Affairs departments. Based in San Francisco, Audentes is now a clinical stage biotechnology company of nearly 200 employees, focused on manufacturing, developing, and commercializing gene therapy products for patients living with serious, life-threatening, rare diseases. Kendra's background is in intraoperative electrophysiological neuromonitoring, the systemic and computational biology of complex human disease, and rare disease drug development.

TK Booker Porter, PhD

Senior Director, Global Medical Writing and Regulatory Operations
Greenwich BioSciences, United States

T.K. Booker Porter leads global medical writing at Greenwich Biosciences/GW Pharma. She is passionate about continuous improvement in an environment that is ever-changing due to shifting global regulatory requirements, trends with patient input, and advances in technology. She has been instrumental in developing and implementing technical opportunities to improve the efficiency of document preparation and recently led an effort to implement structured content management (SCM) for pharma.

David Brown, MA, MSc

Therapy Area Leader, Medical Communications
AstraZeneca Pharmaceuticals, United States

David Brown manages regulatory medical writers involved in CTD production and is involved in development of company best practice. He has 17 years of experience in regulatory medical writing and is a graduate of Oxford and Sheffield Universities in the UK.

Cyndi Carr, PhD

Senior Manager, Medical Writing
Ventana Medical Systems, Inc. A Member of the Roche Group, United States

Cyndi currently works as a senior manager in the clinical science function at Roche Tissue Diagnostics. She leads a team of medical writers responsible for preparing clinical trial protocols and clinical study reports. Her experience includes medical writing for in vitro diagnostic clinical trials supporting multiple 510k and PMA submissions to FDA. Cyndi holds a BS in Molecular and Cellular Biology and a PhD in Neuroscience with a minor in Pharmacology from the University of Arizona. She has completed the American Medical Writers Association basic and advanced curriculums and has over 15 years of clinical research experience.

Michelle Clausen, PharmD, RPh

Senior Director, Chief Medical Office- Strategy & Innovation Team
Pfizer, Inc., United States

Michelle Clausen is Senior Director and lead of the Pfizer Medical Strategy and Innovation Team which supports the Chief Medical Office at Pfizer. Michelle has 17 years experience in industry working across various roles within Medical Communications and now leads a team with a mission of driving strategy through innovation and insights to accelerate and advance the value of division’s contribution towards a healthier world. The team focuses on data & analytics, strategic communications, and innovative projects in collaboration with the groups they support. Michelle has her Doctor of Pharmacy (Shenandoah School of Pharmacy) and BS in Pharmacy (Rutgers College of Pharmacy).

Deborah Collyar

President
Patient Advocates In Research (PAIR), United States

Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic skills to bridge gaps between scientists, medical providers, payers, governments, and patients. Deborah has vast research experience in translational, clinical, epidemiology, health outcomes, and health delivery fields while working with academia, federal agencies, companies, non-profits, and patient communities. Key patient insights are delivered throughout development, clinical trials, results reporting, data-sharing, standards, genomics, and into practice.

Evelyn R. Hermes-DeSantis, PharmD

Director, Research and Publications
phactMI, United States

Evelyn R. Hermes-DeSantis, PharmD, BCPS, is the Director for Research and Publications for phactMI and Professor Emerita at the Ernest Mario School of Pharmacy at Rutgers, the State University of New Jersey. She is dedicated to advancing and elevating the practice of medical information. She received both a BS in Pharmacy and a PharmD from Rutgers and completed a Drug Information specialty residency at the Medical College of Virginia Hospital in Richmond, Virginia prior to working at the University of Utah Hospital Drug Information Service. For 25 years she was the Director of Drug Information Services at Robert Wood Johnson University Hospital and a Clinical Professor at the Ernest Mario School of Pharmacy at Rutgers.

Kelly Pincus, PharmD

GlaxoSmithKline, United States

Kelly T. Pincus, Pharm.D. Therapeutic Area Director, US Medical Information, Specialty, HIV and Classic and Established Medicines GlaxoSmithKline Kelly is the Therapeutic Area MI Director with GSK, supporting Specialty, HIV, and Classic and Established Medicines. She has over 20 years’ experience in the pharmaceutical industry, and has held several positions within GSK. Kelly received her Pharm.D. from Mercer University College of Pharmacy in Atlanta GA. She has also earned a Masters from the College of Business at Western Carolina University. Prior to joining industry, Kelly was an assistant professor in Pharmacy Practice at Creighton University in Omaha, NE.

Kathleen Meyer Ritz

Vice President, Global Medical Information
ProPharma Group, United States

Kirk V Shepard, MD

Senior Vice President, Head of Global Medical Affairs Oncology
Eisai, Inc., United States

Dr. Kirk Shepard has 25+ years of experience in the pharmaceutical industry. He is a board-certified medical oncologist and hematologist physician. He is currently Senior Vice President, Head of Global Medical Affairs Oncology at Eisai Inc. Dr. Shepard’s experience in multiple therapeutic areas includes operational and strategic product development from Phases I through IV and the diverse disciplines of medical affairs and product commercialization, such as leading compliance and SOP/policy efforts, health economics & outcomes research & patient access, data generation, field-based medical teams (MSLs), PV/safety, medical communication & publications, patient advocacy, and public relations.

Darren Taichman, MD, PhD

Executive Deputy Editor
Annals of Internal Medicine, United States

Dr. Taichman is the Executive Editor of the Annals of Internal Medicine and Vice President of the American College of Physicians. He is an Adjunct Professor of Medicine at the University of Pennsylvania where he practices Pulmonary and Critical Care Medicine. Dr. Taichman also serves as Secretary of the International Committee of Medical Journal Editors. He earned his MD and PhD from the University of Pennsylvania, completed Internal Medicine residency training at the Beth Israel Hospital, Harvard Medical School, Pulmonary and Critical Care Fellowships at the Hospital of the University of Pennsylvania and research / post-doctoral fellowships at the Brigham and Women's Hospital, Boston and the Children's Hospital of Philadelphia.

Mark Barnes, JD, LLM

Partner
Ropes & Gray, LLP, United States

Mark's law practice at Ropes & Gray focuses on human and animal research, stem cell and genetic research, research grants and contracts, research fraud, and international research. Mark formerly served at Harvard as the Senior Associate Provost for Research, and in 2004 started and directed for several years Harvard's HIV/AIDS treatment programs in Nigeria, Tanzania and Botswana. He has served as chief administrative officer at St. Jude Children’s Research Hospital, and has held senior appointed positions in the New York City and State departments of health. Mark is co-chair of the Subcommittee on Harmonization of Research Regulations, HHS Secretary’s Advisory Committee on Human Subjects Protections.

Elizabeth Blalock

Managing Editor, Journal of Investigative Dermatology
Society for Investigative Dermatology, United States

Elizabeth Blalock is Managing Editor of the Journal of Investigative Dermatology. She holds a Masters degree in English from the University of North Carolina and has 20 years of editorial management experience. She is a founding member and former President of the International Society for Managing & Technical Editors, and she is a regular presenter for the Council of Science Editors' Short Course on Publication Ethics.

Amber Daugherty, MBA

Sr. Training Manager, Global Learning and Performance – R&D
Amgen, Inc., United States

Amber holds a Bachelor’s degree in Psychology and has a Master’s degree in Business Administration. Amber is a learning and development professional at Amgen. Over the past fourteen years she was served in multiple training roles supporting the Medical Affairs and broader R&D organizations. She specializes in professional development for both individual and leaders.

Michelle Drozd

Deputy Vice President, Policy & Research
Pharmaceutical Research and Manufacturers of America (PhRMA), United States

Michelle Drozd is a Deputy Vice President in the Policy and Research department at the Pharmaceutical Research and Manufacturers of America (PhRMA). Michelle focuses on addressing the barriers to value-based contracting, and policies related to the pharmaceutical supply chain. Prior to joining PhRMA, Michelle worked in quality improvement and business planning at Partners Healthcare, an integrated delivery system. She also worked at RTI International in implementing demonstration projects for the Centers for Medicare & Medicaid Services. Michelle holds a BA in economics and public policy from Duke University and a SM in health policy and management from Harvard School of Public Health.

Jenna Elder

Chief Scientific Officer
PharPoint Research, Inc., United States

Dr. Elder is the Chief Scientific Officer at PharPoint Research, Inc., a CRO specializing in data management and biostatistics. Dr. Elder served as the lead statistician on pivotal studies for two novel compounds in a new class of antiretroviral medications in indications for the treatment of HIV and viral hepatitis. She participated in the completion of several NDA, MAA, sNDA, and IND applications and provided strategic consulting, clinical program development planning, and statistical analysis oversight for over 100 projects. Additionally, her experience includes providing statistical support for several pharmaceutical industry sponsored pregnancy registries and phase I through IV clinical trials.

Joyce P. Fairclough, PharmD

Senior Manager, Medical Information Services
Sanofi, United States

Medical Information within the Pharmaceutical Industry for over 15 years. Currently working on the Sanofi US MI team, responsible for MI support and strategy for the Diabetes insulin product portfolio including standard response development and review, compendia review and submission, AMCP dossier development, insight generation and metric reports. Other teams/groups I am active with include: Sanofi Global Medical Information with a focus on global content and insights and analytics; Sanofi Patient Engagement Working Group; PhactMI Standards Subteam. Education: Graduate of the University of Connecticut School of Pharmacy Undegraduate Program, Idaho State University College of Pharmacy Doctor of Pharmacy Program.

Tim Fish, BSN, MBA, RN

Alkermes, United States

Dr. Fish is the Director of Global Medical Information at Sarepta; a Registered Nurse with 25 years of experience and a unique professional in healthcare systems leadership and worldwide process collaborations. He has launched new medical information department in Europe, North and South America, as well as consultation support in Asia/Pac. Dr. Fish has presented and published on medical affairs best practices and optimizing nurses in medical information on several occasions. Currently also volunteers as a board member and COO for HandReach, developing international programs to support pediatric burn survivors and performed a healthcare systems capabilities assessment in Ghana, Africa.

Taren Grom

Founding Partner/Editor-in-Chief Emeritus
PharmaVOICE, United States

Taren Grom is co-founder of PharmaLinx LLC and editor of PharmaVOICE magazine. With more than 20 years of experience in covering the life-sciences, she has extensive knowledge of the issues and trends — from molecule to market — impacting the industry. Grom also is a dedicated volunteer for the Healthcare Businesswomen’s Association, having served on multiple committees for more than 12 years.

Ryan Thomas Hietpas

Consultant, Global Scientific Communications
Eli Lilly and Company, United States

Ryan Hietpas, PhD, formerly a bench scientist in biochemistry, is a medical writer focusing on device regulatory documents at Eli Lilly and Company.

Cynthia Louise Hooper, MA

Advisor, Biometrics Business Management
Eli Lilly & Company, United States

Cynthia Hooper is an Advisor for Biometrics Business Management at Eli Lilly and Company. She is responsible for business planning, resource management, and external sourcing for Global Statistics and Scientific Communications. She previously held management and writing roles in Scientific Communications, where she led submissions and launches; was a vendor relationship lead; and held research positions at the Institute of Mental Health Research in Ottawa, Canada. She holds psychology degrees from Bishop's University and the University of Guelph, a certificate in alliance management, is a Six Sigma Black Belt, and completed the Harvard Business School CORe: Credential of Readiness program.

Lisa Iacono Sheehan, PharmD

Director Global Regulatory Strategy
Bristol-Myers Squibb, United States

Lisa has been at Bristol-Myers Squibb for 15 years. Her first 10 + years was spent in Clinical Pharmacology where she ran clinical pharmacology studies and provided support for oncology and metabolic drug development. For 4 years, Lisa has been a Documentation Lead supporting Clinical Pharmacology aspects of worldwide oncology submissions. For the last year Lisa transitioned into the Global Regulatory Strategy group where she is supporting the development of oncology compounds.

Monica Kwarcinski, PharmD

Vice President, Medical Affairs
Purdue Pharma L.P., United States

Monica Kwarcinski is currently the Vice President of Medical Affairs at Purdue Pharma. In this role Monica oversees Medical Information, MSLs, Medical Communications and Strategy, Health Economic and Outcomes Research, Epidemiology, and FDA Postmarketing Requirement studies. Prior to joining Purdue Pharma, Monica held various positions of increasing responsibilities within Abbott Laboratories Medical Affairs Department. She received her PharmD from Creighton University in Omaha, Nebraska followed by a Drug Information Residency University of North Carolina, Chapel Hill and Glaxo. Monica has 25+ years of industry experience and frequently speaks on topics related to industry medical communications compliance and department processes.

Gregory Maglinte

WWHERO Oncology Lead
Bristol-Myers Squibb, United States

Experienced Health Economics and Outcomes Researcher (HEOR). Currently Director World-Wide HEOR and Immuno-Oncology Lead at Bristol-Myers Squibb, and previously at Allergan and Amgen. Has supported pipeline, launch, and in-line assets for end-stage renal disease, heart disease, migraine, schizophrenia, and prostate, colorectal, gastric, and esophageal cancers. Trained in epidemiology and health services research, with an MPH and PhD from UCLA. Dissertation focused on preference-based health related quality of life (HRQOL) measures, including the EQ-5D, SF-36, HUI, and QWB. Experience validating and developing patient-reported outcomes (PRO) measures, and conducting preference studies (i.e., discrete choice experiments).

Raleigh E. Malik, PhD

Senior Director, Global Medical Affairs
Eli Lilly and Company, United States

Dr. Raleigh Malik is a Sr. Scientist at DIA in Washington, DC, where she supports the advancement of DIA’s global content strategy by providing scientific expertise related to therapeutic drug development and regulatory disciplines. Prior to joining DIA, Dr. Malik supported medical and commercialization functions within pharma as both a medical writer and medical reviewer. Dr. Malik has a PhD in Molecular Biology and Biochemistry from Indiana University School of Medicine and a BS in Cell Biology and Biochemistry from Bucknell University.

Lori Mouser, PharmD

Senior Director, Global Head of Oncology Scientific Engagement and Congresses
Daiichi Sankyo Inc., Switzerland

Lori Mouser is the Global Head of Medical Customer Engagement at Roche. She champions the success of field medical teams and medical information teams to advance medicine through their engagements with healthcare providers and patients. Leading medical engagement teams for over 18 years, Lori brings the experience from a range of therapeutic areas. She has US and Global experience and operates with a commitment to creating solutions through collaboration. Lori’s first MSL position was at Aventis (now Sanofi) where she quickly gravitated to leading MSL teams during her 12 years with the company. Joining the Roche organization at Genentech in 2012, Lori ultimately was responsible for the national US Oncology MSL and field leadership team.

Hiren Patel, PharmD, RPh

Director, Medical Information
Sunovion Pharmaceuticals Inc., United States

Hiren Patel is Director of Medical Information at Sunovion Pharmaceuticals Inc. During the past 3 years, Hiren has primarily supported the Psychiatry franchise and is now responsible for overseeing the US Medical Information team. Prior to joining Sunovion, Hiren spent 7 years at Janssen Pharmaceuticals, which included completion of a 1-year Medical Information and Education Residency with Janssen Pharmaceuticals in conjunction with the University of the Sciences in Philadelphia. During this time, he supported the Pediatric, Psychiatry, and Metabolic franchises at Janssen Pharmaceuticals. Hiren obtained his PharmD degree from the University of the Sciences in Philadelphia.

Meera Patel, PharmD

Associate Dierctor, Medical Information and Knowledge Integration
Janssen Pharmaceuticals, United States

Meera has 15+ years of experience in Medical Information in the pharmaceutical industry. She is an Associate Director in Medical Information at Janssen Pharmaceuticals where she has oversight of products in infectious diseases. Prior to joining Janssen, she was a Medical Information Manager at Schering Plough. Meera Patel received her Doctor of Pharmacy degree from the University of Sciences in Philadelphia and completed her fellowship at Schering Plough focusing on Medical Information, Regulatory, and Health Outcomes.

Theresa Shalaby, MSN, RN

Sr. Regulatory Services Manager
Certara Synchrogenix, United States

Ms. Shalaby has 30 years of experience in the clinical research and drug development industry. Throughout those 30 years, she held several writing roles including lead author and contributing writer for investigator’s brochures (IBs), phase 2 and phase 3 clinical study reports (CSRs), investigational new drug applications (INDs), new drug applications (NDAs), study protocols, informed consent forms (ICFs), and plain language summaries (PLS). She has experience in the therapeutic areas of pediatrics, neonatology, pediatric and adult oncology, hematology, gastroenterology, pulmonary and respiratory diseases, genetic diseases, cardiology, multiple sclerosis, and rare diseases. She is the functional lead for PLS at Synchrogenix.

John Warwick, PharmD

Director , Medical Information
GRIFOLS Inc., United States

Isabelle C. Widmer, DrMed

CEO elytra GmbH, Consultant
elytra GmbH, Switzerland

Isabelle Widmer, MD is a life science consultant and coach based in Europe. Isabelle supports teams in both Fortune 500 companies and biotech to deliver global transformation programmes in Medical Affairs and Med Info. Combining an entrepreneurial mindset, analytical and project management skills with the ability to design and implement tailored solutions, Isabelle takes pride in proposing pragmatic, sustainable and cost-effective solutions. A published author, frequent conference presenter, recent Programme Director at Basel University in postgraduate education in pharmaceutical medicine and a Program Committee member for the DIA Annual European Medical Information and Communications Meeting she is passionate about continuing education.

Tanya Basu, JD, PharmD

Sr. Director, Global Regulatory Affairs Strategy
Takeda, United States

Michael Bourque, MS

Director of Global Submissions
Synchrogenix, a Certara Company, United States

Michael Bourque has over 18 years of medical writing and clinical research experience across a wide range of therapeutic areas including infectious diseases, vaccines, pain, oncology, and pediatric medicine. He is currently Director of Global Submissions at Synchrogenix. In addition to serving as a lead author, he provides guidance to project teams on the strategic development of regulatory documents in order to best position their submission to achieve approval from regulatory authorities.

Ari Gnanasakthy, MBA, MS, MSc

Head, Patient Reported Outcomes
Novartis Pharmaceuticals Corporation, United States

Ari Gnanasakthy, MBA, MSc, is Head of Patient-Reported Outcomes at RTI HS. He has 30+years of experience in the pharmaceutical industry. After receiving his bachelor's degree in mathematics, statistics, and computing, Mr. Gnanasakthy joined Rothamsted Experimental Station (UK), where he was responsible for the statistical analysis of survey data of agricultural soil in England and Wales. Mr. Gnanasakthy's extensive experience in the field of statistics and outcome research has resulted in numerous abstracts and almost 40 publications. Mr. Gnanasakthy has developed and validated over a dozen patient-reported outcomes instruments and currently serves in the editorial board of Cancer Clinical Trials.

Amy Holbrook

Director of Medical Writing
Keryx Biopharmaceuticals, United States

Amy has worked in drug development for over 20 years, working as a study site coordinator at the Massachusetts Eye and Ear Infirmary, a study manager and site monitor for multiple industry sponsors, and a clinical scientist, before finding her true home in medical writing. She is currently the Director of Medical Writing at Keryx Biopharmaceuticals in Boston, developing the medical writing functional area as the company expands.

Michael S. Labson, JD

Partner
Covington & Burling LLP, United States

Mike is a partner in the Food, Drug & Device practice at Covington & Burling LLP. He provides strategic advice to biopharmaceutical clients in dealing with FDA and other agencies. He has litigated extensively and works actively on transactional and legislative matters. Mike graduated magna cum laude from Harvard College, and magna cum laude from Harvard Law School. He was an officer of the Harvard Law Review, and clerked for the Hon. David Ebel on the U.S. Court of Appeals for the 10th Circuit.

Randy Miller, PharmD

National Director, Medical Science Liaisons
Alnylam Pharmaceuticals, United States

Randy Miller, PharmD, is Director of Medical Science Liaisons at Alnylam Pharmaceuticals. His pharmacy career began in community practice and included 3 years in academia. Randy spent 15 years at Boehringer Ingelheim where he focused on MSL excellence and capability development along with medical affairs business process definition, compliance, governance and training.

Carri Taylor, MBA

Associate Director, Medical Writing
Syneos Health, United States

Carri Taylor is an Associate Director of Medical Writing at INC Research/inVentiv Health and manages a group comprised of managers, writers, and editors who support regulatory and publication documents, CM&C, lay summaries, and publishing. She received a B.A. degree in English Literature from Purdue University and an M.B.A. in Business from Ball State University. As a leader in the medical writing and project management fields for 20 years, she has championed projects across multiple therapeutic areas and phases.

Kelly Vaillant

President
Vaillant Consulting, LLC, United States

Partnering with Industry Organizations in a collaborative, transparent, and trust based approach to deliver operational excellence and ensure process optimization utilizing Six Sigma/Lean principles (Green Belt certified).

Jonathan Todd Weiner, PharmD, MBA

Director of Innovation in Scientific Exchange
Sanofi, United States

Jonathan Weiner is Head of Innovative Medical Engagement at Sanofi where he leads efforts to drive Innovation in the methods medical utilizes to engage and learn from external stakeholders. Jonathan has been with Sanofi since 2015, initially supporting North America Medical Affairs and then the Diabetes and Cardiovascular Business unit. Prior to Sanofi, he held various roles within Medical Affairs at Shire and P&G, including Leading Global Medical Training, Virtual Medical Information and being a Medical Science Liaison. Jonathan received a Doctor of Pharmacy degree from the University of Rhode Island and a MBA from LaSalle University in Philadelphia.

Rania Gaspo, PhD

Director, Global Therapy Area Team Lead, External Medical Communications
Pfizer Inc, Canada

Rania Gaspo earned her Pharmacy Degree and her PhD at University of Montreal, Faculty of Pharmacy. She served as a Post-Doctoral fellow at Montreal Heart Institute before moving into industry in 1998 as a Senior Scientist. Rania joined Pfizer in 2003 where she held positions in medical information, medical affairs and clinical development in various therapeutic areas. She also served as a guest speaker for 24 years at University of Montreal. In her current role Rania leads a team of Experienced Medical Information Managers within Neuroscience and Pain category leadership in US and Canada and Globally. Rania authored/co-authored about 25 peer-reviewed publications and 50 scientific communications.

Rebecca Williams, PharmD, MPH

Senior Clinical Trials Subject Matter Expert
Essex, Part of Emmes Group, United States

Rebecca Williams, PharmD, MPH, is a Clinical Trials Subject Matter Expert with Essex, Part of Emmes Group. In this role she supports strategic policy and data initiatives with the National Cancer Institute’s Coordinating Center for Clinical Trials. Prior to this role she was the Acting Director of ClinicalTrials.gov at the National Library of Medicine (NLM) after having served as the Assistant Director for over a decade. She has also worked in regulatory and policy aspects of prescription drug advertising and promotion at the Food and Drug Administration and as a consultant. She received her Pharm.D. from the University of Wisconsin-Madison and MPH from Johns Hopkins Bloomberg School of Public Health.

Holly Zoog, PhD

Exec Dir, Medical Writing
Ultragenyx, United States

Holly Zoog, PhD, ELS, is Executive Director and Head of Medical Writing at Ultragenyx Pharmaceutical Inc. where she grew the department from an N of 1 to a team supporting clinical and regulatory writing, scientific publications, clinical trial transparency, and digital content. Prior to Ultragenyx, Holly was Director, Medical Writing at Amgen leading a team supporting publications in the Bone Therapeutic Area. Holly received a PhD in Nutritional Biochemistry from the University of Wisconsin and a BS in Biochemistry from Penn State University.

Matthew Robillard

Senior Director, Regulatory Strategic Writing
AbbVie, United States

Matthew Robillard is a Senior Director of Regulatory Strategic Writing for AbbVie, based in North Chicago, IL. Matt began his career with Abbott Laboratories in 1992 in Technical Communications, and in 1996 became a Medical Writer in the Hospital Products Division. His career has progressed (as have many in Medical Writing) through an individually owned business, through CROs and back within industry; most recently with Takeda Pharmaceuticals (2006 to 2016) and PRA Health Sciences (2017). He currently leads a team of Medical Writers dedicated to handling regulatory interactions and communications at AbbVie. He is happily married and resides in a northwest suburb of Chicago.

Schedule At-A-Glance

Speakers