Speakers
Dannis Chang, PharmD
Director, Hematology Medical Information Team Lead, Genentech, Inc., United States
Dannis Chang, PharmD., is currently the Hematology Medical Communications Team Lead at Genentech Inc, where he leads the strategic development, planning, and delivery of scientific content, as well as enabling timely, relevant, personalized, accurate, balanced, and impactful communication of clinical information or scientific evidence to customers to enhance their experiences, support improved patient outcomes, and foster an ongoing connection aimed at maximizing medical progress. He received a doctorate of pharmacy degree from University of Southern California and a post-doctoral fellowship from Rutgers University.
Amy Van Sant, PharmD, MBA
President, Medical Affairs, Inizio Engage, United States
With nearly 20 years of experience in the healthcare and pharmaceutical industry, Amy has held various roles of increasing responsibility within the areas of Medical Affairs and Regulatory. As the current head of US Medical Affairs, she is responsible for developing, communicating and driving strategy and leading the organization to success with a prioritized focus on the design and delivery of MI and MSL programs. Prior to joining Ashfield, Amy spent more than 10 years at Johnson & Johnson supporting the biopharmaceutical business in the areas of Immunology, Infectious Diseases, Vaccines, Global Public Health, Strategic Customer Group (Market Access), Established Products Group, and the Research & Development areas.
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.
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.
Ruggero Galici, PhD
Director, Nonclinical and Clinical Pharmacology Writing, Alexion Pharmaceuticals, AstraZeneca Rare Disease, United States
Dr. Galici has a background in Drug Discovery and Clinical Development with expertise in Pharmacology. He has over 15 years of experience successfully and strategically planning and delivering scientific, medical communications and global regulatory submissions to support Oncology, Vaccine, Rare Disease, Neuroscience, Pain, Immunology and Inflammation, and Consumer Health (nutrition, Rx-to-OTC switch) programs. He is currently the co-chair of the DIA MASC forum.
Hanady Elhadidy, PharmD
Senior Director, Global Customer Engagement , Bristol Myers Squibb, United States
Hanady has 15 years of experience in Medical Affairs and Medical Information. She currently leads the Global Customer Engagement team at Bristol Myers Squibb. Hanady is an executive board member of the phactMI Board of Directors. Prior to BMS, Hanady worked with large and mid-size pharmaceutical companies in a variety of roles, always with a focus on simplification, standardization, and innovation.
Marie-Ange Noue, PhD
Senior Director, Head of Scientific Communications , EMD Serono, Canada
Marie-Ange Noue is a PhD chemist trained at Curie University in Paris and at the University of Houston. She started her career working as a research scientist in petrochemicals. She later found her niche upon joining EMD Serono in 2008, where she’s held a number of positions of increasing responsibility. In her current role as Senior Director, Head of US Scientific Communications, she provides strategic leadership and oversight for activities related to Medical Information, Medical Communication, Medical Training, and Medical Education for the US. Marie-Ange chairs the Board of Directors of the Canadian Medical information network, and serves as Vice President on the Executive Board of PhactMI.
Sonia Sandhu, PharmD
Senior Director, Medical Information, Gilead Sciences, Inc., United States
Currently serving as the Senior Director of Global Medical Information at Gilead Sciences, she specializes in Virology. In her role, she actively shapes the industry's knowledge advancement through her authorship of articles on medical affairs and medical information. Dr. Sandhu contributes to the medical community with a focus on HIV, COVID-19 and Liver diseases. As a leader, she develops strategy, engages in cross-functional work, and impacts medical narrative. With academic credentials including a Bachelor of Science in Biological Sciences from UC Davis and a Doctor of Pharmacy from Midwestern University, Dr. Sandhu is dedicated to advancing healthcare.
Diane Cleverley, PhD
Senior Regulatory Writer, Certara, United States
Dr. Cleverley has more than 20 years experience in the medical publication field, which she entered shortly after earning her PhD in Microbiology and Molecular Genetics as a joint degree from Rutgers and UMDNJ. During that time, she proposed the “glycine hinge” theory. She has contributed editorial support for publications for prestigious higher tier journals such as NEJM and JCO. Dr. Cleverley has also written award-winning patient literature, clinical trial materials, and healthcare provider education. She currently is lending her writing talents to the regulatory field. She developed a patient advocacy tool for making diagnosis more effective. Dr. Cleverley has been an active team member of AMWA, ISMPP, and MAPS, and holds a CMPP.
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.
Meera Kodukulla, PhD
Senior Director, Scientific Publications, AstraZeneca, United States
In her current role as Head, Scientific Publications, BioPharmaceuticals R&D at AstraZeneca, Meera provides leadership in developing and shaping Publication and Communication strategies. Her experience spans all phases of drug development in multiple therapy areas. With her multi-domain expertise, Meera brings a unique advisory perspective to help build pharma publications/medical writing capabilities and process/compliance excellence. She is passionate about developing and mentoring publication professionals. Meera holds a PhD in Organic Chemistry. She is a certified emotional intelligence trainer and commits her time to mentoring and leadership development for women in Healthcare/Business/STEM.
Andrea Tuttle Meyers
Senior Vice President, Clinical Operations, Syneos Health, United States
Ms. Meyers is a Senior Vice President at Syneos Health. She has led clinical operations and medical writing teams for more than two decades in both CRO and sponsor organizations. Ms. Meyers has authored documents across all phases of clinical development for pharmaceutical products as well medical devices, including regulatory dossiers and submissions. In addition, she has also led regulatory and clinical development, leading two oncology products to NDA submission and subsequent approval. Prior to her career in clinical research, Ms. Meyers practiced neuropsychology. In 2020, Ms. Meyers was honored to be named a Healthcare Businesswomen's Association Luminary in recognition of her 25+ years of service in Clinical Research.
Donna Booth, PharmD
Head, Field Medical Accounts-East, US Medical Affairs, GlaxoSmithKline, United States
Donna V. Booth, B.S, PharmD. is the Head of Field Medical Accounts (East) at GlaxoSmithKline. She has extensive experience across Medical Affairs in various leadership and strategy roles including Medical Information, HEOR and Field Medical. She currently leads a team of field liaisons focused on medical engagements related to clinical, economic and humanistic topics with Population Based Decision Makers at Payers and Health Systems. Donna received her Bachelor of Pharmacy from University of Georgia & her Doctor of Pharmacy from Medical University of South Carolina. Before joining industry, Donna was a clinical pharmacist with faculty appointments at local colleges of pharmacy.
Danielle Day, PhD
Senior Medical Director, Immunology, Rare Disease, Sobi, United States
Danielle has held progressive field- and headquarters-based medical leadership roles in both large pharma and small biotech organizations including AstraZeneca, Fractyl Laboratories, Novo Nordisk and uniQure. Currently she is the Senior Medical Director for Immunology and Rare disease at Sobi. Before joining industry, Danielle held academic faculty roles at the University of Massachusetts and University of New England and was employed as a research physiologist for the U.S. Army Research Institute of Environmental Medicine. Danielle earned her M.S. and Ph.D. in Integrative Physiology from the University of Colorado in Boulder where she studied, and remains passionate about, sex differences in the research and treatment of diseases.
Sonja Hokett, PharmD, MS, MSc
Executive Director, Medical Managed Care & HEOR, BioXcel Therapeutics, United States
Residing in Branson, Missouri, Sonja holds PharmD degree from the University of Louisiana Monroe, Master of Science degree in Hospital Pharmacy Administration from the University of Houston, and Executive Master's degree Health Economics, Policy & Management from the London School of Economics. During her 19 years in the pharma industry, Sonja has held both Field and Headquarter pharma Medical Affairs positions at BioXcel Therapeutics, Jazz, Intercept, and Genentech. She currently manages a Medical Managed Care field team and oversees HEOR for BioXcel Therapeutics.
Paul Minne, PharmD, RPh
Senior Director, MSL Team, Neurocrine Biosciences, United States
Paul Minne has over 20 years of experience in medical affairs within the biopharmaceutical industry. During his career, he has had substantial experience with all phases of drug development and support, multiple new product launches, and management of MSL Teams. He has earned a BS from Drake University and a Doctor of Pharmacy from the University of Colorado Health Sciences Center, is a licensed pharmacist and preceptor with the State of Colorado, and is an adjunct professor at the University of Colorado Skaggs School of Pharmacy. Paul resides in Parker, Colorado.
Kay Uttech, PharmD, MA, RPh
VP, Strategic Initiatives, Indegene, United States
Kay Uttech is VP for Strategic Initiatives at Indegene working with companies to build and optimize medical affairs services. She has more than 20 years’ experience in the pharmaceutical and medical device industry. Kay has held roles in Medical Affairs as a MSL and leading MSL teams in North America. Additionally, she has also held other responsiiblities in Medical Communication and Information; development of global scientific knowledge management systems; grants for ISS and medical education; and promotional review. Her current work is focused on leveraging technology to drive efficiency that optimizes the medical and scientiifc expertise of Medical Affairs teams.
Tamei Elliott, MS
Associate Director, Scientific Programs, DIA, United States
Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.
Stacey Follman, PharmD, RPh
Director, Global Content Management, Pfizer, United States
Dr. Stacey Follman has spent her 26-year pharmacy career at Pfizer including 15 years in the World-Wide Safety and Regulatory department in Safety Evaluation and Reporting and 11 years in Medical information. Formerly the Director, Student Affairs and currently Director, Global Content Management in Pfizer’s Global Medical Information Department . Dr. Follman has experience overseeing scholarly activities associated with approximately 10 APPE Pharmacy rotational students annually, the Student Summer Worker program and the recruitment and preceptorship of post-doctoral Fellows. In addition, she maintains internal/external partnerships, leading student/fellow initiatives with multiple scientific institutions.
Rebecca Sleeper, PharmD
Co-Chair Sex and Gender Summit, Senior Associate Dean and Professor, TTUHSC Jerry H. Hodge School of Pharmacy, United States
Dr. Sleeper is a Professor of Pharmacy Practice in Geriatrics at the Texas Tech University Health Sciences Center Jerry H. Hodge School of Pharmacy, and is currently the Senior Associate Dean of Curriculum, Assessment and Accreditation. She is a Board Certified Pharmacotherapy Specialist and a Fellow of the American College of Clinical Pharmacy and the American Society of Consultant Pharmacy. She is the co-editor of the textbook Fundamentals of Geriatric Pharmacotherapy. Her focus expanded to include Sex and Gender Health education in 2011, joining the Curricular task force of the Laura Bush Institute for Women’s Health. She was a core member of the team to draft the proposed educational tenets in Sex and Gender Health Education.
Robert Tamburri, PharmD, MBA
Director, Medical Information , Johnson & Johnson, United States
Rob is a Director of Medical Information at Johnson & Johnson responsible for the overall leadership of the Heme Oncology Medical Information team. His team has a focus on developing responses to medical information requests from HCPs and the provision of medical review for scientific and promotional materials. In addition to his 17 years of pharmaceutical industry experience, Rob also has 11 years of experience as a practicing pharmacist in various pharmacy settings. Rob earned his Bachelor of Science in Pharmacy from Temple University, his Doctor of Pharmacy degree from Shenandoah University, and his MBA from Drexel University.
Suneet Walia
CEO, Soterius, Inc., United States
Lakshmi Ramkumar
Senior Director, Head of Medical Writing, Moderna, United States
Karen Joyce Hager, MS
Director, Clinical Trial Management, Global Clinical Operations, Vertex Pharmaceuticals, United States
I am a Clinical Operations leader with over 15 years of experience in clinical trial execution, strategic oversight, and leadership of global clinical project teams. During my time at several Sponsor organizations I have supported a spectrum of clinical studies including studies evaluating vaccine candidates and potential treatment for rare diseases. I specialize in execution of aggressive clinical plans through successful partnership with clinical development, program teams, Contract Research Organizations (CRO), technology vendors, central lab vendors and global affiliates.
Payal Desai, PharmD
Associate Director, Integrated Evidence Team Lead, Janssen Scientific Affairs, LLC., United States
Payal Desai earned a PharmD degree from the University of Sciences in Philadelphia. Dr. Desai worked in community practice before transitioning to a career in pharmaceutical industry. Over 20 years, Dr. Desai served at several pharmaceutical companies. In her current role at Janssen, she is the Integrated Evidence Team Lead and is responsible for generating the evidence generation plan within Medical Affairs. Previously, she was the Associate Director of Medical Information, where she was responsible for the successful launch of cardiovascular products, promotional review, and development of scientific responses. . She provides strategic medical support and participates in several cross-functional teams.
Barry Drees, PhD
Senior Partner, Trilogy Writing & Consulting, Germany
Barry holds a Ph.D. in molecular genetics. Following his postdoctoral work as a fellow of the NIH, he worked as a medical writer in the pharmaceutical industry for 32 years, and leading several regulatory submission teams. Barry is a frequent speaker on medical writing, statistics, and other scientific communication topics for Management Forum, the DIA, the European Medical Writers Association (EMWA) and other pharmaceutical associations. He is the former Editor-in-chief of “The Write Stuff”, the Journal of EMWA, and was the President of EMWA. He is currently a Co-founder and Senior Partner of Trilogy Writing & Consulting, continuing to personally lead submission teams as well as providing training for the industry around the world.
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.
Kajal Patel, PharmD
Executive Medical Reviewer, Takeda Pharmaceuticals, Inc., United States
Kajal is a seasoned pharmacist with 15+ years of experience in pharmaceutical and managed care sectors. She has in-depth knowledge and experience in business planning and execution of clinical strategy. Kajal serves as the lead medical reviewer for one of Takeda’s top products. She is skilled at extensive evaluation and providing strategic scientific consults on promotional patient-facing, HCP-facing, and payor-facing materials. Her diverse background ranges from launching branded social media platforms (Twitter, Facebook and YouTube), disease awareness materials, DTC TV ads, implementing CFL guidance in promotion and HCEI guardrails in payor materials, as well as implementing OPDP advisory comments.
Ellen Whipple, PharmD
Owner/Principal Writer, EW Associates, LLC, United States
Ellen is the co-owner of Scientific Content Solutions, LLC and the sole proprietor of EW Associates, LLC. She was previously a director of medical communications with an agency. Ellen has experience with medical information-related documents (e.g., standard letters, FAQs, dossiers, escalated inquiries), continuing education articles, primary author publications, promotional review, payer materials, and advisory board meeting reports. As a member of AMCP Format Executive Committee, Ellen contributed to AMCP Format 4.1. She serves as a Clinical Assistant Professor at the University of Georgia College of Pharmacy. Since 2000, Ellen has been a Medical Advisor for the MS Foundation.
Raquel Billiones, DrSc
Director, Medical Writing, Alexion Pharmaceuticals (AstraZeneca Rare Disease), Switzerland
Raquel Billiones, PhD has >25 years combined experience in scientific and clinical research. She has been a regulatory writer for >15 years, covering both pharmaceuticals and medical devices. Her core competencies include clinical trials and submissions documents, data disclosure and protection, and project and people management. Over the years, she took on a wide range of industry positions, as freelancer, as employed regulatory writer, and as head of medical writing departments in the CRO and big pharma settings. Raquel is currently editor-in-chief of Medical Writing, the official EMWA journal and is a member of the EMWA executive board and education committee. She is currently employed at Alexion Pharmaceuticals in Switzerland.
Carol Heggie, RN
Vice President - Field Medical, Takeda Pharmaceuticals USA Inc, United States
In her current role as Vice President - Field Medical, Carol provides leadership to both Medical Science Liaison and Field Medical Educator Teams at Takeda. Her scope also extends to Learning and Development and Field Operations, which allows her to build innovative approaches to Team Excellence and Leadership at all levels through use of cutting-edge technology and personalized learning strategies. In a career spanning over 25 years; Carol has also worked at Sanofi as Head of MSL. GEM Business Unit, where she deployed and led MSL teams across the globe, and at Shire where she led MSL teams through roles of increasing responsibility, ultimately in the role of Head of MSL - International.
Joanna Rizos, MBA, RPh
Associate Director, Medical Affairs, Eli Lilly Canada Inc., Canada
In her current role, she provides strategic leadership and oversight for activities related to Medical Information and Medical Information Digital solutions. She began her career as a community pharmacist, before joining the Pharmaceutical Advertising Advisory Board (PAAB) as an Assistant Commissioner. She joined Lilly, 21 years ago, first supporting Medical Information before holding various roles in Legal, Sales, Compliance and Medical Affairs. Joanna obtained her B.Sc. in pharmacy from the University of Toronto and her MBA from the Schulich School of Business. Joanna is also a board member of the Pharmacovigilance and Medical Information Network (PVN-MI) Canada.
Komal Bawa, PharmD
Senior Evidence Synthesis Scientist, US Medical Affairs, Genentech, United States
Dr. Komal Bawa has taken on various roles in Medical Affairs at Genentech since joining in 2014. She currently focuses on evidence synthesis in the health economics and outcomes research organization, leading the dossier strategy for the portfolio. Similar to many other pharmacists, Komal started in medical communications before venturing out into other roles to broaden her experience. Prior to joining industry, she worked as an emergency medicine clinical pharmacist at UCSF and Brigham and Women's Hospital. Komal lives in San Francisco where she has been "getting to know" her family a little too well these days, but enjoys cooking with the kids, long walks with her mom, and can't wait to travel again.
Gary Messplay, JD
Partner, King & Spalding, LLP, United States
Gary Messplay is a Partner in the Washington, D.C., office of King & Spalding. He represents life sciences clients before the Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other federal and state agencies. Mr. Messplay's practice includes regulatory and administrative law matters, clinical trials, criminal and civil enforcement matters, healthcare compliance, internal investigations, litigation, liability counseling, and transactional work related to pharmaceutical products. He has written extensively about pharmaceutical compliance issues and is a frequent speaker on regulatory and compliance matters. He is a member of the Food and Drug Law Institute, where he serves on FDLI’s Editorial Advisory Board.
Veejaye Sinha, PharmD, RPh
Medical Review Assoc Director, Takeda Pharmaceuticals, United States
Veejaye Sinha (VJ) is an Associate Director of Medical Information & Review for Takeda Pharmaceuticals U.S.A., Inc with a focus reviewing promotional and scientific materials within the bleeding disorders portfolio. Since academics, VJ has has worked in the hospital, agency, and industry settings. His 10 years across various medical organizations including publications, scientific communications, medical strategy execution, and medical information gives him an extensive foundation upon which he is able to support his current function and stakeholders in bringing transformative medicines to patients.
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.
Morgan Bron, PharmD, MS
Ingrezza Franchise HEOR Lead, Health Economics and Outcomes Research, Neurocrine Biosciences, United States
Morgan Bron has worked in the HEOR field in various positions through all phases of drug development. She has held global, US headquarters and field based positions. She has supported the launch of 13 products in various disease areas such as diabetes, metabolism, hematology/blood disorders, CNS and neurology for both US and global departments. She has presented and published extensively and has served on various professional committees.
Elizabeth Brown, MS, PMP
Executive Director, Medical Writing & Disclosure, Merck & Co., Inc., United States
Elizabeth Brown is a Senior Director and TA Lead of Oncology Medical Writing at Merck & Co, Inc. near Philadelphia, PA. She has led regulatory projects and initiatives in the pharmaceutical industry for 20+ years. First as a laboratory scientist, then as a clinical researcher, and currently as a medical writer. Elizabeth brings a project and people management focus to her role as a regulatory medical writer and department leader. With this focus, she has developed a passion for developing people, advising teams and providing strategic guidance how to deliver efficient, effective, and high-quality documents.
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.
Mary Coffey, PharmD, RPh
Senior Director, WW Scientific Content and US Market Capabilities, Bristol Myers Squibb, United States
Jennifer M Davis, PharmD, MS
Associate Director Medical Training - Vaccines, Sanofi Pasteur, United States
Jennifer Davis is the Associate Director of Medical Training for Sanofi Pasteur in the US. In this role, she is responsible for onboarding and training Medical Science Liaisons, with a goal of ensuring the scientific rigor of the US Medical team at Sanofi Pasteur. Jen joined Sanofi Pasteur as a Medical Science Liaison in 2018. Prior to that, she was a clinical pharmacist, specializing in the areas of HIV and vaccines. She was responsible for teaching the APhA Immunization Delivery program to pharmacists in Arizona, which sparked her passion for education and training. Jen holds both a BS and MS in Biology from Purdue University and received her PharmD from Midwestern University-College of Pharmacy Glendale.
Lisa DeTora, PhD, MS
Associate Professor, Director of STEM Writing, Hofstra University, United States
Lisa is an assistant professor of Writing Studies at Hofstra University, where she teaches a wide range of courses including scientific writing, health communication, medical humanities, and narrative medicine. Her research interests include vaccination policy, medical humanities, publication ethics, regulatory writing, and theories of the body. Lisa is the lead author of Good Publication Practice Guidelines for Company-Sponsored Biomedical Research: 2022 Update and the editor of Regulatory Writing an Overview.
Charlie Guerini
Sr. Director Global Operations & Head of Innovation, Alphanumeric, United States
Charlie Guerini is passionate about both his love of countries and cultures across the globe and his dedication to innovation—namely artificial intelligence. It is no wonder why Alphanumeric selected Charlie to drive global intelligent automation strategy. Charlie’s track record includes multi-national operations strategy and execution, service desk operations, and site management for the likes of .idea, CIBC, and Citi. Charlie studied international business at Champlain Regional College in Quebec. He believes the key to success is trusting and learning from your employees, because they will take care of your customers. Outside of work, Charlie loves to explore nature and run along the Portugal coast line.
John Jones, MBA
Technology Director, PhactMI, United States
John Jones is an experienced IT Strategist focused on developing innovative technology solutions for unmet business needs in Life Sciences. John is currently the Founder and CEO of Entitech Solutions, a Life Sciences focused IT Software and Consulting firm. Prior to starting his company, John led Quintiles’ IT Consulting Division from 2010 – 2015 focusing on IT Advisory and Implementation services in Life Sciences. John has more than 20 years experience in developing and delivering IT Solutions for various companies, and has extensive experience in the clinical, regulatory, and commercial areas.
Diane Litwinko, PharmD
Director, Global Medical Customer Interface, Organon LLC, United States
Diane Litwinko, Pharm D is currently Director, Global Medical Affairs, Global Medical Customer Interface at Organon where she has responsibility for ensuring customers have the right information and tools to support their healthcare decision making through Medical Review, Medical Information, and Designated Point of Contact activities. Prior to joining Organon, Diane worked at Merck and Schering-Plough in the medical information and has practiced Pharmacy. She received her B.S. in Pharmacy from Rutgers University School of Pharmacy and her Doctor of Pharmacy degree from Shenandoah University.
Gordon Pennycook, PhD, MA
Assistant Professor, Behavioral Science, Hill/Levene Schools of Business, University of Regina, Canada
Gordon Pennycook's expertise is human reasoning and decision-making and has applied this expertise to tackle the problem of online misinformation. He obtained his PhD in Cognitive Psychology in 2016 at the University of Waterloo. Prior to starting at the University Regina in 2018, he held a Social Sciences and Humanities Research Council of Canada Banting Postdoctoral Fellowship at Yale University. He has published 85 peer-reviewed articles and has received several awards, such as the Governor General’s Gold Medal and Poynter Institute’s International Fact-Checking Network “Researcher of the Year”. He was elected to the Royal Society of Canada’s College of New Scholars, Artists, and Scientists in 2020.
Hira Shah, PharmD
Director, Regulatory Affairs Advertising & Promotion, Regeneron, United States
With 10+ years of experience in Regulatory Advertising & Promotion in the pharmaceutical industry, Hira Shah is Director of Regulatory Ad Promo at Regeneron Pharmaceuticals. She is responsible for the oversight of the Immunology, Infectious Disease and General Medicine therapeutic areas’ promotional activities, ensuring compliance with FDA & OPDP regulation and alignment with FDA guidance. Her expertise involves providing guidance on company initiatives and objectives, while maintaining compliance with regulation and acting with integrity. Hira received a doctorate of pharmacy degree from Long Island University in Brooklyn, NY and completed a two year post-doctoral fellowship from Rutgers University in partnership with Johnson & Johnson.
Angela Sykes, MA, MS
Senior Director, Team Leader; Publications Standards and Best Practices Lead, Pfizer, Inc., United States
Angela Sykes is a Content & Education Director at Pfizer with nearly 20 years of experience in medical publications. She has extensive experience in many aspects of medical education, communications and publications across various therapeutic areas including: cardiovascular disease, infectious disease, autoimmune disease, diabetes, obesity, ophthalmology, psychiatry and osteoporosis.
Christina Wright, PharmD
National Director-MSLs Immunology , Sobi Pharmaceutical, United States
Raegan McClain, JD, LLM
Chief Compliance Officer, Oyster Point Pharma, Inc., United States
Raegan has over 20 years of legal and compliance experience working in large and specialty global pharmaceutical and medical device organizations. She began her career as an attorney in a large law firm in Chicago and has worked in small, midsized and large life sciences companies in legal and compliance roles where she was responsible for partnering with cross-functional teams to strategically build and evolve corporate healthcare compliance programs to support commercialization. She held her first in-house role at Sanofi-aventis and most recently served as Chief Compliance Officer at OptiNose US, Inc. Raegan has a B.S. from The Pennsylvania State University, a J.D. from The University of Pittsburgh and an LL.M. in Health Law from Loyola
Vineeth Nair Nair, PharmD, MPH
GMI Content Manager, Sanofi, United States
I am a licensed Pharmacist with a Doctor of Pharmacy degree and Master of Public Health degree. I currently function as a Global Medical Information Content Manager with Sanofi Global Medical Information.
Katie Bates
Medical Writer and Consultant, Whitsell Innovations, Inc., United States
Trishna Bharadia
Patient Advocate, International Speaker, Writer, Advisor and Content Reviewer, The Spark Global, United Kingdom
Multiple award-winning patient advocate Trishna Bharadia raises awareness & improves support for people affected by chronic illness. She aims to put the patient voice into the entire healthcare journey. She collaborates with organisations globally, including from industry, the third sector, and HCPs, to improve support, services and patient engagement. She writes, reviews content & is a highly sought after speaker. She advises on patient centricity & diversity issues, and is a media contributor on health. She's also a patron/ambassador for several health-related and disability-related charities and sits on various advisory committees. Awards include being a "Points of Light" recipient from the UK Prime Minister's Office.
Demetrius Carter, MBA
Senior Vice President, Regulatory Sciences and Medical Affairs, Certara, United States
Demetrius is a Clinical Development Executive with 20+ years of drug development experience, across the pharmaceutical and medical device industries. Prior work experience includes R&D roles at Glaxo SmithKline and Pfizer. He also spent time at JNJ as a Global Trial Manager before transitioning into the CRO industry. Demetrius held roles of increasing responsibilities in Project Management, Clinical Monitoring, and Central Laboratories at both IQVIA and Syneos Health. Currently, Demetrius serves as the SVP, Regulatory Sciences at Synchrogenix, where he is responsible for Regulatory Writing and Operations. Demetrius holds a BS degree in Biological Sciences from North Carolina State University and an MBA from Fairleigh Dickinson University.
Roseanne P Degnan, PharmD
Associate Director, Medical Information & Knowledge Integration, Janssen Scientific Affairs, United States
Michael DeLuca, PharmD, MBA, MS, RPh
Executive Vice President, Global Medical Affairs & Medical Information, EVERSANA, United States
Michael is the Executive Vice President of Global Medical Affairs and Medical Information at EVERSANA and has 20+ years of healthcare and pharmaceutical industry experience in multiple leadership roles at several pharmaceutical companies. He has extensive experience in medical information, medical communications and in supporting medical review of promotional / non-promotional materials. Throughout his career, Michael has supported multiple product launches, and he has led MI activities from both a US and global perspective. He has led and grown established MI teams and has built a MI department and services from the ground up. His educational background includes Doctor of Pharmacy, MBA, and Master of Science in Regulatory Affairs degrees.
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.
Sandeep Gantotti
Associate Vice President, Enterprise Medical Solutions, Indegene Pvt Ltd, India
Sandeep Gantotti is a clinical pharmacist by background and Associate VP, Enterprise Medical at Indegene, Pvt Ltd, a leading multinational healthcare solutions provider. He has held positions of increasing responsibility in medical information, medical communications, and medical affairs at Zeneca Pharma, GSK, and Amgen. Sandeep has participated in several DIA local champion events and industry forums such as PhactMI and MAPS to contribute to a performance-driven culture within medical affairs. He is focused today on pioneering the use of modern technologies to solving today’s challenges in content development, multichannel engagement, and demonstrating organizational value of medical affairs .
Mae Kwong, PharmD
Senior Director, Medical Managed Care, BioXcel Therapeutics, United States
Mae Kwong has >20 years of industry experience in remote& in-house medical affairs, currently as Senior Director, Medical Managed Care with BioXcel Therapeutics. She has been a HEOR Liaison, Director of Clinical Sciences, Medical Project Scientist, and MSL across multiple therapeutic areas working for Mesoblast, Johnson & Johnson, Kos, and Wyeth Pharmaceuticals. Before industry, Mae worked at the American Society of Health-System Pharmacists focused on ambulatory care,managed care,home and long term care. She worked at and completed an ambulatory care residency at Virginia Commonwealth University Hospitals. She started her pharmacy career at Kaiser Permanente in California. Mae received her PharmD and research fellowship from UCSF.
Elaine Nadeau, PharmD
Senior Director, Head of US Field Medical Affairs & Medical Excellence, Sobi, United States
Sean William Ryan, MD
Consultant, NYO - McKinsey & Company, United States
Samit Shah, PharmD
Associate Director, MICC Omni Channel, Janssen Scientific Affairs, LLC, United States
Samit is Associate Director of the Medical Information Communication Channels team at Janssen. In his current role at Janssen, he is responsible for leading, developing, shaping and implementing Medical Information Omni-Channel Communication strategies as well as oversight of operations for the team. In addition to almost 20 years of pharmaceutical industry experience, Samit has experience in developing and launching new technologies and platforms, working on cross-functional teams, and mentoring pharmacy students. Samit earned a PharmD degree from the University of Sciences in Philadelphia.
Seth Tyree, MS
Senior Director, Product Management, Sorcero, United States
I have 18 years experience in healthcare data and analytics, working to generate intelligence across providers, payers and pharma, always with the goal of driving better health outcomes. In my current role at Sorcero, I help Med Affairs teams around the world utilize AI to optimize engagement and drive better care for patients. At GSK, I was Director of Data Science, US Med Affairs. While there, I built a Center of Excellence for Data Science to develop and apply ML and NLP capabilities to accelerate the very manual process of mining unstructured data for insights on customers and patients. As Head of Product at Stratifyd, my remit is to grow our text analytics platform to meet market needs, with a key focus on Medical Affairs.
Jeff Vaughan, PharmD, MS
National Director, Field Medical Science , Ashfield Engage, United States
Current role: National Director, Ashfield Engage, Medical Affairs. Served in medical affairs leadership for last 15 years for various small and large pharmaceutical companies covering numerous therapeutic areas. Prior to industry, I served our country as an Air Force officer over a span of 12+ years as clinical pharmacy director, treating clinician and trained expert in the fields of cardiometabolic disease, trauma medicine and internal medicine. While serving as a pharmacy director, I pioneered several pharmacy/medical school residency programs, serving as an adjunct professor at the University of Florida, LECOM and FAMU. Currently residing in Tampa, Florida, interests include podcasts and promoting the Medical Affairs profession.
Chris Wasden, EdD, MBA
Head of Pharma Specialty Solutions and Corporate Strategy, Happify Health, United States
As Head of Happify Health’s Pharma Specialty Solutions/Corporate Strategy, Chris is leading the effort to bring Happify’s Intelligent Health platform to the pharmaceutical and healthcare industry. Recently he served as a Board Member of the Digital Therapeutic Alliance (DTA). In addition, he was a professor at the University of Utah and served as Executive Director of the Sorenson Center for Discovery & Innovation, a digital therapeutic game incubator. He is the co-author of two books on innovation, creativity, and leadership: Tension - The Energy of Innovation; and Solving for Why - Change Your Identity, Change Your Future. He is the named inventor on 12 issued patents, has been a founding leader in 10 startups.
Mari Ylipelkonen Welke, MA
Owner, Yellow Pelican Writing & Consulting, L.L.C., United States
Stephanie Young Moss, PharmD, MS
Pharmacist, Owner, Integrative Pharmacy Outcomes and Consulting, United States
Dr. Stephanie Young Moss received her Doctor of Pharmacy degree from Xavier University of Louisiana College of Pharmacy and a Masters of Health Services Administration with a concentration in Health Economics from The University of Wyoming. She has worked in various areas in pharmacy, Community, Regulatory Compliance, Managed Care, and Health Economics and Outcomes Research. Over the past 20 years Dr. Moss has advocated for decreasing disparities in health care through her volunteer work. She is also the owner of Integrative Pharmacy Outcomes and Consulting, which focuses on educating underserved communities on ways to reduce and prevent health disparities. This is achieved through health literacy, cultural competency, and technology.
Colin Baughman, MBA
Managing Partner and Founder, True North Solutions Inc., United States
Colin Baughman leads True North, a Medical Affairs Analytics & AI consulting practice based in Cambridge, Massachusetts, USA. His team has worked across more than 25 conditions and over 100 projects ranging from use of AI for Medical Information, deep learning for advisory board insights, neural networks in social media monitoring, claims-based patient landscaping & access models, Medical Education unmet need prediction, scientific congress analytics using NLP, chat bots, and other programs. In addition, the True North team has led development of several digital health partnerships (including study design) in areas such as voice biomarkers, keystroke signatures, and wearables for disease identification and recurrence.
Rachel Couchenour, PharmD, MBA
VP, Head of Medical Affairs , Travere Therapeutics, United States
Rachel Couchenour, PharmD, MBA is a Medical Affairs leader with over 20 years experience in the biotech and pharmaceutical industry. She currently serves as Vice President, Global Medical Affairs at Travere Therapeutics, accountable for building and executing the medical affairs strategy for both commercial and pipeline products at this biopharmaceutical company. Previous experience includes Head of US Medical Affairs at AveXis / Novartis Gene Therapy, Field Leadership at Lundbeck & Chelsea, and advocacy / healthcare policy roles at Sanofi. Prior to joining the industry she was in academia with clinical practice in ambulatory care. BS in Pharmacy, UNC-Chapel Hill; DrPharm-Medical University of South Carolina; MBA-Drexel.
Sophie Forge Forge, MS
Global Head of Medical Data to Insights, GSK, United States
Sophie Forge leads GSK's Medical Data to Insights group, which mission is to infuse GSK's medical strategies and tactics with voice of the customer(VoC)-based insights. Sophie spent most of her career in technology, building and implementing Machine Learning (ML) / Natural Language Processing (NLP) platforms and solutions that deliver business value and growth. Prior to joining GSK, Sophie worked at IQVIA Technologies, where she led the development and commercialization of a "Next best" intelligent platform, and at Elsevier, where she led the Smart Content team, applying NLP to medical content to power better search, retrieval and content creation.
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.
Darshan Kulkarni, JD, PharmD, MS
Principal Attorney, The Kulkarni Law Firm, United States
Dr. Kulkarni is Principal Attorney for the Kulkarni Law Firm which focuses on providing legal and regulatory solutions to pharmaceutical companies and their providers. He is a pharmacist & lawyer and advises clients on bringing their product to market, focusing on post IND thru commercialization and genericization.
Sara Parambil, PharmD
Associate Director, MI Engagement and Established Brand Lead, AstraZeneca, United States
Sara has been working at AstraZeneca in Medical Information for various brands and roles for 11 years. In her current role, she serves as the MI Engagement & Established Brands Lead with a specific focus on increasing engagement globally with local market MI teams. She also leads in creating onboarding guides and other valuable resources for local market MI teams, maintaining guidances/SOPs, and assisting with divestments and acquisitions. She graduated from University of the Sciences in Philadelphia with a Pharm.D. and completed a Clinical Pharmacy residency at Christiana Hospital in Delaware. Prior to joining AstraZeneca, she worked at Wyeth Pharmaceuticals in Medical Information and in Publications.
Felicity Katherine Poole
Commissioning Editor , Taylor and Francis, United Kingdom
Felicity Poole is a Commissioning Editor for the publisher Taylor & Francis. She has worked across a range of therapy areas in T&F's extensive medical portfolio, including their Dove Medical Press titles. She currently manages Expert Review of Vaccines, and Expert Review of Anti-infective Therapy, part of the Expert Collection series. The Expert Collection is an authoritative reference point for research, spanning the entire drug development pipeline from drug discovery to post-launch marketing surveillance and drug safety, and all offer article enhancements including plain language summaries. Felicity has a keen interest in open science and ethical and transparent publishing, as well as patient engagement and plain language summaries.
Constance Stangarone
Convention Services, Principal Manager, Genentech, United States
Constance Stangarone is part of the Genentech Strategic Events Services Team as the Conventions Services Principal Manager. In this role, she is accountable for convention channel strategy and building an integrated customer congress experience. She previously was on the U.S. Medical Affairs Oncology Congress Team. During her time on the USMA Oncology Team she developed the 2021 congress strategy and led execution of medical education booth materials. This includes approaches for AACR and ASCO to deliver a cohesive customer engagement and trying to identify new ways for medical engagement for congresses. She earned her bachelor’s degree from Villanova University with a major in psychology and minors in business and cognitive science.
Carol Vu
Thought Leader Liaison Director, Sobi, United States
Christy Cheung, PharmD, RPh
Lead, Digital Innovation & Transformation, Sanofi, Canada
Christy is a Digital Innovation & Transformation Lead at Sanofi and Co-founder of the AI Collective. She received her PharmD from the University of British Columbia, completed a Medical Director Fellowship at Sanofi, before taking on an MSL role, and more recently, making the transition from Medical to Digital. In her current role, she aspires to improve digital foundational literacy across internal stakeholders and to empower them to adopt a digital-first mindset in delivering innovative solutions to patients, healthcare professionals, and the broader healthcare system. Christy has been invited to speak at conferences such as DHX Virtual and ASHP. She also acts as a guest lecturer on the topics of digital health and AI.
Truc Dinh, PharmD
Associate Director, Global Medical Information, Gilead Sciences, Inc., United States
Truc Dinh is an Associate Director in Global and US Medical Information at Gilead Sciences focused on Virology and COVID-19. She brings over 5 years of experience in Medical Information launch excellence, medical and promotional review, insights generation and cross-functional collaboration. She received a Bachelors degree in Public Health and Public Policy from the University of California, Berkeley and a Doctor of Pharmacy degree from the University of California, San Francisco with an emphasis on the Health Sciences and Policy Management pathway. She completed her postdoctoral fellowship in Medical Information with Gilead Sciences and the University of Southern California.
Shannon LaMey, BSN, MS
MSL Field Director, Neuroscience, US Medical Affairs, Genentech, Inc., United States
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