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.

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.

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.

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.

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.

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.

Elizabeth C. Froom, PharmD, is a Senior Director in the Medical Writing and Healthcare Communications team at Evidera. She has over 20 years of medical information and writing experience. In her role she provides strategic direction and oversight to a global team of medical writers who deliver medical information services including standard response documents, custom responses, Academy of Managed Care Pharmacy (AMCP) dossiers, infographics, and promotional review. Her educational background includes a BS in pharmacy and a PharmD from the University of South Carolina College of Pharmacy.

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.

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.

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.

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.

Blake is a Scientific Medical Writer at Aroga Biosciences, Inc. with experience authoring documents for regulatory submissions, including INDs, IBs, DSURs, protocols, and CSRs. Blake also serves as Vice President of Member Relations and Secretary of the San Diego Regulatory Affairs Network (SDRAN) and holds the RAC-Drugs designation from RAPS. Prior to joining Aroga, Blake worked as a research scientist at Inovio Pharmaceuticals, Inc., serving as lead scientist on multiple nonclinical research programs. Blake conducted his postdoctoral training at La Jolla Institute for Immunology and holds a PhD in Biomedical Sciences from Tulane University School of Medicine.

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.

I started in the industry as a Medical Affairs fellow in 2015 then became a Medical Science Liaison supporting products in the immunology and ophthalmology space. I later transitioned into Medical Communications before taking on my current role at Amgen as the Associate Medical Director supporting the rare disease team focused on neuroimmunology

Richard Swank is the former head of US Field Medical and Global Field Medical Excellence at Amgen and Founder of Scientific Engagement LLC. He has spent most of his career building medical capabilities in Medical Affairs, including building and managing MSL teams, managing medical information call centers, and improving how medical teams execute and measure field medical performance. He has a PhD in Biochemistry and Molecular Biology and prior to joining industry completed an NIH Postdoctoral Fellowship and was a senior fellow in Medical Genetics at the University of Washington.

Iris Tam, PharmD, FAMCP, is Senior Vice President & Head of Medical Affairs and HEOR at COEUS Consulting with over 30 years of experience in health care, including hospital pharmacy, managed care pharmacy, and the biopharmaceutical industry. In previous industry roles, she led Medical Affairs strategies and tactics that support market access, product value, and patient access, including accountabilities for medical communications, HEOR, AMCP dossiers, compendia submissions, guideline bodies engagement, and payer communications. From 2008 to 2021, Iris served on the AMCP Format Executive Committee which oversees the AMCP Format for Formulary Submissions for dossier development, including serving as the Chair for the last 3 years.

Sarah Jarvis leads our Global Medical Affairs consulting space at ZS. Based now in San Francisco, California, Sarah has worked in the lifesciences industry for over 25 years and has focused exclusively on working with medical affairs clients for the past 15 years at ZS. ZS has worked with more than 100 companies' Medical Affairs organizations. Sarah also previously worked at Genentech in a variety of different roles on products that spanned therapy areas and phases of the lifecycle. With COVID acting as an accelerator on the medical function, ZS is partnering with clients to support the growth and change needed to meet global demands - in the field and in headquarters - through strategy, advanced analytics, and operations projects.

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.

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.

Stacey leads MedInfo at Amgen and her 19 year career journey is marked by a series of contributions to MedInfo and patient care. With her background as a pharmacist and a MedInfo professional, Stacey possesses a profound understanding of the challenges and opportunities within the field. At Amgen, Stacey leads a global team of dedicated professionals, driving forward the integration of cutting-edge technologies and AI to enhance MedInfo services and redefine industry standards. Stacey is passionate about the potential of AI to transform MedInfo, believing that the next evolution of MedInfo lies in leveraging technology to provide more personalized, accessible, and timely support, creating a more informed, empowered, and healthier world.

Dr. Karen Tilstra is a driving force in the innovation sector. She's responsible for the first-of-its-kind design thinking lab in healthcare, education, pro-sports, and government sectors. A two-time TEDx speaker with an extensive speaking portfolio, Karen and her team have successfully completed 610+ Design Thinking projects, earning three innovation awards. In addition to her innovation pursuits, she's a licensed Educational Psychologist with a Ph.D. in Creative Leadership. As an author, she's penned 'The Deathline: Stopping the #1 All Time Killer of Human Potential' (2022) and '101 Ways to Ignite Collaboration, Boost Creativity & Fuel Innovation' (2023).

Dr. Nimita Limaye leads R&D Strategy and Technology at IDC Health Insights, providing research-based advisory and consulting services on the Life Sciences industry. She represents Healthcare and life science on IDC's AI Council. She is an executive business leader with more than two decades of life sciences leadership experience in the pharma/CRO/tech consulting industry. She focuses on the role of data and technology in transforming drug development, RWD, synthetic data and analyzing and predicting evolving trends in the life sciences industry. Nimita was the chair of the SCDM board, chaired several conferences roundtables, given keynote talks, participated in fireside chats, and authored close to a 100 thought leadership papers.

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.

Kari is Vice President and Chief Compliance Officer for Cytokinetics, Inc., where she provides executive management, direction, and oversight for all aspects of the compliance program, policies, monitoring, training, privacy, and brand-legal advisory. Previously, Kari was the US Healthcare Compliance and Privacy Officer and Senior Corporate Counsel at Vifor Pharma, Inc., and a Senior Director/Senior Compliance Counsel at Jazz Pharmaceuticals. She has extensive experience in providing legal and compliance advice on sales, marketing, promotional and medical materials review, Medical Affairs, managed care, commercial compliance, as well as U.S. Sunshine / aggregate spend and compliance operations.

Stephen is responsible for leading and directing Parexel’s enterprise patient data strategy. He is also leading the development of Parexel's AI strategy. Stephen trained as a statistician, and began his career in academia (London), where he held various research and teaching positions. He subsequently joined the pharmaceutical industry where he was fortunate to have the chance to take on a number of global leadership roles, at Pfizer and GSK. Stephen has also been honoured to serve on the Boards of a number of professional and not-for-profit organisations, including among others: PSI Board Chair, RSS Vice President, CDISC Board Chair. Stephen Studied Mathematics and Statistics at University of York and Imperial College, London.

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.

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.

Christian has over 15 years of industry experience in R&D and medical affairs encompassing translational research, medical affairs, HEOR, patient advocacy, and public health. Christian is currently Vice President, Medical Affairs at Lassen Therapeutics where he is responsible for building out and leading medical communications, external engagement, patient advocacy, and driving clinical trial enrollment. Over his career, Christian has held roles of increasing responsibility at Myriad Genetics, Bristol Myers Squibb, Gilead Sciences, Astellas, Mirati Therapeutics, and Kinnate, facilitating early asset development as well as leading the medical affairs launch of several FDA approved products.

Brian leads ZS’s Health Decision Science research practice. He serves as a consulting subject matter expert for primary research and design in questions of clinical judgment and decision making in medicine. Brian draws from over 15 years of experience in the fields of cognitive neuroscience, experimental psychology, and psychiatry research. He is a coauthor of publications in the areas of molecular psychiatry, neuroeconomics, and human affective neuroscience. His primary area of academic research was the functional neurocircuitry of human emotion and judgment, specifically the interface of somatic signals, emotion and cognition, as mapped using functional magnetic resonance imaging (fMRI).

As the Director of Leadership Excellence, Purvi builds leadership capability within medical and commercial teams at EMD Serono, a critical investment in enhancing current and future leaders’ skills, abilities and confidence. Purvi brings 20+ years’ experience, most recently 7 years as a Senior Executive Consultant at the FDA, helping the agency develop their leadership development strategy and approach. As an ICF-certified coach, Purvi has worked with leaders at all levels, helping them gain important insights and empowering them to operationalize who they want to be as leaders. Purvi holds a BS in Health Science from the Univ. of Texas HSC, a MEd in Public Health Ed from Univ. of Houston, and a MPA from George Mason Univ.

Eid has more than 20 years of experience in real-world evidence, epidemiology and biostatistics. Her passion for better public health led her to work for USAID, CDC and other donors in global health development with a focus on reproductive health and family planning and infectious diseases. Her current focus is supporting regulatory, safety, late-phase and post-marketing activities across therapeutic areas using clinical and real-world data to glean real-world insight.

Jon is an Associate Principal for ZS and lead of the Field Medical capabilities for the Medical Affairs practice. In this role, Jon leads the development, oversight, and innovation of Medical Affairs projects that impact strategy through execution for field medical teams.     During his 9.5 years at ZS, Jon’s focus has been within the Medical Affairs practice at ZS. He’s supported Medical teams across the industry across the different stages of the product lifecycle. He has helped clients by bringing data-driven and customer-oriented solutions for medical strategy and field medical execution. Jon holds a Ph.D. in Biomedical Sciences from the University of California, San Diego and a BS in Biochemistry from Colorado State University

With over 20 years in the pharmaceutical industry within both clinical and scientific affairs, Robert now serves as the North America Medical Information Director for EMD Serono. In this role, Robert oversees and is responsible for all activities related to the handling of unsolicited medical information inquiries from healthcare providers, and is also responsible for overseeing the development and implementation of various digital initiatives on the medical resources website.

Jones is an Associate Partner at ZS Associates, a Global Healthcare Management Consulting Firm and leads the Medical Omnichannel / Digital Transformation Domain. He has over a decade of experience and worked with 20+ pharma organizations across omnichannel / digital domains spanning strategy, technology and analytics. He has supported organizations in areas like digital and omnichannel strategy & roadmapping, technology ecosystems, digital blueprint and activation, engagement process redesign, omnichannel orchestration, digital analytics and reporting Jones holds an MBA from Washington University in St. Louis and a Bachelors Degree in Electronics and Communication Engineering from Cochin University, India

Kim Jochman is a Senior Director, Medical Writing at Merck. She has a Ph.D in biological psychology and has been a regulatory medical writer since 2007, with experience across a broad range of document types, development phases, and therapeutic areas. Kim is passionate about training, mentoring, and process optimization. In her current role, she leads a variety of training, technical, and strategic initiatives to maximize the quality and efficiency of the authoring process. These include developing & leading training programs for early career Medical Writers, conducting industry trainings on lean authoring & data interpretation, and supporting technology initiatives at Merck.

April graduated from the University of Florida College of Pharmacy in 2002 and completed an Ambulatory Care Residency in 2003. She then spent three years in academia at the FSU College of Medicine before transferring to the payer space, where she spent seven years at a nationally recognized HMO, both as a Clinical Pharmacist and a Pharmacy Director. This was followed by three years at a Pharmacy Benefit Management company, where she served as both a Clinical Advisor and an Executive Advisor for Product Innovation and Management. April made the transition to industry in 2015, working initially as an Evidence and Outcomes Liaison for Eli Lilly, and most recently, serving as a Regional Director for Medical Science Liaisons at Novartis.

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.

Katie Kelm has more than 14 years of clinical research experience in academic and contract research organization settings. She provides oversight for medical writing projects and programs, including the client relationship, quality, timelines, resourcing, and finances. She has led revisions to standard operating procedures and has developed process guides and tools for describing decentralized clinical trial methodologies in protocols, risk mitigation, medical writing project management roles and responsibilities, audit preparation, financial systems, and electronic document management systems.

Jeff is a senior HEOR leader, with a focus on generating and communicating value evidence for payor audiences. Jeff led the Global Health Outcomes and Payer MSL teams at Allergan after several years as International Director of Pharmacoeconomics at Glaxo. Jeff is an ACCP Fellow, led development of ACCP's pharmacoeconomics fellowship training programs, and was Chair of the AMCP Format Executive Committee, where he led development of the AMCP Format 4.0. He also actively supported AMCP's advocacy efforts around preapproval information exchange in Congress. At Lumanity, Jeff is the US Region Lead within the Value Demonstration Practice, advising clients across the spectrum of value evidence generation and communication activities.

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.

Mary Mehrabian is the Associate Director, Global Head of Content Development and Medical Review at EVERSANA, leading teams of medical writers, medical fact checkers, medical reviewers, and MLR coordinators in the United States, Europe, and India. She is a dual board-certified PharmD, who received her degree from the University of Illinois at Chicago and possesses over 20 years of experience in various therapeutic areas. Mary serves on two PhactMI committees and is passionate about leveraging technology to create fair and balanced medical information deliverables in a digestible and easy-to-use format for her biotech and pharma clients.

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.

Jane has over 25 years of experience improving clinical trials and patient experiences. She has focused on driving innovation in trial design and execution to accelerate getting medicines to patients. Jane transitioned from molecule focus to portfolio focus about 14 years ago, first concentrating on patient recruitment, then patient experience and input, followed by adoption of patient-facing technology. In her current role as Program Director for the Decentralized Trials and Research Alliance (DTRA), she merges these focus areas. Additionally, she is a member of the Board of Directors of The Myositis Association, adding her experience to their mission. She has held roles across pharmaceutical, biotech, CRO and tech start up organizations

Blake Scott is Professor of Writing & Rhetoric at the University of Central Florida, where he teaches graduate and undergraduate courses related to health and medical writing/communication. He is the founding co-editor of the journal Rhetoric of Health and Medicine and now co-edits a digital column for the journal called "Graphic RHM" (which explores the intersection of comics, rhetoric, and medicine). Dr. Scott has published fives books and edited collections, most recently Methodologies for the Rhetoric of Health and Medicine (with Lisa Meloncon). He co-leads a multidisciplinary research team exploring the uses of comics to combat HIV stigma and to support nurses well-being.

Denise has over 25 years of experience in the pharmaceutical contact center industry at PPD. Currently serving as a Director of Operations, she manages global teams providing medical information, pharmacovigilance, and product complaint processing for pharmaceutical and biotechnology clients. Prior to her current role, she dedicated her time to roles focused on ensuring quality and compliance. Denise received her Doctor of Pharmacy degree from Campbell University in North Carolina.

Colleen Tholen is Director, Global Medical Information at Intercept Pharmaceuticals where she oversees all aspects of Medical Information as well as medical review of promotional and medical materials. Colleen has served as medical reviewer both at Intercept and her previous company and enjoys the dynamic nature of the role, working collaboratively in a cross-functional environment, and staying up-to-date with the data and science. She is eager to share her experiences and best practices as a Medical Information professional within advertising and promotional content review.

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.

Jenny Boyar is a Principal Medical Writer at AbbVie, with nearly a decade of experience in medical and scientific writing. She has contributed to publications with professional organizations like the Regulatory Affairs Professionals Society, and her academic work has appeared in multiple scholarly journals. A Fulbright recipient, she holds a PhD in English from the University of Rochester. With extensive experience across a variety of clinical and regulatory documents, she is invested in working collaboratively and cross-functionally to produce impactful writing.

Rebecca is a seasoned professional with a rich background in both academia and the pharmaceutical industry. Beginning her career at Mercer University School of Pharmacy, she spearheaded a successful research program, collaborating with prestigious institutions. Transitioning from academia to Arbor Pharmaceuticals, Rebecca took on progressively higher responsibilities in Medical Affairs. Seeking fresh challenges, she joined UCB in 2019 where she currently is the Head of US Medical for Epilepsy and Rare Syndromes, leading all functions of US Medical Affairs across the Epilepsy and Rare Syndromes portfolio. In this role, she strives to create an environment and vision for the team that inspires innovation and patient centricity.

Andrea is a Senior Regulatory Medical Writer at Aroga Biosciences, Inc. with experience authoring protocols, IBs, DSURs, briefing packages, CSRs, and manuscripts. Prior to joining Aroga, Andrea worked as a Senior Drug Regulatory Specialist at Registrar Corp. Andrea serves as the Southern Virginia Regional Event Coordinator for the American Medical Writers Association Mid-Atlantic Chapter. She received her BS degree in biology from Salisbury University and MS and PhD degrees in chemistry from Old Dominion University.

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.

After receiving her PhD in Developmental Neurobiology, Julia became a medical writer in 1997. In 2002, she co-founded Trilogy Writing & Consulting, a company specialized in medical writing of regulatory documentation. As a Senior Partner she continues to bring her enthusiasm and experience to client projects. She has twice been President of the European Medical Writers Association (EMWA), is an experienced trainer of medical writers, and runs workshops for EMWA, AMWA, DIA, and pharma companies around the world.

Natalie Gearhart is an employee of Johnson and Johnson. Her 23-year history with the company includes leadership of multiple product launches, inspections, change management initiatives, and reorganizations, as well as roles in multiple functions and therapeutic areas. She is currently serving as an Associate Director, External Engagement Strategy in Medical Affairs. Her current focus includes fostering an insights-driven medical organization and developing innovative strategies for stakeholder interactions in a rare disease therapeutic area. Prior roles have been in the areas of Pharmacovigilance, Medical Information, and Medical Call Center. She received her Doctor of Pharmacy degree from the University of Pittsburgh.

Dr. Howard is currently the Global Medical Digital Lead in the Medical Operations and Effectiveness group in Sanofi Specialty Care. In this capacity, he is responsible for leading a team to evaluate and develop novel digital platforms and processes to support a fully realized Medical Omnichannel strategy. Specifically, these projects have internal impact, such as NLP insight analysis and social media monitoring, or external impact to facilitate HCP access to the right content, on the right channel, at the right time. Every project is informed by his prior experience in the field as an Oncology MSL with a keen focus on improving field efficiency and maximizing HCP value.

Industry veteran of nearly 30 years with experience in and passion for field medical affairs.

Throughout my two-decade tenure in pharmacy, I've dedicated myself to pharmaceutical contact centers. Beginning as a phone agent, I progressed to spearheading Medical Information Contact Centers. Joining Alphanumeric in 2016 as a Team Lead, I steadily advanced into senior leadership positions. By 2021, I held the esteemed role of Global Director for a Covid-19 Global Medical Information Contact Center within one of the world's leading pharmaceutical companies. Presently, I oversee two Medical Information Contact Centers, one based in the US and the other in Canada.

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.

Randy Levitt is the Director of Pharmacovigilance and Medical Affairs at Paladin. He is also the local compliance champion and works closely with the legal and compliance teams at Endo, the parent company of Paladin. He joined Paladin in 2011 as Manager, Scientific Communications and Publications after Paladin’s acquisition of Labopharm, where he had worked in the medical department since 2008. Randy completed his undergraduate and graduate degrees at McGill University, graduating with his PhD in Experimental Medicine in 2006.

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.

Jenny has over 19 years of experience in providing global, multilingual Medical Information and Pharmacovigilance contact center services; holding various roles within Operations, Client Services, Management, and Leadership. Much of her career has focused on designing and delivering Medical Information teams across Europe, MEA, the Asia-Pacific region, and the Americas. Working directly with clients to enable, expand, and evolve services and strategies and was involved with integrating several Pharmacovigilance (PV) acquisitions in Europe and supported the globalization of PV functionality. Jenny obtained her Bachelor of Science (BSc) in Biological Sciences from Bristol University and has lived and worked globally throughout her career.

Gunasekaran Singaravelu, Ph.D., earned his doctorate in Life Science from Gwangju Institute of Science and Technology. He brings over a decade of experience to his work. Dr. Singaravelu specializes in medical writing, focusing on oncology, immunology, specialty medicine, geriatrics, and ophthalmology. As Medical Writing Manager at Daiichi Sankyo Inc., he oversees regulatory document preparation and provides leadership in writing strategies. Previously, at Alcon and T.A. Sciences Inc., he contributed to regulatory and scientific documentation. Dr. Singaravelu's research includes primary publications and reviews in respected journals.

Dena Sonnenberg is an Executive Medical Reviewer, US Medical Information and Review for Takeda. She supports both promotional and medical strategies for the neuroscience and vaccine portfolios. Dena has been with Takeda since 2014. Prior to that, she worked at Eli Lilly as a Neuroscience Medical Liaison in Medical Affairs, and in R&D and Demand Realization Finance; she has also worked in biotech venture capital. Dena has enjoyed adding to both the depth and breadth of her experience at Takeda.

Tony is a biopharmaceutical professional with in-depth experience in clinical development operations and medical affairs. He oversees Amgen's US MedInfo function, leading teams to optimize performance and efficiency by adopting new technology and strengthening cross-functional partnerships. Other areas of focus, current or previous, include expanded access, product launches, clinical trial site selection and activation, and field medical effectiveness. Prior to joining industry in California, he ran clinical trial recruitment at several of Boston’s top academic medical centers. Tony is passionately driven by organizational efficiency and finding elegant and pragmatic solutions to confront challenges to serve patients on a global scale.

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.

Leanne Woehlke, is a Director of Life Sciences Solutions at TransPerfect where she helps clients create transformational impact with language, technology and business consulting. She is also a Trainer for Tony Robbins, Professional Certified Coach and Host of the Clinical Research Coach podcast. Her career began as a CRA then she worked her way up to Director before consulting in patient recruitment, training and process optimization. Following an entrepreneurial decade, she returned to the corporate world integrating her knowledge of clinical research, patient recruitment and digital marketing. She is passionate about impacting the industry in meaningful ways and brining life changing treatments to patients who need them.

Shengjie Xu is currently a Senior Medical Writer at Merck working on clinical documents to support global regulatory approval for various vaccine programs. Prior to joining Merck, she was trained as a bench scientist and specialized in immunology, most notably in host-microbial interactions. Shengjie has published original research works in multiple peer-reviewed journals and has been an invited speaker at several international conferences. She also served as an IRB member for two years, where she reviewed clinical research conducted at Duke University Health System. Shengjie received her PhD in immunology from Duke University in North Carolina and her BS in biology from Purdue University.

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.

Kevin?Chen is a freelance medical writer in the pharmaceutical industry, providing clinical and regulatory writing and business development services. Previously, he held full-time medical writing positions at small- and mid-size companies, emerging within less than a decade as a strategic leader with a passion for managing chaos, optimizing process, and nurturing talent. He lives in the San Francisco Bay Area with his wife and son, enjoying a life of food, sports, music, family, and friends.

Jackie Cytacki has more than 23 years of experience in the pharmaceutical industry. Currently, she is a Senior Principal Medical Writer at Parexel International, where she serves as a client-partnership liaison and as a lead writer/submission coordinator. Jackie also mentors junior writers and supports their professional growth. Before joining Parexel, Jackie worked as a Medical Writing Consultant at Comprehensive Clinical Development, and prior to that, she held various positions at Kos Pharmaceuticals, including Associate Director of Drug Information Services, Manager of Medical Writing, and Drug Information Specialist. Jackie holds a BA in Chemistry from Florida Atlantic University and a PharmD from Nova Southeastern University.

Donna Holder has over 30+ yrs experience in the pharma. She is the Executive Director & Head of Digital Strategy and Innovation in Global Oncology Medical Affairs at Daiichi Sankyo where she focuses on implementing digital technology, platform and processes. Previous to that she led Global MSL Excellence at Daiichi Sankyo, Merck & Co, and AstraZeneca. In these roles she drove consistency, standards and the development of tools & processes in Field Medical. Donna has spent the majority of her career in Medical Affairs leading teams across multiple functions. Donna is a PharmD graduate of the University of Michigan.

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.

Leena is Director, Medical Information at Janssen Pharmaceutical Companies of Johnson & Johnson. She has been with J&J since 2000. In her current role, Leena is responsible for leading global content and Innovation for Janssen’s Medical Information community. In the past Leena has managed Medical Information teams across various TAs including Metabolism, Infectious Disease, Pain, Women’s Health, Urology products. Leena is responsible for defining processes, developing strategies, integrating technology to create innovative customer response solutions and executing projects. Leena earned her Doctor of Pharmacy degree from Rutgers College of Pharmacy, New Jersey, in 2000.

Susant Mallick comes up with 23+yrs of Pharma and IT background on building disruptive solutions/products in Clinical and Regulatory space. He is technology evangelist on cutting edge technology like (Artificial Intelligence, Machine Learning, IoT, Cloud etc) and an industry leading speakers across geographies. He has been working with various customers and partners in pharma and healthcare to drive digital transformation in clinical and regulatory landscape. He was instrumental in implementing/building many Regulatory solutions using advanced technology. Innovation and Digital Transformation in Healthcare and Life Sciences are two key focus areas.

I completed my bachelor’s degree in pharmacology at the University of Sherbrooke in 2012 and received my master’s degree in clinical pharmacology from the University of Montreal in 2014. I then started working for Pharmascience Inc. as a Medical Information Associate before becoming a Specialist in Scientific Communication. For the past 4 years, I have been working as a Medical Information Scientist at Pfizer Inc. where I’m responsible for managing medical information content and activities related to the COVID-19 vaccine.

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.

Ann is a Senior Knowledge Expert in McKinsey & Company’s Minneapolis Office. In her 10+ years at the Firm, she has served clients across the pharmaceutical industry, focused on medical topics including Chief Medical Officers, Medical Affairs, and real-world evidence. Ann leads McKinsey's medical service line and related internal knowledge efforts in Medical Affairs, Real World Evidence and other related topics. Prior to joining McKinsey & Company, Ann earned her M.D. from Johns Hopkins University School of Medicine and completed her residency in pediatrics at New York Hospital / Weill Cornell Medicine.

Joy is the Business Innovations Lead on the Global Strategic Capabilities team supporting Global Medical Information at Gilead Sciences, Inc. In her current role, Joy leads initiatives focused on new ways of working and innovative solutions to connect customers and patients with Medical Information. Joy also spent several years supporting numerous products/therapeutic areas as a Medical Information Specialist. Prior to joining Gilead in 2014, she practiced clinical pharmacy at the California Pacific Medical Center in San Francisco, California. Joy has a Doctor of Pharmacy degree from the University of the Pacific Thomas J. Long School of Pharmacy in Stockton, California.

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.

With 17 years of immersion in the Life Sciences sector and credentials including a PharmD and MSc in Clinical Analysis, Sandrina Clemente operates from Portugal, dedicated to enhancing global well-being through streamlined processes and top-notch customer service. Her passion lies in pioneering innovative solutions and tackling challenges with creativity. Sandrina's expertise spans leveraging cutting-edge technologies and artificial intelligence to ensure secure and efficient service delivery. Continuously forward-thinking, she delves into the evolving interplay between processes, human resources, and technology, anticipating future synergies.

I received a BSc in Biology/Neuroscience from McMaster University, and a PhD in Physiology/Medicine from Queen’s University. I began my career as a junior Medical Writer at ApoPharma Inc. before becoming a primary Medical Writer at Appili therapeutics Inc. and then a Clinical Research Scientist. For the past 4 years, I have been working as a Senior Medical Writer at Parexel International. I work primarily on a Strategic Partnership, supporting that client’s established product portfolio. My medical writing focuses on preparing documents for regional Health Authorities including responses to Health Authority Queries and Clinical Overviews to support changes to product labeling.

Leveraging my extensive technical and business management background, I am a high-performing medical affairs and informatics professional with a passion for innovation and results. I have been in Pharma for the past 20 years with a deep focus in Medical Affairs Digital Transformation and Omnichannel.

Beth obtained her Doctor of Pharmacy from the University of Tennessee, Memphis. After graduation, she completed a residency in Family and Community Medicine at the University of Arkansas for Medical Sciences. She work in clinical out-patient care and investigational protocol writing until 2005 when she transitioned into Medical Communications. For the past 18 years, Beth worked in creating scientific content deliverables such as standard responses, slide decks, dossiers, and manuscripts. She has supported strategic publication planning, industry software implementation, and served in various leadership positions. She also holds an appointment as Assistant Clinical Professor for the University of Tennessee College of Pharmacy.

Medical Communicator, Innovator, Challenger, Collaborator Mylene S. Serna, PharmD is a dedicated Medical Affairs professional with a solid performance record in the pharmaceutical industry, with a career spanning nearly 17 years in Medical Affairs. Highlights of her career include building Medical Information capabilities, developing strategy for medical communications content, building Medical Information service solutions, and leading a medical communications team to provide strategy and oversight for various medical affairs functions. She received her Doctor of Pharmacy at Mercer University College of Pharmacy and completed a pharmacy practice residency at Mayo Clinic Jacksonville.

Marie is the Associate Director, Medical Digital Strategy at UCB, Inc. She has 15+ years of experience across the retail, hospital, & industry settings, including experience leading a cross-functional team focused on Medical Information, Medical Training & Operations, & Publications. Marie earned her PharmD degree from the University of Georgia, and B.S. degrees in Chemistry & Biology from Armstrong Atlantic State University (now Georgia Southern University). She completed a Pharmacy Practice Residency at Columbus Regional Healthcare System in Columbus, GA, & a Drug Information Residency with Solvay Pharmaceuticals (now Abbvie)/Mercer University in Atlanta, GA