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.

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 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.

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.

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

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 Ruffolo is a Senior Manager in Immunology, Dermatology at AbbVie. She began her career as a Clinical Pharmacist within her local hospital system and joined AbbVie 4 years ago in Global Medical Communications, first supporting Specialty before joining Immunology. She currently leads the Dermatology team, most recently co-leading and supporting two new major product launches. She also recently led the department’s first ever Health Care Provider Virtual Advisory Board to gain customer feedback, and presented findings at DIA MASC 2020. Amy obtained her bachelor’s degree in biology from the University of Wisconsin-Parkside and her PharmD degree from the University of Wisconsin-Madison.

Peter is a seasoned, medical communications, accounts leader and business developer with ~ 20 years of experience managing international teams, building accounts from the ground up, and developing strong client relationships with emerging biotechnology organizations to top-5 pharmaceutical corporations. He is considered a healthcare content development specialist and has personally developed digital assets, scientific narratives, slide presentations presented at the DHHS, strategic analyses and supported publications and other scientific deliverables. He has developed ground breaking educational agendas and initiatives that have led to the unique education of HCPs in a variety of therapeutic areas.

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.

Dan Benau, PhD, Director of Biomedical Writing Programs, Professor of Biomedical Writing at the University of the Sciences. Wyeth-Ayerst Research: Scientific Writer - Principal Medical Writer (1991 - 2001), Sanofi-Synthelabo: Medical Writing Project Leader (2001 - 2003), Freelance (2003 - 2008). DIA Professional Education, Development, Training Community (2004 - 2016), DIA Medical Writing Community (2003 - present). Other memberships: AMWA, RAPS. Interests: Systems approaches to medical writing, regulatory writing, medical writing technology, holistic integration of medical writing genres.

Sudipta Chakraborty is a Plain Language Summary Manager at PRA Health Sciences. After earning her PhD in neuroscience from Vanderbilt University, Sudipta joined the medical writing space with the desire to help the public better understand the complexities of science and medicine. Collectively, Sudipta has over 10 years of biomedical communication, with her current specialization in plain language summaries of clinical study results. This has included supporting the operationalization of plain language summaries for sponsors, as well as advising sponsors on plain language best practices and regulatory requirements. Sudipta has also trained and managed other writers in the areas of plain language summary development and management.

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.

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.

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.

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.

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.

Josh currently serves as a medical affairs consultant with Scientific Commercialization, a boutique medical affairs consulting firm. Through this opportunity, he helps clients to mindfully build and empower their medical affairs organizations, as well as to develop and lead the execution of integrated medical affairs strategies and associated tactical plans. Prior to Scientific Commercialization, Josh worked at Novartis as an MSL on the Immunology and Dermatology team. Before transitioning into the field, Josh was a member of Novartis' Safety Risk Management team and built REMS programs and risk management plans. Josh earned his PharmD at the University of Rhode Island and his MBA at the University of Massachusetts.

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 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.

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.

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.

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.

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 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 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.

George Carroll is a High Energy Speaker, Mindset Trainer and Author of 4 books, including Maximum Performance and Productivity. His engaging and motivational style combined with actionable tips and his laugh-out-loud sense of humor will leave you feeling inspired, invigorated and ready to tackle challenges and changes happening in the workplace, and in your personal life.

Robin M. Weinick, PhD. brings 25 years of experience to her DIA role as Senior Vice President & Managing Director, Americas, and Global Program Officer.Robin joins DIA from RTI International, a large, nonprofit research institute dedicated to improving the human condition. She also has served as Associate Director for Health at the RAND Corporation, a premier U.S.-based think tank, and on the faculty of Harvard Medical School and Massachusetts General Hospital. She began her career in federal service with the U.S. Department of Health and Human Services. She holds a B.A. in Health and Society from the University of Rochester and a Ph.D. on Population Dynamics from Johns Hopkins University.

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.

Joel Davis is a Associate Director, US Regulatory Affairs Advertising & Promotion for AbbVie. His organization is responsible for the review and approval of promotional material across the AbbVie portfolio. At AbbVie, he also has held roles in Medical Information, Medical Review, and Medical Affairs. Joel has over 18 years of diverse experience in healthcare, serving in practical, clinical, research, and industry settings. His experiences within the Medical and Regulatory organizations gives him a unique view in the roles of a Medical Information professional and reviewing promotional materials through the lens of Medical and Regulatory reviewer.

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.

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.

Terry Jo Bichell worked as a documentary filmmaker, then became a public health nurse-midwife after filming a difficult birth in West Africa. When her youngest child, Lou, was diagnosed with Angelman syndrome (AS), she switched from midwifery to clinical research on AS, eventually earning a PhD in neuroscience from Vanderbilt University. Lou has served as Patient Zero in several clinical trials, teaching his mother what it means to be a patient, a subject and a son simultaneously. In 2019, Dr. Bichell founded COMBINEDBrain (Consortium for Outcome Measures and Biomarkers for Neurodevelopmental Disorders) to assist patient advocacy organizations for other rare neurodevelopmental disorders in preparing for clinical trials.

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.

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.

Kent is Executive Director and Head, Global Medical Affairs at Orchard Therapeutics, a biotech company dedicated to unlocking the curative potential of hematopoietic stem cell – gene therapy for the benefit of individuals, families, and society. He is an accomplished medical affairs leader with >20 years of relevant clinical and scientific experience as well as multiple successful product launches within rare and ultra-rare diseases. In his current role, he brings substantial real-world experience to bear on the ever-evolving therapeutic landscape of gene therapy for the treatment of severe genetic diseases.

As Senior Consultant, Health Economics and Outcomes Research at IQVIA, Katharine Coyle is responsible for all aspects of research and analysis for the practice. Her core expertise includes large literature reviews and information synthesis. Coyle’s extensive experience in coverage and reimbursement issues with all payer types provides valuable support to the team. During her 13 years at IQVIA, Ms. Coyle has worked on a broad variety of projects including AMCP dossiers, product value dossiers and value development plans. Prior to joining IQVIA, Ms. Coyle was a research associate at United BioSource’s Center for Pricing and Reimbursement and its predecessor companies for many years.

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.

Julia Dmitrieva, is the KOL engagement Leader for the Strategic Clinical Marketing division at Philips Healthcare. As part of her role, Julia develops customer engagement strategy and thought leadership programs, streamlines global clinical marketing efforts, and works closely with innovation and medical affairs groups to create solutions that improve diagnostic accuracy, workflows and efficiency. Julia has a Doctorate degree in Business Administration, she is a registered diagnostic medical sonographer, vascular technologist, and cardiac sonographer. Since 2017 Julia is a fellow of Society for Vascular Ultrasound. Julia joined Philips 15 years ago and worked in various roles, sharing her clinical knowledge to support customer needs.

Gladys is the Director of Medical Affairs Strategic Planning & Operations at Myovant Sciences. She collaborates with the Medical Affairs Leadership Team across the Prostate Cancer and Women’s Health Franchises. Her role involves strategic planning for Medical Affairs, general business management, budgeting, and special projects to drive alignment and performance across Medical Affairs. Gladys was recently a member of the Strategic Business Improvement team at Janssen Pharmaceutical Companies of Johnson & Johnson. She supported their newest therapeutic area of Pulmonary Hypertension. Her responsibilities included collaborating with executive leadership on strategic planning across the business.

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.

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 has been in the Pharmaceutical events industry for over 16 years. She started her career with Ashfield Meetings & Events managing global programs including congresses, advisory boards, Investigator meetings and large sales conferences for various healthcare clients. She then moved into a leadership role in 2009 where she was responsible for nurturing strategic partnerships on her global key accounts and managing a large team. Katie’s current focus in her role as Director, Business Development & Client Services is seeking out business partnerships with new healthcare clients on virtual, hybrid and live events and experiences.

Vibha Kumar has over 15 years of experience in the pharmaceutical industry as a regulatory affairs professional. She has supported CMC development and regulatory submissions for a variety of finished product dosage forms with emphasis on regulations and electronic Common Technical Document requirements. In her current role at Synchrogenix, a Certara company, as Associate Principal Regulatory Writer, Vibha leads and writes regulatory documents ensuring they follow current regulations and guidances.

Wes Michael is President and Founder of Rare Patient Voice, a unique market research sample provider that has built a patient and caregiver panel by recruiting in person at patient events. Before forming Rare Patient Voice in 2013, Wes worked in healthcare market research firms Kantar Health (previously TNS Healthcare and Migliara/Kaplan) and OSG. He previously was a brand manager and market research manager at McCormick (the spice company) and entered the market research field at General Mills. He has a BA from the University of Pennsylvania (with a year at Edinburgh University) and an MBA from the University of Chicago.

For most of my over 30 years of experience in clinical research, I have specialized in Regulatory Medical writing . My background in small start-ups to large, established biotech and pharma has given me a good depth of understanding of the drug development process. Graduate work in Regulatory affairs strengthened the knowledge of regulations I have attained within industry, and my background as a clinical scientist and global project manager gives me insights into how what we do affects the outcomes we desire. For me, it's all about the patients - my early days as an RN and my life experience reinforce the importance of what we do and keeps me interested in learning how to do it better.

After beginning her professional life as a hospital pharmacist, Cathleen had a long career as an executive in the pharmaceutical industry, where her functional responsibilities over the years included medical information, medical writing, regulatory affairs, and pharmaceutical labeling. She has authored several articles on pharmaceutical labeling, and is editor and author of a recently-published textbook covering many aspects of this topic. Prior to her permanent shift into academia she taught graduate and undergraduate students at several universities and a community college. Cathleen is a rated pilot (helicopters, hang gliders, paragliders).

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.

Dr. Jacqui Whiteway brings more than 18 years experience in clinical research to her current role as Senior Director and Head Pediatric Strategy Liaison in the Centre for Paediatric Clinical Development (CPCD) at ICON. She has a PhD in Molecular Biology, was a Postdoctoral Fellow in cancer genomics at the BC Cancer Agency and was a Research Scientist at a biotech company developing precision therapeutics. At ICON she has worked in Biometrics and Therapeutic Expertise, and was leading the Global Feasibility team before joining the CPCD. Compassionately curious, her passion for clinical trial planning arises from the need to devise the optimal approach for conducting challenging studies, particularly for pediatric populations.

SENIOR VICE PRESIDENT, GLOBAL OPERATIONS, & CIO Digital Transformation strategist. Cultivator of outstanding CX and ops that run like a well-oiled machine. I lead Alphanumeric to deliver a patient and HCP experience that sets us apart. We do this by combining digital transformation, intelligent automation, and a passion for the people who bring our customers’ goals to life. I set the strategy for our global expansion, remote workforce, and strategic business partnerships. I lead the team to continue our track-record of zero interruptions to business and a near-perfect customer satisfaction rating. I received my BSBA in Finance from Appalachian State University.

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.

Kate Doucette, Ph.D. has been in Medical Affairs for 13 years. Currently, she is the Director of the Inflammation & Bone Medical Science Liaison team for the Northeast region at Amgen. Prior to joining Amgen, Kate worked for Biogen for 4 years as a Principal Medical Science Liaison as part of the Hemophilia team, Associate Medical Director for Hemophilia Franchise, and Field Director for the East Hemophilia Medical Science Liaison team during the launches of two novel molecules, ALPROLIX and ELOCTATE. Prior to joining Biogen, Kate was an MSL at Novo Nordisk Inc. for 4 years where she established relationships within the hemophilia community across the United States.

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 .

Avikk is co-founder and CEO of Kernel. Previously, he directed strategic mobile initiatives at Intuit where his team was responsible for product strategy, mergers & acquisitions and best-practice innovations in the wireless ecosystem. Before Intuit, Avikk was vice president, marketing and business development at Mercora and worked in corporate development at RealNetworks. Avikk serves on the board of trustees at the Ghose Foundation. He is on the board of advisors at Virtual Mobile Technologies (Pty) Ltd in Cape Town, South Africa and is a senior advisor at Endeavor. Avikk received an undergraduate degree in economics from the University of Washington and an MBA from New York University.

As co-founder of Javelin Bioscience, Richard brings over 15 years of life science experience. Prior to Javelin, Richard founded Rype Health, a boutique medical affairs strategic consulting firm. Within the industry, he led medical affairs teams at Ultragenyx, Genentech, Cline Davis & Mann, and Astrazeneca. Javelin Bioscience is a data analysis and consulting company that uses artificial intelligence-deployed systems engineering to streamline complex drug development processes.  The AI works within pre-built end-to-end frameworks, which automates processing tasks and accelerates data-driven decision making.

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.

Liz Lathers started her career surrounded by test tubes, pipettes and mice. She earned her B.S. in Chemistry from Lafayette College and Ph.D. in Pharmacological Sciences from the University of Pennsylvania, where she also completed a post-doc. Passionate about education and helping people facing difficult diseases, she joined EMD Serono, Inc. in 2008 as a US Medical Information (USMI) Analyst. For 7 years, she took on broader roles within USMI, and for the last 5 years, Liz built and led US Scientific Communications, a platform function accountable for USMI, Communications, Education, and Training. At the end of 2020, Liz stepped into a new role as Head of North America Medical Affairs (NAMA) Strategy & Operations.

Emily Lemiska joined U.S. Pain Foundation in early 2016 as Associate Director of State Advocacy. In 2017, she moved into a new role as Director of Communications and Educational Programming. In this role, she oversees the organization’s websites, newsletter and email messaging, social media accounts, and blog, as well as several educational initiatives, including the Pain Education Portal (PEP) Talk series and Living Well with Chronic Pain content. Prior to U.S. Pain, Emily worked as an Internal Communications Officer at Massachusetts General Hospital and spent several years as a freelance writer and editor for various health and higher education clients.

Since 2010, Laurie has led Merck’s global health literacy efforts. Laurie earned a national health literacy award for including respondents with low health literacy in patient labeling research. She works, speaks, and publishes internationally. She has co-chaired two working groups on lay summaries and health literacy in clinical trials at the MRCT Center. She served on the EU lay summaries working group. She was an invited speaker by the FDA at a 2017 labeling conference, with an international audience of over 2000 people in 42 countries. She serves on the NAM Health Literacy Roundtable. She won an MM&M Top 40 Healthcare Transformers Award. She has a Bachelor’s degree from Yale and an MBA from Wharton.

Mirela Iovu Niculita is a Regulatory Service Manager working for Synchrogenix, a Certara company that partners with Sponsors worldwide to accelerate medicine development and patients' access to new therapies. After spending a decade working in regulatory and scientific writing, Mirela knows what truly drives regulatory medical writers' interest to produce comprehensive, high-quality documents under stringent regulatory guidelines to convey information to its specific audience. At the same time, they have to develop and implement innovative solutions to accelerate the document development process working with diverse teams worldwide. Mirela has supported over 30 Sponsors with either multiple deliverables for their product submission or co

Paul is an executive director and the Global head of the Real World Evidence Analytic Center of Excellence at Boehringer Ingelheim. Paul works to ensure the management and oversight of high-quality real world studies along with developing and implementing the real world evidence (RWE) strategies for our products in collaboration with our cross-functional colleagues. Paul is a trained Epidemiologist (MPH and ScD) with a strong background in epidemiologic methods and RWE, including observational and experimental study designs and analysis, post authorization safety/effectiveness studies and risk management as well as in-depth knowledge of public and private epidemiologic resources and databases.

Pooja Phogat brings a unique breadth of operational experience, global leadership, and technical expertise establishing Kinapse as a global market leader in Clinical Trial Disclosure. Currently, Pooja is leading Development Operations group, where she is responsible for Clinical Trial Disclosure and Medical Writing services. She has over 18 years of experience in the Life Sciences Industry with 13 years in disclosure. Pooja’s career started in pharmaceutical industry as a Ph.D in Microbiology and thereafter moving to industry. Pooja is recognized externally as a global thought leader in disclosure with a comprehensive knowledge of disclosure regulations such as FDAAA, Final Rule EU-CTR, Health Canada PRCI and others).

Adesh Saxena has been supporting product registration of pharmaceuticals, veterinary medicines and agrochemicals for over 30 years. Currently providing medical writing oversight and leadership to overseas-based medical writers to author complex documents in partnership with global teams to support worldwide clinical submissions, pharmaceutical product label maintenance and support.

Elaine Taylor, VP, Regulatory Strategy and Policy at Synchrogenix, a Certara company, has more than 30 years of experience in the pharmaceutical industry and has extensive experience in developing and providing strategic guidance and regulatory advice at all stages of product development. She began her career in nonclinical (pharmacology, toxicology) research and then moved to clinical research and regulatory affairs. Ms. Taylor’s specialties include creating innovative and efficient regulatory strategies for drug development programs, including 505(b)(2) programs, and conducting gap analysis; advising on regulatory agency meetings, responses to regulatory agencies; and preparation and submission of INDs, NDAs, and BLAs.

Jennifer Park is a Global Content Manager at Sanofi working in the Global Medical Information organization with a focus in Consumer Healthcare. She received her Pharm.D. from Rutgers University. Prior to joining Sanofi, Jennifer completed a two-year fellowship in Medical Information with the Rutgers Pharmaceutical Industry Fellowship program. She serves as a preceptor for Rutgers fellows and pharmacy students in her department.

Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into the process of clinical research, and always keeping the needs of patients, participants and the public at the forefront of his work.

Bethsheba Johnson is a board-certified gerontological nurse practitioner (GNP-BC). She received her Bachelor of Science in Nursing (BSN) from Chicago State University and both her Master of Science in Nursing (MSN) as a pulmonary clinical nurse specialist (CNS), and a Post-Master’s certificate as a GNP from Rush University in Chicago, and Doctor of Nursing Practice (DNP) from the University of Texas Health Sciences Center Cizik School of Nursing as a Nurse Executive. Gilead Sciences, Incorporated currently employs Dr. Johnson as a Senior Director for HIV Prevention Field Director for the Western United States. Bethsheba’s team of seven healthcare providers, including PharmDs, Nurse Practitioners, and Physicians. Her dynamic team mission

Stephen Li is currently the Vice President of Regulatory Affairs at Karyopharm Therapeutics Inc. Prior to joining Karyopharm, Stephen was at EMD Serono (Merck KGaA of Darmstadt, Germany) for over 15 years, and had assumed many roles including Head of U.S. and Canada Regulatory Affairs, Head of U.S. Regulatory and Scientific Policy, and Head of Global Regulatory Marketed Products (based in both Germany and U.S.) with a portfolio of over 20 products in 6 therapeutic areas while also managed International Regulatory Affairs and Medical Devices. Previous to that, Stephen worked at Baxter, ApoPharma, and IMS Health. Stephen also taught Regulatory Affairs at the postgraduate level for many years.

Dr. Pratty is a bilingual psychiatrist specializing in adolescent, adult and geriatric psychiatry with sub-specialties in Treatment Resistant Depression, Alzheimer’s disease, Schizophrenia, Affective Disorders and Psychiatric Utilization Review, and is a Board Certified Addictionologist. He is Service Chief of the Psychiatric ICU of College Hospital of Cerritos, and Past Chief of Psychiatry at Lakewood Regional Medical Center. College Hospital is one of the largest and busiest freestanding psychiatric hospitals on the West Coast averaging about 600 plus admissions per month. He is involved in clinical trials in Addiction Medicine, Schizophrenia, Bipolar Disorder, Obsessive Compulsive Disorders, and Anxiety Spectrum Disorders since 1987.

Originally from NJ, Prachee obtained her PharmD from Rutgers University. After graduating she started her career in Medical Information and spent time at several pharmaceutical companies on the East Coast. Most recently she moved to San Francisco to join the Medical Information department at Gilead Sciences, where she is currently an Associate Director. Prior to the pandemic, she enjoyed traveling, attending concerts, and exploring the city. Now she spends most of her spare time with her newly adopted puppy!

Scott Schliebner is a clinical drug development executive with a 25+ year background, specializing in rare diseases and orphan drug development. His experience encompasses all trial phases; a broad variety of study designs; interventional and observational studies; across a diverse range of rare indications. Mr. Schliebner has held leadership positions within the biotech, non-profit, and CRO sectors, and currently serves on the Board of Uplifting Athletes, where he also leads the Upifting Athletes Scientific Advisory Board. Additionally, Mr. Schliebner serves as Co-Chair of Global Genes' Corporate Alliance and is committed to patient-focused approaches to accelerate the development of new rare disease therapies.

With over 10 years of experience in the pharmaceutical industry, Dr. Wanderer brings innovative thinking and lean process-focused approach. As the Head of Medical Writing at Syros Pharmaceuticals, Tatyana leverages experience in both biotech/pharma side and the vendor side. On the vendor side, Tatyana developed and grew a significant new writer training program, as well as a comprehensive continuous learning program, ultimately serving over 170 writers. The success of this program enabled a nearly 10-fold growth in writing staff, integration and development of new writing tools, and the rapid geographic and portfolio expansion.

Debbie Yen grew up in southern New Jersey and Pennsylvania. Debbie received her bachelor's degree in biology from Duke University and her PharmD from the University of North Carolina at Chapel Hill. Debbie completed her PGY1 and PGY2 Cardiology at Duke University Hospital in Durham, NC. After residency, she took a cardiology clinical pharmacist position at Massachusetts General Hospital in Boston, Massachusetts, where she covered cardiology and cardiac intensive care units. She then moved to Colorado to join her husband, where she was a clinical pharmacist in the cardiology and internal medicine clinics at the United States Air Force Academy. In July 2019, Debbie transitioned to her current position as a medical science liaison at Sanofi.

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.

Mary Alice is the VP, Consulting Services with Synetic Life Sciences, providing consulting services for Medical Affairs, Safety, Clinical and Regulatory with a focus on strategy and fit for future operating models. In her previous role at AstraZeneca, Mary Alice was Vice President of Global Medical Excellence (GME), an organization that included Global Publications, Global MSL Excellence, Global Nominated Signatory, the Medical Academy, Medical Resources, and Patient Centricity. She also held roles as Head of US Field Medical and Vice President of US Medical Affairs at AstraZeneca. Mary Alice has led scientific and medical teams at Takeda, Pharmacia, and Searle and worked in clinical drug development at Hoffmann-LaRoche and Glaxo.

Nicola (Nicky) Haycock is currently a Medical Writing manager at PRA Health Sciences. After graduating from the University of Sheffield with a degree in Biomedical Science, Nicky's career has been focused in the CRO industry, with much of her experience gained from her years spent as a Medical Writer. Her Medical Writing work has spanned many document types, therapeutic areas, and sponsors, building a solid experience base which has formed the foundation of the management role Nicky now holds. Nicky also has experience in clinical operations and biometrics operations prior to her current role. She lives and works in the UK.

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.

Vivian Larsen serves as a Director in the R&D Patient Engagement Office at Takeda, where she leads operations and support strategy development to ensure quality and timely implementation aligned with Takeda’s commitment to R&D Patient Engagement. She collaborates with pharmaceutical research teams and people living with various conditions to surface valuable insights that inform strategic decisions in drug development. Vivian is helping Takeda transform from developing medicines *for* patients to developing medicines *with* patients in order to elevate partnering with patients to a whole new level where there is a more balanced and reciprocal relationship with patients during the process of drug development.

Jaquetta has a background in Computer Science and over five years of experience as a healthcare information technology professional. She is a Spring 2021 graduate candidate in the Master of Science Biomedical Writing program at the University of the Sciences in Philadelphia. She is tech-savvy and passionate about communicating how medical devices and medicines can cure diseases and improve lives. Jaquetta is joining the Merck & Co., Inc., Future Talent Program as a 2021 Medical Writing Intern.

Dr. Mitchell is a graduate of the University of Texas at Austin with her bachelors as well as of University of the Pacific with her PharmD. She completed here PGY1 at New York Harbor VA Medical Center in New York, NY before completing her PGY-2 at VA San Diego. Following residency, she joined faculty of Long Island University in Brooklyn, New York where she managed a Coumadin clinic, rounded on a mental health and a geriatric floor while precepting both IPPE and APPE students. She now practices at Riverside University Health System Medical Center as a Senior Clinical Pharmacist, overseeing special projects including installation of new services and products, and is the PGY2 psychiatric pharmacy residency program director.

I grew up with a love for science and endless curiosity about the medical field. How do you find a cure cancer? How do physicians save lives? When my mother returned home each evening from her work at the hospital, she would tell me stories of the life-saving feats she witnessed. It’s no surprise that I chose to pursue a career in healthcare. I dove deeper into the puzzle of oncology after graduating from Pharmacy school and heading the Hem/Onc Residency Program at Walter Reed Medical Centre. Once in pharma, as an MSL, I loved collaborating with world experts for the benefit of patients. We were changing lives together! Since then, it has been an honor to lead teams as Manager, Director, Executive Director in various roles in MA

Annette Ogbru is a PharmD/MBA by training and has been in the Pharmaceutical Industry for 15 years. Annette has worked within the Medical Affairs Division with expertise in field management, scientific communications, medical strategy development, and field medical roles. Annette also has proven expertise within business components of the pharmaceutical industry by supporting various marketing and brand strategy developments through business analytics. Annette has worked in various therapeutic fields including Neurology, Allergy, Dermatology, Rheumatology, Cardiovascular and Ophthalmology.

Prior to industry, Bo's work experience includes university medical settings, hospitals, academia, home IV, skilled nursing facilities/long-term facilities, and managed care. He has spent over 20 years in industry in different field medical roles at both Janssen and Lundbeck.