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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Paul Minne has over 20 years of experience in medical affairs within the biopharmaceutical industry. During his career, he has had substantial experience with all phases of drug development and support, multiple new product launches, and management of MSL Teams. He has earned a BS from Drake University and a Doctor of Pharmacy from the University of Colorado Health Sciences Center, is a licensed pharmacist and preceptor with the State of Colorado, and is an adjunct professor at the University of Colorado Skaggs School of Pharmacy. Paul resides in Parker, Colorado.

Kay Uttech is VP for Strategic Initiatives at Indegene working with companies to build and optimize medical affairs services. She has more than 20 years’ experience in the pharmaceutical and medical device industry. Kay has held roles in Medical Affairs as a MSL and leading MSL teams in North America. Additionally, she has also held other responsiiblities in Medical Communication and Information; development of global scientific knowledge management systems; grants for ISS and medical education; and promotional review. Her current work is focused on leveraging technology to drive efficiency that optimizes the medical and scientiifc expertise of Medical Affairs teams.

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.

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.

Dipam Doshi graduated with his PharmD from University of the Pacific in 2010. After graduating he completed a one year fellowship at Daiichi Sankyo within the Rutgers Pharmaceutical Industry Fellowship program. From 2011-2015, Dipam Doshi has been a Medical Science Liaison with Daiichi Sankyo. From May 2015, Dipam has been a Sr. MSL at ZS Pharma covering Southern California. More recently, Dipam has been a Principal Medical Science Liaison at SpringWorks Therapeutics. As one of the first MSLs at ZS Pharma and SpringWorks Therapeutics, he enjoys strategically building out tools and capabilities for the MSL team.

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.

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.

Michael is the Executive Vice President of Global Medical Affairs and Medical Information at EVERSANA and has 20+ years of healthcare and pharmaceutical industry experience in multiple leadership roles at several pharmaceutical companies. He has extensive experience in medical information, medical communications and in supporting medical review of promotional / non-promotional materials. Throughout his career, Michael has supported multiple product launches, and he has led MI activities from both a US and global perspective. He has led and grown established MI teams and has built a MI department and services from the ground up. His educational background includes Doctor of Pharmacy, MBA, and Master of Science in Regulatory Affairs degrees.

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.

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.

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.

Kajal is a seasoned pharmacist with 15+ years of experience in pharmaceutical and managed care sectors. She has in-depth knowledge and experience in business planning and execution of clinical strategy. Kajal serves as the lead medical reviewer for one of Takeda’s top products. She is skilled at extensive evaluation and providing strategic scientific consults on promotional patient-facing, HCP-facing, and payor-facing materials. Her diverse background ranges from launching branded social media platforms (Twitter, Facebook and YouTube), disease awareness materials, DTC TV ads, implementing CFL guidance in promotion and HCEI guardrails in payor materials, as well as implementing OPDP advisory comments.

Matt Becker is an Advisory Industry Consultant with the SAS Global Hosting and U.S. Professional Services division. Matt’s more than 30 years of life science experience includes over 9 years with SAS concentrating on next generation clinical trials, data management, analysis, advanced analytics and deployment options in Life Science. As a leader for developing technology solutions to life science initiatives, Becker addresses the challenges that life science companies are having around the analytics lifecycle. The challenges result from new infrastructures that provide more data points than ever before, content management, compliance, collaboration and analytics.

Christy is a Digital Innovation & Transformation Lead at Sanofi and Co-founder of the AI Collective. She received her PharmD from the University of British Columbia, completed a Medical Director Fellowship at Sanofi, before taking on an MSL role, and more recently, making the transition from Medical to Digital. In her current role, she aspires to improve digital foundational literacy across internal stakeholders and to empower them to adopt a digital-first mindset in delivering innovative solutions to patients, healthcare professionals, and the broader healthcare system. Christy has been invited to speak at conferences such as DHX Virtual and ASHP. She also acts as a guest lecturer on the topics of digital health and AI.

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 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.

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.

Dr. Matthew Gitlin, is Founder and Managing Director of BluePath Solutions, a health services research consulting firm started in 2013 with a focus on population decision makers. He spent nearly a decade at a large biotechnology company working in global and European regional offices across market access related functions, supporting research and commercial activities. Matthew holds a Doctor of Pharmacy from the University of California, San Francisco (UCSF) and Bachelor of Science in Chemistry and Biochemistry from University of California, Santa Barbara. He has authored over 75 publications and is an Assistant Professor for the School of Pharmacy at UCSF.

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.

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.

Shoshana Lipson is a patient advocate, speaker, and writer. She has a passion to encourage, support, educate and inspire people living with migraine & chronic pain disorders, to find purpose and value in the midst of illness, and not give up hope. Shoshana leads an online community of over 20,000 members through Migraine Meanderings and Hope for Migraine, and in 2021 launched a new initiative called, Empowering Patient Voices. Shoshana collaborates with various advocacy organizations and pharmaceutical companies, is a contributing writer for Migraine.com, and speaks regularly on the topic of patient centricity. She is the President of Hope in Pain, Inc. and the Executive Director of Migraine Meanderings.

Trevor Standish is a Product Director with over ten years of experience in creating and implementing innovative software products across multiple industries, including pharmaceuticals, finance, and marketing. He is a customer-focused team leader with expertise in various areas such as product SDLC management, UI/UX design, AI/ML systems, and innovation. Trevor has extensive experience in managing software development life cycles, defining global product strategy and roadmaps, and leading teams in the transition to Agile methodologies. He has presented at various industry conferences, assisted global sales teams, and presented at executive roundtables. He has held positions at Certara, Concentric, Synchrogenix, and Fifth Third Bank.

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.

Brenda Taylor is a Director, Global Submissions at Synchrogenix, a Certara company and has over 20 years of experience in the biotechnology and pharmaceutical industry. She has led global writing teams and completed numerous Investigational New Drug and marketing authorization submissions to global regulatory agencies. With experience in writing virtually all submission documents, she brings writing and leadership abilities to submissions of any size. Brenda’s research background in microbiology and immunology includes design and performance of nonclinical studies. Her therapeutic areas of expertise include oncology, cardiovascular, and anti-infective agents, spanning both small molecule drugs and biologics.

Esther Wojuade is currently the Director of Global Medical Information at Gilead Sciences, where she oversees a team supporting the liver, inflammation and established product franchises. Her current responsibilities include leading a team in providing both global medical information support along with medical review committee & promotional review committee support. She has over 17 years of industry experience primarily in medical affairs across multiple therapeutic areas and has held various positions with increasing responsibilities. She received a B.S. in Chemistry from the University of Missouri-Columbia and her Doctor of Pharmacy from the University of Missouri- Kansas City.

Donna V. Booth, B.S, PharmD. is the Head of Field Medical Accounts (East) at GlaxoSmithKline. She has extensive experience across Medical Affairs in various leadership and strategy roles including Medical Information, HEOR and Field Medical. She currently leads a team of field liaisons focused on medical engagements related to clinical, economic and humanistic topics with Population Based Decision Makers at Payers and Health Systems. Donna received her Bachelor of Pharmacy from University of Georgia & her Doctor of Pharmacy from Medical University of South Carolina. Before joining industry, Donna was a clinical pharmacist with faculty appointments at local colleges of pharmacy.

A skilled leader and communications professional with a record of outstanding achievement and rapid advancement into more progressively challenging positions.

Lisa Ambrosini Vadola is currently a Manager of Medical Writing at Whitsell Innovations, Inc, where she leads a team of medical writers and supports clients in the pharmaceutical and biotechnology industries with the preparation of clinical regulatory documents, including submissions to global regulatory agencies. In addition, Lisa provides consultation and training in regulatory medical writing. Before joining Whitsell Innovations, Inc., Lisa earned a PhD in Chemistry from Columbia University and completed postdoctoral training in the Laboratory of Chemical Biology and Microbial Pathogenesis at the Rockefeller University.

Mahek Chhatrapati is the CEO of DocNexus, a healthtech company that is reinventing the global medical affairs ecosystem with search via AI-powered knowledge graphs. DocNexus is delivering insights from millions of scientific publications, clinical trials, claims, and news that would normally take days within seconds and making connecting with HCPs across the ecosystem a seamless process. Mahek is an experienced executive that has expertise delivering value to customers through innovative products at Amazon & AWS, where he helped large enterprise customers develop and scale their data lakes. Mahek holds his Masters in Business Administration from Duke University and his Bachelors of Science from The University of Texas.

With over a quarter of a century devoted to localization industry, Anna is currently a leading member of the life sciences team in Morningside, a Questel company. Using a consultative approach, she advises her clients in pharma, biotech, medical devices, and healthcare, and on all aspects of localization for their regulatory, clinical and marketing needs. Combining her MBA in International Business, industry experience and knowledge of localization technology, Anna utilizes a strategic approach to mitigate global challenges and set-up processes tailored to the specific multi-language needs and requirements of life sciences companies.

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.

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.

Dewey McLin is a Medical Affairs leader with experience in CNS and rare diseases, with a career that has focused on leading the creation and development of new departments while also providing clinical support during the pre-approval period. Dewey joined the pharmaceutical industry in 2004 after completing a PhD in Neuroscience at the University of California, Irvine, where he also served as Adjunct Faculty. His professional experiences have spanned product support across all phases of development, from pre-approval to mature lifecycle management, and included both niche and multi-billion dollar products.

Dan Michel has a Pharm.D. from Creighton University and a drug information residency from the University of Texas Austin. He has been in pharmaceutical industry for over 30 years, ~15 in medical information/pharmacovigilance roles and the last ~15 as a medical science liaison (MSL), in large, medium, and small companies supporting psychiatry, movement disorder neurology, epilepsy, rheumatology, and other therapeutic areas.

As ever-questioning medical communication professional with an international reputation, I have been communicating science to children, grandmothers, business professionals, government agencies, and scientific experts for more than 15 years. My technical areas of expertise span across infectious disease, immunology, oncology, and vaccines and include content deliverables at all stages within a product's lifecycle.

Cheri has over 20 years’ experience in the biopharmaceutical industry, primarily in Medical Affairs but also in US Commercial and organizational transformation. She has led teams across multiple therapeutic areas, all stages of drug development, and various geographic constructs (global, regional, & local). As the Head of Medical Communications at Amgen, she has led strategic communication planning, worldwide medical content creation, multichannel execution, & digital innovation. Cheri earned a PhD in Molecular, Cellular, & Integrative Physiology from the UCLA School of Medicine, focusing on neuroscience. She also holds a Masters in Physical Therapy from UCSF and worked in sports medicine for several years prior to her career in industry.

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.

Helle manages Medical Affairs writing, with a staff of Regional Leads and is responsible for special projects. She joined Johnson & Johnson, former Janssen Research Foundation (JRF), in 1997 and was closely involved in developing JRF’s first electronic submission. She led the oncology writing group and assumed early development MW for global Research units. She worked in the CDISC Glossary Group and in the standards developing organizations of HL7/RCRIM/CDISC Working Group for the Protocol Representation Model. She represented PhRMA on the ICH E3 Q&A Implementation Working Group. She’s a member of the TransCelerate Transparency Leadership Team, is the CSR Redaction Sub Team Co-Lead, and has 40+ years in the pharmaceutical industry.

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.

Natalie currently works as a Senior Medical Science Liaison at Alimera Sciences covering the West Coast. In her current role she strives to develop and maintain long-term collaborative relationships with residents, fellows, and key opinion leaders (KOL) and provide in-depth scientific, clinical, and educational support to the medical community as well as internal training. Natalie earned her Bachelor of Science in Psychobiology from UCLA, her Medical Degree from Universidad Autónoma de Guadalajara, and her MBA with an emphasis in healthcare administration from University of Redlands.

Brentt has dedicated his entire career to the field of education and professional learning. After a brief stint teaching, he spent over a decade conducting economic research to help spur investment in early childhood education. This led to multiple state funded universal pre-K programs. He also worked at a coaching organization focussed on helping K12 districts manage change. More recently I have transitioned to the educational technology and virtual reality sector. For eight years I have led growth and innovation for Mursion, the leading XR platform for practicing difficult conversations. I am responsible for supporting growth in our new markets, like healthcare and the public sector, and I manage strategic alliances for Mursion.

Allyson Chambers currently serves as Director, Regulatory Affairs for Alkermes, Inc, a global biopharmaceutical company. She provides strategic regulatory guidance in the review and approval of advertising, promotional, educational and other materials for FDA-regulated products. With over 20 years of industry experience, Allyson has served similar roles in other companies, contributing to successful DTC advertising, corporate communications and social media campaigns for various brands.

Sheryl Flores is a Director and TA Lead of Vaccines Medical Writing at Merck near Philadelphia, PA. She has 18+ years of pharmaceutical industry experience, ranging from designing late stage clinical programs to leading global regulatory submissions. Sheryl focuses on building high performing teams by cultivating cross-functional relationships and providing opportunities to develop medical writer talent in support of clinical programs and worldwide regulatory dossiers. With this focus, she leads teams through strategic discussions while leveraging her passion for growth and development, to maximize each team members’ ability to prepare clear, effective, and high-quality clinical and regulatory documentation.

Stacey Fung, PharmD is the Head of Global Medical Information at Gilead Sciences. Prior to joining Gilead, she held positions in the Medical Affairs departments of Genentech, Chiron Therapeutics and Protein Design Labs and has practiced in hospital and retail pharmacy settings. She is a seasoned presenter and has chaired meeting sessions at DIA workshops and annual meetings. She has authored several clinical, scientific, and pharmaceutical industry-focused articles. She received a BS in Biology from University of California Davis and PharmD from University of the Pacific. She received post-graduate training at the University of California San Francisco and a drug information residency at University of the Pacific.

Ezinneka is currently the Associate Director of Scientific Communications & Medical Education at Chiesi Global Rare Diseases, where she's responsible for the execution of Medical Education, Training and Scientific Communication strategy for rare disease products, globally. In this role, she also drives medical information & communication initiatives (e.g., symposia, congress planning and content, independent medical education etc.). Previously, Ezinneka has held roles in Medical Review, Medical Information and Pharmaceutical Quality Assurance. She holds a Bachelor’s degree from the University of Texas and a Doctor of Pharmacy (PharmD) degree from Fairleigh Dickinson University.

Regina Lynn Preciado is the Senior Director of Content Strategy Solutions at Content Rules. She leads content strategy teams to help pharma and biotech organizations adopt structured content successfully. She has 25+ years of experience in structured content strategy for pharma/biotech, med device, high tech, financial services, and manufacturing. Regina is an industry expert in structured content authoring, component content management, and content reuse and automation. She lives a dogspotting lifestyle.

Rena Rai is a Manager of the Content Strategy and Innovation team at Janssen. In her current role, Rena is responsible for the development and execution of differentiated content strategies for innovative and digital content for both global and omnichannel consumption across the portfolio. Rena earned her Doctor of Pharmacy at Rutgers University in 2019 after which she completed a residency in Drug Information and a post-doctoral fellowship in Medical Information & Executive Leadership.

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.

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.

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.

Allen brings 15 years of experience in the pharmaceutical industry. After receiving a Pharm.D degree from University of the Pacific, Allen completed a postdoctoral fellowship in market research and competitive intelligence with Janssen Pharmaceuticals and Rutgers University. Currently, Allen is the Director, MSL team lead at Alexion Pharmaceuticals, the rare disease unit of Astrazeneca, where he leads the hematology and nephrology team for the west coast.

Dr. Jennifer Riggins has extensive experience in medical affairs, medical information, medical communications, and digital channels. She is the President of JSR Medical Affairs Consulting and also serves as the Partnership and Technology Strategist for phactMI, a non-profit organization that is both an industry Medical Information center of excellence and the single source of industry medical information. Dr. Riggins, a DIA Fellow, has served on the DIA Board of Directors and Advisory Council of North America among other activities. A dedicated PharmD student preceptor and former director of drug information residency and fellowship programs, Dr. Riggins earned her Doctor of Pharmacy degree from Butler University.

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.

I am an MD physician by training, with 20 years of experience in drug development and medical and scientific affairs. I am presently AVP and Global Head for Medical Affairs and Regulatory at a global technology enabled healthcare solutions provider. I have led many successful global Regulatory Authority engagements across the globe, for developed as well as the Rest of the World- emerging/ developing countries, enabling clinical development plans, strategies, marketing authorisations and post approval compliances for various products including biosimilars. I have a keen interest and experience in enhancing medical value add and scientific information dissemination for medicinal products, in the peri approval and post approval space.

Dr. Doyle is an epidemiologist and health services researcher who specializes in studying the risks, benefits, and value of healthcare interventions. He has over 25 years of experience in conducting research covering specialties such as pharmacoepidemiology, health economics and outcomes research, and real-world evidence. He leads a global team of expert consultants across the product development lifecycle, helping customers navigate complex and fast-changing business and regulatory environments.

Dr. Biagi serves as Clinical Site Management Team Lead for UCB, Inc. She brings over 20 years of experience within the pharmaceutical industry. She has held many memberships and designations over the years including positions with the American Medical Writers Association and the Georgia Pharmacy Association. Dr. Biagi received her PharmD and Drug Information Residency from Mercer University.

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