Speakers
Elizabeth Froom, PharmD, RPh
Senior Director, Medical Writing and Healthcare Communications, PPD, United States
Elizabeth C. Froom, PharmD, is a Senior Director in the Medical Writing and Healthcare Communications team at PPD. 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.
Elizabeth Brown, MS, PMP
Executive Director, Medical Writing & Disclosure, Merck & Co., Inc., United States
Elizabeth Brown is an Executive Director in Medical Writing & Disclosure at Merck & Co, Inc. near Philadelphia, PA. She has led regulatory projects and initiatives in the pharmaceutical industry for 20+ years, as a laboratory scientist, a clinical researcher, a medical writer and an organizational leader. With her project and people management focus, she has developed a passion for developing people, advising teams, and providing strategic guidance how to create efficient, effective, and high-quality scientific communication deliverables.
Richard Swank, PhD
Founder, Scientific Engagement LLC, United States
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 holds 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.
Barbara Nardi, PharmD
Global Director - Medical Communications, Thermo Fisher Scientific, Brazil
Bárbara is a PharmD and holds a B.S. in Marketing and Business Management, with 20+ years professional experience in the Pharma and Bio Pharma environment, working across several areas (Medical Affairs, Pharmacovigilance, Quality, Compliance, Customer Service and Marketing) in different Regional and Global industries. Bárbara joined PPD in 2017 and is currently an Operations Director at PPD, part of Thermo Fisher Scientific, with extensive experience in the pharmaceutical industry, supporting businesses and bringing her technical and medical expertise.
Marta Avellar, MBA
Medical Information Regional Head, Latin America Canada, Takeda Pharmaceuticals, Brazil
With over 20 years in the pharmaceutical industry, Marta Avellar leads Medical Information strategy and operations for Latin America and Canada at Takeda. Her career includes leadership roles in Pharmacovigilance and Medical Information at Wyeth (now Pfizer), Janssen (now J&J), and Shire (now Takeda). At Takeda, she has continuously driven digital innovation and operational excellence, and played a key role in global M&A integration, including a U.S.-based rotation focused on leadership transformation in Medical Information. Marta is an active member of the Medical Information Committee of Sindusfarma, a pharmaceutical industry association based in São Paulo, Brazil.
Meera Patel, PharmD
Head of Global Medical Information, Content, Bayer, United States
Meera serves as the Head of Global Medical Information, Content at Bayer in Whippany, NJ, where she leads a large, global team responsible for medical information, content strategy and communication, of Bayer's complete pharmaceutical portfolio. Her leadership has driven innovation, including the creation of a dedicated group within Bayer Oncology focused on cutting-edge content and medical insights. Building on over 20 years of pharmaceutical experience, including roles at Johnson & Johnson and Schering-Plough, Meera has participated as a speaker at industry conferences such as DIA Annual and MASC.
Donna A. Holder, PharmD
Executive Director, Head of Digital Strategy and Innovation, Daiichi Sankyo, Inc., United States
Donna Holder has over 30+ yrs experience in the pharma. She is the Executive Director & Head of Digital Strategy and Innovation in Global Oncology Medical Affairs at Daiichi Sankyo where she focuses on implementing digital technology, platform and processes. Previous to that she led Global MSL Excellence at Daiichi Sankyo, Merck & Co, and AstraZeneca. In these roles she drove consistency, standards and the development of tools & processes in Field Medical. Donna has spent the majority of her career in Medical Affairs leading teams across multiple functions. Donna is a PharmD graduate of the University of Michigan.
Sejal Vora, PharmD
Senior Director, Medical Information, Beone Medicines USA, United States
Sejal Vora has over 20 years of industry experience within Medical Affairs, including Medical Information, Publication Planning, Investigator Initiated Research, and serving as a medical reviewer for promotional and medical review committees. She earned her PharmD at the University of North Carolina at Chapel Hill and completed a pharmacy practice residency at University of California at San Diego before starting a career in the pharmaceutical/biotech industry. Her experience within Medical Information includes building and maintaining multiple response databases, leading a medical information team, and collaborating closely with internal partners to build a medical information website and a dynamic medical information dashboard.
Elizabeth Olbrich, MS, RN
Associate Director, PPD, United States
Elizabeth Olbrich, RN, MS, is known for engaging teams through hands-on leadership and conviction to do what it takes to produce quality output and achieve milestones. She has earned reputation for fostering positive vendor/client relationships, establishing and leading teams, and vendor performance turn-around. Elizabeth has provided strategic leadership for global medical writing, CRO partnerships, and quality control activities. She currently oversees a global medical information program involving 12 medical writers and editors who deliver over 1,000 annual documents while exceeding client KPIs.
Nimita Limaye, PhD
Research VP, Life Sciences R&D Strategy and Technology, at IDC, IDC, United States
Dr. Nimita Limaye provides strategic advisory and market analysis on key topics related to Life Sciences R&D Strategy and Technology, and is IDC's primary life sciences AI analyst. An executive business leader with over three decades of life sciences leadership experience, spanning pharma, CRO, and tech consulting, she has led business strategy and managed large global operations. An extremely well networked thought leader, she has been ranked amongst the top 50 analysts in the AR100 Market Amplifiers Power 100 list in Q4 2025. She was the recipient of the 2024 DIA Global Inspire Award and has served as the past chair of the SCDM board. She is the current chair of the DIA Global Medical Writing community.
Sudipta Chakraborty, PhD
Clinical Trial Transparency Strategy Lead, Biogen, United States
While working on her PhD, Sudipta discovered her passion for helping the public better understand science. In her first position as a medical writer, Sudipta learned of the new requirements for patient-friendly summaries of clinical trial results. Since then, Sudipta has worked with over 20 sponsors in developing a pipeline of plain language deliverables. She has also built teams that effectively use health literacy and patient-focused strategies in their communications. Currently, Sudipta is a Senior Manager of Clinical Trial Transparency at Biogen, where she oversees transparency commitments and leads initiatives to help Biogen become more patient-centered in their communications.
Fabiana Ebihara, MSc
Director, Medical Writing Services, Parexel International, United States
Fabiana Ebihara has over 19 years of extensive experience in the field of medical writing, with a particular focus on leadership and regulatory medical writing. Throughout her career, Fabiana has held several key leadership positions at Parexel International, where she has played a pivotal role in managing medical writing partnerships with pharmaceutical companies. She provided financial and operational oversight and led projects covering a range of therapeutic areas. Fabiana has successfully collaborated with her clients, implemented process improvements, and mentored cross-regional teams.
Nancy Tam, MS
Head of Medical Writing, Pfizer Inc, United States
Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. Nancy has implemented automated solutions for content creation at several sponsor companies and is working to implement AI-assisted technologies throughout the R&D organization at Pfizer.
Jenny Boyar, PhD
Principal Medical Writer, AbbVie, United States
Jenny Boyar is a Principal Medical Writer at AbbVie, with nearly a decade of experience in medical and scientific writing. She has contributed to publications with professional organizations like the Regulatory Affairs Professionals Society, and her academic work has appeared in multiple scholarly journals. A Fulbright recipient, she holds a PhD in English from the University of Rochester. With extensive experience across a variety of clinical and regulatory documents, she is invested in working collaboratively and cross-functionally to produce impactful writing.
Iris Tam, PharmD
Senior Vice President and Head, Medical Affairs and HEOR , COEUS, United States
Iris Tam, PharmD, FAMCP, is Senior Vice President & Head of Medical Affairs and HEOR at COEUS Consulting with 34 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.
Sarah Jarvis, MBA
Global Medical & Evidence Lead, ZS Associates, United States
Sarah Jarvis leads our Global Medical & Evidence 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.
J. Lynn Bass, PharmD, RPh
Medical Affairs Lead, Mesoblast, United States
In her 25+ years of industry experience, Lynn has served in both individual and leadership positions within Medical Affairs at both large and start-up companies. She is currently Sr. Director, Medical Science Liaisons at BridgeBio, where she is building and leading a field medical team in the rare cardiovascular therapeutic area. Lynn is a transformative leader with proven excellence in building & developing high performing teams. Along with her leadership positions, Lynn is very active in growing/expanding the MSL profession across the industry and is a frequent invited speaker. She has also authored/ co-authored several MSL surveys highlighting and assessing the MSL role.
Mitra Sadeghi, PharmD
Sr. Director, Medical Affairs, Genentech, United States
Maria Paula Bautista Acelas, MSc
Senior Scientific Project Manager, DIA, United States
Maria Paula offers expert scientific content guidance and project management support for DIA's global consortium initiatives and specialty meetings. She is dedicated to ensuring the development and delivery of impactful, patient-centric scientific content that generates evidence to facilitate the integration of innovation in medical product development. She brings experience in public health, patient engagement, and research management. She holds a Master of Science in Health Care Management from Marymount University and a Bachelor of Science in Microbiology and Bioanalysis from Universidad Industrial de Santander, Colombia.
Jon Gonzales, PhD
Field Medical Capabilities Lead , ZS Associates, United States
Jon is an Associate Principal for ZS and lead of the Field Medical capabilities for the Medical Affairs practice. In this role, Jon leads the development, oversight, and innovation of Medical Affairs projects that impact strategy through execution for field medical teams. During his 9.5 years at ZS, Jon’s focus has been within the Medical Affairs practice at ZS. He’s supported Medical teams across the industry across the different stages of the product lifecycle. He has helped clients by bringing data-driven and customer-oriented solutions for medical strategy and field medical execution. Jon holds a Ph.D. in Biomedical Sciences from the University of California, San Diego and a BS in Biochemistry from Colorado State University.
Evelyn R. Hermes-DeSantis, PharmD
Director, Research and Publications, Phactmi, United States
Evelyn R. Hermes-DeSantis, PharmD, BCPS, is the Director for Research and Publications for phactMI and Professor Emerita at the Ernest Mario School of Pharmacy at Rutgers, the State University of New Jersey. She is dedicated to advancing and elevating the practice of medical information. She received both a BS in Pharmacy and a PharmD from Rutgers and completed a Drug Information specialty residency at the Medical College of Virginia Hospital in Richmond, Virginia prior to working at the University of Utah Hospital Drug Information Service. For 25 years she was the Director of Drug Information Services at Robert Wood Johnson University Hospital and a Clinical Professor at the Ernest Mario School of Pharmacy at Rutgers.
Patrina Pellett, PhD
Co-CEO, MSL Mastery, United States
Patrina Pellett is the Co-CEO of MSL Mastery and a leading expert in strategic, AI-powered Medical Affairs training. She helps MSLs and leaders think strategically, communicate at an executive level, and generate insights that drive strategy. Known for doing things differently, Patrina builds innovative, practical learning experiences that push past traditional training. As a trusted thought leader, she shares clear, practical advice that strengthens the strategic voice of Medical Affairs teams.
Sylvia Baedorf Kassis, MPH
Program Director, MRCT Center of Brigham and Women's Hospital and Harvard, United States
Sylvia Baedorf Kassis, MPH has over 25 years of clinical research experience. She currently serves as Program Director at the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. Her main foci over the past seven years has been on health literacy, return of results, and patient engagement. Her clinical research interests include integrating study participant experiences into research, supporting research coordinators through networks and training, and ensuring researchers have access to vital information that supports the ethical and compliant research conduct. Sylvia earned her MPH in Global Health at Boston University School of Public Health (2008) and a BSc at the University of Toronto (2001).
Pooja Srivastava Banerjee, MPharm
Senior Director & Head, Medical Communications, Krystelis Ltd, India
With 18+ years of experience, Pooja holds a Master's degree in pharmaceutical chemistry and a postgraduate diploma in health communications. She currently leads Medical Communications at Krystelis, managing publications, medico-marketing, and medical education. Pooja specializes in strategic communication for pharma and biotechnology, having worked on public health campaigns, advisory boards, RWEs, and developing consensus statements and clinical guidelines. She has worked with top pharma clients, and other healthcare stakeholders. Pooja is also a published author, having received the PRS Global Open "Best International Collaboration-Gold Award" in 2020. Actively involved as a faculty member in workshops and conferences.
Jason Casavant, JD
Executive Director, Medical Writing, Synterex, Inc., United States
Jason Casavant is the current head of medical and regulatory writing at Synterex, Inc. Over his 25+ years of experience in the life sciences and clinical research industry, he has specialized in medical writing, GCP quality assurance, operations, and training. This breadth of expertise reflects a strong foundation in both technical and leadership domains, allowing him to drive compliance and operational excellence across complex projects. In addition to technical expertise, he has contributed thought leadership through presentations and discussions on topics such as motivation, engagement, and agile methodologies in regulated environments, emphasizing continuous improvement and adaptive project management practices.
Purvi Dunn, MEd, MPA, PMP
Director, Capability Building Leadership Excellence, EMD Serono, United States
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.
Marie-Luise Helmich, PhD
Head of Global Medical Information Key Markets - Global Medical Information, Sanofi, Germany
Marie-Luise is Head of Global Medical Information Key Markets at Sanofi, overseeing operations in Europe, Japan, China, and the Greater Gulf. She previously led Medical Information for Europe after establishing the function in Germany, Switzerland, and Austria. In addition to ensuring high-quality information delivery, she is driving the integration of digital media into MedInfo channels. Marie-Luise co-founded the Medical Information subcommittee at the German VFA, is a member of MILE, and has served on the DIA Medical Information Conference program committee for over a decade. Her background also includes leadership roles in Medical Affairs, Supply Chain, and Quality, including work as a Qualified Person.
Valerie Huh, PharmD, MBA
Director, Global Innovation and Implementation, Propharma Group, United States
Valerie Huh has over 21 years of experience in the pharmaceutical, healthcare, and education sectors, with more than 11 years specializing in Contact Center and Medical Information Process Improvement. She holds a Pharm.D and an MBA and is passionate about leveraging advanced technology and innovative work methods to drive operational efficiency. In her current role at ProPharma, she focuses on enhancing customer experiences by optimizing processes within the Global Contact Center.
Roanie Levy
CCC Legal Advisor, Copyright Clearance Center, United States
Anmol Limaye
Manager, Alcon, United States
Mary H Ost, PhD, MS
Associate Director, Regulatory Medical Writing, Johnson & Johnson , United States
Mary Ost, PhD, is Associate Director of Regulatory Medical Writing at Johnson & Johnson Innovative Medicine, with 30 years of experience across the pharma and CRO spaces. As AI-assisted Operations Lead, Mary has defined strategy and led solution deployment for AI-driven initiatives for RMW at J&J. Mary is interested in best practices for integrating AI into regulatory and clinical documents to drive efficiency while preserving quality and compliance.
Wesley Portegies, MBA
Chief Strategy Officer & Founder, Medcomms Experts, United States
Risa Reuscher
US Medical Regional Therapeutic Area Lead – South/Southeast, Genentech, United States
Natalia Sanchez Gandarillas, MPharm
Associate Director Med Affairs and Med Info, EVERSANA, United Kingdom
Vince Santucci
Field Director Endocrinology Medical Science Liaison Team, Recordati Rare Diseases, United States
Ghazaleh (Gigi) Shafai, PharmD
VP Medical Affairs & Digital Transformation, Transperfect Life Sciences, United States
Julie Taitsman, JD, MD
Managing Director, BDO USA, United States
Julie Taitsman MD JD, Managing Director BDO Healthcare Forensics, brings 20 years’ experience combating fraud and promoting program integrity in health care. Dr. Taitsman served as Chief Medical Officer for the Office of Inspector General for the U.S. Department of Health and Human Services. Dr. Taitsman lent medical expertise to audits, evaluations, inspections, and enforcement actions and led physician education initiatives. She previously served as Special Counsel for Health and Science at the Senate Finance Committee and authored the Staff Report on Industry Funding of Medical Education. She earned a BA from Brown University, MD from Brown University School of Medicine, and JD from Harvard Law School. She completed the Preliminary Med
Jeanette Towles, MA, RAC
CEO, Synterex, Inc., United States
Jeanette Towles, MA, RAC is the Founder and CEO of Synterex, Inc., a clinical and regulatory consulting firm pioneering the digital transformation of regulatory science in life sciences and healthcare. Under her leadership, Synterex is developing a digital regulatory ecosystem—a network of AI-enabled micro-SaaS applications that connect data, content, and compliance across the drug development lifecycle. Recognized for its EcoVadis sustainability certification, Synterex integrates responsible automation, accessibility, and ethical AI into every layer of its design. Jeanette champions a vision of democratized AI in healthcare—where technology accelerates discovery, enhances transparency, and expands equitable access to innovation.
Lisa Chamberlain-James, PhD
Senior Partner, Trilogy Writing & Consulting, United States
Lisa Chamberlain James is a Senior Partner and Chief Executive Officer of Trilogy Writing & Consulting. Aside from management activities, she also leads client projects, with extensive experience in a variety of documents and a special interest in drug safety and patient information. After receiving her Ph.D. in Pathology, Lisa began her medical writing career in Cambridge in 2000. Since then, she has been heavily involved in the EMWA on the Education Committee and as a workshop leader, is a visiting lecturer for King’s College London, initiated and chaired the EMWA PV and Communicating with the Public SIGs, is chair of the Geoff Hall Scholarship Committee, section editor for Medical Writing, and a Fellow of the Royal Society of Medicine.
Andrea Clark, PhD
Principal Medical Writer, Eldridge Writing & Consulting LLC, United States
Andrea Clark is an experienced medical writer with a PhD in chemistry and a background in regulatory affairs, biochemistry research, and academic teaching. With more than four years of experience developing clinical regulatory documents, she has contributed to a range of drug development programs across multiple therapeutic areas. She has led and mentored a team of medical writers, promoting effective collaboration and ensuring the delivery of high-quality, compliant documents. An active member of the medical writing community, she has presented at industry conferences and currently serves as the Volunteer and Membership Coordinator for the AMWA Mid-Atlantic Chapter.
Nicole Griswold, PharmD
Executive Medical Director, Head of Allergy/Immunology US Medical Affairs, Novartis, United States
Dr. Nicole Griswold has 20 years of Medical Affairs experience and is currently leading medical strategies for flagship immunology brands at Novartis. She is passionate about empowering medical teams to become strategic medical leaders who bring measurable impact to cross-functional teams, clinical practice, and patient outcomes. She has built high-performing field teams known for effectively translating complex science into data narratives relevant to patient care decisions - moving the conversation beyond activity-based KPIs to true scientific and clinical influence.
Florian Hoehn
Director, Technology Strategy & Data Practice , Mavens (A Komodo Health Company), United States
Kim Jochman, PhD, RAC
Senior Director, Medical Writing, Merck & Co., Inc., United States
Kim Jochman, PhD, RAC, is a regulatory medical writing leader, with a career spanning almost 2 decades and expertise across a wide array of document types, development phases, and therapeutic areas. Kim is deeply committed to talent development, spearheading medical writing development programs at Merck, including summer internships, an entry-level Associate Medical Writer program, and a cross-development program. She champions the advancement of new technology by driving change management initiatives that empower her team and enhance operational efficiency. Kim is also active with the American Medical Writers Association (AMWA) and is a 2024 AMWA Fellow, an AMWA educator, and a past 2-time Carolinas Chapter President.
Jung Lee, PharmD
Senior Director, Global Medical Content Strategy, Digital Enablement, AstraZeneca, United States
Jung began her career at AstraZeneca in 2000 and has over 17 years of Medical Affairs experience, in various roles and in multiple therapeutic areas. She started as an MSL in NYC & Philadelphia prior to beginning her HQ-based roles. Jung received a BS and PharmD from Philadelphia College of Pharmacy & Science. She completed a managed markets pharmacy residency at Advance Paradigm/University of Maryland. Prior to AZ, she was a clinical pharmacist for HIP of New York.
Michelle Linggi, PhD
Director, Medical Writing and QC, Aroga Biosciences, United States
Sabine Lischka-Wittmann, DrSc
Sr. Director - Medical Information, Europe, Lilly Deutschland GmbH, Germany
Sabine Lischka-Wittmann, PhD is currently the European Medical Information Director for Eli Lilly & Company. She was previously the Senior Manager of the Medical Information and Medical Liaisons teams in Germany. Sabine is a highly experienced Medical Information manager: she has managed the German team for over 20 years. Sabine has lead numerous projects across the European region during her role as a European MedInfo Coordinator, including the implementation of Virtual MedInfo Teams in Europe to increase productivity, a quality assurance system for MedInfo responses, and the harmonization of process flows in this function. Sabine has presented at the DIA US Medical Communications workshop as well as the European Med Info conference.
Kari Loeser, JD
Vice President, Chief Compliance Officer, Cytokinetics, United States
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.
Tom Peddicord, PharmD
Senior Director, Payer and Immunology MSLs, argenx, United States
Tom is a Medical Affairs leader within biotech at argenx, where he leads the Immunology and the Payer MSL teams. At argenx, he is focused developing and implementing unique solutions starting with clinical development and continuing through commercialization, in rare diseases. Related to this session, Tom has focused on the intersection of healthcare and technology for years, applying learnings from adjacent verticals to the biotech space.
Matthew Renda, PhD, MS
Senior Director Medical Writing Operations, Alexion, Astrazeneca Rare Disease, United States
Matt Renda He has 13 years of academic research experience focused on gene therapy and 18 years of pharmaceutical development experience providing regulatory submission management and medical writing leadership to optimize cross-functional processes, implement innovative technologies and efficiently develop clinical documents. Matt joined Alexion in 2016 and leads a team focused on evaluating and implementing new technologies for Medical Writing. He received Platinum accreditation for completing the AstraZeneca Generative AI Accreditation Programme and has presented on Structured Content Authoring at Industry user forums, DIA Global, AMWA, RAPS and RSIDM.
Mary K. Sendi, PharmD
Medical Information & Review, Global US Regional Lead, Pfizer Inc, United States
Mary is the Global Content Strategy and US Regional Lead for Pfizer Medical Information [MI]. Mary earned both a Bachelors and Doctorate degree in Pharmacy. Mary has greater than 20 years pharmaceutical industry experience specific to medical information. Outside of Pfizer, Mary is active in advancing the medical information profession through her leadership/collaboration roles in the Drug Information Association and phactMI [Pharma Collaboration for Transparent Medical Information]. Mary is currently serving on the phactMI board of directors for the term 2019-2020.
Shalini Dwivedi, MPharm
VP, Krystelis Limited, India
Shalini is a Clinical Research Scientist who has expertise in regulatory and publication writing, and training clinical research professionals in various aspects of Clinical Research including Drug Development, Project Management, Publication Ethics, and Regulatory and Commercialization writing. Shalini completed Masters in Pharmacy from Jamia Hamdard, a prestigious university in Delhi, India. She has almost 15 years of academic and clinical research experience. Currently Shalini is working in Trial Transparency domain and she oversees Clinical Trial Disclosures projects, including redaction and anonymization projects for EMA Policy 0070 and Health Canada PRCI. Shalini is an avid reader and Indian classical music enthusiast.
Julia Forjanic Klapproth, PhD
Senior Partner, Trilogy & Consulting GmbH , Germany
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. 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.
Maureen Kashuba, BSN
Director, Health Literacy Projects , Merck Sharp & Dohme LLC, Rahway, NJ USA, United States
Maureen Kashuba has over 20 years of Pharma experience. She leads the Plain Language Summary (PLS) program at Merck Sharp & Dohme LLC, United States. She led the development of the company’s > 1250 term Health Literate Glossary which has been reviewed, tested for cultural competency and approved for use internally. She’s led Patient Panel and Cultural Competency reviews to engage diverse insights on terms and concepts. Maureen co-chairs the DIA PLS Working Group is a member of the MRCT Center Glossary Development Review Team and the EFPIA CREG joint subteam on patient friendly language. She is passionate about clear communication of research information to empower patients to make informed health choices for themselves and their families.
Darshan Kulkarni, JD, PharmD, MS
Principal Attorney, Kulkarni Law Firm, PC, United States
Dr. Kulkarni is Principal Attorney for the Kulkarni Law Firm which focuses on providing legal and regulatory solutions to pharmaceutical companies and their providers. He is a pharmacist & lawyer and advises clients on bringing their product to market, focusing on post IND thru commercialization and genericization.
Billy Soffera, PharmD
Associate Director of Operations, PPD, United States
Billy Soffera, PharmD, Associate Director of Operations, Medical Communications at Thermo Fisher Scientific, leads initiatives to enhance efficiency, quality, and innovation in medical information services. With nearly 20 years of healthcare and operations experience, he focuses on integrating technology to improve communication and compliance. At DIA, he will present a case study on using generative AI to streamline document search, enabling front-line agents to deliver more complete and timely medical information.
Woo Song
CEO, Xogene, United States
As a seasoned technology entrepreneur and business builder, Woo oversees Xogene’s strategic direction as well as the services and technology divisions. Prior to Xogene, Woo co-founded Intrasphere, a technology and services provider to the biopharmaceutical industry, which was acquired by Deloitte Consulting. Woo also co-founded PharmaCM, a leading clinical disclosure platform, now acquired by Citeline. A former derivatives trader, Woo is also a founder of Reval, a global leader of SaaS platform for treasury and risk management with clients and employees in North America, EMEA, and the Asia Pacific, now a part of Ion Group.
Angela Russell Winnier, PhD
Executive Director of Medical Writing, Pfizer Inc, United States
Angela joined Pfizer in 2018 and is Executive Director of Medical Writing and the therapeutic area lead for internal medicine and inflammation/immunology. In addition to her pipeline support, Angela serves as technology lead for medical writing, providing strategic and operational oversight to all MW technology projects to achieve successful technical implementation, change management, and operational efficiencies. Angela has led innovative and complex technology projects and has played a critical role in technology upskilling efforts in the medical writing group. Starting in 2023, she has been part of prioritized cross functional efforts focused on AI-assisted authoring solutions.
Jordana Wollmann, PharmD
National Clinical Account Director, AstraZeneca, United States
Dr. Jordana Wollmann earned both her Bachelor’s degree in Business Administration and Doctor of Pharmacy from the University of Florida. She completed a postdoctoral fellowship in Managed Care Medical Communications at Genentech, where she went on to spend four years in medical communications and one year as a Managed Care Liaison. In 2020, she joined AstraZeneca, where she has spent the past five years in field medical roles supporting payer engagement—initially with regional accounts and now with national accounts—focused on advancing the clinical and economic value of medicines across the healthcare landscape.
Katie Moy, PharmD
Associate Director, Medical Information & Review, Acadia Pharmaceuticals, United States
Katie Moy currently serves as Associate Director in Medical Information and Review at Acadia Pharmaceuticals Inc. She has supported 7 product launches in her career, globalized Medical Information workstreams, and led Medical Communications and Information content creation across a range of therapeutic areas including Rare Disease, Neuroscience, Ophthalmology, Immunology, and Bone Health. Katie is dedicated to mentoring; she precepts pharmacy student industry rotations and has established a Medical Affairs postdoctoral fellowship program. Katie completed her fellowship at Baxter Healthcare and earned her PharmD from the University of California, San Diego.
Behtash Bahador, MS
Senior Director, Community Engagement & Partnerships , Center for Information and Study on Clinical Research Participation (CISCRP), United States
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.
¿Tiene una cuenta?