Pooja Phogat holds a PhD in Microbiology and has over 20 years of pharmaceutical industry experience. For the past 18 years, she has specialized in medical writing, clinical trial disclosure, and data transparency, including Board-level leadership and regulatory consulting. As Co-Founder and Co-CEO of Krystelis, she leads global medical writing, communications, and trial transparency services. A recognized thought leader, she chairs the DIA India Medical Writing Community and co-chairs multiple DIA and EMWA working groups. She is also a member of ISMPP and ISCR and has presented at global conferences, authoring peer-reviewed publications and earning national awards.

Dr Hetal Shah, PhD Pharmacologist & SME-Medical Writing, is the founder & business owner at ‘MeWriT®’ – a niche MSME offering Medical Writing & Training Services. A recognized MW expert with 20+ years of experience; gold medalist with 70+ publications, ‘Woman Entrepreneur in Pharma & Healthcare’ Awardee (2019) by AIC-LMCP, ISCR’s Hall-of-Fame Awardee (2021-2023), and certified for ‘Do your Venture: Entrepreneurship for Everyone’ by IIMB's NSRCEL WSP. DIA’s active member, Mentor for DIA’s global Mentorship Program, and SME and Speaker at various DIA forums. ISCR’s life-member, MW council ex co-chair (Sep 2024-Mar 2025), and Section Editor-MW for PICR Journal.

Annie brings over 18 years of expertise in medical writing, with a specialization in a wide range of regulatory documents. In her current role as Associate Director at GSK, she leads a team of experienced medical writers, managing the development of complex regulatory documents, including submission documents. Annie is a recognized subject matter expert in clinical study reports and is highly regarded for her coaching, mentorship of medical writers, guiding on various documents, processes and regulatory guidelines. She holds a Master’s degree in Biotechnology and Diploma in Clinical Research from University of Pune. She’s an active member of the DIA Medical Writing Group and has presented on several topics at various medical writing forums.

Sherin has over 11 years of experience in medical writing, including regulatory writing and medical communications. She holds a Master of Pharmacy degree in Pharmacology from Manipal University. In her current role as an Associate Director at Lilly Bengaluru, she leads a team of regulatory writers, manages few assets, and actively coaches writers to develop their submission expertise. Sherin is skilled in the development and management of regulatory documents for global submissions. She specializes in crafting content strategies for submissions. Additionally, she is a certified structured authoring trainer and has served as a program committee chair for DIA and as a panelist and speaker at multiple ISCR conferences and workshops.

Sam is a medical communications professional and GCC leader with 20 years of experience in the pharmaceutical industry. He has held roles across both pharma and services organizations, including Novartis, Accenture, Biocon, GSK, Cactus Life Sciences, and AstraZeneca. He has built CoE in medical communications and medical writing for multiple organizations, leveraging process excellence, AI, and automation. He currently leads the Medical Delivery team within AstraZeneca GBS.He serves on executive committees of several editorial bodies, including as a Director of the Asian Council of Science Editors and the Asia-Pacific Association of Medical Journal Editors (WHO - IMSEAR), and holds editorial board positions with international journals.

Pinki has over 20 years of experience in strategic medical communications (MedCom) at global pharmaceutical organizations and MedCom agencies. She holds a PhD in Biochemistry and business management degree from IIM Bangalore. At Novartis and Parexel, she established and led multiple MedCom functions, ensuring delivery excellence to medical affairs globally (US, UK, Europe, Japan, APAC) across multiple products and therapy areas. She has managed publications and medical education programs from early- to late-phase drug development. Currently at Parexel, she is spearheading the MedCom APAC region and driving the India MedCom center of excellence. She is passionate about people and business management.

Priyanka Tiwari has more than 19 yrs of experience in clinical research and the pharmaceutical industry. She is currently an Associate Director, Medical Writing at PPD, part of Thermo Fisher Scientific, where she leads medical writing teams and oversees complex regulatory and clinical documentation projects. Her role includes delivering high-quality documents within timelines, supporting document development, training, and mentoring talent to drive performance excellence. She contributes to regional budget management, business development initiatives, and the expansion of medical writing capabilities. She has extensive experience authoring a wide range of clinical, regulatory documents and is recognized for her strong scientific foundation.

With over 15 years of experience in drug discovery and scientific communications, I am a seasoned scientist committed to advancing science through clear, impactful communication. Following doctoral training at the Medical University of Graz, Austria, and bench research in oncology and inflammation, I transitioned into scientific communications. I have expertise in contextualizing pre-clinical and clinical data across therapeutic areas including anti-infectives, neurosciences, metabolic diseases, and vaccines. A key career highlight has been establishing an in-house publication writing team, covering recruitment, training, operations, quality oversight, and mentoring writers to deliver compliant, high-impact outputs.

Ashok serves as General Manager & Executive Director, DIA India, leading strategy, operations, and partnerships across the country. A pharmaceutical physician with 29 years of experience spanning the Indian Army, academia, and leading global pharmaceutical companies, he brings deep expertise in clinical development, medical affairs, regulatory affairs, and drug safety. Prior to joining DIA, Ashok held senior leadership roles at Novartis, Dr. Reddy’s Laboratories, and Themis Medicare, leading complex development programs and cross-functional teams. He holds an MBBS and MD in Pharmacology, with executive education from IIM Calcutta and certification in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine, UK.

Piyush Upadhyay is a Senior Manager in Regulatory and Patient Document Solutions, Global Medical Writing, Thermo Fisher Scientific with more than 12 years of experience across medical writing, scientific writing, drug intelligence, project management, and people leadership. He has led teams and managed complex regulatory and scientific deliverables. His experience spans oncology, metabolic diseases, immunology, and inflammation across global Phase I–III studies. Piyush holds an M. Pharm in Pharmacology from the University of Pune and a B. Pharm from Bundelkhand University.

Prof. Bikash Medhi is Professor, Department of Pharmacology, PGIMER, Chandigarh, and an internationally recognized leader in pharmacology, clinical research, and pharmacovigilance. He serves as IUPHAR Chairman for Basic & Translational Science, GCP Chairman for the Government of India, and is a member of INSA. He coordinates the PGIMER Pharmacovigilance and Materiovigilance Centre for North India and serves as Regional Coordinator, NADA (North Zone), Ministry of Youth and Sports. An accomplished academic and researcher, he has published over 700 research papers, authored 10 books, and contributed 300 book chapters.

Asees Bajwa is a Manager in Medical Communications and Content Solutions at Pfizer, specializing in vaccines. She holds a Master’s in Public Health with a specialization in Epidemiology from Tata Institute of Social Sciences and Bachelor’s in Dentistry. She previously worked in real-world evidence at Novartis, supporting protocol development and statistical analysis plans. In her current role, she leads end-to-end development of scientific content, including different types of manuscripts, posters, medical content decks and social media posts collaborating with cross-functional teams to deliver high-quality, evidence-based outputs. Her work focuses on translating complex data into impactful medical and scientific communications.

Deepali Chaku is a regulatory writing professional with over a decade of experience spanning clinical research, regulatory affairs, and scientific communication. Based in Hyderabad, she currently serves as a Regulatory Writer at Novartis, where she has been at the forefront of automating Clinical Study Reports, Informed Consent Forms & patient narratives driving efficiency & precision across regulatory submissions. A Base SAS-certified expert and author of six peer-reviewed publications, Deepali brings a rare blend of scientific rigor, data fluency, regulatory expertise to every project.

Ubhaya has 18 years of experience in medical communications. Prior to joining Sanofi, she has worked on publications, medical communications projects, and regulatory documents at Biocon, Novartis, Siro ClinPharm Pvt Ltd, and GSK, across therapeutic areas. She is an ISMPP Certified Medical Publication Professional (CMPP™) and excels in strategic leadership, publication strategy, operational efficiency, developing high-performing teams, and transversal collaboration. She is a part of the ISCR Medical Writing Council (2024, 2025).

Divya Murarka, is a Senior Director and Head of Medical Writing Services, India, at Parexel International. She is a senior healthcare professional with 19+ years of experience in medical writing and leadership roles across pharmaceutical companies and CROs. Her expertise encompasses authoring and overseeing regulatory submission documents with specialisation in oncology.

A Clinical Trial Transparency SME with over 14 years of experience, specializing in project delivery, business continuity, and quality management. Neha is currently serving as Associate Director, Medical Writing at SyneosHealth. In her current role, she actively manages database activities for clients and is responsible for workflow management and User Acceptance Testing (UAT) ensuring that client and regulatory requirements are met during different stages of database lifecycle. Besides transparency platform management, she also leads NIH comment resolution initiatives, advisory support and training initiatives for both clients and internally at SyneosHealth. Neha holds master’s degree in Pharmaceutical Chemistry from BITS, Pilani.

Vidhi leads Plain Language services at Krystelis, where she focuses on delivering clear, patient focused communication across clinical research and trial disclosure. With 15 years of experience in clinical research, clinical trial disclosure, and medical writing, she has successfully integrated AI into plain language writing and is driving AI adoption across multiple processes at Krystelis. In her current role, Vidhi also provides advisory support to sponsors in setting up and strengthening plain language processes. She is passionate about making clinical research accessible and understandable for patients and the public through clear, meaningful communication.

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.

Dr. Alap Chavda is a Principal Publications Writer at GSK, specialising in publication writing and management across therapeutic areas, with a focus on General Medicine and Specialty Care. He previously held writing-focused roles in Medical Communications and Medical Affairs before shifting his career focus to publications. At GSK, Alap prepares manuscripts, abstracts, and congress materials, ensures adherence to journal and ethical requirements, and facilitates the dissemination of clinical and real-world evidence to scientific audiences.

Shruti Diggavi has over 18 years' experience in functional leadership, building teams, and driving operational excellence in QA and GCP audits, centralized/risk-based monitoring, medical writing and scientific communications. She has co-authored EMWA publications on GenAI-augmented structured content authoring and global collaborations in medical writing. Shruti is a recognized thought leader and speaker at ISCR, DIA, and PHUSE EWGs. She holds an M.Sc. in Biomedical Technology and a B.Sc. in Biochemistry and is currently employed at Krystelis Ltd. as Principal Medical Writer (QC), medical communications.

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 18 years of academic and clinical research experience. Currently Shalini is working in Trial Transparency domain and she oversees medical writing projects, including redaction and anonymization projects for EMA Policy 0070 and Health Canada PRCI. Shalini is an avid reader and Indian classical music enthusiast.

Binutha is a medical writer with more than a decade of experience in the field. Before her tenure at Eli Lilly, she worked with GlaxoSmithKline (GSK) Pharmaceuticals Limited.Her writing portfolio includes study protocols, informed consent forms, clinical study reports, investigator brochures, and clinical summaries.She has contributed to a range of therapeutic areas, including immunology, diabetes, respiratory conditions, oncology and infectious diseases.Binutha holds a postgraduate degree in Microbiology from St. Joseph’s College in Bangalore.

Dr. Akshata holds a BDS, PG Diploma in Clinical Research, and MBA in Pharmaceutical Management. With over 18 years of experience in clinical research, she has spent 14+ years leading operations across Medical Writing, Pharmacovigilance, Medical Data Review, Data Transparency, and Quality processes. She has managed global teams, driven transformation initiatives, and led continuous improvement programs. As a service delivery lead for 7 years, she has hands-on experience in planning, contract negotiations, financial management, and business expansion.

Nalin Taneja is a Senior Manager in Patient Safety Medical Writing at Parexel with over 12 years of experience in pharmacovigilance. Nalin has led end-to-end PV projects spanning medical writing, signal detection, case processing, and literature screening. Nalin’s expertise includes authoring and reviewing key safety documents such as PBRERs, DSURs, PADERs, ACOs, and SASRs, ensuring high-quality regulatory compliance. A skilled trainer and team leader, Nalin is passionate about building high-performing teams and delivering client-focused solutions. Nalin actively contributes to innovation, technology initiatives, and inclusion efforts.

Dr. Swapna Bolegave is a Principal Medical Writer at PPD, part of Thermo Fisher Scientific, with over 12 years of experience in regulatory medical writing. She specializes in nonclinical and clinical regulatory documentation for global submissions, including protocols, clinical study reports, investigator brochures, safety narratives, and CTD summaries. She has supported Phase I–IV clinical trials across diverse therapeutic areas, including BA/BE studies, biosimilars, and pivotal development programs, and has contributed to submissions to major regulatory agencies, including the FDA, EMA, and PMDA.

Dr. Rajesh is a Physician (MD) by qualification with MBA in Healthcare & has around 25 years of industry experience in Medical Writing & Medical Affairs. He brings rich medical writing experience throughout product life cycle spanning across Regulatory Writing, Clinical Trial Disclosures, Safety writing, Scientific Communications and digital content writing. He has expertise in building strategic Medical writing partnerships for various global pharma’s, and contribute to development of innovative technology solutions for Medical writing domain. He is currently working as Head of Medical Writing and Medical Affairs at Tata consultancy Services and is based out of Mumbai. He is happily married and blessed with two lovely daughters.

Swapnil Puranik is Head of Strategy, Enterprise Medical Solutions, at Indegene, leading the strategic agenda across medical affairs, regulatory affairs, HEOR, and pharmacovigilance. His current focus is on transforming the medical collaboration model - elevating it from a production function to a strategic capability that connects scientific evidence across the enterprise. An engineer by training, he holds an M.S. in Electrical Engineering from Penn State and an MBA from the Indian School of Business, and is the author of six patents and a peer-reviewed publication in the life sciences sector.

Dr. Rahul Rathod is a seasoned Medical Affairs, Clinical Research, & Evidence Generation leader with 25+ years of experience across global & Indian organizations including AbbVie, Dr. Reddy’s, Bayer, Mitra Biotech, Zydus, and Glenmark. Currently serves as CMO & Co-Founder, Gabriel & Co, & Chief Consultant & Founder, Syvantae Advisory. He has led medical strategy, lifecycle management, & scientific initiatives across therapies like oncology, cardiometabolic disorders, & dermatology. He has 85+ peer-reviewed publications in national & international journals & led 60+ real-world evidence clinical programs. Widely recognized for advancing publication strategy, clinico-regulatory excellence, & scientific leadership

Over 22 years of experience at pharma and service provider organisations, in medical writing (safety, clinical, regulatory, medcom), document quality, data management, technology, and medical services.She has also held site and country head positions. She Leads the Safety Medical Writing team within Parexel’s Global Safety Services, which includes aggregate, signal evaluation and risk management reports. Expertise in growing large teams of medical writers and bridging teams across regions. She is Physician with Post-graduate diploma in medical law and ethics and EMWA certificate in medical writing

Dr. Deepthi Chandra is Associate Director at IQVIA, leading the Quality Control (QC) group and overseeing QC review operations and reviewer teams. With 19 years of experience in medical writing, she has extensive expertise in authoring and reviewing regulatory documents, including clinical study protocols, clinical study reports, patient narratives, and Investigator’s Brochures. A dentist by training with a diploma in Clinical Research, she has worked with IQVIA (legacy Quintiles), Syneos, Clintec, and Accenture. Her current focus is on driving quality excellence through robust QC processes, advanced tool utilization, and AI-enabled medical writing solutions.

Overall, Shruti has 16 years of clinical research experience in real world data (RWD) solutioning, medical writing, product strategy and medical communications, at Parexel and at GSK. Extensive experience in the development of RWD strategies across different therapeutical areas (e.g., oncology, respiratory, cardiovascular, metabolic, and rare diseases). ?Expertise in regulatory writing, authoring protocols, study reports and consent forms. As a Lead Publications Manager, building communication plans and overseeing publication development for three vaccine portfolios. Thought leadership engagements include presenting at Clinical Trials Europe, EMWA, DIA India and ISCR. She holds a MSc in Biochemistry from Bangalore University.

A seasoned professional with over 22 years of experience in the pharmaceutical and healthcare industry, currently serving as Director, Medical Writing at Syneos Health. She specializes in Regulatory Medical Writing and Clinical Trial Transparency, with expertise in CSRs, CTD Modules, CERs, global trial registration, results disclosure, and redaction/anonymization (EMA Policy 0070 and EU CTR). She leads strategic initiatives to build high-performing teams and Centers of Excellence, driving quality and innovation. She also contributes to business development through client engagement and account growth. She serves as Co-Chair of the ISCR Medical Writing Council (2024–2028)

Raina Agarwal is an accomplished professional with over 17 years of experience in clinical trial transparency and medical writing. As Associate Director – Strategy & Growth at GenInvo, she leads initiatives that integrate regulatory writing expertise with innovative technology solutions. Raina has led global teams of medical writers, transparency specialists, and developers, delivering high-quality clinical and regulatory documents. She has contributed to developing SOPs, quality frameworks, and automated platforms for authoring, review, and anonymization of clinical data. A strong advocate of cross-functional collaboration, she is passionate about advancing efficient, compliant, and technology-driven practices in regulatory writing.

Dr. Shivanand is Director and Head of India Medical Writing operations at IQVIA. He joined legacy Quintiles in January 2015, bringing over 19 years of medical writing experience, supported by medical and pharmacy qualifications and a clinical research diploma. His prior experience spans inVentiv Health, Cognizant, and Accenture, where he authored key clinical regulatory documents and led medical writing teams. A dynamic leader, he excels in team building, strategic planning, and project management. His passion for innovation and technology has driven impactful automation initiatives enhancing efficiency and fostering a culture of collaboration and excellence.

Dr. Alben Sigamani is a physician-researcher and clinical trials expert with 20+ years of experience. He bridges science and communication, advancing medical writing, translation research, and real-world evidence to improve patient-centered outcomes. A passionate mentor, he actively trains young writers and researchers in clinical communication and evidence synthesis.

Pallavi Dasgupta is Manager, Medical Communications and Content Solutions – Vaccines, at Pfizer, leading development of scientifically rigorous, audience-focused content for global medical affairs. She partners with cross-functional teams to translate complex scientific data into clear, compliant communications for healthcare professionals and internal stakeholders. Her work spans manuscripts, posters, slide decks, social media, and digital content, with a growing focus on AI and automation in medical writing. Pallavi holds a PhD and MSc in Nanoscience and Engineering from Indian Institute of Science and a B.Tech in Chemical Engineering, and is passionate about positioning medical writers as strategic partners in scientific dissemination.

Ambika Subramanian is a scientific writing leader with nearly 20 years of experience spanning regulatory writing, real-world evidence (RWE), health economics and outcomes research (HEOR), and medical communications. Her experience includes roles across large pharma companies as well as large and small contract research organizations (CROs). She has a strong track record of building and leading high-performing teams that deliver global projects, advance best practices, improve operational efficiency, and mentor the next generation of medical writers. She also brings domain expertise to automation initiatives aimed at enhancing quality, consistency, and productivity in scientific communications.

With over 13 years of experience in the pharmaceutical industry, Eishita brings expertise spanning clinical and regulatory writing, AI-enabled content strategy, and agile digital transformation across global teams. She began her career as a biomodelling scientist, spent over a decade at GSK, and joined Eli Lilly in January 2026 as Director, Systems and Solutions Lead within Scientific Communications. Eishita is passionate about shaping the future of scientific communications and driving high-quality delivery through thoughtful innovation. Her approach to leadership is rooted in clarity and collaboration- powerful catalysts for meaningful progress that help teams deliver impactful outcomes and remain future-ready.

Bishwapriya is a healthcare and data analytics professional with nearly 20 years of experience, including over 18 years in Data Management and Biometrics. He holds a Bachelor of Dental Surgery degree and an MBA in Analytics from IIM Kashipur. He joined Eli Lilly in 2021 after working with Premier Research (formerly Cytespace) and IQVIA. In his current role, he leads Data & Analytics for the Diabetes, Obesity, and Cardiovascular Complications portfolio in India. A Certified Clinical Data Manager, he is passionate about CDISC standards and Data Science. He also completed an Executive Program in Data Science from IIM Lucknow and has presented at industry and academic forums, including SCDM and ISCR.

Dr. Sheetal Pradhan (MBBS, MD) is a medical doctor and pharmaceutical publications professional with 25 years’ experience across Healthcare, Publications, Medical Writing and Med Comms in the pharmaceutical industry. Sheetal has a wide range of experience across team leadership, strategic direction, operational excellence, capability building and people development. In her current role as Director – Head, GCC Publications at GSK, Bangalore, Sheetal leads teams involved in all aspects of Publications including Publications Planning, Writing, Management, Process Management and Operations across all therapy areas.

Ram Prasanna is a business leader in Real World Evidence (RWE) and Health Economics & Outcomes Research (HEOR) with 20+ years in the pharma domain. At EVERSANA APAC, he leads project management and client engagement for RWE & HEOR services. Previously, he worked at GSK, Sanofi, Baxter, Frost & Sullivan, SIRO Clinpharm, and IQVIA, focusing on clinical research, HEOR project management, client engagement, and business development. Experienced in client liaison, observational studies, data analytics, market research, and health economic projects, Ram has supported pharma clients across APAC, US, EU, and Middle East. He holds MSc degrees in Health Economics & Pharmacoeconomics and Biotechnology, plus an IIM certification in Sales & Marketing.