Jillian Carinci is Sr. Director, Head of Submission Sciences group at Biogen. Jillian leads Biogen’s Global Delivery Managers and is responsible for overseeing global submissions, establishing processes, ensuring compliance, robust submission planning, tracking metrics, high quality submission delivery and process improvements. Jillian began her career at Octagon Research Solutions before transitioning to Accenture. During her tenure at Accenture Jillian partnered with sponsors to manage numerous regulatory submission projects, ensuring compliance with global regulatory requirements, delivering within scope, on time, and with the highest quality.

Cary is the Managing Partner of LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, and simplify information management and the use of technology. Her areas of expertise include regulatory information management, intelligent automation, data strategy/governance, e-submissions, R&D and GxP content management, IT strategy, enterprise architecture, Agile, business process optimization, and project/program/portfolio management. Cary co-leads the DIA RIM Working Group, leads the DIA RIM Intelligent Automation Topic Team, leads the new RAPS AI Community, and regularly serves as an industry thought leader.

Sandy Krogulski is an experienced and solution oriented individual with over 10 years of submission experience. Sandy joined BMS in 2018, working on global submissions and process evolution. In her current role, Sandy is focusing on digitalization and automation of processes to improve submission strategy and business operations.

Cindy Chiu is a Senior Director in Global Regulatory Affairs and Clinical Safety group at Merck & Co. She has over 20 years of experience in the pharmaceutical and energy industries, focusing on post-merger process integration and operations excellence. She has served in various leadership roles overseeing project management, business process improvement and change management initiatives. In her current role at Merck & Co., she is the Lead of the Regulatory Content Authoring and Archiving Management group. Prior to Merck, she worked as a management consultant, where she assisted clients with change management and business process redesign as a result of merger activity or technology integrations.

Jonathan Resnick is a member of CDER’s Division of Data Management Services and Solutions, with a focus on eCTD and has been with FDA for 14 years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

Rita Algorri, PhD is a Senior Manager, Regulatory Affairs CMC at Amgen Inc. in Thousand Oaks, CA. In this role, her responsibilities include leading and orchestrating internal and external engagement activities relating to regulatory modernization, digitization, automation, and emerging technologies. She also serves within Amgen’s Advocacy and External Engagement function which fosters collaboration with multiple internal and external cross-functional teams to coordinate and progress company and industry initiatives. Rita is a microbiologist by training and holds a PhD in Clinical and Experimental Therapeutics and M.S. in Regulatory Science from the University of Southern California.

Jennifer Dames is Director, Regulatory Submissions at AbbVie. She has over 10 years experience in Regulatory. Jennifer has experience with implementation of a Regulatory Information Management system, Document Management, Submission Management, Publishing, and system support.

Regulatory Affairs Business Solution expert with proven industry experience in project management, advisory services, business analysis and business support of the Department. With her 10 years’ experience at AstraZeneca leading Regulatory IT projects, spanning business/technology analysis, project management, validation/testing, business training development and delivery she has credibility speaking with both IT and Regulatory business stakeholders. As an end-to-end RIM process data and system expert with 9 years’ experience in Regulatory consulting for top pharma clients she has led business process optimization, RFP and vendor selection, implementation, and migration projects.

Dominik Gigli is a senior expert in Regulatory Information Management and IDMP with 10+ years in the pharmaceutical industry driving the digital transformation in Regulatory Affairs. With his strengths drawing the big picture and vision towards data driven regulatory submissions and particular understanding of the steps and obstacles how to get there, Dominik is helping Life Science transform their organization to a digital future. Before joining MAIN5 in 2022, Dominik was working in several leading positions in Regulatory Operations focusing on RIM, IDMP, Data Management, Data Governance Data Quality, Reporting and Analytics in Merck Healthcare and Fresenius Kabi.

Handsome Ji is highly driven and experienced, with 18 years regulatory operational, project and change management experience within multi-cultured global environments. Handsome was invited as guest speaker in DIA China 7th, 10th and 11th Annual Meeting, served as host and Speaker for CMWC (China Medical Writing Community) forum in 2015 and 2016 and Program lead for DIA China M4/M8 Workshop(2020-2023), Handsome holds a seat for DIA China YMAC(2018-2019) and was nominated as Taskforce co-Lead for DIA China RA Community since 2019. Besides, Handsome is co-lead of RDPAC ‘Regulatory Requirement’ Workstream, including eCTD, Filling Review & ICH Harmonization for Registration, e.t.c.

Mr. Lantzy has over 20 years experience solving technology and people problems in government, vendor, consulting, and industry environments. He is a former member of CDER's Electronic Submission Support Team at the US FDA and currently leads the Global Regulatory Affairs Operations team at Novavax, Inc. His current interest is on improving the exchange and review of data between industry and regulatory health authorities, to ultimately provide safer and more effective products to patients and for public health.

Kunal Lal is a UK-based Consultant with Red Nucleus and a subject matter expert in Regulatory Information Management and IDMP/XEVMPD. He has over 13 years of experience working across the Regulatory, Pharmacovigilance, Clinical and Supply Chain functions of pharmaceutical organizations, with robust knowledge of related regulations, processes, and systems. Kunal has led and contributed to many projects for regulatory readiness, process assessment, definition and optimization, data maturity assessment and governance and application support and maintenance.

Dan Offringa has a regulatory career spanning over thirty years. For the past 20+ years he has worked in the electronic submissions field for both the FDA and industry, with responsibilities including guidance promulgation, standards and process development, and systems implementation. He is the owner of eSub Solutions, an electronic publishing consultancy, and has been responsible for thousands of submissions to multiple regulatory authorities. Dan holds a bachelor of science degree from Duke University.

Director of Global Regulatory Systems, overseeing the implementation, support and development Eisai's Regulatory technology strategy. Active member of IRISS and Committee Member in PhRMA's Regulatory IT Workstream. Prior to Eisai, performing similar roles in supporting the Regulatory functions at Big Pharma, Consultancies and mid-size biotech's for the past 20+ years.

Vladimir Penkrat is AVP of Regulatory Affairs at Indegene. With an MBA in International Business, Vladimir has provided strategic leadership throughout his career across R&D functional areas including clinical development, biometrics, biostatistics, medical writing, pharmacovigilance, and regulatory affairs. Over the past three decades Vladimir has experience in top pharmaceutical, biotech startups, CROs, and consulting firms. Vladimir's leadership has enabled clients’ businesses to prepared and adapt to the evolving digital landscape and prepare for changes. As a business leader he has scaled business operations greater than 500 FTE in size globally to deliver services across the R&D landscape.

Noelia leads Daiichi Sankyo’s Process Excellence & Analytics group for Global Regulatory Affairs. She is responsible for managing GRA’s controlled procedural documents, optimizing global processes, ensuring compliance, and delivering metrics that support data-driven decision making in Regulatory. She began her career at Accenture and joined Daiichi Sankyo in December 2022. During her tenure at Accenture, Noelia partnered with a variety of sponsors on global transformation programs across Clinical and Regulatory, with a focus on improving processes with enabling technologies.

Theresa has over 20 years of experience in the life sciences industry, where she has developed and delivered innovative and user-friendly solutions for regulatory, clinical and QA processes. She is currently the Director of Regulatory Solutions at Kivo, a company that provides a unified cloud-based platform for managing regulatory activities and content, TMF and QMS documents. She is passionate about empowering emerging life science groups to accelerate their research and development and bring their products to market faster and safer. She fosters a culture of inclusion and collaboration within teams, leveraging her diverse background in library and information science, business and her global experience with various pharmaceutical clients.

Maria Barhams Sagoua joined Accumulus Synergy as Director, Regulatory Innovation where she is responsible for translating regulatory requirements into practice within the Accumulus Platform. Prior to joining the Accumulus team, Maria served as SAS’ Principal Consultant to the U.S. FDA where she was responsible for partnering with the Agency to advance digital transformation goals across regulated products.Throughout her career, Maria has worked across the biomedical research (NIH), regulatory (FDA), technology (DrFirst) and clinical (Kaiser Permanente) ecosystem to support the design, development, and delivery of innovative solutions. Maria holds a BS-Biology from Ball State University and MHSA from the George Washington University.

Mr. Senay is a visionary leader with a focus on innovation and positive change. At the heart of his mission is the widespread adoption of cutting-edge Informatics solutions, aimed at ensuring the availability of safe, effective, and new medicines for patients. As a U.S Excellence in Government Leadership Fellow, Mr. Senay is recognized for his excellence in delivering impactful results. Holding a master's degree from The Johns Hopkins University and being a Certified Program Manager, he brings extensive knowledge and expertise to advance the FDA CDER mission.

Matthias works as a Senior Consultant at Main5 GmbH & Co. KGaA. The focus of his work is Data Management, where he provides consultancy and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions and compliance projects (e.g. IDMP). In these projects, he is looking to gain more for the client than just compliance, by engaging people, processes, and tools, he is working to improve the client's data quality and processes. Additionally, Matthias has experience in software development and validation in a highly regulated environment.

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.

Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions and standardized data. Some of Ron’s activities include: chair of the PDUFA VI information technology committee, Regulatory Chair of the ICH M11 Expert Working Group on the standardized clinical protocol template, and chair of the IDMP Working Group under the International Pharmaceutical Regulators Programme. Ron received a PhD in statistics from the University of Maryland and MBA from University of New Haven.

Aliza began her career supporting molecular teams and leading complex regulatory submissions. Over her 20+ years in biopharmaceuticals, she has expanded her focus into automation-assisted content authoring, generation, and management. Today, she leverages her foundation to drive content innovation within Roche, transforming theoretical strategies into scalable, sustainable operations. Known for her collaborative leadership, Aliza partners across regulatory, technology, and business units to shape, standardize, and implement solutions that anticipate the future of work. She is passionate about building adaptive, compliant systems and processes that empower teams to deliver in an ever-evolving regulatory landscape.

As Director, R&D Lead at Pfizer, Craig Anderson is responsible for research, development, business and process-related functions across the International Labeling organisation. This includes topics such as electronic labelling, medicinal product information, digital health, and data standards. Craig is also Co-lead of HL7’s Vulcan accelerator project for electronic Product Information (ePI) and co-lead for HL7 BR&R's Pharmaceutical Quality (Industry) project.

Bala heads VB Insights, an advisory firm for the Healthcare and Life Sciences sector. Bala brings over 35 years of experience. During his long tenure, he has been responsible for the introduction of Web, document management, global team collaboration, and regulatory information management applications to large pharma. Until recently, Bala was Head of the Healthcare and Life Sciences Industry Solutions Group at Orion Innovation. As an entrepreneur and a thought leader, he has been involved in initiatives to transform regulatory affairs from a document-centric function to a data-driven function. Bala has been associated with DIA for more than 14 years, most recently as the DIA RIM Working Group subteam lead for the RIM Reference Model.

Rachel has 13+ years of experience in regulatory operations and helping sponsors achieve their eCTD submission goals. She has led the eCTD submission publishing of a variety of application types for different regions, from small amendments to large-scale original marketing applications, as well as mentored and trained others in eCTD publishing and submission management. She has also spoken at industry conferences on topics pertinent to investigational and marketing related submissions and produced a variety of blogs, presentations, and other materials to share valuable industry insights.

Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market strategies and data harmonization. She was named PharmaVoice’s top 100 most inspiring individuals for Mentorship and Team Development and received the esteemed Excellence in Service award from DIA. Brooke has an integral role in shaping the discourse surrounding data and technology in regulatory affairs through her work with DIA as programming chair for the Data & Technology Track and as the co-chair of the DIA RA Community.

Scott Cleve is currently the Vice president of Global Regulatory Labeling, Operations and Writing at Daiichi Sankyo where he leads a global organization responsible for delivering compliant and timely regulatory data and information to global Health Authorities and building a regulatory information management framework that is fit-for-purpose. In his career he previously led Regulatory Operations teams at bluebird bio, Boehringer Ingelheim, AbbVie and Astellas. Scott’s focus is on developing the people in his organization, investigating technology to improve process and compliance, and partnering within industry to improve standards, process and technology.

Heather Crandall has been with the FDA since 2012, working in CDER’s Office of Business Informatics. She currently focuses on standards and processes around electronic submissions.

Tony Fantana is the Global Regulatory Affairs Innovation and Technology Lead at Eli Lilly. He is passionate about creatively solving unmet medical needs through innovative technology solutions. Trained at Harvard Medical School, Tony held roles of increasing responsibility driving innovation and organizational change. At Lilly, he started Digital Health and patient-centric blood sampling, and won twice the Top 100 Innovator Award. Tony leads an Innovative Health Initiative consortium and works with regulators in the US and EU. Recognized as an expert in digital health and enabling better data at lower patient burden, he served as a Visiting Professor at Massachusetts General Hospital and Brown University, and as a healthcare startup CEO.

Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., a global Life Science benchmarking and advisory firm specializing in performance improvement, strategy, industry analysis, benchmarking and organizational transition. His early career was spent at Johnson & Johnson in a variety of management positions and then transitioned to consulting where he lead global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton. His organization is well known for their insightful industry benchmarks and World Class RIM thought leadership. Steve has a Bachelor’s of Science in Business Computer Science and a Master in Organizational Development and Performance.

Kåre is an IT consultant at NNIT with 3 years of experience and a 7-year entrepreneurial background. Specializing in pharmaceutical and regulatory data standards, he is passionate about leveraging FHIR to enhance operational efficiency, streamline data workflows, and enable real-time data exchange with regulatory authorities. Kåre has a proven track record of developing innovative solutions that bridge business needs and technology, from optimizing data integrations to crafting strategic roadmaps. In addition: his expertise includes establishing robust data governance frameworks, ensuring GxP compliance, and architecting scalable data solutions tailored to the life sciences industry.

Sridhar (Sri) Mantha is currently Director of the Office of Strategic Programs (OSP) at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. As the Director of OSP, Sri leads center-wide strategic and operational planning, performance analysis, and implementation and business informatics. Prior to joining CDER in Dec 2020, Sri spent 25 years in the Lifesciences industry spanning Drugs, Biologics and Medical Device products. Sri held operational and leadership roles across Clinical Regulatory Informatics, Drug Safety, Quality and Information technology functions. Sri has master's degrees in Engineering, Business Administration and Data Science.

Gerhard leads the Regulatory Competence Center at EXTEDO GmbH in Munich, Germany, which serves as the backbone for EXTEDO’s regulatory competence and ensures the life sciences business operates compliant. Gerhard is responsible for all aspects of regulatory intelligence at EXTEDO which includes eCTD, IDMP, PV, PP... and supports EXTEDO to explore new innovations and markets. With more than 27 years of life sciences industry expertise, he has a deep understanding of the underlying regulatory business processes of the pharmaceutical industry and the national competent authorities. Gerhard graduated in analytical chemistry at the Karl-Franzens-University of Graz, Austria and holds a doctorate degree from the University of Regensburg, Germany.

Katherine Novak provides experience as a strategic consultant across the full drug product lifecycle, including Clinical Operations, Regulatory Operations, Regulatory Informatics, Pharmacovigilance, and large-scale Manufacturing. Katherine supports clients in global Regulatory strategy, digitalization, system implementation, process development, and data quality. Her passion is in data standard harmonization and collaboration, specifically submission data and optimization for Regulatory decision-making.

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.

I am Brandon and I lead Product at Weave. We are building AutoIND, an AI-powered software platform to streamline every aspect of IND preparation. I am deeply committed to building products that positively impact human lives, create meaningful value for our customers, and are delightful to use. I have spent the majority of my career in life science startups, spanning drug manufacturing (new CGT manufacturing platforms), discovery (CRISPR-based target discovery), and diagnostics (multi-omic early cancer detection). I am obsessed with the discovery of pragmatic applications for incipient technologies.

David Ross (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics industry. In his Global Regulatory Policy role, David is actively involved in Reliance and Collaboration efforts at AZ. David is Bio Representative in the ICH Task Force for PQKM Feasibility Assessment. As the GSO IRISS Lead (2016 to present) David hosts monthly meetings on Regulatory Submission and Data innovation. As AZ Lead for PhRMA IT Group (2014 to 2023), David helped lead the PhRMA IT White Paper on Cloud based computing with global collaboration.

Salim Saglam is a Director and Business Transformation Lead at Roche / Genentech Product Development. He brings >10 years of industry and consulting experience across the Life Sciences value chain. Areas of past work include tech ops, product transfers, business development, and operating model (re)design. For the past five years he has been working on digital transformation and implementation and scaling of innovative solutions in Life Sciences. More recently he has been focusing on establishment and operationalization of structured content management and automation capabilities across and beyond the submission documentation landscape within Roche Product Development organization.

Pat Shafer is a Managing Director at FTI Consulting. He is responsible for delivering services, solutions and thought leadership for pharmaceutical, biotech and medical device clients. He has over 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of regulatory affairs and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance. He currently leads the development of the RIM Whitepaper 3.0 as part of the RIM Working Group, and leads the Culture of Quality initiative as part of the FDA/MDIC Case for Quality.

Sam Thompson is an information technology professional with 35 years of experience in data management, of which 25 are the life sciences industry. He focuses on the applied use of data technology for clinical, regulatory and safety applications. Specific experience includes the design and implementation of lakes/warehouses, implementing regulatory compliant data management solutions and compliance with data standards, including FHIR, IDMP, CDISC and PQ/CMC. In his spare time, Sam enjoys mountain biking, officiating field hockey and is a volunteer firefighter.

Michelle Wu is the founder and CEO of NyquistAI, with over a decade of experience in pharmaceuticals, medical technology, and digital innovation. She has been featured by Forbes and has spoken at various conferences on AI in life science. Before founding NyquistAI, she was the youngest global strategy manager at Novartis, where she played a pivotal role in the industry’s first and only asset swap deal between Novartis, Eli Lilly, and GSK. This experience highlighted the challenges of manual data research, sparking her vision to create NyquistAI. Before Novartis, she worked for BCG, advising major pharma and Medtech companies on their global product development and emerging market strategies. She holds an MBA from Stanford University.

After an international career in management consulting and information technology at Software AG and Comshare, Akira Yamaguchi joined LORENZ Life Sciences in 1995. His initial role was software development in the field of electronic submissions, achieved in 2001 with the release of docuBridge as a major company milestone. In 2003, Mr. Yamaguchi became responsible for LORENZ' overall software product development. In his Project SME role, Mr. Yamaguchi advises larger customer implementation projects. His current task is to develop the strategic directions of LORENZ' software portfolio.

Donna Yosua leads the Merck Data Harmonization & Interoperability project which includes the implementation of a regulatory data hub and canonical data model with reusable data publications, and the corresponding regulatory data governance framework. Donna is a seasoned Life Sciences Strategist/Business Architect and an expert in Regulatory Information Management with 25 years of experience guiding organizations toward improved business performance by leading the development and deployment of new strategies, processes, and enabling technologies. She has global experience in the pharmaceutical, technology development, and consulting industries.

Toban has over 20 years of experience creating drug development software. He has consulted at 47 of the top 50 pharmaceutical companies and worked directly with over 200 companies to align with global regulatory submission standards. As CEO of Kivo, Toban combines his years of experience working with regulators, clinical, regulatory, and quality groups with enterprise process management best practices to bring regulatory software into the 21st century.

Peter Caetano is a Senior Director, Global Regulatory Affairs, and Global Regulatory Lead at Ipsen in Cambridge, MA, US. He had previous regulatory roles at Allergan-AbbVie, UK, Genzyme-Sanofi, MA, and P&G, Ohio. He has FDA, EMA, PMDA, NMPA CDE, ANVISA, etc. regulatory strategy expertise throughout product life cycle, including development strategy, submissions, and postmarketing commitments, in neurology, oncology, rare diseases, etc. Dr. Caetano has a PhD in Pharmaceutics, where at the University of Michigan he collaborated with FDA, USP, Viatris (formerly Mylan, UpJohn), BMS, and Merck. Peter completed a PharmD at Ohio State, an MPH at Harvard, an MBA at ESSEC-Mannheim, and postgraduate diplomas at Oxford, Hertfordshire, and London.

Helena Corte-Real Correia is the VP, Regulatory Portfolio Data and Content Lead within Product Development at Roche. With a PhD in Marine Genetics from the University of Liverpool and over 10 years of research in molecular genetics at Oxford University, the Portuguese National Institute of Health, and Basel University, she transitioned to the pharmaceutical industry to apply her scientific knowledge and skills to advance healthcare. She joined the Regulatory Affairs group at Roche in 2003 and has had various roles of increasing responsibility as Late Stage Head for Regulatory Documentation, Global Head of Regulatory Operations and Regulatory Portfolio Data and Content Leader.

Wim DHaeze, PhD, ELS, has been the Regulatory Information and Document Management System (RIMS/DMS) Lead at Sarepta Therapeutics since June 2021. He is responsible for access to and training on Registrations, Submissions, and Submissions Archive and collaborates cross-functionally to implement complex changes and to keep RIMS/DMS in a validated state. He played a key role in the successful implementation of the connector between Vault eQMS and Vault RIMS/DMS and is currently working cross-functionally to initiate the implementation of the connectors between the PromoMats and Clinical Vaults and Vault RIMS/DMS. Most recently, he kicked off the cross-vault governance Center of Excellence at Sarepta.

Malin Fladvad is a Portfolio officer at Uppsala Monitoring Centre (UMC). In this position she is responsible for the WHODrug Product Portfolio which dictionaries and applications are used in clinical trials and safety monitoring worldwide. Malin is also engaged in various efforts for global implementation of the ISO standard for Medicinal Product Information (IDMP) such as ISO TC 215 WG6 and co-chair the Global IDMP Working Group (GIDWG). She has a master’s in Molecular Biotechnology Engineering and a PhD in Medical Biophysics from Karolinska Institute, Sweden.

Sheetal Gaiki, Sr. Principal Scientist II, CMC Dossier Development & Operations, Johnson & Johnson Innovative Medicine, has 20+ years of industry experience in development of biologics, combination products and small molecules. In her current role, she is responsible for developing content strategy and delivering biologic and combination products dossiers for global submissions. She is involved in, and leading various internal and cross-industry efforts related to CMC data standardization, GenAI and use of emerging technologies for regulatory information management. To mention, developing a new FHIR PQ (Industry) IG and Controlled Terminologies for CMC data, automating regulatory dossier authoring through structured content and GenAI tools.

Ginny serves as Chief of CBER's Data Standards Branch, where she leads a multidisciplinary team that advances standards such as eCTD, CDISC, IDMP, ICSR, SPL and related terminologies. She is Program Manager for Project PRISM, co-Chair of the FDA Data Standards Advisory Board and FDA Topic Lead for the ICH M2 Electronic Standards EWG. Ginny has worked in informatics at FDA since 2004.

John Jones is the Founder and CEO of Entitech Solutions, a system integrator focused on developing innovative technology solutions for unmet business needs in Life Sciences. John has more than 25 years experience in developing and delivering IT Solutions for various companies, and has extensive experience in the clinical, regulatory, and commercial areas. His technical specialties include: enterprise architecture planning and definition, long-term technology strategy development, knowledge and content management, information architecture and metadata definition, structured component authoring and data integration/business intelligence platform implementation

Alissa Minkoff is currently Executive Director, Head of Regulatory Affairs at Third Harmonic Bio. She has 15+ years of experience in the pharmaceutical and biotech industry and has served in several leadership roles across regulatory strategy, operations, and medical writing functions. Prior to Third Harmonic Bio, she oversaw regulatory affairs and medical writing at Ventus Therapeutics and Surface Oncology, and previously held regulatory roles at Deciphera Pharmaceuticals and Vertex Pharmaceuticals. Alissa holds a bachelor of science degree from Boston University and master of science degree from Northeastern.

Jason has over 25 years of life sciences experience and has held positions of increasing responsibilities in information technology, business consulting, finance, clinical operations, medical affairs operations, and regulatory affairs operations. Currently, Jason is leading the Innovation, Digital, and External Partnerships organization for regulatory affairs within Gilead. In this role he is establishing a digital strategy and engaging with external partners to drive transformative change for regulatory affairs. Jason holds a BS in computer science from Ursinus College and holds an MBA with a focus in management from Saint Joseph’s University. He is a certified six sigma green belt and a certified project manager.

Matt Neal is an author and frequent keynote speaker. He joined Atara Biotherapeutics in 2019 as the Head of Regulatory Operations. Prior to that, Matt was the Head of Product Management for the InSight Suite of Regulatory Information Management Solutions at Parexel, Inc. and partnered with Microsoft. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. (2003-2016) and was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline (1996-2003). Matt has been publishing and submitting electronic dossiers to the FDA since 1996, and submitted the very first fully electronic NDA for GSK in 1999.

Rebecca Nebel, PhD, is a Senior Director of Science and Regulatory Advocacy at PhRMA. In this role, she leads advocacy efforts to advance FDA regulatory policy on key issues including digital health, regulatory information and technology, real-world evidence, and combination products. Prior to joining PhRMA, Dr. Nebel worked at the Society for Women’s Health Research where she led scientific initiatives designed to improve research, diagnosis, treatment, and access to quality care for women, and at the National Institutes of Health where she managed and implemented strategic initiatives to improve operational processes. She was also a Christine Mirzayan Science & Technology Policy Graduate Fellow at the National Academies.

Heiner Oberkampf is the CEO and Co-founder of ACCURIDS, providing a software for data standardization, helping large pharma, e.g., in the implementation of IDMP standards through a federated product data graph. With a group of pharma companies, Heiner has initiated the IDMP Ontology project under the umbrella of the Pistoia Alliance to promote a universal implementation of the IDMP standards in a collaborative manner in alignment with health authorities.

Rodrigo Palacios is an Executive Director in Regulatory Policy at Roche. He is responsible for advancing global policy on data and technology in the regulatory domain. These topics include Cloud Submissions, Data Standardisation (e.g. IDMP), structured data submissions, eCTD and Regulatory Information Management. Rodrigo represents Roche in EFPIA and PhRMA Regulatory Technology expert groups and acts as PhRMA's deputy topic lead in the ICH M4Q R2 Expert Working Group. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

Abby Peterson is an Associate Director, Research Innovation and Information Management at Merck, within Global Regulatory Affairs and Clinical Safety. Her diverse career has spanned banking and finance, telecommunications, nonprofit and government sectors. As a former Captain in in the United States Marine Corps, she served six years as a Public Affairs Officer, refining her information management expertise. Based in Rahway, NJ, Abby leads her department’s Hyperautomation Service, bringing together AI, Robotic Process Automation, and Power Platform services to expand on a “citizen developer” ethos, alleviating strain on enterprise IT while optimizing the workdays of her colleagues. She holds her MPA from Rutgers University.

Alishay Pringle is a seasoned regulatory professional with extensive expertise in project oversight, operational enhancements, and automation of regulatory submission processes. Alishay career spans over two decades of driving process efficiency, implementing system solutions, and managing vendor relations to enhance submission quality and compliance. In Alishay’s current role as a Global Delivery Manager she oversees publishing deliverables for assigned programs, enhancing process efficiency and regulatory compliance through innovative management and strategic partnerships.

Andrew Robertson is the Global Head of Strategy and Transformation for Sanofi-R&D Digital & Data Sciences. Andrew has more than 14 years of collective experience working in life sciences, policy and law, and has authored multiple peer-reviewed articles on topics pertaining to health product development, in vitro diagnostics, health technology law and innovation incentives.

Vaibhav Shinde is a Managing Director with Deloitte Consulting and an information/content management strategist. He specializes in complex technology transformations, including the implementation of enterprise solutions for document and content management in highly regulated industries. Over the past 6-8 years, Vaibhav has worked with multiple clients to automate the end-to-end document generation process for regulatory submissions, utilizing a range of reporting, data management, and, most recently, AI/GenAI technologies.

Ankita Sunilkumar carries over a decade of experience in the pharmaceutical industry. She holds a Bachelor’s degree in Pharmacy, along with Master’s degrees in Regulatory Affairs, and Project Management. Currently, Ankita is a key player in the Global Regulatory Operations team at Otsuka Pharmaceutical Development and Commercialization Inc., where she focuses on ensuring system and tool readiness for various submissions and submission formats, across new and existing markets. Additionally, she identifies business needs that can benefit from Automation (RPA) and Artificial Intelligence (AI), driving innovation and efficiency within the organization.

Ranjit is the Director of Business Informatics Governance at FDA Center for Drug Evaluation and Research. During his career at CDER he has had held multiple roles within informatics and led multiple modernization efforts. He has also worked in consulting and in technology at Intel corporation. Ranjit has an MBA as well as a BS in Mechanical Engineering.

Michael Abernathy, Executive Director, leads Amgen’s Global RA Chemistry, Manufacturing and Controls (CMC) function. The extent of Michael’s product oversight and responsibilities traverse molecular discovery, early and late-stage clinical development and approved life-cycle programs. He also founded Amgen’s RA CMC External Engagement function targeting activities that comprise a CMC focus, promoting company and industry initiatives, engaging with Health Authorities around the world and contributing to industry organizations. He is currently leading Amgen’s regulatory digitalization initiative, and he is also co-developer of HL7 FHIR Product Quality International Standard (UV-pharm-quality https://build.fhir.org/ig/HL7/uv-dx-pq/).

Ryan is experienced in directing global delivery teams that solve complex industry and regulatory challenges in life sciences. Through proven implementation processes and innovative software solutions, Ryan and his team provide the highest level of service to ensure every client meets its business, quality and compliance, and return on investment goals.

Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics Architect, including Data Management, Analytics and Business Intelligence, Electronic Submission and Portal Collaboration programs. Ethan has over 20-years’ experience in Data Management, Enterprise Architecture, Solution Development and System Integration.

Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing medical policy with a focus on data science and the use of Artificial Intelligence (AI) in drug development. These efforts include overseeing an AI policy group, as well as engaging external stakeholders and advancing the development of regulatory science around the use of AI in drug development. She also contributes to the development of medical policy related to real-world evidence and the use of digital health technologies for medical product development.

Vahé has over 24 years of global regulatory operations, project management and regulatory technology experience, with special focus on regulatory information management, data governance, business process optimization, regulatory intelligence, medical imaging, publishing and global submissions strategy. Vahé has had various leading roles at Alexion, Takeda, Dyax, Millennium, Parexel, and Datafarm, and has also been involved in consulting activities. He is currently heading the Global Regulatory Operation at Apellis. Vahé is an active member of the DIA-RIMWG sub-team on RIM Reference Model.

Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices, and combination healthcare products. Her work at various pharmaceutical and biotech companies includes digital innovation, process management, and preparation of marketing applications for Health Authorities.

Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the future. Prior to joining EMA, from 2011 to 2020, he served as the Director for Business Informatics at the U.S. Food and Drug Administration leading the transformation of medicines regulatory data, advancing data analytics, and modernizing the scientific computational and collaboration platforms that underpin operations.

Currently the VP of Life Sciences and Product Owner at DocShifter, Paul has over 20 years of experience in helping to provide regulatory software and service solutions to Life Sciences organisations globally. Paul has practical industry and commercial experience in delivering content authoring & rendering, Regulatory Information Management, submission and report-level publishing, and electronic Document Management solutions.

Dr. Niklas Jänich is Head of Global Labeling Operations & Digitization at Boehringer Ingelheim. In this position Dr. Jänich is responsible for Labeling process, systems, compliance and digitization as well as for driving the implementation of structured content management in the GxP-regulated Labeling process. Dr. Jänich is a certified pharmacist and holds a PhD in medicinal chemistry and a Master of Drug Regulatory Affairs.

An influential and data-driven executive professional with a robust background in the Pharmaceutical and Public Health sectors, bringing a unique blend of expertise in leading digital transformation initiatives and leveraging data to guide corporations through complex business changes. Recognized as a thought leader/industry expert in the data, digital health, and AI ecosystem, excelling at understanding industry trends and developing strategic perspectives to guide digital health and AI partnerships and investments. High-level analytical skills and deep expertise in drug development, clinical, safety and regulatory processes, data management, digital innovation, and governance.

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal products worldwide. He received his degrees from Johns Hopkins University, University of Southern California, and the University of Maryland.

With 20 years of experience in Regulatory Operations as a dedicated leader in submission management, archiving and employee development. I strive for creating efficiencies, fostering a culture of collaboration, and a growth mindset within my team. I have technical experience using a variety of document management systems, publishing tools, and project tracking tools. I am excited to be a part of the conference as a speaker this year and look forward to connecting with new and seasoned attendees.

Allison Steffen is currently the RO Submissions Lead at WAYS Pharmaceutical Services. With over 12 years in client services, she is well versed in the compilation and submission of eCTD applications. She has been the project lead on nearly 80 Initial Applications, as well as hundreds of lifecycle sequences for a wide range of products across multiple Global Health Authorities.

Frits Stulp is Managing Director of Iperion a Deloitte business, with over 20 years of industry and consultancy experience. In this role he leads a team of regulatory / IDMP experts active in various projects to deliver value to both pharmaceutical companies as well as regulators. Frits is the IDMP topic group lead for the IRISS Forum and heavily involved in the EU-SRS project for the Medicines Evaluation Board / European Medicines Agency as part of SPOR landscape. Frits is also Chariman of the Board of CTADHL, involved in Transatlantic adoption of IDMP (www.ctadhl.org). Regarded as an SME on IDMP, he gladly shares his gained knowledge and experience in various occasions around the globe.

Kevin Tompkins is the Executive Director, Regulatory Information and Submission Management at Bristol Myers Squibb. He joined BMS in 2018 and has over 20 years of experience in different roles leading regulatory operations teams. In his current role, Kevin is responsible for the strategic direction and delivery of regulatory submissions, product data, and regulatory systems for BMS. He holds a B.S. in Information Systems and a M.B.A. from LaSalle University.

Philipp Weyermann is a team leader in the Regulatory Assessment division at Swissmedic, the Swiss therapeutic products agency. His role includes responsibility for substance management and the substance database. Philipp is a long time member in several international standardisation bodies, including the Global Identification of Medicinal Products (IDMP) Working Group (GIDWG) and the IDMP Working Group under the International Pharmaceutical Regulators Programme (IPRF). He is a chemist by training with a Msc from the University of Berne and a PhD from ETH Zurich as well as a Postdoc at Caltech. Before joining Swissmedic in 2010 he worked in the pharmaceutical industry as a medicinal chemist an project leader for several years.

Martine Zimmermann is Senior Vice President, Head of Global Regulatory Affairs at Ipsen since January 2023. Dr Zimmermann has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion Pharmaceuticals (part of AstraZeneca since 2021) in 2009 and has since then been dedicated to the registration of several orphan medicinal products across the globe, as well as to the shaping of the regulatory environment for medicines under development for rare diseases. Prior to Alexion Pharmaceuticals, Dr Zimmermann held numerous R&D and regulatory roles in companies such as Aventis (now Sanofi), Servier and H. Lundbeck A/S. Dr Zimmermann also serves currently as a Director in the Board of Inventiva Pharma.

Zhouxi Wang joined CDER FDA in 2017, where she has been conducting quality assessments for a diverse array of applications, covering original and supplemental ANDAs/NDAs and inspections. She actively contributes to several working groups and initiatives, including Knowledge-aided Assessment and Structured Application (KASA), Pharmaceutical Quality/Chemistry, Manufacturing & Controls (PQ/CMC), and guidance drafting. She brings her expertise to support various projects, specializing in quantitative analysis, facilitating software development, and optimizing databases.

Paul is SVP, Head of Regulatory Affairs at Intercept Pharmaceuticals, a wholly owned subsidiary of Alfasigma S.p.A., and has more than 30 years of experience in small, mid-size and large Pharma in various regulatory strategy roles. The last 10 years, he has expanded his responsibilities to leading regulatory operations, labeling and medical writing departments.

Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He was the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives, including the Pharmaceutical Quality/Chemistry, Manufacturing, and Controls structured data project. He is also serves as a delegate to the International Organization for Standardization's (ISO) Technical Committee (TC 215) on health informatics which deals with the IDMP standards. Currently he is Associate Director in FDA’s Office of Process and Facilities in CDER. He has never served time in prison.