An established Regulatory Information Management expert with extensive skills and experience in life sciences. As the VP and GM of Enterprise Technology at Calyx Jo is responsible for the Commercial and SME functions. Our expert team are responsible for strategic consultancy and delivery of services and solutions to facilitate our clients’ business using the Calyx RIM, Calyx CTMS and Calyx EDC technologies. With a remit to ensure that the our suite of technologies aligns with the changing regulatory landscape and client needs and to provide strategic regulatory input into the software development lifecycle, Jo is responsible for the overall budget to align with Calyx fiscal requirements.

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.

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.

Rob is a seasoned Regulatory Affairs Operations professional with over 30 years of experience. He was an early planner and adopter for the electronic Common Technical Document (eCTD), previously serving on Bio and PhRMA working groups for eCTD and electronic submissions. Rob has served as a leader of dynamic Regulatory Operations teams of all sizes, including past roles at Janssen, Millennium, Sunovion, and Alexion. His submission expertise includes global investigational and marketing applications. Rob has a demonstrated ability to drive and deliver operational strategies and an in-depth understanding of all facets of Regulatory Operations, including publishing, submission management, document management, and regulatory systems and tools.

Mr. O’Keefe has over 18 years of R&D management and IT consulting expertise, working with both top tier pharmaceutical firms, and early stage biotechs. Prior to joining Astrix, he led Business & Technology Consulting at Just in Time GCP; he established and led the R&D Consulting Solutions practice for Paragon Solutions/CGI Life Sciences, where he focused on helping drive adoption of business capabilities such as: submissions management and archiving; IDMP; electronic management of Trial Master Files and investigator interactions; and defining and implementing risk-based monitoring programs. He has over 20 years of business and IT consulting experience, with the past 15 years focused in life sciences clinical and R&D.

Alison is Sr. Director, Regulatory Affairs Submissions at AbbVie Inc. She has many years of experience in all aspects of regulatory operations including global submissions management and publishing, data and document management systems, quality assurance, regulatory information management and system support.

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.

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.

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our reports into WordPerfect format for the FDA reviewer?" -- and he didn't say "no." Since then, he's been involved with content management, custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard both as a vendor/consultant and within biopharma companies.

Vahé has over 20 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.

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.

Teresa joined Bayer in August 2009 and has held increasing levels of responsibility in Submission Management. Currently, as Senior Director, Teresa drives strategic technology initiatives, compliance and submission activities for the US region while operating within a global network. She began her career at Interleaf, Inc. building and supporting electronic document management and publishing systems. This experience developed into further opportunities to hold publishing responsibilities within Wyeth Consumer Health, Johnson & Johnson, Schering-Plough and other companies. Teresa brings over 30 years of publishing experience and has a Bachelor of Science in Computer Science from Muskingum University with specialization in Math and Chemistry.

Katherine Novak provides experience as a Business Analyst across the full drug product lifecycle, including Clinical Research, Regulatory Operations, Regulatory Information Management, Pharmacovigilance, and large-scale Manufacturing. She obtained her MS degree from Georgetown University in Clinical and Translational Research, where she focused on large-scale meta-analyses as a basis for clinical trials. With over four years of experience in the life science industry, Katherine supports clients in system implementation, process development, and data quality. Her passion is in data standard harmonization, specifically Regulatory data and optimization for Regulatory decision-making.

Dan Offringa has 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, including guidance promulgation, standards and process development, and system 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.

Neel Patel is a Principal Consultant at Red Nucleus with many years of experience in spearheading digital transformation initiatives within the Life Science industry. As a strategic, operations, and advisory consultant, Neel excels in digital innovation, technology transformation, business process optimization and software product development, showcasing a results-oriented approach and a track record of successfully executing complex business and technology programs. Neel is recognized for building and leading high-performing teams and cultivating key customer relationships across Clinical, Pharmacovigilance, Regulatory, and IT functions in pharmaceutical organizations.

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.

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 13 years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector 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.

Kristen has 20 years of experience helping life sciences clients create modern and innovative regulatory practices and processes that leverage cutting-edge technology to satisfy both FDA requirements and their bottom line. She has built and led global regulatory operations and project management teams for top industry organizations using forward-facing strategy and business systems. Her experience includes comprehensive knowledge of electronic submissions requirements, connections into e-subs group, strong experience in pharmaceutical process and submission preparation through pre-market and NDA stages of development, and strong exposure and awareness of post-marketing and international filings.

Matthias works as a Senior Data Management Specialist for Qdossier, a Celegence company. 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/DADI). 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. Additionally, Matthias has experience in software development and validation in a highly regulated environment.

Cary Smithson is the Senior Director, Business Transformation and Systems Management at PharmaLex and has over 30 years of experience helping life science Regulatory, Clinical and Quality organizations drive increased productivity, streamline information management and enhance regulatory compliance. Her areas of expertise include regulated content and information management, regulatory information management, eTMF, GxP quality / compliance, IT strategy, business process optimization, Agile and project / program management. Cary co-leads the DIA RIM Working Group, leads the DIA RIM Intelligent Automation Topic Team, contributes to the RIM and EDM Reference Models and led the development of the DIA GMP Quality Systems Reference Model.

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.

Sam has 20 years of cross functional, multi-disciplinary experience across Life Science, Healthcare, and Information Technology, focused on the applied use of data technology for clinical, regulatory and safety applications. His specific experience includes the design and implementation of lakes/warehouses, ETL scripting, and implementing regulatory compliant data management solutions. Special experiences/knowledge within: • Identification of Medicinal Products (IDMP) Readiness Assessment and Implementation • Clinical, Safety and RIM Vault implementations • Data Architecture with specific focus on Master data Management, Data Stewardship and Data Governance • SDTM, ADaM, PQ/CMC FHIR, IDMP (ISO) standards.

I am specialized in various pharmaceutical data standards and FHIR. Enjoy data modelling and data mapping.

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.

Robert Baldry leads Genpact's Data and RIM migration practice focused on projects to improve regulatory data management through better technology, process and governance. Robert has over 15 years of experience implementing new technologies to the pharmaceutical industry. Projects include xEVMPD and IDMP migration projects. Enterprise wide multi-source legacy RIM to cloud based RIM system implmentations. Global data remediation and migration programs as well as paper to digital transformation projects. Robert studied business and technology at the University of Wolverhampton, United Kingdom and InHolland University of Applied Sciences, the Netherlands

For over 15 years’ I have been in Regulatory Affairs for large and small Pharmaceutical and Medical Device companies. I am currently Senior Regulatory Affairs Manager of Global Regulatory Affairs for Gan & Lee Pharmaceutical US Corporation. During my years in the industry, I have contributed to the production, manufacturing, registration, and marketing of medicinal products, that include biopharmaceuticals, Oligonucleotides, and orphan-drugs designated for specified rare diseases or conditions.

Eric Cardwell is the Director of Regulatory Information Management at AbbVie. Prior to joining AbbVie in 2014, he was the Director of Quality and Regulatory Affairs for Cardinal Health with oversight of three manufacturing sites. Eric has held several positions at Hospira, including Sr. Manager Commercial Quality and Device On-Market Support. Before Hospira, Eric was the Continuous Improvement Lead for the medical device division of Rexam. Eric earned his MBA from Roosevelt University and graduated University of Illinois at Chicago with bachelor’s in Biology. Eric holds professional certifications including two Six Sigma certifications (ASQ & TQM), his Six Sigma Master Black Belt (Stat-A-Matrix) and his Certified Quality Engineer (ASQ).

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.

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.

Frank Dickert started with an apprenticeship in the pharmaceutical industry and afterwards studied biochemistry with a focus on bioinformatics and structural biochemistry. In 2011 he took an opportunity as a Regulatory Affairs Specialist at a pharmaceutical company and was responsible for centralized, DCP/MRP and national procedures. In 2017 Frank joined EXTEDO’s Regulatory Competence Center and since then, he is consulting pharmaceutical companies in regulatory business and eCTD submissions and IDMP worldwide. Furthermore, he is analyzing and optimizing regulatory business processes and document lifecycles with or without software, resolving customer support issues with different eSubmission tools, and offers regulatory consulting with

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 7 years’ experience in Regulatory consulting for top pharma clients she has led business process optimization, RFP and vendor selection, implementation, and migration projects.

With more than 25 years of experience in the Life Sciences industry, David is a seasoned executive with extensive experience delivering solutions to customers, with a particular focus in the areas of regulatory information management (RIM), content management and collaboration. His main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite and ensure that the solution meets the needs of the customer. David also leads the DIA EDM Submission Reference Model team that developed a document architecture for use when designing and building content management solutions.

Kavya Konka is the Senior Manager of Medical Writing Operations at AbbVie. She has over a decade of experience in Medical Writing Operations and Trial Disclosure areas, and some of her key competencies include project management, business process analysis, process optimization, gap analysis, and system design and implementation. In her current role, she manages a team of Medical Writing Coordinators, Documentation Specialists and Report Publishers who assist the Clinical Medical Writing team.

Amanda Lewis is an experienced outsourcing manager with over 8 years of experience in the global regulatory space. In her current role, Amanda is responsible for partnering with internal and external stakeholders to ensure successful, high-quality vendor relationships. Amanda oversees contract execution, accurate financial deliverables, and a detailed KPI/metrics system. She also drives supplier relationship management and governance efforts for strategic vendors in regulatory submissions and labeling operations for BMS.

Sridhar (Sri) Mantha is currently Director of the Office of Business Informatics (OBI) at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. As the Director of OBI, Sri is charged with leading informatics development to modernize CDER's drug regulatory operations. 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.

Aliza has over 20 years of experience in the biopharmaceutical industry. She is an expert in structured content authoring, component content management, and content reuse. Over the last several years, she has used her extensive and varied expertise to evolve a theoretical enterprise content strategy into sustainable content operations for the Roche pharma organization. She collaborates with various organizational units to standardize content practices, implement structured content management technology solutions, and drive results that align with future work paradigms.

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.

Katja has a Master’s in Pharmacy and has been in Pharmaceutical Industry for 20 years. Her journey in Billev Pharma East Ltd. started in September 2008, as a Director of Regulatory Affairs and EU QPPV. Presently, she is responsible for the business development within the company and empowering the team with a profound understanding of intricate pharmaceutical business processes. Her expertise has been sought when she was called upon to assume the role of Subject Matter Expert in the EMA ePI Pilot Project, representing the Pharmaceutical Industry perspective since July 2022. She is a member of Medicines for Europe working groups (RSAC, Telematics), TOPRA and an ePI Topic Group Lead in IRISS Forum.

Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role, Dr. Pei is involved in development, implementation, and support of bioinformatics initiatives within OND. She is the current FDA topic lead for ICH M11 expert working group on the Structure and Content of Clinical Protocols. Dr. Pei is also the current lead for Standard Tables and Figures and Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of NASH guidance.

David Ross has led enterprise projects at AstraZeneca and Abbott Labs. He implemented enterprise solutions at AZ for cross-functional CSR Initiative, led the PQ/CMC pilot for AZ, developed roles for Early Clinical Authoring and leads Clinical Study Start up improvements in alignment with EU CTR 2022. He has delivered strategic and process improvements in labelling, CMC and Non-Clinical. He led the first eCTD Implementation in AZ. He is AZ representative of the PhRMA Regulatory IT Knowledge Group. He leads the GSO IRISS IRISS Forum, and is the AZ PhRMA IT group representative. He holds a B.SC in Biochemistry and a BASc. in Chemical Engineering. His graduate degrees include an MBA and Engineering Management from University of Ottawa.

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.

Stacy Tegan is a Program Director at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical development process. She has expertise in Regulatory Operations, Clinical Development processes, and Project Management gain through 20+ years of experience working for sponsor, consulting, technology, and nonprofit organizations in the pharmaceutical industry.

As Vice President of the SAS Data Ethics Practice, Reggie Townsend leads a globally coordinated effort to empower employees and customers to deploy data-driven systems that promote human well-being, agency and equity. The US Department of Commerce has named Townsend to the National Artificial Intelligence Advisory Committee (NAIAC). The NAIAC will advise the president and the National AI Initiative Office on a range of issues related to AI. Townsend also sits on the board of EqualAI, a nonprofit organization focused on reducing unconscious bias in the development and use of AI. Townsend has more than 20 years of experience in strategic planning, program management, consulting and business development.

Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.

Dr. Vyas is currently a Product Jurisdiction Office in CBER/Office of Director. Dr. Vyas has served in FDA for 15 years. She has worked on a broad range of matters covering quality assessment, policy, strategy and programmatic levels for drugs and biological products. Most notably, Kavita focused on scientific and policy questions to help implement certain key provisions related to biosimilars. In addition, she contributed to numerous Agency, Inter-Center initiatives and steering committees and external stakeholder engagements. Prior to joining FDA, she served as research faculty at the Johns Hopkins University and School of Medicine in basic biomedical sciences.

Wilesha Wright is a gamechanger, leader, Regulatory Operations expert and professional with 16+ successful years of experience. She is the Associate Director of Regulatory Operations at MacroGenics, Inc. in Rockville, Maryland where she leads and manages the company's Regulatory Operations group as a people manager and oversees all programs which include electronic platform management, publishing of regulatory eCTD submissions to FDA, and administrator of Veeva RIM (Regulatory Information Management) Vault, Veeva PromoMats Vault, and IQVIA’s RIM Smart publishing tool. Her experience spans the gamut with her experience at CROs (PPD & IQVIA) as Regulatory Affairs Manager and Officer, as well as completion of tenure as CMC Specialist at GSK.

Katherine Yang-Iott is a core member of the Gens & Associates team with 20 years of experience in the healthcare and pharmaceutical industry, leading and managing complex interdisciplinary projects. Her earlier career was spent working in R&D as a research scientist in industry, academia, and healthcare at companies including Regeneron Pharmaceuticals and the Children’s Hospital of Philadelphia before transitioning to organizational consulting work. As a change practitioner and thought leader, her expertise is in strategy development and change management in evolving organizations. Katherine has a Master of Science in Organizational Dynamics from the University of Pennsylvania and a Bachelor of Science in Biochemistry from Virginia Tech.

Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that enable organisations to generate value from data. In their current role, Vanni is the Regulatory Data Lead at Roche and is based in South San Francisco.

Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP. Remco is Chair of Medicines for Europe Telematics group; and President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals.

Sadia leads the team responsible for RIM Smart Submission Management at IQVIA. She has over 20 years of experience in IT and Life Sciences Industry working globally for consulting and technology solution companies. Sadia has comprehensive knowledge of global electronic submissions publishing, business process optimization, document management, systems integrations, and regulatory information management.

Craig is responsible for leading regulatory informatics projects like the implementation of the Structured Product Labeling (SPL) standard; development of health informatics policy and IT modernization.

Cynthia Ban is the Global Head Regulatory CMC & Devices for Vaccines at Sanofi. Senior Global Leader in the pharmaceutical industry specializing in Regulatory Affairs. Worked for small biotech and large multinational companies. Led and developed teams across multiple geographies and a wide range of therapeutic areas including, Vaccines, Oncology, HIV, Specialty Care, Rare diseases and established brands. Highly adaptable with extensive experience in new and rapidly changing environments such as pandemics. A strategic thinker who likes to disrupt the status quo.

Jessica Bernhardt currently is the Program Manager for the Electronic Submissions Gateway (ESG) and AdminApps programs at the Food and Drug Administration (FDA). She took on the role of ESG Program Manager at the start of 2023 and oversaw the successful completion of the ESG AWS Migration. Jessica joined the FDA in 2020 as the AdminApps Program Manager, which she has successfully managed for the past three years. Jessica started her career in Government nine years ago when she joined the Social Security Administration (SSA) as an IT Specialist. After a year working as an IT Specialist for a year, was assigned to lead and manage an IT Modernization project, promoting the use of the Agile development lifecycle. In 2016 she was promoted

Rachel Bombara is a Regulatory Services Manager at Certara with 12+ years of experience in Regulatory Operations and helping clients achieve their submission goals. She has managed the submissions 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 regulatory operations.

Greg Brolund is a management and technology consultant with experience with global pharmaceutical companies’ regulatory information management business processes and supporting technology. He was at the FDA / CDER for over 25 years was the rapporteur of the ICH M2 group leading to the initial eCTD specification. After FDA, Mr. Brolund was the Chief Technology Officer for the US Department of Health and Human Services and has been a pharmaceutical industry consultant for the last 18 years.

Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. He has over twenty years of experience with the FDA, the NIH & in the pharmaceutical industry. His work includes compounding reporting guidance, data management of FAERS system, Safety Reporting Portal for mandatory post-marketing electronic submissions and the FAERS Public Dashboard.

Wim DHaeze 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 the Registrations, Submissions, and Submissions Archive and collaborates cross-functionally to implement complex changes and keep RIMS/DMS in a validated state. Most recently, together with the Regulatory CMC, QA, and IT teams, he participated in a successful implementation of the Connector between Vault eQMS and Vault RIMS/DMS. The eQMS-RIMS/DMS Connector streamlines business processes supporting Change Controls with Regulatory Impact.

Richard has 20+ years of pharmaceutical industry experience. He started his career at GSK in the Clinical Document Management group, finally managing the UK team before becoming more engaged in technological process & system development and implementation. For the last 7-8 years he has been involved in clinical transparency activities, including managing document anonymisation for GSK pharma, disclosing European Medicines Agency Policy 0070, Health Canada Public Release of Clinical Information, as well as in support of voluntary disclosures and local transparency requirements; he now focuses on supporting disclosure at Pfizer.

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

I have been in the life sciences industry for over fifteen years functioning entirely in the Regulatory Operations space. My career began in regulatory publishing and over the past decade has gravitated towards the technology and process side of the business. I currently lead the RIM group at Mersana Therapeutics where I am responsible for the creation and evolution of the Regulatory Information Management business unit; RIM ecosystem, publishing and associated operating procedures. Prior to Mersana I have worked at several other pharmaceutical/biotech companies including Black Diamond Therapeutics, GSK/Tesaro, Shire, Sunovion, Ariad, Ironwood, Pfizer, Regeneron, Ipsen and Genzyme.

Since 2016, Dr. Gordon has been a lead for data standardization efforts including those for pharmaceutical quality, manufacturing, and labelling, as well as real-world data derived from health information technology for use in clinical research and pharmacovigilance. Before arriving at FDA, Dr. Gordon received his core scientific training with a Ph.D. in Molecular Microbiology from Tufts University Medical School, entered the public health domain in 2005 working on public health emergency preparedness and from 2011 with a focus on public health informatics.

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.

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

Leslie Kitchen is a Senior Director in the Regulatory Innovation & Information Management organization at Merck. She joined Merck in 2007 after a successful career as a cardiac nurse. She served in various roles across Safety and Regulatory Affairs including Global Safety Operations, Process and Portfolio Management, and Business Development, Sourcing, and Alliance Management. In her current role at Merck, she leads a Regulatory Information & Communication Management group focusing on developing and supporting innovative digital solutions to manage information across Global Regulatory Affairs. Leslie is also pursuing a Master's degree in Information Technology Management through Georgetown University.

Francesca Mangia joined the Regulatory Affairs department at F. Hoffmann-La Roche after completing her Doctoral Degree in Structural Biology and Biophysics at the University of Basel. She works in the CMC Regulatory International Operation & Policy group at F. Hoffmann-La Roche where she drives filings strategy in International Markets integrating Reliance approaches and advocating for convergence and harmonization.

Bettsy Mayes is a seasoned professional in the field of Informatics, currently serving as a Product Manager with a focus on Document and Structured Content Management for the past three years. Prior to her current role, she held the position of Program Director and Business Technology Lead in Regulatory for several years, where she played a pivotal role in managing diverse programs related to document management, Clinical Trial Regulation (CTR), and eSubmissions. Her extensive experience in Informatics includes a previous role as a Delivery Service Manager, where she led a large global operational group that provided critical support to over 8,000 users.

Dr Neupane is the head of AI and NLP at Takeda Pharmaceuticals. His group provides ‘AI-ML-NLP as a service’ and ‘Experimentation-as a Service’ which includes design and development of POCs/MVPs within Clinical, Non-Clinical, Med Affairs, Document Processing, and lately Gen AI capabilities etc. to several Takeda business units and business functions such as R&D, Digital data and Technology, Data Science Institute to name a few. Dr Neupane teaches graduate level courses in Natural Language Processing, Text Mining, Predictive Analytics, and Data Science. Previously, he was a member of Natural Language Processing group at IBM Watson and Microsoft Operating Systems group in engineering disciplines.

Jim has nearly 30 years of experience with compliant software solutions for regulated processes in both the insurance and life sciences industries. He has held senior management positions at Intracorp (a CIGNA company), Liquent, Thomson Reuters, ePharmaSolutions, DitaExchange and Cunesoft. Following the merger of Cunesoft into Phlexglobal, Jim is now the Chief Product Officer at Phlexglobal. Phlexglobal is now part of Cencora PharmaLex. Jim holds a Bachelor of Science in Mathematics from The Pennsylvania State University.

Rodrigo Palacios is an Associate 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. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

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.

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.

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.

Mr. Reynolds has over 30 years of experience as a successful entrepreneur, senior executive, and managing consultant with core competencies focused on enterprise content management, mobility, business process engineering, imaging, and records management. Currently, Mr. Reynolds is the Founder and CEO of Docxonomy. The breadth of his knowledge includes the architectural design and development as well as project management of numerous global, large-scale document/records management initiatives across multiple industries including pharmaceutical, biotechnology, medical devices, financial services, insurance, healthcare, and the public sector.

CAPTAIN Helen Saccone serves as a Senior Advisor within CDER’s Office of Strategic Programs (OSP). In this role, she manages the strategic development and implementation of CDER priorities including PDUFA VII technological commitments and CDER’s Artificial Intelligence Steering Committee. CAPT Saccone was also a member of the inaugural team that initiated the US-EU Mutual Reliance Initiative in 2014, that led to the negotiations and implementation of an international trade agreement for the FDA.

Brian is a leader in KPMG’s Life Sciences Consulting practice, with a focus on Regulatory Affairs. He has extensive experience helping clients improve efficiency and enable compliance by implementing process and technology changes. His experience includes leading programs related to global RIM deployments, RA operating model and process redesign, data cleansing/harmonization and adoption of emerging digital technologies.

Olga Alfieri is the Director of Global Submissions Management at Eisai with over 25 years of Global Regulatory Operations and Submission Management professional experience. She operates as a global strategic partner and subject matter expert for the Global Submissions team (US, Europe, Asia and Emerging Markets). She is key contributor for supporting global implementation for Regulatory Systems (RIM, Document Management, Submission Management Applications, and other systems.

V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience. Prior to Orion, Bala was the President and CEO of Cabeus, a niche Life Sciences services firm where he was also responsible for vision and strategy for a cloud platform called ReALM® to transform the regulatory value chain for Life Sciences. Bala developed IT strategies and capabilities for Bristol-Myers Squibb, Roche, Aventis, Merrill Lynch, AT&T, Bell Atlantic and IBM. Bala has his PhD and MBA from Rutgers University and MS in Computer Science from NJIT.

Ari is CEO and Co-Founder of Weave Bio, a generative AI startup helping biopharma companies to "weave' together regulatory documentation directly from the source studies. Weave's first product, AutoIND is currently in beta with a commercial release planned for March 2024. Previously, Ari was the first Chief Analytics Officer at Memorial Sloan Kettering (MSK) where he drove pioneering efforts using clinical data to analyze patient outcomes. Ari’s team at MSK developed the first operational AI model to match patients to clinical trials. While at MSK, Ari also played a role catalyzing startups like Flatiron Health and Paige AI. In 2019, Ari cofounded Daat.AI which was acquired by Tempus Labs, where Ari served as SVP of RWD.

Kevin has worked as an implementation and strategy consultant for over 13 years, in financial services, technology solutions, and life sciences. With a background in organizational behavior and business strategy, he has lead business process transformations that helped redesign Wall Street back office operations and changed how patient service organizations connect with those undergoing treatment. Currently, Kevin works with Astrix to support the clinical and regulatory strategy and operations of top-10 pharmaceutical clients from submissions and regulatory information management, to data integrity in the manufacturing and quality space.

Kelly is a recognized industry leader in RIM and IDMP with 30 years in the pharma industry, the last 17 focused on Regulatory Affairs. She currently heads K2 Consulting, a specialty firm focused on Regulatory Affairs, has previously held leadership positions in IT and Regulatory Operations/RIM at Wyeth, Pfizer, Shire and Teva. Kelly is part of the Gens & Associates World Class RIM core reasearch team, has been actively involved in the EU implementation of IDMP as a member of the SPOR Task Force and its PMS subteam, and currently the President of IRISS Forum.

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. In addition, conducts technical validation of clinical study data, leads related reviewer training, and industry outreach. She is 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, previously serving as Director, Data Management Services and Solutions in OBI/CDER. She developed CDER’s electronic submissions and reviewer training program, encompassing eCTD and CDISC Standards and well as contributing to the 745A binding guidances.

Handsome Ji has rich experience in sharing Electronic Common Technical Documents (eCTD) knowledge on many conferences of domestic and international. In 2016, Handsome was invited to China Regulatory Summit as an industry specialist and advisor for eCTD Symposium. In early 2018, Handsome was nominated to a consultant of Regulatory Affairs of Young Member of Advisory Committee (YMAC), DIA, as well as Taskforce co-Lead for DIA China RA Community. From 2015 to 2023, Handsome has chaired sub-forums of ICH Theme Day of DIA China Annual Meetings and DIA China M4/M8 Workshops and presented topics about Regulatory Operation.

Dr. Priyanka has over 19 years of experience in the clinical and pharma sector. A dental surgeon by profession and a postgraduate diploma in clinical research, Dr. Priyanka has around 7 years of experience in clinical practice and another 12+ years of experience in various facets of clinical research, including regulatory affairs, global/local labeling, and medical writing. Her core area of specialization involves delivering Regulatory Intelligence assistance, offering Strategic Consultation, HA interactions, formulating Labeling Strategies, and providing Regulatory Submission support to big and mid-sized pharmaceutical sponsors across geographies. She excels in managing health authority queries and crafting responses to questions (RTQs).

Stephen Philipp has worked at Merck for more than 20 years supporting various aspects of the pharmaceutical industry including Operations, Technology and Engineering Initiatives and Regulatory Affairs. In 2014 he started supporting drug and diagnostic regulatory submissions. In his current role within Regulatory Digital Health, Stephen continues to provide project management expertise in support of EU Regulatory Submissions. Stephen currently leads a policy execution team in the assessment, implementation, and tracking of regulatory policies that impact multiple functional areas within Regulatory Affairs. Stephen holds a BS in Biology from Millersville University and is a certified Project Management Professional (PMP).

Bachelor in Pharmacy and Biochemistry with 27 years of practice in the Pharmaceutical industry. Developed his career holding responsibilities in Quality Assurance, Clinical Trial and Regulatory Affairs. Former Regulatory head of Eli Lilly and Pfizer Peruvian subsidiaries. Worked as Regulatory Strategist for the Emerging Markets at Pfizer Inc. New York Head Quarters. Current in a transition role from Head of the Latin American regulatory hub team managing new product applications and the product lifecycle in the Pfizer Global Regulatory Science group.

Salim Saglam is a Business Transformation Lead, Principal Product Leader 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 ~5 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.

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.

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.

Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry collaboration through a cloud-based data exchange model. Cesar supports efforts that permit the adoption of the Accumulus platform by both sponsors and regulators. Additionally, he leads a Topic Group Digitalization in Regulatory for IRISS, pushing forward industry-wide digital advancements. Cesar has over two decades of experience, the last 12 years he spent in Submissions Management leadership roles within Regulatory Operations at Pfizer.

Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories, Food Registration, and GMP Inspection. He started his career at Anvisa in 2007 as an Inspector of Good Manufacturing Practices. Aquino holds a Bachelor's degree in Pharmacy and Biochemistry and a Master's degree in Pharmaceutical Sciences from the University of São Paulo. He also has specializations in Health Surveillance from the Oswaldo Cruz Foundation and in Micropolitics of Management and Work in Health from the Federal University of Fluminense.

Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs. She represents Gilead in various external capacities In 2021, she was appointed as the PhRMA Topic Lead for ICH M4Q(R2) and was appointed to the ISPE Board of Directors in 2022. She concurrently serves as the Rapporteur of the ICH Quality Discussion Group (QDG). Previously, Sarah served at AstraZeneca for over 5 years, holding roles in the CMC Regulatory Affairs space. Prior to that, she held a lengthy tenure at FDA, lasting from 2002-2018.

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.

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.

Dr. Tapasya Bhardwaj is the Associate Director of Regulatory Operations at Syneos Health, with a 12-year track record in healthcare management and innovation. Armed with a master’s in health and Hospital Management, she applies her expertise in AI, NLP, and analytics to advance clinical research and technology. She is adept at steering product development from conception to practical applications. Presently, Dr Bhardwaj is dedicated to enhancing digital processes, refining submission strategies, and bolstering operational effectiveness in healthcare.

Jake Doran is currently the Head of Digital @ MAPS Public Benefit Corporation. In this role, Jake is responsible for overseeing the development and implementation of the digital and IT strategy as the MPBC organization transitions from a clinical research startup to a commercial entity and industry pioneer. Prior to joining MPBC, Jake was the Head of Global R&D IT at Bausch Health. Jake prides himself in being a biologist by study and a technologist by trade and throughout his career has positioned himself at the intersection of science and technology. Earlier in his career, Jake held positions of increasing responsibility at Genpact, Janssen Pharmaceuticals and Schering Plough.

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.