Powerful Community, Fresh Ideas

Matt is an experienced regulatory operations leader with a track record of driving innovation across the pharmaceutical and biotech industries. As Executive Director of Global Regulatory Operations, Strategy and Innovation at BeOne Medicines, he leads global initiatives focused on digital transformation, operational excellence, and regulatory modernization. His career spans leadership roles at GSK, Amgen, and Atara, and he was recognized as a Veeva Hero in Regulatory in 2023. Matt is passionate about advancing regulatory science through technology, collaboration, and bold thinking.

Cory is a seasoned leader in the field of pharmaceutical safety and pharmacovigilance. He has over two decades of experience managing global systems, regulatory compliance, and operational strategy. He currently leads efforts to optimize business system ownership and governance frameworks, ensuring alignment with both industry regulations and emerging technologies. Known for his collaborative approach and ability to translate complex technical processes into actionable strategy, Cory brings a practical and visionary perspective to every initiative. He is passionate about driving innovation while upholding the highest standards of patient safety.

Since joining Merck in 2017, Jennifer has held varied roles of increasing responsibility and seniority within GCTO and the broader R&D organization. This involved functional leadership of global organizations (including quality, data management, site monitoring and partnerships and diversity & inclusion) as well as leadership of North America Country Operations. She has also served as the R&D integration lead for high-profile acquisitions including VelosBio, Peloton Therapeutics and Acceleron Pharma, overseeing transition of clinical development to MRL that yielded timely approvals for WELIREG and WINREVAIR. Jennifer has over 25 years of experience in pharma, biotech and CRO companies. She has a bachelor’s degree from the University of Pittsburgh in molecular biology, master’s in public health (epidemiology) from the University of Alabama-Birmingham and is an ACRP certified clinical research professional.

Marc is Vice President, Regulatory at Veeva Systems, responsible for the overall growth and execution of the regulatory product line. Prior to joining Veeva in June 2017, he served as client partner and RIM consulting lead at Kinapse, now Syneos Health. Marc also spent fourteen years in Accenture’s Pharmaceutical R&D practice where he led the organization’s Regulatory advisory, business development, and alliance efforts. During that tenure he helped half of the world’s top 20 biopharmaceutical organizations in various consulting and program delivery roles spanning regulatory and pharmacovigilance.

Peter is the visionary behind Veeva, one of the world’s most successful and innovative cloud software companies. He pioneered the industry cloud category when he founded Veeva in 2007 with the belief that vertical cloud software would be the next wave of cloud innovation. Today, Veeva helps more than 1,000 life sciences companies bring new medicines and treatments to patients faster.

With more than 30 years experience at leading technology companies, Peter has been at the forefront of every major transition in enterprise software, from the mainframe at IBM Silicon Valley Lab, to client-server at PeopleSoft, the cloud at Salesforce, and industry cloud software at Veeva. He was a key visionary force behind three of the industry’s most successful enterprise application platforms: Veeva Vault, the Salesforce Platform, and PeopleTools.

Peter currently serves on the board of directors of Veeva and Zoom. He holds a bachelor of science degree in computer science from Oregon State University.

As the VP of Product Management for the Vault Platform at Veeva Systems, Larry builds the industry cloud for life sciences to deliver innovative and scalable solutions that empower our customers to streamline their processes, enhance their compliance, and improve their outcomes.

As Sr. Director of Development Cloud Strategy, Jared drives the vision and execution to deliver connected and streamlined processes across clinical, regulatory, safety and quality businesses. With over 15 years of experience in life sciences and healthcare technology, including his prior work at Epic in the electronic medical records space, Jared brings deep expertise in leveraging technology to improve operational efficiency and patient outcomes.

John is Vice President of Veeva Safety Strategy and is responsible for growing Veeva’s safety market adoption while ensuring the success of its customers. Before joining Veeva, John led the consulting practice at Octagon Research Solutions (now Accenture), which specialized in helping customers develop CDISC-based data and regulatory submission capabilities to achieve global regulatory compliance while maximizing operating efficiencies. He has 25 years of experience in the pharmaceutical industry and extensive experience with implementing globally-deployed systems.

Alison joined Veeva in March 2020. She serves as the US SMB Director of Strategy for the Veeva Regulatory Information Management (RIM) product suite. In this role, she contributes to the product’s direction, customer engagement, market adoption, and strategic alliances. She has 20 years of experience, including a broad range of strategic and operational activities from development to commercialization. She started her career as an eCTD publisher at Octagon Research Solutions, then moved into TMF management at Omnicare Clinical Research. After that, she was a Regulatory Affairs Consultant for drug development activities in North America, where her roles included serving as U.S. agent for foreign sponsors and FDA meeting facilitation. Before coming to Veeva, she designed and oversaw global regulatory outsourcing programs for medium and large pharmaceutical companies at Parexel.

As President of Development Cloud, Jim is responsible for the strategy, execution, and growth of Veeva products in the life sciences market. He has more than 20 years of experience in industry software, strategy, and consulting. Prior to Veeva, Jim was a senior leader at Accenture, responsible for clinical and regulatory technology transformation programs. He joined Accenture through the acquisition of Octagon Research Solutions in 2012, a services and technology startup that pioneered the industry’s transition from paper-based electronic regulatory submissions to digital.

Jim also serves on the board of directors at ACRO, an industry organization that works with global stakeholders to promote a better and more efficient clinical trial process, where he currently serves as chair.

Martin is an experienced life sciences professional with over 18 years’ experience in pharmacovigilance. Martin has a broad experience across the pharmacovigilance spectrum, with experience operating at CROs, local affiliates and global positions. His current position is leading the PV systems team at AbbVie, responsible for strategy, implementation, oversight and innovation across the portfolio of PV applications. Martin’s passion and aim through his work is to simplify, innovate and make things better, one step at a time.

Francisco is an accomplished and dynamic executive with over 25 years of experience in the pharmaceutical and health technology industry. Currently, Francisco serves as chief executive officer at Accumulus Synergy, he was the first employee and built the organization from the ground up. He has been recognized for his ability to lead large organizations with very high employee engagement, while consistently delivering on business results. Among his many notable accomplishments, Francisco is proud of his work on market access where he spearheaded a paradigm shift for how new medicines are developed with the aim to address the needs of payers worldwide. Additionally, he established a strategic framework for increased impact to patients in China through advancement of China disease prevalence-oriented portfolio, academic center engagement and partnerships with local health-tech companies.

Leianne is the head of data management at Alcon and business lead for the implementation of Veeva Clinical Data. She is an established leader in clinical research with over 15 years of experience leading global teams in operations, data management, standards and systems.

Paul is a seasoned leader in regulatory technology and operations with over two decades of experience driving innovation in global regulatory affairs. As vice president at Alnylam Pharmaceuticals, he leads cross-functional teams focused on submission management, regulatory systems, regulatory intelligence and compliance strategy. With a background in computer science and an MBA in health sector management, Paul is known for modernizing regulatory processes through cutting-edge technology and fostering high-performing teams. He has played a pivotal role in multiple successful NDA and MAA submissions.

Astros is a senior specialist in the QC operation team at Alvotech. She is one of the main leaders in Veeva LIMS implementation project. She has been involved in multiple roles within QC, as an analyst and data reviewer.

Sonja is a seasoned learning and development executive with over 20 years of experience in global pharmaceutical/biotechnology organizations.She is recognized for leading enterprise-wide initiatives that enhance regulatory compliance and business excellence through digital learning technologies, data-driven insights, and cross-functional collaboration. Sonja’s collaboration fosters continuous improvement, operational readiness, and leadership development in highly regulated environments while advocating innovative and simplified methodologies.

With over 25 years of experience, Edsel has successfully delivered global regulatory and quality process and technology implementations. His career includes leadership roles at Pfizer, Daichi Sankyo, Fannie Mae, Sodexo, Astellas, Becton Dickinson, and Amgen. Edsel’s key skills encompass building high performing teams, leading strategic initiatives, data management, and global process and technology implementations. He holds a BA from Alfred University, an MA from Michigan State University, and an MBA from the University of Massachusetts, Amherst.

As Amgen’s Global Head of Programming, Analytics & Solutions, David Hansen leads the strategy and execution for all clinical technologies, data sciences, and statistical programming. He oversees a global team who ensures the timely and efficient delivery of Amgen’s diverse portfolio of new medicines.

Steph Viscomi, is an experienced TMF professional with a career spanning across the biopharma industry. She has spent a greater part of her career developing and implementing TMF teams, improving organizational TMF culture, building CRO partnerships and most importantly consistently striving for inspection readiness. She has held multiple roles with both the CRO and sponsor settings providing her a broad knowledge base to apply to the evolving TMF industry. She also is a member of the Reference Model TMF Education subcommittee as well as Triage Committee. Steph currently leads a TMF team who handles the TMF day-to-day activities across vendors and CRO’s.

Atar is a dedicated professional with extensive experience in pharmaceutical industry specializing in clinical operations systems and processes. He has led the successful implementation of two Veeva CTMS systems as well as additional customized tools and solutions to optimize clinical operations processes.

An accomplished, strategic executive who drives global business transformation and continuous improvement in the pharmaceutical and technology spaces. Kari has excelled in areas that require a strong, broad view, visualizing connections/gaps and helping organizations to improve their operations and execution in a regulatory and compliance industry. She is recognized as a trusted partner to commercial, technical and scientific colleagues alike. Kari has over 20 years of experience in learning and development, performance management, talent development, organizational development, and learning technology. Kari earned her MBA from Boston University and resides in the Boston area.

Goutham is the director and product owner for regulatory information management systems (RIMS) at AstraZeneca, where he has contributed to the regulatory operations function for the past decade. His areas of expertise span submissions, submissions archiving, and publishing, and he has been instrumental in the successful implementation of advanced RIMS solutions, including Vault RIM. He works to ensure robust systems and processes are in place to accelerate regulatory submissions to health authorities worldwide. Goutham holds a master’s degree in regulatory affairs and project management. He is committed to driving operational efficiency and innovation within regulatory affairs, regularly sharing insights on best practices and the evolving landscape of regulatory information management.

Debbie has over 35 years of experience working in drug development at AstraZeneca, primarily in Regulatory. She is interested in working with systems to automate and bring best practice across the industry with the goal of delivering medicines to patients quicker.

Cindy has been working in the biotech and pharmaceutical industry for over 30 years. Cindy spent the bulk of her career supporting the labs by implementing numerous systems, including LIMS, Empower, SDMS, ELNs and a lab instruments. She worked at multiple companies as they navigated through the M&A process, both as the acquiring and acquired company. She also has experience with a project to deploy an integrated laboratory systems solution for a new-built manufacturing facility in Ireland. Cindy is currently working at Avidity BioSciences delivering strategic capabilities to research, clinical development, regulatory affairs, quality, and IT compliance.

Emma has over 20 years of experience in the pharmaceutical industry. She started as a monitor and has held various positions in clinical development operations. During that time, Emma worked on multiple systems and process implementation projects. She works with a team of business solution managers responsible for implementing, maintaining, and supporting key systems utilized by clinical development operations, including Veeva Vault Clinical and Vault Study Training. In 2021, Emma received the Veeva Hero Award for her work to eliminate system siloes at Bayer.

Vada is vice president, global head of regulatory intelligence and policy for Boehringer Ingelheim. He is a former FDA senior advisor for Regulatory Science with global regulatory policy and intelligence expertise in applying international standards to regulatory science and policy initiatives. His continued collaboration with national and international stakeholders promotes convergence in policy and strategy in the assessment of medicinal products worldwide. He received his degrees from Johns Hopkins University, the University of Southern California, and the University of Maryland.

Karteek brings over 15 years of experience in regulatory operations, processes, and systems, with a strong track record of leadership across the life sciences industry. He has held diverse roles at organizations such as ISI, PPD, EXTEDO, and Veeva, where he played a key role in advancing regulatory technologies and delivering high-impact services. Currently, Karteek serves as senior director of global regulatory operations at BridgeBio, where he supports regulatory publishing, systems, and process optimization, driving operational excellence across the organization.

With over 19 years of drug development experience ranging from lab work and patient coordination to trial monitoring and management, Kurt currently serves as a Product Manager in the Veeva Vault Clinical space. In this role, he is responsible for delivering a best-in-class Clinical Trial Management System with a primary focus on study start-up and monitoring features.

Mano is director of IT in drug development, leading the trial operations product line. His scope of responsibilities covers technology capabilities in the areas of trial operations, site payments and vendor outsourcing. Technology innovation for automation and study acceleration are key priorities for his team.
He leads a team of product managers focused on all aspects of business solutions in this area, with Veeva Clinical (CTMS, SSU, eTMF) being a core technology solution but several other internal/ external solutions supporting this space as well. His team is always looking to implement the best available solutions in this space, supporting Bristol Myers Squibb’s trial execution needs, and ensuring flexibility, scalability, compliance and automation.

Ann has worked in the pharmaceutical industry for over 30 years, primarily in quality. She enjoys working in the clinical quality area developing and implementing quality systems while building and promoting a quality culture. Her role has included support of GMP and GCP functions as well as the oversight of computer software validation.

Khushbu is a GxP systems manager at C4 Therapeutics, where she has been a key contributor for over three years. She specializes in computer system validation, training compliance, and Vault system administration, supporting the company’s commitment to quality and regulatory standards. In her previous role at Veeva Systems, she was part of the Quality Professional Services team, where she assisted customers with implementing Veeva QualityDocs.

Angie Badgett is the executive director, global project management and strategic solutions at Celerion, a clinical research organization that works with pharmaceutical companies to test and support the development of new medicines. Angie has worked at Celerion for 19 years and currently oversees a team of global project managers who lead client activities at Celerion. In addition, Angie has responsibility for the implementation, enhancement and maintenance of Celerion’s strategic software solutions including the Veeva platform.

Dr. McDonald is responsible for global systems, processes, feasibility, and scheduling of clinical drug development programs at Celerion. She has over 25 years of experience in early clinical research. Staci holds a Doctor of Pharmacy from the University of Nebraska Medical Center, College of Pharmacy. She is a member of the American Society of Hospital Pharmacists, the Nebraska Pharmacists Association, and the American Pharmaceutical Association.

Abhishek is a curious and result driven professional who enjoys learning new things and solving problems. He thrives in collaborative environment and values clear and open communication. He has 24 years of experience working in call centers, healthcare and pharmacovigilance.

Vishu is the executive director and global head of regulatory operations at Daiichi Sankyo, where he leads global teams in driving complex regulatory submissions to health authorities. A transformative, results-oriented leader, Vishu has overseen numerous successful NDA, BLA, and MAA submissions at top 10 pharma companies which were delivered in record time. With a master’s degree in computer science and a certification in Artificial Intelligence from MIT, Vishu brings a unique blend of technical insight and strategic leadership to the pharmaceutical industry. His passion lies in leveraging technology to streamline regulatory processes and accelerate access to life-saving medicines. Vishu is also a recipient of the prestigious President’s Award at AbbVie, recognizing his exceptional contributions.

As a dynamic leader at the intersection of technology and pharmaceuticals, Janet specializes in building and guiding high-performing teams that leverage cutting-edge innovations such as AI and machine learning. Her mission is to accelerate the drug development process, ensuring that breakthrough medicines reach patients more quickly and efficiently. With a proven track record of delivering impactful results, she excels at fostering collaborative working environments.

Mike Ward, Senior Director of eSource Capabilities at Lilly, has focused his 27-year career on advancing clinical trial data collection within Lilly and across the pharmaceutical industry. He leads the implementation of site eSource platforms and advances seamless EMR-to-EDC interoperability to streamline source data capture and reduce site burden. In addition to his leadership within Lilly, Mike has been an active driver of industry standards through leadership with CDISC, HL7, and TransCelerate. He is now a sponsor advisor for i~HD’s eSource Scale-up Task Force, which is focused on revolutionizing the execution of clinical trials worldwide.

Bradford is an enthusiastic quality leader, with a passion for IT. His professional journey includes contributions to several global companies and FDA, including small biotech, consulting, software, and research in cell and molecular biology. He has experience implementing and owning Veeva systems at multiple companies, and has worked across Asia, Europe, and the US.

Laquisha is a leader that centers her leadership philosophy around vision engagement, effective change management, and accountability whilst also being grounded by her faith. Laquisha earned a BS and an MS degree in chemistry from Lincoln University, PA, and Drexel University, respectively and she earned a doctorate degree from the University of Southern California in organizational change and leadership. Laquisha has over 25 years of progressive leadership experience working in the pharmaceutical industry, inclusive of international experience living and working in Basel, Switzerland for eight years.

Aileen brings an extensive depth of drug development experience in global operations including trial design and execution across a broad array of indications. Prior to joining Immunovant, Aileen was at HUTCHMED International where she was responsible for portfolio and project management and business operations for the execution of the international portfolio. While spending almost 20 years at Eli Lilly and Company, Aileen was a collaborative leader with a proven track record of delivering broad transformational initiatives and excelled in a fast-paced, innovative and dynamic environment. Before joinng, Eli Lilly, Aileen worked at several academic medical centers in both clinical and research administration roles.

Thomas is a regulatory operations leader with over 30 years of experience helping organizations maximize the value of their regulatory information. He helps organizations to positively engage with Health Authorities through high quality submissions and related activities. Thomas was an acknowledged pioneer in electronic submissions and document management and has and successfully led the filing of over 40 original applications in multiple markets. Thomas is also an expert in AdPromo operations and systems.

Joe Lengfellner is a healthcare IT and clinical research leader with over twenty years of experience improving clinical trials at the intersection of technology and trial operations. A pioneer in clinical trial innovation, he has advanced initiatives like EHR-to-EDC, decentralized trials, FHIR interoperability, and eSource adoption at Memorial Sloan Kettering Cancer Center. Joe co-founded and leads the Clinical Research Innovation Consortium (CRIC), a network accelerating the validation and scaling of digital solutions. His work focuses on modernizing trial design, operations, and analytics to deliver more efficient, patient-centered research.

With over 25 years of broad pharmacovigilance experience, Sandy has led significant initiatives in clinical safety and risk management operations across complex business processes and systems at Merck. As a senior director over the past three years, her work has been on advancing safety signaling, risk management strategies, and system innovation with integration across clinical development and post marketing environments with a focus on process simplifications and efficiencies while ensuring quality and compliance. Her expertise spans operational leadership, strategic innovation, and the intersection of safety science and technology.

Ravi brings over two decades of expertise in the pharmaceutical, biotechnology, and cell therapy industries. Currently serving as AVP of digital, data, and AI products at Merck, Ravi leads innovation in manufacturing quality and laboratory operations. He also brings entrepreneurial experience as a co-founder of a healthcare startup focused on orthopedic care pathways. Outside of his professional achievements, Ravi enjoys spending time with his family and exploring the outdoors through hiking.

Adela is a pharmaceutical quality leader with a successful track record of leading quality organizations, building and enhancing quality systems, and managing pre-approval readiness activities for newly launched pharmaceutical products and cell and gene therapy products. Adela holds a masters degree in chemistry from Seton Hall University, a bachelors degree in biology, and is an active member of several regulatory, quality, and compliance organizations.

Jennifer has over twenty years of experience in training, learning and development, CI, and technology. Primarily focused in biotech (cell and gene) and pharmaceutical industries specializing in employee training (GxP and Non GxP), learning and development, and process improvement/performance consulting.

Amber is a regulatory operations specialist with a strong foundation in regulatory sciences and a passion for ensuring quality and compliance across global health industries. She has contributed to the successful submission and lifecycle management of regulatory applications, with expertise in eCTD publishing and submission strategy. Amber is especially interested in optimizing regulatory processes and leveraging technology to streamline operations. Her work reflects a commitment to precision, collaboration, and advancing healthcare through regulatory excellence.

Sonja, BScBA, MAOM, is a senior regulatory affairs leader with over 25 years of experience driving global regulatory operational excellence in the pharmaceutical and biotechnology industries. She currently leads strategic initiatives in regulatory submissions, system implementation, and digital transformation. Known for her collaborative leadership and enterprise mindset, Sonja is also an active contributor to industry forums and serves as vice president on the executive committee of the IRISS Forum. Her work consistently advances compliance, innovation, and organizational effectiveness across global teams.

Ibrahim is a senior leader in clinical data management at Novo Nordisk and has 20 years of experience working with data and clinical studies. Ibrahim has also led multiple projects that evolve the way data management is conducted at Novo Nordisk and the broader industry. He is currently leading the DataNow Program to renew the digital infrastructure for clinical studies, with end users and patients as the focus.

John is a veteran in the life sciences industry with over 30 years of experience, first at GSK, then at Merck, and joining Orchestrall, Inc. as senior vice president, US consulting in 2016. His background includes sales, marketing, corporate staffing, information technology, human resources, research and development, and 25 years in learning and development. John’s expertise lies in the application of learning to business strategy to drive workforce effectiveness and the application of technology to drive learning effectiveness and efficiency. He is a Hall-of-Fame member of the Life Sciences Trainers and Educators Network

Joe is a visionary leader with over 25 years of experience driving regulatory innovation and transformation in the biopharmaceutical industry. At Pfizer, he serves as the head of regulatory innovation, data governance and excellence, where he spearheads enterprise initiatives that harness the power of data and AI to modernize regulatory capabilities. Joe plays a key leadership role in Pfizer’s global RIM transformation program, which is on track to go live across all modules within two years. He also brings deep Veeva implementation experience, having successfully led a RIM deployment for a top 10 biopharma company that was an early adopter. Joe’s passion for a user centric mindset combined with his experience enables him to provide unique change management insights.

Murali is a seasoned digital leader with over 25 years of experience in digital transformation, IT strategy and applications across the life sciences industry. He was instrumental in establishing large global centers of excellence (CoE) across R&D, manufacturing and quality applications. He was a Veeva Hero Award winner in the past. He is currently leading the Global Veeva CoE at Pfizer.

Kate is a regulatory compliance professional in the life sciences industry with over 14 years of experience in IT compliance, computer system validation, quality assurance, and GxP regulations. In her four years at Resilience, she has established a company-wide computer system validation framework and has pioneered the procedural harmonization across multiple sites within the Resilience network, along with acting as the business process owner for Resilience’s eVLM ecosystem. She has a passion for program development and quality compliance within the regulated biotechnology industry.

Shashank has over twenty years of experience in life sciences focusing on development, implementation, and continuous enhancement of the IT Control framework, policies and its associated controls including the integration of compliance concepts into broader strategic planning and mitigation activities. In his current role Shashank manages a portfolio to strengthen IT Compliance posture that includes: global computer system validation, global infrastructure compliance, IT training and document management, and IT compliance.

With over 16 years of experience at Genentech/Roche, Suresh has made significant contributions in both the regulatory business and informatics organizations. Currently, he serves as the IT program lead for the E2E RIM program since the program’s inception five years ago. This program marks his third generation of RIM implementation at Roche, transitioning from internal systems to a Veeva-based solution. In addition to his work on the E2E RIM program, Suresh has been actively engaged in initiatives on RegIntel and Accumulus, collaborating with industry peers and Health Authorities to advance strategies such as Reliance Pathway Submissions and Real-Time Submission Reviews.

Joanne is a regulatory leader with 20 years of industry experience and 13 years’ experience managing people and leading global teams. She has demonstrated ability to lead, influence, and collaborate effectively across cultural, functional, and hierarchical boundaries in pursuit of success for the wider organization. She shows extensive regulatory experience in global regulatory operations, documentation processes, quality and writing. Most recently she was the business lead for the Veeva end-to-end RIM implementation at Roche.

Madhavi 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.

Christine is the head of global submissions management and data operations at Sanofi, bringing extensive expertise in clinical development and regulatory affairs. Renowned for her ability to drive transformational change, Christine is always looking for innovative ways to enhance process efficiency while maintaining the highest quality standards. Her visionary leadership and relentless pursuit of excellence make her a pivotal force in the industry.

Delphine has over 25 years of experience across global matrix pharma organizations in clinical learning and development, from learning strategy to deployment. She has a strong commitment to engaging learners using innovative technologies. She is involved in different initiatives to improve study training and reduce training time for site staff.

Markus has worked in the pharmaceutical industry for more than 21 years in a broad variety of roles with increasing responsibility. Two years ago he joined Takeda’s GMS/GQ DD&T leadership team as the head of digital quality in Zürich. Together with his team, he drives the end-to-end data, digital, and technology agenda, accelerating the ongoing digital transformation for global quality.

Diane Sitki-Green, PhD, brings over 20 years of experience in drug development, pharmacovigilance, and project leadership. She has a current focus on safety signal detection and benefit-risk management. As benefit risk excellence lead at UCB, she drives strategic initiatives that leverage tools to optimize operational workflows and ensure inspection readiness. Diane is recognized for her collaborative spirit and her ability to simplify complexity with practical solutions. Her career has been shaped by a commitment to advancing patient safety through continuous process innovation.

Meghan is responsible for leading a team of regulatory affairs professionals to provide clinical trial support and ensure compliance with local, state, and federal regulations governing review and reporting for human subject research. She serves as a key opinion leader and subject matter expert guiding institutional policy development. She is passionate about reducing regulatory burden and improving efficiency in maintaining required regulatory documentation. Meghan has defined best practices for creating and maintaining electronic regulatory investigator site files for the ACC leveraging the new technology, SiteVault.

Kate is the senior director of regulatory compliance, data and technology at Vertex Pharmaceuticals. She leads enterprise-wide initiatives to modernize regulatory processes through data-driven strategies and technology innovation. Kate brings a strong track record of delivering scalable solutions that improve compliance outcomes and operational efficiency.

Crystal is a Government Strategist at Veeva Systems, leading efforts to modernize data and submission standards. With leadership experience at the FDA and Booz Allen Hamilton, she specializes in regulatory submissions, data modernization, decision support, and interoperability. Passionate about leveraging technology for better healthcare outcomes, Crystal focuses on optimizing health IT solutions and improving decision-making through data.

Mark is responsible for helping enrich the Developer Experience for Veeva Vault. He works with customers, partners, services, and product teams to ensure Vault Developers have a seamless and productive experience.

AJ has been at Veeva Systems 2.5 years, serving first as a Services Consultant and now as a Solution Engineer. His experience as a back end consultant has contributed to his success as a Solution Engineer, allowing him to speak about Veeva products at a deep level.

Stephen has product management responsibilities for the Veeva QualityDocs, Station Manager, and Training products within the Quality Cloud. He, along with his dedicated team of product managers, is focused on building excellent features across these products that solve our customers’ needs. Prior to joining Veeva, he spent almost fifteen years at a healthcare technology company working on electronic medical record products.

Jon joined Veeva in May 2014 and has worked on several parts of the Vault Platform including Search, Jobs, User Management, Audit Trail and more. He currently leads a product management team focused on documents, renditions, search and annotations. Prior to Veeva, he spent 6 years working on the Search Intelligence team at Ask.com which built Q&A services that could directly answer many of the questions asked by users on the site.

Samantha is a Solution Consultant for Quality at Veeva. She has previously worked cross-functionally in the Quality space for over nine years, across a number of industries including pharma, biotech, and diagnostic testing. She is enthusiastic about all things surrounding process improvement, and brings her lived experiences to the table to help relate and offer viable solutions to the customers she works with.

Oliver comes from a background of biomedical sciences, and has been working with the Vault Platform for the last eight years. He has a passion for understanding and improving patient outcomes in healthcare.

As Vice President of Product Management for Veeva Safety, Eldar leads the product teams for Safety, SafetyDocs, Safety Workbench, and Safety Signal, focusing on transforming the safety landscape through innovation and developing world-class applications. A seasoned software leader with over 20 years of experience, Eldar has a proven track record of delivering high-impact technology solutions and driving measurable value for enterprise customers globally. Before joining Veeva, he dedicated his career to solving complex challenges using cutting-edge technologies across a range of industries.

Paola leads product strategy for QualityDocs and Station Manager, leveraging over 25 years of diverse Quality and IT experience. Her deep expertise covers enterprise document management, training, QMS, lab, and Pharmacovigilance systems. Paola’s unique career journey through industry, consulting, and software provides a comprehensive understanding of the challenges and opportunities in this space. She is passionate about empowering the industry to achieve greater compliance and efficiency in Quality through optimized document management systems, sharing best practices, and driving innovative solutions.

Mike is the strategy lead for Veeva Batch Release, specializing in innovative solutions that automate and streamline batch release processes. He collaborates closely with customers to transform traditional paper-based systems into efficient digital workflows, significantly enhancing operational visibility and ensuring robust market shipment decisions. Mike joined Veeva with over 15 years of extensive experience in the life sciences quality domain.

Mike’s focus is on providing education on Platform functionality through our Veeva Connect Communities and helping ensure that Veeva customers have the best possible information to adopt and leverage Vault Platform functionality. Within the Platform team, Mike works closely with the PMs an‍d Product Experts, focusing specifically on Docs, Reporting, Email/Notifications, EDLs, and Security.

Drew’s career in pharmaceutical technology spans over 25 years and includes significant expertise in EDC, clinical site monitoring, and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015 and he has authored multiple patents. Drew joined Veeva in 2016 to lead the ground-up design of Veeva’s clinical data management solutions. In his current role of Chief Technology Officer for Clinical Data, Drew collaborates with customers, partners, and the industry to set the vision and direction of Veeva’s Clinical Data product family.

Before joining Veeva in 2015, Graham was a consultant at L.E.K. Consulting and an investor at Upfront Ventures. He holds bachelor’s degrees in Economics and Business from the University of California, Berkeley, and a master’s degree in Computer Science from the University of Illinois, Urbana-Champaign.

Joby leads the product management team for Veeva LIMS. Joby has over ten years of experience designing and delivering enterprise quality and training solutions for the life sciences market.

Brittany is the Regulatory Intelligence Analyst for RIM, monitoring global health authorities and their activities that may impact any of RIM’s applications or customers.

Prior to Veeva, Brittany spent ten years as Director of Quality and Regulatory Affairs at a startup MedTech company specializing in sleep diagnostic software and hardware using AI. During this time, Brittany was also intimately involved in the clinical development of new sleep biomarkers (Odds Ratio Product, ORP) to objectively measure sleep depth and propensity.

Brittany is an RAC holder and a certified ISO 13485 Lead Auditor, with additional certifications in leading Management Systems Audit Teams.

Katie Graham spent seven and a half years at Epic Systems implementing electronic health record (EHR) solutions for healthcare systems of all sizes. While at Epic, she attended Northwestern University’s Kellogg School of Management part-time and graduated with her Masters of Business Administration in 2023. Katie joined Veeva in 2022 as a Consultant for the RIM Professional Services team, eventually promoting to Senior Consultant before becoming a Team Manager in 2025. Katie has worked with SMB, Enterprise, and G17 clients at Veeva in the Project Manager and Services Delivery Lead roles.

Andy leads AI Solutions and the Common Data Architecture (CDA) for Veeva. Andy’s team is focused on defining and delivering AI-enabled products and solutions. He has more than 25 years of enterprise software experience and has held product positions at NextLabs, Siebel Systems, and Accenture.

Jason is a product manager passionate about helping customers meet their educational goals through technology. He focuses on helping customers while defining and executing the product roadmap for Veeva Training. Prior to coming to Veeva, he worked for 18 years in the education industry as a developer, administrator, and product manager of learning management systems.

Ron has nearly 25 years of industry experience primarily focused within Regulatory Operations and electronic publishing. Throughout his career, he has implemented and managed various eCTD publishing tools and Electronic Document Management Systems to support marketed and development-stage products. Since joining Veeva, he’s supported the implementation of Veeva RIM applications from small to enterprise-level customers.

Manaphan joined Veeva in October 2016 and has held product leadership roles in commercial content and Asia. He is currently the senior director of product management for Veeva QMS. Manaphan is passionate about making products that customers love to use and building software solutions that simplify the complex. Before joining Veeva, he spent more than 15 years supporting, implementing, and building sales and marketing automation software across multiple verticals and geographies. Manaphan received an Master of Science in computer science from Boston University and a Bachelor of Business Association in Management Informatin Systems from the University of Texas at Austin.

For the past 20 years, Mike has worked with many of the top pharmaceutical and biotechnology companies to lead PV strategy, digital transformation, and process optimization efforts as a business consultant. In February 2020, Mike joined Veeva to help Veeva’s safety team bring to market and progress toward it’s goal of providing a modern, innovative end-to-end pharmacovigilance solution.

For the past eight years, Ray has run product for the EDC and CDB at Veeva, helping Veeva to grow its Clinical Data business from scratch to where it is now. He has over 30 years of experience design and developing software for the enterprise and has been working in clinical data management since 2012 when he was the COO and head of product at another EDC company. Prior to that, he worked in FinTech on low-latency and high-volume quantitative electronic equities trading.

Tristram leads the Safety Signal and Safety Workbench applications. He has worked in product management on data and analytics platforms for over 15 years across a number of industries.

Frank is an experienced clinical operations consultant who has worked at the site level and with sponsors of all sizes. This has included assessments for bringing on clinical technology that cover the people, change, and process needed to be successful. At Veeva, Frank is passionate about working with small and scaling companies to achieve their operational goals and support the exciting science happening in emerging biopharma.

Cindy joined Veeva in 2017 as a professional services consultant in RIM, where she worked on multiple RIM implementations from large to small. She moved to the RIM Product Management team in 2019, where she was responsible for RIM Submissions including content plans and Submission Wizard. Her latest focus as a Product Manager responsible for RIM Core include Active Dossier & Health Authority Interactions. Cindy enjoys collaborating with customers to design solutions to problems.

Kent has led Veeva’s training product portfolio for over seven years. Prior to his role at Veeva, Kent spent the majority of his career developing, deploying, and supporting life sciences training solutions for quality, compliance, and commercial learner audiences. Working at companies such as UL EduNeering, ClearPoint Learning, and AdMed, he has worked closely with leaders in the space to best understand the factors most critical to changing behaviors that lead to ideal outcomes.

Michelle is the SVP of product management for sites and patients at Veeva. She has over 25 years of experience in life sciences and software development, with a passion for transforming clinical trials through innovative technology and analytics. At Veeva, Michelle is globally responsible for the product design, development, and success of eCOA.

Since joining Veeva in 2015, Ryan has been working as a part of Veeva’s Professional Services organization, supporting nearly every application on the Vault Platform during that time. In his current role, Ryan leads Global Technical Services, a team that focuses on integration, migration, custom development, and multi-vault architecture across the Development and Quality Clouds. Ryan is an advocate for best practice in Vault operations and the power of the Vault Platform across the enterprise. Prior to Veeva, Ryan worked as a control systems engineer in the chemical manufacturing industry, garnering a deep understanding of enterprise architecture and systems engineering principles. He holds a Bachelor of Science in Biochemistry.

Mike is the strategy lead for Veeva Batch Release, specializing in innovative solutions that automate and streamline batch release processes. He collaborates closely with customers to transform traditional paper-based systems into efficient digital workflows, significantly enhancing operational visibility and ensuring robust market shipment decisions. Mike joined Veeva with over 15 years of extensive experience in the life sciences quality domain.

Laycee is an experienced solution consultant with a strong background in quality assurance, regulatory affairs, and quality management systems within the biotechnology industry. She has held roles as a Quality Auditor, QMS Associate, and RA Associate, bringing a well-rounded perspective to her work in life sciences. Passionate about optimizing quality processes and ensuring regulatory compliance, Laycee has a proven track record of driving efficiency and supporting digital transformation initiatives. Her collaborative approach and deep understanding of industry regulations make her a trusted partner in delivering impactful solutions.

Rich is a strategic thought leader in life sciences technology, specializing in regulatory information management. His extensive experience has been instrumental in developing innovative software solutions that empower organizations to accelerate time-to-market while ensuring compliance. At Veeva, he leads the product management team responsible for Veeva RIM, driving the future of regulatory solutions.

Marius is the product architect for Veeva Safety, focused on helping the life sciences industry innovate and solve complex problems. Since 2017, Marius has been on mission to modernize pharmacovigilance on one unified system, drawing upon his 20 years of experience in building world-class products and platforms towards this goal. Prior to joining Veeva in 2015, Marius worked at a leading FinTech, where he built their enterprise lending compliance platform and designed their next-generation products.

Angela is dedicated to empowering life sciences organizations to move with speed and operate at scale through automation and connected environments. As a product manager focusing on Veeva Connections, her solutions dive deep into cross-Vault workstreams and transform siloed, manual processes into automated ones that drive operational efficiency across connected systems.

Pam is the Veeva RIM SMB Services Lead in Veeva’s professional services group, responsible for leading the implementation of Vault RIM solutions for small and medium-sized customers. Pam joined Veeva in 2016 and has over 24 years experience in technology and process consulting in the life sciences industry.

Pratyusha Pallavi is executive director of Veeva RIM Strategy at Veeva Systems. She is responsible for overall growth, execution and success of large biopharma with Veeva RIM. She also contributes to the long-term strategy and direction of Veeva’s product capabilities – currently, focused on Veeva AI for Regulatory. She has over 20 years of experience in software product strategy, enterprise customer sales engagements, product management, and engineering in life sciences and healthcare industries.

Paheli is the Product Manager for Veeva Submissions responsible for data management, including Submission Wizard, and document management across Global Content Plans, Submission Content Plans, and Report Level Content Plans. During her four years at Veeva, Paheli also previously worked on US UDI Submissions as a Product Manager for Veeva Registrations and on RIM implementations for pharmaceutical and medtech customers as a Consultant.

Rachael is a solution consultant in the clinical operations space with a strong background in the industry. She previously held roles as a clinical research coordinator, CRA, and CTA before joining Veeva. She is passionate about helping clinical operations teams optimize their processes, enhancing efficiency in study management, and driving impactful solutions for clinical trials.

Tom leads Product Management for Veeva SafetyDocs, driving efficiency and automation across a range of purpose-built features serving Pharmacovigilance professionals. With over 25 years of experience, Tom specializes in partnering with customers to craft intuitive digital user experiences across diverse industries and product lines. Before joining Veeva Safety, he spearheaded a startup product team within Veeva dedicated to building a superior clinical trial search tool for patients, research sites, and investigators.

Chris joined Veeva in March 2024 and has been focused on Validation Management within the Veeva Quality Cloud. Before joining Veeva, Chris spent the last 20 years focused on validation, environmental, health, and quality enterprise SAAS applications as both a product manager and solution architect. Chris is passionate about solving industry problems through solutions that customers love to use and helping move the life science industry forward.

Thilo was born and raised in Germany and is a trained medical doctor and health economist. Before joining Veeva’s Development Cloud strategy team, he was a business consultant at McKinsey & Company.

Bernat is a Solution Consultant at Veeva, specializing in Validation Management. With five years at Veeva spanning all Quality and Manufacturing solutions, Bernat brings a wealth of experience. Previously, he contributed to Roche Diagnostics by developing software for diagnostic devices and supervised clinical trials for cardiovascular diseases at Novartis. His extensive pharmaceutical industry knowledge and technological expertise uniquely position him to bridge the gap between technology and business transformation.

Abbey has been on the Veeva RIM Professional Services team for seven years, focusing on implementing Veeva RIM solutions. As a Practice Manager she leads a team of implementation consultants, ensures service delivery excellence, and develops implementation methodology and best practices. Over the years she’s driven initiatives to support adoption in areas like xEVMPD/IDMP, Active Dossier, Veeva Submissions Publishing eLearning, and most recently Submission Content Planning.

Nick leads the product management team for Veeva Registrations. Nick joined Veeva in 2018 and brings over 15 years of experience developing enterprise SaaS products for life sciences and other industries. Prior to joining Veeva, he built products for regulated document management, risk management analytics, and more.

Jordan is a Senior Product Manager on the Veeva RIM Submissions Publishing team. He has been pivotal in building out extensive eCTD regional support and is now helping to lead the industry forward with the development of eCTD 4.0 capabilities within Veeva RIM.

Eric is the product lead for Veeva AI for Safety. Eric was previously a product manager for Veeva SafetyDocs and Veeva Safety, working on features across both applications. The main areas he worked on in core Safety are follow-up, SDK, narratives, medical review timeline, distributions, and correspondence.