2022 Speakers

Anthony leads global teams accountable for driving the quality strategy, systems, and performance across the internal and external manufacturing, suppliers, and distribution network. In addition to corporate quality functions and strategy, Anthony oversees global teams responsible for the pharmaceutical quality management system, issues management teams, global marketing company quality, Alexion rare disease unit central quality, quality business performance/LEAN, and digital strategy for quality. Before joining AstraZeneca, Anthony held operations leadership positions in global strategic, overseas, and regional/site roles in manufacturing, quality, and compliance roles at Amgen, Biogen, Catalent Pharma Solutions, and Johnson & Johnson.

Board-certified in Internal Medicine, Dr. Scarazzini has over 20 years of experience in the pharmaceutical industry. In 2016, industry peers selected her to serve as the BioPharma Representative on FDA Drug Safety and Risk Management Advisory Committee. Dr. Scarazzini’s multiple publications include the recently released textbook “Pharmacovigilance: A Practical Approach” as co-author and co-editor, along with her AbbVie PV team members.

Her passion for helping people, most importantly patients, has been a driving force throughout her career. She has built upon this passion by leading various cultural initiatives to promote inclusion, diversity of thought, and health literacy. She leads with a sense of curiosity and is committed to supporting rising talent within her organization and within various academic settings.

Rynita is the senior director of information technology at CSL Behring. She is a strategic, results-driven professional. She focuses on systems implementation, business development, organizational alignment, change management, and process improvements while demonstrating a customer-centric philosophy.

Sean has more than 20 years of experience in the industry, most of that time spent building up innovative global regulatory operations teams, achieving product approvals, and supporting global expansion at smaller companies. As vice president of regulatory platforms and systems at GSK, he plans to revolutionize the GSK Vault RIM while focusing on compliance and quality. In conjunction with other GSK Vaults, Sean is working to simplify processes and allow flexibility for innovation.

Dr. Uli Broedl, MD, is passionate about research, science, and innovative tools and technologies to improve patient access and care. Uli held various leadership roles at BI over the last years, including global head of late clinical development of BI’s diabetes portfolio, country medical director of Canada, and head of global clinical operations. He is an adjunct professor of medicine at the University of Munich, Germany, and holds a Doctorate of Medicine from the University of Munich.

Avril is the general manager of Veeva Vault, a fast-growing cloud software platform and suite of applications to manage content, data, and business processes for life sciences and other regulated industries. Under Avril’s leadership, Veeva Vault has grown to represent 40% of Veeva revenues. Avril has more than 20 years of experience building and scaling product teams, including 15 years at innovative software-as-a-service companies. She was a key contributor in two successful IPOs and played leadership roles at world-class organizations including Oracle’s PeopleSoft, Cisco’s WebEx, and IBM’s DemandTec. Avril holds a bachelor of commerce honors degree from Queen’s University in Ontario, Canada, and has received numerous professional and academic awards.

As vice president of Vault Development Cloud at Veeva, Jim leads a global team responsible for customer engagement, market adoption, and strategic alliances. For the last 20 years, Jim has held a variety of senior positions in life sciences technology and consulting, where he has led software delivery and sales efforts in clinical operations, regulatory, clinical data standards, and content management.

Jared is a director of strategy at Veeva working across the Development Cloud applications. In his role, Jared brings together cross-functional application teams to ensure a holistic approach is delivered in strategy, product, and services. Before moving to the strategy team at Veeva, Jared ran a team responsible for scoping and planning application implementations. In addition to his years in life sciences, Jared also brings experience from prior consulting roles at Epic delivering electronic medical records systems to hospitals.

John Lawrie has 20 years+ of experience in the pharmaceutical industry. He is currently vice president of strategy for the Veeva Vault Regulatory Information Management (RIM) and Safety product suites. In this role, he’s responsible for product direction, customer engagement and market adoption.

Before joining Veeva, John led the consulting group at Octagon Research Solutions (now Accenture), which specialized in assisting clients with the planning and development of CDISC-based data and regulatory submission capabilities in order to achieve regulatory compliance while maximizing operating efficiencies. He has extensive experience with implementing globally-deployed systems. John has also worked for Computer Sciences Corporation, where he led business analysis, process design, organizational change and project management activities.

John graduated from Bucknell University with a bachelor of science degree in mechanical engineering.

Kelly is responsible for strategy for the Vault Safety suite of applications. She has extensive knowledge and experience with the US FDA, and EMA Safety and Quality regulations. Kelly has applied specialized knowledge of regulatory and compliance aspects of business processes across life sciences to define and implement strategy, design/re-design processes, support technology implementations, and define governance across the spectrum of PV activities.

Kelly has over 20 years of pharmacovigilance experience and has worked both in industry and consulting. Her in depth industry knowledge and awareness helps our customers define their goals and objectives to stay aligned with industry-leading practices.

Marc is the senior director of regulatory strategy at Veeva Systems. He is responsible for managing the market approach for the Vault Regulatory suite of products in the US. Before joining Veeva in June 2017, he served as a client partner and RIM consulting lead at Kinapse. Marc also spent fourteen years in Accenture’s pharmaceutical R&D practice, leading the organization’s regulatory advisory, business development, and alliance efforts. During that time, he helped half of the world’s top 20 biopharmaceutical organizations in various consulting and program delivery roles spanning regulatory and pharmacovigilance.

As vice president of the Vault Quality product suite, Mike is responsible for product strategy, customer engagement, and business development. Previously, he served as vice president of product management and strategy for Sparta Systems, where he was instrumental in the company’s rapid growth, driving product development, vertical market strategy, and strategic partner alliances. Educated at Rutgers, he holds a bachelor’s degree in marketing and an MBA in strategy and global business.

Peter Gassner 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.

Aquino is a dynamic senior tech leader with over 17 years of experience designing, implementing, and operating strategic enterprise technology platforms. His focus is on quality supply chain and research and development functions within healthcare. He is the tech head for quality products at Haleon, responsible for end-to-end quality systems strategy and delivery. Being part of two joint ventures: Novartis CH — GSK and GSK CH — Pfizer CH, Aquino has led integration planning workstreams within tech for quality products.

Alan has worked in multiple roles across most areas of the product lifecycle, including automation, R&D, process development, capital projects, validation, biopharmaceutical manufacturing, sterile filling, and quality. Currently, he leads the Global AstraZeneca Quality Risk program. He works with others to build a fully integrated quality system to proactively drive continuous improvement in quality, compliance, and supply reliability.

Alex leads patient and site-facing digital engagement within clinical operations at Vertex Pharmaceuticals. He has held several positions in clinical operations and business transformation functions across the life sciences industry. He is passionate about the ability of digital platforms to transform the drug development process for sites and trial participants.

Amit is a seasoned IT professional with over 22 years of corporate experience designing and delivering technology solutions. Before joining Gilead, Amit successfully led a content and collaboration system consulting practice with a national systems integrator and helped develop and deliver various global enterprise solutions. In his current role, Amit leads a global technology team for the Veeva Vault platform, Vault Quality, and Digital Workplace with Content and Collaboration. Previously he led the implementation of Veeva Vault Quality Docs and now contributes to and leads scaling the global Vault platform within the organization.

Brian is a senior industry executive specializing in client collaboration to establish a vision and partners closely through the transformation journey. Drawing on diverse industry experience early in his career, Brian now works closely with high-growth and major biopharmaceutical clients. He focuses on quality, scientific, and laboratory functions across the value chain.

Brian has worked in BMS’s clinical and medical IT departments for the past 19 years. He has delivered large strategic programs and currently serves as the product owner of Vault Clinical at BMS. Before BMS, he consulted for five years at various pharma companies and worked at United HealthCare for two years.

Brian is a clinical data management and systems leader with over 20 years of experience developing, building, implementing, and managing CDM teams and clinical trial systems in the biopharmaceutical and medical device spaces. He brings extensive experience in clinical systems implementation, validation, and deployment, including business process development, training, and systems integration across multiple geographies and clinical research business units. He has detailed knowledge of the overall clinical research process and the operational and system-based inter-dependencies between functional groups within clinical development.

Bryan has over 20 years of experience working in life sciences in technology and clinical operations organizations. At AbbVie, he sits at the crossroad between effectively using technology and employing it to drive business processes. Currently, he is accountable for the technology supporting AbbVie’s regulatory affairs, development, and R&D QA business functions.

Bryan has over 25 years of clinical research experience ranging from small CRO to large pharma, including 20 years at Merck & Co., Inc. He has approximately ten years of site monitoring experience. He has dedicated 11 years to evolving trial master file (TMF) processes and technologies. His TMF experience includes multiple global eTMF system implementations and global TMF process owner. He has also managed substantial health and regulatory agency sponsor inspections and internal audits (e.g., defending standard processes, system explanation/training, and CAPAs).

Bryce is the BTS director of content management systems, supporting the quality organization within AbbVie. She is responsible for the portfolio’s operational application management, strategic initiatives, and business partnerships for platforms, including enterprise-wide document, learning, and artwork management solutions. Before the AbbVie / Allergan merger, Bryce held similar positions with Allergan supporting signature quality projects involving numerous M&A technology consolidations and process harmonization alignment into new solutions.

Casey has a broad range of experience in clinical operations, lab informatics, clinical systems, and IT at pharma and biotech companies, including Novartis Institutes for Biomedical Research (NIBR) and bluebird bio. At EQRx, Casey and his team are committed to continuous improvement, efficiency, and quality through the utilization of innovative technologies. They focus on building user-friendly and integrated systems to optimize pharmaceutical drug development.

Casey has experience as an end-user, system admin, and project manager, leading multiple successful Veeva migration and implementation projects at various companies in medtech and biotech. Before joining Abiomed, she held roles of increasing responsibility in clinical research and systems for other medical device and biotech companies. Her passion for clinical systems fuels the continuous promotion of technology, adoption of new features, and optimized systems useage to support business needs.

Charlene is a customer-focused quality systems leader with a proven track record of delivering results. She has experience in people development, quality learning, document management, deviation/CAPA, change control, and risk management. She is proficient in ICH, FDA, EMA, and PMDA guidelines.

Colleen is a regulatory affairs professional with over 25 years of experience. She specializes in delivering high-quality global drug product labeling from the pre-approval core data sheet stage through draft submission and commercial labeling. With expertise in post-marketing changes, she knows how to navigate a complicated, fast-paced supply chain.

Dave is a 13-year veteran of pharma IT, with experience across clinical data acquisition and management, site engagement, and clinical operations. As the IT business partner for CTMS at BMS, he ensures the business gets what they need from technology. He is passionate about empowering people to make informed decisions about technology.

Dee has over twenty years of experience in regulatory operations, regulatory systems, and submissions management. She has overseen the successful submission of marketing applications globally. Dee is an expert in eCTD, structured product labeling (SPL), regulatory content and data systems, and business process development to support submissions and systems-related activities. Before launching Veeva RIM at Cerevel, Dee led the successful change management program to implement Veeva RIM at Vertex Pharmaceuticals. Dee has a degree in biotechnology science from Northeastern University, has obtained the RAC Certification in Regulatory Affairs, and is Veeva Vault Platform Certified.

Deepak oversees data management, EDC build, data analytics, and risk-based monitoring activities. He has over 19 years of clinical data management experience in various therapeutic areas. His expertise includes managing changes, innovation, and transformation (including process & technology) across clinical R&D and implementing eClinical technologies (EDC, ePRO, clinical data repository, knowledge management systems). Deepak holds a master’s degree in information systems and an MBA in marketing.

Denise has over 18 years of experience within the Pfizer Digital Organization, supporting global quality operations. She has successfully managed the digital strategy, roadmap, and delivery of global quality solutions for QA, QC, and EHS. Before joining Pfizer, she supported software strategy and delivery in other industries, including agriculture, manufacturing, insurance, and marketing.

Di is an experienced information technology professional with over 20 years of experience implementing global services. She led enterprise-wide technology-driven transformation at Lilly for many years. She is Lilly’s Vault Clinical Operation system owner and has worked to scale-up CTMS in Vault Clinical Operation for the past three years.

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. Emma heads a team of system managers and specialists responsible for implementing, maintaining, and supporting key systems utilized by clinical development operations.

Eric is an accomplished clinical data manager with over twenty-five years of experience in the clinical research environment. He has held multiple positions in research organizations, from small biotechnological firms to large contract research organizations (CROs). Eric has experience in all aspects of data management of genomic studies, investigator initiated studies, and phase 1 to 4 clinical trials. He also developed a strong knowledge of clinical and statistical programming.

Greg has over 25 years of IT experience in developing, managing and delivering technology solutions and services. Currently, he is the executive director of IT, accountable for global technology solutions utilized by R&D, regulatory, quality, QC labs, and manufacturing engineering departments.

Grishma leads the pharmacovigilance domain across operations, advisory, and technology implementation services. She has broad experience in program and project management, business process development and transformation, change management, and systems delivery across various safety technology solutions. Grishma leads the Veeva-Accenture global alliance for the Safety domain and provides executive oversight of all Veeva Vault Safety programs in which Accenture is the system integration partner.

Hitesh is the safety operations and integrations manager at CSL Behring. He has 13 years of life sciences and IT industry experience in system administration, support, maintenance, and upgrades in the different areas of pharmacovigilance and clinical trials.

Jason has over 17 years of pharmaceutical experience with companies and teams of various sizes. He works as a bridge between an organization’s business and technology arms, providing multidisciplinary support across the pharmaceutical developmental and commercial landscape. He has extensive experience with implementation and development, as well as day-to-day operation and support of various Veeva Vaults and modules. In 2021, Jason was recognized as a Veeva Hero for his work on rethinking regulatory systems at Dermavant.

Jean-Baptiste is a transformation leader with strong digital and business consulting background. He has 25 years of experience driving digital and business transformation programs in pharma and other industries. He enjoys enabling cultural diversity and complex ecosystem management and driving people’s collaboration, decision-making, and execution. He currently heads the global regulatory affairs operations team at Sanofi.

Jennifer leads a diverse team of business, technical, strategy, and process experts, in addition to more traditional safety operations such as ICSR processing. The strategic operations team provides efficient processes, tools, and oversight infrastructure that allow safety experts to focus on patient safety and compliance experts to focus on day-to-day oversight. Jennifer and her team are responsible for patient safety, process, and technology decisions. Jennifer’s passions include reducing churn across the organization and supporting the growth and development of empathetic leaders.

Jennifer has 20 years of experience in regulatory operations and a master’s degree in regulatory affairs from Northeastern University. She has spent the last three years at ModernaTX, Inc., where she led the creation of a global regulatory operations team, including submission management, RA project management, and regulatory information management. During this time, her team rolled out registration tracking, commitment tracking, and health authority question and response tracking tools. She is also involved in rolling out artificial intelligence tools to create more effective ways of working across the business.

Jennifer is responsible for validation and quality oversight of key enterprise quality systems, acts as business process owner for global deviation and CAPA management processes, and manages a dedicated deviation investigations team. Jennifer also facilitates cross-functional projects with internal and external parties for key quality initiatives and sustained continuous improvement. Most recently, she was the business lead for Gilead’s multi-year global program to transform and harmonize quality management systems through implementing Vault QMS.

Jennifer is the director of enterprise-wide quality information systems at Gilead Sciences, where her team acts as the business owners of Vault QualityDocs, Vault QMS, and the GxP Learning Management System. Gilead’s “GVault” system has been used for external partner collaboration and data exchange since 2015 and internal document management since 2018. And now, they are enabling the transformation and global alignment of quality event and risk management with the implementation of Vault QMS. Jennifer has worked in the biotech/pharma industry for over 25 years and thrives on delivering innovative solutions to improve business efficiency and make compliance easy.

Jennifer has over 17 years of quality assurance, training, and computer system validation experience in the pharmaceutical industry. She has implemented multiple quality management, learning management, and document management systems.

Joe is a passionate leader who fosters a “what if?” mindset to make a case for change. He has 25 years in pharma, partnering across regulatory, supply chain, and quality to transform ways of working with a focus on user experience. Joe led Sanofi’s global regulatory affairs transformation program to reimagine and simplify regulatory information management, enabling the company’s broader digital and data transformation. He currently heads Sanofi’s GRA business process & innovation team, where they cultivate and drive new ways of working across process, data, and digital.

John is an established transformational change leader. He has led enterprise-level programs in several global support functions (procurement, IT, HR/learning, corporate strategy office, global ethics & compliance) and, most recently, R&D clinical operations. He now heads the Veeva Center of Excellence at GSK.

Jonathan has worked in TMF management for 15 years. As the head of TMF systems and archives at Astellas, he supports the ongoing evolution of TMF systems and tools. His role includes identifying TMF system trends and challenges, proposing solutions, and developing reports and analytic tools. He serves as the TMF archivist of record for Astellas, ensuring the correct archival of TMF records at the end of a clinical trial. He is also a member of the HSRAA.

Kate has partnered with life science companies of all sizes to implement innovative software solutions that keep pace with regulatory and industry rates of change. Kate has an extensive background in content management, submission compilation, and registration tracking. Her experience has given her unique insights into the problems and pressures facing life sciences companies as they look to get new treatments onto the global marketplace. With over twenty years of experience in regulatory information management, Kate is a credible expert skilled at helping companies find the most efficient way to leverage people, processes, and technology in a changing landscape.

Kelsey is the associate director of RIM and PromoMats at Turning Point Therapeutics, Inc., a Bristol Myers Squibb company, capitalizing on 10+ years within the biotechnology industry. Her passion and commitment enable system users to derive value and increase productivity through the smart use of best-in-class technology. Her excitement for Vault for RIM, PromoMats, MedComms, and Quality is the realization of cross-functionally leveraged documents and data, which promises to enhance product speed to market.

Khadija is an experienced leader with a comprehensive background in the pharmaceutical industry. She has held various roles in quality assurance, manufacturing, and supply chain management. Previously, she worked at Sanofi Pasteur on building a new vaccine manufacturing plant in Toronto, and currently, she leads global quality risk management at Roche. She is passionate about using data to make data-driven decisions in the industry and drive proactive use of risk management to prevent issues.

Kirstin has more than 12 years of regulatory experience across various functions. She started her regulatory career leading regulatory strategy for a CRO in Prague, Czech Republic, for five years. Following her return to the US, she spent time providing regulatory support for oncology clinical trials at a cancer center before returning to regulatory operations. Over the past six years, Kirstin has worked in smaller late-stage pharma in regulatory operations, advertising, and promotion roles. She joined Agios Pharmaceuticals at the beginning of 2021.

Kurt is the business lead for site monitoring and study start-up at BMS. He provides overall leadership and governance, encompassing process and technology strategy implementation.

Mark balances his academic background in historical research and teaching with a passion for delivering technology solutions to make life better for his partners, customers, and, hopefully, the people around him. He has over 20 years of experience managing IT projects, teams, and challenges. For the past four years, he has been exploring challenges across sponsor and site-facing spaces in the pharmaceutical industry.

Mary has over 20 years of experience in product development from concept to launch, quality management system transformations, clinical trials administration, pharmacovigilance, supply chain analytics, and digital tools for predictive analytics. Mary is a Veeva-certified Business Administrator in Quality Docs and QMS. Her current role at Resilience Biopharma is to lead the Veeva QMS system implementation across all the sites, including building the corresponding global processes, systems, and operating model.

Mayank leads data strategy and management for global clinical operations at GSK. He has held global responsibilities across multiple reputed organizations where he was instrumental in implementing organizational change such as data lakes, risk-based monitoring, MDR, AI/ML, and RPA. In his current role, Mayank is designing the future strategy for clinical data, including transforming the way GSK manages clinical data. Mayank also advocates for patient centricity and D&I.

Megan has been a quality professional for over five years, focusing on quality systems. She holds a Vault Platform White Belt Certification and has extensive experience with successful quality system implementations and maintenance. Her expertise in Veeva Systems, ability to drive complex projects, and management of critical configuration changes have enabled her to succeed in her current role at Sarepta Therapeutics as the manager of global eQMS and administration.

Melissa has over 13 years of experience in the pharmaceutical industry, most recently leading clinical operational systems, data governance, and analytics strategy. In addition, she has held various leadership roles ranging from trial master file (TMF) strategy, oversight, and inspection readiness to providing management for global clinical operations study support teams. She also led TMF readiness for MHRA and FDA GCP inspections and served as the subject matter expert for TMF acquisitions and divestitures. Melissa holds a Bachelor’s degree in Business Administration from Rowan University and a Master’s degree in Leadership from Northeastern University.

Michael is responsible for the strategic planning, prioritization, and execution oversight of the quality systems capabilities across Gilead. Throughout his 18-year career in life sciences (in industry and consulting), he has identified opportunities to innovate with technology that enables business strategies to achieve better quality outcomes. Currently, Michael is the overall IT program lead for Gilead’s multi-year global program to transform and harmonize quality management systems through the implementation of Vault QMS.

Michael has more than 20 years of experience in building ML/AI/data science platforms and data infrastructure. Michael served as CEO and VP of products in four start-ups that Fortune-100 companies acquired. In addition, Michael was the infrastructure GM/VP at Marvell, leading the growth to a $650M P/L. Michael holds an MS in Computer Science, an MBA from Tel Aviv University, and a BScEE (Summa Cum Laude) from Tel Aviv University.

Michelle is a clinical data manager with over 24 years of industry experience. She is currently a Director at Vertex Pharmaceuticals, an early adopter of Veeva CDMS. Michelle is responsible for all early-phase studies and has been assisting with building late-phase studies.

With 16 years of regulatory experience, Milagros is focused on solutions that foster relationships and build logistics to deliver high-quality, compliant applications for licensure. As the senior director of regulatory operations at Intellia Therapeutics, Inc, she oversees the entire submission process and leads efficient, standardized best practices for submission document management. She has worked with Vault RIM for eight years and is the business owner for Intellia’s RIM system, driving the implementation and adoption of the system and related processes. She also developed RIM eLearning training modules, streamlined the submission process, transitioned applications to eCTD format, and centralized regulatory archives.

Mingyue has over 17 years of clinical data management experience in different pharmaceutical companies and has worked across multiple therapeutic areas, including oncology, GI, CNS, and medical devices. Before joining Innovent, she worked as the head of clinical data management at Rafael Pharma. She also led a global data management team with Allergan/AbbVie, and contributed to many initiatives, from building a business case to tactical realization and change management. Mingyue completed her master’s degree in computer science at New York University.

Nadine is a senior organizational change lead in portfolio, strategy, and execution at Roche. She is a versatile, accomplished strategic leader with expertise in organizational design and change management. Her passion for people and experience in systems-thinking means she effectively addresses complex issues and opportunities. Nadine currently works on two Veeva initiatives at Roche, one in clinical operations and as a change lead for Veeva across pharma (Development Cloud).

Nancy has worked in the biopharma industry for over 20 years, spending the last four years at Ultragenyx. She is an experienced digital platforms manager with extensive experience leading intranet migration and development, optimizing business systems and collaboration tools. At Ultragenyx, she leads a QA document control and records management team and oversees the quality standards for document management.

Natasha is an industry-recognized bio-pharmaceutical leader focusing on advancing quality management systems. In her current role with Incyte Corporation, she leads transformational quality culture initiatives for the organization. Natasha has an extensive technical background, supported by a vast knowledge of various Health Authorities’ regulations, experience at multiple global pharmaceutical companies, and a passion for developing and leading high-performing teams. These skills enable the team to implement innovative and effective solutions, assuring safe medicines are delivered to patients on time.

Dr. Nicholas Lakin has over 20 years of experience as an R&D strategy consultant and currently leads clinical consulting services at Syneos Health. He started his career as a computational scientist and has a skillset covering organizational redesign, technology strategy, and business process optimization. Nick has led major transformational programs in clinical operations, CDM, and RWD Analytics, often leveraging the Veeva Vault Suite. His team of R&D consultants operates globally from the UK, India, Argentina, and the US. Nick is well positioned to advise and support clients on establishing new operating models which combine technology and strategic sourcing investments.

Nicholas has diverse systems implementation experience across R&D in the pharmaceutical and medtech space, including five years in Veeva Professional Services, focused on progressing regulatory and cross-platform implementation methodologies. Nicholas is committed to leveraging Vault Development Cloud as a unified, integrated platform and continuously improving systems at EQRx.

Nicolas is an executive leader and change agent with 33 years of global experience in the immunodiagnostics, biopharmaceutical, and medical device businesses. He holds an outstanding record for driving successful compliance, operational excellence, and personnel development. He has led multiple large-scale projects to grow business and organizational capacity. At Gilead Sciences, Nicolas has spearheaded the quality digital strategy, including advancing the implementations of Veeva Vault Quality Docs, QMS, and RIM. He is complementing these with a global strategy for advanced analytics, data visualization, technology adoption tools, and modernizing the employee learning experience.

As the leader for organizational learning and development at Tolmar, Nicole brings her passion for data-driven continuous improvement to the world of people performance. Throughout her career, she has leveraged her knowledge of organizational development and training to lead teams to more effectively and efficiently meet organizational goals.

Noreen has worked in TMF management for over 20 years, with her most recent experience heading the standards and process of the TMF at Astellas. She is accountable for establishing the global standards and processes for managing the TMF, which includes the classification and naming conventions for records filed in the eTMF. She has also volunteered on the TMF Reference Model Change Control Board for the past two years and on other projects within that organization.

Padma has over 15 years of experience in the pharmaceutical industry in clinical and manufacturing quality. She worked in the medical device industry in the process development area, developed risk-based quality strategy in the clinical space, and led auditing teams conducting risk-based audits. She currently leads Gilead PDM’s quality risk management program.

Patrick is passionate and dedicated to driving value to pharma and life science through the thoughtful adoption of technology. A Veeva alum with deep functional knowledge of quality, clinical, regulatory, and commercial domains, he has designed leading-edge solutions for top 10 pharma companies globally over the last eight years. As a director in PwC’s Cloud & Digital Practice, he is part of the team pushing the next wave of innovation and integration in the AI/ML space, specifically for life sciences in quality and clinical.

Paul is a life sciences SE manager at MuleSoft. He has over ten years of experience in the integration and API management space, helping organizations unlock the value of their data. He has worked exclusively with life sciences companies for the past five years.

Rachel has worked in Pharma for more than 30 years. She started with GSK as a data analyst in IT and now heads a highly experienced regulatory operations team within ICON. Over the last ten years, Rachel has built a best-in-class regulatory information and technology function, which is now paired with proven regulatory project management and submissions operations group to deliver a market-leading team.

Rich has been with CSL for the past eight years, after having spent 12 years working across many areas in global medical safety at Johnson and Johnson. Before joining the pharmaceutical industry, Rich spent five years at Accenture and was an airborne ranger qualified infantry officer. He earned his undergraduate degree from the University of Richmond and an MBA from Rutgers University.

Rob Saiter is a managing director and leads Accenture’s life sciences Veeva Vault practice. Rob has over 22 years of experience developing and delivering business and technology change programs within biopharmaceutical R&D organizations, CROs, and industry consortia. Rob’s work has focused extensively on clinical development operations, clinical data management and analytics, portfolio management, R&D finance, and collaboration amongst development scientists.

Ryan is the associate director of quality management at Forge Biologics. He has over a decade of quality experience in small molecule, sterile injectable manufacturing and four years of experience in the cell and gene therapy industry. He joined Forge in November of 2020 and has been responsible for developing and implementing the Veeva Quality Management System to support clinical manufacturing for Forge’s clients.

Sally has been in the biotech industry for seven years. She started as a clinical administrative assistant in a biotech start-up and quickly advanced through the industry, ultimately finding passion in TMF. As a business operations manager at GBT, she cultivated a culture of TMF accountability, built and expanded TMF operations, led TMF migrations, and served as an SME in inspection.

Samantha joined Takeda in 2021. Before joining Takeda, she was a product consultant for Ambra Health, where she led and managed enhancements and feature work for the web user interface (UI) and services engineering teams. Samantha has also held management roles with Medidata Solutions and Finch Therapeutics.

Sandra’s career focuses on identifying and implementing technology solutions that enable business strategies. She specializes in transforming organizations and their systems. Throughout the transformation process, she works to create cross-functional teams that collaborate and deliver innovative solutions.

Shannon started at Allergan in 1998 supporting various quality initiatives including system implementations and data migrations. Shannon is the business owner of Veeva Quality Docs for AbbVie.

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.

Stephen is a bench-to-market drug development expert with direct experience in pre-clinical and clinical R&D work and an academic background in commercializing and evaluating biotechnology products and companies. His most recent experiences focused on clinical research operations, including risk-based quality management, GCP auditing, GxP system administration, and clinical operations oversight. Stephen is adept with technology and quick to learn and apply technology to established processes.

After practicing as a registered nurse, Tawny transitioned to the pharma industry, where she has worked for nine years. She has held various roles within pharmacovigilance and medical call center operations. Her area of focus has primarily been in the dermatology specialty working with products within cosmetic, RX/OTC biologic, and medical device portfolios.

Vasthi has 14 years of clinical research experience, with the last ten years focused on study start-up. She is passionate about leveraging systems to decrease cycle times during study start-up. This interest developed into an opportunity in 2021 to lead a specialized team within the SSU organization at AbbVie. Vasthi’s team focuses on finding and implementing system solutions in Vault Clinical to increase efficiency and decrease cycle times.

Wim started as the regulatory information and document management system (RIMS/DMS) lead at Sarepta Therapeutics, Inc. in June 2021. He is responsible for access to and training on the Registrations, Submissions, and Submissions Archive Vaults. Wim also collaborates cross-functionally to implement complex changes and keep the RIMS/DMS in a validated state. Most recently, he has spearheaded the implementation of Active Dossier and Vault Connections, including the Vault Quality to Regulatory Connection. Before Sarepta, he was a key member of the core team responsible for implementing and validating the Submissions, Submissions Archive, and Publishing Vaults at Arena Pharmaceuticals, Inc.

Andy Han is responsible for Vault Platform Product Management. His team is focused on delivering a robust platform for the development of Vault Applications. Andy has over 20 years of enterprise software experience and has held product positions at NextLabs, Siebel Systems, and Accenture.

Annie is a product manager on the Vault Clinical Operations team and is responsible for designing and delivering functionality for the Vault CTMS application. Before joining this team, Annie spent a few years as a professional services consultant where she implemented the Vault Clinical Suite for a variety of life sciences companies.

Anusha is the strategist and market owner for Site Start-up and Engagement. She is responsible for growing and sustaining the market for the Vault Study Startup, Clinicaltrials.Veeva, and Site Connect. Anusha has over 13 years of experience in technology and consulting and has spent most of her career implementing life sciences technologies with a focus on Study Startup for the last 7 years.

Asi joined Veeva in 2018 to help us build Vault Safety, with the goal of modernizing the pharmacovigilance space. Asi is responsible for the overall product success of Vault Safety. He loves to connect with our customers’ core challenges and deliver focused solutions that enable them to operate better. Before Veeva, Asi spent over 15+ years launching cloud-based and mobile solutions to the commercial real estate industry in the area of building operations. He received a Bachelor of Computer Science degree from York University, and continues to live, work, and play in Toronto.

Bonnie has over 15 years of product management experience creating software for life sciences and health care customers. At Veeva, she oversees the MyVeeva Platform, providing the building blocks that enable other teams to develop new features with speed, consistency, and quality.

Brian is a senior product manager on Vault’s Clinical Operations team, where he is responsible for defining and delivering the product roadmap for Vault Study Startup. Brian joined Veeva in early 2017. As a product manager, he has overseen work in clinical systems integrations, data warehousing and analytics, and the collection, management, and analysis of market data regarding clinical trials, drug pipelines, and corporate partnerships, mergers, and acquisitions.

As a product manager, Cindy is responsible for the design and delivery of RIM Submissions. Her current focus is to improve usability within Vault Submissions and content planning. Cindy joined Veeva in August of 2017 as a professional services consultant, where she worked on implementing the RIM suite of applications for both SMB and global enterprise customers.

Dustin started at Veeva on the services side where he learned how to create customer success through successful implementations. Dustin then moved to product where he is excited to build future features and innovation within the RIM publishing space. Prior to joining Veeva, he worked closely with a strong development team to create and release a consumer marketplace app for iOS.

As vice president of product management for regulatory, Eldar is responsible for the product teams for Registrations, Submissions, Submissions Archive, and Submissions Publishing. Eldar has over 18 years of experience in enterprise software delivering innovative and industry-leading technology solutions across the globe.

Eric is the product lead for Vault SafetyDocs. He’s been working in some capacity on the Vault Safety Suite for three and a half years. Eric was one of the first members of the Vault Safety services team in 2019, delivering Safety to early adopters. He joined the Safety product team in 2020, working on Vault Safety before taking on SafetyDocs earlier this year. Eric enjoys working on Safety because he sees the direct impact that it has on patients’ lives and looks forward to seeing how we can improve pharmacovigilance document management.

For the better part of the last decade, Faisal has been helping sponsors and CROs leverage technology to accelerate clinical research. Working on the technology vendor side, Faisal began creating solutions to improve speed, quality, and cost of clinical data collection. In his most recent role as senior director of CDMS strategy for Veeva Systems, Faisal takes a leading role in challenging industry peers to generate efficiencies in clinical research that result in medical advancements reaching patients faster. Faisal combines his technology experience with an understanding of the needs of all the stakeholders to build realistic, future focused adoption paths.

Graham is the product management lead for Vault Platform Services which includes Reports and Dashboards, Expressions and Audit, Workflows and Lifecycles, API Tools, and Common Components.

Prior to joining Veeva in 2015, Graham was a consultant with L.E.K. Consulting, and an investor at Upfront Ventures. He graduated with highest honors from the University of California, Berkeley, earning degrees in business and economics, and he earned a master’s degree in computer science from the University of Illinois Urbana Champaign.

Jason is an industry veteran with over two decades of multifaceted roles within pharmaceutical quality control. Through leading multiple global LIMS programs, building lab informatics support services, and owning lab platforms, Jason brings a honed perspective to leading the market strategy for Veeva Vault LIMS.

Jenn has been a part of developing products for over 20 years. While new to life sciences, she had great success prior to Veeva in the patient care side of healthcare. She is thrilled to be a part of Veeva and a part of creating Vault LIMS.

Joby is a principal product manager responsible for the Vault Training product. Before Veeva, Joby worked in the life sciences technology space delivering regulatory and compliance solutions for the life sciences market.

Kelly is a RIM registrations product manager. Since joining Veeva in June 2019, she has focused on developing functionality to support IDMP and xEVMPD submissions. Before joining Veeva, she built, deployed, and managed software in service of various industries, including life sciences.

Kent has spent the majority of his career delivering technology-enabled training solutions to life sciences, holding leadership positions at industry leading companies such as AdMed, ClearPoint (Red Nucleus), UL EduNeering (UL), and now at Veeva Systems. His focus has been almost exclusively on developing, delivering and supporting Learning Management System (LMS) and mobile training technologies for life sciences.

Kyle started his career regularly using Veeva Vault at a medical device company. He fell in love with the product and joined Veeva as an associate consultant. Now, after seven years with Veeva, Kyle is a director of product management who owns the direction and strategy for the Veeva ePRO product within the MyVeeva team.

Manaphan joined Veeva in October 2016 and is responsible for the design, development, and delivery of Vault QMS capabilities. He is passionate about making products that customers love to use and building software solutions that make the complex simple.

Before Veeva, he spent over 20 years supporting, implementing and building sales and marketing automation software across multiple verticals and geographies. He has a MS in computer science from Boston University and a BBA in MIS from the University of Texas at Austin.

Manny Vazquez, CCDM has spent 17 years in life sciences, predominantly in Clinical Data Management. He began his career in small oncology biotech before moving to the CRO space for 10 years where he spent his time in DM management, supporting multiple high-profile strategic partnerships as well as overseeing innovative initiatives such as an industry-first, indication-seeking DCT. In February 2022, Manny joined Veeva Systems helping to guide strategy for the Vault Clinical Suite of applications as well as Veeva’s Digital Trial platform.

Marc has worn many hats on his way to Veeva, each on consumer facing app teams in health tech across primary care, population health, and now clinical trials. Today Marc is the product owner for Veeva eConsent, working with strategic partners to solve the challenges of digitizing consent and moving to a decentralized model.

As vice president of product management for safety, Marius is responsible for the Vault Safety, Vault SafetyDocs, and Vault Signal product teams. Marius has been building world-class products and platforms for 20 years. He joined Veeva in 2015, and prior to Safety, he helped build the Vault platform bringing innovations to Commercial and R&D customers. Before Veeva, Marius worked at D+H (now Finastra), a top 20 FinTech, building their enterprise lending compliance platform and design of next-generation products.

Mark is responsible for helping enrich the developer experience for Veeva Vault. His role is to take feedback from customers and internal resources and manage the world-class integration features for the Vault Platform.

Mark is responsible for the Veeva CDB roadmap, product innovation and customer success. He has been with Veeva for seven years and comes from a background of both product management and software engineering. His favorite thing about Veeva is the speed of solution delivery: “Our product roadmap is always ambitious. I love to watch the team execute on it, to make those innovations real for our customers. It’s a constant source of pride for us.”

With over 19 years of industry experience spanning technical support, project management, sales and strategy roles, Natalie has designed and delivered RTSM solutions for an extensive range of studies and customers. She has a passion for driving innovation and collaborating with industry peers to deliver better clinical trial experiences for all stakeholders, especially sites and patients.

Nick focuses on the needs of regulatory professionals within the MedTech industry in his role as principal product manager, Vault RIM – MedTech. Nick brings over 15 years of experience developing enterprise SaaS products for the life sciences and other industries. Before joining Veeva, he built products for regulated document management, risk management analytics, and more.

Nima is the vice president of product management for Quality & Manufacturing products at Veeva. She has over 20 years of experience building and scaling product and engineering teams for sophisticated and high-performing direct-to-consumer and enterprise cloud software systems. At Veeva, she is globally responsible for the design, development, and success of the Vault Quality Suite and family of applications that span across Quality, Manufacturing, Digital QC Labs, and Learning Management Products. Nima holds a BS and MS in electrical engineering.

Pavel developed clinical data expertise as a statistical programmer. He found success where clinical data collection and analysis meet process and technology. His proudest moments came building global programming and training teams to deliver results for customers. In 2020, Pavel established the CDB Services team at Veeva. Over 18 months, this team enabled CDB early adopters to establish expertise and scale. Now, as general manager, Pavel is driving CDB toward transforming data management. Sometimes, he still opens up a programming editor to answer a question with data.

Peter is the director of product management for the Vault Validation Management application at Veeva Systems helping the life sciences industry transform their validation processes. Peter has worked in industries ranging from the power generation and the utility sectors to manufacturing of industrial inkjet systems and cloud QHSE software. Most of his career was spent in manufacturing in engineering, quality, and new product development, and has spent the last 8 years focused on product management, developing cloud QMS solutions. Peter has a degree in mechatronics engineering from the University of Toronto and an MBA from the Rotman School of Management.

Pukar is a product manager for Reports and Dashboards. He has over 11 years of product management and engineering experience in devising elegant and innovative solutions within diverse domains.

Ray leads the development of Veeva Vault CDMS, helping customers improve data quality and speed to cut the cost and complexity in clinical trials.

Ray brings over 25 years of experience to Veeva delivering enterprise and cloud-based software. He comes to Veeva from Medrio, Inc., where he spent the past several years as chief operating officer and head of product, owning the product roadmap and delivery of their cloud-based eClinical EDC and eSource products. Through his many years of experience, Raymond has developing firsthand knowledge of the best practices and challenges faced by product, engineering, marketing, and sales in delivering technology products to market. Ray holds a bachelor of arts degree in economics from Rice University.

Rich has spent over twenty years partnering with life sciences companies to implement and innovate software solutions that meet the evolving standards within regulatory and technology. Rich has been involved with regulatory information management systems since 2000, supporting, implementing, and designing solutions to streamline the submission and registration management process. Currently, Rich is responsible for leading the design and development of Vault Submissions, Submissions Archive, and Submissions Publishing.

Richard is VP of strategy for Vault CDMS, and a 25-year veteran in life sciences. Richard is responsible for defining strategy and direction for Vault CDMS, especially concerning clinical data management. Richard brings Veeva customers both keen executive vision and proven operational experience in data management, eClinical solutions, and advanced clinical strategies.

Sara joined Veeva over 3 years ago as a Vault RIM implementation consultant. She recently moved into Product Management to support RIM Registrations and IDMP. Throughout her career, Sara has supported various aspects of the Regulatory process, from publishing and submission management to Regulatory Affairs and ensuring compliance with data standards like SPL, xEVMPD and IDMP.

As a senior manager in the RTSM team, Sean is responsible for the RTSM system throughout its lifecycle, from award through study close out. Sean has eight years of RTSM project management experience working with customers to ensure the RTSM system supports successful study progress. He also has experience as a clinical supplies manager, overseeing all things clinical supplies, such as forecasting, packaging configuration, label design, distribution and returns.

With over 15 years in the pharmaceutical services industry and over 20 years of software development experience, Shad has a strong foundation for delivering real value to Veeva’s clients and partners.

Shad currently leads Veeva’s strategy for Vault Study Training, a recently announced application that brings together research sites, CROs, and sponsors into a single platform for end-to-end clinical study training.

Stephen joined Veeva in January 2022 and has been leading the QualityDocs and Station Manager products within the Quality Suite.

Before joining Veeva, Stephen spent almost 15 years in the healthcare technology industry in a variety of technical roles helping transform healthcare via digitization. Most recently, he helped lead the product strategy and execution of a couple of B2B2C consumer health products.

Stephen has a bachelor’s degree in computer engineering and a master’s degree in computational biosciences.

Steve is the SVP of product management. He is responsible for the Site Vault, Clinical Operations and MyVeeva for Patients product lines.

Steve has over 20 years of experience in the life sciences industry. As general manager for Veeva RTSM, Steve is responsible for leading the strategy, product & engineering, services, and support teams of Veeva RTSM. A 10 year Veeva veteran, Steve has been helping scale and grow multiple teams at Veeva.

Steve founded Veracity Logic, a provider of IRT/RTSM solutions. The company was acquired by Veeva Systems in 2021 and Steve currently works in the RTSM Product group.

Tim has over 25 years of experience working in the life sciences industry from a pharmaceutical company, CRO, and technology vendor perspective.
Most notably he was the Founder & CEO of Exco InTouch Ltd, a patient engagement and eCOA mobile application provider, which he scaled through to a successful trade sale and exit in 2016.Tim is currently vice president of strategy at Veeva Systems. His primary focus is on the strategic development of MyVeeva for Patients, a patient-facing application suite.”

As VP of product management for clinical operations, Tom leads a team responsible for the Vault eTMF, SSU, CTMS, and Vault Payments products. He has over ten years of experience as an eClinical developer and product manager. Before joining Veeva, he worked on eClinical solutions for Medrio, TrialWorks, Parexel, and Quintiles. He shares the belief that great products are built by listening to the customer and putting them first.

Tristram is responsible for the Vault Signal application and has worked in roles building complex data and analytics software for over 15 years. He is passionate about usability and design of enterprise applications.

Vera is a Senior Product Manager for the RIM Application Suite. Vera is primarily focused on the Submissions Archive application. She joined Veeva just recently with a diverse background in High Tech and Healthcare.

Vinny is a principal product manager on the Veeva Digital Trials team. He has spent much of his career in the Life Sciences space and has always been interested in pursuing innovative ways to improve the industry. At Veeva, Vinny continues to work on features that span Clinical Operations and SiteVault, including those designed to enhance the collaborative experience between Sponsors and Site.

Walid is a product manager on the Vault Platform managing Lifecycles & Workflows. His goals for 2022 are closing the gaps between legacy workflows and OneWorkflow, delivering multi-record Workflows on single objects, related objects & documents, and multi-objects, and improving the task completion user experience.