2021 Speakers

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.

Jörg Möller, MD is the global Head of Research and Development (R&D) at Leo Pharma A/S and a member of the Global Leadership Team. Prior to his current role, Jörg Möller was the global Head of Research and Development and a member of the Executive Committee of Bayer AG’s Pharmaceuticals Division. He also served as a member of the board of directors at BlueRock Therapeutics and Casebia Therapeutics. Under his leadership, the R&D function has developed and implemented a global innovation model emphasizing productive, innovative collaboration models with leading academic institutions, small and large biotech players, and established pharmaceutical companies.

As Global VP for GSK, Mayank heads data strategy and management for clinical operations. He has held positions with worldwide responsibilities across organizations like Accenture, Cognizant, TCS, Syneos Health, and Bristol Myers Squibb. For the last six years, he has worked as a global director across organizations. He has been instrumental in driving key outsourcing and innovation strategies in the pharma R&D business. Currently, Mayank is vice-chair for the SCDM Board and has served on the board since 2019.Mayank is working towards designing a future strategy for clinical data. He is striving for innovation disruptions that will change the way the industry is working. Mayank is a strong advocate for patient centricity and D&I. His initiative to support “WE” vs. “I” philosophy is key to D&I advocacy.

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.

Michael is a global head in late-stage clinical operations at Roche. He is responsible for developing and implementing operational strategy and overseeing broad geographic, disease area, and strategic enablement activities.He represents late-stage development as a part of Roche’s Digital Transformation Office, supporting the digital enablement of customer interactions. He is a member of GCP Council, which oversees GCP compliance across Roche R&D. He also chairs the Joint Clinical Operations Committee, a group that seeks to balance enterprise-scale solutions with fit-for-purpose solutions across all stages of R&D enterprise-wide.

As Vice President of R&D Strategy at Veeva, Jim is responsible for customer engagement, market adoption, and strategic alliances, with a focus on clinical. For the last 20 years, Jim has held various senior positions in life sciences technology, where he has led software delivery and sales efforts in clinical operations, regulatory, clinical data standards, and content management.Jim holds an MBA in information systems from Villanova University and a B.S. in neuroscience from the University of Scranton.

As SVP of product management for clinical operations, sites and patients, Steve is responsible for the Vault clinical suite, Site Vault, and MyVeeva product teams. Steve has been working in content management for the life sciences industry for 20 years. For the last ten years, he has helped build the Vault platform and many applications built on top of it. Before joining Veeva, Steve worked with the IBM Software Group and PricewaterhouseCoopers as a consultant and architect.

Dinesh is an executive leader passionate about creating digital business solutions and delivering results. He is an industry expert in commercial technology within biopharma/life sciences. As an innovator and change agent, Dinesh solves business and customer challenges. He is a leader in shaping and enabling enterprise platform strategy with partners like Veeva and transformation organizations.He is consistently recognized for exceeding expectations, increasing margins and shareholder value by reducing operating expenses and driving revenue growth while improving customer experience.

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

As a non-scientist in the pharmaceutical industry, Jennifer leads a diverse team of business, technical, strategy, and process experts, in addition to more traditional safety operations (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 all patient safety processes and technology decisions. Jennifer’s passions include reducing “churn” across the organization and supporting the growth and development of empathetic leaders.

Sandy is a passionate IT executive at AbbVie. She is leading global, cross-functional teams in developing and delivering progressive strategies to solve complex problems. She is currently spearheading key safety, digital content, and real-world data initiatives leveraging cloud services in the regulated pharmaceutical industry.Prior to AbbVie, Sandy held various roles, including chief innovation officer for Adjoined Consulting and vice president of strategic initiatives at Cambridge Technology Partners. In these roles, Sandy delivered business solutions leveraging new and innovative technologies.Sandy graduated with a BS from Purdue University, and she is a CPA. She has four children and lives in La Grange.

With nearly 30 years of industry experience providing business technology solutions and services to top biopharma organizations, Sara has deployed many large-scale and global IT systems in regulated environments. She has strong skills in enterprise architecture, master data management, BI technologies, and business process re-engineering. In Pfizer and AstraZeneca she was the IT business partner for the chief medical officer’s organization. She graduated with a master’s degree in chemistry and computer science.

Vita is the executive director of PV processes at AstraZeneca. She is a registered nurse by training and spent 15 years as a staff nurse and nurse manager at the Children’s Hospital of Philadelphia. She started her career in the pharmaceutical world as a medical reviewer in data management. She quickly moved over to clinical trial management, first as an associate and then a CRA, where she monitored oncology, pain management, and immunology studies. She joined AZ as a clinical scientist and project leader for a pediatric study then quickly moved to key products and other leadership roles. She has been in patient safety for the last 15 years in multiple roles, mainly focusing on partnerships and collaborations.

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 PV experience. Her in-depth industry knowledge and awareness helps customers define their goals and objectives to align with industry-leading practices.

Valerie is senior vice president of quality assurance in pharmaceutical development and manufacturing at Gilead Sciences, Inc. She leads a global team, including internal sites and PDM affiliates, responsible for quality and compliance in producing and distributing active pharmaceutical ingredients, drug product intermediates, oral solid dosage forms, parenterals, biologics, and medical devices for worldwide development and commercial markets. She has over twenty-five years of experience in the pharmaceutical and biopharmaceutical industries with expertise in quality control, quality assurance, and worldwide health authority regulations. In 2010, Valerie joined Gilead to lead the Commercial API Quality group responsible for the external supply of active pharmaceutical ingredients formulated in drug products. In 2013, she assumed the additional responsibility for commercial quality and compliance oversight of finished dosage forms as well as devices manufactured for and on behalf of Gilead. She holds a BS degree in biology and chemistry from Averett College and a master’s in healthcare management from Saint Joseph’s University.

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.

Vijay is currently a regulatory transformational leader at Roche Products Ltd. He works across pharma development regulatory, pharma technical regulatory, and drug regulatory affiliates. He leads a team that is transforming the regulatory landscape towards a digital state. He has over 20 years of experience in the pharmaceutical industry, with 13 years at Roche. Vijay started his career as a statistician and holds MSc in Statistics. At Roche, Vijay has led teams in inflammation and oncology. Over the years, Vijay has also led several transformative initiatives ranging from PKPD, clinical, real-world data, CDISC, and analytics integration.

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.

Leonie has held various leadership roles in data management and study management. She led an innovative global cross-functional team of data managers and CRAs to drive new ways of working and improve data quality. Leonie has championed major technology projects in CTMS, EDC, and CDISC within GSK. Currently, she is the business lead for Vault CDMS and focuses on delivering industry-leading performance and modernizing the data management and CRA user experience.

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 10 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 inspection engagements (e.g., defending standard processes, system explanation/training, and CAPAs).

As a senior solution consultant, Tom is responsible for supporting the Vault Clinical applications, including CTMS, Payments, eTMF, SSU, Site Connect, and SiteVault. Tom has worked in the multi-tenant SaaS content management and collaboration space for over 20 years. Before joining Veeva, he worked at IntraLinks, focusing on the life sciences industry, specifically in the clinical study start-up area. For many years he also volunteered for the local ambulance core as a licensed emergency medical technician.

Brandi joined Veeva as a senior consultant on the clinical operations services team and spent almost two years implementing Vault Clinical applications before becoming a solution consultant. As part of the solution consulting team, Brandi specializes in the Vault Clinical Operations application suite and is responsible for demonstrating the process and business value of the clinical solutions.

Susan has over 25 years of progressive clinical trial management and leadership experience, including global systems and process management. Susan joined Heron Therapeutics in early 2019 following a long career at a large CRO. One of Susan’s key goals, when she joined Heron, was to implement a CTMS system.

Harry is an information technology (IT) professional at Eli Lilly and Company. Currently, he is the director, clinical operations/digital solutions in medicines development information and digital solutions (MD IDS). Prior to his current role, Dr. Tunnell was the advisor for wearables & sensors (IoT), where he led strategy development for the wearables, sensors, and IoT capability in MD IDS.Dr. Tunnell has a Ph.D. in human-computer interaction from Indiana University and an MS in information systems from the University of Maryland, Baltimore County. He is also an adjunct lecturer in the department of human-centered computing at the Indiana University School of Informatics and Computing in Indianapolis.

Lukas is an information technology professional at Eli Lilly and Company. Currently, he is the clinical operations/digital solutions manager in medicines development information and digital solutions (MD IDS). His current responsibilities include the IT implementation of Vault Clinical Operations.Prior to his current role, Lukas was the manufacturing and quality information and digital solutions (MD IDS) manager, where he led global development, delivery, and support for laboratory information management systems and lab execution systems. He has a B.S. in computer and information science from Taylor University, Upland, IN.

Mark is the president of clinical operations and commercial solutions at Labcorp Drug Development. He oversees global project delivery, clinical delivery, functional service provider, Covance market access, patient solutions, safety and data sciences. In addition, Mark supervises the global commercial organization’s enterprise client solutions, including strategic deal development, proposal, and contracts for our early development, clinical trials testing solutions, and clinical development and commercialization services. Mark joined Covance in 2017 from Quintiles, where he spent 16 years in progressive leadership positions across the enterprise, including VP of global business operations and capabilities across the clinical development organization. Mark is a North Carolina native. He attended North Carolina State University, earned a B.Sc in economics, and previously served two terms on the board of advisors for North Carolina State University College of Management.

Michelle joined Veeva in July of 2021 as a solution consultant for Vault CDMS. With nearly 15 years of experience in clinical data management and clinical research, Michelle is a seasoned data manager and study builder who loves bringing technology innovation to clinical research and data 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 technology solutions to improve the speed, quality, and cost of clinical data collection. In his most recent role as director of CDMS strategy for Veeva Systems, Faisal takes a leading role in driving the adoption of clinical data management tools to build efficiencies that result in medical advancements reaching patients faster.

Basu is the director of product management for Veeva Vault Workflows. He is responsible for all workflows and lifecycles in Vault and has been building products in the enterprise content management and file sharing industry for the last decade, with the last four years at Veeva. Basu was previously responsible for Vault Objects and has helped build many areas of the Vault Platform. His focus is always on building delightful products and making customers successful.Before Veeva, Basu has worked in EMC, Oracle, Adobe, and some startups, developing and building products for the last 15 years. Basu holds a bachelor’s and master’s degree in computer science.

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.

Walid is a product manager on the Vault Platform team. He is responsible for Vault API tools, including Vault Loader, Configuration Migration, Vault Compare Report, Vault Configuration Report, and Scheduled Data Exports. Before joining Veeva, he spent six years working in the environmental, health & safety (EHS) industry as a product manager on the cloud platform team. There he worked on the platform API and industrial IoT integrations with gas detection technologies.

As Director of Product Management, Igor is responsible for the new Vault Mobile team. Igor has been with Veeva for eight and a half years. Before the Vault Mobile team, Igor helped build the Vault Developer platform, empowering developers to build robust new applications and integrations. He also spent many years designing and building platforms at various consumer software companies as an engineer and a product manager.

Bob is the director of product management for the Vault Platform. He has worked on key parts of the platform, including Vault Object, Vault Java SDK, and Vault UI. With over 20 years of experience in enterprise software platforms, he has extensive knowledge of cloud platform designs, from data modeling and programming APIs to user interface frameworks. Bob is passionate about making Vault a world-class platform that gives customers the necessary tools to address their most demanding business application needs.

Jonathan is a chemist by training and started his career in pharmacovigilance in 2010. 4 years ago, he joined Incyte to improve its PSMF content and management process. He also worked to implement Vault SafetyDocs as part of the PSMF improvement project.

Charlotte is a pharmacist by training and started her career in the drug safety area 8 years ago. She began in the public sector and then worked for pharmaceutical companies. Charlotte is interested in finding new and well-suited software-driven solutions to help Incyte manage global pharmacovigilance requirements. Recently certified as a Project Management Professional (PMP), she has successfully led a team that adapted the company’s safety database to the local pharmacovigilance team’s needs.

Colleen is a senior solution consultant for the Vault Safety Suite. Before joining Veeva, her experience has always been on the implementation side of PV projects for large pharmaceutical companies. During this time, Colleen played various roles from business analyst to data analyst to validation lead to trainer to project manager.

Scott has over 22 years of experience in safety and pharmacovigilance. Currently, he is sharing the benefits of Vault Safety, Vault SafetyDocs, and Vault Safety.AI. His goal is to support problem resolution with technology to increase efficiency for customers and, ultimately, their patients.

Elliot is an ex-physician/scientist/engineer turned repeat founder/CxO, startup investor, and occasional executive. At Resilience, Elliot is responsible for all things digital, including infrastructure, applications, data science, software development, and security. Previously, Elliot was at Amazon’s cloud computing arm (AWS), where he started and led the company’s work supporting startups, scale-ups, and investors in highly specialized industries.Elliot earned MD and Ph.D. degrees at Penn Med doing computational research on Alzheimer’s disease and memory function. He specialized in massively parallel simulations of large networks of biophysically realistic neurons. Earlier, he attended Johns Hopkins, where he learned about chip design on the way to degrees in electrical and computer engineering.

Heather is a quality professional with over 20 years of experience in the pharmaceutical and medical device industries. In her current role as head of quality systems compliance at Astellas, she is responsible for developing and maintaining quality systems that meet global GMP requirements.

Alan has over 30 years of experience working in the pharma/biopharma industries across multiple business areas. His expertise is in new facility construction and start-up, process automation, validation, and quality system management. Now he leads the AstraZeneca Quality Risk Program.

Stephanie has over 29 years of experience in quality in the pharmaceutical industry. Her experience includes many quality roles supporting development, manufacturing, testing, and distribution at small private companies and big pharma. She was involved in planning and implementing several business and quality solutions throughout her career.

Verchel has over 15 years of experience in the biotech and pharmaceutical industry. She has focused on IT system development, support, and maintenance. During her four years at Seagen, she has worked in the regulatory affairs department managing technology initiatives, including the implementation of Veeva Vault RIM.

Scott has ten years of clinical research experience, mainly focused on regulatory affairs. For the last two years, Scott has been involved with the Veeva Vault RIM rollout at Seagen Inc. in various capacities. Scott is originally from northern New England but now calls the Pacific Northwest home.

I have two decades of experience in Regulatory Operations with leadership roles at Moderna, Baxter Healthcare, and Boehringer Ingelheim Pharmaceuticals. Throughout my career I’ve led Global Submission Management, Publishing teams, and RIM teams. I’ve driven implementation of systems and processes enabling global eCTD publishing, registration tracking, commitment tracking, and health authority question and response tracking. I am now exploring how AI can help transform regulatory and the business as a whole.

Maulik is a systems manager and business administrator with a demonstrated history of working effectively in the biotechnology industry within GxP – Regulatory, Quality, and IT. He has experience in delivering technical solutions and process improvements with a strong focus on understanding the business process and collaborating on efficient digital solutions. Achievement to date: Playing a (very) small part in saving the world from a pandemic with Moderna.

Amy is a Senior Director of Global Clinical Operations at Parexel. She began her career as a management consultant on software-enabled business transformation projects for major retailers, manufacturers, and nonprofits. She later moved to the CRO industry, where she has worked for over ten years on strategic initiatives involving large-scale process and technology changes that drive business benefits. At Parexel, she leads the process and change management for Parexel’s risk-based quality management initiative.

Ed leads a team of clinical process and technology experts at Parexel. They help define the most effective clinical technology strategy for the clinical operations business and ensure the right technology is implemented quickly and effectively to maximize the value of these investments. Ed has over 25 years of experience working in the pharmaceutical and CRO industry.

Stephen is an interdisciplinary scientist. He began his career as a biotechnologist in labs, then moved into clinical research as a GCP auditor. Now, Stephen works as a cross-portfolio clinical oversight lead in clinical operations oversight. He has always loved understanding and adopting new technology and building efficiencies into day-to-day routines.

Kimberly has been a solution consultant at Veeva for just over a year. She supports the clinical operations and site products, specifically eTMF, Site Connect, SiteVault, and MyVeeva for Patients. Before joining Veeva, she worked in the EHR space for over three years.

Lauren is a senior solutions consultant in the Vault Clinical Operations group providing value-based demonstrations of the Vault Clinical Suite and connections. Before joining this team, Lauren spent a few years implementing the clinical solutions with many customers on both the CRO and sponsor sides, which allows for a perspective of best practices across the industry.

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.

Alesia joined Vanderbilt University Medical Center Clinical Trials Center (VICTR) in June of 2018 from Birmingham, Alabama. She attended the University of Alabama and UAB, where she earned bachelor’s degrees in psychology and biology. She is currently working toward her master’s in public health at UNC-Chapel Hill. Before her time at Vanderbilt, Alesia worked in specialty clinics and hospitals in the Birmingham area in various administrative and patient care roles. She enjoys seeing live music and theater performances in her free time, watching movies and television shows, and is part of the Voices of Vanderbilt choir.

Jill is the director of the Vanderbilt Coordinating Center Local Support Services Division and the Business Intelligence and Informatics unit. Jill has served the last 23 years supporting Vanderbilt investigators in various roles. She has spent the last 15 years providing investigators with study management oversight, providing trained research personnel, and offering insight into breaking barriers to research.

Jenn holds a bachelor’s degree in biology from Indiana University–Purdue University Indianapolis. She has over 18 years of clinical research experience across various roles, including study coordinator, data manager, data standards implementation lead, design hub consultant, and study build programmer. Currently, Jenn is a group lead for the study build team at Eli Lilly and Company. In her free time, Jenn enjoys shopping, reading, gardening, traveling, and spending time with family.

Mita is a senior team lead for study build programming at Eli Lilly. Before joining Lilly, Mita spent over 13 years in clinical data programming, working with global CROs where she managed a team of database/SAS programmers. She is a visionary, strategic, solution-driven, and result-oriented leader committed to creating and maintaining strong sponsor/CRO relationships.

Eric has over 20 years of pharmaceutical and medical device industry experience. Over the last decade, he focused on data management and technology adoption. As a CDMS Solution Consulting Team member, Eric’s main responsibilities include adding technical product expertise with real-world experience during the sales cycle for new business and expanding business with current clients. He enjoys helping people realize the potential in our technology to improve their clinical quality, outcomes, timelines, and quality.

John is a senior product manager at Veeva based in Europe. He works on the Vault API & tools team and focuses on delivering new platform features and easy-to-use tools for the rapid development of Vault Applications. He also provides guidance and support to customers and services teams on third-party integrations. John has a strong background in implementation, systems integration, and development, with over 20 years of experience in IT working across several market sectors.

Robert is part of the Vault Platform product management team, where he oversees the docs & data area. His background is in enterprise software at NetSuite, Adaptive Insights, and Zuora, where he was on the platform teams. He holds a BS in computer science from UC Berkeley and an MS in software development and management from Carnegie Mellon.

Jennifer is a highly experienced pharmacovigilance and medical device vigilance professional with over 17 years of global clinical research experience in pre- and post-market product safety. She has experience in safety database design and development and case report form design. Jennifer also oversees risk management, suspect product recall management, and global clinical trial project management. Her expertise includes case report form development, clinical trial protocol development, clinical evaluation reports, standard operating procedures, supplier management, quality auditing, and regulatory inspection readiness.

David brings more than 25 years of software product development, applications engineering, systems integration, project management, and compliant business solutions design experience to his role. His experience has been concentrated in enterprise-class research, manufacturing, and business and marketing systems for premier clients in the life sciences, financial services, and manufacturing sectors. As a co-founder of Valiance, David led the initial development of Valiance’s core software products TRUcompare and TRUmigrate. His thorough understanding of the supported platforms, user interface design, and novel testing techniques directly resulted in Valiance’s unique product direction path. David earned a B.S. in Electrical Engineering from the University of Rochester in New York and is a Phi Beta Kappa Society member.

Raj leads safety services and is responsible for delivering the Vault Safety Suite. He has been in drug safety and pharmacovigilance for over two decades, and before joining Veeva, he worked on product development. Raj spent most of his professional life in Mumbai, Bangalore, and Tokyo before moving to the United States in 2011.

Meghan is the senior director of quality management at Forge Biologics. Meghan has over 17 years of experience in FDA-regulated industries, including drugs and medical devices, as well as pharmaceutical excipient manufacturing. Prior to joining Forge Biologics, Meghan held a quality management role at Abeona Therapeutics, where she gained experience in cell and gene therapy. She started her career in the industry at Ben Venue Laboratories (a Boehringer Ingelheim Company) in 2004 after graduating from Case Western Reserve University with a degree in biology.

Ashley has over a decade of experience in the life sciences industry, focusing on solutions for the quality space. As the director of Vault Quality at Veeva, Ashley is responsible for product strategy, customer engagement, and business development. Before Veeva, she served as industry solution manager in the product management and strategy team at Sparta Systems, where she led the pharmaceutical vertical market efforts. Ashley received her bachelor of science degree in biology and music from Boston College and a master’s degree in biotechnology from Columbia University.

Anastasia works closely with sales, services, and product management teams to oversee Vault Quality strategy. When she first joined Veeva in 2018, she was a services consultant focused on delivering Vault Quality to customers.Anastasia is a certified quality auditor with a diverse background in life sciences–from academic research to quality and regulatory. Prior to joining Veeva, she spent several years working in the industry as a quality professional, where she implemented and maintained quality systems. Anastasia also worked with a cross-functional team of experts at the FDA to provide final premarket approval for medical devices and combination products. Anastasia holds a bachelor of science and a Ph.D. in biomedical engineering.

Matt’s career started by developing in-house quality management solutions for a top-five life-science organization. He has spent the last 15+ years working for industry-leading quality management software vendors. He has held roles in support, training, implementation, and project management. He currently manages the North American quality solutions consulting team at Veeva.

Manaphan joined Veeva in October 2016 and has held product leadership roles in commercial content and Asia. He is currently a senior director of product management for Quality products. He is passionate about making products that customers love to use and building software solutions that simplify the complex.Before joining Veeva, he spent over 15 years supporting, implementing and building sales and marketing automation software across multiple verticals and geographies. He received an MS in Computer Science from Boston University and a BBA in MIS from the University of Texas at Austin.

Julie is a quality assurance training manager at Dicerna Pharmaceuticals, responsible for developing and maintaining the training program. She has over twenty years of experience in the pharmaceutical industry. Julie has participated in multiple LMS integrations and continuous improvement projects. Since joining the Dicerna Quality team in February 2020, she has helped make significant process improvements utilizing Vault Training.

Justin is an associate director of quality assurance at Dicerna Pharmaceuticals, where he leads the quality systems group. He has been directly involved in the implementation and use of Vault, seeing it grow from an initial implementation of the QualityDocs module to include QMS and training as well as links to clinical, regulatory, and commercial Vaults.With 18 years of industry experience, Justin has developed expertise in customizing and adapting quality systems to the organization’s particular needs, avoiding common pitfalls, and ensuring a quality product, regulatory compliance, and patient safety.

Diane is a director of IT account management supporting research quality at Merck. She brings a unique perspective to her job after working with manufacturing quality for many years. Diane has partnered with the manufacturing team to further the use of Vault Quality Suite across the Merck Divisions.

Matt joined Atara Biotherapeutics in 2019 as the head of regulatory operations. Before that, Matt was the head of product management for the InSight Suite of regulatory information management solutions at Parexel, Inc. and partnered with Microsoft. From 2003-2016, Matt was a director of regulatory & safety operations at Amgen, Inc. He was also one of the pioneering members of the regulatory submissions department for GlaxoSmithKline. Matt has been publishing and submitting electronic dossiers to the FDA since 1996 and submitted the first fully electronic NDA for GSK in 1999.

Craig is a regulatory operations management professional with over 15 years of industry experience. He has experience planning, collaborating, and managing regulatory submissions. Craig specializes in the implementation of scalable SaaS regulatory and adjacent content management system infrastructure. He focuses on maximizing internal RegOps strategic capabilities supported by flexible sourcing models.

Michael is the head of regulatory informatics (submission management, systems/tools, RegIntelligence & medical writing) at Blueprint Medicines. Michael has almost 20 years of extensive regulatory experience in various companies like Genzyme, Biogen, EMD Serono, and Seres Therapeutics. Michael enjoys transforming his industry experience into learnings. He has developed original clinical, regulatory, and professional development lectures and course materials for various universities and academic partners. Michael is a natural trainer, facilitator, and counselor. He is warm and gracious and believes in a philosophy of “live and let live.”

Paula is an advisor for the regulation information and process automation group at Eli Lilly in Indianapolis, Indiana. She received her BS in Pharmacy at Purdue University. She began her career at Lilly in manufacturing technical services and then held assignments in clinical trial management (packaging and labeling) and quality assurance before arriving in global regulatory affairs. Over the past 17 years, she has held regulatory director roles in CMC, advertising/promotions, and labeling. She has now taken on the opportunity to lead the implementation of an integrated platform across global regulatory systems and processes.

Amber is an information technology professional at Eli Lilly and Company with over 20 years of experience across research, clinical, and regulatory affairs. Amber holds a bachelor of science degree from Indiana University – Kelley School of Business in computer information systems with a minor in biology. In her early career, Amber led several large-scale research IT initiatives focusing on analytical chemistry and in vitro biology. She then led the initial analytics solution implementation for risk-based monitoring at Lilly. She built strategies and solutions around clinical lab results modernization, clinical users working environment, and the initial strategy work for devices and digital biomarkers in clinical trials. Amber is the chair of Women in IDS at Lilly, an organization designed to foster an environment where women in IT thrive. Currently, Amber is leading the IT implementation of the regulatory information management (RIM) program to transform the regulatory submission process to improve overall quality and speed.

Jason is a Vault administrator and performs full publishing functions for Dermavant in RIM Publishing. His background is in laboratory instrumentations, and he switched to regulatory publishing about 1.5 years ago. He was instrumental in Dermavant’s recent NDA submission to the FDA using RIM.

Dan has nearly 20 years of experience in the biotech and pharma technology space, including submission management and publishing. With a wide range of diverse experience in implementing, supporting, and operating applications and platforms, he supports medical, regulatory, quality, and clinical groups at local, regional, and global organizational levels. He has worked with Veeva Vaults for over a decade.His most recent implementations have been Vault Safety and Vault Publishing, and Dermavant used these systems to complete and submit their first NDA submission.

Lorena has over 20 years of experience in clinical development, with more than seven years specializing in study start up. She began her career as a Phase I study coordinator at PPD and went on to hold monitoring and project management positions at Parexel and AstraZeneca. Lorena held start up leadership roles at Abbott and AbbVie, and was promoted to director of study start up at Allergan/AbbVie from 2016-2020. She is now the senior director of global study start up, PRO management and digital implementation at AbbVie.Lorena holds a BS in microbiology, a BA in molecular biology, and was an NIH fellow in the University of Texas at Austin pharmaceutics Ph.D. program. She was awarded the 2011 Pharma Times Clinical Researcher of the Year silver medal in the project management category. She was also a core team member for the TransCelerate Shared Investigator Platform and Investigator Registry Initiatives. Lorena is an active speaker at industry conferences and recently appeared in the healthcare issue of Hispanic Executive magazine.

Jarek is a versatile and accomplished professional with over 12 years of experience leading various regulatory affairs and study start-up facets. He has proven success in defining regulatory submission strategy and driving start-up. His keen understanding of relevant aspects of drug development helps him drive operational excellence and organizational development.

Alex has held multiple roles within clinical operations at GSK, including early and late phase operations and clinical data management. As part of the GSK digital analytics and performance team within GSK clinical operations, he provides high-quality feasibility data. This data enables country and site selection decision-making and influences patient recruitment and retention. He also leads a team of study start up specialists to achieve upper quartile study start performance.

Vasthi has worked in clinical research for 13 years, focused on study start up for the last nine years. She supported the configuration of Vault Study Start Up for Allergan’s Vault in 2019 and then had the opportunity to repeat the project in AbbVie’s Vault. Her focus on study start up and technology led her to her current position. She leads a small but mighty team solely focused on supporting the SSU team using AbbVie’s Vault Clinical (eTMF, SSU, Site Connect) through training and configuration updates to the system.

Christina is a Trial Master File (TMF) Operations professional. She has experience in clinical operations, TMF operations, and clinical (GCP) compliance across large, mid-sized, and small biopharmaceutical organizations.

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

Jonathan is the Senior Director of Informatics at EQRx. Formally trained as an organic chemist, Jonathan has held roles leading software engineering, informatics, and IT efforts. He has experience at various biotechnology companies, including Relay Therapeutics and Vertex Pharmaceuticals. At EQRx, Jonathan and his team are responsible for enabling efficiency at scale by building a modern and innovative development and commercialization platform.

Casey is the associate director of clinical systems at EQRx. Casey has a broad range of experiences in clinical operations, lab informatics, clinical systems, informatics, and IT. He has held roles 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 by utilizing innovative technologies. They focus on building user-friendly and integrated systems to optimize pharmaceutical drug development.

Jennifer joined Kronos Bio as the director of clinical data management and programming in September of 2020. She began her data management career over twenty years ago at Quintiles (now IQVIA), and her first task was separating the pink and yellow copies of three-part NCR CRFs. Since then, she has worked at several different sponsor and CRO companies in North Carolina, Ohio, and California. She has worked in all study phases and a variety of therapeutic areas. Since the mid-2000s, she has worked on EDC studies and does not miss paper CRFs (or DCFs) one bit.

Sharmin has over 18 years of experience spanning the life sciences, device, and software industries. In leading Veeva’s global solution consulting team for Veeva Vault CDMS, Sharmin works with clients to understand their business challenges and present solutions targeting those needs. She has specialized in clinical research innovation, especially in modern clinical trial designs, digital health, pharma, and app-based studies. Sharmin earned her B.A.Sc. in electrical engineering from the University of Waterloo and her M.S. in bioengineering from Stanford University.

Richard joined CluePoints in September 2018 and is based in the UK. As VP, solution expert, his role is to support organizations’ adopting CluePoints solutions from a technical, functional, and business process perspective, particularly as they execute their vendor selection programs. Additionally, he has product management responsibilities and provides a bridge between customers, prospects, and ongoing product development. He has worked for technology vendors for over 20 years, but he worked in data management with Fisons Pharmaceuticals and Astra before. Richard graduated from DeMontfort University, Leicester, with a bachelor of science degree in computer science.

Brent has been building analytics solutions and leading technical delivery teams for 18 years. Currently, he leads the business team that directs product management, marketing, and business development for clinical solutions. Prior to his work at PerkinElmer Informatics, he designed and built innovative clinical, operational, post-marketing, and other analytics solutions at IQVIA and PPD. Outside of the clinical trial space, Brent has also built analytic solutions for the defense industry and led shipboard technical teams as an officer in the US navy. Brent holds a BA from The Citadel and an MBA from Meredith College.

Jean-Christophe is a product manager at Veeva Systems in charge of the Vault Platform security, covering authentication, access control, and user management. Before joining Veeva Systems, he had 15 years of product management experience in B2B/B2C eCommerce and partner portal products, where enabling online collaborative flows to preserve security and privacy is of utmost importance.

Graham is a director of product management focused on Veeva’s Vault Platform. Before 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. He completed a master’s degree in computer science at the University of Illinois Urbana Champaign.

Rachel is a dentist by training who decided to pursue a career in Public Health. Currently, she focuses on clinical research in her role in pharmacovigilance sciences and operations. Rachel has been involved with implementing Veeva Safety System and now manages the production of Veeva Safety Vault. In her free time, Rachel likes to play the guitar and go on hikes.

Bo has over 13 years of medical device, drug, and product development experience in the healthcare, consumer beauty, and cosmetic industries.Before joining Bellerophon, Bo served in senior leadership roles at Iluminage Beauty Inc, a joint venture of Syneron Medical and Unilever Ventures.She has worked within clinical operations and development, regulatory affairs and intelligence, quality system management, risk management, and compliance.When not working, find her snowboarding or cruising on her motorcycle.

Karteek joined Veeva a little over three years ago, and he works as the practice manager for Vault Safety. Primarily, he focuses on supporting implementations and safety operations at Veeva. Karteek earned his bachelor’s degree in electronics and communication engineering in India and received his master’s in electrical engineering at the University of Missouri.

Janelle has over 12 years of experience in drug safety and pharmacovigilance at small and large biotech companies. At Parker Institute for Cancer Immunotherapy (PICI), she is currently responsible for patient safety, pharmacovigilance, and safety outsourcing. Prior to PICI, Janelle was the senior manager of pharmacovigilance at Clovis Oncology and drug safety manager at Medication.

Prannoy leads Veeva’s Quality Risk Management and Post Market Surveillance applications. He has over eight years of experience building highly successful technology-driven products in B2B and B2C categories in the healthcare, retail, finance, F&B, and education sectors.

Nima Shah is the VP of product management for quality products at Veeva. She has over 18 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, Nima is responsible for the design, development, and success of the Quality Suite and family of applications – Quality Docs, QMS, Training, Station Manager, and Product Surveillance (MedTech).

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

Gerome is the associate product manager for the Vault Quality Suite. Currently, he is supporting Quality Docs and Station Manager products. He studied at Santa Clara University, where he majored in computer science and engineering.

Chris is a senior product manager for the Vault Quality Suite of applications. He assists in the definition and function of all of the applications which make up the Vault Quality product Suite. Chris has over ten years of experience working with, building, and delivering solutions in the life sciences industry.

Kent has spent most 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 systems (LMS) and mobile training technologies for life sciences.

Graham is a general manager for Veeva LearnGxP. Before joining Veeva, he spent 21 years working in various quality roles within the life science sector ranging from GMP, compliance, quality systems, validation, and training.

Lexie is a quality business partner, proactively implementing scalable processes and programs. She specializes in quality and regulatory compliance covering all GxP from inception to commercialization. She works to build quality teams with depth & breadth and lays a quality infrastructure and overall culture of quality. Through leadership and guidance, Lexie establishes quality and business processes ensuring they are optimized, efficient, and sustainable. She has implemented various Veeva Vaults including QDocs, QMS, Training.

Eldar’s role at Veeva is to lead the design and development of Vault’s Regulatory Information Management (RIM) suite of applications. He is passionate about building industry-leading applications to help streamline and optimize all regulatory processes for customers of all shapes and sizes. Eldar works closely with all Veeva teams from sales and strategy to services and engineering to ensure the RIM suite of applications continues to lead, innovate and harmonize all things regulatory.

Rolando is the director of product management for the RIM Application Suite at Veeva. He has worked with life sciences organizations for over twenty years focused on providing software solutions for regulatory.

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, he is responsible for the design, development, and success of Vault Submissions Publishing.

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.

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.

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.

Sara joined Veeva over three 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.

Vera is a senior product manager for the RIM Application Suite. She focuses on the Submissions Archive application. She joined Veeva recently with a diverse background in high tech and healthcare.

As VP of product management for clinical operations, Tom leads a team responsible for the Vault eTMF, CTMS, Vault Payments, and Clinical Network Site Connect product. He has over ten years of experience as an eClinical developer and product manager. Prior to working for 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.

Brian is a senior product manager on the Vault 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 clinical systems integrations and data warehousing and analytics. He also handles the collection, management, and analysis of market data regarding clinical trials, drug pipelines, and corporate partnerships, mergers, and acquisitions.

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.

Predrag is currently the executive director of regulator operations at Seattle Genetics. He oversees the regulatory submission, information and project management, and regulatory advertising & promotions teams. Before joining Seattle Genetics in September 2018, he spent five years working at AbbVie, where he managed their regulatory submission planning and operations department. Overall, he has over 26 years of industry experience with numerous regulatory roles, including regulatory affairs, strategy, and operations in pharma, generics, and biotech companies. Predrag holds an MSc in Pharmacology from the University of Toronto, certifications in business analysis and project management, and he is a Drug Information Association member. Through his experiences, he has established expertise in global regulatory e-submissions, project management, and people management.

Muralikrishnan is a senior IT leader with over 22 years of achievement. His experience spans IT leadership, manufacturing, supply chain management, quality, regulatory and commercial, with particular specialization in biotech, pharma, and medical device. Muralikrishnan delivers IT-enabled solutions that structure companies for optimal performance and efficiency with his unique blend of hands-on technical expertise and strong operations background. He has led large-scale IT projects that streamline operations, mitigate risks, improve quality, and ensure compliance to all regulatory standards, including stringent FDA requirements.

Drew’s career in pharmaceutical technology spans over 25 years. It includes significant experience in eClinical system architecture, design, and development, as well as process design, solution validation, and international implementation and support. Drew joined Veeva in 2016 as vice president of product management and led the ground-up design of Veeva’s Vault EDC solution. In his current role of chief technology officer at Vault CDMS, Drew shares and collaborates with customers, partners, and the industry to set the vision and direction of Veeva’s CDMS product.

Alice is a solutions engineer on the Veeva Vault Clinical Data Management team, providing value-based demonstrations of the Vault CDMS product and connections. Before joining the CDMS solutions consulting team, Alice spent a couple of years on the CDMS services team configuring studies with many customers on the CRO and sponsor sides. She has expertise in study build best practices within the Vault CDMS product.

Marc has spent his entire career in the eClinical technologies space, with most of that time focused in the area of IRT. Having spent years on the client services side, Marc has worked with 7 of the top 10 pharmaceutical companies and 6 of the top 7 CROs to design, implement, and maintain IRT solutions across a variety of therapeutic areas. As a Co-founder and Director of Business Development at Suvoda, Marc uses his IRT subject matter expertise to provide creative solutions to customers’ problems, all while growing Suvoda’s business globally.

Wilmer leads a cross-functional team responsible for delivering Interactive Response Technology (IRT) for randomization and drug supply management in clinical trials. He has a B.S in chemistry from Ursinus College.

Ashley, client manager at 4G Clinical, has ten years of experience in RTSM system implementation, configuration, and project management. She has worked on various RTSM platforms from both the vendor and sponsor perspectives. Ashley has a passion for understanding the technical elements of clinical trial implementation and simplifying the client’s journey, allowing her to build meaningful partnerships both internally and externally. Ashley graduated from Stockton University with a Bachelor of Science in biology with a minor in chemistry.

Marie joined Pacira Pharmaceuticals in May 2017 as senior manager of regulatory affairs in charge of ad promo. In January 2019, she was promoted to associate director of regulatory compliance. She is currently leading the group responsible for PCRC (ad promo), submissions management, and RIMS. She is also a member of Pacira’s Regulatory Leadership Team. Marie has over 20 years of experience in regulatory operations and submissions management. In November of 2010, Marie received her RAC Certification in Regulatory Affairs. Currently, Marie is spearheading Pacira’s implementation and migration of Veeva RIM.

Since joining Pacira BioSciences in 2018, Joy publishes and submits electronic dossiers to the FDA and performs the coordination function for Vault promo mats. Because of this unique positioning in both publishing and ad promo, she was instrumental in transitioning to a streamlined all-inclusive electronic OPDP submission process a year in advance of the FDA’s deadline. Previously, Joy performed labeling and regulatory roles while at Eisai from 2004-2017. Presently, she is engaged in implementing Veeva RIM, looking forward to enhancements of its archiving, collaborative authoring, and publishing features.

Karen has spent her career in and around regulatory, specializing in content management and publishing. She enjoys helping customers get the most out of their Vault RIM investment by showcasing new and existing functionality.

Jessica is a customer success manager for Veeva’s enterprise quality customers. She has focused her over 20-year career in life sciences on quality and manufacturing practices. Jessica began her career in the industry, helping implement ERP systems with Pfizer’s global manufacturing IT department. She was also an administrator of regulated systems at Teva and a senior consultant in Accenture’s supply chain group. Most recently, she was the product manager for OpenText’s Documentum for quality and manufacturing product (D2).

Marius is responsible for the Vault Safety suite of products. He has built world-class enterprise, small business, and consumer software products for close to 20 years across various industries. Since joining Veeva in 2015, he has focussed on helping life sciences organizations innovate and solve complex problems. Currently, that energy is being channeled into pharmacovigilance.

Kyle is a life science industry veteran with over 20 years of experience. His background is in quality, regulatory, and learning management systems. His primary focus for the past ten years and at Veeva is on Quality applications. His professional proficiencies and expertise include software pre-sales, implementation, process solutions, and training consultation.

Snehal is a leader in the quality strategy team at Veeva and has ownership of Vault Quality solutions for top 30 pharma customers. He has over 16 years of experience in the industry, including experience consulting in the manufacturing and quality space. Prior to Veeva, Snehal led the quality systems practice at PwC, where he supported large pharma customers to drive operational efficiencies by implementing Quality 4.0 transformation programs.

Glen has been in the life science industry for over 16 years working in the IT quality systems space. His experience ranges from being an application administrator to an IT business analyst.

Danielle is a director of strategy focused on the Vault Quality Suite applications. She has spent nearly her entire career within the QMS space and is passionate about continuous improvement. Danielle holds an MBA and an MS in strategic management, and her experience includes leadership positions in quality and management consulting with PwC’s digital quality practice.

Jason is responsible for Veeva Site Connect and eTMF market strategy. Before joining Veeva in 2013, Jason held various roles within clinical development at the Dana Farber Cancer Institute, Wyeth Research, and Vertex Pharmaceuticals. He received his M.S. in drug development and regulatory affairs from Northeastern University and his B.A. in psychology from the University of Vermont.

Seth is responsible for the Vault Connections that connect the Vault R&D suites to support customers’ end-to-end drug and device development and commercialization. Before joining Veeva, he helped start a company called Amplion that used machine learning techniques to extract biomarker information from scientific literature and clinical trial information.

Saba is responsible for safety strategy and customer success. She has close to 20 years of consulting experience supporting biotech and pharmaceutical companies. Saba has extensive experience and knowledge optimizing PV business processes, implementing and managing PV systems, including aggregate reporting and safety signal solutions.

Mike joined Veeva in February of 2020 to partner with the Vault Safety Strategy team. Their focus is on innovating the product’s capabilities to address industry challenges and delivering on customer success goals. With over 20 years of industry, software, and consulting experience in the pharmaceutical and healthcare industries. Working with many of the top pharmaceutical and biotechnology companies, Mike brings a passion and focus on supporting customers with their transformational goals by leveraging these industry insights and best practices to support PV process and system optimization efforts.

Pesh is the director of quality professional services at Veeva. He has 20 years of life science experience delivering solutions in the quality and manufacturing, commercial, medical, and regulatory space.

Melissa is a life sciences system implementation veteran with over 20 years of consulting experience. In nearly ten years at Veeva, she has implemented Vault across the enterprise: Commercial, Quality, Clinical, and Regulatory. Currently, she is Veeva’s vice president of global RIM professional services, leading a team of over 40 consultants, building and refining our Vault RIM implementation methodology and strategies. She has been heavily involved in delivering Vault RIM to nearly all major enterprise RIM customers.