2020 Speakers

Amy P. Abernethy, M.D., Ph.D. is an oncologist and internationally recognized clinical data expert and clinical researcher. As the Principal Deputy Commissioner of Food and Drugs, Dr. Abernethy helps oversee FDA’s day-to-day functioning and directs special and high-priority cross-cutting initiatives that impact the regulation of drugs, medical devices, tobacco and food. As acting Chief Information Officer, she oversees FDA’s data and technical vision, and its execution. She has held multiple executive roles at Flatiron Health and was professor of medicine at Duke University School of Medicine, where she ran the Center for Learning Health Care and the Duke Cancer Care Research Program. Dr. Abernethy received her M.D. at Duke University, where she did her internal medicine residency, served as chief resident, and completed her hematology/oncology fellowship. She received her Ph.D. from Flinders University, her B.A. from the University of Pennsylvania, and is boarded in palliative medicine.

Avril England 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.

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 625 life sciences companies bring new medicines and treatments to patients faster. Peter serves on the board of directors of Veeva Systems, Guidewire Software, and Zoom Video Communications.

As VP of product management for clinical operations, Steve is responsible for the Vault eTMF, CTMS and Study Startup product teams. Steve has been working in content management for the life sciences industry for 15 years. For the last eight years, Steve has helped build the Vault platform along with many of the applications built on top of it. Prior to Veeva, Steve worked with the IBM Software Group and PricewaterhouseCoopers as a consultant and architect.

As general manager of Veeva Vault CDMS, Henry has overall responsibility for the Veeva Vault CDMS product and is focused on having Veeva become the market leader for data collection and cleaning for clinical trials. Henry has spent 25 years working to transform how the $1.7 trillion life sciences industry improves patient health.

Prior to Veeva, Henry was chief commercial officer for PPD. Before that, he led Accenture’s global life sciences R&D practice.

As Vice President of data strategies and solutions at Bioforum, Tanya du Plessis has vast experience across the industry. Throughout her career, Tanya has worked with multinational pharmaceutical companies as well as small-to-mid size biotechs and startups. She has led various data management operations and programs, heading numerous innovation teams and spearheading the development of strategies for customized data delivery solutions, focusing on timely, quality data.

A certified clinical data manager (CCDM, SCDM), Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State in South Africa. She also has a project management professional certification (PMP, PMI).

Dominique has over 20 years of International Regulatory Affairs experience, with the last 15 years spent in Global Regulatory Operations management role in industry and service providers. Today, Dominique works at Amgen as the Head of Global Regulatory Operations with the past 2 years fully dedicated to the implementation of Veeva Vault RIM globally. Dominique holds a Pharm D and a Master’s in International Regulatory Affairs from the University of Paris.

Marc Nephtali, director of business systems at Vertex, has a pharmacologist and bioinformatics background. He has 20 years of experience in Biotech/Pharma supporting Clinical, Regulatory and Drug Safety systems.

Anders, who has a science background with a PhD in Biochemistry, is currently working as a Digital Transformation Leader in Digital Health for AstraZeneca R&D.

He has more than 20 years experience of global drug development across all phases of the value-chain through both project leadership and line management roles. In addition, he has also spent a number of years working with portfolio and capacity management gaining significant experience of the management of the R&D business. He is passionate about driving transformation with the aim to ultimately improve healthcare for patients.

Dennis Rodman is the Director of Global Quality Management Systems at Bristol Myers Squibb. In this role, his primary responsibility is the business lead for Infinity, the brand name of the Veeva QMS Solution at BMS. Dennis has over 20 years experience across the Pharma/Biotech industry.

Kelly leads safety strategy at Veeva and has over 18 years of industry and consulting experience supporting Biotech and pharmaceutical companies, and has extensive knowledge and experience with the US FDA, and EMA Safety and quality regulations. She has experience applying specialized regulatory and compliance knowledge to help define and implement strategy, design/redesign processes, support technology implementations, and define governance across the spectrum of PV activities and life sciences.

Rusty Ang joined Seattle Genetics, Inc., a leader in ADC technology, 8 years ago and currently leads the publishing and global submissions team in the US office. He has oversight on all submissions across global markets and serves as the business subject matter expert for the vault RIM suite. Rusty was responsible for the implementation of Vault Submissions and Vault Submissions Archive. He is actively engaged in the configuration of Vault Registrations and future evaluation of Vault Submissions Publishing.

H Bondar is a Senior IT Project Manager who partners with business stakeholders and leads cross-functional project teams to deliver innovative technology solutions that support the development of transformative cancer drugs — medicines that make a meaningful difference in people’s lives. Having worked for several decades in the software, telecommunications, financial services, and life sciences industries, H knows what it takes to deploy successful technology solutions: establish technical credibility, communicate clearly, and build strong interpersonal relationships to “bridge the gap” between business and engineering teams. H is PMP® certified and holds a BA in English with a Computer Science minor from Northeastern University.

Javier Briceno is a quality leader, passionate for strategic global initiatives that drive measurable and sustainable business results to reduce complexity and increase compliance in the Life Sciences industry.

Patricia Carlos has over 20 years of comprehensive experience in regulatory affairs encompassing early drug development through regulatory approval and post marketing. Her expertise includes work in HIV and CKD, with a concentration in immuno-oncology and hematology. Patricia has been responsible for securing regulatory approvals for the successful global development of eight oncology compounds, including both small and large molecule compounds.

John Cavanagh is part of the Global Applications & Development team within GSK Technology organization and is accountable for program delivery and product management of Veeva Vault QualityDocs. John and his team partner with the GSK business teams across Pharma Supply Chain, Consumer Health, Research & Development and various support functions to deliver this new capability for the enterprise, replacing legacy solutions and ways of working.

Craig Gassman, M.S. is currently the Director of Regulatory Operations and Quality Information Systems at Vericel Corporation. He has worked within Regulatory Operations, Submissions, and Content Management roles for 15+ years within the Greater Boston area. Craig has previously worked at other biopharmaceutical organizations including Genzyme, BioVex, Aveo Oncology, Biogen, and Karyopharm Therapeutics. He has also provided private consulting services for Regulatory Information Management system implementations and related business processes. His key interest is the intersection of Regulatory Content Management, hybrid resourcing models, and process optimization. He has broadened system expertise beyond RegOps within general content management, eTMF, promotional material management, and Medical Affairs. Craig received a B.S in Microbiology from the University of Massachusetts, Amherst, and an M.S. in Regulatory Affairs from Northeastern University.

Jason Grimmer has over 25 years of IT experience in the pharmaceutical industry, with successful business partnerships and proven delivery of large transformational initiatives throughout clinical development, regulatory submission and clinical material management.

His current focus is on enabling a seamless clinical data flow to accelerate drug development efforts. This includes partnering to improve clinical data collection, advance our data management through integration, and speed the delivery of clinical datasets through automation.

Lisa Hornick, M.D. is the chief medical officer and leads medical and safety at Catalyst Clinical Research. Board-certified in internal medicine, Lisa was in private medical practice for seven years before joining the industry as a medical director at a major CRO. She advanced to managing the global medical monitoring group and subsequently led multiple business units including Pharmacovigilance and Medical, Medical Communications, and Early Development. Lisa earned a Bachelor of Science degree in Chemistry from Texas A&M at Kingsville and a Doctor of Medicine degree from the University of Nebraska College of Medicine.

Marcus is part of the Quality Systems team within the GSK Pharma Supply Chain Quality organization. He and his team provide Quality Oversight and have business process ownership across a broad range of systems in Quality, IT, Automation and Engineering. Marcus is also a member of the Tech and Digital Automation leadership teams and is the overall GSK business lead for Veeva Quality Docs.

Ivan Mihalic is an experienced and successful life sciences information technology Consultant, having worked in different positions including Business Analysis, Product Management, and Project management.

Ivan manages all the project planning, implementation, and validation of Arriello’s pharmacovigilance IT systems and is the principal IT contact for IntelliCASE, Arriello’s Case intake, and Triage system.

Day to day he ensures the Veeva Vault safety database and PV eco-system work perfectly to maintain compliance at all times for their clients.

As VP of product management for safety, Marius is responsible for the Vault Safety, Vault SafetyDocs, Vault Safety.AI, and Vault Signal product teams. Marius has been building world class products and platforms for 19 years, and before joining the safety team, he worked on the Vault platform bringing new innovations to both Commercial and R&D customers. Prior to Veeva, Marius was Director Product Management / UX at D+H (now Finastra), a top 20 FinTech, overseeing their enterprise lending compliance platform and design of next generation products.

Garrick Myers, Director of Technology and Operations Innovation at Vertex Pharmaceuticals, supports its Global Clinical Operations function. He has over 15 years experience designing, developing, and deploying life sciences technology and business process solutions in support of clinical research, in both the Sponsor and CRO space. Garrick has held a variety of positions throughout his career related to technology, data governance, clinical quality, process development, inspection readiness, innovations, and operational efficiency.

In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, Medical Coding, Safety, and Business Intelligence systems.

Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications finance, Oracle database administration, and relational database design.

Jess Robinson is an enthusiastic and motivated clinical research leader with 9+ years experience in strategic study delivery across different therapeutic areas and study phases and a passion for line management, coaching and development. She currently leads a global Study Start-up Leads team, driving innovative ways of working in order to remain globally competitive.

J.C. Sheridan has 10+ years experience in clinical trial operations. As a Senior TMF Compliance Specialist with Janssen, he was the project lead for the implementation of Non Essential classifications.

Jennifer Trundle is a Director for enterprise Quality Management Systems at Gilead Sciences. She has worked in the biotech/pharma industry for 25 years, starting in IT with a variety of document management and content management systems. Jennifer was excited to join Gilead 4 years ago for the opportunity to lead an implementation of Veeva Vault QualityDocs as a transformative quality project across the entire global Gilead organization. Jennifer serves as the Business Process Owner for the newly-expanded “GVault” system at Gilead, which is also used for collaboration and data exchange with external partners. Jennifer’s team also has business management responsibility for Gilead’s learning management system and quality event management system.

Ayesha Ullah is an Associate Director in Regulatory Affairs group at Viela Bio and has over 18 years’ of experience in regulatory operations. In her current role, she serves as a business process owner of Veeva Vault RIM at Viela Bio, manages authoring templates for regulatory submissions and postmarketing submissions of promotional materials. Prior to this, she worked at AstraZeneca/MedImmune where she was the line manager of US publishing team and was responsible for overseeing publishing and delivery of submissions to global health authorities for their Biologics product portfolio.

Michael Underhill is an experienced pharmaceutical professional, skilled at evaluating business processes and translating associated requirements into solutions. Mr. Underhill has worked with data and business systems for his entire career, including almost 20 years at Lilly. He is a leader and team player that values diversity and what can be accomplished by leveraging the strengths of others.

Jessica (Jess) Vicari, Director, Clinical Digital Solutions, joined Immunomedics in 2019 as TMF Head and Business System Owner for Vault Clinical to drive the transformation and ongoing operations of the eTMF function across the portfolio and to launch CTMS as an impactful tool for unified sponsor oversight and intelligence.

Jeff Wiley has been in the clinical research industry for more than 20 years, all within the CRO space. Following positions of increased responsibility across Clinical Operations, as a Director, Jeff has led teams focused on study startup, in-house support, monitoring, and clinical team leadership. Jeff led the North American Oncology monitoring team at Covance and recently transitioned to lead a global team of CTLs focused on the execution of late phase oncology trials.

Verchel Wunpheng has 20+ years experience in IT systems support, maintenance, and deployment in the biotech and pharmaceutical industries. She is proficient in computer systems validation and understanding of GxP regulations and principles. Verchel’s primary focus for the last 3 years have been the implementation of various Veeva Vaults for Seattle Genetics and the Regulatory Affairs Department.