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.

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.

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.

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.

Chris Lamont is Executive Director, Global Quality Systems at Bristol Myers Squibb Company where he leads a team that optimizes, integrates, and automates quality processes across the end-to-end Quality Management System including the implementation of Veeva Quality Vault. Before joining BMS, Chris spent 21 years with Schering-Plough/Merck and Actavis/Teva in roles across Quality, Manufacturing, and Engineering with a focus on quality systems, continuous improvement and project management. Chris holds a bachelor’s degree in Mechanical Engineering from Rutgers University.

Mary Olakangil leads BMS’ global IT operations and digital capability at the platform level for Veeva Regulatory RIMS and Veeva Quality Management solutions. With deep technology knowledge and close collaboration with regulatory and quality organizations, Mary successfully converts business requirements into functional solutions. Mary also worked with multiple teams around the world to develop a streamlined and robust process to harmonize the global and regional release management of the Veeva regulatory and quality applications.

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.

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.

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.

In 30 years of manufacturing experience and over 20 years in GxP regulated industries, Scott Chapell has held a variety of operational and functional roles in engineering, quality compliance, manufacturing operations, enterprise architecture strategy, IT solutions, and mergers/acquisitions business development. He is currently focused on standing up a new manufacturing and quality IT solution architecture for the 2nd largest animal health company in the world. Scott is passionate about delivering innovative information solutions that allow the company to efficiently meet customer’s needs.

Scott Cleve leads the Regulatory Operations and Compliance team at bluebird bio. In his past roles, Scott built and led publishing and regulatory operations teams at Astellas, AbbVie, and Boehringer Ingelheim. While many of his roles have been technical in nature, what inspires Scott is building high-performing teams and helping people develop and meet their career goals. On the technology side, he is interested in building efficient, easy-to-use processes and systems along with exploring the latest trends in technology like AI, ML, and automation.

Dr. Stephen Cook is the Regulatory Program Lead for deployment of the Veeva Vault RIM suite within GSK. He is responsible for process harmonization and optimization across GSK’s Pharma and Vaccine business units and the deployment of a single Vault RIM for the global regulatory function. Whilst Stephen has experience of regulatory operations and systems, his primary experience lies in product registration. In his previous role, he was Vice President, Head of International Region (Emerging Markets and Asia Pacific / Japan / WHO) for Global Regulatory Affairs at GlaxoSmithKline.

Deirdre Dacombe is a Senior Manager, Quality Systems at VielaBio, responsible for implementation and oversight of the VielaBio Quality System. Prior to VielaBio, Deirdre spent 25 years in the industry, starting in a small NJ microbiology lab working with human bone for transplant. This was then followed by developing a calibration and validation program for Eli Lilly’s new insulin manufacturing facility in Manassas, VA, and more recently managing a global QA team and successfully implementing an enterprise document management system while working for the R&D arm of AstraZeneca in Gaithersburg, MD.

Anthony Davis has more than 25 years of professional experience working in GxP environments, building quality assurance systems from initial conception to beyond commercial deployment. He has certifications in Six Sigma methodologies and Project Management, coupled with a record of streamlining quality operations and procedures, to gain maximum effectiveness.

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).

Richard Dyer is a Senior Consultant with over 20 years of experience in management, development, implementation, and operation of systems. He has worked in a variety of industry verticals including life sciences, healthcare, finance, and software development specializing in strategy, planning, validation, and systems integration. The last 12 years have been within the drug safety/pharmacovigilance domain with extensive experience in drug safety business process design and optimization, safety database implementations and upgrades, safety database migrations, system and application validation, and application development and modification.

Leianne Ebert is currently the Head of Data Management at Alcon, bringing over 14 years of clinical trial experience. Leianne has held leadership roles in standards, clinical systems, and data operations at both Alcon and Novartis, which includes an International Assignment in India as the Global Head of Operations with Novartis. Leianne is highly experienced managing large cross functional projects and change management initiatives.

Heather Frankhouser is a Temple University Graduate, BS and MS with 18+ years experience in the pharmaceutical industry. She has a background in Regulatory, Quality and Compliance, and Clinical realms with 16+ years of TMF management experience. She has worked in both the device and pharmaceutical sectors in leadership roles to enhance TMF use, improve processes, and support inspection readiness.

Regina Freunscht has 25+ years of experience supporting clinical development with multiple positions in Clinical Operations and Quality Assurance, both in the biopharmaceutical and CRO industry. She joined Merck Serono in 2013 as VP, Head of Global Research and Development Quality Assurance where she designed the Merck Serono R&D Quality Management System that is sustainable and fit for purpose. Since May 2015, Regina has been the Head of the SVP Office of Global Regulatory Affairs with a focus on the development and implementation of an effective GRA strategy. Regina is instrumental in driving the GRA organization and navigating strategic transitions into action.

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.

Caitlin Henderson is the current Elanco Sr. IT Analyst – Manufacturing IT. She oversees Elanco and Explorer Quality Vaults at the IT Lead.

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.

With nearly 20 years of Regulatory Operations and Regulatory systems specialization, Jason Maze has had the opportunity to be involved in organizations of various sizes and complexities from Biotech and start-up BioPharma to Global Pharmaceutical both directly and on the Services side within a CRO. He has been focused primarily on the ‘Regulated System’ side of things, supporting Content Management, Publishing, Clinical Operations (eTMF), Medical Affairs, Quality Assurance, and Computer System Validation. Jason enjoys providing a bridge between the technology and the functional teams using that technology.

Joe McLaughlin is a strategic information management executive who partners with leaders to identify, define and drive innovative solutions (process, data and technology) with measurable outcomes. Joe has over two decades of increasing leadership experience in Regulatory Affairs Information Management and Technology. Joe leads Sanofi’s Global Regulatory Affairs Transformation Program to simplify the way Regulatory information is managed, which includes implementing new global transversal processes and systems. This Sanofi Executive Committee endorsed Program is foundational to enabling Sanofi’s future digital and AI transformation. Joe Heads the Sanofi Global Regulatory Affairs Business Process and Operation Excellence team to build on the Program’s transformation and manage the continuous improvement model.

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.

Raghu Nandan is an Associate Director, R&D and a Veeva Architect at Bristol Myers Squibb Company. He is a senior technology and management professional with extensive experience in conceptualizing, developing, and implementing enterprise solutions across multiple geographies (US, Europe & APAC).

Matt Neal joined Atara Biotherapeutics in 2019 as the Head of Regulatory Operations. Prior to that, Matt was the Head of Product Management for the InSight Suite of Regulatory Information Management Solutions at Parexel, Inc., and partnered with Microsoft. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. (2003-2016) and was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline (1996-2003). Matt has been publishing and submitting electronic dossiers to the FDA since 1996, and submitted the very first fully electronic NDA for GSK in 1999.

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.

Anthony Ochoa, director of regulatory operations at Myovant Sciences has been using RIM since June 2019, and Subs Publishing since August 2019.

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.

Lisa Owens holds 2 BAs from San Diego State University and an MBA from the Paul Merage School of Business, University of California Irvine. She has 20 years of industry experience. In 2003, she filed the first official eCTD through the centralized procedure in Europe. Since then, Lisa has worked with several companies implementing software systems, global Regulatory Operations best practices, and building departments and dynamic teams. She has managed groups in the US, the UK, and China. She is currently Senior Director of Regulatory Operations within Arcus where she is establishing a new Regulatory Operations team.

Lisa Pitt Global Regulatory Affairs registration strategist, experienced in small molecule/biologic pharmaceutical product development from early phase through registration and post-marketing, managing communications with global health authorities including the Food & Drug Administration (FDA), European Medicines Agency (EMA), European Union (EU) member states, Pharmaceuticals and Medical Devices Agency (PMDA) and Health Canada Biologics & Gene Therapy Directorate (BGTD) as appropriate. She is a subject matter expert with strong knowledge of global registration requirements, superior scientific knowledge base including cardiovascular, metabolic, endocrine, gastroenterology, respiratory and inflammatory therapeutic disease areas, pediatric and rare disease product development. Lisa has broad experience in global pharmaceutical and healthcare industries including related trade associations.

For over 15 years, Leila Ponce coordinated oncology clinical trials, developing a deep passion for her patients through a shared goal to improve their quality of life. Her desire to have an impact on cancer patients’ lives led her to Seattle Genetics, where she began as a Sr. Clinical Trials Associate, and thereafter, transitioned into a manager position. Today, Leila continues to be driven by her passion for patients in leading the Clinical Records Team and Trial Master File operations in the Regional Clinical Trial Operations department, with a focus on inspection readiness.

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.

Julie Saathoff is proud of her 20+ year career in clinical research where she has supported the development of biopharmaceuticals and FDA-mandated research in the tobacco and nicotine industries. Julie began her career as a Clinical Coordinator at a Celerion legacy company and quickly moved into Project Management. She ultimately served as the Clinical Director of the Lincoln, NE Phase 1 clinical pharmacology unit, with over 200 beds. One of three CPUs within Celerion, the Lincoln facility encompasses the broadest clinical pharmacology offerings within the organization. Following this full immersion in the Celerion offerings, Julie transitioned to head Celerion’s Trial Master Files and Monitoring services. Career highlights include management of multiple CTMS/TMF systems, extensive Phase 1 experience, 10 years of Project Management, and review of several hundred monitoring reports. She is passionate about using technology to improve workplace efficiency.

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.

Jessica Skrine, Associate Director of Clinical Trial Management at Vertex, supports Global Clinical Operations. She leads a team of Associate Clinical Trial Managers and is serving as the Vault Clinical implementation and change lead for her department. During her tenure at Vertex, Jessica has served in a variety of capacities leading programs and studies across the development life-cycle. Jessica’s past experience includes work at biotechnology and pharmaceutical companies as a study operations lead and Lead CRA.

Marianne S. Smith currently leads learning and development initiatives for Sanofi Global Regulatory Affairs. She directs organizational change management strategy for transformation initiatives related to regulatory systems and processes. She facilitates learning analysis, implementation of learning strategy and availability of learning materials, focused on regulatory systems. Marianne focuses on competency development for regulatory professionals. She is a versatile professional with experience in learning, regulatory affairs, clinical, and information management. She is skilled with process re-engineering, education, adult learning concepts, organizational development, interpersonal communication, and presentation skills. Marianne has a formal education in science and human organizational science/human resources.

Mike Tarsa has 10 years of Electronic Systems Compliance experience, providing QA oversight of enterprise applications used to support GCP and GPVP activities at Gilead. He transitioned to BeiGene to provide ownership of their Veeva Center of Excellence. In three years at BeiGene, he has implemented and run-state maintenance of Vault Submissions/SubmissionsAcrhive, Vault QualityDocs, Vault QMS, Vault eTMF, Vault PromoMats, and Vault MedComms. In March, Mike joined Arcus Biosciences as system owner/validation lead and has gone live with Vault Submissions/SubmissionsArchive and Vault QualityDocs, is in-flight with Vault eTMF, and about to kick off Vault Training implementation.

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.

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.

Donna Wolfington is the Head of Global Regulatory Submissions Management at Sanofi. Donna has 20 years of experience in Regulatory Affairs, and has worked for companies including Merck, GSK, Wyeth, Pfizer and Shire prior to joining Sanofi. She has expertise in project management, eCTD strategy, submission publishing, training, change management, process design/implementation, team management, and vendor governance. Most recently, Donna also played a key role in a transformation program for Sanofi (GRA Horizons). This led to the consolidation of many legacy systems and processes into a single set of global capabilities, with Vault RIM as the primary and foundational platform.

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.