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.
From 2010 to 2018, Joseph Jimenez held the position of Chief Executive Officer (CEO) of Novartis, one of the world’s leading pharmaceutical companies. Under his leadership, Novartis developed one of the largest pipelines of self-originated drugs in the industry, driven by a strong commitment to R&D. Mr. Jimenez also transformed the company’s portfolio to focus on innovative patented medicines under Novartis Pharmaceuticals and Novartis Oncology, generics under Sandoz, and eye care devices under Alcon.
Prior to serving as CEO of Novartis, Mr. Jimenez held the position of Division Head, Novartis Pharmaceuticals. He joined Novartis in 2007 as Division Head, Novartis Consumer Health.
Mr. Jimenez is currently a member of the Board of Directors of General Motors Company and The Proctor & Gamble Company. Additionally, he served on the Board of Directors of Colgate-Palmolive Company from 2009 to 2015, and of AstraZeneca PLC, from 2002 to 2007.
He graduated in 1982 with a bachelor’s degree from Stanford University and in 1984 with a Master of Business Administration from the University of California, Berkeley.”””
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.
Robert is currently the Vice President of the Clinical Design Delivery & Analytics, a component of Lilly Research Laboratories. In this role, Robert has responsibility for worldwide delivery of clinical research across all therapeutic areas and phases of clinical development. He is also responsible for Lilly’s Biometrics and Advanced Analytics organization, which provides Research and Development with leading capabilities in data, information, and analytics.
After completing his Ph.D. in Pharmacology and Toxicology at Queen’s University in Canada, Robert joined Eli Lilly Canada in the Regulatory Affairs organization where he led successful approval efforts, for neuroscience and anti-infective new chemical entities. His next opportunity led him to the Lilly Corporate Center in Indianapolis where, as a member of the Global Project Management organization, he led cross-functional teams in the global development and registration of new molecular entities in Lilly’s diabetes and osteoporosis portfolios.
Following this opportunity, Robert returned to Lilly Canada where he had leadership responsibility for Regulatory Affairs, Health Outcomes, and Quality. Robert’s next assignment was in Japan where he led the Project Management and Pharmaceutical Development organizations for Lilly Research Laboratories, Japan. After 4 years in Japan, Robert returned to the Lilly Corporate Center in Indianapolis as a Director in Project Management with responsibility for the Project Management organizations supporting early and late-stage drug development.
In 2005, Robert was named Executive Director, Global Patient Safety with worldwide responsibility for adverse event case management, pharmacovigilance, and quality systems in support of product safety. In 2009, Robert was named Vice President, Global Ethics and Compliance where he had responsibility for providing Ethics and Compliance leadership to functional and geographic areas across Eli Lilly, included implementation of an effective compliance program.
After 2 years, Robert returned to Lilly Research Laboratories as Vice President Global Regulatory Affairs-North America, with responsibility for leading Lilly’s interactions with the FDA, including submissions, review, and approvals, as well as representing industry in engagement with the FDA on key policy topics, including negotiation of user fee agreements (specifically PDUFA VI). In 2017, Robert assumed responsibility for Global Clinical Development.
Paul Sekhri has more than 25 years’ experience in life sciences, having served in executive leadership positions at some of the most widely regarded pharmaceutical companies in the world. He is President and CEO of eGenesis, a biotechnology company focused on xenotransplantation. Previously, Paul served as president and CEO of Lycera, an innovative biopharmaceutical company focused on treatments for autoimmune diseases and cancer. Prior to Lycera, he was operating partner at Highline Therapeutics, a biotech incubator launched by Versant Ventures. Paul also served as senior vice president, integrated care at Sanofi where he led the creation of innovative solutions and business models to meet patient needs. Before Sanofi, Paul led global business development and was chief strategy officer at Teva. He also served as operating partner and head, biotech ops group at TPG Biotech, the life sciences venture arm of the global private investment firm TPG, where he was responsible for a portfolio of more than 50 life sciences companies. He has held the roles of founder, president, and chief executive officer of Cerimon Pharmaceuticals; president and chief business officer of ARIAD Pharmaceuticals; and partner for healthcare investments of New Leaf Ventures. Paul spent four years at Novartis, where he held various senior positions, including senior vice president, head of global search and evaluation, business development and licensing, and global head, early commercial development, where he developed the disease area strategy, and founded the early commercial development department.
Paul has served as a director on more than 24 private and public company boards, including Ipsen, Compugen, Alpine Immune Sciences, Pharming N.V., Topas Therapeutics, Petra Pharma Corporation, Enumeral Biomedical Holdings, Inc., KAI Pharmaceuticals, Intercept Pharmaceuticals, Macrogenics, PatientSafe Solutions, Tandem Diabetes, and as board advisor to IMS Health.
Paul completed post-graduate studies in clinical anatomy and neuroscience at the University of Maryland, School of Medicine and received his bachelor of science degree in zoology from the University of Maryland, College Park.
As Co-founder and Board Member of Veeva, Matt Wallach helped build the company into one of the most valued and trusted partners to the world’s largest pharmaceutical companies and emerging biotechs. With almost 20 years of life sciences expertise, he played a pivotal role in helping meet customers’ most pressing global requirements in developing and bringing products to market.
Prior to Veeva, Matt held leadership positions in product management, marketing, and business development at various healthcare technology companies. Earlier in his career, Matt was the general manager of the pharmaceuticals & biotechnology division at Siebel Systems, where he established the company as the market leader in Pharma CRM and clinical trial management systems (CTMS) before its acquisition by Oracle.
Matt also serves on the board of directors of HealthVerity. He received an MBA from Harvard Business School and a Bachelor of Science in economics from Yale University.
Lale began her career in research in Vienna, Austria in 1996 performing data support and programming functions for a research organization. She obtained her MBA from UofL in 2005 and her ACRP certification in research monitoring (CCRA) in 2006. She oversees all aspects of UofL/CTU clinical trial program and provides leadership to the research unit in all functions. Lale develops and maintains productive relationships with the research and clinical community and other important stakeholders through effective communication, leadership, and guidance.
As a Senior Product Manager, Mohammed focuses on Clinical Coding and other CDMS ecosystem applications. Prior to Veeva, Mohammed has 6 years of SaaS Product Management experience and he has worked as a Business Consultant at Accenture and an Engineer at Intel Corporation. He loves Product Management because it’s the perfect balance between Business Strategy, Design, and Engineering.
Associate Vice President, Life Sciences Application Services
Associate Vice President, Life Sciences Application Services
Gaurav has more than 15 years working experience in strategy development and execution of IT outsourcing and transformation within the life sciences industry. Gaurav’s strengths are in developing services, building global units and delivery models with cost-effective strategies; streamlining operations and optimizing processes to deliver user-centric support services. His primary life sciences industry experience is within R&D, regulatory, medical devices, manufacturing and supply chain.
Douglas Arnold is Director, Client Service Leader, Global Pharmaceutical Operations Science and Technology, MMD Information Technology at Merck, a role he has held since 2015. Douglas has been working in the Information Technology organization at Merck for 20+ years and has had roles in Strategy Development, Business and Solution Architecture, Program Management and Account Management supporting a wide set of organizations, business capabilities and technology services. Prior to joining Merck, Douglas spent 10 years working in Academia on Federally Funded Research Programs as a Research Assistant and Statistical Programmer.
Dana Baird joined PRA Health Sciences in 1997 after attending both Piedmont Virginia and University of Virginia. She currently manages the QMS Operations team, within Process and Learning Management (PLM). Dana and her team oversee the Veeva Vault Content Management – QMS system and work alongside the Learning Management System, Process Development and Issue Management teams.
In addition, Dana manages the PLM Audit Support team who participate in Sponsor audits and inspections, with Quality Assurance. Dana has over 25 years’ experience in quality, project management, process development and continual improvement initiatives
Hironmay Basu is the Product Manager for Veeva Object Framework in Veeva Vault Platform, a fast-growing cloud software platform and suite of applications to manage content, data, and business processes for life sciences and other regulated industries. Objects form the backbone of Veeva Platform and are heavily used in wide variety of Vault Applications across Clinical, Regulatory, Quality and Safety. Prior to Veeva, Basu spent a decade building Enterprise Content Management Platforms and Applications in Startups as well as in large companies like Adobe and EMC.
Group Leader, Global Regulatory Business Capabilities
Group Leader, Global Regulatory Business Capabilities
Danielle obtained her PhD in biochemistry from Laval University Canada. After a 13-year career in microbiology drug discovery, she moved into regulatory operations where she managed several drugs at different stages of development in the US and EU. In 2014 Bristol-Myers Squibb began working toward replacing their older RIM solution with a new authoritative source for RIM, and selected the Veeva Vault RIM suite to accomplish that goal. Danielle has been the business lead for that effort from process definition/simplification to configuration, change management, and roll out.
Derek is the Clinical Operations Systems Specialist at Neurocrine Biosciences and has been instrumental in the success of the company’s implementation of eTMF and CTMS. He is also working with Neurocrine IT to establish a center of excellence for other Veeva applications company wide. Derek has over 5 years of clinical research experience and leads the Clinical Operations team as they transition from paper and tracker-based processes to using electronic systems to manage many trial related activities.
Amit Chachra is a seasoned IT professional with an excellent balance of technology and management with 18+ years corporate experience designing and delivering technology solutions. In his current role as a Director of IT Enterprise Platforms, Amit leads a global technology team for Digital Workplace with Content and Collaboration and most recently he has led the implementation of Quality Document Management solution with Veeva Vault Quality Docs at Gilead Sciences.
He brings In-depth experience in Life Sciences domain with wide range of technology management solutions with Quality Document Management, Manufacturing Batch Records, and Web based Content Management, Reporting and Analytical Solutions, Middleware integration with Lab Information Systems and GxP Processes. In his role prior to Gilead, Amit has successfully led a Content and Collaboration system consulting practice with a National Systems Integrator and helped develop and deliver various global enterprise solutions.
James Choi is Vice President and Chief Information Officer at Samsung BioLogics. Prior to joining Samsung, James held various technology and operations leadership positions at major global healthcare and informatics companies including Philips Healthcare (Customer Service eBusiness, Operations, Information Systems), Altegrity (CIO and CTO), and Beckman Coulter’s Clinical Diagnostics and Life Sciences businesses (CIO and CSO).
Dr. Stephen Cook is the Regulatory Program Lead for deployment of the Veeva Vault RIM suite within GSK. In this role, he is responsible for process harmonisation and optimisation 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.
Aaron currently works as a Project Manager within the Global Regulatory Affairs group at Amicus Therapeutics. Additionally, he leads the Regulatory Submissions Management team. He and his team support various rare disease programs in all stages of development, managing global submission activities including submission content planning, Health Authority commitment tracking and timeline management.
Anthony Davis has more than 20+ years of professional experience working in GxP environments building quality assurance programs from initial conception to beyond commercial deployment. Anthony brings extensive experience within Quality Assurance and Compliance Systems from working with market leaders in the Life Sciences sector. Including the current global responsibility for Quality for a major biotech company based in Cambridge, Massachusetts.
Born In North Carolina and worked in the RTP area before moving to the Northeast over 14 years ago. He enjoys the cold weather, reading and playing golf – when it’s warm.
He also has certifications in Six Sigma methodologies and Project Management coupled with a record of streamlining quality operations and procedures, to gain maximum effectiveness. Anthony is also a certified Training Director and Clinical Research Associate.
Maryanne DiMarco is currently serving as Manager of Regulatory Operations at REGENXBIO, Inc. where she has been instrumental in building the Regulatory Operations Department from the ground up over the last 3 years. Maryanne has over 15 years’ experience of increasing responsibility in Regulatory Operations roles in both private industry and CRO settings. She has served as the project manager for compilation, publishing, and submission of major applications in the US (IND’s, BLA, NDA’s) and ex-US (IMPD’s, CTA’s) as well as for routine maintenance submissions.
Evelyn Dorsey has been a fixture within the clinical research field close to 20 years with most of those years being spent in Data Management and Project Management. With direct experience in FDA, MHRA, PMDA and Health Canada audits, Evelyn has been instrumental in study drug approvals in USA, Canada, Japan and Europe.
Currently as an Associate Director of Data Management at Cara Therapeutics, Evelyn supervises and leads the Data Management Department. This includes all aspects of data management activities supporting Cara Therapeutics clinical programs such as DM Strategy, database start-up through database lock, and CSR/submission.
As a certified clinical data manager, Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State, as well as her project management professional certification. She has vast industry experience with over 14 years with IQVIA (legacy Quintiles). As manager of various data management operation teams, Tanya has actively lead strategies for customized data delivery solutions focusing on timely quality data. She has driven numerous innovation teams, and her dedication to optimal customer service/delivery is visible through her long-standing relationships.
Director, Trial Capabilities, Trial Master File, Records Management
Eli Lilly and Company
Director, Trial Capabilities, Trial Master File, Records Management
Tonya Edison is Director of Trial Capabilities, Trial Master File (TMF) and Records Management, at Eli Lilly and Company. She is accountable for the development and execution of business processes governing the TMF and records management. In her role, she leads cross-functional collaboration to ensure TMF regulatory compliance, maintain study-level inspection readiness, and drive strategy for continuous improvement of the TMF system.
Executive Director, Global Regulatory Operations Head
Executive Director, Global Regulatory Operations Head
Wil Foster’s career in the pharmaceutical industry spans over 20 years. After a leading role at GSK supporting their transition to eCTD in Europe, he joined Eisai in 2007 to establish an internal EU Operations team.
With the success of this challenge, Wil was appointed to a series of senior roles including head of Global Submissions management where he developed and implemented numerous process strategies promoting global working procedures to reduce submission timelines. He is a long-standing member of the EFPIA expert group and continues to be a leading contributor towards the materialization of Eisai’s vision to improve and enhance their Regulatory based technologies and business models.
Sandy has worked in the pharmaceutical industry for over 25 years in various roles supporting clinical trial research. Currently an Associate Director, Global Clinical Operations in the Medical Affairs group at Janssen and a member of the Veeva Vault Study Start Up Cross-Sector Implementation Team within Johnson and Johnson. Sandy enjoys working in the Study Start Up space employing new technologies and innovative ideas to help get medicines to patients more efficiently.
Vice President, Head of Global Regulatory Operations
Merck Healthcare KGaA
Vice President, Head of Global Regulatory Operations
With 30+ years of experience big pharma and international CROs, Regina brings a wealth of background into Regulatory Operations. Before joining Merck has Head of R&D Quality Assurance and her later move into Head of Global Regulatory Operations, she held various posts in Clinical Trial Management, Data Management, Project Management, Marketing, Communication and Quality Assurance. Regina is passionate about driving the digital transformation at Global Regulatory Affairs, that comprise people, processes, data and technology. Her recent projects on electronic process mining and robotic process automation in the highly regulated and complex field of regulatory affairs gained a lot of recognition inside and outside her company.
Craig Gassman, M.S. is currently the Director of Regulatory Operations at Vericel Corporation located in Cambridge, MA. He has worked within Regulatory Operations, Submissions, and Information Management roles for almost 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 consulting services for Regulatory Information Management system implementations. His key interest is the intersection of Regulatory Content Management, advanced technologies, and process optimization.
Craig also has a passion for educating and enjoys creating training content that distills complicated, technical topics into visually-appealing components. Craig received a B.S in Microbiology from the University of Massachusetts, Amherst, and an M.S. in Regulatory Affairs from Northeastern University.
As Practice Manager of Vault CDMS Customer Services, David Gemzik brings over 20 years of experience in enterprise software development and services focusing on clinical trial technology. David is responsible for the Veeva CDMS Configuration Services team delivering study design, build, study execution, and data management services to clinical trial sponsors, sites, and partners.
Prior to joining Veeva Systems David held positions in client and professional services, research and development, and business development specializing in innovative applications for clinical R&D and operations.
David was an active member in the development of Clinical Data Interchange Standards (CDISC) including ODM and BRIDG, and the Protocol Representation Group. He has also been a featured presenter at various conferences, including Drug Information Association (DIA), AMWA, and the CDISC Interchanges.
David received his bachelor’s degree in industrial engineering from Lehigh University in Bethlehem, Pennsylvania.
Lorena has more than 20 years of experience in clinical development and is currently the Global Director of Study Start Up at Allergan. Prior to joining Allergan in 2016, Lorena oversaw Start Up Strategy and Clinical Outcomes Assessment Management at AbbVie, as well as holding other leadership positions in Clinical Operations and Program Management.
She holds a BS in Microbiology, a BA in Molecular Biology, and was an NIH fellow in the University of Texas at Austin Pharmaceutics PhD program. In 2011, she was awarded the Pharma Times Clinical Researcher of the Year silver medal in the Project Management Category. She has also participated in the TransCelerate Shared Investigator Platform and Investigator Registry Initiatives since 2013.
Ashley Gregory has 10 years’ experience in the pharmaceutical industry with an expertise in quality auditing and training. She is currently the Corporate Training Manager at Xeris Pharmaceuticals where she has been responsible for successfully implementing multiple Vault applications, including QualityDocs, eTMF, and Vault Training.
Ashley maintains overall responsibility for the Training and Document Control programs at Xeris. Prior to Xeris, Ashley was responsible for Supplier Auditing and Performance Monitoring, Auditor Qualification, Document Control, and Complaint Handling at Catalent Pharma Solutions.
Eric Hanson is an IT Manager for Sarah Cannon, the cancer institute for HCA Healthcare located in Nashville, TN. Eric and his team support 13 applications for Sarah Cannon’s CRO and recently led the initiative to migrate to Veeva CTMS. When he isn’t working, Eric enjoys spending time with his wife and two young children.
Michelle has over 20 years of clinical data management experience. She is currently the director of clinical data management at Vertex Pharmaceuticals where she has been instrumental in their drive for operational excellence. Prior to Vertex, Michelle worked in data management at PAREXEL, Coley Pharmaceutical group, and BioBridges LLC. She completed her undergraduate studies at University of Massachusetts Dartmouth and her graduate studies at Boston University.
Brittany Johnson is a Trial Master File (TMF) Consultant. In her role, she serves as a subject matter expert for the TMF. She is accountable for supporting the end-to-end process governing the TMF, ranging from process development to implementation. Additionally, she cross-functionally collaborates with and supports business partners to ensure TMF compliance.
Sonja Alexander Justice is a results-driven leader offering 25+ years’ experience driving operational excellence, managing global content management systems and publishing systems/tools, leading regulatory operations, system implementations, project management, business processes, and ensuring compliance with legal and regulatory requirements. She is currently is the Director/Global Head of Regulatory Operations at Amicus Therapeutics with oversight for Dossier Management, Publishing Operations and RIM Governance. Sonja is a Veeva Vault Certified Administrator. She holds a BSc in Business Administration from NC Wesleyan College and an MA in Organizational Management from University of Phoenix.
“David Katzoff brings more than 25 years of software product development, applications engineering, systems integration, project management and compliant business solutions design experience to his role. Much of that experience is 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 member of the Phi Beta Kappa Society.”
Bob is a Senior Customer Success Manager, focused on the Quality Suite of applications. He has 25 years of experience providing implementation and consulting services to quality organizations in the life sciences industry. Bob has been with Veeva since 2012, and in addition to his role as a CSM, he also has responsibility for the Quality User Community.
Andrea is a Clinical Data Manager with a demonstrated history of working in the research industry. She is a strong research professional skilled in Clinical Data Management, Market Research, Management, CRO Management, and Business Process Improvement.
Dominique has over 20 years of International Regulatory Affairs experience with the last 15 years spent in Global Regulatory Operations management. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel, Dendreon and TCS.
Today, Dominique is working at Amgen as the Head of Global Regulatory Operations currently dedicated to the Implementation of Veeva Vault RIM.
Dominique holds a Pharm D and a Master in International Regulatory Affairs from the University of Paris.
Chris Lamont is the Director of Global QMS Programs at Bristol-Myers Squibb Company where he leads a team that is responsible for the implementation and administration of electronic quality management systems. Chris has recently led the implementation of Veeva Vault QMS for change control, audits and action management at BMS.
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.
Sharon is an experienced Product Manager with 15+ years experience, She has been in the Life Sciences industry for about 7 of those years. Sharon is responsible for rolling out EDC ancillary products, first Local Labs, and then Randomization. Her passion lies in understanding the customer workflow and building intuitive, user-friendly products to support the workflow.
Senior Vice President and General Manager, Veeva Vault Safety
Senior Vice President and General Manager, Veeva Vault Safety
As senior vice president and general manager of Veeva Vault Safety, Brian Longo is responsible for the definition and direction of Veeva’s safety products for life sciences, ensuring that Veeva delivers modern and adaptive cloud applications purpose-built for safety.
Over the past 10 years, Brian has designed and delivered enterprise and custom application for various pharmaceutical organizations with specific focus on sales force effectiveness, managed markets and key opinion leader management. In addition, he spent several years architecting and implementing industry leading solutions in the medical affairs and drug discovery areas of the pharmaceutical industry. In 2013, Brian was named to the PharmaVOICE 100 which recognizes the 100 most influential people in the life sciences industry.
Prior to joining Veeva Systems in 2007, Brian worked at Siebel and Accenture where he was consistently recognized as a top performer and aligned to critical business needs to ensure customer satisfaction and successful implementations.
Brian holds a bachelor of science degree in chemical engineering from Pennsylvania State University.
Melanie Lougheed joined PRA Health Sciences (PRAHS) in 2001, continuing her career in clinical data management, until a transition into the process and learning team in 2017, where she took on the role of Project Director for the Quality Vault implementation project and indulging her passion for process. With 20 years’ experience in biometrics and clinical trial delivery, Melanie understands the importance of providing a Quality Management System (QMS) that supports an organization who values consistent service, continual improvement and innovation.
Melanie serves as the Business System Owner for PRAHS’s QMS and with her team is responsible for maintaining the validated state of the QMS which includes adopting new features and keeping system functionality current with emerging business needs and industry requirements.
Michael Martelli is the Regulatory Operations lead at Blueprint Medicines. With over 15 years of extensive regulatory operations experience in a variety of companies like Genzyme, Biogen, EMD Serono, and Seres Therapeutics. Michael enjoys transforming his industry experience into learnings. He has developed original lecture and course material for Salem State University and Northeastern University for their Clinical and Regulatory graduate certificate and degree programs. Michael is a natural trainer, facilitator, educator and counsellor. He is warm and gracious and believes in a philosophy of “live and let live”.
“Caroline Masterman-Smith is a Senior Manager in Technology & Innovation at Kinapse. Caroline has worked in pharmaceutical consulting for 5 years, gaining significant experience in Regulatory Affairs including regulatory operations, information management and technical writing. Caroline has broad experience across industry processes and applies this to perform RIM landscape assessments and business process transformations. She focusses on the future of regulatory information management and how and why regulatory operating models are evolving.
Caroline holds a Master’s Degree in Research with Distinction and a 1st Class (Hons) degree in Biological Sciences.”
Courtney McGaw has been working in research for 5 years. She started in Clinical Operations and moved over to IT as a Product Analyst in April 2019. She has been involved in both the eTMF and CTMS implementations and supports both products.
Sean McNiff is a Global Regulatory Affairs group leader with focus on mentoring and career development. He has 18 years in the industry, including experience in many aspects of investigational and marketed medicinal products, including drugs, biologics, and devices.
Ami Dudzinski Mehr is an energetic & results oriented senior leader with over 20 years of Professional Services experience. Ami has devoted her career to implementing EDC and IRT/IVRS software for clinical trials. Ami is currently part of the Vault CDMS leadership team and responsible for Services Sales and Strategy. Prior to this role, she built and led the services organization. Earlier in her career she was responsible for trial build and enablement delivery at Oracle and Phase Forward. Ami holds a B.A. in the Mathematical and Physical Sciences from Wells College and Leadership Certificate from the Simmons School of Management.
Aatif has 6 years of experience in delivering transformational regulatory technology projects. He has supported clients assess the fitness of their regulatory technology landscapes as well as driven implementation of new RIM technology solutions including Veeva Vault RIM. He has worked with global clients to define regulatory processes, develop RIM data models and improve regulatory capabilities through BPM and automation
Jennifer Nezzer is the Director of Biometrics at Lotus, Clinical Research. Home based in Austin, TX, as the head of the biostatistics and data management departments, she is responsible for the recruitment and management of team members, providing technical leadership on the data management and biostatistical aspects of all development projects as well as serving as lead statistician on multiple programs.
Prior to joining Lotus, she was a member of the biostatistics leadership team at Premier Research and supported the biostatistical development of numerous global programs at Premier and PPD for more than 10 years. Jennifer has represented biostatistics in interactions with sponsor companies, in multiple NDA submissions and represented multiple sponsors in both phone and face to face interactions with regulatory agencies.
Anthony has over 15 years of Regulatory Operations experience in the Biotech industry, in both a U.S. and global environment. He is involved with several implementation projects for various Regulatory Information software and tools.
Bella Oguno is a Director of Clinical Operations at Global Blood Therapeutics. Her role is currently responsible for identifying and implementing processes supporting Operational Excellence, Inspection Readiness and Partner Alliance activities. Bella has over 15 years of experience within development, specifically, Clinical Operations. Prior to joining GBT, she was at Genentech’s gRED group and Amgen’s GDO group.
Chris Otto is a Clinical Development Professional with over 25 years of experience with Eli Lilly and Company. His extensive experience in Clinical Drug Development spans several disciplines including Clinical Data Management, Clinical Laboratory and Diagnostics, Medical Writing, Clinical Pharmacology and R&D IT. Chris currently is the Senior Director for Clinical Labs and Data Sciences.
Chris currently manages a diverse global organization and lived in Asia for 5 yrs leading several clinical development and IT functions.
Chris holds a Bachelor’s of Science in Accounting and Computer Systems Analysis from Taylor University.
Shelley Padgett is an Information Technology Professional with over 30 years of experience with Eli Lilly and Company. Her extensive experience spans Clinical Development, Biometrics, Data & Information Management and Customer Relationship Management. Shelley currently is the Senior Director of IT for Clinical Development.
Shelley presently sits on the strategic council for the Life Sciences Coalition where she influences industry to improve Clinical Development. She was recently named the Lilly CIOvation winner for Diversity and Inclusion in 2018. Shelley holds a Bachelor’s of Science in Business Administration with a concentration in MIS from Central Michigan University.
Bonnie M. Pappacena is currently the Vice President, Quality at Foamix Pharmaceuticals in Bridgewater, NJ. Ms. Pappacena has over 30 years of quality experience across good clinical practices (GCP), good laboratory practices (GLP), good manufacturing practices (CGMP) for clinical supplies and commercial product, and good pharmacovigilance practices (GVP). She has worked primarily in the pharmaceutical industry and her expertise includes drug product as well as combination product development.
Prior to Foamix, Ms. Pappacena served as Vice President, Quality at G&W Laboratories, Vice President, Quality at Turing Pharmaceuticals, and Vice President, Quality at Acorda Therapeutics. She held positions for increased responsibility at Genta, Inc. and Schering Plough Research Institute. She has been implementing electronic quality systems for over 15 years.
Anders, who has a science background with a PhD in Biochemistry, is currently leading the Clinical transformation at AstraZeneca. He has 20+ years experience of global drug development across all phases of the value-chain through both project leadership and line management roles. He is passionate about finding simple intuitive solutions on complex business challenges.
Lexie Pieper is an innovative leader with extensive Medical Devices, Pharma, Life Sciences and Biotech experience across multiple functions and disciplines. She is currently the Senior Director of Quality at Celularity, Inc. located in Warren, NJ, and has held numerous quality and regulatory roles within Roche and Thermo Fisher Scientific organizations. Lexie has diverse, world-wide experience covering end-to-end process and product lifecycle, including process harmonization and automation. Lexie received her degree from Worcester Polytechnic Institute.
Shelly Plapp has over 15 years’ experience in the pharmaceutical industry with an expertise in regulatory operations. She is currently the Director of Regulatory Operations at Melinta Therapeutics, Inc. where she has been instrumental in successfully launching multiple Vault platforms within Melinta. Most recently, she was the first customer to implement Vault Publishing. Since the implementation in November 2018, Melinta has successfully submitted over 200 submissions. In addition to publishing, she is responsible for the strategic and tactical regulatory operations. Prior to Melinta, Shelly was responsible for submissions operations at Lundbeck Pharma and Abbott Laboratories.
Mr. Saiter is a Managing Director in the Accenture’s Life Sciences R&D practice. He leads Accenture’s Veeva Vault practice. His work has focused extensively on clinical development operations, clinical data management, statistical programming, clinical supplies, and site and investigator collaboration. He has 22 years of experience developing and delivering business and technology transformation programs within Pharmaceutical R&D organizations.
Kate has been in the industry for over 20 years, working in multiple Clinical-related disciplines such as Medical Writing and Clinical Trial Management. In her current role, Kate is the Business and Process Owner for eTMF at Alkermes. She was instrumental in bringing on Alkermes’ 1st electronic TMF system and revamping the process for filing Clinical documents. She works hand-in-hand with her CRO partners to ensure that all studies have a quality TMF.
Doug Schantz is the Executive Director of US Site Management and Monitoring for AstraZeneca, based in Wilmington Delaware. In this role, he’s responsible for a group of approximately 280 people who provide clinical operations support to AstraZeneca’s R&D portfolio across all therapy areas.
Nicole Sheetz serves as an Advisor at Lilly within the Clinical Design, Delivery and Analytics organization. She has nearly 20 years of experience including clinical development operational leadership, business and IT solutions, and complex internal and external global communication and change management strategies. She serves on multiple external boards and committees including both the Pharma and non-profit sectors, each focused on patients, caregivers, health care providers, innovation, and/or creativity. Nicole holds a PharmD from the University of North Carolina.
Rachel Sheppard, MBA, CCRA, CCRC, is a certified clinical research monitor (CCRA) and a certified clinical research coordinator (CCRC). She has been working in research since 1996 specifically in regulatory management, trial conduct, data management, clinical management, and resource management. Rachel has served as an auditor on a variety of federally and industry funded clinical trials. She has been actively involved in the development and support of UofL’s internal CTMS system for the past 14 years. She oversees the clinical and regulatory teams in the Clinical Trials Unit at the University of Louisville as well as developing policies that govern their activities. They support approximately 30 specialties and 150 active trials at any given time.
Harbal Sidhu is a Senior Manager in Data Management at ICON Plc. Harbal leads ICON’s CDMS delivery for SaaS and homegrown EDC systems. He has over 13 years of EDC programming experience and is the business system owner for Veeva CDMS.
Harbal holds a Bachelor’s Degree in Information Science & Engineering.
Kristofer Spahr is the Director of Regulatory Information Management at Daiichi Sankyo, Inc. In this position, Mr. Spahr is focused on providing strategic & tactical Regulatory Information Management leadership for Daiichi Sankyo’s US and European businesses and is the global business owner for several global RIM systems. In his previous work experience, Mr. Spahr has held a variety of information management & information technology leadership positions in other sponsor organizations and as a consultant in support of regulatory affairs, clinical research, supply chain management, enterprise content management, collaborative healthcare initiatives, and regulatory intelligence. Mr. Spahr has also been previously active in industry committees and working groups and has participated in a variety of forums including PhRMA, Health Level 7, ICH, ANSI, and ISO. As an information technology and regulatory affairs professional for over thirty years, he has a Bachelors of Business Administration degree in Business Management and Economics from Temple University.
David Templeton is the manager of clinical systems at Penumbra, a global healthcare company that designs, develops, manufactures, and markets innovative products that address challenging neuro and vascular conditions. Having spent over 15 years working with clinical systems for medical device sponsors and with an EDC vendor, David has a breadth of experience with multiple EDC, ePRO, IRT, and imaging platforms.
Jamie has over 20 years of experience in the pharmaceutical industry, with many years spent in IT/Informatics. She has been with Daiichi Sankyo, Inc. since 2016 as the director/head of TMF operations. Prior to that she worked at Covance for eight years within the trial master file space. Jamie is a steering committee member for the DIA TMF Reference Model Working Group and on the operations committee and a director for the Health Sciences Records and Archives Association (HSRAA).
Tony is a Senior Product manager on the Vault CDMS team at Veeva. He brings over 15 years of experience in enterprise software development specifically in the life sciences industry. Tony has spent the majority of his time around clinical trial technologies and is currently responsible for building intuitive and easy to use experiences for electronic data capture users.
Heather Wilson is a technical QA/IT professional and senior writer with 25 years of experience in the pharmaceutical, biotech, clinical research, and IT industries. She acts as the lead Vault System Administrator for the Veeva Systems cloud-based delivered application, is a Veeva Certified System Administrator, and has Vault Owner and Configuration Specialist responsibilities.
At Xencor, Heather is also responsible for Vault configuration management, change control management, validation efforts, and system oversight for all five Vaults currently in use. Specialties in Vault Platform, Vault Training and Vault QualityDocs.
JP is a partner at PriceWaterhouseCoopers (PWC). He co-leads the Quality practice. His specialty is implementing modern quality management systems and transforming quality organizations. He developed the Quality 4.0 framework to provide a comprehensive vision for the future of Quality in the Pharma and Medical Device industry