2019 Speakers

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.

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.

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.

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).

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.

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.

Rich Fredericks has been in the life sciences industry for 10+ years, operating entirely within the Regulatory Operations space. His career began as a publisher, and over the past decade has been gravitating towards the technology and process side of the business. Currently, he leads the Regulatory Systems and Information Management group at Tesaro where he is responsible for the RIM systems & associated processes across the organization. Before Tesaro, he was at Shire where he held a similar role by providing systems/technical knowledge & support to the Global Regulatory Affairs and Operations teams. Prior to Shire, he worked at several other pharmaceutical/biotech companies including Sunovion, Ariad, Ironwood, Pfizer, Regeneron, Ipsen and Genzyme.

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.

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.

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.

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.

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”.

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.

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.

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.

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.

Jamie Scialdone has been in the life sciences industry for over 15 years, always in the regulatory operations space. She is currently the director of regulatory operations at Agios Pharmaceuticals where she leads the team and is responsible for submission management along with system and process management within the regulatory department.

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.

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).