Regulatory Submissions, Information, and Document Management Forum
Venkatraman Balasubramanian, PhD, MBA
- President and CEO
- Cabeus, Inc., United States
V. “Bala” Balasubramanian is the President & CEO of Cabeus, a niche firm providing information management products, solutions & services for Life Sciences. With over three decades of IT experience, Bala is a thought leader & presenter on RIM, IDMP, regulatory analytics, enterprise architecture & process design. He provides the vision for a cloud platform called ReALM™ to transform the regulatory value chain for Life Sciences. Prior to Cabeus, Bala developed IT strategies & capabilities for companies such as Bristol-Myers Squibb, Roche, Aventis, Merrill Lynch, AT&T, Bell Atlantic & IBM. Bala has his Ph.D. & MBA from Rutgers University, M.S. in Computer Science from NJIT and B.S. in Electronics Engineering from India.
Brooke Casselberry, MS, RAC
- Cyan Life Sciences, United States
Brooke is a partner at IDENTIFICA focusing on Client Engagement and Regulatory Strategy. She has more than 15 years of experience in Life Sciences supporting industry clients in standards and process implementation, strategy, and business development. Brooke volunteers her time supporting networking communities like DIA and mentoring others in Regulatory for Life Sciences.
Michelle L. Charles, MPH
- Director, Regulatory Affairs, Gene Therapy Program & Orphan Disease Center
- University of Pennsylvania, Perelman School of Medicine, United States
Michelle began her career at Merck in 2001 and has moved into various roles within regulatory. Most recently Michelle has moved into the RIM group as Business Lead for Merck’s RIM system. In this role she is responsible for the development of process and the regional support of the system. Michelle has also participated in multiple forums including PhRMA and eRI DIA. Michelle received her BS in Biology from Millersville and a Masters of Public Health from Johns Hopkins.
- Director, Regulatory Affairs Operations & Quality Management
- Merck & Co., Inc., United States
- Founder, Managing Director
- List Innovations, LLC, United States
Jake has 20+ years of life sciences leadership experience across various roles. Jake has recently left corporate executive role to form LiST Innovations, an organization dedicated to assisting life sciences companies in their quest to implement innovative technology solutions. Prior to this venture, Jake held key leadership positions with Johnson & Johnson, supporting Global Regulatory Affairs and the Clinical Development organizations. In addition, Jake has also worked closely with various industry trade groups, where he is a key partner with the FDA and an industry advocate for the PDUFA V and upcoming PDUFA VI technology implementation strategies.
- President and CEO
- LMK Clinical Research Consulting, United States
Sholeh, a recognized innovative professional with over 15 years of experience in the Clinical Research Industry, has expertise & knowledge in all areas of the clinical trial & document management processes. Her experience includes TMF Reference Model subject matter expert, eTMF management, clinical trial management, site selection, vendor relations, EDM, regulatory submissions, QC processes & implementation, IRB communications & regulatory inspection participation and preparation. The Principal Consultant & President & CEO of LMK Clinical Research Consulting & the Facilitator for the Metrics Champion Consortium's (MCC) newly formed TMF initiative, she leads cross-functional experts to develop & implement TMF metrics and processes.
Ron D. Fitzmartin, PhD, MBA
- Senior Advisor, Office of Strategic Programs, CDER
- FDA, United States
Ron Fitzmartin is Sr. Advisor in the Office of Strategic Programs, CDER, FDA where he is focused on electronic submissions and standardized study data to support regulatory review. Prior to FDA, Ron was VP, Informatics at Daiichi Sankyo, VP, Biostatistics and Data Management at Daiichi Medical Research, and Exec Dir, Biostatistics and Data Management at Purdue Pharma L.P. Ron was elected President of the DIA 07-09. Ron received a PhD in statistics from the University of Maryland.
Mark A. Gray
- Senior Project Manager, BSS, CBER
- FDA, United States
Mark has over 30 years experience in Information Management including; software developer/project manager in CBER; Director of Applications Development & Services in CDER; and PDUFA IT Program Director. Mark currently work’s for CBER’s Bioinformatics Support Staff. His responsibilities include representing CBER in the development of international electronic submission standards, with a focus on the ICH electronic Common Technical Document (eCTD).
- Data Standards Program Manager, OD, BSS, CBER
- FDA, United States
Virginia Hussong is Program Manager for Data Standards in the Center for Biologics Evaluation and Research, U.S. FDA, and has been with FDA for 13 years, overseeing implementation of data standards and electronic submissions. Her current focus is data standards strategy, development and related policy within CBER, including collaboration with other FDA Centers, government agencies and SDOs to achieve a better quality review process.
Joanne S. Malia, MS, MSc
- Associate Director, Clinical Documentation Management
- Regeneron Pharmaceuticals, United States
Joanne Malia is currently the Associate Director of Clinical Documentation Management at Regeneron, a biopharmaceutical company located in Tarrytown, NY. She has worked in clinical research at various global biotech, device, CRO and big pharma companies in the areas of quality & risk management, trial master file and computer system validation for over 25 years. She is a frequent presenter and workshop leader. She has a Bachelor’s degree in Biology and Master degrees in both Microbiology and Management.
Thomas J. Noto
- Senior Director, Regulatory Operations
- Lexicon Pharmaceuticals, United States
Daniel F. Orfe, MS
- President & CEO
- Regulatory eSubmissions, LLC, United States
Dan has 25 years of experience in Regulatory Operations and Submission publishing. He’s a subject matter expert in "cloud-based" eCTD and EDMS solutions and consults via Regulatory eSubmissions. At Radius Pharmaceuticals he had responsibility for activities associated with production/delivery of regulatory filings and EDMS processes/tools. At Teva Dan oversaw an initiative to harmonize submission publishing and document management. At Datafarm he had responsibility for global Submission and Publishing Services. At Merck, Dan established and managed electronic submission production group. Speaker/session chair at 11 DIA Annual meetings, DIA EDM Conference Co-chair from 2009 through 2011 and DIA RSIDM Conference program committee member.
Sarah Powell, RAC
- Powell Regulatory Services, United States
Sarah has over 29 years of experience in pharmaceutical and related regulated industries. Most recently, Sarah has worked on assisting clients with projects related to process improvements, standards development, defining filing strategies and writing and review of submission content. Prior to that, Sarah worked on projects related to implementation of regulatory solutions and has contributed to defining product strategies for industry leading software solutions.
- Associate Director, Business Informatics Division, HPFB
- Health Canada, Canada
Vik is responsible for the strategic and operational leadership of the HPFB IT investment plan and governance aimed to modernize and drive efficiencies within the regulatory program areas. Vik holds an Undergraduate Degree in Biochemistry & Finance from the University of Ottawa, second Undergraduate Degree in Computational Biology/Computer Science Graduate Degrees in Genomics & Computer Science from McGill University.
- Regulatory Information Scientist
- eCTDconsultancy B.V., Netherlands
Michiel Stam is a Regulatory Information Scientist at eCTDconsultancy B.V. and has a strong focus on electronic submissions for Drug Regulatory Affairs and Pharmacovigilance. In this role he has lead various submission and information management projects for Pharma and Biotech companies. eSubmission projects include preparation and submission of initial marketing authorization applications and post-authorization maintenance for Agencies in the EU (CAPs, NAPs and MRP/DCP), US (NDA and BLA) and other regions, including GCC and Swiss Medic submissions. Since 2011 Michiel has worked on XEVMPD and IDMP (Identification of Medicinal Products) related topics, Registration Tracking and Semantic interoperability.
Stacy J. Tegan
- Manager, Regulatory Technology Consulting
- Accenture Accelerated R&D Services, United States
Stacy Tegan is a Manager of Regulatory Technology Consulting in Accenture Accelerated R&D Services, bringing 18+ years of experience in the Pharmaceutical industry. She works with pharmaceutical and biotech organizations to improve R&D processes.
- Director, Regulatory Affairs
- Astellas, United States
Jamie Marie Toth, MS
- Director/Head of TMF Operations
- Daiichi Sankyo, Inc., United States
Ms. Toth has over 18 years of IT experience in the pharmaceutical industry. She joined Daiichi Sankyo after working at a CRO for 8 years, spending 5 years in the launch of an eTMF project, system selection and building of an operational group to support eTMF. She is a Steering Committee member for the DIA TMF Reference Model Working Group and a member of the Scientific Archivist Group (SAG). She received her Master’s Degree in Clinical Research & Organizational Management at Drexel University, a Bachelor of Arts in Business & Technology from Fairleigh Dickinson University and has an Associates of Applied Sciences in Computer Systems & Technology from Mercer County Community College.
James Riddle, MS
- Vice President of Client Services
- Kinetiq, a Division of Quorum IRB, United States
James Riddle, MCSE, CIP, CPIA Kinetiq Vice President, Client Services Served as Assistant Director at the Fred Hutchinson Cancer Research Center and has over 15 years of experience leading human subject protection programs. He has served as a site visitor for AAHRPP, is a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research, served on the Board of the Northwest Association for Biomedical Research, and is a Certified IRB and IACUC Professional.
Jim St. Clair
- Institute for Healthcare Financial Technology, United States
Jim is a senior professional with over 20 years combined experience in risk management, technology and cyber security for numerous organizations in various industries, emphasizing healthcare and public sectors. Given the dramatic changes in technology and healthcare delivery, Jim recently founded the Institute for Healthcare Financial Technology, which is a non-profit organization dedicated to improving the healthcare value chain to reduce costs and streamline access and delivery of healthcare. IHFT builds on the innovations of financial, insurance and healthcare technology, especially in such concepts as distributed ledgers, blockchain, Robotic Process Automation (RPA) and Artificial Intelligence (AI).
Mitzi Allred, PhD
- Director,Global Clinical Development Medical Writing Content Standards
- Merck & Company, Inc, United States
Mitzi leads the development and evolution of structured content management and document management including Clinical eTMF. Mitzi works in collaboration with clinical, regulatory and labeling SME to implement structure content management from both business and technical aspects. Twenty years ago, Mitzi joined the pharmaceutical industry to bring this acumen to regulatory and clinical. Mitzi worked in the Aerospace industry focusing on interoperability through Process Reengineering paradigm changes gaining her reputation and certifications.
- Manager, Pharmacovigilance
- AnGes, Inc., United States
Bernie Coney, MA
- Head of Regulatory Advisory Services
- Kinapse, United States
Bernie Coney is the Head of Regulatory Information Management (RIM) Advisory Services at Kinapse who works with clients and industry on technology and processes related to areas that include Information Management, Registration Management, Submissions Management/Publishing, Labeling, IDMP and other areas that impact the Regulatory Affairs discipline. Prior to Kinapse, Bernie was the Head of Regulatory and Quality Assurance IT at Shire Pharmaceuticals, responsible for the Technology strategy, implementation, and innovation within R&D IT, as well as the Head of Regulatory Technology and Information Management. He has also work in the software vendor space delivering SCM and RIM solutions, as well as Pfizer Regulatory.
La Misha Fields
- IT Program Manager, Electronic Submissions Gateway, OIMT, OC
- FDA, United States
La Misha Fields is the Program Manager of the FDA’s Electronic Submissions Gateway (ESG) under the Office of Information Management and Technology located in Rockville, MD. She is an informatics and technology professional with over 6 years of FDA experience, including 5+ years in the Center for Drugs. Ms. Fields completed her bachelor’s degree in Computer Networking and her master’s degree in Business Administration at Strayer University.
Richard F Fredericks
- Associate Director, Regulatory Systems and Information Management
- Tesaro, United States
Steve Gens, MS
- Managing Partner
- Gens and Associates Inc., United States
Steve has 30 years of experience with the majority in the biopharmaceutical industry. His early career was spent at J&J and then moved into consulting where he managed several healthcare consulting practices for Booz Allen Hamilton and First Consulting Group. Steve has deep experience in strategic planning, organization development, industry benchmarking, and leading or facilitating strategic change. Steve has a Masters in Organization Development and a Bachelors of Science in Computer Science.
- Sr. Director, RIM
- Teva, United States
Morten Lindaa, MSc
- Consulting Director, Life Sciences
- NNIT, Denmark
Greg John May
- Assistant Director, Regulatory Affairs
- Nabriva Therapeutics, United States
Matt Neal, MA
- Senior Director, Product Management, Regulatory & Clinical Solutions
- PAREXEL, United States
Matt Neal joined PAREXEL in 2016 as the Senior Director of Product Management for Regulatory Solutions. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. and prior to that he was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline and has been publishing and submitting electronic dossiers to the FDA since 1996, and submitted the very first fully electronic NDA for GSK in 1999. Matt holds a Masters in Communication from Temple University.
Matthew Pazdernik, MBA
- Director, Regulatory Submission Planning and Portfolio Management
- Merck & Co., Inc., United States
Matt Pazdernik is the Submission Planning & Portfolio Management Lead for Merck Regulatory Affairs, responsible for the global enterprise system to manage Regulatory Submission Plans, an enterprise-level Portfolio Planning & Project Management capability integrating the process and tools for Submissions Planning and Portfolio Management, delivery of an authoritative source for submission milestone tracking and management to align and drive enterprise operations, and ensuring a high-quality Submission Requirement Management capability to drive effective regulatory submission planning.
Vada A. Perkins, BSN, MS, MSc, RN
- Founder and Managing Principal
- Identifica, United States
Vada A. Perkins is the Founder and Managing Principal of IDENTIFICA LLC, an independent global regulatory consulting practice offering Global Product Lifecycle (GPLC) data governance solutions in conformance with regional regulatory requirements and international data standards to optimize business for clients from concept to execution.
Cheryl A. Ressland
- Executve Director, Regulatory Operations
- Daiichi Sankyo, United States
- Associate Director, Clinical and Regulatory Optimization
- Paragon Solutions, United States
Leonard Sacks, MD
- Associate Director for Clinical Methodology, Office of Medical Policy, CDER
- FDA, United States
Dr. Sacks is the associate director for clinical methodology in the Office of Medical Policy at FDA. He is an infectious disease doctor by training with previous clinical experience in local and foreign hospitals. Since joining FDA in 1998, he has occupied various positions, as a medical reviewer and team leader in the office of antimicrobial products and as an acting director of the Office of Critical Path Programs prior to his current position.
Elizabeth M Turek
- Senior Director, Global Regulatory Operations
- Johnson & Johnson, United States
Adair Turner, MSc, RAC
- Principal Consultant, Director Regulatory Operations
- PharmaLex GmbH, Germany
Adair has over 13 years of experience in Regulatory Operations and Affairs and has worked both in industry and on the vendor side. At Arivis she manages the Professional Services Group and provides strategic planning, industry best practices, and implementation planning for eDMS, eTMF, and eCTD.
Alex Butler, MBA
- Product Marketing Manager
- MasterControl, United States
- Acting Director, Division of Data Management Services and Solutions, OSP
- CDER, FDA, United States
Dalia El-Sherif, DrSc
- Pyxa Solutions, United States
Cheryl A. Grandinetti, PharmD
- Health Scientist, Policy Analyst
- FDA, United States
- Director, Regulatory Submissions Operations
- Cardinal Health Regulatory Sciences, United States
- Director, Strategy Implementation Leader
- Merck KGaA, Germany
Peter Lassoff, PharmD
- Vice President and Head, Global Regulatory Affairs
- IQVIA, United Kingdom
Dr. Peter Lassoff, Pharm.D., is Vice President and Head, Global Regulatory Affairs for IQVIA. Peter is responsible for a large group of regulatory professionals around the world for the only fully integrated human data sciences provider, offering regulatory execution and strategic services on a global basis.
Kristen Sauter, MBA
- Director, R&D Consulting
- Paragon Solutions, United States
- Manager, Regulatory Operations and Submissions
- Inovio Pharmaceuticals, Inc., United States
Thomas Christensen, RAC
- Senior Regulatory Affairs Manager
- SynteractHCR, United States
Thomas Christensen has 15 years industry experience in regulatory affairs focusing on document management, publishing and submission of applications / authorizations. He has managed electronic publishing projects for submission to competent authorities this includes submission life-cycle management and maintenance during approval and into post-marketing.
- QA/RA Director, Gas Sensing, Analysis & Delivery
- Maxtec, United States
Vahe Ghahraman, PhD
- Sr. Director
- Alexion Pharma, United States
Stephanie J Hughes
- Publishing Associate
- Teva Pharmaceuticals Inc., United States
Sandra A. Krogulski
- Regulatory Operations Submission Manager
- Accenture, United States
Sandy Krogulski is currently a Submission Manager at Accenture. As a Submission Manager, Sandy oversees the management of numerous regulatory submission projects ensuring projects are in compliance with global regulatory requirements and meeting submission timelines. Her primary focus is on life-cycle submissions, helping support over 1,000 sequences this past year including CMC supplements, labeling supplements, Advertising/Promotional Labeling submissions and other amendments.
- Regulatory Information Director
- Asphalion S.L., Spain
Remco Munnik has a Bachelor degree in a study of Management, Economics & Law. Since 1999 he is working for Sandoz. From 01-2007, Remco moved to the function of Regulatory Affairs Information Manager, is acting as chairman for the EGA working group for eCTD and a member of TIGes.
- Vice President
- Cunesoft Inc., United States
Jim has nearly 30 years of experience with compliant software solutions for regulated processes in the Life Sciences and Healthcare arena. Currently, Jim serves as the Vice President Life Sciences, North America for Cunesoft. He also is the President & CEO of the IRISS Forum – a not-for-profit organization. Jim has held executive management positions at Liquent, Thomson Reuters, ePharmaSolutions and DitaExchange. He has a Bachelor of Science degree in Mathematics from The Pennsylvania State University.
- Sr. Associate, Global Regulatory Affairs
- Johnson & Johnson Group of Consumer Companies, United States
Kevin Tompkins, MBA
- Director, Head of North America, Global Submissions Management
- Teva Pharmaceuticals, Inc, United States
- Clinical Solutions Specialist
- Montrium, Inc., Canada
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