Regulatory Submissions, Information, and Document Management Forum
Sudip Parikh, PhD
- Senior Vice President and Managing Director, DIA Americas
- DIA, United States
Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute
Venkatraman Balasubramanian, PhD, MBA
- Senior Vice President, Life Sciences
- Orion Business Innovation, United States
V. “Bala” Balasubramanian is the President and CEO of Cabeus, a niche firm providing information management products, solutions and services for Life Sciences. With over 3 decades of IT experience, Bala is a thought leader and presenter on Regulatory Intelligence, RIM, IDMP, regulatory analytics, enterprise architecture and process design. At Cabeus he is responsible for strategy, leadership and vision for a cloud platform called ReALM® to transform the regulatory value chain for Life Sciences. Prior to Cabeus, Bala developed IT strategies and capabilities for companies such as Bristol-Myers Squibb, Roche, Aventis, Merrill Lynch, AT&T, Bell Atlantic and IBM. Bala has his PhD and MBA from Rutgers University, MS in Computer Science from NJIT.
Danielle Beaulieu, PhD
- Head, Global Regulatory Business Capabilities
- Bristol-Myers Squibb, United States
Danielle Beaulieu, PhD Danielle obtained her PhD in Biochemistry from Laval University Canada. After a 13 years career in Microbiology Drug Discovery, she moved into regulatory operations where she managed several drugs at different stages of development in the US/EU. In 2012, she was promoted to Director, Regulatory Information Management, managing BMS’s home grown RIM Solution. She also envisioned, help developed and instituted a Data Quality program. In 2014 BMS began the work toward replacing their older RIM solution with a new authoritative source for RIM. Danielle has been the Business lead for that effort, from process definition and simplification to configuration and roll out.
Brooke Casselberry, MS, RAC
- Head, Regulatory Information Management
- Beigene, United States
Brooke Casselberry has been a regulatory consultant for 20 years focusing on data, technologies, small business entrepreneurship, and regulatory compliance for clients globally. She is currently Director, Consulting Expert with CGI Technologies for RnD and Technology Innovation. Brooke has dedicated much of her career to professional volunteerism to continue development and mentorship through communities such as DIA.
Michelle L. Charles, MPH
- Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center
- University of Pennsylvania, Perelman School of Medicine, United States
Michelle Charles, MPH is the Director of Regulatory Affairs in the Gene Therapy Program at the University of Pennsylvania, Perelman School of Medicine, providing guidance on global regulations, submission support and strategic regulatory planning. She co-chairs the DIA RSIDM Conference and has participated as a committee member for several years. Before joining the University of Pennsylvania’s Gene Therapy Program Michelle held multiple positions at both Merck & Co., Inc. and PAREXEL International. During her time in industry Michelle focused on regulatory operations, project management and business process development for global regulatory information management. Michelle holds a Masters of Public from Johns Hopkins University.
Ethan Chen, MBA
- Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
- FDA, United States
Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led the several critical initiatives as the CDER Informatics Architect, including Data Management and Business Intelligence programs. Ethan has over 20-years’ experience in Data Management, Enterprise Architecture, Solution Development and System Integration.
- Director, Regulatory Affairs Operations and Quality Management
- Merck & Co., Inc., United States
Cindy Chiu is Director in Global Regulatory Affairs and Clinical Safety group at Merck & Co. She has 18 years of experience in the pharmaceutical and energy industries, focusing on post-merger process integration and operations excellence. She has served in various leadership roles overseeing project management, business process improvement and change management initiatives. In her current role at Merck & Co., she is the Regulatory Content Authoring Management Lead. Prior to Merck, she worked as a management consultant, where she assisted clients with transitioning to and adopting new processes as a result of merger activity or technology integrations.
- Chief Technology Officer
- Genpact, United States
Jake Doran is the Chief Technology Officer at Genpact Pharmalink. In this role, Jake is responsible for establishing the strategic direction and defining the digital solutions across Regulatory Affairs. Prior to joining Genpact, Jake was with List Innovations LLC where he was Founder and Managing Director. List Innovations is a specialized technology development and consulting company providing Regulatory and IT solutions to the Pharmaceutical industry. Earlier in his career, Jake held positions of increasing responsibility at Janssen Pharmaceuticals and Schering Plough. Jake has a Bachelor’s Degree from Fairleigh Dickinson University where his area of specialization was Biological Sciences.
Ron D. Fitzmartin, PhD, MBA
- Senior Informatics Advisor, OD, CBER
- FDA, United States
Ron Fitzmartin is Senior Project Manager, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions and standardized data. Some of Ron’s activities include: chair of the PDUFA VI information technology committee, Regulatory Chair of the ICH M11 Expert Working Group on clinical protocol standards, and chair of the IDMP Working Group under the International Pharmaceutical Regulators Programme. Ron received a PhD in statistics from the University of Maryland and MBA from University of New Haven.
- Chief, Data Standards Program, CBER
- FDA, United States
Ginny Hussong is Chief of CBER’s Data Standards Program, and has been with FDA for 14 years. She was previously Director of Data Management Services and Solutions within CDER. As Chair of CBER’s Data Standards Committee, Ginny’s recent projects include creating a new joint data standards strategy and action plan with CDER, modernizing CBER’s study data validation process and evaluation of the SEND standard for CBER. Ginny also serves as Deputy Topic Lead for FDA, ICH M2, Electronic Standards.
Joanne S. Malia
- Director, Clinical Documentation Management
- Regeneron Pharmaceuticals, United States
Joanne Malia is Associate Director of Clinical Documentation Management at Regeneron Pharmaceuticals where she drives operational activities related to the implementation and management of an eTMF and associated clinical document management processes. She serves as the business owner for eTMF implementation across the organization. In this capacity she interacts with internal senior level management, external vendors, collaboration partners, clinical study and other internal personnel to ensure compliance with regulations, Regeneron business practices and clinical research program objectives.
Karen McCarthy Schau
- Director, Consulting Services, Health & Life Sciences
- CGI, United States
Clinical Research/Clinical Management Professional with 20 years diversified experience across functional areas and global regions with current focus in Clinical Operations business process improvement consulting and eClinical Systems deployment with emphasis on eTMF, Risk-Based Quality Management (RBQM), Investigator Portal, CRO Engagement and Clinical Architecture. Career includes greater than 9 years specializing in process reengineering and eClinical system implementation for a large global CRO and currently focuses on helping companies deploy solutions to streamline processes, improve productivity and operational efficiency, and better manage information.
- IRISS Forum, United States
Sue Metz, Technical VP PAREXEL is a senior regulatory professional with over 30 years of experience in the life sciences industry. She was responsible for the implementation of PAREXEL’s flagship platform, LIQUENT InSight RIM from 2003 to 2014, and is now helping to reinvigorate the platform to enhance our client’s UX and functional needs. Sue is considered a SME for RIM and IDMP and is an active member of the ISO/TC215/WG6, the EMA’s SPOR Task Force, Rutgers University CX Advisory Board and is the CEO/President for the IRISS-forum Organization, a non-profit dedicated to the implementation of regulatory submission standards around the world. She frequently presents as a Subject Matter Expert on RIM and IDMP at Industry Conferences globally.
Thomas J. Noto
- Senior Director, Regulatory Operations
- Lexicon Pharmaceuticals, United States
Thomas is a 20+ year experienced leader in Pharmaceutical, Diagnostic and Medical Device Regulatory Affairs, Electronic Publishing and Document Management. He has a strong track record of successful regulatory interactions and filings, resulting in the approval of over 25 new drugs, devices and diagnostics. He has worked for a number of organizations both in the Consulting and CRO industry, as well as on the sponsor side of the equation. He has developed services and led global teams resulting in the consistent delivery of high-quality output aligned with business needs. Some of Thomas’s skills include regulatory process and workflow excellence, eCTD publishing, document management, commercial regulatory, and computer systems validation.
Daniel F. Orfe, MS
- President and CEO
- Regulatory eSubmissions, LLC, United States
Dan is a Leadership professional with 20+ years experience in Regulatory Submission production. A subject matter expert for eCTD & EDMS solutions. A business process analyst for submission assembly and eCTD publishing. He’s been a key member of several industry/agency initiatives for electronic submission standardization & efficiency. Dan has presented or chaired sessions at DIA Annual Meeting & DIA RSIDM/EDM Conferences. He's a DIA RSIDM Conference Program committee member. Dan established/directed eCTD publishing groups at Merck & Co., Inc. & Datafarm Inc. (leading eCTD software & services provider). At Teva, Dan led a initiative to harmonize the publishing environment into a single tool set (EDMS, eCTD Publishing etc.).
- Regulatory Information Scientist
- Qdossier B.V., Netherlands
Michiel Stam works as a Regulatory Information Scientist at eCTDconsultancy and is Product Manager for Dossplorer, a regulatory dossier viewer. He is a specialist in electronic submissions and regulatory information management and worked for various Pharma and Biotech companies in the past 10 years. Michiel has a strong focus on XEVMPD, IDMP and Regulatory Information Management projects.
- Senior Program Manager
- Transcelerate Biopharma Inc., United States
Stacy Tegan is a Sr. Program Manager at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical development process. She has expertise in Regulatory Operations, Clinical Development processes, and Project Management gain through 20+ years of experience working for sponsor, consulting, technology, and nonprofit organizations in the pharmaceutical industry.
Peter Terbeek, MBA
- Senior Director, Publishing and Submission
- United States
Peter is the Sr. Director of Publishing & Submissions for Astellas. This global group has responsibility for compiling, dispatching and archiving submissions and ensuring those activities are captured in the appropriate systems. Peter has been involved in multiple global programs targeting process improvements around product change control, document management and master data management. Prior to moving into Regulatory Operations, Peter worked in IT at Astellas focusing on informatics in the areas RA, QA and document management. Peter has a Bachelor’s degree in Mathematics from Austin College in Sherman, TX, and an MBA from the Lake Forest Graduate School of Management.
Kevin Tompkins, MBA, MS
- Global Lead, Global Dossier Management, Group Director
- Bristol-Myers Squibb, United States
Kevin Tompkins is a Group Director, Global Lead in the Global Dossier Management group at Bristol-Myers Squibb. He joined BMS in April of 2018. Kevin began his career in submission publishing and product consulting at Octagon Research before moving to Cephalon. He then managed the N.A. Submissions Management group at Teva before joining BMS. Kevin has over 16 years of regulatory submission and information management experience. He has implemented systems, technologies, and processes in regulatory submissions management for a number of pharmaceutical companies. He holds a B.S. in Information Systems and a M.B.A. from LaSalle University.
Betsy Fallen, RN
- BAFallen Consulting LLC, United States
Ms. Fallen is an authority on the business processes and associated use of information technology in drug development with a focus on regulatory and clinical. A passionate advocate for moving life sciences business on-line, Betsy is an expert on regulatory and clinical operations. Over the two decades of outstanding contributions at Merck, she was recognized for her leadership and excellent representation of the organization on internal transformational teams and in many industry initiatives. Now consulting, she continues to be recognized for her knowledge in technical innovation, process efficiency and ability to assess and assure compliance in documentation, execution and oversight.
Michael Agard, MS, RPh
- Sr. Consultant
- CGI, United States
Michael joined CGI in 2010 and is engaged in the technical architecture and business analysis of clinical and regulatory operations. Michael works with clients to improve their regulatory compliance and lean business operations. Currently, he is working to increase the agility and automation of clinical processes with clients. Michael worked at Sanofi-Aventis for over 25 years. He has experience in Clinical Operations, Data Management, and Clinical Supply Operations. Michael has a Masters in Leadership Development and a BS in Pharmacy.
Joel Alvarez, MSc
- Global Regulatory Compliance, Operations and Labeling Leader
- Bill & Melinda Gates Medical Research Institute, United States
- Assistant Vice President
- Genpact Pharmalink, United States
- Senior Specialist
- Merck, United States
Adam Bone has spent over 20 years in the Pharmaceutical industry. He has worked for 4 companies during that time, with the last 13 years being at Merck. He is the Subject Matter Expert for Merck's Outsourced Documents and Vendors. He plays tennis at a high level and loves the Red Sox. Adam has a Bachelor's Degree in Criminal Justice. Hopefully the audience for this Program will enjoy the presentation as much as Adam enjoys winning the crowd over.
Meredith K. Chuk, MD, MHS
- Acting Associate Director for Safety, OHOP, CDER
- FDA, United States
Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Hematology and Oncology Products in CDER at the FDA.
Heather Fisher, MS
- Senior Manager, Regulatory Operations
- Arivis, United States
Heather Fisher is a Senior Regulatory Operations Manager at Arivis, where she serves as a collaborative extension of pharmaceutical clients’ regulatory teams. She is proud to support clients throughout the life of their regulatory applications to ensure life-changing medications are brought to market while meeting internal and agency driven goals. Heather has worked with Accenture for ten years prior to joining Arivis and has completed multiple NDA, IND, CTA and MAA applications in her tenure. She enjoys working with clients and helping them to learn eCTD and advance their knowledge to better meet the needs of their company.
- Managing Director, Regulatory Submissions Operationsite
- Cardinal Health Regulatory Sciences, United States
Laurie Henricks is Managing Director, Submission Operations and Business Technology, for the Regulatory Sciences group of Cardinal Health Specialty Solutions. She has more than 33 years of experience in the pharmaceutical industry, focusing in the areas of publishing and compilation of pre- and post-approval global regulatory submissions. She is responsible for oversight of all regulatory submission publishing (eCTD and all formats) and project specialist services, which support global submissions and large outsourced publishing projects for small virtual to large pharmaceutical and biotechnology companies.
Marina Nisenzon, MS
- Regulatory Affairs
- Merck, United States
Kristen Sauter, MBA
- Director, Consulting Services
- CGI, United States
Kristen has 20 years of experience helping life sciences clients create modern and innovative regulatory practices and processes that leverage cutting-edge technology to satisfy both FDA requirements and their bottom line. She has built and led global regulatory operations and project management teams for top industry organizations using forward-facing strategy and business systems. Her experience includes comprehensive knowledge of electronic submissions requirements, connections into e-subs group, strong experience in pharmaceutical process and submission preparation through pre-market and NDA stages of development, and strong exposure and awareness of post-marketing and international filings.
- Vertex Pharmaceuticals, Inc, United States
- Technical Design Expert
- Novartis, United States
4 Years working for software company supporting and delivering solutions for Pharmaceutical Companies. 8 Years as a consultant at Pharmaceutical companies helping implement and administer systems supporting electronic submission processes. 9 Years as a Novartis company employee continuing to implement a wide range of systems and develop business processes to meet the changing electronic submission landscape. I have also been involved in system strategy for submission gateways and next gen publishing system evaluations. In my personal life I am a husband and father of 3, and I enjoy spending time with my kids and taking them to their various baseball and basketball games
Kim Young, MSc
- Director, Global Regulatory Intelligence
- Instem, United Kingdom
Teresa M Booth-Genthe, MS
- Vice President, Global Regulatory Operations, Global Regulatory Affairs
- Teva Pharamceuticals , United States
Ms. Booth-Genthe has over 20+ years in the pharmaceutical industry. The last 12 years she has worked in Regulatory Affairs, both in strategy and operations. She is currently responsible for the Global Submissions Group at Wyeth and has been active in PhRMA ERS, HL7 and eCTD working groups.
Vera Buris, MS
- Senior Manager, Quality and Operations, Submission Sciences
- Biogen, United States
Sandra A. Krogulski, MA
- Associate Director, Submission Management
- Bristol-Myers Squibb, United States
Sandy Krogulski is a Regulatory Submission Manager with 9 years of experience and this is her fourth time speaking at RSIDM. She has experience managing and reviewing submissions to the US, Health Canada, Swissmedic, Australia and other Rest of World countries. In addition to submissions, Sandy has a background in training/developing teams, SOP writing and change initiatives. Currently in her second year with BMS, Sandy has previous vendor experience supporting submissions to numerous health authorities.
Jared Lantzy, PMP
- Manager, Global Regulatory Agencies and Processes
- LORENZ International LLC, United States
Jared Lantzy, PMP, is the Manager of Global Regulatory Agencies and Processes at LORENZ International LLC. In this role he monitors the world of regulatory operations to inform industry of emerging requirements and best practices. His primary expertise is in the implementation of electronic submission processing, validation, and review solutions. Mr. Lantzy is also a former member of the FDA CDER electronic submission support team. He holds a B.S. in Information Technology from Juniata College in Huntington, Pennsylvania, USA.
Kristen Mandello, DVM
- Executive Sales Consultant
- Ennov, United States
- Solution Architect
- Google Cloud, United States
Ken Sakushima, MD, PhD, MPH
- Medical Reviewer, Office of Advanced Evaluation with Electronic Data
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Teginder Singh, MPharm
- Senior Director, Regulatory Affairs
- Johnson & Johnson, United States
Rune Bergendorff, MSc
- Director, Consulting Services
- NNIT, Denmark
Rune Bergendorff is Director of the Life Sciences Business Areas: RA, Clinical, Laboratory, Production & Quality. Before taking his current position, he spent 9 years working with and driving forward the RA area working with RIM, Submissions, EDMS and extensively with topics as ISO IDMP, xEVMPD and SPL. Rune has been member of the ISO TC215 WG6, developing the IDMP guidelines and is member of the EMA IDMP Task Force. He is executive sponsor on a number of global programmes in the industry across Scandinavia, Europe and USA.
Richard Finch, MA
- Global Head of Consulting Life Sciences
- Clarivate Analytics, United States
Steve Gens, MS
- Managing Partner
- Gens and Associates Inc., United States
Steve Gens (MSOD) is the Managing Partner of Gens and Associates Inc., a global Life Science consulting firm specializing in strategic planning, RIM program development and execution, industry benchmarking, and organizational performance. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he lead global healthcare consulting practices for First Consulting Group and Booz Allen Hamilton. His organization is well known for their insightful industry benchmarks and World Class RIM thought leadership. Steve has a Bachelor’s of Science in Business Computer Science and a Master in Organizational Development and Performance. He was named to the PharmaVoice 100 for 2017.
Ken Keefer, MBA, PMP
- Principle Consultant
- Keefer Consulting Inc, United States
Ken Keefer is founder of Keefer Consulting Inc. He managed the review of the eTMF Exchange Mechanism Standard (eTMF-EMS), Version 1.0, an initiative under the TMF Reference Model. eTMF-EMS is a common standard for exchanging TMF documents between systems and organizations. Ken continues to work with sponsors, CROs, and eTMF vendors to test and enhance eTMF-EMS. He has dedicated fifteen of his 40 years in consulting to helping clients including GSK, Merck, and Pfizer to transform their business processes and data resources. He holds a MBA from Temple University and a Post-graduate Certificate in Pharmaceutical and Healthcare Business from the University of the Sciences in Philadelphia.
- Project Manager, CBER
- FDA, United States
Adair Turner, MSc, RAC
- Principle Consultant, Director Regulatory Operations
- PharmaLex, United States
Adair has 17 years of experience in Regulatory Affairs and has worked for companies such as ImClone Systems and Celgene where she led the planning, review, and delivery of high-quality regulatory submission dossiers in support of the development and registration of anti-cancer compounds worldwide. At PharmaLex Adair leads a team of Regulatory Operations professionals and is accountable for the overall planning and management of Regulatory Operations resources to effectively support timely and quality submissions to Health Authorities (i.e., FDA, Canada, etc.). Adair is experienced in defining, assessing, and improving processes and works closely with life sciences companies to plan and manage successful Regulatory projects.
Sheila Mahoney Jewels, MBA
- Independent Workforce Advocate
- LifeSciHub, United States
Sheila has over 25 years of experience in reg/clin ops, having operated as an SME on both the sponsor and vendor sides. Her current focus as an independent consultant (IC) is advocating for the independent workforce, and helping sponsors engage with them. Sheila has spent the last two years immersed in the world of HR and Procurement tech in order to transition mature, "Future of Work" technologies from other verticals to life sciences in the form of LifeSciHub. LifeSciHub is an online resource marketplace of SME ICs, the goal is to provide extremely easy, and compliant, access and engagement for the Sponsors who need specifically qualified experts for projects. Think Airbnb or Lyft, for SMEs!
Karin Schneider, MLIS, MS
- Document Management Enablement Head
- Janssen Pharmaceuticals, Inc., United States
She spent 10 years in Switzerland where she discovered her love for cheese and hate for fog but no progress on punctuality whatsoever. Now she is in the US for 18 years still with Johnson & Johnson, still not punctual and still with a solid German accent. She has been in Content Management for all these years but in very different capacities: as information broker, information architect, end user, solution engineer. She is very passionate in what she does and her spongy curiosity leads to many “why”, “what if” questions. After seeing the problems from many different angles, she truly believes RIM is ready for breakthrough innovation to solve what really matters.
Matt Neal, MA
- Senior Director, Product Management
- 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. (2003-2016) and prior to that he was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline (1996-2003) 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 Master’s Degree in Communication from Temple University. He and his wife Beth live in Los Angeles, CA and spend most of their time entertaining their two kids, Claudia & Tobias and their dog, Laverne.
Susant Mallick, MBA
- Leader and Evangelist, Healthcare and Life Sciences, EMEA
- Amazon, Netherlands
Susant Mallick is leading Amazon AWS HCLS professional services for EMEA region. He comes up with 20+yrs of Pharma and IT background on building disruptive solutions/products in Clinical and Regulatory space. He is technology evangelist on cutting edge technology like (Artificial Intelligence, Machine Learning, IoT, Cloud etc) and an industry leading speakers across geographies. He has been working with various customers & partners in pharma & healthcare to drive digital transformation in Clinical & Regulatory landscape. He was instrumental in implementing/building many Regulatory solutions using advanced technology. Innovation & Digital Transformation in Healthcare & Life Sciences are two key focus areas for him in AWS.
Rob Connelly, MBA
- Executive Director, Product Development
- Synchrogenix, A Certara Company, United States
Rob Connelly, Senior Director, Product Management, Synchrogenix- A Certara Company, brings a wealth of experience from the pharmaceutical and life-science industry, primarily focused on developing the people, processes and products needed to submit compliant regulatory filings with global health authorities. His job responsibilities focus on the management of multiple life-science software product lines and developing new products or services based on market opportunities and requirements. Previous job experience leading project teams in the planning and filing of successful clinical and marketing drug applications with global health authorities.