Regulatory Submissions, Information, and Document Management Forum
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.
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.
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.
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.
Mark A. Gray
- Senior Project Manager, BSS, CBER
- FDA, United States
Mark has over 30 years’ experience in Information Technology & Management. Mark began his career developing commercial applications and has been working for FDA for over 20 years. Mark’s FDA responsibilities have included; software development and project management in CBER; Director of Applications Development & Services in CDER; PDUFA IT Program Director; and Director, Division of Data Management Services & Solutions managing CDER’s electronic submission program. Mark’s current responsibilities include representing CBER in the development of international electronic submission standards, with a focus on the ICH electronic Common Technical Document (eCTD).
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.
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.
Sarah Powell, RAC
- Powell Regulatory Services, United States
Ms. Powell is the President of Powell Regulatory Services. Sarah has 30+ years of experience in pharmaceutical and related regulated industries (Clinical, Quality Control, Regulatory Affairs and Regulatory Operations). In the past 17 years as a consultant, she has assisted clients with projects related to regulatory process improvements, standards development, defining filing strategies and writing/review of submission content. She has extensive experience with projects related to design and implementation of regulatory solutions including document management, submission planning, publishing, and registration management. Sarah is a past executive at Chiron, First Consulting Group and Liquent, PAREXEL
T.J. Sharpe, PMP
- Patient Advocate
- Starfish Harbor LLC, United States
T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 Blog. He was diagnosed in August 2012 with melanoma tumors in multiple organs, only four weeks after his second child was born. Since then, he has undergone six surgeries and four immunotherapy treatments over two different clinical trials. The initial failures, and subsequent complete response, have been chronicled in his blog posts since December 2012. In addition to writing, he is a keynote speaker and consultant to the biopharma and clinical research industries, bringing an educated patient voice as a true stakeholder in challenging healthcare's status quo and making a difference in patients' lives via his company, Starfish Harbor LLC.
- 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.
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.
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.).
Norman Schmuff, PhD
- Associate Director for Science
- FDA, United States
Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He is currently the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives, including the Pharmaceutical Quality/Chemistry, Manufacturing, and Controls structured data project. He is also serves as a delegate to the International Organization for Standardization's (ISO) Technical Committee (TC 215) on health informatics which deals with the IDMP standards. Currently he is Associate Director in FDA’s Office of Process and Facilities in CDER.
- Research Scientist
- Bristol Myers Squibb, United States
Katherine has worked in the field of nonclinical research at Bristol-Myers Squibb since 2002. Her comprehensive background and experience in all aspects of toxicology study conduct and operations served as a launching pad to her current role in nonclinical report management. In this role she manages the flow of nonclinical study reports and regulatory documents through the authoring and publishing process to enable health authority submission.
David Gwyn, MBA
- Global Solutions Architect
- AMPLEXOR Life Sciences, United States
With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience delivering solutions to clients, with a particular focus in the areas of content management and collaboration. As a global solution architect for AMPLEXOR Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite to ensure that the solution meets the needs of the customer. He also leads the DIA EDM Submission Reference Model team, who developed a document architecture for use when designing and building content.
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.
Fred Wood, PhD, MS
- Vice President, Consulting Services
- Data Standards Consulting Group, A Division of TalentMine, United States
Fred is Vice President, Consulting Services at TalentMine. He leads the Data Standards Consulting Group, and is an SDTM and SEND Implementation Advisor. He has been active in leading the development of CDISC standards since 1999. He is a founding member of the SDS Team (1999), the SEND Team (2002), and the Medical Devices Team (2007), and has led or co-led these for many years; he currently serves on the Leadership Teams of all three. Fred previously worked at Procter & Gamble Pharmaceuticals, Octagon Research Solutions, and Accenture, managing and consulting on data standards.
- Chief Corporate Development Officer
- BurstIQ, United States
Amber Hartley currently serves as Chief Corporate Development Officer for BurstIQ, a Denver-based startup that has developed the first enterprise-level blockchain platform for health data. The company works with health systems, insurers, digital health providers, B2B service providers, and government entities to help them securely manage, share and monetize data-driven products and services. Within her role at BurstIQ, Amber oversees partnerships, marketing, legal, and corporate strategy. Prior to joining BurstIQ, Amber ran the Center for Healthcare Innovation at Catholic Health Initiatives. She has over 20 years of experience leading business development and strategy in high tech, biotechnology and healthcare.
- Director, Innovation and Outreach
- CGI Federal, Inc., United States
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.
Suranjan De, MBA, MS
- Deputy Director, Regulatory Science, OSE, CDER
- FDA, United States
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. He has over twenty years of experience with the FDA, the NIH & in the pharmaceutical industry. His current work includes compounding reporting guidance, data management of FAERS system, Safety Reporting Portal for mandatory post-marketing electronic submissions and the FAERS Public Dashboard.
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.
Hans van Bruggen, MSc
- Chief Executive Officer and Regulatory Affairs Scientist
- Qdossier, Netherlands
He has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of medicinal products for patients. Using that scientific background he approaches interdisciplinary and international processes. Hans has been involved with eCTD submissions from the beginning, back in 2000. Key areas of expertise include: lean authoring of regulatory documents, managing regulatory information and lean data, document and dossier management focusing on reuse rather then recreate.
- Sr Expert, Program Delivery
- Health Canada, Canada
Craig Anderson is a Senior Expert, Program Delivery in the Business Informatics and Data Sciences Division at Health Canada. Craig is responsible for leading regulatory informatics projects like the implementation of the Structured Product Labeling (SPL) standard; the IDMP standard and IT modernization. Craig has over 13 years of experience in pharmaceutical regulatory operations and regulatory information management. He has operated as a global line manager with staff in Canada, USA and Sweden; and global responsibility for regulatory submission and information management.
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.
Sandra Brown Stephens, MBA
- Director, Regulatory Information Management
- AbbVie, Inc., United States
Sandy has worked within Regulatory Affairs at AbbVie since 2010. During this time, she has successfully implemented enhancements to global processes and systems in the areas of global labeling, registration management, submission planning, and submission tracking. Her primary focus has been on streamlining interactions between central/headquarters and affiliate regulatory team members. Prior to joining AbbVie, Sandy spent 18 years in management consulting working with companies from various industries including healthcare, transportation, and consumer products. Sandy has a BA from Dartmouth College, an MBA from Booth School of Business, and is certified in the Prosci change management methodologies.
Ta-Jen Chen, MS
- Project Management Officer, OSP, CDER
- FDA, United States
TJ is a project management Officer at Office of Strategic Programs, CDER, FDA, where he is responsible for the development, testing, and implementation of electronic data standards for CDER regulatory review. As a FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he has been actively participating in the development of E2B (R3) Implementation guide and the utilization of ISO IDMP standards in ICSR reporting. Mr. Chen has more than 30 years of experience in program management and various IT areas since graduated from Indiana University. He also worked for a pharmaceutical company before join FDA in 2005.
- Head of Global Regulatory Operations
- Boehringer Ingelheim, Germany
Scott Cleve is currently the Head of Global Regulatory Operations at Boehringer Ingelheim responsible for submission publishing, regulatory information management, and system business support. His past experience includes roles within Regulatory Operations at AbbVie and Astellas. Scott's areas of experience and expertise include document management, submission management and systems, regulatory information management, and process improvement. As part of his current role, Scott is exploring the use of emerging digital technologies to improve processes and systems within Regulatory Affairs. Scott earned a Bachelor of Business in Public Accounting from Loyola University Chicago.
Brooke Leslie Czapkowski, MBA
- Global Submissions Manager
- Pfizer, United States
Brooke currently works as a Global Submissions Manager at Pfizer. Within this capacity, she project manages timelines and deliverables for regulatory submissions in emerging markets. She hosts and leads Regulatory Submission Kick-off Meetings which bring together the key submission stakeholders—Product Strategists, CMC strategists, Regional strategists, regional team members, dossier coordinators, and artwork/labelling/sample colleagues. She drives the timelines and deliverables for these submissions to health authorities worldwide. She holds a Bachelor’s degree in Biochemistry from Worcester Polytechnic Institute (WPI) and a Master’s degree in Business Administration (MBA) from Iona College.
- 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.
John V Janick
- Director, Regulatory Affairs, Information Integration
- Merck & Co., United States
John Janick is a Director within Global Regulatory Affairs and Clinical Safety at Merck. He has a diverse background of innovation, process improvement, and technology acumen with over 20 years of pharmaceutical industry experience. John has held a variety of positions of increasing responsibility across regulatory and global human health. He leads a team responsible for labeling operations, information integration, and intelligent business automation. He is a Sigma Black Belt, mentor, and Kaizen leader. He earned his BS in Chemical Engineering from Lehigh University and his Masters in Information Systems Management from the Stevens Institute of Technology.
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.
Venugopal Mallarapu, MS
- Practice Director
- Cognizant Technology Solutions, United States
Venu Mallarapu is Practice Director and Global Head of Regulatory Affairs Advisory consulting. He has 20+ years of experience in strategic consulting of which 15+ years has been in the Life Sciences industry advising global clients in the areas of Clinical, Regulatory and Safety. He has advised clients in transforming their Business & IT Landscape to continually comply with changing regulations, maintain technology currency, improve operations and innovate. He has been working with various industry groups and clients as a thought leader in ideating and promoting “Transformation & Innovation in Regulatory Affairs”.
- 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.
- Regulatory Information Director
- Asphalion S.L., Spain
Remco has over fifteen years’ experience in European and FDA submission procedures and is a specialist in electronic submission and regulatory data management. Since 2011 Remco works for Asphalion, an international Regulatory Affairs consultancy, with offices in Barcelona, Madrid and Munich. Within Asphalion, Remco is responsible forall electronic submission projects. His team prepares eCTD on global level, xEVMPD compliance and IDMP implementation. In addition he is the chairman of Medicines for Europe Telematics working group and in direct contact with EMA and NCAs for the eSubmission roadmap, eCTD specification, validation criteria, eAF, CESP, Gateway, xEVMPD and ISO IDMP.
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.
- Sr. Director, eSubmission Services, Head of Regulatory Operations
- PharmaLex GmbH, Germany
Timm Pauli joined PharmaLex in 2014 as Head of Regulatory Operations, where he is responsible for all electronic submission activities, regulatory information management and related topics worldwide. He is also leading and supporting process optimization projects within Regulatory as well as providing consultancy for Regulatory Information Management, IDMP-related topics and eCTD publishing systems. Previously he worked at Merck Serono heading the Dossier & Submission Management department and at Baxter, where he held several global positions in Biostatistics, Pharmacovigilance and IT. Timm studied Pharmacy and Medical Informatics at the Universities of Frankfurt and Heidelberg (Germany).
Vada A. Perkins, DrSc, MS, MSc
- Global Regulatory Policy and Intelligence
- Bayer Pharmaceuticals, United States
Vada A. Perkins, Bayer Pharmaceuticals Head, Regulatory Intelligence Director, Regulatory Policy & Intelligence Vada A. Perkins (CAPT, ret.) is a former FDA Senior Advisor for Regulatory Science and a recognized global regulatory policy & intelligence expert with thought leadership in the application of technology, standards, and data management. He is active in interactions with national and international stakeholders in promoting technology and innovation to support international regulatory convergence for medicinal product regulation. He received his degrees from The Johns Hopkins University, University of Southern California, and the University of Maryland.
Jonathan Resnick, PMP
- Project Management Officer, OBI, OSP, CDER
- FDA, United States
Jonathan Resnick is a member of CDER’s Electronic Submissions Team, with a focus on eCTD and has been with FDA for eight years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.
James Riddle, MS
- Vice President, Strategic Consulting
- Advarra, United States
James Riddle is the VP of Strategic Consulting for Advarra, where he employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Advarra Consulting worldwide. Mr. Riddle is also a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R); a member of the CTTI Steering Committee; and leader of the ACRES SASI technology domain accreditation team. Prior to joining Advarra, Mr. Riddle served as a leader of the human subject protection and animal care and use program at the Fred Hutchinson Cancer Research Center, one of the nation’s largest independent cancer research centers.
Sandra Sanford, MSN, RN
- Director of Quality Control
- Advarra, United States
Sandra M. Sanford, RN, MSN, CIP has been involved in the conduct of human subjects research for more than 30 years in a wide variety of roles – research nurse (George Washington University, Department of Emergency Medicine), Director of Education and Certification (ACRP), Director of Accreditation (NCQA), Director of Research Subject Protections (George Mason University) and the Human Research Protections Education Specialist (contractor to the Department of the Navy HRPP). Currently she holds the position of Director of Quality Control at Advarra IRB.
Lena Shafir, MD
- Product Manager, Life Sciences Regulatory Solutions
- OpenText, United States
Lena Shafir - Director, Life Sciences Lena Shafir head of OpenText Life Science Solution Product Management team. Lena is an accomplished leader bringing a wealth of experience in Life Sciences. Lena offers solution-oriented, business-outcome approach backed by years of field experience in ECM, Regulatory Solutions, and business process development. Lena is defining strategy to deliver enterprise-grade solutions to Life Sciences customers supporting full product development cycle.
- VP of Marketing, North America
- ENNOV, United States
Chet Shemanski is the Vice President of Marketing, North America at Ennov. Chet is a business and information technology professional with over 30 years of experience serving the healthcare and global life sciences industries. He has specific expertise in software product commercialization including product management, product marketing, solution strategy and full-lifecycle solution delivery. With a focus on Regulatory, Quality and Clinical content and process management solutions, Chet was worked for a variety of software and services companies including PAREXEL, LIQUENT, NextDocs, CSC and First Consulting Group.
- Manager, Regulatory Submissions Operations
- Cardinal Health Regulatory Sciences, United States
Robin Zumbrunnen is Applications Manager, Submissions Operations, for the Regulatory Sciences group of Cardinal Health Specialty Solutions. She has more than 34 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 regulatory submission publishing tools, technical support, processes and training.
Wim Cypers, MPharm
- SVP Regulatory
- ArisGlobal, United States
Wim Cypers has been with ArisGlobal for 23 years. In his current role, he heads all business unit operations for our regulatory domain, including overall product vision, strategy, implementation, and success of ArisGlobal’s Regulatory Solution Suite. Wim has long standing experience in converting business requirements into application functionality; and consistently showing industry thought leadership through speaking engagements at several industry events. He has applied his pharmacist training into a keen understanding of how to solve complex business issues. Before focusing exclusively on ArisGlobal’s Regulatory Business Unit, Wim managed the company’s strategy and product management function for both the safety and regulatory solutions.
Brian Burke-Green, MSc
- Regulatory Manager
- Pfizer, United States
Brian Burke-Green is a Regulatory Submissions Manager within Worldwide Regulatory & Safety, WRO - Submissions Management. Brian specializes in Emerging Markets with a current focus on the Latin American Region, overseeing a portfolio of over fifteen hundred Submissions. Brian is also functioning as Project Lead on advancing submission processes through AI & Automation. Brian has worked in several Regulatory Consulting roles involved with Global Submissions Management prior to joining Pfizer has over eight years’ experience as a Pharmacy technician. Brian holds a B. Sc. In Biology from Temple University and a M. Sc. In Regulatory Affairs from St. John’s University.
Lawrence Nicholas Callahan, PhD
- Chemist, OCS, OCPP, Office of the Commissioner
- FDA, United States
Larry Callahan obtained his Ph.D. in Chemistry from the University of Chicago. He was previously employed at FDA, NIH and the United States Pharmacopiea (USP). He has been involved in Nucleic Acid, HIV, tuberculosis research and the development of analytical methods for biotechnology-derived products. He is responsible for the development of the FDA’s Global Substance Registration System (G-SRS). The G-SRS links substances to products, applications clinical trials and adverse events and has a number of relationships between substances.
Jillian E. Carinci, MS
- Associate Director Regulatory Operations
- Biogen, United States
Jillian Carinci is Associate Director in the Regulatory Operations group at Biogen. Jillian leads Biogen’s Global Delivery Managers and is responsible for overseeing global submissions, establishing processes, ensuring compliance, robust submission planning, tracking metrics, high quality submission delivery and process improvements. Jillian began her career at Octagon Research Solutions before transitioning to Accenture. During her tenure at Accenture Jillian partnered with sponsors to manage numerous regulatory submission projects, ensuring compliance with global regulatory requirements, delivering within scope, on time, and with the highest quality.
Amy Cheung, MBA
- Deloitte, United States
Amy Cheung is a Principal in Deloitte Consulting’s Life Sciences practice specializing in R&D. Amy has over 16 years’ consulting experience in the pharmaceutical industry. She worked for Merck as a researcher in chemistry prior to receiving her MBA from Cornell University. At Deloitte, she works with clients to improve productivity and reduce costs using robotics and cognitive solutions. Her experiences include development of knowledge management strategies, operating model design for R&D organizations, including functions such as Regulatory Affairs, Clinical Operations and Data Management, and large scale implementation of RIM solutions. She is currently leading an industry forum on Regulatory Intelligence.
- Director, Regulatory Affairs
- Merck, United States
Christina Frey is a Director in the Global Regulatory Affairs and Clinical Safety group at Merck & Co. She has 20 years of experience within the Pharmaceutical Industry, specifically Regulatory Affairs, Quality Assurance, Quality Control and Manufacturing Operations. She has a strong track record within the Regulatory and Quality Organizations, serving in various leadership roles around business process improvements, specifically quality and compliance initiatives. She is responsible for the business design and development of a global Dossier Change Control Management (DCCM) capability. This tool is the first of its kind in industry, providing users with global access to both current and historical views of changes to the dossier.
Teresa Genthe, MS
- Vice President, Regulatory Solutions
- Genpact Pharmalink, United States
Terri Genthe has over 30 years experience in the biopharmaceutical arena, with over 20 in Regulatory Affairs. In Regulatory she has experience in global major submissions in Strategy and Operations roles. Prior to Genpact, she was the Vice President of Regulatory Operations at Teva Pharmaceuticals where she was responsible for the Information Management systems, publishing and centralized services.
Mark Gregorio, MSN
- Director of Clinical Services
- Pfizer, Inc., United States
Mark Anthony Gregorio is an Adult Nurse Practitioner from New Haven, CT with many years of nursing experience across various specializations. He is currently the Director of Clinical Services at Pfizer Inc.’s Phase I New Haven Clinical Research Unit in New Haven, CT. He has oversight of research and health professionals and paraprofessionals that are responsible for the entire provision of clinical services and coordination activities in early drug development programs and clinical trial operations across various therapeutic areas and business/research units.
- K2 Consulting, United States
Kelly is a recognized industry leader in RIM and IDMP with over 20 years in the pharma industry, the last 11 focused on Regulatory Affairs. She has led implementation of large-scale global systems and processes and is passionate about the potential for pharma companies to improve productivity and compliance through process-focused management of critical data. Kelly is an industry leader on the EU implementation of IDMP as a member of the SPOR Task Force and its PMS subteam and is also a member of ISO TC/215. Kelly heads K2 Consulting, a specialty firm focused on Regulatory Affairs, has previously held leadership positions in IT and Regulatory Operations/RIM at Wyeth, Pfizer, Shire and Teva, and is currently the Vice President of IRISS.
LaTarsha Jones, MSc
- Senior Manager, Global Regulatory Operations
- Indivior Inc., United States
LaTarsha Jones began her 15 year career as a chemist with Cirrus Pharmaceuticals. While at Transave Inc., she discovered an interest in Regulatory Affairs. Following that interest, LaTarsha joined then Reckitt Benckiser Pharmaceuticals (currently Indivior Inc.) as a Regulatory Coordinator. She now leads a Global Regulatory Operations team at Indivior as a Senior Manager. LaTarsha earned her Bachelors of Science in Chemistry from Clemson University and Master of Science in Pharmaceutics from the University of North Carolina-Chapel Hill.
Armen Kherlopian, PhD
- Chief Science Officer
- Genpact, United States
Dr. Armen Kherlopian serves as Chief Science Officer at Genpact and has provided high impact Data Science advisory for Global Fortune 100 companies as well as government organizations. He is a co-founder of the Data Science Bowl, the largest data challenge for social good, and a co-author of the Field Guide to Data Science, which has over 25,000 copies in distribution. Also, Dr. Kherlopian is an awardee of the U.S. National Science Foundation Graduate Research Fellowship, U.S. Department of Energy Computational Science Graduate Fellowship, and a U.S. delegate to the Lindau Nobel Laureates Meetings. He holds a BS and MS in Biomedical Engineering from Columbia University, a PhD in Biophysics from Cornell University.
Raymond Nomizu, JD
- CRIO, Inc., United States
Raymond Nomizu is the co-founder of Clinical Research IO, a site-centered electronic Source and CTMS solution. Clinical Research IO allows research sites to collect data accurately and contemporaneously, and sponsors to view the data in real-time, without costly source data verification. Prior to founding CRIO, Raymond owned and operated an independent clinical research site, co-founded a real estate data analytics firm, and served as a management consultant focusing on process improvement. Raymond has AB and JD degrees from Harvard University.
Marie A Parrish, PhD, MS
- Director, Regulatory Affairs, Innovative
- Glenmark Pharmaceuticals, United States
Marie Parrish is a Director of Regulatory Affairs, Innovative at Glenmark Pharmaceuticals. She has a Ph.D. in Pharmaceutical Analysis from Rutgers University and over 25 years experience in the pharmaceutical industry with small to large pharma. She has extensive experience in global CMC submission requirements, quality and cGMP issues. Marie has been a member and later a leader of the IRISS CMC Topic Group since its inception.
- MSD Czech Republic S.r.O, Czech Republic
Lena Rampula is leading the Natural Language Processing (NLP) Capability at Merck Prague IT Hub. The NLP group is developing solutions for gaining knowledge and insight from unstructured data. In all stages of drug development, NLP can be applied to provide intelligent search, extract key information from documents and automate processes. Lena holds a double master degree in Computational Linguistics.
- Vice President, Delivery
- Cabeus, Inc., United States
Meredith K Sewell
- Executive Director, Global Regulatory Submissions
- Allergan, United States
Meredith Sewell is Allergan’s Executive Director of Global Regulatory Submissions and International Operations. Meredith joined the company in Irvine, CA in 2006, and most recently, as part of the Actavis-Watson-Warner Chilcott-Forest acquisitions, has led Regulatory activities related to M&A, divestitures, and harmonizing systems and processes across the global organization. She enjoys spending time with her husband, four step-children, and Charlotte, the Cavalier King Charles Spaniel.
Frits Stulp, MSc
- Managing Director
- Iperion Life Sciences Consultancy, Netherlands
Frits Stulp is Managing Director of Iperion Life Sciences Consultancy, with over 20 years of industry and consultancy experience. In this role he leads a team of regulatory / IDMP experts active in various projects to deliver value to both pharmaceutical companies as well as regulators. Frits is the IDMP topic group lead for the IRISS Forum and heavily involved as EU-SRS project manager for Medicines Evaluation Board / European Medicines Agency. Regarded as an SME on IDMP, he gladly shares his gained knowledge and experience in various occasions around the globe.
- Generis, United Kingdom
Dave Warner has more than eighteen years experience working in Life Sciences EDMS as a Senior Developer, Technical Lead, Business Analyst, Project Manager and Implementation Specialist with FCG, CSC and -for the last couple of years - as a Regulatory Solutions SME with Generis. He's still amazed that no two days turn out the same, and excited at the new problem-solving opportunities promised by the latest developments in RIM.
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.
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.
- Sr. Director, Vault RIM
- Veeva Systems, United States
Marc Gabriel is a Senior Director of Product Strategy at Veeva Systems where he is responsible for defining the enterprise market approach for the Vault Regulatory suite of products. Prior to joining Veeva in June 2017, he served as client partner and RIM consulting lead at Kinapse. Marc also spent fourteen years in Accenture’s Pharmaceutical R&D practice where he led the organization’s Regulatory advisory, business development, and alliance efforts. During that tenure he helped half of the world’s Top 20 biopharmaceutical organizations in various consulting and program delivery roles spanning regulatory and pharmacovigilance.
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.
- Project Management Officer, OBI, OSP, CDER
- FDA, United States
Valerie M Gooding has been with FDA since January 2008. Valerie has over 18 years of Regulatory experience. She is currently a Project Management Officer (Team Lead) with Office of Business Informatics. As member of CDER’s Electronic Submissions Team, Valerie advises on eCTD, validation, guidance and compliance with electronic submission policies. Valerie facilitates eCTD viewer training to CDER review community and review and assess sample eCTD submissions and Briefing Packages. Prior to joining the FDA, Valerie worked 8 years for a local Pharmaceutical Company in Rockville, where she served as Regulatory Affairs Administrator in both Clinical and Regulatory Department.
Cheryl Grandinetti, PharmD
- Health Scientist, Policy Analyst, OSI, OC, CDER
- FDA, United States
Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and scientific and clinical oversight to FDA field investigators. She serves as a subject matter expert in GCP inspections to evaluate data integrity, quality, and safety of human subjects in clinical trials.
Andrea Herrmann, PharmD
- Head of IDMP Office
- Merck KGaA, Germany
Professionally Andrea studied pharmacy in Heidelberg. After University, she started to work at Pharmalex as a contractor for Merck KGaA and then in 2003 joined Merck KGaA holding different positions within Global Regulatory Affairs (GRA) and Strategy & Business Operations within Research & Development (R&D). While working at Merck, she first did her Master of Drug Regulatory Affairs at DGRA (“Deutsche Gesellschaft für Drug Regulatory Affairs”) in Bonn and afterwards she did her doctor of science at the University of Bonn in the field "Regulatory Affairs". Since January 2018 she has taken over the role of Head of IDMP office, leading IDMP project as well as the implementation of IDMP, covering XeVMPD and other technology topics.
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.
- Consultant / Partner
- CGI, United States
Fran Ross is an R&D Consultant at CGI Life Sciences. Focused on trial operational efficiency and quality risk management, she has 30 years industry/academic experience, including compliance, TMF, CTMS, QMS, study start and risk management. Fran is active in industry, and on the Steering Committee of the TMF Reference Model. Fran is passionate about robustly meeting GCP without over complicating process, and applying the right solution for speed, efficiency and quality. Ask Fran about ICH E6 R2 and risk.
- Director, Data Stewardship and Compliance
- Bristol-Myers Squibb, United States
Lisa obtained her Bachelor’s Degree in Chemistry from Rutgers University. Her career at BMS began in 1999 where she worked in Global Regulatory, Chemistry, Manufacturing, and Control for 14 years. In 2013 she moved to Global Regulatory Science-Regulatory Information Management where she worked on data compliance for BMS’ RIM system. BMS began work to replace the homegrown system with a new authoritative source for regulatory information management, Lisa was involved in choosing the tool, configuration, data governance, stewardship and compliance. In 2016 Lisa was promoted to Director, Data Stewardship and Compliance. As the Lead Regulatory Data Steward she has responsibility for overseeing the data compliance program.
- Senior Product Solutions Specialist
- Medidata Solutions, United States
Michael is a member of Medidata’s Mobile Health team and is a subject matter expert in electronic informed consent and virtual trials. Over the last six years, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of electronic informed consent and virtual trials. His 30-year career in medical research includes 8 years with the US government conducting and supporting surgical research and 22 years working in the commercial sector. Michael has been a participant in two clinical trials...but had to consent on paper because eConsent had not been invented yet!
- 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.
Wei (Lisa) Lin, MBA, PMP
- Study Data Standards Manager, Office of Director, CBER
- FDA, United States
Lisa Lin has worked as a Study Data Standards manager at FDA CBER for over a year. Currently she is responsible for all study data standards projects in CBER, including data validation, evaluation and testing of SEND standard for CBER, data analysis tool training and support. Before CBER, Lisa had worked in CDER as Data Standards lead. Her contribution includes the Development of Technical Rejection Criteria, Technical Conformance Guide, FDA Business Rules, eData mailbox, training and support of analysis tools, consultation on Pre-NDA/Pre-BLA/IND meetings. Before joining FDA, Lisa had worked as project lead on clinical trial analysis in pharmaceutical companies.