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 Senior Vice President for Life Sciences at Orion, a global digital transformation products, solutions and services company. With over 3 decades of IT experience, Bala is a thought leader on digital transformation of Life Sciences. Prior to Orion, Bala was the President and CEO of Cabeus, a niche Life Sciences services firm where he was responsible for strategy, leadership and vision for a cloud platform called ReALM® to transform the regulatory value chain for Life Sciences. 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 and MS in Computer Science from NJIT.
Brooke Casselberry, MS, RAC
- Senior Director, R&D Consulting
- NNIT, United States
Brooke Casselberry is Head, Regulatory Information Management with BeiGene and co-chair for the RIM Business and Technology tracks for DIA RSIDM. She has worked with bio-pharma sponsor organizations for nearly 20 years leading business implementation for systems and processes for regulatory data management in RIM, DMS, and Publishing and developing teams within Regulatory functions for consulting and sponsor organizations. Additionally, she is the founder of the non-profit organization, Youth STEM Foundation, providing scholarship funding for economically disadvantaged youth to after school STEM programs in the Denver area.
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.
- 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 over 20 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 Submission Content Authoring Operations Lead. Prior to Merck, she worked as a management consultant, where she assisted clients with change management and business process redesign as a result of merger activity or technology integrations.
- Head of Global R&D IT
- Bausch Health, United States
Jake Doran is the Head of Global R&D IT @ Bausch Health. In this role, Jake is responsible for establishing the strategic direction and defining the digital solutions across Bausch's R&D portfolio. Prior to joining Bausch Health, Jake was with Genpact, as the Chief Technology Officer focusing on the life sciences vertical. Jake prides himself in being a biologist by study and a technologist by trade and throughout his career has positioned himself at the intersection of science and technology. 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.
- President and CEO
- LMK Clinical Research Consulting, United States
Sholeh is an internationally known TMF Subject Matter Expert with over 15 successful years of experience in the Clinical Research Industry. Her experience includes the TMF Reference Model Subject Matter Expert, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations, electronic document management, regulatory submissions, quality control processes and implementation and regulatory inspection preparation and participation. She is currently Principal Consultant and President and CEO of LMK Clinical Research. She is also the Facilitator for the Metrics Champion Consortium's (MCC) TMF initiative.
Ron Fitzmartin, PhD, MBA
- Senior Informatics Advisor, Office of the Director, CBER
- FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, 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 the standardized clinical protocol template, 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.
Mark A. Gray
- Senior Project Manager, DSS, 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).
- Chief, Data Standards Program, CBER
- FDA, United States
Ginny is Chief of CBER's Data Standards Program. She has worked in informatics at FDA since 2004, previously serving as Director, Data Management Services and Solutions in OBI/CDER. She was instrumental in developing CDER’s electronic submissions and training program, encompassing eCTD and CDISC Standards and well as the 745A binding guidance. She moved to CBER in 2016 to lead the development of a data standards program within the Center. In this role, she leads a multidisciplinary team that advances standards such as eCTD, SDTM, ADaM, SEND, ICSR, IDMP, LOINC and related terminologies. The team also provides reviewer training and support related to study data submissions.
Joanne S. Malia, MS, MSc
- 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.
- 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 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.).
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
- 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 Degree in Genomics & Computer Science from McGill University.
- Head of Data Management and Regulatory Information Scientist
- Qdossier, Netherlands
Michiel Stam works as a Regulatory Information Scientist and is heading the Data Management group at Qdossier. 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 registration tracking, master data management, XEVMPD and IDMP.
- 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
- Astellas, 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.
Jamie Marie Toth, MS
- Director, Head of TMF Operations
- Daiichi Sankyo, United States
Jamie has over 18 years of IT experience in the pharmaceutical industry. She has been with Daiichi Sankyo, Inc. since 2016 as the Director/Head of TMF Operations. She is a Steering Committee member of the DIA TMF Reference Model Working Group and on the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA). Jamie is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified.
James Riddle, MS
- Vice President, Institutional Services and Strategic Consulting
- Advarra, United States
James Riddle is the VP of Institutional Services & 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.
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).
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.
La Misha Fields, MBA
- IT Program Manager, Electronic Submissions Gateway, OIMT, OC
- FDA, United States
La Misha Fields is the Program Manager of 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 10 years of FDA experience, including 5+ years in the Center for Drugs. She currently manages all activities from initiation of new requirements, development, operations and maintenance of the Gateway.
Richard F Fredericks
- Director, Regulatory Systems and Information Management
- Tesaro, United States
I have been in the life sciences industry for 10+ years operating entirely within the Regulatory Operations space. My career began as a publisher and over the past decade has been gravitating towards the technology and process side of the business. Currently I lead the Regulatory Systems and Information Management group at Tesaro where I am responsible for the RIM systems & associated processes across the organization. Before Tesaro I was at Shire where I held a similar role by providing systems/technical knowledge & support to the Global Regulatory Affairs and Operations teams. Prior to Shire I have worked at several other pharmaceutical/biotech companies including Sunovion, Ariad, Ironwood, Pfizer, Regeneron, Ipsen and Genzyme.
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, 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.
Cheryl Grandinetti, PharmD
- Clinical Pharmacologist, 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.
- VP IRISS Forum
- IRISS Forum, 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.
- Vice President, Advisory
- Kinapse, United States
Michael is the Vice President of US Advisory Services for Kinapse. He has an exceptional combination of life sciences industry and consulting experience. He is focused on offering a wide array of industry-tailored services designed to improve business performance and processes in the areas of clinical operations, manufacturing, regulatory, quality, and supply chain. He has developed both strategic and tactical programs to help organizations define and implement desired changes to their operations environment. He has worked with many of the Top 20 Pharmaceutical, Biotech and Medical Device to achieve transformational change through operations improvement.
Morten Lindaa, MSc
- Consulting Director
- NNIT, Denmark
Morten is an experienced IT professional with 20 years expeirence in the field of IT for Life Sciences. Morten's experience covers more or less every value cycle within Life Sciences from Clinical, Regulatory, Quality, Manufacturing Supply Chain and Commercial. At NNIT, Morten holds the position of Consulting Director, where his primary responsibilities are Client Engagement, Strategy, Services and Partnerships. During the last four years, Morten has lead NNIT's Digital Transformation efforts for Life Sciences, to drive business, data and technology driven services towards value creation for our customers and eventually improved health outcomes for the patients they serve.
Greg John May
- Assistant Director, Regulatory Affairs
- Nabriva Therapeutics, United States
Greg is currently Associate Director Regulatory Affairs at Nabriva Therapeutics and has worked in regulatory affairs for over 16 years with CROs and small/medium size Pharma. Greg specializes in eSubmission projects including the preparation and submission of INDs/BLAs/NDAs. His responsibilities include interacting with global regulatory authorities, implementation of document management systems, and tracking life-cycle submissions.
Eileen E. Navarro Almario, MD, MS, FACP
- Lead Medical Officer, OCS, OTS, CDER
- FDA, United States
Eileen Navarro, MD, FACP serves as lead in the Office of Computational Science which implements regulatory science (tools, standards and analytic approaches) to support a modern regulatory review process.
Matt Neal, MA
- Senior Director, Regulatory Affairs
- Atara Biotherapuetics, 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.
Vada A. Perkins, DrSc, MSc
- Executive Director, Regulatory Policy and Intelligence
- Bayer Pharmaceuticals, United States
Vada A. Perkins, Bayer Pharmaceuticals, Executive Director, Regulatory Policy & Intelligence, Head Regulatory Intelligence- Vada A. Perkins, CAPT (ret) is a former FDA Senior Advisor for Regulatory Science and a recognized global regulatory policy & intelligence expert with regulatory thought leadership in the application of data governance, technology, data standards throughout the product lifecycle . He is active in interactions with national and international stakeholders in promoting technology and innovation (e.g., RWD/RWE) 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.
Cheryl Ann Ressland
- Executive Director, Regulatory Operations
- Daiichi Sankyo, United States
- Practice Director, Trial Master File
- Advanced Clinical, United States
Fran Ross is Practice Director for Trial Master File Practice at Advanced Clinical, driving the implementation and expansion of our document management solutions and TMF consulting offerings. Fran oversees eTMF optimization projects, including conversions, system deployment, migrations, reporting and inspection surety. Fran has over thirty years of industry and academic trial experience including CTMS, QMS, TMF, clinical operations and risk management. Fran is an active member of TMF Reference Model Steering Committee.
- Associate Director, Submission Services, GDM
- Bristol-Myers Squibb Company, United States
Sharon has been with Bristol-Myers Squibb for over 26 years. She has worked in many different roles over the years. She has been in Regulatory Operations for 18 years. She is currently the Associate Director of the Submission Publishers and Publishing Planning for US and EU. She is also on the Outsourcing team for Dossier Publishing where she has worked for 5 years developing procedures and relationships with BMS' vendors to work efficiently and effectively. She most recently converted dossier publishing from a project based process to a central publishing process.
Laura Shelley, RPh, PMP
- Merck & Co., Inc, United States
Laura has 30+ years of experience in the pharmaceutical industry, working largely in Supply Chain Management and Regulatory Affairs. She’s had responsibility for the manufacturing coordination of multiple worldwide new product launches, as well as in-line supply. Most recently, she has been involved with improvements to the submission planning business process to optimize benefits for regulatory, production and marketing stakeholders. In her current role, she is focused on building performance management capabilities within the Regulatory Portfolio and Submission Management group. She holds Bachelor’s Degrees in Biology from LaSalle University and Pharmacy from the Temple University.
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.
Cynthia Boucher, MS
- Clinical Trials Specialist
- National Institutes of Health (NIH), United States
Cynthia is currently a Clinical Trials Specialist at the National Center for Advancing Translational Sciences (NCATS). She was recently on special assignment with the NIH Office of Science Policy working on the NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template, and a related web-based e-protocol writing tool. She has experience in clinical research operations, trial management and oversight. Cynthia holds an M.S. in Biochemistry and Molecular Biology from Georgetown University.
Alex Butler, MBA
- Product Marketing Manager
- MasterControl, United States
Alex Butler is MasterControl’s manager of medical device solutions. He leads the development efforts for MasterControl Registrations. He’s also responsible for developing and/or improving other software solutions, namely MasterControl Customer Complaints, Bill of Materials (BOM), Projects, Risk Management, and PDM Connector. His medical device experience includes working as a product development manager for an orthodontic product manufacturer where he helped launch several Class II medical devices.
Nicholas Drago, MS, RAC
- Associate Director, Regulatory Policy and Intelligence
- Bayer, United States
Nicholas Drago is Associate Director of Regulatory Policy & Intelligence at Bayer Pharmaceuticals. In this role, he leads projects applying data science to support decision making in regulatory affairs and leads several regulatory policy initiatives. Nicholas has 7 years of experience in regulatory affairs. He holds a B.S. in biology from University of Rochester and M.S. in regulatory affairs from Northeastern University.
Dalia El-Sherif, DrSc, PhD
- Pyxa Solutions, United States
Dalia earned a doctorate in Biomedical Science and has over 20 years of experience in the industry. Dalia’s unique background blends entrepreneurship, management consulting and industry in the pharmaceutical, medical device and healthcare industries, delivering innovative solutions in research, operations, strategy and technology. Dalia was top Strategy/Change consultant at PA Consulting & IBM & a top performer at Shire. Dalia is currently a Partner at Pyxa Solutions, her comprehensive background, has positioned her to lead Pyxa’s R&D Consulting and Technology Services.
Vahe Ghahraman, PhD
- Sr. Director
- Apellis Pharma, United States
Vahé has over 17 years of global regulatory operations, project management and regulatory technology experience, with special focus on regulatory information management, publishing and global submissions strategy. Vahé has had various roles at Takeda, Dyax, Millennium, Parexel and Datafarm, and has also been involved in consulting activities. He is currently heading the Global Regulatory Operation at Alexion.
James Hanly, MBA
- Head of IT, Regulatory, Safety and Biometrics
- Bristol Myers Squibb, United States
Jim's passionate about solving business problems with strong teams that get that special mix of people, process, technology & data just right. He's been solving problems at Bristol Myers Squibb for 17 years and a couple years in the US Navy before that. He is the Head of IT for Regulatory, Safety and Biometrics @ BMS. All the details on jobs and degrees are on LinkedIn.
Mickel Hedemand, MSc
- Special Advisor, Medicines Licensing, Workflow
- Danish Medicines Agency, Denmark
Mickel Hedemand is Special Adviser at the Danish Medicines Agency (DKMA) where he has been working for 11 years. He is managing DKMA’s electronic format requirements and procedures for receiving, technically validating, registering and archiving submissions in the medicines regulatory area. This also includes maintaining tools and processes supporting these activities. Among other things he is an active member of EMA’s Human Harmonisation Maintenance Group and has put his footprint on the technical validation criteria and the harmonised eCTD and NeeS guidances. He has an M.Sc. in Engineering and a past history as an IT consultant.
- 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.
Andrea Herrmann, PharmD
- Head of Regulatory Compliance & Regulatory Information Management
- Merck Healthcare 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.
- Chief Information Security Officer
- Johns Hopkins University, United States
Darren Lacey has been serving as Chief Information Security Officer and Director of IT Compliance for Johns Hopkins University and Johns Hopkins Medicine for the past fourteen years. He has been working in the technology sector, as a developer, attorney, consultant and executive for twenty-five years. He was the first Executive Director of the Johns Hopkins University Information Security Institute, a National Security Agency Center of Academic Excellence in Information Assurance. He is a graduate of Baylor and Harvard.
Peter Lassoff, PharmD, RPh
- SENIOR VICE PRESIDENT, HEAD OF REGULATORY
- Syneos Health, United Kingdom
Dr Peter Lassoff Pharm.D., FTOPRA, has over 30 years’ experience within global regulatory affairs and is the Senior VP, Regulatory Affairs, for Syneos Health. Peter has deep domain expertise in regulatory affairs and drug development, and has established and grown businesses in the regulatory outsourcing sector on a global basis. Peter is a Fellow of TOPRA, the professional society for regulatory affairs; is on the Board of Supervisors for the University of Southern California's regulatory affairs programme, and has won a lifetime achievement award for regulatory affairs, the Innovation in Regulatory Science Award at the USC School of Pharmacy.
Fiona Maini, MS
- Principal Global Compliance and Strategy Principal
- Medidata a Dassault Systèmes Company, United Kingdom
As a Medidata Global Compliance and Strategy Principal, Fiona’s focus includes evaluation of GxP relevant regulatory changes coupled with the regulatory aspects of technological advancements and geo-political dynamics impacting the Life Sciences and Healthcare industries, specifically within in the clinical research domain. In this role Fiona regularly interacts with authorities on emerging patient centric technologies. Fiona is currently the Chair of the ACRO Decentralised Clinical Trials Working Party in the EU, focused on the end to end process, technology, data and regulatory frameworks for virtual clinical trials. Fiona is also a member of the EU Alliance on Artificial Intelligence. Prior to Medidata Fiona was a Director at Deloitte,
- Manager, GRAAS Ops Publishing
- Amgen, Inc., United States
Jennifer Moore is a Manager within Amgen’s Global Regulatory and Affairs Operations, located in Thousand Oaks, California. She has been working to bring new M1 eCTD opportunities to Amgen since 2010, when she participated in a pilot project with the PhRMA group EASE (Electronic Advertising Submission Effort) to submit AdPromo pieces in eCTD format to OPDP. Jennifer is now a member of the IRISS AdPromo group, assisting with the creation of best practices and standards for M1 Submissions. She manages Amgen’s AdPromo Publishing team, which now successfully submits promotional materials for 16 marketed products via eCTD.
Leonard Sacks, MD
- Associate Director for Clinical Methodology, Office of Medical Policy, CDER
- FDA, United States
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently as a reviewer at FDA. He is a clinician, board certified in Internal Medicine and Infectious Diseases.
Kristen Sauter, MBA
- Director, Global Regulatory Informatics & Analytics
- Takeda Pharmaceuticals, 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.
- Manager, Regulatory Operations and Submissions
- Inovio Pharmaceuticals, Inc., United States
Ms. Sinsel has a passion for Regulatory that began with her first professional career in Regulatory Affairs at Merck in 2002. She has been with Inovio for 4 years and has embraced the small company atmosphere and the challenges that come with it. Most noteworthy, she, along with her IT colleagues, moved Inovio into the "electronic submissions world’’, as well as in helping others find solutions to do the same. Combining her associate’s degree in Business Administration; paralegal, her bachelor’s degree in Organizational Management and her 15 years of experience in various Regulatory groups, Regulatory Operations is a combination of all.
Cary Smithson, MBA
- Director, Digital Transformation & Management
- Grant Thornton LLP, United States
Cary Smithson is a Director in Grant Thornton's Digital Transformation & Management practice and has over 20 years of experience in life sciences and healthcare leading projects to drive increased productivity, streamline information management and enhance regulatory compliance. Her areas of expertise include regulated content and information management, regulatory information management, eTMF, GxP quality / compliance, IT strategy, business process optimization and project / program management. Cary participates on the DIA RIM and EDM Reference Model working groups and led the development of the DIA GMP Quality Systems Reference Model.
- VP, Global Head of Publishing & Product License Support
- Pfizer, United States
Karen currently serves as VP, Publishing and Product License Support for Pfizer having dedicated 20 years to the global Regulatory Operations arena. Karen is passionate about ensuring optimum quality and efficiency for high end delivery of regulatory submissions and regulatory information custodianship. Karen has led her organization with innovative leading edge strategies to generate new business opportunities and dynamic global operating models ensuring data and cost transparency. Karen earned a BA (Hons) degree in Civil Engineering from Aston University, UK and currently serves on the Board of Directors for IRISS (Implementation of Regulatory Information Submission Standards) Industry forum.
Elizabeth M Turek
- Head, Knowledge Management
- Johnson & Johnson, United States
Beth joined J&J Regulatory Operations in 2015 to design & implement a new regulatory operations organization that serves the needs of the Pharmaceutical, Medical Device & Consumer businesses at J&J. Currently, her group is responsible for optimizing translations, access to Regulatory Requirements, and the optimal use of technology solutions to deliver future state Regulatory capabilities. With >30 years’ experience, 23 years at J&J, Beth has provided regulatory leadership & support for US and global teams for consumer products, medical devices, biologics, and pharmaceuticals.
Mitzi Allred, PhD
- Director, Clinical Operations
- Merck & Co., Inc., United States
Mitzi Allred is a Director at MSD where her focus is on Structured Content Management. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured content reuse to leverage time. quality and efficiency for content within documents . Over the last fifteen years, she has led improvements in electronic documents, structured content management reuse implementations. Mitzi participates in the TransCelerate Clinical Content & Reuse workstream and ICH M11 Working group. Additionally, Mitzi has PhD in engineering and 15 years of experience in Aerospace.
Thomas Christensen, RAC
- Senior Regulatory Affairs Manager
- SynteractHCR, United States
Thomas has 15+ years industry experience in Regulatory Affairs focusing on document management, publishing and submission of applications / authorizations. Managed electronic publishing projects for submission to competent authorities this includes submission life-cycle management and maintenance during approval and post-marketing.
- QA/RA Director, Gas Sensing, Analysis & Delivery
- Maxtec, United States
Lillian is the QA/RA Director at a small life sciences organization which sells product in over 20 countries. She is fortunate to have worked and trained in various industries, from laboratory to software to medical device. In each setting, Lillian has further developed her passion for applying risk-based innovation to the sometimes-complicated field of regulatory compliance. Lillian lives and works in Salt Lake City, Utah.
Stephanie J Hughes
- Regulatory Submissions Management Associate
- Teva Pharmaceuticals Inc., United States
Stephanie currently works for Teva Pharmaceuticals as a Regulatory Submissions Management Associate. She has more than 10 years of experience in regulatory eCTD publishing. This includes publishing NDAs, BLAs and ANDAs. Stephanie has recently lead publishing efforts in both original ANDAs and safety report management. She has also lead projects that have offshored transactional work and has helped standardized submission processes and standards. Stephanie holds a Bachelors of Science from Walden University.
John Kiser, MSc
- Kiser Regulatory Services, United States
25+ years with Abbott/Abbvie in both Pharmaceutical and Nutritional product development. Career has spanned multiple areas within the Information Technology group including support for Nutritionals, Medical Devices and Pharmaceuticals. Within Pharmaceutical R&D responsibilities for the International Scientific and Medical Affairs organizations which included Regulatory Affairs and affiliate support. Transitioned to business operation as the Head of Registration Planning and Operations for International Regulatory Affairs in support of drug registrations in paper and the movement to electronic submissions globally including eCTD and NeeS formats eventually expanding responsibilities as Head, Global Submission Operations.
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.
Harv W Martens
- Technical Expert for JPMA on ICH M2 and M8 Expert Working Groups
- United States
Mr. Martens has over 37 years of experience in information systems development for Life Sciences and has served for over 22 years as a Technical Expert for the JPMA on the ICH (www.ich.org) M2 and M8 Expert Working Groups. Mr. Martens has worked with clients and regulatory agencies in the EU, Japan, Canada and the US in the areas of eSubmission strategy, document and records management, tool and vendor selection, and software integration. He is the co-founder of IRISS (www.iriss-forum.org) and serves on its Steering Committee.
- Director, Process Excellence and Risk Management
- Daiichi Sankyo Inc, United States
Ann E. McCabe Director, Process Excellence & Risk Management Ann McCabe is Director, Process Excellence & Risk Management at Daiichi Sankyo. She has worked in clinical research for over 20 years at various global pharma, biotech, medical device and consulting companies. She has worked in the areas of Clinical Operations, Quality, Process Improvement and Training. She is currently assisting Daiichi Sankyo in the implementation of Risk Based Quality Management (ICH E6 R2), study metrics and various process improvement projects. She has Bachelor’s degrees in Biology and Medical Technology from the University of Delaware.
- Associate Director
- Iperion, Netherlands
Remco Munnik is Associate Director of Iperion Life Sciences Consultancy, with over 20 years of experience in Regulatory Affairs, with a special focus on Global submission procedures, electronic submission (eCTD) and regulatory data management (xEVMPD, ISO IDMP and RIMS). He has worked at both pharmaceutical industry and consultancy. In addition, Remco has been directly involved in the development and roll-out of the EU Telematics environment and has in-depth knowledge of the systems. Remco is member of the EMA ISO IDMP Taskforce Product & Organisation group.
- VP, Product Management
- Phlexglobal, United States
Jim has nearly 20 years’ experience with compliant software solutions for regulated processes in Life Sciences. He's held senior management positions at Liquent, Thomson Reuters, ePharmaSolutions and DitaExchange and holds a Bachelor of Science in Mathematics from The Pennsylvania State University.
- Gxp Authority, United States
Lawrence Rich is a founding partner of the regulatory compliance and information technology consultancy GxP Authority, Inc. and an internationally recognized expert on the regulations that govern electronic records, electronic signatures, electronic submissions, and data privacy in the life sciences industry. During his 28-year career in the life sciences industry, Lawrence has successfully delivered secure, reliable, scalable, and cost-effective information technology and regulatory compliance solutions to scores of biotechnology, medical device, and pharmaceutical companies. Lawrence has undergraduate and graduate degrees in applied mathematics, and is available on a consulting basis across North America, the European Union, and Japan.
Eckart W. Schwarz, MD
- Senior Vice President, Global Regulatory Platforms & Delivery
- GlaxoSmithKline, United States
Dr Eckart Schwarz currently is the Senior Vice President of Global Regulatory Platforms and Delivery, GSK. Eckart originally trained and worked as a physician in the UK, and then in the last 26 years has had roles of increasing seniority in GSK, right across the drug development spectrum, in areas such as Reg. Affairs, Med. Affairs, Marketing, Clinical and Quality Assurance / Compliance. He is based in the US but has lived and worked in Germany, UK, Singapore, India and Belgium.
- Sr. Associate, Global Regulatory Affairs
- Johnson & Johnson Group of Consumer Companies, United States
Kevin Tompkins, MBA, MS
- Group Director, Global Lead, Global Dossier Management
- 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 Solutions before moving to Cephalon. He then managed the North America 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.
Hans van Bruggen, MSc
- CEO and Senior RA Consultant
- Qdossier, Netherlands
Hans van Bruggen 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.
- Pfizer, Inc., United States
Cesar joined Pfizer Regulatory Operations in 2011 leading the US submissions team, in 2013 Cesar was appointed as Submissions Management Head of Dossier Excellence, further expanding his responsibility the following in 2014 by representing Submissions Management as overall NDA/MAA/IRD Business Process Owner across Regulatory Strategy. In 2017, Cesar was appointed as Head of U.S & Canada Submissions Management team. Prior to Pfizer, Cesar began his career in 2000 with Liquent (Paraxel) forming part of a team whom delivered publishing services to a key client out of Northern New Jersey, in 2002 Cesar joined Novartis’ Regulatory Operations team in submissions before moving to Bayer Healthcare in 2007.
David W. Berglund
- Board Member
- IRISS Forum, United States
David Berglund is the Global Head of Regulatory Operations in AstraZeneca/MedImmune. Oversing regulatory & document publishing, registration & submission lifecycle, and dossier management throughout all disciplines, world wide. David has held a number of positions in AstraZeneca, including Program Director for a number of change programs in the regulatory information space. Currenly based in Gaithersburg Maryland, USA, and previously worked in United Kingdom and Sweden. David holds a BSc in Computer Artificial Intelligege from the University of Uppsala, Sweden.
Valerie Marie Gooding
- 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.
Christina Mantzioros , MS
- Clinical Solutions Specialist
- Montrium, Inc., Canada
Christina Mantzioros holds a Master of Science degree in Pharmaceutical Sciences from the University of Montreal. Christina has worked for both academic and contract research organizations in the setup and management of international, complex clinical trials in different therapeutic areas. She brings important industry and clinical research experience to Montrium, facilitating the expansion and innovation of Montrium’s Electronic Content Management platform. She has recently become involved in a subgroup of the TMF Reference Model Project Team working towards the development of a standard mechanism for eTMF exchange.
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 nine years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.
Jean M. Mulinde, MD
- Policy Advisor, Division of Clinical Compliance Evaluation, OSI, OC, CDER
- FDA, United States
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in OND. She received her M.D. and completed a residency in Internal Medicine at the University Of South Alabama School Of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine.
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