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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 7:00 PM - Feb 13, 2019 8:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum


Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences , Orion Innovation, United States

V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience. Prior to Orion, Bala was the President and CEO of Cabeus, a niche Life Sciences services firm where he was also responsible for vision and strategy for a cloud platform called ReALM® to transform the regulatory value chain for Life Sciences. Bala developed IT strategies and capabilities for 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

Brooke Casselberry, MS, RAC

Vice President, Consulting Services, Epista Life Sciences, United States

Brooke Casselberry is a leading Life Sciences consultant working with Life Sciences Organizations and Health Authorities to educate, develop, and deploy technologies as accelerators to regulatory initiatives. She has been awarded PharmaVoice top 100 of the most inspiring people, DIA's Excellence in Service award, and she has published a number of articles and public presentations on regulatory operations topics. Brooke is a programming chair for DIA Global Annual Meeting with the Data and Technology track and as well as the co-chair of the DIA Regulatory Affairs Community.

Ethan  Chen, MBA, MS, PMP

Ethan Chen, MBA, MS, PMP

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 several critical initiatives as the CDER Informatics Architect, including Data Management, Analytics and Business Intelligence, Electronic Submission and Portal Collaboration programs. Ethan has over 20-years’ experience in Data Management, Enterprise Architecture, Solution Development and System Integration.

Cindy  Chiu

Cindy Chiu

Senior Director, Regulatory Affairs Operations and Quality Management, Merck & Co., Inc., United States

Cindy Chiu is a Senior 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 Lead of the Regulatory Content Authoring and Archiving Management group. 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.

Jake  Doran

Jake Doran

Head of Digital, Lykos Therapeutics, United States

Jake Doran is currently the Head of Digital @ MAPS Public Benefit Corporation. In this role, Jake is responsible for overseeing the development and implementation of the digital and IT strategy as the MPBC organization transitions from a clinical research startup to a commercial entity and industry pioneer. Prior to joining MPBC, Jake was the Head of Global R&D IT at Bausch Health. 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 Genpact, Janssen Pharmaceuticals and Schering Plough.

Betsy  Fallen, RN

Betsy Fallen, RN

Consultant, 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

Mark A. Gray

Senior Project Manager, DSB, 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 30 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; Director, Division of Data Management Services & Solutions managing CDER’s electronic submission program, and ICH M8 (eCTD) Rapporteur. Mark has been with CBER's data standards group since 2014, and his current responsibilities include representing CBER in the development and implementation of international electronic submission standards.

Joanne  Malia, MS, MSc

Joanne Malia, MS, MSc

Director, Development Records Management, Regeneron Pharmaceuticals, United States

Joanne Malia is Director, Development Records Management at Regeneron Pharmaceuticals and responsible for the TMF group and Clinical Archives and is the Business Process Owner for the eTMF. Throughout her 25+ year career in life sciences she has worked for diagnostic, biotech, pharmaceutical companies and CROs. She serves on the CDISC TMF Reference Model Steering Committee, on the organizing committee for DIA’s Regulatory Information Document Submission Meeting and presents frequently at industry conferences.

Karen  McCarthy Schau

Karen McCarthy Schau

Director, Risk-based Study Management, Vertex Pharmaceuticals, United States

Clinical Research/Clinical Management Professional with 24 years diversified experience across functional areas and global regions with current focus in Clinical Operations Risk-based Quality Management business process improvement and eClinical Systems deployment. Career includes greater than 9 years specializing in process reengineering and eClinical system implementation for a large global CRO and 6 years helping companies deploy solutions to streamline processes, improve productivity and operational efficiency, and better manage information across CTMS, eTMF, Risk-Based Quality Management (RBQM), Investigator Portal, CRO Engagement and Clinical Architecture.

Thomas  Noto

Thomas 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

Sarah Powell, RAC

President, 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 23 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, and PAREXEL

T.J.  Sharpe, PMP

T.J. Sharpe, PMP

Patient Engagement Program Manager , Medidata Solutions, United States

T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in his Patient #1 Blog.  He was diagnosed in August 2012 with metastatic melanoma, weeks after his second child was born. He has undergone six surgeries and four immunotherapy treatments over two different clinical trials.  The initial failures and subsequent complete response were chronicled in his blog. He is now a writer, keynote speaker, and consultant in the biopharma and clinical research industries, working as a patient advisor for major healthcare-related companies and TransCelerate. He brings an educated patient voice as an equitable stakeholder in drug development while challenging the healthcare status quo via his company, Starfish Harbor LLC.

Michiel  Stam

Michiel Stam

Director Regulatory Information Management, Qdossier - A Celegence Company, United Kingdom

Michiel has 15 years of experience in Regulatory Affairs and Information Management. He provides strategic direction and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions. His focus goes beyond compliance, Michiel specializes in unlocking the true value of an organization’s data – whilst taking advantage of initiatives such as XEVMPD, IDMP and SPOR. Through the alignment of people, cross-functional processes, and tools, he has enabled efficient and sustainable data quality for a wide range of customers.

Stacy  Tegan

Stacy Tegan

Program Director, Transcelerate Biopharma, Inc., United States

Stacy Tegan is a Program Director 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

Peter Terbeek, MBA

Senior Director, Regulatory Operations, 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 submission 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

Kevin Tompkins, MBA

Executive Director, Regulatory Information & Submission Management, Bristol Myers Squibb, United States

Kevin Tompkins is the Executive Director, Regulatory Information and Submission Management at Bristol Myers Squibb. He joined BMS in 2018 and has over 20 years of experience in different roles leading regulatory operations teams. In his current role, Kevin is responsible for the strategic direction and delivery of regulatory submissions, product data, and regulatory systems for BMS. He holds a B.S. in Information Systems and a M.B.A. from LaSalle University.

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States

Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, 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.

Daniel  Orfe, MS

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.).

Norman  Schmuff, PhD

Norman Schmuff, PhD

Associate Director for Science, OPMA, OPQ, 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 was 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. He has never served time in prison.

Katherine  Dubrow

Katherine Dubrow

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

David Gwyn, MBA

VP, Business Consulting Services, fme US, United States

With more than 25 years of experience in the Life Sciences industry, David is a seasoned executive with extensive experience delivering solutions to customers, with a particular focus in the areas of regulatory information management (RIM), content management and collaboration. His main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite and ensure that the solution meets the needs of the customer. David also leads the DIA EDM Submission Reference Model team that developed a document architecture for use when designing and building content management solutions.

Jared  Lantzy, PMP

Jared Lantzy, PMP

Lead Associate, Booz Allen Hamilton, United States

Jared Lantzy, PMP, is a Lead Associate in Booz Allen Hamilton's Civilian Services Group. His expertise is in the development, implementation, and maintenance of data standards for the life sciences. Mr. Lantzy is a former member of the FDA CDER electronic submission support team (eSUB team) and is a former employee of a leading electronic submission tool vendor.

Fred  Wood, PhD, MS

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.

Amber  Hartley

Amber Hartley

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.

Venkat  Kodumudi

Venkat Kodumudi

Director, Innovation and Outreach , CGI Federal, Inc., United States

Meredith K. Chuk, MD, MHS

Meredith K. Chuk, MD, MHS

Acting Associate Director for Safety, OOD, OND, CDER, FDA, United States

Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Oncologic Diseases in OND/CDER at the FDA.

Suranjan  De, MBA, MS

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 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

Karin Schneider, MLIS, MS

Associate Director, Johnson & Johnson Innovative Medicines, United States

German citizen, who worked in Switzerland and now lives in the US. I have been in the Pharmaceutical Industry for my entire career. I looked at Content Management from many different angles: Information broker, information architect, solution engineer and end user in various business domains and regions. The time is now to prepare for fundamental change in RIM. We have done Document and Data Management in silos for decades. The past couple of years AI dominated the solution space with various success. It is time to fundamentally rethink how we work with content and design business centric solutions that actually deliver desired results. I love conversations with disruptive thinkers, walking my dog and training in the local circus schoo

Hans  van Bruggen, MSc

Hans van Bruggen, MSc

CSO, Qdossier, a Celegence Company, Netherlands

Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans 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. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.

Craig  Anderson

Craig Anderson

Director, R&D Lead, International Labeling Group, Pfizer Inc , Canada

Craig is responsible for leading regulatory informatics projects like the implementation of the Structured Product Labeling (SPL) standard; development of health informatics policy and IT modernization.

Danielle  Beaulieu, PhD

Danielle Beaulieu, PhD

Senior Director, 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 began managing BMS’s home grown RIM Solution. She also envisioned, helped develop and instituted a Data Quality program. In 2014 BMS began the work to replace their older RIM solution with a new authoritative source for RIM. Danielle was been the Business lead for that effort, from process definition and simplification to configuration and roll out, and she is now the head of the Business Capabilities group for regulatory at BMS.

Sandra  Brown Stephens, MBA

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

Ta-Jen Chen, MS

Project Management Officer, OSP, CDER, FDA, United States

Mr. Chen is a project management Officer at Office of Strategic Programs, CDER, US Food and Drug Administration, where he is responsible for the development and implementation of electronic data standards for CDER regulatory review. As an 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, ISO/HL7 ICSR message standard, and the ISO IDMP standards. TJ has more than 30 years of experience in program management and various data standards and message standards areas. He worked for a pharmaceutical company before join FDA in 2005.

Scott  Cleve

Scott Cleve

Vice President Regulatory Operations Information and Compliance, Daiichi Sankyo, United States

Scott Cleve is currently the Vice president of Regulatory Operations and Compliance at bluebird bio where he leads a team responsible for building and executing publishing, project management, RIM, and compliance activities to support the regulatory organization. In his career he previously led Regulatory Operations teams at Boehringer Ingelheim, AbbVie and Astellas. Scott’s focus is on developing his team, investigating technology to improve process and compliance, and partnering within industry and vendors to improve standards, process and technology.

Brooke Leslie Czapkowski, MBA

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.

Laurie  Henricks

Laurie Henricks

Sr Director, Regulatory Operations, Arena Pharmaceuticals, Inc., United States

John V Janick

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

Ken Keefer, MBA, PMP

Principle Consultant, Keefer Consulting Inc Visa, United States

Ken Keefer, MBA, is founder of Keefer Consulting Inc., dedicated to helping biopharmaceutical companies solve business problems through information technology. He has worked with clients including Pfizer, Merck, and GSK in transforming R&D and commercial business processes. He managed the review of the eTMF Exchange Mechanism Standard (eTMF-EMS), Version 1.0, for the TMF Reference Model Group, an initiative under the auspices of DIA. (eTMF-EMS is a common standard for exchanging trial master file documents between systems.) He holds an 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

Venugopal Mallarapu, MS

Senior Director and Global Head of Life Sciences R&D, Cognizant, United States

Venu Mallarapu is a leading industry expert in Life Sciences R&D. In his current role he is working as global market lead for Cognizant Life Sciences R&D technology consulting services. He spent the past 20 years in providing business and technology strategies to transform Clinical, Regulatory Affairs, Safety & PV. He is actively working in helping the industry in adoption of Decentralized Clinical Trails, building technology to drive Digital Medicine, implement platforms to drive end-to-end transformation in Safety & PV and Regulatory Affairs and develop solutions to adopt disruptive technologies like AI, ML, NLP and Blockchain in Life Sciences R&D.

Sue  Metz

Sue Metz

President/CEO, IRISS Forum, United States

Sue Metz currently works for parexel as Vice President Regulatory Product Management, and is a subject matter expert with hands on experience in RIM, XEVMPD, and IDMP. Sue has over 30 years of experience defining and designing software, processes, and services in the life sciences industry. She is a standing member of the EU ISO IDMP Task Force and the Product sub-group, the US TAG ISO/TC 215/WG6 and is the President/CEO of the IRISS Forum.

Remco  Munnik

Remco Munnik

President, IRISS Forum, Spain

Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP. Remco is Chair of Medicines for Europe Telematics group; and President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals.

Matt  Neal, MA

Matt Neal, MA

Senior Director, Regulatory Affairs Operations, Atara Biotherapuetics, United States

Matt Neal is an author and frequent keynote speaker. He joined Atara Biotherapeutics in 2019 as the Head of Regulatory Operations. Prior to that, Matt was the Head of Product Management for the InSight Suite of Regulatory Information Management Solutions at Parexel, Inc. and partnered with Microsoft. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. (2003-2016) and was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline (1996-2003). Matt has been publishing and submitting electronic dossiers to the FDA since 1996, and submitted the very first fully electronic NDA for GSK in 1999.

Timm  Pauli

Timm Pauli

Head of Regulatory Operations, PharmaLex , United States

Vada  Perkins, DrSc, MSc

Vada Perkins, DrSc, MSc

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer-Ingelheim, United States

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal products worldwide. He received his degrees from Johns Hopkins University, University of Southern California, and the University of Maryland.

Jonathan  Resnick, PMP

Jonathan Resnick, PMP

Project Management Officer, OBI, OSP, CDER, FDA, United States

Jonathan Resnick is a member of CDER’s Division of Data Management Services and Solutions, with a focus on eCTD and has been with FDA for 13 years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

James  Riddle

James Riddle

Senior Vice President, Global Review Operations, Advarra, United States

JJames Riddle is the Senior Vice President of Global Review Operations at Advarra, the world’s largest provider of ethics, safety, and compliance oversight reviews services. With 25+ years’ experience providing support to the clinical research community, Riddle has operational responsibility for Advarra’s global review services including IRB, IBC, DMC, EAC. In this role, he helps sponsors, CROs, and research sites advance clinical research with a mission to improve human health. Riddle is a regular speaker at industry events and has written abundantly on research compliance and efficiency topics. He is also a member of CTTI, NWABR, SASI, and PRIM&R.

Sandra  Sanford, MSN, RN

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

Lena Shafir, MD

Senior Consultant, Veeva Systems, 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.

Chester  Shemanski

Chester Shemanski

VP 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.

Robin  Zumbrunnen

Robin Zumbrunnen

Sr Manager, Arena Pharm., 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

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

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

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

Jillian E. Carinci, MS

Senior Director, Head of Submission Sciences, Biogen, United States

Jillian Carinci is Sr. Director, Head of Submission Sciences 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

Amy Cheung, MBA

Principal, Deloitte, United States

Amy Cheung is a Principal in Deloitte Consulting’s Life Sciences practice specializing in R&D. Amy has over 15 years’ consulting experience in the pharmaceutical industry. She worked for Merck as a researcher in chemistry prior to receiving her MBA. At Deloitte, she worked with clients to develop and implement options for productivity improvements and cost reduction; design and implement new operating models, governance and organizational structures. Her other experiences include development an outsourcing strategy, implementation of a clinical sample management strategy to enable biomarker research, and redesign of preclinical and clinical processes to improve quality and compliance.

Christina  Frey

Christina Frey

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

Teresa Genthe, MS

Vice President, Regulatory Solutions, Genpact, 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

Mark Gregorio, MSN

, 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.

Kelly  Hnat

Kelly Hnat

Principal, K2 Consulting/Gens & Associates, United States

Kelly is a recognized industry leader in RIM and IDMP with 30 years in the pharma industry, the last 17 focused on Regulatory Affairs. She currently 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. Kelly is part of the Gens & Associates World Class RIM core reasearch team, has been actively involved in the EU implementation of IDMP as a member of the SPOR Task Force and its PMS subteam, and currently the President of IRISS Forum.

LaTarsha  Jones, MSc

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

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

Raymond Nomizu, JD

CEO, CRIO, United States

Raymond Nomizu is the co-founder and CEO of CRIO, an e-clinical provider for sponsors, CROs and sites. CRIO's system 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 both independently and as a principal for The Boston Consulting Group. He has over 10 years of experience consulting senior management across multiple industries on issues of business strategy and process improvement. Raymond has AB and JD degrees from Harvard University.

Marie  Parrish, PhD, MS

Marie Parrish, PhD, MS

, SPARC, United States

Lena  Rampula

Lena Rampula

Technical Leae EMEA - Pre Sales,, 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.

Nishchal  Sehgal

Nishchal Sehgal

Senior Vice President, Life Sciences, Orion, United States

Meredith K Sewell

Meredith K Sewell

Vice President, Regulatory Operations, Sarepta Therapeutics, United States

Meredith Sewell is Sarepta’s Executive Director of Global Regulatory Operations, heading up the RIM and Submissions space. Meredith joined the company in 2019, and is enjoying working at a smaller, rare disease, gene therapy company after 14 years in Reg Ops at Allergan, and prior to that, Amgen Inc.

Frits  Stulp, MSc

Frits Stulp, MSc

Managing Director, Iperion Life Sciences Consultancy, Netherlands

Frits Stulp is Managing Director of Iperion a Deloitte business, 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 in the EU-SRS project for the Medicines Evaluation Board / European Medicines Agency as part of SPOR landscape. Frits is also Chariman of the Board of CTADHL, involved in Transatlantic adoption of IDMP ( Regarded as an SME on IDMP, he gladly shares his gained knowledge and experience in various occasions around the globe.

David  Warner

David Warner

Subject Matter Expert, Generis Knowledge Management, 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.

Robert  Connelly, MBA

Robert Connelly, MBA

Senior Director, Global Regulatory Operations, Incyte, 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

Heather Fisher, MS

Director, 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.

Marc  Gabriel

Marc Gabriel

Vice President, 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

Steve Gens, MS

Managing Partner, Gens & Associates Inc., United States

Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., a global Life Science benchmarking and advisory firm specializing in performance improvement, strategy, industry analysis, benchmarking and organizational transition. His early career was spent at Johnson & Johnson in a variety of management positions and then transitioned to consulting where he lead global Life Science 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.

Valerie Marie Gooding

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.

Cheryl  Grandinetti, PharmD

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.

Andrea  Herrmann, PharmD

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.

Sandra  Krogulski, MA

Sandra Krogulski, MA

Director, GRSO Innovation and Business Operations Lead, Bristol-Myers Squibb Company, United States

Sandy Krogulski is an experienced and solution oriented individual with over 10 years of submission experience. Sandy joined BMS in 2018, working on global submissions and process evolution. In her current role, Sandy is focusing on digitalization and automation of processes to improve submission strategy and business operations.

Fran  Ross

Fran Ross

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.

Lisa  Scott

Lisa Scott

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.

Michael  Tucker

Michael Tucker

, Medidata, a Dassault Systèmes Company, 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!

Ginny  Hussong

Ginny Hussong

Branch Chief, Data Standards, CBER, FDA, United States

Ginny serves as Chief of CBER's Data Standards Branch, where she leads a multidisciplinary team that advances standards such as eCTD, CDISC, IDMP, ICSR, SPL and related terminologies. In addition, conducts technical validation of clinical study data, leads related reviewer training, and industry outreach. She is co-Chair of the FDA Data Standards Advisory Board and FDA Topic Lead for the ICH M2 Electronic Standards EWG. Ginny has worked in informatics at FDA since 2004, previously serving as Director, Data Management Services and Solutions in OBI/CDER. She developed CDER’s electronic submissions and reviewer training program, encompassing eCTD and CDISC Standards and well as contributing to the 745A binding guidances.

Wei (Lisa)  Lin, MBA, PMP

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.

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