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Regulatory Submissions, Information, and Document Management Forum

Don’t miss the latest conversations in RIM, EDM, and ERS! Join your industry colleagues and regulatory thought leaders and register for the Regulatory Submissions, Information, and Document Management Forum.


Speakers

  • Venkatraman  Balasubramanian, PhD, MBA

    Venkatraman Balasubramanian, PhD, MBA

    • Senior Vice President and Global Head, Healthcare and Life Sciences
    • Orion Innovation, United States

    V. “Bala” Balasubramanian is Senior Vice President and Global Head for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services company. With over three decades of IT experience, Bala is a thought leader on digital transformation. 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 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.

  • Sheila  Mahoney Jewels, MBA

    Sheila Mahoney Jewels, MBA

    • Small Business Innovation and Aggregator Advocate
    • LifeSciHub , United States

    Life sciences R&D Ecosystem Expert, Independent Small Business and Workforce Advocate, Software Platform Developer and Investor. Focus areas include: Regulatory and Clinical Operations, Strategic Patient Engagement, CMC, Real World Evidence, Pharmacovigilance, and Biometrics, Medical Affairs, Market Research, Medical Writing, Data Management, Discovery, Toxicology, Pharmacometrics and Pharmacology, and all of the technology that enables these functional areas, others. Actively creating crypto for organizations in the form of LifeSciHub, a nascent Decentralized Autonomous Organization. Exactly how crypto has upended traditional currency in incredible ways, DAO is a new way that groups can create value outside of hierarchical structure.

  • 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.

  • Ashley  Brown

    Ashley Brown

    • Senior Submission Coordinator, Regulatory Operations
    • Accenture, United States

  • Brooke  Casselberry, MS, RAC

    Brooke Casselberry, MS, RAC

    • Associate Vice President, US Life Sciences Advisory and Consulting
    • NNIT, Inc., United States

    Brooke Casselberry is Associate Vice President of NNIT Inc, leading the US Life Sciences Advisory and Consulting team consisting of Clinical, Regulatory, Digital Technology, Training/OCM, and Program Management. Brooke is programming chair for DIA US Annual Meeting with the Data and Technology track and she has worked with bio-pharma sponsor organizations for nearly 20 years leading business domain development.

  • Michelle L. Charles, MPH

    Michelle L. Charles, MPH

    • Director, Regulatory Affairs, Gene Therapy Program
    • University of Pennsylvania, Perelman School of Medicine, United States

    Michelle Charles, MPH is the Director of Regulatory Affairs in the Gene Therapy Program at the University of Pennsylvania, Perelman School of Medicine, providing guidance on global regulations, submission support and strategic regulatory planning. She co-chairs the DIA RSIDM Conference and has participated as a committee member for several years. Before joining the University of Pennsylvania’s Gene Therapy Program Michelle held multiple positions at both Merck & Co., Inc. and PAREXEL International. During her time in industry Michelle focused on regulatory operations, project management and business process development for global regulatory information management. Michelle holds a Masters of Public from Johns Hopkins University.

  • Ethan  Chen, MBA

    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 several critical initiatives as the CDER Informatics Architect, including Data Management and Business Intelligence programs. While leading the CDER Division of Data Management Service and Solution, Ethan had successfully implemented the eCTD electronic submission mandate in 2017 for NDAs, BLAs and ANDAs, and again in 2018 for Commercial INDs and DMFs (excluding DMF Type III). 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 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.

  • Ron  Fitzmartin, PhD, MBA

    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

    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 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; 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).

  • Virginia  Hussong

    Virginia Hussong

    • Chief, Data Standards Program, CBER
    • FDA, United States

    Ginny serves as Chief of CBER's Data Standards Program, where she leads a multidisciplinary team that advances standards such as eCTD, SDTM, ADaM, SEND, ICSR, IDMP, SPL and related terminologies. In addition, the team leads reviewer training and support related to the review of study data. She serves as co-Chair of the FDA Data Standards Advisory Board and is 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.

  • Barbara  Lopez Kunz, MBA, MS, MSc

    Barbara Lopez Kunz, MBA, MS, MSc

    • Global Chief Executive
    • DIA, United States

    Barbara Lopez Kunz serves as President and Global Chief Executive of DIA, driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. She previously served as President of Health and Life Sciences at Battelle, one of the world’s largest, most respected R&D organizations. She has also served as Senior Vice President/General Manager for Thermo Fisher Scientific’s Biosciences Division, as SVP for DuPont, and head of R&D for ICI. A dedicated volunteer for children's health, Barbara chairs the board of Children's National Research Institute, serves as advisor to the UC I4H Fellowship, and as Director for Aptevo Therapeutics.

  • Joanne  Malia, MS, MSc

    Joanne Malia, MS, MSc

    • Director, Clinical Documentation Management
    • Regeneron Pharmaceuticals, United States

    Joanne Malia is Director, Clinical Documentation 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 as co-lead of the Change Control Board for the TMF Reference Model group, 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, Global Clinical Operations
    • Vertex Pharmaceuticals, United States

    Clinical Research/Clinical Management Professional with 23 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.

  • 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.

  • 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.

  • 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.).

  • Michiel  Stam

    Michiel Stam

    • Head of Data Management and Regulatory Information Scientist
    • Qdossier, Netherlands

    Michiel Stam is heading the Data Management group at Qdossier and works as a Regulatory Information Scientist. 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 product and registration data management, master data management and IDMP.

  • Stacy  Tegan

    Stacy Tegan

    • Associate Director, Program Management
    • 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
    • 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 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

    • Senior Director, Global Submission Management
    • Bristol-Myers Squibb Company, United States

    Kevin Tompkins is a Senior Director in Global Submission Management 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 Inc. He then managed the North America Submissions Management group at Teva Pharmaceuticals before joining BMS. Kevin has over 18 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

    Hans van Bruggen, MSc

    • CEO and Senior RA Consultant
    • Qdossier, 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.

  • 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.

  • Michael  Agard, MS, RPh

    Michael Agard, MS, RPh

    • Team Leader, Clinical Consulting US
    • NNIT, United States

    Michael joined NNIT in 2021 and is managing the US clinical consultants at NNIT. Michael works with clients to improve their clinical operations compliance and operational efficiency. He is working to increase the agility and automation of clinical processes with several clients. Michael has worked at CGI, Paragon Solutions and Sanofi-Aventis prior to joining NNIT. He has experience in Clinical Operations, Data Management, and Clinical Supply Operations. Michael has a Masters in Leadership Development and a BS in Pharmacy.

  • Joel  Alvarez, MS, MSc

    Joel Alvarez, MS, MSc

    • Global Regulatory Compliance, Operations and Labeling Leader
    • Bill & Melinda Gates Medical Research Institute, United States

    With over 20 years in the biopharmaceutical industry and extensive experience in global submissions and document management, Joel has played an active role in large and small organizations providing strategic vision and leadership in the implementation of regulatory systems. Most recently, Joel implemented EDMS/RIM solutions at the Bill & Melinda Gates MRI and Takeda Vaccines. He has successfully managed initial marketing applications for simultaneous global submissions and has been responsible for over 950 lifecycle regulatory filings annually. He is an industry thought leader in the areas of regulatory intelligence, process design, and emerging trends and technologies. Joel holds a BSc in Computer Science and a MSc in Regulatory Affairs.

  • Craig  Anderson

    Craig Anderson

    • Sr Expert, Program Development
    • Health Canada, Canada

    Craig Anderson is a Senior Expert, Program Development in the Transformation and Business Informatics Division at Health 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.

  • Adam  Bone

    Adam Bone

    • Senior Specialist, Regulatory Affairs
    • United States

    Adam Bone has spent over 20 years in the Pharmaceutical industry. He has worked for 4 companies during that time, with the last 13 years being at Merck. He is the Subject Matter Expert for Merck's Outsourced Documents and Vendors. He plays tennis at a high level and loves the Red Sox. Adam has a Bachelor's Degree in Criminal Justice. Hopefully the audience for this Program will enjoy the presentation as much as Adam enjoys winning the crowd over.

  • Meredith K. Chuk, MD, MHS

    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.

  • Vivian  Combs, MS

    Vivian Combs, MS

    • Advisor/Process Owner, Clinical Systems and Supply Planning
    • Eli Lilly and Company, United States

    Vivian Combs currently leads the TransCelerate workstream responsible for the development of the TransCelerate Clinical Template Suite. She is the rapporteur for the ICH M11 CESHarP (Clinical Electronic Structured Harmonized Protocol) Expert Working Group, and is a full-time Process Owner within Eli Lilly and Company's Clinical Systems and Supply Planning organization, where she is focused on medical writing, content reuse, and automation.

  • Lina  Cong, MS

    Lina Cong, MS

    • FDA, United States

  • Robert  DiCicco, PharmD

    Robert DiCicco, PharmD

    • Vice President, Portfolio Management
    • TransCelerate Biopharma, United States

    Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. Rob joined TransCelerate from IBM Watson Health where he was the Deputy Chief Health Officer. At IBM he worked closely with software designers and developers to inform product roadmaps. Rob also conducted research to assess the performance of solutions applied in the e-clinical environment. Prior to joining IBM, Rob had a long career with GlaxoSmithKline where he served in a variety of leadership positions. Rob received his Doctor of Pharmacy Degree from the University of the Sciences in Philadelphia. His areas of expertise and interest include clinical trial design, clinical operations, protocol quality, and ethics in research.

  • Kelsey  Edwards, MS

    Kelsey Edwards, MS

    • Manager, Regulatory Information Management
    • Vertex Pharmaceuticals Incorporated, United States

    Kelsey is the business lead for Vault RIM at Vertex capitalizing on 10+ years across a spectrum of interrelated functions within the biotech environment. Her professional dedication to ensuring the accuracy of data & details and making it available for colleagues & management to support corporate directives & goals is creating for Vertex cutting edge regulatory knowledge on-demand. She is a visionary and innovator, while recognizing that the fundamentals of solid execution of systems and processes, measured by key performance indicators creates a repeatable, sustainable and successful departmental function. Her excitement for Vault RIM is the near-future solution for a decades long lack of integration between regulatory and quality.

  • Laurie  Henricks

    Laurie Henricks

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

  • Christina  Kim

    Christina Kim

    • Director, Vault RIM
    • Veeva Systems, United States

    Christina Kim started her Life Sciences career over 15 years ago as a submission publisher, managing some of the first eCTD submissions to FDA. Her experience led her to eCTD consulting, with a strong focus on advising Sponsors on eSubmission software evaluations. After moving over to Study Start Up and a short stint in pharmacovigilance, Christina returned to the world of regulatory affairs and operations, where her passion firmly lies. As part of the Veeva strategy team, she contributes to the global strategy and customer success efforts for the Vault RIM Community.

  • Paul  Miller, MBA

    Paul Miller, MBA

    • Senior Director, Regulatory Technology, Operations and Filing Excellence
    • Alnylam Pharmaceuticals, United States

  • Chris  Mureithi

    Chris Mureithi

    • Manager, Regulatory Implementation (RIM)
    • Parexel, United States

    Experienced Regulatory Information Management systems (RIM) professional, with a demonstrated history working in the medical device and pharmaceutical industry. Eighteen years of experience, skilled in business processes harmonization, system integrations, system design, system analysis, creation and execution of system test scripts, training, support and deployment of global RIM systems.

  • Marina  Nisenzon, MS

    Marina Nisenzon, MS

    • Regulatory Affairs
    • Merck, United States

    Marina has over fifteen years of experience implementing system and process solutions at leading life sciences companies. Marina joins Merck from Accenture (legacy Octagon Solutions), where she worked as a Process Consultant in the Life Sciences group. As part of that team she led document management and submission tool implementations for tools such as Veeva Vault RIM, FirstDocs R&D and Q&M, and Insight Publisher. In additional to system implementations, Marina’s projects have included global content migrations as well as e-submission global process and standards evaluations and implementations. Her projects have supported companies such as Teva, Cephalon, Sanofi, Vertex, Baxter, Alcon, and TransCelerate. Prior to joining the process c

  • Jamie  O'Keefe

    Jamie O'Keefe

    • VP, Business & Technology Consulting
    • Just in Time GCP, United States

    Mr. O’Keefe has over 15 years of R&D management and IT consulting expertise, working with both top tier pharmaceutical firms, and early stage biotechs. Prior to joining Just in Time GCP as Vice President of Business & Technology Consulting, he established and led the R&D Consulting Solutions practice for Paragon Solutions/CGI Life Sciences, where he focused on helping drive adoption of business capabilities such as: submissions management and archiving; IDMP; electronic management of Trial Master Files and investigator interactions; and defining and implementing risk-based monitoring programs. He has over 20 years of business and IT consulting experience, with the past 15 years focused in life sciences clinical and R&D.

  • Donald  Palmer, MA

    Donald Palmer, MA

    • Senior Regulatory Affairs Director; Business & Technology Transformation
    • IQVIA, Inc., United States

    As the Senior Regulatory Affairs Director for Business & Technology Transformation, Donald works with the Global Regulatory Affairs (GRA) team at IQVIA to add and update technology solutions to the business processes. His experience bridges the business and technology divide that spans Regulatory submissions, document management, and Regulatory Information Management, especially as they integrate with other departments and systems. Having worked in several organizations of different sizes, he provides perspectives from sponsors, vendors and now CROs. He is a strong proponent of standards and data governance. With a BA and MA in Mathematics, Donald has over 20 years experience in the industry.

  • Wanda  Rosado

    Wanda Rosado

    • Global Regulatory Information Management Lead
    • Bristol Myers-Squibb, United States

    Wanda Rosado is the Global Lead of RIM Services at Bristol-Myers Squibb. Her group maintains the regulatory database with product information, tracking activity from the planning stages through submission/ approvals and country level implementation. Wanda's pharmaceutical career spans 30 years. She's held positions in Regulatory Operations and as an IT Business Partner facilitating strategic projects, driving process improvements and supporting change management. Wanda is a Lean Six Sigma Black Belt and has a B.S. degree in Biomedical Computer Science from Rochester Institute of Technology

  • Kristen  Sauter, MBA

    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.

  • Adair  Turner, MSc, RAC

    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.

  • Vyvyca  Walker, PhD, MS

    Vyvyca Walker, PhD, MS

    • Scientific Communicatons Consultant
    • Eli Lilly and Company, United States

    Vyvyca is a scientific communications consultant at Eli Lilly and Company (Lilly). For the last 2 years, she’s been involved in the implementation of structured authoring at Lilly. Prior to joining Lilly, Vyvyca completed 2 years of postdoctoral training at the University of Alabama at Birmingham (UAB) in Birmingham, AL. At UAB, she was a scholar in the joint NIH and NIGMS funded Mentored Experiences in Research, Instruction, and Teaching (MERIT) Program. In the MERIT Program, she gained research experience at the UAB and teaching experience at nearby colleges. Vyvyca earned her PhD in Pharmacology from the University of Michigan in Ann Arbor, MI. She earned her BS and MS in Chemistry from Jackson State University in Jackson, MS.

  • Ray  Wang, MBA, MS

    Ray Wang, MBA, MS

    • Data Standards Program Lead, OSP, CDER
    • FDA, United States

    Ray Wang, MS, MBA leads the Data Standards Team within CDER’s Office of Strategic Programs. He is responsible for managing CDER’s Data Standards Program portfolio that covers a spectrum of projects that include Study Data, Product Quality Data, Postmarket Data standards development & implementation, Real-World Data initiatives, as well as standards-related policies and rulemaking activities with an aim to drive greater consistency and efficiency in submission data for regulatory review. Mr. Wang has a M.S in Technology Management, and an MBA from University of Maryland.

  • Olga  Alfieri, MBA, MSc, RAC

    Olga Alfieri, MBA, MSc, RAC

    • Director, Global Submission Management
    • Eisai Pharmaceuticals, United States

    Olga Alfieri is the Director of Global Submissions Management at Eisai with over 25 years of Global Regulatory Operations and Submission Management professional experience. She operates as a global strategic partner and subject matter expert for the Global Submissions team (US, Europe, Asia and Emerging Markets). She is key contributor for supporting global implementation for Regulatory Systems (RIM, Document Management, Submission Management Applications, and other systems.

  • Mitzi  Allred, PhD

    Mitzi Allred, PhD

    • Director, Clinical Operations
    • 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.

  • Robert  Baldry

    Robert Baldry

    • Assistant Vice President
    • Genpact Pharmalink, United States

    Robert Baldry leads Genpact's Data and RIM migration practice focused on projects to improve regulatory data management through better technology, process and governance. Robert has over 15 years of experience implementing new technologies to the pharmaceutical industry. Projects include xEVMPD and IDMP migration projects. Enterprise wide multi-source legacy RIM to cloud based RIM system implmentations. Global data remediation and migration programs as well as paper to digital transformation projects. Robert studied business and technology at the University of Wolverhampton, United Kingdom and InHolland University of Applied Sciences, the Netherlands

  • Vera  Buris, MHS

    Vera Buris, MHS

    • Senior Manager, Quality and Operations, Submission Sciences
    • Biogen, United States

    Clinical Research professional with 24 years of experience in the biotechnology industry providing outstanding management expertise in research analysis within Global Safety Submission Sciences Quality and Operations. Recognized for effective leadership with strong management skills, focused on efficiency and quality of work product, formulating policies and procedures, and ability to lead the clinical team through GCP inspection with the FDA and MHRA. Capable of improving profit margin through development and planning of human resources and continued process improvement programs.

  • Nicole  Cocuzza, MBA

    Nicole Cocuzza, MBA

    • Senior Manager, Regulatory Submissions
    • Allergan, United States

    Nicole has been with Allergan for almost 12 years. She began her pharmaceutical career at Johnson & Johnson's Ortho-Clinical Diagnostics where she was exposed to various different positions within the Quality, Regulatory and Compliance group, before moving on to Forest Laboratories as a Regulatory Publisher. She later obtained her MBA in Pharmaceutical Management from Rutgers University and continues to seek opportunities to educate herself within the industry. Nicole is a long-time resident of Hoboken New Jersey and spends much of her free time training the puppy she recently adopted from East Coast Canine Rescue.

  • 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 current work includes compounding reporting guidance, data management of FAERS system, Safety Reporting Portal for mandatory post-marketing electronic submissions and the FAERS Public Dashboard.

  • La Misha  Fields, MBA

    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.

  • 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.

  • 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.

  • G. Scott  Gordon, PhD

    G. Scott Gordon, PhD

    • Senior Health Informatics Officer, OSP, CDER
    • Food and Drug Administration, United States

    Scott Gordon is a Senior Health Informatics Officer for the Office of Strategic Programs in the Center for Drug Evaluation and Research at FDA since 2016. Dr. Gordon is responsible for a range of activities to standardize data for clinical research, submissions to FDA, and post-market surveillance. A significant aspect of Dr. Gordon’s work includes a focus on “real-world data” derived from health information technology to supplement traditional clinical trials and current pharmacovigilance methods. In parallel, Dr. Gordon also works to standardize pharmaceutical quality and manufacturing data for submission to FDA. He also prior experience is in public health informatics, emergency preparedness, and microbiology research.

  • Sandra  Krogulski, MA

    Sandra Krogulski, MA

    • Associate Director, Submission Management
    • Bristol-Myers Squibb Company, United States

    Sandy Krogulski is a Regulatory Submission Manager with 10 years of experience and this is her sixth 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 third year with BMS, Sandy has previous vendor experience supporting submissions to numerous health authorities.

  • 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.

  • Kristen  Mandello, DVM

    Kristen Mandello, DVM

    • Global PV, Signal Detection Manager
    • Zoetis, United States

    Dr. Mandello received her B.S. from the University of Georgia, and her DVM from The Ohio State University and has a passion for safety and innovation. Kristen brings more than a decade of global vigilance experience and develops creative solutions to efficiently meet global compliance standards and surveillance needs. Prior to joining Zoetis, as Head of the Global Pharmacovigilance at Merial (Sanofi's AH Division) and at Ennov, she lead development of automated systems to facilitate statistical signal detection, signal tracking and risk management for marketed pharmaceutical and biological products worldwide. Kristen is also an Associate Professor at University of Georgia's College of Pharmacy, International Regulatory Sciences Program.

  • Vivian  Neilley

    Vivian Neilley

    • Solution Architect
    • Google Cloud, United States

    Vivian Neilley is a Solution Architect in Healthcare and Life Sciences for Google Cloud. Her focus in the position is around enabling enterprise customers to ingest, harmonize, and derive insights from data to meet business needs and prepare for scale in the new age of AI. She began her career in healthcare working as staff support for the surgical unit in the South Carolina Health Systems while conducting research and publications on surgery start delays. Immediately prior to joining Google, Vivian was in a similar role in Solutions at IBM Watson Health working on their Explorys Clinical Analytics Platform. Vivian holds a bachelor’s degree in Biology and Public Health from Clemson University. She lives in Boston, Massachusetts.

  • Juhi  Saxena, MSc

    Juhi Saxena, MSc

    • Associate Director, Regulatory and Clinical Informatics Platforms
    • Moderna, United States

    Juhi is a seasoned professional with more that 10 years of experience in delivery IT solutions involving working with business sensitive data, heightened need of analysis accuracy and time line sensitivity, best practices in pharmaceutical (GxP – Quality, Clinical and Regulatory) and tax industry across all phases of Software development Life Cycle (SDLC). She has lead several projects to manage and support different GxP systems to meet business needs in GxP regulated environment. She is an accomplished project manager, business analyst, subject matter expert, validation lead and technical lead and possess indepth knowledge of different aspects of a project from conception to delivery.

  • Cary  Smithson, MBA

    Cary Smithson, MBA

    • Director Regulatory Solutions
    • Phlexglobal, United States

    Cary Smithson is the Director of Regulatory Solutions at Phlexglobal and has over 25 years of experience helping life science Regulatory, Clinical and Quality organizations 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, Agile and project / program management. Cary leads the DIA RIM Intelligent Automation Topic Team, contributes to the RIM and EDM Reference Models and led the development of the DIA GMP Quality Systems Reference Model.

  • Jamie  Toth, MS

    Jamie Toth, MS

    • Global Head, TMF Management & Records
    • Beigene, United States

    Jamie has over 18 years of IT experience in the pharmaceutical industry. She has been with BeiGene since January 2022 as the Global Head of Trial Master Management & Records. Prior to that she was with Daiichi Sankyo, Inc., for over 5 1/2 years. 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). She also serves on the AVOCA Safety Leadership Advisory Board. Jamie is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified.

  • Cesar  Vinces

    Cesar Vinces

    • eSubmission Strategy and Innovation Lead
    • Pfizer Inc, United States

    Cesar is currently eSubmission Strategy & Innovation Lead within Regulatory Operations in Submissions Management at Pfizer. Upon joining Pfizer in 2011, Cesar was responsible for the US submissions lifecycle team, and, in 2013 Cesar was appointed as Submissions Management Head of Dossier Excellence and Business Process Owner across Regulatory strategy for NDA/MAA/IRDs. Prior to Pfizer, Cesar started his career in 2000 with Liquent (Paraxel) and in 2002 Cesar joined Novartis’ Regulatory Submissions Operations before moving to Bayer Healthcare's Regulatory Operations Submissions Management team in 2007.

  • Milagros  Vitor-Butzen

    Milagros Vitor-Butzen

    • Associate Director, Regulatory Operations
    • Takeda Vaccines, Inc., United States

    With over 15 years of regulatory experience, Milagros is focused on solutions that foster relationships and build logistics to deliver high-quality, compliant applications for licensure. In her current role as Associate Director, Regulatory Operations, at Takeda Vaccines, Inc., she oversees the entire submission process and leads efficient, standardized best practices for regulatory submission document management. She is the Product Owner for Takeda VBU’s EDMS/RIM, driving the prioritization and evolution of regulatory systems, tools and processes. She has also developed EDMS eLearning training modules, streamlined the submission process, transitioned applications to eCTD format, and centralized legacy regulatory archives.

  • Cham  Williams, MS

    Cham Williams, MS

    • Associate Director, Business Systems
    • IQVIA, United States

    Cham Williams is an Associate Director of Business Systems at IQVIA, responsible for designing products that help shape the next generation of RIM solutions. He has more than 20 years’ experience in the life sciences industry working globally for pharmaceutical, consulting and technology solutions companies. His expertise includes managing regulatory technology, business process optimization and systems planning and implementation.

  • Stephanie  Leuenroth-Quinn, PhD

    Stephanie Leuenroth-Quinn, PhD

    • Pharmacologist, Office of New Drugs, CDER
    • FDA, United States

    Stephanie Leuenroth-Quinn earned her Ph.D. in pathobiology before beginning her postdoctoral work in small molecule mechanism of action research. She joined the FDA in 2009 within the Division of Metabolism and Endocrinology Products (DMEP) in the Office of New Drugs (OND) as a nonclinical drug reviewer. Since 2017, Stephanie has been working on nonclinical policy and process initiatives within the Immediate Office of OND, including the Standard for Exchange of Nonclinical Data (SEND).

  • Rune  Bergendorff, MSc

    Rune Bergendorff, MSc

    • Associate Vice President, Life Sciences Business Areas
    • NNIT, Denmark

    Associate Vice President of the Life Sciences Business Areas: RA, Clinical, Laboratory, Production & Quality. Before taking his current position, he spent 9 years wI think the RA area working with RIM, Submissions, EDMS and extensively with topics as ISO IDMP, xEVMPD and SPL. Rune has been member of the ISO TC215 WG6, developing the IDMP guidelines and is member of the EMA IDMP Task Force. He is executive sponsor on a number of global programmes in the industry across Scandinavia, Europe and USA.

  • Alison  Buno, MBA

    Alison Buno, MBA

    • Sr. Director, Regulatory Submissions
    • Abbvie, Inc., United States

    Alison is Sr. Director, Regulatory Affairs Submissions at AbbVie Inc. She has 23 years of experience in all aspects of regulatory operations including global submissions management and publishing, data and document management systems, quality assurance, regulatory information management and system support.

  • Dee  DeOliveira, RAC

    Dee DeOliveira, RAC

    • Director, Global Regulatory Operations
    • Cerevel Therapeutics, United States

    Dee has twenty years’ experience in regulatory operations and submissions publishing. She is currently an Associate Director at Vertex Pharmaceuticals focused on regulatory business process and information management. Over the course of her career she has held positions of increasing responsibilities within Regulatory Operations at Genzyme, Shire and Alexion. She has overseen the submission of hundreds of thousands of sequences for global filings in the US, EU, Canada, Australia and other regions. Her expertise lies in eCTD, Structured Product Labeling (SPL), and regulatory content and data systems. She recently led a successful Change Management program for the implementation of Veeva Vault RIM at Vertex.

  • Joel  Finkle

    Joel Finkle

    • Associate Director, Regulatory Information Management
    • BeiGene, United States

    Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our reports into WordPerfect format for the FDA reviewer?" -- and he didn't say "no." Since then, he's been involved with content management, custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard both as a vendor/consultant and within biopharma companies.

  • James  Hendry

    James Hendry

    • Head of Global Regulatory Operations
    • GE Healthcare, Pharmaceutical Diagnostics, United Kingdom

    James Hendry is a Regulatory Operations Professional with 19 years' experience in the industry, including 9 years at a major innovator as well as stints in outsourcing, consulting, Generic Pharma and now Nuclear Medicine. James is an expert in eCTD Submission Publishing and Submissions Management in all global regions, having started with hands-on publishing before moving onto leadership roles in both industry and with vendors. James also has wide knowledge of system and process design, data migration, training and system ownership for RIM systems and extensive experience of setting up Submissions Publishing organisations, both on and offshore, using a mixture of in-house and external staff.

  • Ken  Keefer, MBA, PMP

    Ken Keefer, MBA, PMP

    • Principle Consultant
    • Keefer Consulting Inc, 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.

  • Murthy  Koppu, MS

    Murthy Koppu, MS

    • Principal Consultant
    • fme US, LLC, United States

  • Rob  Labriola, MS

    Rob Labriola, MS

    • Exec. Director, Regulatory Operations
    • Synchrogenix, United States

    Rob oversees the Regulatory Operations services group at Synchrogenix, a Certara Company. His over 35 years-experience in leadership positions of increasing responsibility managing high technology programs and initiatives, include over 25 years expertise in Regulatory Operations. He was an early planner and adopter for the electronic Common Technical Document (eCTD), having previously serving on Bio and PhRMA working groups for eCTD and electronic submissions. Rob is a builder and leader of teams of all sizes, including past roles at Janssen, Millennium, Sunovion, and Alexion. His submissions experience includes coordinating submissions for investigational and marketing programs, and has been an operator, planner, gatekeeper and champion.

  • Kelly  Lengyel, MS

    Kelly Lengyel, MS

    • Director, Global Medical Writing, Regulatory Affairs
    • Allergan, United States

    Kelly Lengyel is a Director of Medical Writing at Allergan and oversees the medical writing team for multiple therapeutic areas. Kelly has nearly 15 years of regulatory affairs and medical writing experience across multiple pharmaceutical companies. Over the course of her career in medical writing, she has led global medical writing teams and she has supported numerous medical writing projects for clinical trials and global regulatory submissions. She has led numerous process improvement initiatives to simplify complex documentation practices and accelerate global submission timelines. She earned her MS in Physiology and Neurobiology at the University of Connecticut and her MS in Biology at Saint Joseph University.

  • Christopher  Mundy, MS

    Christopher Mundy, MS

    • Global Life Sciences Solutions Lead
    • Clarivate Analytics, United States

    Christopher leads our Solutions Consulting practice at Clarivate Analytics representing a cross-functional team of industry veterans that span discovery & translational sciences, clinical & regulatory affairs, pharmacovigilance, business development & portfolio strategy and enabling technologies. He brings 13 years of experience of data & analytics experience after spending over a decade working in biopharma supporting R&D and Medical Affairs in data/knowledge management, process engineering & project management roles at Intercept Pharmaceuticals, Accuray and Amylin Pharmaceuticals. Christopher received his M.S. in Information & Knowledge Strategy from Columbia University and his B.A. from the University of California – San Diego.

  • Lisa N Pitt, PharmD

    Lisa N Pitt, PharmD

    • Head of Regulatory Affairs
    • Viela Bio, United States

    Lisa has over two decades of Drug Development and Global Regulatory Affairs Strategy experience from pre-clinical through post-marketing phases across multiple therapeutics areas. She currently serves as the Head of Regulatory Affairs at Viela Bio. Prior to this, Lisa served as Vice President, Global Regulatory Affairs at Premier Research, worked at the Food and Drug Administration (FDA), Astra Zeneca/MedImmune, PAREXEL Consulting and Novartis Pharmaceuticals Corporation. Lisa has received a Doctor of Pharmacy from the University of Maryland at Baltimore and a Masters of Science in Jurisprudence in Health Law and Policy from the Seton Hall University School of Law.

  • Vaishali  Popat, MD, MPH

    Vaishali Popat, MD, MPH

    • Associate Director, Biomedical Informatics and Reg Review Science, OND, CDER
    • FDA, United States

    Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of pre-marketing data more efficient and consistent, data standards, as well as leveraging data from internal and external sources to make regulatory decisions.

  • Ronnie  Rajkumar

    Ronnie Rajkumar

    • Senior Manager, Regulatory Submissions
    • Allergan, United States

    I've been in Regulatory submissions since 2004, and have had the pleasure of working for several Pharmaceutical Companies. During that time, I've been part of implementing 3 separate DMS systems and integrating them into publishing solutions.

  • Norman Robert Schmuff, PhD

    Norman Robert 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.

  • Teginder  Singh, MPharm

    Teginder Singh, MPharm

    • Senior Director, Regulatory Affairs
    • Johnson & Johnson, United States

  • Vali  Tschirgi

    Vali Tschirgi

    • Project Manager, CBER
    • FDA, United States

  • Dustin  Weisman

    Dustin Weisman

    • Technical Design Expert
    • Novartis, United States

    4 Years working for software company supporting and delivering solutions for Pharmaceutical Companies. 8 Years as a consultant at Pharmaceutical companies helping implement and administer systems supporting electronic submission processes. 9 Years as a Novartis company employee continuing to implement a wide range of systems and develop business processes to meet the changing electronic submission landscape. I have also been involved in system strategy for submission gateways and next gen publishing system evaluations. In my personal life I am a husband and father of 3, and I enjoy spending time with my kids and taking them to their various baseball and basketball games

  • Helena  Sviglin, MPH

    Helena Sviglin, MPH

    • Data Standards Advisor, FDA CDER Office of Strategic Programs
    • FDA, United States

    Helena is the Chair of the Study Data Technical Conformance Guide (sdTCG) and the FDA Business Rules CCB

  • 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.

  • 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.

  • Ryan  Hernandez

    Ryan Hernandez

    • Director of Regulatory Operations
    • Radius Health, United States

    Ryan Hernandez is the Director of Regulatory Operations at Radius Health, Inc. where he oversees all submission and RIM related activities. Ryan started his career with Octagon Research Solutions where he gained experience in regulatory publishing. At Teva Pharmaceuticals, Ryan lead large publishing teams and developed efficient processes to ensure the timely and accurate completion of critical submissions. Currently, he is optimizing regulatory processes and RIM systems at Radius to gain efficiencies and reduce costs. Ryan holds a B.S. in Biochemistry and is currently enrolled in Temple University's MBA program.

  • Ken  Sakushima, MD, PhD, MPH

    Ken Sakushima, MD, PhD, MPH

    • Principal Reviewer (Clinical Medicine), Office of New Drug 3
    • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Dr. Ken Sakushima is a principal reviewer (clinical medicine) of the Office of New Drug ? in the Pharmaceuticals and Medical Devices Agency (PMDA).

  • Heather  Crandall, MA

    Heather Crandall, MA

    • Operations Research Analyst, OBI, OSP, CDER
    • FDA, United States

    Heather Crandall has been with the FDA since 2012, working in CDER’s Office of Business Informatics. She currently focuses on standards and processes around electronic submissions.

  • Deborah  Lahr

    Deborah Lahr

    • Associate Director, Regulatory Content Information Management
    • Merck & Co., Inc., United States

    Deb Lahr is an Associate Director in the Global Regulatory Affairs and Clinical Safety (GRACS) group at Merck & Co. In her current role, she is the Regulatory Content Archive Business Lead, engaged in the archival of submissions content across the globe and supporting headquarter and country documents are globally accessible by GRACS and its partners. Deb has 30+ years of experience in pharmaceuticals, such as Hoffmann-La Roche, Schering-Plough and Merck & Co., within Clinical Research and Regulatory Affairs submissions and content management.

  • 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.

  • 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 19 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

  • Michael  Sauter

    Michael Sauter

    • Senior Director, Global Regulatory Operations
    • United States

    Michael Sauter has spent more than 25 years working in the pharmaceutical industry at leading companies located in both the US and Switzerland. He has worked in management and executive management roles that have included Chemistry, IT, and Regulatory Affairs, and R&D technology solutions. Michael spent almost 15 years leading Biogen's  Global Regulatory Operations, Project & Information Management functions, and finally as Senior Director, Digital Health Technologies Office at Biogen, he was participating in the formation and implementation of the Biogen Digital Health and Analytics Strategies. Michael is Head of Global Regulatory Operations at Alexion in Boston now.

  • Hanming  Tu, MSc

    Hanming Tu, MSc

    • Vice President, IT
    • Frontage Laboratories, Inc., United States

    * MS, MCRP * VP, Clinical IT & Database Administration (DBA) at Frontage * Manager, DBA in Accenture Life Science Cloud * Director, Clinical IT in Octagon Research * Over 20 years of pharmaceutical and clinical IT experience * Oracle Certified Professional (OCP) and DBA Master from Oracle University. * Presented on emerging technologies, data standardization and visualization, and transformation and automation intelligence to the conferences such as DIA, CDISC Interchanges, PhUSE, etc.

  • 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.

  • 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 11 years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

  • Sylva Jana Krizan, PhD, RAC

    Sylva Jana Krizan, PhD, RAC

    • Global Compliance, Healthcare and Life Sciences
    • Amazon Web Services (AWS), United States

    Sylva Krizan PhD, has spent her career across government, academia, biotech and tech industries. Before joining Amazon (AWS) in 2018 (leading Global Healthcare, Life Sciences Compliance) she built and led the regulatory affairs team at a cancer diagnostics company that recently licensed its Dx technology to Veracyte. In that role she was responsible for regulatory compliance of all life sciences and diagnostics products, including global regulatory submissions. She was also a Commissioner's Fellow and Biomedical Engineer at the US FDA, appointed to both CBER and CDRH with a focus on regenerative medicine combination products, cell therapies and medical devices. She holds a B. Eng in Chem. Eng., and M. and PhD. in Biomed. Eng.

  • Jiang  Xu

    Jiang Xu

    • Business Informatics Specialist
    • FDA, United States

  • 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.

  • 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, 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.