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Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.


Speakers

  • Venkatraman  Balasubramanian, PhD, MBA

    Venkatraman Balasubramanian, PhD, MBA

    • Senior Vice President, Life Sciences
    • Orion Business Innovation, United States

    V. “Bala” Balasubramanian is the President and CEO of Cabeus, a niche firm providing information management products, solutions and services for Life Sciences. With over 3 decades of IT experience, Bala is a thought leader and presenter on Regulatory Intelligence, RIM, IDMP, regulatory analytics, enterprise architecture and process design. At Cabeus he is responsible for strategy, leadership and vision for a cloud platform called ReALM® to transform the regulatory value chain for Life Sciences. Prior to Cabeus, Bala developed IT strategies and capabilities for companies such as Bristol-Myers Squibb, Roche, Aventis, Merrill Lynch, AT&T, Bell Atlantic and IBM. Bala has his PhD and MBA from Rutgers University, MS in Computer Science from NJIT.

  • Christian A. Buckley, MBA, RAC

    Christian A. Buckley, MBA, RAC

    • Associate Director, Regulatory Affairs
    • Astellas, United States

    With a career spanning over two decades in various regulatory roles, Chris recently changed career focus reporting into the Regulatory Affairs Oncology Strategy group at Astellas. His specialties include leading implementation projects for submissions and RIM processes to improve global harmonization. Under his belt, Chris has scores of global filings across four organizations. With his MBA degree, RAC certification and biotech management experience, he has enjoyed contributing to the RSIDM space to improve regulatory processes. Chris has a passion for outdoor adventures with his family and friends.

  • Brooke  Casselberry, MS, RAC

    Brooke Casselberry, MS, RAC

    • Head, Regulatory Information Management
    • Beigene, United States

    Brooke Casselberry has been a regulatory consultant for 20 years focusing on data, technologies, small business entrepreneurship, and regulatory compliance for clients globally. She is currently Director, Consulting Expert with CGI Technologies for RnD and Technology Innovation. Brooke has dedicated much of her career to professional volunteerism to continue development and mentorship through communities such as DIA.

  • Michelle L. Charles, MPH

    Michelle L. Charles, MPH

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

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

  • Jake  Doran

    Jake Doran

    • Chief Technology Officer
    • Genpact, United States

    Jake Doran is the Chief Technology Officer at Genpact Pharmalink. In this role, Jake is responsible for establishing the strategic direction and defining the digital solutions across Regulatory Affairs. Prior to joining Genpact, Jake was with List Innovations LLC where he was Founder and Managing Director. List Innovations is a specialized technology development and consulting company providing Regulatory and IT solutions to the Pharmaceutical industry. Earlier in his career, Jake held positions of increasing responsibility at Janssen Pharmaceuticals and Schering Plough. Jake has a Bachelor’s Degree from Fairleigh Dickinson University where his area of specialization was Biological Sciences.

  • Betsy  Fallen, RN

    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.

  • Ron D. Fitzmartin, PhD, MBA

    Ron D. Fitzmartin, PhD, MBA

    • Senior Informatics Advisor, OD, CBER
    • FDA, United States

    Ron Fitzmartin is Senior Project Manager, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions and standardized data. Some of Ron’s activities include: chair of the PDUFA VI information technology committee, Regulatory Chair of the ICH M11 Expert Working Group on clinical protocol standards, and chair of the IDMP Working Group under the International Pharmaceutical Regulators Programme. Ron received a PhD in statistics from the University of Maryland and MBA from University of New Haven.

  • Mark A. Gray

    Mark A. Gray

    • Senior Project Manager, BSS, CBER
    • FDA, United States

    Mark has over 30 years’ experience in Information Technology & Management. Mark began his career developing commercial applications and has been working for FDA for over 20 years. Mark’s FDA responsibilities have included; software development and project management in CBER; Director of Applications Development & Services in CDER; PDUFA IT Program Director; and Director, Division of Data Management Services & Solutions managing CDER’s electronic submission program. Mark’s current responsibilities include representing CBER in the development of international electronic submission standards, with a focus on the ICH electronic Common Technical Document (eCTD).

  • Sheila  Mahoney Jewels, MBA

    Sheila Mahoney Jewels, MBA

    • Independent Workforce Advocate
    • LifeSciHub, United States

    Sheila has over 25 years of experience in reg/clin ops, having operated as an SME on both the sponsor and vendor sides. Her current focus as an independent consultant (IC) is advocating for the independent workforce, and helping sponsors engage with them. Sheila has spent the last two years immersed in the world of HR and Procurement tech in order to transition mature, "Future of Work" technologies from other verticals to life sciences in the form of LifeSciHub. LifeSciHub is an online resource marketplace of SME ICs, the goal is to provide extremely easy, and compliant, access and engagement for the Sponsors who need specifically qualified experts for projects. Think Airbnb or Lyft, for SMEs!

  • Andrew  Marr, PhD

    Andrew Marr, PhD

    • Managing Director
    • Marr Consultancy Ltd, United Kingdom

    Managing Director, Marr Consultancy Ltd. Recognised expert in IDMP through work in ISO, EU IDMP Task Force, Conference Speaker and numberous engagements with top 25 pharma (and other pharma clients), software houses and service providers in the e-Regulatory space.

  • Thomas J. Noto

    Thomas J. Noto

    • Senior Director, Regulatory Operations
    • Lexicon Pharmaceuticals, United States

    Thomas is a 20+ year experienced leader in Pharmaceutical, Diagnostic and Medical Device Regulatory Affairs, Electronic Publishing and Document Management. He has a strong track record of successful regulatory interactions and filings, resulting in the approval of over 25 new drugs, devices and diagnostics. He has worked for a number of organizations both in the Consulting and CRO industry, as well as on the sponsor side of the equation. He has developed services and led global teams resulting in the consistent delivery of high-quality output aligned with business needs. Some of Thomas’s skills include regulatory process and workflow excellence, eCTD publishing, document management, commercial regulatory, and computer systems validation.

  • Daniel F. Orfe, MS

    Daniel F. Orfe, MS

    • President and CEO
    • Regulatory eSubmissions, LLC, United States

    Dan is a Leadership professional with 20+ years experience in Regulatory Submission production. A subject matter expert for eCTD & EDMS solutions. A business process analyst for submission assembly and eCTD publishing. He’s been a key member of several industry/agency initiatives for electronic submission standardization & efficiency. Dan has presented or chaired sessions at DIA Annual Meeting & DIA RSIDM/EDM Conferences. He's a DIA RSIDM Conference Program committee member. Dan established/directed eCTD publishing groups at Merck & Co., Inc. & Datafarm Inc. (leading eCTD software & services provider). At Teva, Dan led a initiative to harmonize the publishing environment into a single tool set (EDMS, eCTD Publishing etc.).

  • 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 17 years as a consultant, she has assisted clients with projects related to regulatory process improvements, standards development, defining filing strategies and writing/review of submission content. She has extensive experience with projects related to design and implementation of regulatory solutions including document management, submission planning, publishing, and registration management. Sarah is a past executive at Chiron, First Consulting Group and Liquent, PAREXEL

  • Michiel  Stam

    Michiel Stam

    • Regulatory Information Scientist
    • Qdossier B.V., Netherlands

    Michiel Stam works as a Regulatory Information Scientist at eCTDconsultancy and is Product Manager for Dossplorer, a regulatory dossier viewer. He is a specialist in electronic submissions and regulatory information management and worked for various Pharma and Biotech companies in the past 10 years. Michiel has a strong focus on XEVMPD, IDMP and Regulatory Information Management projects.

  • Stacy  Tegan

    Stacy Tegan

    • Senior Program Manager
    • Transcelerate Biopharma Inc., United States

    Stacy Tegan is a Sr. Program Manager at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical development process. She has expertise in Regulatory Operations, Clinical Development processes, and Project Management gain through 20+ years of experience working for sponsor, consulting, technology, and nonprofit organizations in the pharmaceutical industry.

  • Brad  Wintermute

    Brad Wintermute

    • Deputy CIO, Director, Office of Technology and Delivery, Office of Operations
    • FDA, United States

  • Kimberly  Belsky, MS

    Kimberly Belsky, MS

    • Head of Regulatory Policy & Intelligence, Regulatory Affairs
    • Mallinckrodt Pharmaceuticals, United States

    Kimberly (Kim) Belsky is the Head of Regulatory Policy & Intelligence at Mallinckrodt Pharmaceuticals (MNK) assessing changes in the regulatory environment and applicability to the MNK portfolio and activities. Prior to Mallinckrodt, Kim was an Executive director at OneSource Regulatory responsible for AdPromo regulatory review and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals (formally Bausch + Lomb). Kim has diverse experience in medical products including Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices. Kim has more than 28 years of pharmaceutical experience, including 18 years in regulatory.

  • Romuald  Braun, MS, MSc, RAC

    Romuald Braun, MS, MSc, RAC

    • Vice President, Strategy
    • AMPLEXOR Life Sciences, United States

    Braun’s 25-year career to-date has been spent across roles related to Compliance, Document Management, Content Management in the Life Sciences industry – both on the client side and in consulting, spanning delivery, sales, project and line manager roles. His experiences bridge on-premise and cloud environments, in Europe and in US. Braun holds a Master’s degree in Drug Regulatory Affairs from the University of Bonn (Germany) and his diploma in Data Technology from the Technical University (TU) Darmstadt (Germany)

  • Dale  Cooke, JD, MA

    Dale Cooke, JD, MA

    • President
    • PhillyCooke Consulting , United States

    Dale Cooke is president of PhillyCooke Consulting, which helps prescription product marketers use 21st century technology to provide healthcare information while ensuring compliance with FDA regulations written in the 1960s. Dale is the author of Effective Review & Approval of Digital Promotional Tactics, now in its second edition, which was published by the Food & Drug Law Institute.

  • Mark  Cottingham

    Mark Cottingham

    • Sr. Business Lead in Operational Business Excellence Group of Pharma Technical
    • F. Hoffmann-La Roche Ltd, Switzerland

    Mark Cottingham is currently working as a Senior Business Lead within the Pharma Technical Regulatory department at Roche. He has worked in the Pharma industry for over 15 years with the last 10 years in Regulatory. He is currently implementing a RIM solution which will provide a strong framework for implementing structured authoring solutions. He likes to focus on automation to enable the business to focus on value adding activities.

  • Colleen M. Davenport, PhD

    Colleen M. Davenport, PhD

    • Director, Global Regulatory Sciences - Oncology
    • Bristol-Myers Squibb Company, United States

    Over 17 years of experience in the pharmaceutical industry with more than 14 years in regulatory affairs working across multiple therapeutic areas. Colleen has held Regulatory Affairs positions at Sanofi-Aventis, GlaxoSmithKline, and Accenture and is currently the Executive Director of Regulatory Affairs and Pharmacovigilance at AnGes, Inc. a small biotechnology company focused on a Phase 3 gene therapy product for Critical Limb Ischemia. Colleen also has a strong background in immunology with an emphasis on bone marrow transplantation, autoimmune disorders, and immunological tolerance. Colleen has a BS in Microbiology, a Masters in Regulatory Affairs and a PhD in Immunology.

  • Marc  Gabriel

    Marc Gabriel

    • Sr. Director, Vault RIM
    • Veeva Systems, United States

    Marc Gabriel is a Senior Director of Product Strategy at Veeva Systems where he is responsible for defining the enterprise market approach for the Vault Regulatory suite of products. Prior to joining Veeva in June 2017, he served as client partner and RIM consulting lead at Kinapse. Marc also spent fourteen years in Accenture’s Pharmaceutical R&D practice where he led the organization’s Regulatory advisory, business development, and alliance efforts. During that tenure he helped half of the world’s Top 20 biopharmaceutical organizations in various consulting and program delivery roles spanning regulatory and pharmacovigilance.

  • Steve  Gens, MS

    Steve Gens, MS

    • Managing Partner
    • Gens and Associates Inc., United States

    Steve Gens (MSOD) is the Managing Partner of Gens and Associates Inc., a global Life Science consulting firm specializing in strategic planning, RIM program development and execution, industry benchmarking, and organizational performance. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he lead global healthcare consulting practices for First Consulting Group and Booz Allen Hamilton. His organization is well known for their insightful industry benchmarks and World Class RIM thought leadership. Steve has a Bachelor’s of Science in Business Computer Science and a Master in Organizational Development and Performance. He was named to the PharmaVoice 100 for 2017.

  • Ashok  Ghone, PhD

    Ashok Ghone, PhD

    • VP, Global Services
    • MakroCare, United States

    Ashok Ghone, Ph.D. is VP, Global Services at MakroCare USA. He has around 20 years of experience working with big pharmaceutical and clinical research industry. Ashok has good knowledge and understanding of global clinical research, regulatory scenario with hands-on experience in clinical operations, project management, risk management, process development, document management, site management and patient recruitment. He has led various cross-functional teams successfully by providing strategic direction and guidance for accomplishment of local, regional and global projects involving early, late phase studies. Ashok has been involved in development of process, technology related to RBM and centralized monitoring.

  • Ryan  Hernandez

    Ryan Hernandez

    • Sr. Manager, Global Regulatory Operations
    • Teva Pharmaceuticals, United States

    Ryan Hernandez is a regulatory submission manager for Teva Pharmaceuticals. He has been in the industry for ten years and has a wide range of publishing experience. Ryan has been with Teva for six years where his primary focus has been on ANDA original applications.

  • Natalie  Herr, PhD

    Natalie Herr, PhD

    • Medical Writer, Consultant
    • Whitsell Innovations, Inc., United States

  • Virginia  Hussong

    Virginia Hussong

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

    Ginny Hussong is Chief of CBER’s Data Standards Program, and has been with FDA for 14 years. She was previously Director of Data Management Services and Solutions within CDER. As Chair of CBER’s Data Standards Committee, Ginny’s recent projects include creating a new joint data standards strategy and action plan with CDER, modernizing CBER’s study data validation process and evaluation of the SEND standard for CBER. Ginny also serves as Deputy Topic Lead for FDA, ICH M2, Electronic Standards.

  • Sandra A. Krogulski, MA

    Sandra A. Krogulski, MA

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

    Sandy Krogulski is a Regulatory Submission Manager with 9 years of experience and this is her fourth time speaking at RSIDM. She has experience managing and reviewing submissions to the US, Health Canada, Swissmedic, Australia and other Rest of World countries. In addition to submissions, Sandy has a background in training/developing teams, SOP writing and change initiatives. Currently in her second year with BMS, Sandy has previous vendor experience supporting submissions to numerous health authorities.

  • Shylendra  Kumar, MA, MPH

    Shylendra Kumar, MA, MPH

    • Director Product Offering Development
    • IQVIA, United States

    Shy Kumar founder, president & CEO of ACUTA is an entrepreneur and domain expert with 20+ years’ experience in the life sciences industry. Shy has been assisting companies of all sizes with design, development and implementation of solutions and processes. With his team, Shy deployed the very first publishing solution for eCTD in early 2000. Since 2012 he and his team are busy with a brand new cloud based RIM solution. He is also the architect of many PDF tools that are widely used for publishing PDF files for regulatory submissions around the world. Shy has a MPH degree from Boston University and an MA (Social Sciences) degree from Bangalore University. Prior to ACUTA he was founder, president and CEO of Datafarm, Inc.

  • Jared  Lantzy, PMP

    Jared Lantzy, PMP

    • Manager, Global Regulatory Agencies and Processes
    • LORENZ International LLC, United States

    Jared Lantzy, PMP, is the Manager of Global Regulatory Agencies and Processes at LORENZ International LLC. In this role he monitors the world of regulatory operations to inform industry of emerging requirements and best practices. His primary expertise is in the implementation of electronic submission processing, validation, and review solutions. Mr. Lantzy is also a former member of the FDA CDER electronic submission support team. He holds a B.S. in Information Technology from Juniata College in Huntington, Pennsylvania, USA.

  • Marcel  Lissinna

    Marcel Lissinna

    • Specialist Leader
    • Deloitte Consulting, United States

  • Joanne S. Malia

    Joanne S. Malia

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

    Joanne Malia is Associate Director of Clinical Documentation Management at Regeneron Pharmaceuticals where she drives operational activities related to the implementation and management of an eTMF and associated clinical document management processes. She serves as the business owner for eTMF implementation across the organization. In this capacity she interacts with internal senior level management, external vendors, collaboration partners, clinical study and other internal personnel to ensure compliance with regulations, Regeneron business practices and clinical research program objectives.

  • Mauricha F. Marcussen, MBA

    Mauricha F. Marcussen, MBA

    • Founder
    • Auditgraph, United States

    Mauricha Marcussen, CEO of Agano Solutions & Auditgraph, provides consulting and technology solutions in Global Regulatory Affairs & Product Labeling. She has worked for the FDA & many of the industry’s top companies. She was honored for the 2013 PharmaVOICE 100. Auditgraph was nominated for the 2013 Microsoft Innovation in Life Sciences Award, for ComplianceView™, a Global Label Alignment and Compliance platform, and received the 2013 TOPRA Award for Excellence in Regulatory Communications.

  • Timm  Pauli

    Timm Pauli

    • Sr. Director, eSubmission Services, Head of Regulatory Operations
    • PharmaLex GmbH, Germany

    Timm Pauli joined PharmaLex in 2014 as Head of Regulatory Operations, where he is responsible for all electronic submission activities, regulatory information management and related topics worldwide. He is also leading and supporting process optimization projects within Regulatory as well as providing consultancy for Regulatory Information Management, IDMP-related topics and eCTD publishing systems. Previously he worked at Merck Serono heading the Dossier & Submission Management department and at Baxter, where he held several global positions in Biostatistics, Pharmacovigilance and IT. Timm studied Pharmacy and Medical Informatics at the Universities of Frankfurt and Heidelberg (Germany).

  • Vada A. Perkins, DrSc, MS, MSc

    Vada A. Perkins, DrSc, MS, MSc

    • Global Regulatory Policy and Intelligence
    • Bayer Pharmaceuticals, United States

    Vada A. Perkins, Bayer Pharmaceuticals Head, Regulatory Intelligence Director, Regulatory Policy & Intelligence Vada A. Perkins (CAPT, ret.) is a former FDA Senior Advisor for Regulatory Science and a recognized global regulatory policy & intelligence expert with thought leadership in the application of technology, standards, and data management. He is active in interactions with national and international stakeholders in promoting technology and innovation to support international regulatory convergence for medicinal product regulation. He received his degrees from The Johns Hopkins University, University of Southern California, and the University of Maryland.

  • Anjana  Pindoria

    Anjana Pindoria

    • Director Product Strategy
    • EXTEDO GmbH, Germany

  • Ellen  Reilly, MBA

    Ellen Reilly, MBA

    • Vice President
    • DocuSign, United States

    Ellen Reilly has 30 years of experience working in large global pharmaceuticals, biotechnology organizations as well as medical device clients. Currently, Ellen is the Vice President, Life Sciences and Healthcare for Docusign working on driving the adoption into the industry. Prior to joining DocuSign, Ellen held roles at Forest Pharmaceuticals were she was the VP of Global Supply Chain for Forest Pharmaceuticals & the VP of Corporate IT Systems supporting Human Resources, Finance, Informatics and Supply Chain. Ellen holds a Bachelors degree in Computer Science from LaSalle University, and an MBA in the International Management program from Drexel University.

  • Joe  Shepley, PhD, MA

    Joe Shepley, PhD, MA

    • Vice President and Practice Leader
    • Doculabs, United States

    Joe Shepley, PhD, has been involved in document management for 15 years, both as a business person and consultant at Doculabs, where he is currently Vice President and Life Sciences Practice Leader. Joe’s focus is on helping organizations manage GXP documents more effectively to improve the efficiency and profitability of the drug development process. He has worked extensively with large drug and device manufacturers as well as with healthcare organizations more generally, including payers, providers, and pharmacy benefit managers. Joe chairs the content management track of the DOCUMENT Strategy Forum, the premier conference for information management leaders across industries.

  • Cary  Smithson, MBA

    Cary Smithson, MBA

    • Director, Digital Transformation & Management
    • Grant Thornton LLP, United States

    Cary Smithson is a Principal Consultant in the OpenText Life Sciences Professional Services practice and has over 20 years of experience helping life science and healthcare firms drive greater productivity, streamline information management and enhance regulatory compliance. Her areas of expertise include regulated content and information management, regulatory information management, GxP quality / compliance, IT strategy and project / program management. Cary led the development of the DIA GMP Quality Systems Reference Model and participates on the EDM and RIM model teams.

  • 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.

  • Pieter  Vankeerberghen

    Pieter Vankeerberghen

    • Head of Division Research and Development (Human Use) DG Pré Authorisation,
    • Federal Agency For Medicines and Health Products (FAGG AFMPS), Belgium

    Pieter Vankeerberghen studied Industrial Pharmacy, obtained a Ph.D. in Pharmaceutical sciences and holds a master degree in informatics. After working 4 years in R&D, first in Clinical data management and later as project manager in human pharmacology, he joined the Belgian authorities in 2000. After coordinating the agency ICT projects and developments and playing a coordinating role in EU Human/Veterinary esubmissions, he leads the DG pré R&D department.

  • Kristin  Wehr

    Kristin Wehr

    • Publishing Associate
    • Teva Pharmaceuticals, United States

  • Olga  Alfieri, MBA, MSc, RAC

    Olga Alfieri, MBA, MSc, RAC

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

    Olga Alfieri is the AD, Global Submissions at Eisai with over 22 years of GRO professional experience. She operates as a global strategic partner and subject matter expert in collaboration with the GRO Submissions team (Europe, Asia and Emerging Markets) in the design and implementation of technology facilitating the creation and maintenance of global submissions.

  • Rune  Bergendorff, MSc

    Rune Bergendorff, MSc

    • Director, Consulting Services
    • NNIT, Denmark

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

  • Dove  Bunkin-Thomas, MS

    Dove Bunkin-Thomas, MS

    • Senior Manager, Regulatory Writing
    • Amgen Inc., United States

    Dove Bunkin-Thomas, M.S. has 14 years of regulatory writing experience spanning several therapeutic areas. Dove’s expertise includes writing, reviewing, and managing the work of contractors and full-time writers on documents such as CSRs, IBs, and RMPs; clinical documents for global Marketing Applications and global Regulatory Agency briefing documents; REMS and other safety assessment reports; and pediatric, response-to-Agency-question, and Japan CTN documents. Before becoming a regulatory writer, Dove worked as a pharmacokinetics data analyst. Dove’s academic background includes a BS in Biology and a BA in Psychology from UC San Diego, and an MS in Nutritional Sciences from Rutgers University.

  • Elisa  Cascade, MBA

    Elisa Cascade, MBA

    • Chief Product Officer
    • DrugDev (An IQVIA Company), United States

    Elisa Cascade, Vice President at DrugDev.org, manages the Investigator Databank, a pre-competitive, global collaboration between Janssen, Lilly, Merck, Pfizer, and Novartis that aims to decrease investigator burden while providing operational efficiencies for research sponsors. She has 20+ years of industry experience in clinical trial feasibility, site selection and start-up; patient recruitment and retention; clinical operations; health outcomes; late phase research; and commercial programs.

  • Bernie  Coney, MA

    Bernie Coney, MA

    • Head of Regulatory Advisory Services
    • Kinapse, United States

    Bernie Coney is the Head of Regulatory Information Management (RIM) Advisory Services at Kinapse who works with clients and industry on technology and processes related to areas that include Information Management, Registration Management, Submissions Management/Publishing, Labeling, IDMP and other areas that impact the Regulatory Affairs discipline. Prior to Kinapse, Bernie was the Head of Regulatory and Quality Assurance IT at Shire Pharmaceuticals, responsible for the Technology strategy, implementation, and innovation within R&D IT, as well as the Head of Regulatory Technology and Information Management. He has also work in the software vendor space delivering SCM and RIM solutions, as well as Pfizer Regulatory.

  • Charles  Deeck

    Charles Deeck

    • Senior Director, Regulatory Operations and Technology
    • ARIAD Pharmaceutical, Inc., United States

  • Eric  Delente, MA

    Eric Delente, MA

    • President, Patient Solutions
    • DrugDev, United States

    Eric has been innovating, designing, and developing clinical education and tracking systems for patients and providers for more than 20 years. Eric co-founded and led the design and development of the SecureConsent, one of the first eICF systems to market, starting in 2005. SecureConsent has been successfully deployed in hundreds of studies across the globe for leading pharma companies, CROs and Hospital networks. In 2016, SecureConsent became part of DrugDev, an IQVIA company.

  • Meghan Alice Demollari

    Meghan Alice Demollari

    • Regulatory Submission Publishing Manager
    • Accenture, United States

    Meghan Demollari, Submission Manager in Accenture’s Accelerated R&D Services group and has over 12 years life sciences experience in Submission Management within Regulatory Operations. In her current role she is a team lead responsible for the delivery of lifecycle maintenance submissions for 40 regulatory customers supporting a large portfolio of global investigational and marketing applications. Her current focus is ensuring projects are within scope, delivered on time, and produced with the highest quality. Meghan is an experienced speaker at industry conferences on the topics of eCTD, Clinical and Regulatory Cross-functional Projects, and Relationships with Vendor Partners.

  • Robert A. DiCicco, PharmD

    Robert A. DiCicco, PharmD

    • Deputy Chief Health Officer
    • IBM Watson Health, United States

    Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical trial design and project management. During his career he has successfully led the development a number of late phase oncology projects leading to product approvals. Rob also has extensive experience in leading transformational projects with TransCelerate (Common Protocol Template) and CTTI (Mobile Devices in Clinical Trials Novel Endpoints). Rob received his Doctor of Pharmacy Degree from the University of the Sciences in Philadelphia.

  • Mary  Emanoil, MS

    Mary Emanoil, MS

    • Senior Director, Content Management and Authoring, Information Management
    • United States

  • Joel  Finkle

    Joel Finkle

    • Associate Director Offering Management Regulatory Innovation
    • IQVIA, 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?" Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard both within pharma companies and as a vendor/consultant.

  • Nate  Freimark

    Nate Freimark

    • Senior Director, Biometrics Operating Standards Group
    • Theorem Clinical Research, United States

    Nate Freimark has been a member of the ADaM team since 2005 and is the current ADaM team lead, one of the ADaM trainers and a member of the SDS Oncology subteam. Nate is also a lead programmer who has worked on numerous projects involving the creation of SDTM and ADaM datasets and related TLGs.

  • Alexander  Gaffney

    Alexander Gaffney

    • Senior Manager
    • Health Research Institute, Pwc, United States

  • Christopher P Hanna, PhD, PMP

    Christopher P Hanna, PhD, PMP

    • Principal
    • Kattner-Thalmann Partners, United States

    Dr. Hanna has provided quality-related expertise to the life science industry for 25 years. The first half of his career was in leading improvement efforts in both drug and diagnostic R&D processes. For the last 12 years he has provided consultation and senior leadership to various pharmaceutical and diagnostic organizations. These efforts specifically relate to Operational Excellence with particular focus on Quality By Design and Lean operations. He has been awarded 22 patents for his various innovations and has written, taught and spoken broadly on these topics. Chris holds his PhD in Analytical Chemistry from the University of Massachusetts, Amherst and is a Certified Master Black Belt and Project Management Professional.

  • Abhishek  Harde, MBA, MPharm, RAC

    Abhishek Harde, MBA, MPharm, RAC

    • United States

  • Ronald  Hernando, MBA

    Ronald Hernando, MBA

    • Director, Regulatory Operations
    • MacroGenics, Inc., United States

    As a Southern California resident, Ronald Hernando graduated from UC San Diego and was lucky enough to land in Regulatory Affairs right out of college. After 4 years of paper cuts in Regulatory Affairs/Quality Assurance, Ron left paper submissions behind, and has spent the last 12 years focusing on Regulatory Operations. Ron has been enjoying the past 5 freezing winters of Rockville, MD overseeing Regulatory Operations at MacroGenics, Inc. As the Director of Regulatory Operations, he is responsible for 13 INDs, and managing all electronic submissions-related software, training, and personnel.

  • Emily M Huddle

    Emily M Huddle

    • Regulatory Intelligence Manager
    • Gilead Sciences, United States

    Emily Huddle has been working in the pharmaceutical industry for over 15 years, including nine years working in Regulatory Affairs and five years in Regulatory Intelligence. Primary responsibilities in her current role as a Regulatory Intelligence Executive within GlaxoSmithKline's Global Regulatory Intelligence group, include disseminating key US regulatory news and information, coordinating submissions to FDA requests for comments, and providing ad hoc regulatory intelligence and analyses.

  • Lior  Keet, MBA

    Lior Keet, MBA

    • Vice President, Life Sciences R&D
    • HighPoint Solutions, United States

    Mr. Keet is a results-driven Life Sciences R&D executive providing strong record of success in planning and overseeing development, deployment, capacity planning, operations support, and technology sourcing. Proven ability to drive strategic solutions in a complex environment and streamline operations and processes to increase productivity, quality, and efficiency. Prior to his tenure in Life Sciences, Lior served as a Lieutenant in the United States Navy for 5 years.

  • Carrie  Mazrillo

    Carrie Mazrillo

    • Submissions Manager, Global Regulatory Affairs
    • Eisai, Inc., United States

  • Jim  Nichols

    Jim Nichols

    • Chief Operations Officer
    • Cunesoft Inc, United States

    Jim has nearly 20 years’ experience with compliant software solutions for regulated processes in Life Sciences. He's held senior management positions at Liquent, Thomson Reuters, ePharmaSolutions and DitaExchange and holds a Bachelor of Science in Mathematics from The Pennsylvania State University.

  • Ian  Oldham

    Ian Oldham

    • Senior Manager, Regulatory Submissions Management
    • Teva Pharmaceuticals, United States

  • Jim  Reilly

    Jim Reilly

    • Vice President, Clinical Market Strategy
    • Veeva Systems, United States

    Jim Reilly is a Director of Product Strategy at Veeva Systems, where he is responsible for defining the market approach for the Vault Regulatory suite of products. For the last 15 years, he has held a variety of senior positions in Regulatory publishing, software delivery, consulting, and sales. Jim is interested in all things regulatory, data standards, and process engineering-oriented.

  • Kelley  Robinson

    Kelley Robinson

    • TMF/Registry Process Analyst
    • Pfizer, United States

    Kelley currently holds the position of TMF Process Analyst at Pfizer where she is responsible for assessing and improving TMF processes and performance by collecting and analyzing TMF performance data. She is the system owner for Pfizer’s eTMF and is a primary point of contact for the TMF during Regulatory Inspections. She also oversees the end-user support for Pfizer’s eTMF across 7,000 users globally, including Pfizer’s Partners and CROs. Kelley holds a Bachelor of Science degree in Healthcare Administration and a Master of Business Administration degree from the University of Phoenix.

  • Michael M. Sauter

    Michael M. Sauter

    • Senior Director, Regulatory Operations
    • Sarepta Therapeutics, United States

  • Mitchell  Seymour, PhD, RAC

    Mitchell Seymour, PhD, RAC

    • Principal/Founder; Lead, Regulatory Operations
    • R&D Advisors, LLC; University of Michigan, United States

    Dr. Seymour is Founder and CEO of R&D Advisors, LLC. He provides regulatory affairs services for industry and academia including regulatory strategy, regulatory intelligence, and regulatory due diligence, and operational assistance including FDA meeting preparation and engagement and regulatory writing and submissions. He has broad therapeutic area experience relevant to drugs, biologics, and devices. Dr. Seymour also has positions at the University of Michigan in their Medical School and in the College of Pharmacy. Through their Michigan Institute of Clinical and Health Research (MICHR), he serves as Regulatory Project Manager and Lead of Regulatory Operations.

  • Laurie  Strehl

    Laurie Strehl

    • Director Business Processes
    • Bristol-Myers Squibb, United States

  • Hans  van Bruggen, MSc

    Hans van Bruggen, MSc

    • Chief Executive Officer and Regulatory Affairs Scientist
    • Qdossier, Netherlands

    He has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of medicinal products for patients. Using that scientific background he approaches interdisciplinary and international processes. Hans has been involved with eCTD submissions from the beginning, back in 2000. Key areas of expertise include: lean authoring of regulatory documents, managing regulatory information and lean data, document and dossier management focusing on reuse rather then recreate.

  • Samuel  Collier

    Samuel Collier

    • Product Integration and Deployment Coordinator
    • Montrium, Canada

  • Rob  Connelly, MBA

    Rob Connelly, MBA

    • Executive Director, Product Development
    • Synchrogenix, A Certara Company, United States

    Rob Connelly, Senior Director, Product Management, Synchrogenix- A Certara Company, brings a wealth of experience from the pharmaceutical and life-science industry, primarily focused on developing the people, processes and products needed to submit compliant regulatory filings with global health authorities. His job responsibilities focus on the management of multiple life-science software product lines and developing new products or services based on market opportunities and requirements. Previous job experience leading project teams in the planning and filing of successful clinical and marketing drug applications with global health authorities.

  • Robert L. Ferendo

    Robert L. Ferendo

    • Consultant-Process & Technology
    • Eli Lilly and Company, United States

  • Ajitha  Gadangi, MS

    Ajitha Gadangi, MS

    • Associate Director
    • Merck & Co., Inc., United States

    Ajitha Gadangi is Associate Director at Merck. She has a Masters in Computer Sciences, and has over 20 years of System and Software Validation experience. She has been working in the Pharma industry for 13 years with increasing responsibilities. She has expertise with Data Management, Document Management, Quality Control, Quality Assurance, Process Management, Project Management. She is a member of the core team that has been worked on implementing eTMF for Clinical Data Management at Merck and has acted as Zone Lead for Data management within TMF Reference Model group.

  • Mary  Gallagher, MS

    Mary Gallagher, MS

    • Principal Consultant
    • Veeva, United States

    Mary holds a MS Degree from Temple University in Quality Assurance/Regulatory Affairs. She has more than 25 years working within the Life Sciences industry, 18 of which were within the Pharmaceutical industry in various capacities: Regulatory Affairs / Operations / Compliance including 2 years in a sterile injectable manufacturing site where part of her responsibilities involved developing and managing the change control process. In addition, Mary was a core team member for defining strategy and facilitating the implementation of a Documentum based system for a global Japanese Pharmaceutical company.

  • John  Jones

    John Jones

    • Independent Contractor, United States

  • Su-Yueh  Lin, MS, RPh

    Su-Yueh Lin, MS, RPh

    • Executive Director, Regulatory Labeling and Promotion
    • Intercept Pharmaceuticals, Inc., United States

    Currently an independent Sr. Regulatory Labeling Consultant, Su has held various levels of positions at Regeneron, BMS, and former Wyeth with global regulatory labeling responsibilities in different therapeutic areas for small molecules and biologic products. Su specializes in end to end labeling process with emphasis on Target Labeling, Labeling Strategy in Product Development, and Labeling Compliance. Su is the Co-Chair of Labeling Working Group for the DIA Regulatory Affairs Community organizing Labeling Conferences. She is a registered pharmacist in Taiwan and in PA, USA and holds a MS degree in Hospital Pharmacy Administration.

  • William  Mandarino, MSc

    William Mandarino, MSc

    • Associate Director, Product License Knowledge Management
    • UCB, Inc., United States

    William (Bill) Mandarino has 16 years experience in the pharmaceutical industry at UCB in Atlanta GA. Prior to that time, Bill was as a clinical researcher for the University of Pittsburgh Medical Center’s Heart Transplant Program. At UCB, Bill has implemented several key global business systems including UCB’s Clinical Data Management System, Electronic Document Management System (EDMS), Publishing Tools, and Registration Tracking System. Bill is currently focused on UCB’s IDMP Standards implementation program and is responsible for product license knowledge management and strategy. Bill has a Master of Science in Bioengineering from the University of Pittsburgh in Pittsburgh PA.

  • Hitoshi  Matsui

    Hitoshi Matsui

    • Advisor
    • CAC Corporation, Japan

    Hitoshi Matsui has been working for CAC EXICARE, Tokyo as a management consultant to provide strategy services relevant to implementation of Content management, Computerized system validation and Pharmaceutical R&D Business process improvement for approximately twelve years. Prior to joining CAC EXICARE, Hitoshi has over twenty years of experience in the pharmaceutical industry. He had engaged in number of responsible roles in R&D Information Management and Computerized System Validation.

  • Heather Susan McIntosh

    Heather Susan McIntosh

    • Regulatory Operations Manager
    • BTG International Inc., United States

  • Joseph  McLaughlin, MBA

    Joseph McLaughlin, MBA

    • Vice President
    • Genpact Pharmalink, United States

  • Frank J. Meloni, PhD

    Frank J. Meloni, PhD

    • Director
    • Janssen Research and Development, LLC, United States

    Frank is the interim head of Regulatory Medical Writing at Janssen Research & Development. He joined Johnson & Johnson in 1998 at McNeil Consumer Healthcare and transitioned to the Pharmaceutical sector in 2007. He received a doctorate in Biology from Bryn Mawr College, an M.S. from Rutgers University and a B.S. from Saint Joseph’s University. Before joining Janssen, Frank was a medical writer at Wyeth and a Research Assistant Professor at the Cardeza Foundation for Hematologic Research at Thomas Jefferson University. He was a Postdoctoral Fellow at Temple University and the University of Pennsylvania Schools of Medicine.

  • Sue  Metz

    Sue Metz

    • President/CEO
    • IRISS Forum, United States

    Sue Metz, Technical VP PAREXEL is a senior regulatory professional with over 30 years of experience in the life sciences industry. She was responsible for the implementation of PAREXEL’s flagship platform, LIQUENT InSight RIM from 2003 to 2014, and is now helping to reinvigorate the platform to enhance our client’s UX and functional needs. Sue is considered a SME for RIM and IDMP and is an active member of the ISO/TC215/WG6, the EMA’s SPOR Task Force, Rutgers University CX Advisory Board and is the CEO/President for the IRISS-forum Organization, a non-profit dedicated to the implementation of regulatory submission standards around the world. She frequently presents as a Subject Matter Expert on RIM and IDMP at Industry Conferences globally.

  • Matthew  Millstein

    Matthew Millstein

    • Senior Manager, Regulatory Affairs
    • Stealth BioTherapeutics, United States

    Matt has 14 years of Regulatory Affairs experience, and is currently a Senior Manager at Stealth BioTherapeutics. He began his career at Biogen, followed by Cubist and Shire, holding roles in Regulatory Operations, Submission Management, and Regulatory Affairs. Matt has substantial Regulatory submissions experience across all phases of development, including NDA/BLA, DMF, CTA, sNDA, OPDP, and IND.

  • Jean M. Mulinde, MD

    Jean M. Mulinde, MD

    • Policy Advisor, Division of Clinical Compliance Evaluation, OSI, OC, CDER
    • FDA, United States

    Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in OND. She received her M.D. and completed a residency in Internal Medicine at the University Of South Alabama School Of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine.

  • Paul  Nalepa

    Paul Nalepa

    • Assoc. Manager, Information Governance & Compliance, Global Quality & Compliance
    • PPD, United States

  • Gerrit  Nijveldt, MSc

    Gerrit Nijveldt, MSc

    • Contractor
    • United States

    Gerrit Nijveldt is senior Director Global Regulatory Affairs Labeling for the therapeutic area Diabetes and Devices for Sanofi in Bridgewater NJ. Gerrit has more than 19 years of experience in Global labeling in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation, including the labeling for multiple development products. Gerrit is also an associate adjunct professor for Temple University School of Pharmacy teaching Global Labeling in the RA/QA Master’s Program. Gerrit earned his MSc in Medical Biology from University of Utrecht in the Netherlands

  • Jonathan  Resnick, PMP

    Jonathan Resnick, PMP

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

    Jonathan Resnick is a member of CDER’s Electronic Submissions Team, with a focus on eCTD and has been with FDA for eight years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

  • Adam  Roth

    Adam Roth

    • Director, Operations
    • Schulman IRB, United States

  • Karin  Schneider, MLIS, MS

    Karin Schneider, MLIS, MS

    • Document Management Enablement Head
    • Janssen Pharmaceuticals, Inc., United States

    She spent 10 years in Switzerland where she discovered her love for cheese and hate for fog but no progress on punctuality whatsoever. Now she is in the US for 18 years still with Johnson & Johnson, still not punctual and still with a solid German accent. She has been in Content Management for all these years but in very different capacities: as information broker, information architect, end user, solution engineer. She is very passionate in what she does and her spongy curiosity leads to many “why”, “what if” questions. After seeing the problems from many different angles, she truly believes RIM is ready for breakthrough innovation to solve what really matters.

  • Peter  Terbeek, MBA

    Peter Terbeek, MBA

    • Senior Director, Publishing and Submission
    • United States

    Peter is the Sr. Director of Publishing & Submissions for Astellas. This global group has responsibility for compiling, dispatching and archiving submissions and ensuring those activities are captured in the appropriate systems. Peter has been involved in multiple global programs targeting process improvements around product change control, document management and master data management. Prior to moving into Regulatory Operations, Peter worked in IT at Astellas focusing on informatics in the areas RA, QA and document management. Peter has a Bachelor’s degree in Mathematics from Austin College in Sherman, TX, and an MBA from the Lake Forest Graduate School of Management.

  • Elizabeth M Turek

    Elizabeth M Turek

    • Head, Knowledge Management
    • Johnson & Johnson, United States

    Beth joined J&J Regulatory Operations in 2015 to design & implement a new regulatory operations organization that serves the needs of the Pharmaceutical, Medical Device & Consumer businesses at J&J. Currently, her group is responsible for optimizing translations, access to Regulatory Requirements, and the optimal use of technology solutions to deliver future state Regulatory capabilities. With >30 years’ experience, 23 years at J&J, Beth has provided regulatory leadership & support for US and global teams for consumer products, medical devices, biologics, and pharmaceuticals.

  • Justin  Wear

    Justin Wear

    • Principal Consultant
    • Electronic Ink, United States

    As a research principal at Electronic Ink, Justin leads design and research projects to help enterprise clients navigate the complex services they provide to their customers (both internal and external) and create new experiences that best meet user, business and technology needs. He earned a master’s degree in engineering design and innovation from Northwestern University and has served as an adjunct instructor and lecturer at Northwestern and Temple University.

  • B.J.  Witkin

    B.J. Witkin

    • Senior Manager, Regulatory Operations
    • Impact Pharmaceutical Services, United States

    B J. “Beej” Witkin has been working in the pharmaceutical industry since 1998. He got his start at GlaxoWellcome working as a trainer, then as a publisher for nonclinical reports, clinical documents, and regulatory submissions. In his career he has published and submitted over a dozen initial INDs and managed over two-dozen more. In 2013 he published and submitted an NDA with over 250 nonclin reports and 28 CSRs. He is currently the Senior Manager of Regulatory Operations for Impact Pharmaceutical Services, a CRO in Research Triangle Park.

  • La Misha  Fields

    La Misha Fields

    • IT Program Manager, Electronic Submissions Gateway, OIMT, OC
    • FDA, United States

    La Misha Fields is the Program Manager of the 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 8 years of FDA experience, including 5+ years in the Center for Drugs. She joined the ESG team in October, 2015 and is currently managing all activities from initiation of new requirements, development, and operations and maintenance.

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