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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

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

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.


Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

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

V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience. Prior to Orion, Bala was the President and CEO of Cabeus, a niche Life Sciences services firm where he was also responsible for vision and strategy for a cloud platform called ReALM® to transform the regulatory value chain for Life Sciences. Bala developed IT strategies and capabilities for Bristol-Myers Squibb, Roche, Aventis, Merrill Lynch, AT&T, Bell Atlantic and IBM. Bala has his PhD and MBA from Rutgers University and MS in Computer Science from NJIT.

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

Vice President, Advisory and Delivery, Epista Life Sciences, United States

Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market strategies and data harmonization. She was named PharmaVoice’s top 100 most inspiring individuals for Mentorship and Team Development and received the esteemed Excellence in Service award from DIA. Brooke has an integral role in shaping the discourse surrounding data and technology in regulatory affairs through her work with DIA as programming chair for the Data & Technology Track and as the co-chair of the DIA RA Community.

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.

Jake  Doran

Jake Doran

Head of Digital, Lykos Therapeutics, United States

Jake Doran is currently the Head of Digital @ MAPS Public Benefit Corporation. In this role, Jake is responsible for overseeing the development and implementation of the digital and IT strategy as the MPBC organization transitions from a clinical research startup to a commercial entity and industry pioneer. Prior to joining MPBC, Jake was the Head of Global R&D IT at Bausch Health. Jake prides himself in being a biologist by study and a technologist by trade and throughout his career has positioned himself at the intersection of science and technology. Earlier in his career, Jake held positions of increasing responsibility at Genpact, Janssen Pharmaceuticals and Schering Plough.

Betsy  Fallen, RN

Betsy Fallen, RN

Consultant, BAFallen Consulting LLC, United States

Ms. Fallen is an authority on the business processes and associated use of information technology in drug development with a focus on regulatory and clinical. A passionate advocate for moving life sciences business on-line, Betsy is an expert on regulatory and clinical operations. Over the two decades of outstanding contributions at Merck, she was recognized for her leadership and excellent representation of the organization on internal transformational teams and in many industry initiatives. Now consulting, she continues to be recognized for her knowledge in technical innovation, process efficiency and ability to assess and assure compliance in documentation, execution and oversight.

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

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

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

Mark A. Gray

Mark A. Gray

Senior Project Manager, DSB, CBER, FDA, United States

Mark has over 30 years’ experience in Information Technology & Management. Mark began his career developing commercial applications and has been working for FDA for over 30 years. Mark’s FDA responsibilities have included software development and project management in CBER; Director of Applications Development & Services in CDER; PDUFA IT Program Director; Director, Division of Data Management Services & Solutions managing CDER’s electronic submission program, and ICH M8 (eCTD) Rapporteur. Mark has been with CBER's data standards group since 2014, and his current responsibilities include representing CBER in the development and implementation of international electronic submission standards.

Sheila  Mahoney Jewels, MBA

Sheila Mahoney Jewels, MBA

Drug Development Multi-Functionalist, 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.

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  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.).

Sarah  Powell, RAC

Sarah Powell, RAC

President, Powell Regulatory Services, United States

Ms. Powell is the President of Powell Regulatory Services. Sarah has 30+ years of experience in pharmaceutical and related regulated industries (Clinical, Quality Control, Regulatory Affairs and Regulatory Operations). In the past 23 years as a consultant, she has assisted clients with projects related to regulatory process improvements, standards development, defining filing strategies and writing/review of submission content. She has extensive experience with projects related to design and implementation of regulatory solutions including document management, submission planning, publishing, and registration management. Sarah is a past executive at Chiron, First Consulting Group and Liquent, and PAREXEL

Michiel  Stam

Michiel Stam

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

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

Stacy  Tegan

Stacy Tegan

Program Director, Transcelerate Biopharma, Inc., United States

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

Brad  Wintermute

Brad Wintermute

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

Kimberly  Belsky, MS

Kimberly Belsky, MS

Reg Policy & Intell and AdPromo, Regulatory Affairs, Independent, United States

Kimberly (Kim) Belsky is a regulatory professional with expertise in Regulatory Policy & Intelligence and AdPromo. With over 30 years of global experience in the medical product industry, including 20+ years in regulatory affairs, Kim's diverse experience including scale up and tech transfer, quality/compliance, advertising & promotion, labeling, and regulatory policy and intelligence. Her background includes Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices. Kim is the co-chair of the DIA AdPromo WG (part of the RegAffairs Community) and is an active member in RAPS. Kim is passionate about networking, learning, and collaboration.

Romuald  Braun, MS, MSc, RAC

Romuald Braun, MS, MSc, RAC

Managing Director, Uanotau Gmbh, Switzerland

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.

Radius  Davenport, PhD

Radius Davenport, PhD

Vice President Regulatory Affairs, Radius Health, 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

Vice President, Vault RIM, Veeva Systems, United States

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

Steve  Gens, MS

Steve Gens, MS

Managing Partner, Gens & Associates Inc., United States

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

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

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.

Natalie  Herr, PhD

Natalie Herr, PhD

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

Ginny  Hussong

Ginny Hussong

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

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

Sandra  Krogulski, MA

Sandra Krogulski, MA

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

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

Shylendra  Kumar, MA, MPH

Shylendra Kumar, MA, MPH

Senior Director, Regulatory Innovations, GSK, 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

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.

Marcel  Lissinna

Marcel Lissinna

Specialist Leader, Deloitte Consulting, United States

Joanne  Malia, MS, MSc

Joanne Malia, MS, MSc

Director, Development Records Management, Regeneron Pharmaceuticals, United States

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

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

Head of Regulatory Operations, PharmaLex , United States

Vada A. Perkins, DrSc, MSc

Vada A. Perkins, DrSc, MSc

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

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

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

Managing Director, Ankura, 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

Managing Partner, Leapahead Solutions, Inc., United States

Cary Smithson is the Senior Director, Business Transformation and Systems Management at PharmaLex and has over 30 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 co-leads the DIA RIM Working Group, 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.

Adair  Turner, MSc, RAC

Adair Turner, MSc, RAC

Sr. Director, Head of Regulatory Affairs US, Cencora Pharmalex, United States

Adair has 20 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 Affairs professionals and is accountable for the overall planning and management of Regulatory Affairs 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 Clinical Trials, European Medicines Agency, Netherlands

Pieter Vankeerberghen studied Industrial Pharmacy, obtained a Ph.D. in Pharmaceutical sciences and holds a master degree in informatics. After working for 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 leading various projects. From 2016 he led their R&D department for clinical trials and unmet medical need. In this role he was a Member State Product Owner for the CTIS project. Since August 2020, he is head of EMA clinical workstream and CTIS programme manager.

Kristin  Wehr

Kristin Wehr

Publishing Associate, Teva Pharmaceuticals, United States

Olga  Alfieri, MBA, MSc, RAC

Olga Alfieri, MBA, MSc, RAC

Senior Director, Global Submission Management & Operations, 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.

Rune  Bergendorff, MSc

Rune Bergendorff, MSc

Partner, International Life Sciences, Implement Consulting Group, Denmark

Rune Bergendorff, Partner at Implement Consulting, boasts two decades of consultancy experience spanning Europe and the US. Educated in IT and business, his focus is centered on delivering sustainable digital transformations that drive business impact and value. Over the past 15 years, he has honed his expertise within Life Sciences, initially in RA and Quality, then expanding into Clinical and Safety. Rune has spearheaded initiatives such as digitalizing regulatory product submissions and implementing AI in safety and clinical data intake. He actively contributed to industry standards, including development of IDMP with ISO and as member of the EMA SPOR task force. Committed to community advancement, he champions improved digital workflows

Dove  Bunkin-Thomas, MS

Dove Bunkin-Thomas, MS

Head of Vendor Oversight and Resource Management for Global Regulaotry Affairs, Amgen, 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, Advarra, United States

Elisa Cascade, chief product officer at Science 37, has devoted more than 30 years to advancing clinical trial technology, direct-to-patient operations, and healthcare strategy. Throughout her career, she has been instrumental in using technology to transform clinical research to better serve all industry stakeholders. Before joining Science 37 as chief product officer, Elisa held a number of high-profile roles, including executive VP and product line executive for eCOA at ERT; chief product officer at DrugDev, an IQVIA Company; and VP of the digital patient unit at Quintiles.

Bernie  Coney, MA

Bernie Coney, MA

Principal Consultant, NNIT, 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

Consultant, Self-employed, 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 Operations 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  DiCicco, PharmD

Robert DiCicco, PharmD

Vice President, Portfolio Management, TransCelerate Biopharma Inc., 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.

Mary  Emanoil, MS

Mary Emanoil, MS

Head, TMF & Registry Operations, Pfizer Inc, United States

Mary has been with Pfizer for over 25 years and has held a variety of positions in information management with extensive experience in regulatory content management. She is currently Senior Director and Lead of the Authoring and Workflow Business Solutions (AWBS) team within the Information Management Center of Excellence. In this role Mary enables business transformation with authoring, quality and workflow solutions focused on business process automation, structured authoring, natural language generation and automated quality checks. Mary has an MS in Information and Library Science from the University of Michigan.

Joel  Finkle

Joel Finkle

Industry Expert, Retired, 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.

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, MS, RAC

Alexander Gaffney, MS, RAC

Executive Director, Regulatory Policy And Intelligence, AgencyIQ by POLITICO, United States

Alexander Gaffney is the Executive Director of Regulatory Policy and Intelligence for POLITICO's AgencyIQ, where he leads a team of more than a dozen regulatory intelligence professionals. Alexander has worked in regulatory for more than a decade, including at the Regulatory Affairs Professionals Society (RAPS) and PricewaterhouseCoopers (PwC). At AgencyIQ, his research, insights and analysis is relied upon by the regulatory teams of many of the world's leading companies. He is also the author of AgencyIQ's flagship daily newsletter, "FDA Today."

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

Sr. Consultant, Vault RIM Business Process Consulting, Veeva Systems, 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

Associate Director Global Regulatory Policy & Intelligence , Gilead Science, 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

James  Nichols

James Nichols

Director of Sales & Account Management, Lorenz Life Sciences Group, United States

Jim has nearly 30 years of experience with compliant software solutions for regulated processes in both the insurance and life sciences industries. He has held senior management positions at Intracorp (a CIGNA company), Liquent, Thomson Reuters, ePharmaSolutions, DitaExchange and Cunesoft. Following the merger of Cunesoft into Phlexglobal, Jim is now the Chief Product Officer at Phlexglobal. Phlexglobal is now part of Cencora PharmaLex. Jim 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

VP, Vault R&D and Quality, Veeva Systems, United States

As Vice President of R&D and Quality Strategy at Veeva, Jim is responsible for customer engagement, market adoption, and strategic alliances. For the last 20 years, Jim has held various senior positions in life sciences technology, where he has led software delivery and sales efforts in clinical operations, regulatory, clinical data standards, and content management. Jim holds an MBA in information systems from Villanova University and a B.S. in neuroscience from the University of Scranton.

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  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.

Mitchell  Seymour, PhD, RAC

Mitchell Seymour, PhD, RAC

Principal/Founder; Lead, Regulatory Operations, Biohaven Pharmaceuticals, 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

CSO, Qdossier, a Celegence Company, Netherlands

Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.

Samuel  Collier

Samuel Collier

Product Integration and Deployment Coordinator, Montrium, Canada

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.

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

Su-Yueh Lin

Sr. Labeling Consultant, Regulatory Affairs, SYL Regulatory Consulting, Taiwan

Su has held various levels of positions at Intercept, Regeneron, BMS, and former Wyeth with global regulatory labeling and promotion responsibilities in different therapeutic areas for small molecules and biologic products. Su specializes in end to end labeling process with emphasis on Target Labeling planning, Labeling Strategy in Product Development, and Labeling and Promotion Process and Compliance. Su was the Co-Chair of Labeling Working Group for the DIA Regulatory Affairs Community organizing Labeling Conferences and Hot Topics sessions. She is a registered pharmacist 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 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.

Matthew  Millstein

Matthew Millstein

Global Regulatory Team Lead, Sanofi, 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

Associate Director, Division of Clinical Compliance Evaluation, OSI, 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

Global Labeling Consultant , Opus Regulatory Inc., United States

Gerrit Nijveldt is currently Labeling consultant with Opus Regulatory. Gerrit has more than 25 years of experience in Global labeling. He has a broad experience in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation, including the labeling for multiple development products (early phase to approval) and labeling for devices. Gerrit was also an associate adjunct professor for Temple University School of Pharmacy teaching Global Labeling in the RA/QA Master’s Program till 2022. 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 Division of Data Management Services and Solutions, with a focus on eCTD and has been with FDA for 13 years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

Adam  Roth

Adam Roth

Director, Operations, Schulman IRB, United States

Karin  Schneider, MLIS, MS

Karin Schneider, MLIS, MS

Associate Director, Johnson & Johnson Innovative Medicines, United States

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

Peter  Terbeek, MBA

Peter Terbeek, MBA

Senior Director, Regulatory Operations, United States

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

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, 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.

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