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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

    • President and CEO
    • Cabeus, Inc., 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

    Chris has worked in the regulatory setting for over 19 years. By starting out building CANDAs for large Pharma, he has acquired extensive electronic submissions experience on cutting edge technology. With scores of global filings, his experience includes several NDA submissions across four organizations. Chris specializes in leading implementation projects related to submissions and RIM process improvements focused on global harmonization. With his MBA degree, RAC certification, change agent specialization and biotech management experience, he enjoys developing teams to improve electronic submission processes. Chris has a passion for travel focused on mountain adventures with his family and friends.

  • Brooke  Casselberry, MS, RAC

    Brooke Casselberry, MS, RAC

    • Owner
    • Cyan Life Sciences, United States

    Brooke is the founder and lead consultant with Cyan LifeSciences focusing on consulting support services for customers in project management, methodology development, knowledge transfer and training, process development, and software selection and procurement lifecycle. She is heavily involved with blockchain initiatives within the Denver metro area and volunteering her time with networking communities like DIA, the Government Blockchain Association (GBA), and mentoring others in Regulatory for Life Sciences.

  • 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 has a Masters of Public Health from Johns Hopkins University and has been working in Regulatory since 2001. In her current role at the University of Pennsylvania, Perelman School of Medicine in the Gene Therapy Program (GTP), she works as a Director of Regulatory Affairs. Michelle spent the first 14 years of her career working in multiple regulatory roles at Merck & Co., Inc. and then moved to PAREXEL International as a Regulatory Consultant.

  • Jake  Doran

    Jake Doran

    • Chief Technology Officer
    • Genpact Pharmalink, United States

    Jake has 20+ years of life sciences leadership experience across various roles. Jake has recently left corporate executive role to form LiST Innovations, an organization dedicated to assisting life sciences companies in their quest to implement innovative technology solutions. Prior to this venture, Jake held key leadership positions with Johnson & Johnson, supporting Global Regulatory Affairs and the Clinical Development organizations. In addition, Jake has also worked closely with various industry trade groups, where he is a key partner with the FDA and an industry advocate for the PDUFA V and upcoming PDUFA VI technology implementation strategies.

  • Betsy  Fallen, RN

    Betsy Fallen, RN

    • Consultant
    • BAFallen Consulting LLC, United States

    Betsy is an expert on business processes and technology. After 25 years at Merck & Co., as an independent contractor, she now supports sponsors, vendors and clinical sites in their innovation journey while ensuring compliance. Trained as an RN, she is dedicated to ensuring the patients experience is considered as the drug development process continues towards innovation.

  • Ron D. Fitzmartin, DIAFellow, PhD, MBA

    Ron D. Fitzmartin, DIAFellow, PhD, MBA

    • Senior Advisor, Office of Strategic Programs, CDER
    • FDA, United States

    Ron Fitzmartin is Sr. Advisor in the Office of Strategic Programs, CDER, FDA where he is focused on electronic submissions and standardized study data to support regulatory review. Prior to FDA, Ron was VP, Informatics at Daiichi Sankyo, VP, Biostatistics and Data Management at Daiichi Medical Research, and Exec Dir, Biostatistics and Data Management at Purdue Pharma L.P. Ron was elected President of the DIA 07-09. Ron received a PhD in statistics from the University of Maryland.

  • 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

    • Principal Consultant
    • smjstrategies, inc., United States

    Sheila has over 20 years’ experience in regulatory, clinical and IT, having operated on both the sponsor and vendor sides. Her current focus is augmenting and expediting critical innovation through the application of opportunity Win-Loss Review research to vendor corporate strategy. Sheila has, an eMBA from Columbia University and BA from Smith College.

  • 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

  • Daniel F. Orfe, MS

    Daniel F. Orfe, MS

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

    Dan has 20+ years of experience in Regulatory Operations and Submission publishing. Dan’s a subject matter expert in "cloud-based" eCTD and EDMS solutions providing consultation via Regulatory eSubmissions, LLC. At Radius he had responsibility for activities associated with production/delivery of regulatory filings & EDMS processes/tools. At Teva he oversaw an initiative to harmonize submission publishing and document management. At Datafarm he had responsibility for global Submission and Publishing Services. At Merck, Dan established and managed electronic submission production group. Speaker/session chair at 11 DIA Annual meetings, DIA EDM Conference Co-chair from 2009 through 2011 and DIA RSIDM Conference program committee member.

  • Sarah  Powell, RAC

    Sarah Powell, RAC

    • President
    • Powell Regulatory Services, United States

    Ms. Powell is the President of Powell Regulatory Services. Sarah has over 30 years of experience in pharmaceutical and related regulated industries (Clinical, Quality Control, Regulatory Affairs and Regulatory Operations). In the past 16 years as a consultant, she has assisted clients with projects related to regulatory process improvements, standards development, defining filing strategies and writing and review of submission content. She has extensive experience with projects related to design and implementation of regulatory solutions (requirements definition through validation) including document management, submission planning, publishing, and registration management.

  • Michiel  Stam

    Michiel Stam

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

    Michiel Stam is a Regulatory Information Scientist at eCTDconsultancy B.V. and has a strong focus on electronic submissions for Drug Regulatory Affairs and Pharmacovigilance. In this role he has lead various submission and information management projects for Pharma and Biotech companies. eSubmission projects include preparation and submission of initial marketing authorization applications and post-authorization maintenance for Agencies in the EU (CAPs, NAPs and MRP/DCP), US (NDA and BLA) and other regions, including GCC and Swiss Medic submissions. Since 2011 Michiel has worked on XEVMPD and IDMP (Identification of Medicinal Products) related topics, Registration Tracking and Semantic interoperability.

  • Stacy J. Tegan

    Stacy J. Tegan

    • Manager, Regulatory Technology Consulting
    • Accenture Accelerated R&D Services, United States

    Stacy Tegan is a Manager of Regulatory Technology Consulting in Accenture Accelerated R&D Services, bringing 18+ years of experience in the Pharmaceutical industry. She works with pharmaceutical and biotech organizations to improve R&D processes.

  • Brad  Wintermute

    Brad Wintermute

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

  • Kimberly  Belsky, MS

    Kimberly Belsky, MS

    • Senior Director, Regulatory Affairs, Regulatory Policy and Intelligence
    • Mallinckrodt Pharmaceuticals, United States

    Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals. In latter role, Kim was responsible for a diverse portfolio that included Rx drug (brand and generic) OTCs/Nutritionals/Cosmetics, and devices. Kim has 26 years of pharma experience, with 16 in regulatory affairs.

  • Romuald  Braun, MSc

    Romuald Braun, MSc

    • Vice President Strategy Life Sciences
    • AMPLEXOR, Switzerland

    Since 1992 Romuald has been working in roles related to Compliance, Document Management, Content Management in the Life Sciences industry. Romuald has been playing roles on the client side and in consulting, in delivery and in sales, in project roles and in line responsibility. He worked in client server and in cloud environments, in Europe and in US. Romuald is holding the academic degree of Master of Drug Regulatory Affairs in addition to his Engineer diploma in Data Technology. Romuald has been also a frequent speaker on topics relating to content management adoption in Life Sciences. Romuald is located in the Zürich area in Switzerland but is used to work in global environment.

  • Dale  Cooke, MA

    Dale Cooke, 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, 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

    • Senior Director, Regulatory Market Strategy
    • 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 strategy development, RIM, industry benchmarking and organizational performance. His early career was spent at Johnson and Johnson in a variety of management positions and then moved into consulting to lead several 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 was recently named to the PharmaVoice 100 for 2017.

  • Ashok  Ghone, PhD

    Ashok Ghone, PhD

    • Vice President, 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

    • Data Standards Program Manager, OD, BSS, CBER
    • FDA, United States

    Virginia Hussong is Program Manager for Data Standards in the Center for Biologics Evaluation and Research, U.S. FDA, and has been with FDA for 13 years, overseeing implementation of data standards and electronic submissions. Her current focus is data standards strategy, development and related policy within CBER, including collaboration with other FDA Centers, government agencies and SDOs to achieve a better quality review process.

  • Sandra A. Krogulski, MA

    Sandra A. Krogulski, MA

    • Regulatory Operations Submission Manager
    • Accenture, United States

    Sandy is a Submission Manager in Accenture’s Global Regulatory Operations team. In this role, she supports clients through life cycle maintenance through training, overseeing actual submissions and consulting. Sandy oversees the management of numerous regulatory submissions ensuring projects follow global regulatory requirements and meeting submission timelines. Sandy supports a variety of submission types including CMC supplements, labeling supplements, Advertising/Promotional Labeling submissions and other amendments. Sandra has also supported original applications and regions including Canada, EMA and other rest of world dossiers. She has spoken at DIA RSIDM, and is published on Promotional, Labeling and Advertising submissions.

  • Shylendra  Kumar, MA, MPH

    Shylendra Kumar, MA, MPH

    • ACUTA LLC, 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 Life Sciences Group, United States

    Jared Lantzy is the Manager of Global Regulatory Agencies and Processes at LORENZ International LLC. His primary expertise is in the development and maintenance of regulatory data standards for human pharmaceutical registration. Mr. Lantzy is a former member of the ICH M8 Expert Working Group tasked with developing the next major version of the eCTD, eCTD v4.0. Mr. Lantzy’s other experience includes Project Management, IT Business Analysis, and Hardware and Software Systems Analysis. 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, MS, MSc

    Joanne S. Malia, MS, MSc

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

    Joanne Malia is Associate Director, Clinical Documentation Management at Regeneron Pharmaceuticals. She has worked in clinical research at various global biotech, device, CRO and big pharma companies in the areas of quality management, trial master file and computer system validation for over 25 years. She is a frequent presenter and workshop leader. She has a Bachelor’s degree in Biology and Master degrees in both Microbiology and Management.

  • 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. 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). Timm was Merck Serono representative in the EFPIA Regulatory Information and Technology Strategy Committee, in the EFPIA eCTD Focus Group as well as the EMA “Article 57 Implementation Working Group”.

  • Vada A. Perkins, BSN, MS, MSc, RN

    Vada A. Perkins, BSN, MS, MSc, RN

    • Founder and Managing Principal
    • Identifica, United States

    Vada A. Perkins is the Founder and Managing Principal of IDENTIFICA LLC, an independent global regulatory consulting practice offering Global Product Lifecycle (GPLC) data governance solutions in conformance with regional regulatory requirements and international data standards to optimize business for clients from concept to execution.

  • Anjana  Pindoria

    Anjana Pindoria

    • Project Strategy Manager
    • 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

    • Principal Consultant
    • OpenText Corporation, 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

    • Principal Consultant, Director Regulatory Operations
    • PharmaLex GmbH, Germany

    Adair has 15 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

    • Coordinator
    • FAGG AFMPS, Belgium

    Pieter Vankeerberghen studied Industrial Pharmacy, obtained a Ph.D. in Pharmaceutical sciences and holds a 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. Currently, he leads the ICT developments and projects for the Belgian Agency FAMHP and is chair of the EU Veterinary Harmonisation Group – for electronic submissions for veterinary medicinal products. The CVMP endorsed him as VICH expert for the EU. He also plays a leading role in the harmonisation group between agencies and applicants on common business processes related to esubmission.

  • Kristin  Wehr

    Kristin Wehr

    • Publishing Associate
    • Teva Pharmaceuticals, United States

  • Olga  Alfieri, MBA, MSc, RAC

    Olga Alfieri, MBA, MSc, RAC

    • Director
    • Eisai Inc, 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

    • Line Manager
    • NNIT, Denmark

    Rune Bergendorff is Managing Consultant and has been working for NNIT for the past 5 years – with a special focus on regulatory affairs. Rune is global IDMP lead and has been working on IDMP projects since the xEVMPD deadline. Rune is a member of the ISO TC215 WG6, developing the IDMP guidelines as well as the EMA IDMP Task Force and is involved in a series of projects across Scandinavia, Europe and USA.

  • Dove Alexandra Bunkin-Thomas, MS

    Dove Alexandra Bunkin-Thomas, MS

    • Regulatory Writing Senior Manager
    • 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, 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 clinically-oriented education systems for patients and healthcare professionals for more than 20 years. Eric co-founded and led the design and development of the SecureConsent electronic informed consent form (eICF) product lines, one of the first eICF systems to market and the result of years of deep research, regulatory alignment and UX testing. These systems have now been successfully deployed in dozens of studies across the globe.

  • Meghan Alice Demollari

    Meghan Alice Demollari

    • Submission Project 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

    • Vice President, Clinical Innovation and Digital Platforms
    • GlaxoSmithKline, United States

    Rob DiCicco is the Vice President of Clinical Innovation and Digital Platforms at GSK. He is the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate and one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over 25 years of experience in clinical development. His area of expertise includes clinical pharmacology and experimental medicine, clinical trial design, project management and ethics in human research.

  • Mary  Emanoil, MS

    Mary Emanoil, MS

    • Senior Director, Content Management and Authoring, Information Management
    • Pfizer Inc., United States

  • Joel  Finkle

    Joel Finkle

    • Director, Regulatory Innovation & IDMP Strategy
    • ACUTA LLC, 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. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

  • 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

    Christopher P Hanna, PhD

    • Principal
    • Kattner-Thalmann Partners, United States

    Chris has over 20 years’ experience in process excellence within the life science industry. He combines a background in drug development process innovation with many business process improvement projects, with a particular focus on process excellence for the various operations and functions within pharmaceutical regulatory affairs. Chris holds a PhD in Analytical Chemistry, is a Certified Lean Six Sigma Master Black Belt (MBB) and Project Management Professional (PMP), and has published on and been awarded numerous patents for process innovations in the course of his career.

  • 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  Huddle

    Emily Huddle

    • Regulatory Intelligence Manager
    • Gilead Sciences, Inc., 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

    • 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

    • Senior Director, Vault RIM
    • 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

    • Digital Health Technologies, Transformative Innovation, and RWE Analysis
    • Mallinckrodt Pharmaceuticals, 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

    • Regulatory Affairs Scientist
    • eCTDconsultancy B.V., Netherlands

    Hans worked for over 30 yr in Global or EU pharmaceutical industry. He held various scientific positions in Nonclinical Development and Regulatory Affairs. Since 1999 he has been involved in datamodeling for electronic maintenance, storage and exchange of regulatory information. Hans approaches business processes from an adequate benefit-risk evaluation of drugs for the patients. Therefore, he breaks down silos, applies innovative and intuitive solutions and works towards single data sources.

  • Samuel  Collier

    Samuel Collier

    • Product Integration and Deployment Coordinator
    • Montrium, Canada

  • Rob  Connelly, MBA

    Rob Connelly, MBA

    • Senior Director, Product Management
    • Synchrogenix, United States

    Rob Connelly brings a wealth of experience in regulatory operations and electronic publishing to GlobalSubmit, having developed a variety of internal systems and overseen the submission of marketing applications to several countries during his nearly 20 years in the life science industry. Mr. Connelly successfully scaled and presided over a growing regulatory operations group at ViroPharma, and fulfilled a variety of roles in regulatory operations at GlaxoSmithKline. His expertise includes evaluating and working with dozens of publishing, tracking and document management systems, and customizing those solutions to function efficiently within the parameters set forth by individual organizations with unique environments.

  • 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

    • Regulatory Labeling Consultant
    • Independent Consultant, 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

    • Commissioner
    • CAC Croit 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

    • Vice President, Technical
    • PAREXEL International, United States

    Sue Metz, Vice President, Technical, at PAREXEL International, is a senior regulatory professional with over 35 years of experience designing software, processes, and services in the life sciences industry. She was responsible for the initial implementation and ongoing design of PAREXEL’s LIQUENT InSight RIM Platform from 2003 to 2014. Sue is an active member of the EU ISO IDMP/SPOR Task Force and PMS subgroup, the US TAG ISO/TC 215/WG6, the IRISS IDMP Leadership Team and Vice President of the IRISS Executive Committee.

  • 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

    • Senior Policy Advisor, Office of Scientific Investigations, 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

    • Senior Director of Labeling
    • Sanofi US, 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

    Jonathan Resnick

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

    Jonathan Resnick has been with FDA since January 2011. He is currently a Project Management Officer with Office of Business Informatics where he advises on eCTD and guidance as member of CDER’s Electronic Submissions Team. Mr. Resnick has been involved in a number of projects within CDER, working with stakeholders to identify and fulfill business objectives. Prior to joining FDA, Mr. Resnick 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

  • Peter  Terbeek, MBA

    Peter Terbeek, MBA

    • Senior Director, Publishing and Submission
    • Astellas, United States

    Peter is the Senior 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 6 years of FDA experience, including 5+ years in the Center for Drugs. Ms. Fields completed her bachelor’s degree in Computer Networking and her master’s degree in Business Administration at Strayer University.

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