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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2017 7:00 AM - Feb 08, 2017 5:00 PM

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

Regulatory Submissions, Information, and Document Management Forum


Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

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

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

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.

Cindy  Chiu

Cindy Chiu

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

Cindy Chiu is a Senior Director in Global Regulatory Affairs and Clinical Safety group at Merck & Co. She has over 20 years of experience in the pharmaceutical and energy industries, focusing on post-merger process integration and operations excellence. She has served in various leadership roles overseeing project management, business process improvement and change management initiatives. In her current role at Merck & Co., she is the Lead of the Regulatory Content Authoring and Archiving Management group. Prior to Merck, she worked as a management consultant, where she assisted clients with change management and business process redesign as a result of merger activity or technology integrations.

Steven  Clark, MSc

Steven Clark, MSc

Director, Amgen, United Kingdom

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.

Sholeh  Ehdaivand

Sholeh Ehdaivand

Managing Partner, Marlee Clinical Research, United States

Sholeh is an internationally known TMF Subject Matter Expert with over 15 successful years of experience in the Clinical Research Industry. Her experience includes the TMF Reference Model Subject Matter Expert, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations, electronic document management, regulatory submissions, quality control processes and implementation and regulatory inspection preparation and participation. She is currently Principal Consultant and President and CEO of LMK Clinical Research. She is also the Facilitator for the Metrics Champion Consortium's (MCC) TMF initiative.

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.

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.

Ty  Molchany

Ty Molchany

Director, Consulting Expert, CGI, United States

Ty Molchany has been working on content management systems in the regulated pharmaceutical and healthcare industries for the past 15 years. He is a principal in the Information Management and Regulatory groups at CGI and has worked to advise clients on industry best practices and address client specific business needs to develop and implement industry leading solutions. As a volunteer, Ty is a member of the DIA EDM Reference Team SIAC and leads the contributions and updates to the labeling portion of the DIA EDM Reference model.

Theresa  Mullin, PhD

Theresa Mullin, PhD

Associate Center Director - Strategic Initiatives, CDER, FDA, United States

Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations for 2017 reauthorization of the Prescription Drug User Fee Act and also led the 2002, 2007 and 2012 PDUFA reauthorization cycles providing $1B in annual funding.  She received the 2019 Reagan-Udall Foundation Leadership Award for Innovations in Regulatory Science, US Food and Drug Law Institute 2017 Distinguished Service and Leadership Award, 2011 Presidential Rank Award for Distinguished Service, for Meritorious Service in 2006. 

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.).

Sudip  Parikh, PhD

Sudip Parikh, PhD

Senior Vice President and Managing Director, DIA Americas, DIA, United States

Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

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.

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

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.

Michiel  Stam

Michiel Stam

Management Consultant, MAIN5 Gmbh & Co. Kgaa, Germany

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.

Dimitri  Stamatiadis, PhD, MBA

Dimitri Stamatiadis, PhD, MBA

CEO, Maia Consulting, Switzerland

Dr. Stamatiadis graduated from the University of Patras with a BS in Biology and with a Masters degree and a PhD from the University of Paris VI. Subsequently, he obtained an MBA from the University “La Sorbonne”. Dr Stamatiadis has more than 25 years Pharmaceutical industry experience in Europe and the USA. In 2012 he founded MAIA Consulting based in Geneva, Switzerland. Dr Stamatiadis has a long experience in deploying enabling technologies in small and large companies. He is an active member of the DIA, a seasoned presenter and author of several articles on digital technologies in Pharmaceutical R&D.

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.

Jamie  Toth, MS

Jamie Toth, MS

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

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

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.

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.

Emily  Hall

Emily Hall

Associate Director, Regulatory Operations, ACADIA Pharmaceuticals Inc., United States

Emily Hall, Senior Manager Regulatory Operations, Polaris Pharmaceuticals, Inc. (San Diego, CA). Seasoned Regulatory Affairs professional experienced in successfully managing projects both domestically and internationally. Extensive project management experience leading numerous development and improvement teams including multi-national, multi-cultural teams.

Adam  Kroetsch

Adam Kroetsch

Research Director, Biomedical Information and Regulatory Policy, Duke-Margolis Center For Health Policy, United States

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.

Elizabeth  McLellan

Elizabeth McLellan

Director of Compliance and Quality, Suvoda, United States

Meghan  Mendoza, MBA, RAC

Meghan Mendoza, MBA, RAC

Senior Manager, Regulatory Operations, Amgen, Inc., United States

Meghan Mendoza is a Senior Manager of Global Regulatory at Amgen. She serves as the North American Publishing Lead with specific responsibility for the United States and Canada. Meghan has 11 years’ experience working in the biotechnology industry. Prior to leading a Publishing Organization, she served as one of the US Regulatory Information Management Leads with specific responsibility for cross functional interactions and mergers and acquisitions. She’s held various positions throughout Regulatory and Safety. Meghan holds a Masters in Business Administration and has earned her RAC credential from Regulatory Affairs Professional Society (RAPS).

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.

Lisa  Mulcahy

Lisa Mulcahy

Owner, Principal Consultant, Mulcahy Consulting, LLC, United States

Lisa has 28+ year career in the pharmaceutical industry, in the areas of Clinical Operations and Quality Management. She became an independent consultant in 2007 to focus solely on the Trial Master File management process. She assists clients with improvement of their current state and set up and use of eTMF systems. She is also experienced in the quality assessment of study-specific TMFs. Lisa is a co-founder and a current Steering Committee member of the volunteer team of industry representatives that created and maintains the TMF Reference Model. She led the team of industry representatives who recently reviewed and revised the Framework for the Destruction of Paper, v2.0 that was organized and accomplished through the DRM Community.

Matt  Neal, MA

Matt Neal, MA

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

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

Dawn M Niccum, BSN, MS, RN, PMP

Dawn M Niccum, BSN, MS, RN, PMP

Director, Quality Assurance, Inseption Group, United States

Dawn Niccum is Director, Quality Assurance for the inSeption Group and responsible for all areas of QA including compliance, Policies and SOPs, and training. She was formerly with Endocyte, Inc. With over 20 years of pharmaceutical experience, Ms. Niccum holds a Master’s Degree in Regulatory Affairs and Quality Compliance, certifications as a Clinical Research Associate (CCRA), Registered Quality Assurance Professional – GCP (RQAP-GCP) and Project Manager (PMP), and is a registered nurse.

Patti  Palm-Principe, MS

Patti Palm-Principe, MS

Client Engagement Liason Lead, Orion, United States

Patti Palm-Principe, Director of Client Services for Cabeus, Inc., a niche firm providing information management products, solutions & services for Life Sciences. Patti has been recognized as an energetic & inspired IT professional supporting teams from R&D to Manufacturing. She has led the delivery of systems for Dossier & Document Publishing, Regulatory Commitment Management & Information Management, CMC Authoring & Change Control, Quality Systems (GCP & GMP) & alignment of data & processes across business units. Prior to Cabeus, Patti was with Bristol Meyers Squibb where she was recognized as a cross functional team leader thinking strategically & delivering solutions that enhanced business processes & more importantly data quality.

Timm  Pauli

Timm Pauli

Head of Regulatory Operations, PharmaLex , 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.

Kevin  Remphrey

Kevin Remphrey

, Merck, United States

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.

Karin  Sailor

Karin Sailor

Consultant , SRO, Inc, United States

Karin Sailor is a global regulatory professional with 23 years of experience in the medical device industry. She has experience in both regulatory affairs and regulatory operations. Her experience includes work in small, medium and large medical device companies, as well as industry leadership through trade associations and regulator groups.

Mary Ann  Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA, United States

Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in many of the Center’s strategic initiatives including decision support, data standards, program analysis, IT, informatics and governance. Ms. Slack serves on several Boards and Committees where she supports FDA’s needs and perspectives.

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.

Akira  Yamaguchi, MBA

Akira Yamaguchi, MBA

Chief Technical Officer, LORENZ Life Sciences Group, United States

After an international career in management consulting and information technology at Software AG and Comshare, Akira Yamaguchi joined LORENZ Life Sciences in 1995. His initial role was software development in the field of electronic submissions, achieved in 2001 with the release of docuBridge as a major company milestone. In 2003, Mr. Yamaguchi became responsible for LORENZ' overall software product development. In his Project SME role, Mr. Yamaguchi advises larger customer implementation projects. His current task is to develop the strategic directions of LORENZ' software portfolio.

Jack  Yeager

Jack Yeager

CEO, Sylogent, United States

Jack has leveraged his interest in design, technology and automation to build a career in software development. He is currently focused on information automation solutions for the life sciences, insurance and lending industries. “These heavily regulated industries have no choice but to automate their information workflows as they grapple with fewer resources, shorter timelines and more public date disclosure”, stated Yeager.

Hermineh  Aghanian

Hermineh Aghanian

Regulatory Operations Senior Manager, Amgen, United States

Hermineh Aghanian is a Sr. Manager of Global Regulatory Affairs and Safety Operations at Amgen. She serves as the Management of Regulatory Information Lead responsible for the US, CA and Asia Pacific regions. Hermineh has 15 years of experience working in the biotechnology industry. Prior to moving into a Regulatory Operations role, she held various positions throughout Regulatory and started her career in the department of Pharmacokinetics and Drug Metabolism. Hermineh holds a Masters in Regulatory Science from University of Southern California. In 2008, she earned her RAC credential from the Regulatory Affairs Professional Society (RAPS).

Cathy  Carfagno

Cathy Carfagno

Associate Director Merck IT, Merck & Company Inc., United States

Jillian E. Carinci, MS

Jillian E. Carinci, MS

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

Jillian Carinci is Sr. Director, Head of Submission Sciences group at Biogen. Jillian leads Biogen’s Global Delivery Managers and is responsible for overseeing global submissions, establishing processes, ensuring compliance, robust submission planning, tracking metrics, high quality submission delivery and process improvements. Jillian began her career at Octagon Research Solutions before transitioning to Accenture. During her tenure at Accenture Jillian partnered with sponsors to manage numerous regulatory submission projects, ensuring compliance with global regulatory requirements, delivering within scope, on time, and with the highest quality.

Thomas  Christensen, RAC

Thomas Christensen, RAC

Senior Regulatory Affairs Manager, SynteractHCR, United States

Thomas has 15+ years industry experience in Regulatory Affairs focusing on document management, publishing and submission of applications / authorizations. Managed electronic publishing projects for submission to competent authorities this includes submission life-cycle management and maintenance during approval and post-marketing.

Sandra  Herder

Sandra Herder

Director Regulatory Operations, The Medicines Company, United States

Lana Jokhan Holder, MS

Lana Jokhan Holder, MS

Sr. Project Manager, Life Sciences Solutions Transperfect, United States

Lana Holder is a Senior Project Manager at TransPerfect Life Sciences. Lana is responsible for maintaining the quality of client Trial Master File integrity, eTMF contents and management. She also works in conjunction with the Operations Team as well as the Global Document Management Team. Prior to her work at TransPerfect Life Sciences, she worked at Integra life Sciences as part of their Corporate Regulatory Affairs Team in partnership with operations, manufacturing, quality systems and engineering to facilitate overall Regulatory Compliance, with Johnson & Johnson, as well as at Merck & Co. Lana holds a MS degree in the Biological Sciences and Molecular Biology from CW Post, Long Island University, New York.

Thomas  Hornbaek Svendsen, MS

Thomas Hornbaek Svendsen, MS

Managing Consultant, NNIT A/S, Denmark

Thomas Hornbaek Svendsen works as managing consultant at NNIT and has more than 20 years of consulting experience within the life sciences domain with special focus on regulatory affairs and key expertise within document management, submission management and registration tracking. Thomas has recently been part of several IDMP projects across Europe as project manager and subject matter expert.

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.

Rick  London

Rick London

Product Manager, GlobalSubmit, United States

Mr. London could be considered a modern day polymath. He has pioneered a number of products for the digital age including applications, products and services focused on consumer based design that deliver high adoption, user experience and performance. He is Product Manager for GlobalSubmit’s COLLABORATE, a regulatory and submissions focused DMS for Life Science. Mr. London is adjunct professor of Gamification in Business Marketing and Enterprise Applications at Villanova University, pioneered the development of environmentally responsible printing, founded an online rental marketplace for Italian villas, teaches advanced 5-string banjo and an author of 5 contemporary art photography books.

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.

Aaron  Niman, MPH

Aaron Niman, MPH

Research Officer, Office of Surveillance and Epidemiology, CDER , FDA, United States

Mary Anne Potok

Mary Anne Potok

Technical Manager, Regulatory Operations, MMS Holdings Inc., United States

Mary Anne Potok is a Regulatory Operations Technical Manager, having joined MMS Holdings in Canton, MI, in 2013. She serves as Global Resource Manager for the Regulatory department and shares resourcing responsibilities within the MMS-Asia headquarters in Bangalore, India. She brings nearly 15 years of experimental and operational experience in the academic, clinical, and pharmaceutical arenas. Her campaigns for organizational efficiency, inter-departmental cooperation, and global integration have helped pharma partners of all sizes achieve success. She has a strong professional interest in clinical trial transparency and working with small to mid-sized pharma clients as they navigate the electronic submission process.

Beth  Robinson

Beth Robinson

Executive Director, Clinical Compliance and Operations, Horizon Pharma, United States

Olaf  Schoepke, PhD

Olaf Schoepke, PhD

Vice President, Regulatory Solutions, Samarind, United Kingdom

Dr. Olaf Schoepke studied Computing Sciences in Germany and holds a PhD in Computer Architecture from Bath University (UK). He is now the Director of Strategic Development at Samarind Ltd., having worked for PricewaterhouseCoopers, advising pharmaceutical companies worldwide on document and submission management.

Angela  Shain

Angela Shain

Sr. Manager, Regulatory Operations, Amgen, United States

Angela has been at Amgen for 10 years and her current role is Manager, Global Regulatory Affairs and Safety Operations. She currently leads Global Out-licensing and Integrations for Regulatory Operations. During her tenure in Regulatory Operations, she has led the US RIM group as well as the Global Site Initiation team through organizational changes and developed processes to support the changes. Previous to Amgen, she worked at numerous clinical research sites as a Certified Clinical Research Coordinator in multiple specialty disciplines.

Vikesh  Srivastava

Vikesh Srivastava

Associate Director, Business Informatics Division, HPFB, Health Canada, Canada

Vik is responsible for the strategic and operational leadership of the HPFB IT investment plan and governance aimed to modernize and drive efficiencies within the regulatory program areas. Vik holds an Undergraduate Degree in Biochemistry & Finance from the University of Ottawa, second Undergraduate Degree in Computational Biology/Computer Science Graduate Degree in Genomics & Computer Science from McGill University.

Lise  Stevens

Lise Stevens

Prinicpal Owner , Saturn Services LLC, United States

Kevin  Tompkins, MBA

Kevin Tompkins, MBA

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

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

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.

Jan  Voskuil

Jan Voskuil

CEO, Taxonic, Netherlands

After obtaining a PhD in theoretical linguistics, Jan worked for several start-ups in the field of artificial intelligence. Jan has worked as senior solution architect at Logica and was involved in several large-scale, high-profile innovation programs. Jan is a technology evangelist in the field of Linked Data and Semantic Web technology, and specializes in language processing, controlled vocabularies and business glossaries. Jan is currently employed as CEO of Taxonic, which he co-founded in 2012. Taxonic is a consultancy that focusses on applying Linked Data technologies to real world business problems.

Aloka  Chakravarty, PhD

Aloka Chakravarty, PhD

Director, Data Analytics, Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States

Dr. Aloka Chakravarty is currently the Sr. Statistical Advisor in the Office of the Commissioner, FDA for real-world data and evidence activities related to collaborations on COVID-19 and others. She is also working on select strategic data initiatives at FDA with the Chief Data Officer.Prior to that, she was the Deputy Director of the Office of Biostatistics in CDER, FDA. She is an internationally recognized thought leader in multi-regional clinical trials, safety evaluation, real world data and evidence, surrogate markers and biomarkers in drug development. Dr. Chakravarty served as an Adjunct Faculty in Department of Statistics, FAES, NIH and has been on Advisory Board of multiple academic institutions.

Jennifer  Costello

Jennifer Costello

Associate Director, Global Dossier Management, Bristol-Myers Squibb, United States

Jennifer Costello is a Manager in the Regulatory Submissions Management group at Teva Pharmaceuticals. Jennifer began her career in publishing and dossier management at Octagon Research Solutions before moving to Teva. Currently she manages a publishing team that focuses on Post-Approval activities for Teva’s Generics portfolio. Jennifer has over 5 years of submission publishing experience and has been involved with development of standards and procedures, training, and implementation of change management. She has a BS in Business from Chestnut Hill College.

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.

Thomas  Denaro

Thomas Denaro

Senior Business Analyst, Orion Innovation, United States

Thomas Denaro has over 30 years of Medical Device and Pharmaceutical industry experience in the areas of compliance, business process, implementation of global systems. Tom’s background includes successful remediation of critical non-conformances that were under FDA consent decree agreements with two drug-makers. His quality experience provided an opportunity to become Management Representative for a Medical Device company located in both Israel and US. Currently, Tom supports the regulatory organization at BMS by providing regulatory business analysis, interaction with multiple functional areas, and developing document support for the implementation for the IDMP initiative. Thomas holds a BS in business management from Nyack College.

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.

Lindsey  Hart

Lindsey Hart

Senior CMC Regulatory Science Specialist, CMC Regulatory and Process Sciences, Regeneron, 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.

Paul  Houston

Paul Houston

CDISC Europe - Head of European Operations, CDISC, France

With 10 years’ experience within the pharmaceutical industry as a project and programme manager. Nearly 20 years in IT project management. As a programme manager at EMA he led the IDMP programme creating a strong team across 32 ISO member countries and the ICH regulatory jurisdictions. As CDISC Head of European Operations Paul lead many data standards centric projects in regulatory and translational research, including CTR, Biovacsafe, and IMI eTRIKS where he managed the development of translational research systems across genomic and clinical data and developed the strategy for open linked data systems and industry data lakes. He is proficient in PRINCE 2, Scrum, XP and agile methods.

Kanchana  Iyer, MS

Kanchana Iyer, MS

Senior Regulatory Affairs Specialist, PENTAX Medical, United States

Kanchana Iyer, MS is a senior regulatory affairs specialist at PENTAX Medical, a healthcare industry leader in endoscopic imaging. She has worked as a biomedical engineer at the FDA, serving as lead reviewer of premarket submissions in the Office of Device Evaluation and as regulatory communications project manager in the Office of Communication and Education. Kanchana has a Master's of Science in Biomedical Engineering. Her experience in academic research includes investigations of novel biomaterials in the medical device industry, computational modeling of cardiovascular disease and tissue engineering processes. Outside of the office Kanchana enjoys playing the violin, creative writing, and volunteering within the community.

Bhanu  Kannan, MSc

Bhanu Kannan, MSc

Consumer Safety Officer, Office of Compliance and Biologics Quality, CBER, FDA, United States

Bhanu is a reviewer in CBER Bioresearch monitoring Branch for 15 years assigning inspections and assessing regulatory compliance of the insepcted parties with regard to FDA regulations. Prior to joining this Branch she participated in the basic research on signal trasduction mechanisms in CBER labs

Jenny  Lester, MPH

Jenny Lester, MPH

Research Manager, Samuel Oschin Comprehensive Cancer Institute, United States

Jenny Lester, MPH, CCRP, is a Research Manager in the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center. She graduated from the University of Georgia with a Bachelor of Science and earned her Master of Public Health degree from Morehouse School of Medicine. She focused the first half of her career in HIV education, prevention, and testing. She began working in cancer at CSMC in 2006 and has worked over the last several years to improve clinical trial processes.

William  P Liston

William P Liston

Regulatory Associate - Submissions Specialist, Pfizer 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.

Daniel  Offringa

Daniel Offringa

Principal Consultant, eSub Solutions, United States

Dan Offringa has regulatory career spanning over thirty years. For the past 20+ years he has worked in the electronic submissions field for both the FDA and industry, including guidance promulgation, standards and process development, and system implementation. He is the owner of eSub Solutions, an electronic publishing consultancy, and has been responsible for thousands of submissions to multiple regulatory authorities. Dan holds a bachelor of science degree from Duke University.

Mia  Prather

Mia Prather

Supervisory Program Analyst, CDER, FDA, United States

Mia Prather is Lead of the Data Management Services Team within the Office of Business Informatics, CDER. Mia oversees CDER’s document control center operations, records management and master data management functions. Her team has direct responsibility for document intake, processing and delivery to CDER’s reviewer community. Mia has been with CDER for 13 years and was previously with Booz Allen Hamilton.

Patricia  Santos-Serrao, RAC

Patricia Santos-Serrao, RAC

Director of Product Management, Pharmaceuticals and Biologics, MasterControl, United States

Patricia entered the Life Sciences Industry in 1994 starting her career at Schering-Plough in Kenilworth, NJ and later joining Boehringer Ingelheim Pharmaceutical in Ridgefield, CT. Within both organizations she took a leading role in transitioning business processes, document management and submission compilation from a paper to electronic system. She is a member of Regulatory Affairs Professional Society (RAPS) and has also earned her Regulatory Affairs Certification (RAC) from RAPS and the Regulatory Affairs Certification Board (RACB). She is also a member of the Drug Information Association (DIA) and a member of the TMF Reference Model Working Group (sponsored by DIA).

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

Nancy Pire Smerkanich, DrSc, MS

Nancy Pire Smerkanich, DrSc, MS

Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy, United States

Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry peers. In her role at USC, she brings many years of practical regulatory knowledge and experience to academia with a focus on clinical translational science. With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas.

Gareth  Sully, PhD

Gareth Sully, PhD

Vice President, Site Startup and Regulatory, INC Research, United Kingdom

Dr Sully is charge of the global TMF management and was formerly the regional head for clinical trials that were in Start-Up in the EMEA region. A career spanning 18 years working within the clinical operations departments of CROs, he has gained strategic and operational experience with regulatory procedures, challenges of clinical trial (CT) delivery and the evaluation of technologies for CT optimization in the start-up space. He has led INC Research through a reevaluation of the eTMF platform and advised & driven clinical system integrations of in house systems. He earned his BSc in Biochemistry & Pharmacology from Southampton University and his PhD from Imperial College London.

Todd  Tullis

Todd Tullis

Product Manager, Veeva, United States

Todd Tullis has 16 years of experience in clinical technology across pharma, CRO, medical device, and research site organizations. From CTMS to EDC to eTMF, and everything in between, this diverse perspective fuels Todd’s career mission: to improve human health through more efficient and more effective clinical trials. He has been volunteer contributor to the TMF Reference Model for 6 years and currently serves on the Steering Committee. Todd holds a degree in genetics from the University of California, Davis and lives in San Francisco where he coaches youth baseball in his spare time.

Donna  Yosua

Donna Yosua

Director, InforMaster Data Management & Data Governance, Merck & Co., Inc, United States

Donna Yosua leads the Merck Data Harmonization & Interoperability project which includes the implementation of a regulatory data hub and canonical data model with reusable data publications, and the corresponding regulatory data governance framework. Donna is a seasoned Life Sciences Strategist/Business Architect and an expert in Regulatory Information Management with 25 years of experience guiding organizations toward improved business performance by leading the development and deployment of new strategies, processes, and enabling technologies. She has global experience in the pharmaceutical, technology development, and consulting industries.

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.

Paul  Fenton, MBA

Paul Fenton, MBA

CEO, Montrium, Canada

Paul Fenton holds a degree in management from London Metropolitan University as well as an MBA in Technology Management from the Université du Québec à Montréal. Paul has significant industry experience at a senior management level in the development, deployment and management of computerized systems for use in regulated clinical trials. He co-founded Montrium in 2005. He has worked on major clinical technology projects both in Europe and North America and has a strong background in CDISC and ICH standards as well as in the integration of systems and processes for clinical trials. He is a member of the TMF Reference Model Steering Committee and co-chair of the eTMF Exchange Mechanism Standard.

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.

Gina  Ross

Gina Ross

Managing Director, Regulatory Submissions & Admin Ops, Regulatory Sciences, Cardinal Health, United States

Gina A. Ross has been involved in the pharmaceutical industry for the past 18 years and has been Treasurer for IRISS Forum for the past 5 ½ years. Gina has been the Managing Director of Regulatory Submissions Operations for Cardinal Health Regulatory Sciences (CHRS), formerly Beckloff Associates, a pharmaceutical scientific and regulatory consulting firm, for the past 2 years. Prior to her current position, Gina was the Director of Publishing at CHRS for 16 years. Gina has given several presentations to industry and CHRS clients on CTD and eCTD implementation.

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