Regulatory Submissions, Information, and Document Management Forum
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
- 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
- Director, Consulting Expert
- CGI Technologies, United States
Brooke Casselberry has been a regulatory consultant for 20 years focusing on data, technologies, small business entrepreneurship, and regulatory compliance for clients globally. She is currently Director, Consulting Expert with CGI Technologies for RnD and Technology Innovation. Brooke has dedicated much of her career to professional volunteerism to continue development and mentorship through communities such as DIA.
Michelle L. Charles, MPH
- Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center
- University of Pennsylvania, Perelman School of Medicine, United States
Michelle Charles, MPH is the Director of Regulatory Affairs in the Gene Therapy Program at the University of Pennsylvania, Perelman School of Medicine, providing guidance on global regulations, submission support and strategic regulatory planning. She co-chairs the DIA RSIDM Conference and has participated as a committee member for several years. Before joining the University of Pennsylvania’s Gene Therapy Program Michelle held multiple positions at both Merck & Co., Inc. and PAREXEL International. During her time in industry Michelle focused on regulatory operations, project management and business process development for global regulatory information management. Michelle holds a Masters of Public from Johns Hopkins University.
- Director, Regulatory Affairs Operations and Quality Management
- Merck & Co., Inc., United States
Cindy Chiu is Director in Global Regulatory Affairs and Clinical Safety group at Merck & Co. She has 18 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 Regulatory Content Authoring Management Lead. Prior to Merck, she worked as a management consultant, where she assisted clients with transitioning to and adopting new processes as a result of merger activity or technology integrations.
Steven Clark, MSc
- Amgen, United Kingdom
- Chief Technology Officer
- Genpact, United States
Jake Doran is the Chief Technology Officer at Genpact Pharmalink. In this role, Jake is responsible for establishing the strategic direction and defining the digital solutions across Regulatory Affairs. Prior to joining Genpact, Jake was with List Innovations LLC where he was Founder and Managing Director. List Innovations is a specialized technology development and consulting company providing Regulatory and IT solutions to the Pharmaceutical industry. Earlier in his career, Jake held positions of increasing responsibility at Janssen Pharmaceuticals and Schering Plough. Jake has a Bachelor’s Degree from Fairleigh Dickinson University where his area of specialization was Biological Sciences.
- President and CEO
- LMK Clinical Research Consulting, 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
- BAFallen Consulting LLC, United States
Ms. Fallen is an authority on the business processes and associated use of information technology in drug development with a focus on regulatory and clinical. A passionate advocate for moving life sciences business on-line, Betsy is an expert on regulatory and clinical operations. Over the two decades of outstanding contributions at Merck, she was recognized for her leadership and excellent representation of the organization on internal transformational teams and in many industry initiatives. Now consulting, she continues to be recognized for her knowledge in technical innovation, process efficiency and ability to assess and assure compliance in documentation, execution and oversight.
Ron D. Fitzmartin, PhD, MBA
- Sr. Informatics Advisor
- FDA, United States
Ron Fitzmartin is Senior Project Manager, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions and standardized data. Some of Ron’s activities include: chair of the PDUFA VI information technology committee, Regulatory Chair of the ICH M11 Expert Working Group on clinical protocol standards, and chair of the IDMP Working Group under the International Pharmaceutical Regulators Programme. Ron received a PhD in statistics from the University of Maryland and MBA from University of New Haven.
Mark A. Gray
- 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).
- Chief, Data Standards Program, CBER
- FDA, United States
Ginny Hussong is Chief of CBER’s Data Standards Program, and has been with FDA for 14 years. She was previously Director of Data Management Services and Solutions within CDER. As Chair of CBER’s Data Standards Committee, Ginny’s recent projects include creating a new joint data standards strategy and action plan with CDER, modernizing CBER’s study data validation process and evaluation of the SEND standard for CBER. Ginny also serves as Deputy Topic Lead for FDA, ICH M2, Electronic Standards.
- Senior Consultant
- CGI, United States
Ty Molchany has been working on content management systems in the regulated pharmaceutical and healthcare industries for the past 11 years. He is a principal in the Information Management group at Paragon Solutions 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. He also participates in the EMA SPOR Task Force.
Theresa Mullin, PhD
- Associate Director for Strategic Initiatives, OCD, CDER
- FDA, United States
Principal advisor on strategy including CDER international cooperation and harmonization, application of decision science, and other initiatives. Leads FDA Patient Focused Drug Development, and heads the FDA delegation to ICH. Previous work includes leading FDA negotiations for 2002, 2007, 2012 and 2017 cycles of reauthorization of the Prescription Drug User Fee Act, providing nearly $1B in annual funding for new drug review. She has received the SES Presidential Rank Award for Distinguished Service in 2011, Presidential Rank Award for Meritorious Service in 2006, and the FDLI Distinguished Service and Leadership Award in 2017.
Thomas J. Noto
- Senior Director, Regulatory Operations
- Lexicon Pharmaceuticals, United States
Thomas is a 20+ year experienced leader in Pharmaceutical, Diagnostic and Medical Device Regulatory Affairs, Electronic Publishing and Document Management. He has a strong track record of successful regulatory interactions and filings, resulting in the approval of over 25 new drugs, devices and diagnostics. He has worked for a number of organizations both in the Consulting and CRO industry, as well as on the sponsor side of the equation. He has developed services and led global teams resulting in the consistent delivery of high-quality output aligned with business needs. Some of Thomas’s skills include regulatory process and workflow excellence, eCTD publishing, document management, commercial regulatory, and computer systems validation.
Daniel F. Orfe, MS
- 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
- 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, MS, MSc
- Regulatory Policy and Intelligence
- Bayer Pharmaceuticals, United States
Vada A. Perkins, Bayer Pharmaceuticals Head, Regulatory Intelligence Director, Regulatory Policy & Intelligence Vada A. Perkins (CAPT, ret.) is a former FDA Senior Advisor for Regulatory Science and a recognized global regulatory policy & intelligence expert with thought leadership in the application of technology, standards, and data management. He is active in interactions with national and international stakeholders in promoting technology and innovation to support international regulatory convergence for medicinal product regulation. He received his degrees from The Johns Hopkins University, University of Southern California, and the University of Maryland.
Sarah Powell, RAC
- Powell Regulatory Services, United States
Ms. Powell is the President of Powell Regulatory Services. Sarah has 30+ years of experience in pharmaceutical and related regulated industries (Clinical, Quality Control, Regulatory Affairs and Regulatory Operations). In the past 17 years as a consultant, she has assisted clients with projects related to regulatory process improvements, standards development, defining filing strategies and writing/review of submission content. She has extensive experience with projects related to design and implementation of regulatory solutions including document management, submission planning, publishing, and registration management. Sarah is a past executive at Chiron, First Consulting Group and Liquent, PAREXEL
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.
- Regulatory Information Scientist
- eCTDconsultancy B.V., Netherlands
Michiel Stam works as a Regulatory Information Scientist at eCTDconsultancy and is Product Manager for Dossplorer, a regulatory dossier viewer. He is a specialist in electronic submissions and regulatory information management and worked for various Pharma and Biotech companies in the past 10 years. Michiel has a strong focus on XEVMPD, IDMP and Regulatory Information Management projects.
Dimitri Stamatiadis, PhD, MBA
- 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.
- Senior Program Manager
- Transcelerate Biopharma Inc., United States
Stacy Tegan is a Sr. Program Manager at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical development process. She has expertise in Regulatory Operations, Clinical Development processes, and Project Management gain through 20+ years of experience working for sponsor, consulting, technology, and nonprofit organizations in the pharmaceutical industry.
Jamie Marie Toth, MS
- Director/Head of TMF Operations
- Daiichi Sankyo, Inc., United States
Jamie has over 18 years of IT experience in the pharmaceutical industry. She has been with Daiichi Sankyo, Inc. since 2016 as the Director/Head of TMF Operations; prior to that she worked at Covance for 8 years within the Trial Master File space. She is a Steering Committee member on the DIA TMF Reference Model Working Group and on the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA). Jamie is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified.
Olga Alfieri, MBA, MSc, RAC
- 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.
Rob Connelly, MBA
- Executive Director, Product Development
- Synchrogenix, A Certara Company, United States
Rob Connelly, Senior Director, Product Management, Synchrogenix- A Certara Company, brings a wealth of experience from the pharmaceutical and life-science industry, primarily focused on developing the people, processes and products needed to submit compliant regulatory filings with global health authorities. His job responsibilities focus on the management of multiple life-science software product lines and developing new products or services based on market opportunities and requirements. Previous job experience leading project teams in the planning and filing of successful clinical and marketing drug applications with global health authorities.
- 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 F Kroetsch
- Operations Research Analyst
- FDA, United States
Sandra A. Krogulski, MA
- Associate Director, Submission Management
- Bristol-Myers Squibb, United States
Sandy Krogulski is a Regulatory Submission Manager with 8 years of experience and this is her third time speaking at RSIDM. She has experience working and reviewing submissions to the US, Health Canada, Swissmedic, Australia and other Rest of World countries. In addition to submissions, Sandy has a background in training/developing teams, SOP writing and change initiatives. Currently in her first year with BMS, Sandy has previous vendor experience supporting submissions to numerous health authorities.
- Director of Compliance and Quality
- Suvoda, United States
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).
- Technical VP
- Parexel, United States
Sue Metz, Technical VP PAREXEL is a senior regulatory professional with over 30 years of experience in the life sciences industry. She was responsible for the implementation of PAREXEL’s flagship platform, LIQUENT InSight RIM from 2003 to 2014, and is now helping to reinvigorate the platform to enhance our client’s UX and functional needs. Sue is considered a SME for RIM and IDMP and is an active member of the ISO/TC215/WG6, the EMA’s SPOR Task Force, Rutgers University CX Advisory Board and is the CEO/President for the IRISS-forum Organization, a non-profit dedicated to the implementation of regulatory submission standards around the world. She frequently presents as a Subject Matter Expert on RIM and IDMP at Industry Conferences globally.
Lisa D. Mulcahy
- Owner, Principal Consultant
- Mulcahy Consulting, LLC, United States
Owner and Principal Consultant, Mulcahy Consulting, LLC, USA. Lisa has 25+ year career in the pharmaceutical industry, in the areas of Clinical Operations and Quality Management. Since 10 years she is an independent consultant, focusing solely on Trial Master File process and management assisting clients with assessment and improvement of their current state, development of future design, and implementation of systems for the management of electronic records of the TMF. She is experienced in the quality assessment of study-specific TMFs. She is a frequent speaker and experienced workshop leader at TMF-related professional meetings.
Matt Neal, MA
- Senior Director, Product Management
- Parexel, United States
Matt Neal joined PAREXEL in 2016 as the Senior Director of Product Management for Regulatory Solutions. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. (2003-2016) and prior to that he was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline (1996-2003) and has been publishing and submitting electronic dossiers to the FDA since 1996, and submitted the very first fully electronic NDA for GSK in 1999. Matt holds a Master’s Degree in Communication from Temple University. He and his wife Beth live in Los Angeles, CA and spend most of their time entertaining their two kids, Claudia & Tobias and their dog, Laverne.
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
- Director of Client Services
- Cabeus, Inc., 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.
- Sr. Director, eSubmission Services, Head of Regulatory Operations
- PharmaLex GmbH, Germany
Timm Pauli joined PharmaLex in 2014 as Head of Regulatory Operations, where he is responsible for all electronic submission activities, regulatory information management and related topics worldwide. He is also leading and supporting process optimization projects within Regulatory as well as providing consultancy for Regulatory Information Management, IDMP-related topics and eCTD publishing systems. Previously he worked at Merck Serono heading the Dossier & Submission Management department and at Baxter, where he held several global positions in Biostatistics, Pharmacovigilance and IT. Timm studied Pharmacy and Medical Informatics at the Universities of Frankfurt and Heidelberg (Germany).
- VP, Vault Clinical
- Veeva Systems Inc., 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.
- Merck, United States
Jonathan Resnick, PMP
- Project Management Officer, OBI, OSP, CDER
- FDA, United States
Jonathan Resnick is a member of CDER’s Electronic Submissions Team, with a focus on eCTD and has been with FDA for eight years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.
- 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
- Acting Director, Office of Strategic Programs, CDER
- FDA, United States
Ms. Slack has over 30 years’ technology and informatics experience implementing informatics solutions to business problems. Since joining FDA in 2003, she has been engaged in data standards development efforts in CDISC, HL7 and ISO in support of Agency needs. Ms. Slack is an FDA representative to the International Conference on Harmonization (ICH) and currently serves as Acting Director Director for CDER's Office of Strategic Programs and leads CDER's data standards program.
Peter Terbeek, MBA
- Senior Director, Publishing and Submission
- United States
Peter is the Sr. Director of Publishing & Submissions for Astellas. This global group has responsibility for compiling, dispatching and archiving submissions and ensuring those activities are captured in the appropriate systems. Peter has been involved in multiple global programs targeting process improvements around product change control, document management and master data management. Prior to moving into Regulatory Operations, Peter worked in IT at Astellas focusing on informatics in the areas RA, QA and document management. Peter has a Bachelor’s degree in Mathematics from Austin College in Sherman, TX, and an MBA from the Lake Forest Graduate School of Management.
Akira Yamaguchi, MBA
- 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.
- 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.
- 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).
- Associate Director Merck IT
- Merck & Company Inc., United States
Jillian E. Carinci, MS
- Associate Director Regulatory Operations
- Biogen, United States
Jillian Carinci is Associate Director in the Regulatory Operations 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
- 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.
- Director Regulatory Operations
- The Medicines Company, United States
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
- Principal Consultant
- NNIT A/S, Denmark
Thomas Hornbaek Svendsen works as principal consultant at NNIT and has more than 15 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
- Manager, Global Regulatory Agencies and Processes
- LORENZ International, LLC, United States
Jared Lantzy, PMP, is the Manager of Global Regulatory Agencies and Processes at LORENZ International LLC. In this role he monitors the world of regulatory operations to inform industry of emerging requirements and best practices. His primary expertise is in the implementation of electronic submission processing, validation, and review solutions. Mr. Lantzy is also a former member of the FDA CDER electronic submission support team. He holds a B.S. in Information Technology from Juniata College in Huntington, Pennsylvania, USA.
- 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
- CEO, Reg/Clin Ops SME Independent Consultant
- LifeSciHub, United States
Sheila has over 25 years of experience in reg/clin ops, having operated as an SME on both the sponsor and vendor sides. Her current focus as an independent consultant (IC) is advocating for the independent workforce, and helping sponsors engage with them. Sheila has spent the last two years immersed in the world of HR and Procurement tech in order to transition mature, "Future of Work" technologies from other verticals to life sciences in the form of LifeSciHub. LifeSciHub is an online resource marketplace of SME ICs, the goal is to provide extremely easy, and compliant, access and engagement for the Sponsors who need specifically qualified experts for projects. Think Airbnb or Lyft, for SMEs!
Aaron Niman, MPH
- Research Officer, Office of Surveillance and Epidemiology, CDER
- FDA, United States
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.
- Executive Director, Clinical Compliance and Operations
- Horizon Pharma, United States
Olaf Schoepke, PhD
- VP Regulatory Solutions, Samarind
- Instem, 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.
- 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.
- 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.
- Prinicpal Owner
- Saturn Services LLC, United States
Kevin Tompkins, MBA, MS
- Global Lead, Global Dossier Management, Group Director
- Bristol-Myers Squibb, United States
Kevin Tompkins is a Group Director, Global Lead in the Global Dossier Management group at Bristol-Myers Squibb. He joined BMS in April of 2018. Kevin began his career in submission publishing and product consulting at Octagon Research before moving to Cephalon. He then managed the N.A. Submissions Management group at Teva before joining BMS. Kevin has over 16 years of regulatory submission and information management experience. He has implemented systems, technologies, and processes in regulatory submissions management for a number of pharmaceutical companies. He holds a B.S. in Information Systems and a M.B.A. from LaSalle University.
Hans van Bruggen, MSc
- Senior Regulatory Affairs Scientist
- Qdossier, Netherlands
Hans van Bruggen is Director of and Senior Regulatory Affairs Scientist at Qdossier and eCTDconsultancy. He has an MSc in Pharmaceutical Medicine from the University of Surrey (UK) and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of drugs for patients (and healthy volunteers). Using that scientific background he approaches interdisciplinary and international processes concerning circular information management (from data to documents to dossiers and back to data)
- 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
- Acting Director, Office of Biostatistics, Office of Translational Sciences, CDER
- FDA, United States
Dr. Chakravarty joined CDER in 1992. She served as an Adjunct Faculty in Depart. of Statistics, Foundation for Advanced Education in the Sciences, NIH. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development and has presented and published widely on it. Dr. Chakravarty received the FDA Award of Merit in 2008 and Dr. Frances O. Kelsey Drug Safety Excellence Award in 2012. She received her PhD in Statistics from Temple University, and M.Stat from Indian Statistical Institute. Dr. Chakravarty is a Fellow of ASA and an Associate Editor of Statistics in Biomedical Research.
- 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.
- 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 John Denaro
- Director, Regulatory Global Systems
- BD Biosciences, United States
Thomas Denaro has over 25 years of industry experience in Regulatory Affairs and Compliance. In his 12 years at BD, Tom has held positions in clinical operations, corporate regulatory affairs and compliance with accomplishments that include the successful global implementations of clinical data & trial management systems. Since 2011 in his current role as the Director of Corporate Regulatory Global Systems, Tom has implemented a global product registration system and a worldwide advertising & promotional material approval system. Tom holds a Bachelors of Science from Nyack College in New York.
Steve Gens, MS
- Managing Partner
- Gens and Associates Inc., United States
Steve Gens (MSOD) is the Managing Partner of Gens and Associates Inc., a global Life Science consulting firm specializing in strategic planning, RIM program development and execution, industry benchmarking, and organizational performance. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he lead global healthcare consulting practices for First Consulting Group and Booz Allen Hamilton. His organization is well known for their insightful industry benchmarks and World Class RIM thought leadership. Steve has a Bachelor’s of Science in Business Computer Science and a Master in Organizational Development and Performance. He was named to the PharmaVoice 100 for 2017.
- Senior CMC Regulatory Science Specialist, CMC Regulatory and Process Sciences
- Regeneron, United States
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.
- 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
- 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
- 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
- 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
- Regulatory Associate - Submissions Specialist
- Pfizer Inc., United States
- Chief Operations Officer
- Cunesoft Inc, United States
Jim has nearly 20 years’ experience with compliant software solutions for regulated processes in Life Sciences. He's held senior management positions at Liquent, Thomson Reuters, ePharmaSolutions and DitaExchange and holds a Bachelor of Science in Mathematics from The Pennsylvania State University.
- Principal Consultant
- eSub Solutions, United States
Dan has a 25+ year regulatory career. Over the past 15 years he has worked in the electronic submissions field for both FDA and industry, including guidance promulgation, standards and process development, and system implementation. He is currently a Senior Principal Consultant for Pharmaceutical eConsulting with a focus on publishing. He has been responsible for numerous marketing applications and submissions to multiple regulatory authorities. Dan holds a bachelor’s degree in Psychology and Zoology from Duke University.
- 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
- Product Marketing Manager
- 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
- Document Management Enablement Head
- Janssen Pharmaceuticals, Inc., United States
She spent 10 years in Switzerland where she discovered her love for cheese and hate for fog but no progress on punctuality whatsoever. Now she is in the US for 18 years still with Johnson & Johnson, still not punctual and still with a solid German accent. She has been in Content Management for all these years but in very different capacities: as information broker, information architect, end user, solution engineer. She is very passionate in what she does and her spongy curiosity leads to many “why”, “what if” questions. After seeing the problems from many different angles, she truly believes RIM is ready for breakthrough innovation to solve what really matters.
Nancy Pire Smerkanich, DrSc
- Assistant Professor, Department of Regulatory & Quality Sciences, USC School of
- University of Southern California, 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
- 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.
- 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.
- United States
Donna Yosua is a business architect and strategist and an expert in regulatory information management with more than twenty 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 and is the global IDMP business lead for Merck.
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.
Paul Fenton, MBA
- 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 regular speaker at industry events and is actively involved in several projects for the development of clinical research standards and platforms.
Jean M. Mulinde, MD
- Medical Officer, Senior Policy Advisor, OSI, OC, CDER
- FDA, United States
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in OND. She received her M.D. and completed a residency in Internal Medicine at the University Of South Alabama School Of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine.
- 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.