About C3 Summit
Join your industry peers for Conversations on Clinical Content, C3 Summit. Panels of pharma, biotech, CRO, and regulatory thought leaders will explore patient diversity, centricity, and outcome assessments, discussing challenges, opportunities, and strategies through the lens of real-world experience. Take away practical insights and participate in a discussion during the Q&A and post-event cocktail hour.
Agenda
1:00 – 1:30
Welcome & Check-In
1:30 – 2:00
Inspection War Stories
Christopher Utterback
Regional Director
TransPerfect Life Sciences
Gillian Gittens
Director, eClinical Strategy & Solutions, Trial Interactive
TransPerfect Life Sciences
Gillian has over 22 years clinical technology experience, and a wealth of valuable expertise in strategic account management, operations, implementation, project management and the ongoing customer success of global eTMF solutions. She is Subject Matter Expert in all things TMF related and was co-chair of the Quality Team for the DIA Framework for Paper Destruction Initiative and has had several TMF related articles published in recognized industry journals. Gillian is based in London, UK.
Laura Naranjo
Global Head, TMF Operations and Records Management
Daiichi Sankyo, Inc.
After working for the federal government, Laura made the move to pharma and has been working in TMF since 2009. She has worked on both the sponsor and vendor sides throughout her career and joined Daiichi Sankyo TMF Operations in 2016. Laura holds a passion for inspection readiness and efficient CRO oversight. She holds her Masters of Science of Jurisprudence in Pharmaceutical and Medical Device Law and Compliance from Seton Hall Law School.
Jamie Marie Toth
Global Head, TMF Management & Records
BeiGene
Jamie Toth is Global Head, Trial Master File Management & Records at BeiGene, home-based in New Jersey, USA. Jamie is a Steering Committee member on the CDISC TMF Reference Model Working Group, the Chair of the Operations Committee, and a Director for the Health Sciences Records and Archives Association (HSRAA). She has led many industry workstreams for TMF/eTMF, including the clinical trials email guidance, and led and published the TMF Plan Template revision 2 with industry colleagues. Jamie is also on the Board of Directors for the Association for GxP Excellence (AGxPE). Jamie is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and PROSCI certified. She received her master’s degree in clinical research & organizational management from Drexel University College of Medicine, holds a Bachelor of Arts in Business and Technology from Fairleigh Dickinson University, and an Associate of Applied Sciences in Computer Systems & Technology from Mercer County Community College. In her spare time, Jamie enjoys family time—watching her youngest son play football and lacrosse, and boating, swimming, fishing, and attending professional football games.
2:00 – 2:30
Patient Recruitment and Inclusivity – Engagement Strategies for Diversity and Accessibility
Leanne Woehlke
Director of Life Sciences Solutions
TransPerfect Life Sciences
Leanne Woehlke is a Director of Life Sciences Solutions at TransPerfect where she helps clients create transformational impact with language, technology and business consulting solutions. She has extensive experience in clinical research, starting her career as a CRA then working her way up to Director before consulting in patient recruitment and process optimization. She has successfully enrolled patients in some of the most difficult studies, including achieving pediatric patent extension. Her knowledge of digital marketing coupled with her extensive coaching background allow her to bring a unique perspective to patient recruitment and engagement. She is passionate about impacting the industry in meaningful ways and bringing life changing treatments to patients who need them.
Rick Ward
SVP, North America
CluePoints
Rick has over 20 years of experience in the clinical trial industry, primarily focused on disruptive eClinical solutions. As SVP at CluePoints, Rick heads up commercial growth in North America, promoting the industry-leading RBQM/Central Monitoring solution to study sponsors and CROs.
Steve Wimmer
Vice President of Partnerships
1nHealth
Steve Wimmer is the VP of Partnerships for 1nHealth, a patient recruitment company. He brings a wide-ranging scope of experience to his role, having worked previously in digital marketing, e-commerce, and education. Steve holds a bachelor’s degree in psychology from Tulane University and a master’s degree in philosophy of religion from Biola University, both of which inform his approach to marketing clinical trials. He lives in Orlando with his wife, Jenna, and their three children and spends too much of his free time running.
Matt Walz
CEO
Trialbee
Matt is the CEO of Trialbee, a company dedicated to creating the future of global patient recruitment and enrollment for clinical trials. In 2021, Trialbee was named one of PM360’s Most Innovative Companies, and in 2022, Matt was named to the PharmaVoice 100, which recognizes the most inspiring individuals in life sciences. A software engineer at heart, Matt was introduced to clinical development early in his career while working at Microsoft when he was assigned to an initiative with a large pharmaceutical company. Matt later founded NextDocs, a venture-backed software company that grew to be a global leader in clinical, quality, and regulatory document management with offices in the US, Europe, and Japan. NextDocs was acquired by Aurea Software in 2015. Matt and his family of six are natives of Wilmington, Delaware, and he received his Bachelor of Science in Computer Science and Master of Business Administration both from the University of Delaware.
DezBee McDaniel
Co-founder/CEO
CliniSpan Health
Dezbee McDaniel is an award-winning entrepreneur who believes in the importance of changing the communities in which you identify. This led him to work on CliniSpan Health, an influencer software platform for people of color and underserved groups to access clinical research. CliniSpan Health helps pharma maximize the power of social media and has introduced influencer marketing into clinical research to successfully diversify studies. Through this digital health influencer model, the company has helped successfully diversify CMV, COVID, psoriasis, and many more studies. Dezbee is also a former Venture for America and Forbes Fellow.
Del Smith, PhD
CEO/Co-Founder
Acclinate
Dr. Del Smith is passionate about using business to make a positive societal impact. He is the co-founder and CEO of Acclinate, a growing digital health company specializing in accessing and engaging communities of color so they can make informed health decisions. He has leadership experience in healthcare, IT, higher education, and government. Del most recently served as dean of the business school at Alabama A&M University. His experience starting and growing tech-related companies fuels his inquiry on how minority-owned firms achieve high levels of success. Del’s research findings have appeared in publications, such as the Journal of Business Research; the Journal of Developmental Entrepreneurship; and the Journal of Equality, Diversity, and Inclusion. Del earned his Ph.D. in business from the University of Alabama.
2:30 – 2:40
Break
2:40 – 3:10
Real-World Examples of AI/ML Automated Risk Reduction – Patient Safety, Regulatory Submissions, and Clinical Document Quality
April Mattison-Wolfe
Senior Solutions Architect
TransPerfect
April Mattison-Wolfe came to TransPerfect’s Trial Interactive (TI) Technical Services group with 24 years of Clinical Operations experience, including more than 7 years as a Clinical Operations Trainer and Clinical Business Systems Analyst. With experience at both Sponsor companies and CROs, April applies her extensive knowledge of clinical systems requirements and pharmaceutical business practices to help TI clients pinpoint their CTMS needs and configure a solution that is right for them.
Joe Kim
Chief Strategy Officer
ProofPilot
Joseph Kim brings over 23 years of pharmaceutical expertise to ProofPilot, most recently in a senior leadership role as Senior Advisor in Lilly’s Digital Health Office. He brings a wide array of pharmaceutical research industry knowledge and utilizes a unique approach that integrates his experiences working for other Sponsors such as Shire and Merck, in addition to CROs and technology vendors. He has a robust combination of experience across all phases of clinical research, and a well-known history of innovation in the industry, recognized as one of the “Top 100 individuals on the 2015 MedicineMakers Power List,” and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch. He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova.
Rick Ward
SVP, North America
CluePoints
Rick has over 20 years of experience in the clinical trial industry, primarily focused on disruptive eClinical solutions. As SVP at CluePoints, Rick heads up commercial growth in North America, promoting the industry-leading RBQM/Central Monitoring solution to study sponsors and CROs.
Richie Etwaru
Chairman & Chief Creative Officer
Mobeus
Richie Etwaru is a champion for innovation and co-founder of Mobeus, a company that delivers frictionless technology. As Chair and Chief Creative Officer, he designs and delivers a new global sector of technology that redefines what it means to connect. Richie has previously served as Head of Innovation at a global financial services company, Vice President of Technology at a leading investment bank, and Chief Digital Officer of a global healthcare and life sciences company. He has sat on multiple startup advisory boards and has been quoted in news outlets such as The Financial Times, NPR, Forbes, The New York Times, and Wired. Richie has delivered over 100 keynotes worldwide, including three TEDx talks, and has been honored to operate in academia, entrepreneurship, government advisory, and several Fortune 500 companies.
3:10 – 3:55
2023 and Beyond – Sticky Innovations and Approaches from Recent Years that Are Here to Stay (and Predictions for What Comes Next)
Jay Smith
Head of Product
Trial Interactive
Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. He brings over 25 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment and manufacturing. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. Jay has also created and managed products for eCTD submission publishing and review, enterprise quality management, document management, computer validation, as well as mobile apps for physicians, sales reps, and music and sports fans. Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College.
Rick Ward
SVP, North America
CluePoints
Rick has over 20 years of experience in the clinical trial industry, primarily focused on disruptive eClinical solutions. As SVP at CluePoints, Rick heads up commercial growth in North America, promoting the industry-leading RBQM/Central Monitoring solution to study sponsors and CROs.
Craig Lipset
Co-Chair
Decentralized Trials & Research Alliance
Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the Decentralized Trials & Research Alliance, Vice Chair of the MedStar Health Research Institute, and Vice President of the Foundation for Sarcoidosis. He is Adjunct Assistant Professor in Health Informatics at Rutgers University. Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures.
Richie Etwaru
Chairman & Chief Creative Officer
Mobeus
Richie Etwaru is a champion for innovation and co-founder of Mobeus, a company that delivers frictionless technology. As Chair and Chief Creative Officer, he designs and delivers a new global sector of technology that redefines what it means to connect. Richie has previously served as Head of Innovation at a global financial services company, Vice President of Technology at a leading investment bank, and Chief Digital Officer of a global healthcare and life sciences company. He has sat on multiple startup advisory boards and has been quoted in news outlets such as The Financial Times, NPR, Forbes, The New York Times, and Wired. Richie has delivered over 100 keynotes worldwide, including three TEDx talks, and has been honored to operate in academia, entrepreneurship, government advisory, and several Fortune 500 companies.
Len Rosenburg
Head, Clinical Operations
Leukemia and Lymphoma Society/BAML
Dr. Rosenberg is a 35-plus-year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eClinical, and contract research organization sectors. With his diverse background, which includes executive management, clinical and regulatory operations, business development, eClinical technology solutions, and new product/licensing evaluations, he brings tremendous hands-on insights to optimizing the drug development cycle, from the early start-up stage to global product registration. Dr. Rosenberg is Head of Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society, and also Managing Partner of eP2Consulting, Inc. since 2001. Dr. Rosenberg received his Ph.D. from the Kellogg Pharmaceutical Clinical Scientist Program at the University of Minnesota, College of Pharmacy and his Bachelor of Science in Pharmacy from the Philadelphia College of Pharmacy and Science.
Joe Kim
Chief Strategy Officer
ProofPilot
Joseph Kim brings over 23 years of pharmaceutical expertise to ProofPilot, most recently in a senior leadership role as Senior Advisor in Lilly’s Digital Health Office. He brings a wide array of pharmaceutical research industry knowledge and utilizes a unique approach that integrates his experiences working for other Sponsors such as Shire and Merck, in addition to CROs and technology vendors. He has a robust combination of experience across all phases of clinical research, and a well-known history of innovation in the industry, recognized as one of the “Top 100 individuals on the 2015 MedicineMakers Power List,” and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch. He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova.
Joe Dustin
Vice President, Product Strategy for eCOA
Medable
Joe Dustin is the Vice President of Product Strategy for eCOA at Medable where his priority is to accelerate how decentralized clinical trials are defined, executed, and adopted within life sciences companies and change the face of how research is conducted to improve the human condition. Joe has spent 20 years as a voice and thought leader in the life sciences industry, specifically in eClinical technology across all categories of EDC/eSource, eCOA, IRT, CTMS, RBQM, medical imaging, and the rise of decentralized clinical trials. Joe has worked with top pharmaceutical companies, biotechs, and CROs in clinical innovation, change management, implementation, IT, product development, solution consulting, and business development roles. He is focused on making the drug development process faster and providing a better experience for all stakeholders through the eyes of great technology, service, and partnership. Joe is a graduate of the Roger Williams University Gabelli School of Business with a degree in computer information systems and political science. Previously, he worked at eClinical technology companies, such as CRF Health (now Signant Health), etrials (now IBM Clinical Development), and Medidata (now part of Dassault Systèmes). Most recently, Joe was the Head of Clinical Innovation and Change Management at Bristol Myers Squibb. Originally from the Boston area and a current New Jersey resident, Joe is passionate about technology and an avid guitar player and dreams of one day going to space.
3:55 – 4:00
Closing Remarks
4:00 – 5:30
Cocktail Reception
FAQs
Is this event free?
Yes, there is no registration fee associated with this event. However, spots are limited and you will receive a confirmation email once your seat is confirmed.
Will travel and hotel be provided?
No, TransPerfect will not be covering any travel or hotel costs incurred to attend the event.
Who is the event for?
C3 Summit is geared toward executives, directors, and senior managers within Pharma, Medical Device, Biotech, and Contract Research Organizations. Spaces are limited and will be prioritized accordingly, therefore eligibility is subject to approval by the TransPerfect Life Sciences team.
Will I receive a Certificate of Attendance?
All attendees joining the TMF track of the London C3 Summit may request a training certificate. This certificate verifies your attendance and participation in intensive TMF workshops, trainings, and educational discussions that both reinforce and expand on your knowledge of TMF management and successful TMF health and inspection readiness strategies. While not an accredited certification, you can share your certification with relevant parties in your organization as proof of your commitment to ongoing education and excellence. You will be better positioned to support your organization’s efforts towards creating a culture of inspection readiness that can improve quality, reduce risks, and expedite timelines.
