About C3 Summit
C3 Summit (Conversations on Clinical Content) is part of a series of events that offers sponsors, CROs, and biotech professionals opportunities to share knowledge, gain industry insights, and network. The series has been celebrated for its casual yet informative format and time-efficient, well curated discussions. Previous panels have featured topics such as inclusivity and diversity in patient recruitment, practical applications of AI/ML, regulatory inspection stories and best practices, clinical outcome assessments, future-proofing clinical operations, among other important topics.
Why Attend C3 Summit?
NETWORKING
Connect with industry peers in the life sciences community, spend time with familiar colleagues, and make new connections.
KNOWLEDGE SHARING
Acquire new approaches by hearing strategies and experiences from peers sharing successes and lessons learned.
PRACTICAL TAKEAWAYS
Return to your teams with pragmatic insights that can be directly applied to existing strategies and processes.
CONVENIENCE
Enjoy an afternoon of efficient, insight-packed panels followed by a happy hour in an experience celebrated for its concise format.
ONE-OF-A-KIND EVENT
Experience the synergy that only one of TransPerfect’s world class events can provide—where every discussion and new connection contributes to an energy that cannot be replicated.
![](https://thec3summit.com/wp-content/uploads/2023/10/Princeton2023_DSCF2489.jpg)
Interested in seeing last year’s panel discussions?
Watch our 2023 C3 Summit Princeton panel topics, which focused on diversity and inclusivity in patient recruitment, AI/ML in clinical research, inspection war stories, and more.
Speakers
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![Fortrea](https://thec3summit.com/wp-content/uploads/2024/03/Fortrea-scaled.jpeg)
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Agenda
12:30pm – 1:30pm
Check-in
1:30pm – 2:00pm
Digital Mindset in Medical Affairs Transformation: Channeling Opportunities on Insights, Communications, and Evidence Generation
![](https://thec3summit.com/wp-content/uploads/2024/08/Eddie-Power-300x300.jpeg)
Eddie Power PhD MBA GFMD is the CEO of emPower Medical, a medical affairs consultancy empowering pharmaceutical medical professionals and solution providers to achieve their best potential. With over 25 years’ experience in the pharmaceutical industry, he is a recognized expert in Medical Affairs strategy, organizational design, storytelling, and innovation, and has been invited to chair and speak extensively at pharmaceutical congresses. He is an advisory board member for several organizations. He was formerly the VP, North America Medical Affairs, Hospital Business at Pfizer with the privilege of bringing one of the first Covid therapies to the world and has held positions of increasing responsibility during his 25 year career in the pharmaceutical industry, with deep expertise in medical affairs and medicines & device development.
![](https://thec3summit.com/wp-content/uploads/2024/08/Catia-Ferreira.jpeg)
![](https://thec3summit.com/wp-content/uploads/2024/08/ABozas-1-300x300.jpg)
Ana Bozas is currently Director of Scientific Publications and Medical Communications at Ipsen Biopharmaceuticals, Inc, in Boston, MA. Ana is a Certified Medical Publication Professional (CMPP) and holds a PhD in in biochemistry from the University of Utah. Over the past decade, Ana has held positions with increasing responsibilities, starting from HEOR medical writer in management consulting to leading medical communications planning and strategy in several biotech/pharmaceuticals/medical device companies. During her career, Ana has covered a wide range of scientific communication activities across multiple disease areas, with products marketed in the US and world-wide.
![](https://thec3summit.com/wp-content/uploads/2024/08/Matt-Lewis-300x300.jpeg)
Matt oversees the Artificial and Augmented Intelligence function across Inizio Medical, aligned to the Medical Analytics and Innovation department which he Founded and has led to its position of market leadership since 2016. With 25 years of life sciences experience, Matt specializes in partnering with key stakeholders to speed time to decision leveraging artificial intelligence, advanced analytics, digital innovation and bespoke consultancy. He has deep expertise in oncology/hematology, neuropsychiatry and rare disorders and has contributed to the launch of over 60 treatments globally. Matt Co-Chairs the AI Task Force at the International Society for Medical Publication Professionals, where he oversaw the development and publication of the global roadmap and call to action on Artificial Intelligence, published on November 1st, co-authored the Declarative Statement on Artificial Intelligence for the Healthcare Communications Association, published in early October, was the featured speaker in 2023 for the Medical Affairs Professional Society Executive Consortium, on Augmented Intelligence, and helped to architect its Generative AI White Paper, published on September 28, 2023, is a founding Board Member of the Society for Artificial Intelligence and Health, and is the Executive Lead for Inizio Medical’s Business Employee Resource Group on Mental Health and Wellbeing. He is a frequently requested Keynote Speaker on Artificial Intelligence, Medical Affairs and Mental Wellness. Prior to his role at Inizio Medical, Matt led Strategy and Account Planning at Omnicom Health Group, WPP and worked at both Boehringer Ingelheim as a Senior Scientist and at Procter and Gamble Pharmaceuticals as both a Medical Science Liaison and a Regional Scientific Manager. He has his Masters degree in Health Services Research from New York University and his Bachelors, cum laude, from Cornell University in Molecular and Cellular Biology, with a concentration in Management and Marketing. He has done post-graduate work at Columbia University in Adult Learning and Health Psychology and at INSEAD in Corporate Strategy and Digital Health Strategy. He resides in Westchester County, New York, with his wife who is a Director at Memorial Sloan Kettering Cancer Center and his two daughters, 14 and 9, and cavapoo puppy.
![](https://thec3summit.com/wp-content/uploads/2024/08/Gigi-Shafai.jpg)
Gigi Shafai, Pharm.D., is Vice President of Medical Affairs & Digital Transformation at TransPerfect Life Sciences, where she connects dots across people, process, technology culture, and language to advance innovation for human health experiences. Gigi has over 18 years of experience in the life science industry, having worked across therapeutic areas and departments at leading companies. Leveraging her diverse multidisciplinary biopharma and pharmacy background, she has worked in highly matrixed cross-functional settings during business transformation periods and through corporate alliances. She believes in the technological advances that now allow a transformation the way we connect and communicate scientific information and insights in meaningful ways to various audiences and across language and culture. Her experiences from clinical through commercialization brings an integrative cross-functional perspective for R&D and commercialization teams. Gigi has published and presented at scientific conferences, contributed to research design and analysis, supported brand teams and advanced corporate strategy.
2:00pm – 2:30pm
AI-Driven Success: Digital Marketing Strategies for Pharma in Diverse Global Markets
![](https://thec3summit.com/wp-content/uploads/2024/08/Kurt-Mueller.jpg)
Kurt is a distinguished generative AI leader in pharmaceutical digital marketing and digital medical communications, with over 20 years of experience. He holds advanced AI in Healthcare and Generative AI Prompt Engineering certifications from prestigious universities. As a thought leader in the industry, Kurt frequently publishes articles in leading industry publications and is a speaker at prominent conferences. The Bracken Group supports the growth of life science firms. We enable clients to conduct business with broader capabilities, deeper expertise, better processes, and more data than they had before – from ad hoc consulting to regulatory, marketing, data analytics, and C suite services.
![](https://thec3summit.com/wp-content/uploads/2024/08/Matt-Lewis-300x300.jpeg)
Matt oversees the Artificial and Augmented Intelligence function across Inizio Medical, aligned to the Medical Analytics and Innovation department which he Founded and has led to its position of market leadership since 2016. With 25 years of life sciences experience, Matt specializes in partnering with key stakeholders to speed time to decision leveraging artificial intelligence, advanced analytics, digital innovation and bespoke consultancy. He has deep expertise in oncology/hematology, neuropsychiatry and rare disorders and has contributed to the launch of over 60 treatments globally. Matt Co-Chairs the AI Task Force at the International Society for Medical Publication Professionals, where he oversaw the development and publication of the global roadmap and call to action on Artificial Intelligence, published on November 1st, co-authored the Declarative Statement on Artificial Intelligence for the Healthcare Communications Association, published in early October, was the featured speaker in 2023 for the Medical Affairs Professional Society Executive Consortium, on Augmented Intelligence, and helped to architect its Generative AI White Paper, published on September 28, 2023, is a founding Board Member of the Society for Artificial Intelligence and Health, and is the Executive Lead for Inizio Medical’s Business Employee Resource Group on Mental Health and Wellbeing. He is a frequently requested Keynote Speaker on Artificial Intelligence, Medical Affairs and Mental Wellness. Prior to his role at Inizio Medical, Matt led Strategy and Account Planning at Omnicom Health Group, WPP and worked at both Boehringer Ingelheim as a Senior Scientist and at Procter and Gamble Pharmaceuticals as both a Medical Science Liaison and a Regional Scientific Manager. He has his Masters degree in Health Services Research from New York University and his Bachelors, cum laude, from Cornell University in Molecular and Cellular Biology, with a concentration in Management and Marketing. He has done post-graduate work at Columbia University in Adult Learning and Health Psychology and at INSEAD in Corporate Strategy and Digital Health Strategy. He resides in Westchester County, New York, with his wife who is a Director at Memorial Sloan Kettering Cancer Center and his two daughters, 14 and 9, and cavapoo puppy.
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Health and medical content Sara strategized, edited, and produced has been nominated for and won multiple awards including National Magazine Awards, Digital Health Awards, and a James Beard Award.
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Dana Weber specializes in performance marketing, and has led digital marketing solutions for some of the world’s most notable brands including Amazon, JnJ, AMEX, Adobe, LVMH, and many more. Dana leads the TransPerfect Digital Client Services team and knows how to help clients generate business outcomes in any market or language, with a data-led ROI mindset.
2:30pm – 2:45pm
Break
2:45pm – 3:15pm
Adapting to Pharma's Evolving Landscape: Insights from a Training Perspective
![](https://thec3summit.com/wp-content/uploads/2024/08/Matt-Lewis-300x300.jpeg)
Matt oversees the Artificial and Augmented Intelligence function across Inizio Medical, aligned to the Medical Analytics and Innovation department which he Founded and has led to its position of market leadership since 2016. With 25 years of life sciences experience, Matt specializes in partnering with key stakeholders to speed time to decision leveraging artificial intelligence, advanced analytics, digital innovation and bespoke consultancy. He has deep expertise in oncology/hematology, neuropsychiatry and rare disorders and has contributed to the launch of over 60 treatments globally. Matt Co-Chairs the AI Task Force at the International Society for Medical Publication Professionals, where he oversaw the development and publication of the global roadmap and call to action on Artificial Intelligence, published on November 1st, co-authored the Declarative Statement on Artificial Intelligence for the Healthcare Communications Association, published in early October, was the featured speaker in 2023 for the Medical Affairs Professional Society Executive Consortium, on Augmented Intelligence, and helped to architect its Generative AI White Paper, published on September 28, 2023, is a founding Board Member of the Society for Artificial Intelligence and Health, and is the Executive Lead for Inizio Medical’s Business Employee Resource Group on Mental Health and Wellbeing. He is a frequently requested Keynote Speaker on Artificial Intelligence, Medical Affairs and Mental Wellness. Prior to his role at Inizio Medical, Matt led Strategy and Account Planning at Omnicom Health Group, WPP and worked at both Boehringer Ingelheim as a Senior Scientist and at Procter and Gamble Pharmaceuticals as both a Medical Science Liaison and a Regional Scientific Manager. He has his Masters degree in Health Services Research from New York University and his Bachelors, cum laude, from Cornell University in Molecular and Cellular Biology, with a concentration in Management and Marketing. He has done post-graduate work at Columbia University in Adult Learning and Health Psychology and at INSEAD in Corporate Strategy and Digital Health Strategy. He resides in Westchester County, New York, with his wife who is a Director at Memorial Sloan Kettering Cancer Center and his two daughters, 14 and 9, and cavapoo puppy.
![](https://thec3summit.com/wp-content/uploads/2024/08/Amanda-Hernandez-RN-300x300.jpeg)
Amanda Hernandez is a seasoned professional with a unique blend of clinical expertise and extensive experience in sales and leadership. With a foundational background as a Registered Nurse, Amanda transitioned into the business world where she has excelled in sales, training, and development roles for over two decades. Currently, Amanda serves as the Director of Sales Training and Effectiveness at Telix Pharmaceuticals, where she is instrumental in shaping the sales strategy and driving performance excellence. Her role involves leading initiatives that enhance the effectiveness of the sales team, developing impactful training programs, and fostering an environment that supports ongoing professional growth. Amanda’s career is marked by her success as a sales representative and her subsequent leadership roles. She has a proven track record of not only meeting but exceeding sales targets, and her passion for helping others succeed is evident in her approach to training and development. Her unique combination of skills allows her to bridge the gap between clinical knowledge and business acumen, delivering exceptional results and empowering teams to achieve their full potential. With a deep commitment to professional development and a drive for continuous improvement, Amanda remains dedicated to advancing her field and contributing to the success of Telix Pharmaceuticals. Telix is a commercial-stage biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic (‘theranostic’) radiopharmaceuticals.
![](https://thec3summit.com/wp-content/uploads/2024/08/Bob-Holliday-300x300.jpeg)
Bob Holliday is the Senior Director, Training & Medical Education for Cytovale. He has over 30 years of Learning & Leadership development experience across life sciences organizations and the US Air Force; working in startups to very large organizations, both with US and global responsibilities. He holds a BS in Organizational Management and a MBA in Strategic Human Resource Management Cytovale is a medical diagnostics company that uses machine learning technology to help diagnose fast-moving diseases. Its IntelliSep test stratifies the risk of a patient developing sepsis upon presenting at an Emergency department.
![](https://thec3summit.com/wp-content/uploads/2024/08/Jessica-Peyser.jpeg)
Jessica Peyser is a Sr. Sales Director at TransPerfect Life Sciences supporting pharmaceutical, biotech and medical device companies. Jessica joined TransPerfect’s sales team in 2014, and has progressed from an individual contributor to senior management position, manging dozens of client relationships. She has a passion for solving tough problems and building personal relationships with everyone she works with. Most importantly, she loves the positive impact her work has on bringing therapies to patients, herself a rare disease survivor.
3:15pm – 4:00pm
Patient-Focused Paradigm: Navigating Conversations, Challenges, and Outcomes in Engagement
![](https://thec3summit.com/wp-content/uploads/2024/08/Ella-Balasa-300x300.jpeg)
Ella Balasa is a patient advocate, consultant, and a person living with cystic fibrosis. She has committed her time to empowering patients and advancing healthcare strategies. She speaks publicly about the value of patient perspective and has a passion for distilling clinical information for patient communities. Through opportunities working with healthcare organizations on content strategy, writing, speaking, clinical trial development, and sharing the patient experience, she aims to affect the healthcare landscape by raising awareness of rare diseases, promoting self-advocacy to patients, and valuable insights to organizations. More of her work and experiences can be found at www.ellabalasa.com.
![](https://thec3summit.com/wp-content/uploads/2024/08/kristin-smedley-300x300.png)
Kristin is the Co-Founder and CEO of the Curing Retinal Blindness Foundation, the only patient organization for CRB1 LCA/RP, the rare eye disease that caused her sons’ blindness. The foundation has raised over $4 million and achieved the first-ever National Rare Eye Disease Awareness Day, with legislation submitted in Braille. Kristin partnered with Spark Therapeutics to help achieve the first FDA-approved gene therapy for retinal disease. She authored the bestselling Thriving Blind and the award-winning children’s book What I Can Be Is Up to Me and co-created the film The Greatest Equalizer.
![](https://thec3summit.com/wp-content/uploads/2024/08/Matt-Holms.jpg)
Matt Holms is the VP of Sales responsible for overseeing Patient Engagement & Recruitment Solutions at Citeline. He has spent 24 years in the Life Science industry, holding various commercial & executive leadership roles, dedicated to driving innovative technology solutions that enhance clinical research across a diverse spectrum of eClinical technology, Patient Recruitment/RWD, and Sponsor organizations. Beyond his professional endeavors, he is passionate about patient access and awareness of clinical research opportunities, having personally experienced life-changing results and benefits as a clinical research study participant.
![](https://thec3summit.com/wp-content/uploads/2024/08/Joseph-Kim-300x300.jpeg)
Joseph Kim has over 25 years of experience in clinical research from companies like, Merck, Shire and Lilly. He serves as the Chief Strategy Officer of ProotPilot – and award winning platform digitalizing the end-to-end experience for patients and sites.
![Leanne Woehlke](https://thec3summit.com/wp-content/uploads/2024/03/Leanne-Woehlke.jpg)
4:00pm – 5:30pm
Networking Cocktail Reception
12:30pm – 1:30pm
Check-in
1:30pm – 2:00pm
Proven Practices That Move the Needle on Patient Recruitment & Retention
![](https://thec3summit.com/wp-content/uploads/2024/08/Nanci-Eanucci-300x300.jpg)
I am a clinical dietitian with over 20 years of experience in the pharmaceutical/biotech industry. I have worked in various roles including Operations, Site Engagement, Patient Engagement and Patient Enrollment. I am driven by the desire to help find solutions for patients with unmet medical needs as well as bringing awareness, education and opportunity regarding clinical trials to all populations.
![](https://thec3summit.com/wp-content/uploads/2024/08/Joseph-Kim-300x300.jpeg)
Joseph Kim has over 25 years of experience in clinical research from companies like, Merck, Shire and Lilly. He serves as the Chief Strategy Officer of ProotPilot – and award winning platform digitalizing the end-to-end experience for patients and sites.
![](https://thec3summit.com/wp-content/uploads/2024/08/Matt-Holms.jpg)
Matt Holms is the VP of Sales responsible for overseeing Patient Engagement & Recruitment Solutions at Citeline. He has spent 24 years in the Life Science industry, holding various commercial & executive leadership roles, dedicated to driving innovative technology solutions that enhance clinical research across a diverse spectrum of eClinical technology, Patient Recruitment/RWD, and Sponsor organizations. Beyond his professional endeavors, he is passionate about patient access and awareness of clinical research opportunities, having personally experienced life-changing results and benefits as a clinical research study participant.
![](https://thec3summit.com/wp-content/uploads/2024/08/len-rosenberg-300x300.jpg)
Dr. Rosenberg is a 40-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, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society (since 2016) and Managing Partner of eP2Consulting, Inc (since 2001). He is the co-founder of several companies in the biotech & clinical services sector and a board member at multiple companies including non-profits. Dr. Rosenberg received his Ph.D., from the Kellogg Pharmaceutical Clinical Scientist Program, University of Minnesota, College of Pharmacy and his Bachelor of Science, Pharmacy, from the Philadelphia College of Pharmacy and Science.
![](https://thec3summit.com/wp-content/uploads/2024/08/scott-dixon.jpg)
![Leanne Woehlke](https://thec3summit.com/wp-content/uploads/2024/03/Leanne-Woehlke.jpg)
Leanne Woehlke is the Executive Vice President at Soglia, a division of Entrada. As a Patient Experience Organization, or PXO, Entrada is driven to reimagine the way patients interact with pharmaceutical companies throughout their treatment journey. With extensive experience in clinical research, along with knowledge of digital marketing and coaching, Leanne brings a unique perspective to patient recruitment and engagement. Always passionate about impacting the industry in meaningful ways and bringing life-changing treatments to patients who need them, Leanne, is committed to helping patients feel more in control of their health journey.
2:00pm – 2:30pm
Create a Successful Team: Cultivating a Healthy TMF Culture
![](https://thec3summit.com/wp-content/uploads/2024/08/Laura-Naranjo-300x300.jpeg)
Laura Naranjo, M.S.J. , Head of 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 heads up the global TMF Operations and Records Management team driving process and technological efficiency. Laura holds a special 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.
![](https://thec3summit.com/wp-content/uploads/2024/08/Denise-Moak-300x300.jpeg)
Denise is a leader in the life sciences technology innovation space for Clinical R&D solutions and process improvement initiatives. Her comprehensive knowledge of ICH GCP and 21CFR Part 11 compliance requirements govern current leadership in TMF Operations, sponsor oversight improvements in preparation of ICH E6 (R3), and life sciences data modeling for cross systems integrations.
![](https://thec3summit.com/wp-content/uploads/2024/08/Nick-Hargaden-300x300.jpeg)
At Moderna Nick is business owner for eTMF and CTMS applications, and global head of TMF Operations managing in house and vendor teams. He has 25 years in the application of computerized systems to speed drug development and improve quality including TMF,CTMS, IRT, RBQM, and eCOA.
![](https://thec3summit.com/wp-content/uploads/2024/08/laurel-Anne-Schrader-300x300.jpeg)
Laurel-Ann Schrader is a resident TMF subject matter expert. She is a Certified TMF Manager with 21+ years’ experience. Her expertise includes TMF inspection readiness, preparation, and support; best practices for clinical document processes, procedures, and cross-functional culture; eTMF implementation and management; and the real-world application of the TMF Reference Model. She previously worked in clinical operations at Ardea Biosciences, ICON, BioPharm Systems, and Amylin Pharmaceuticals. Laurel is an active participant and contributor to the TMF Reference Model working groups and is a thought leader in the TMF industry.
![](https://thec3summit.com/wp-content/uploads/2024/08/sheri-Brieley.jpg)
Sheri Pudlosky Brierley currently serves as the Associate Director of Operations and Continuous Improvement within the Clinical Operations group at Immunocore. In this role, she oversees Clinical Compliance, Inspection Readiness, and TMF Operations. Over her 8-year tenure at Immunocore, Sheri has held various positions of increasing responsibility within Clinical Operations. With over 30 years of experience in support of Phase I-IV clinical research, Sheri has specialized in CNS, oncology, and vaccine (including pediatric) therapeutic areas, as well as scheduled drug studies. She has experience working for both CROs and sponsors, having held roles such as Project Manager, CTM, and Lead CRA. Her experience includes key roles on pivotal FDA approval studies for such drugs as Treanda®, Sustol®, and KIMMTRAK®. Additionally, Sheri has over a decade of GMP/GLP experience, encompassing Quality Assurance, compliance and auditing, as well as clinical manufacturing. Her expertise includes cell culture scale-up, large-scale fermentation, and purification processes. Immunocore is a commercial-stage biotechnology company that discovered, developed and commercialized the world’s first approved T cell receptor (TCR) therapy. Immunocore’s mission is to radically improve outcomes for patients with cancer, infectious diseases, and autoimmune diseases, by pioneering and delivering transformative immunomodulating medicines. Built on Immunocore’s proprietary ImmTAX platform, they have a diverse pipeline of bispecific therapies across a broad range of indications, including multiple cancers, HIV and HBV.
![](https://thec3summit.com/wp-content/uploads/2024/08/John-Merkel.jpg)
John has worked in the clinical-research industry for almost 10 years, across both CRO and FSP organizations. John has been focused on TMF specifically for the past 7 years working for TransPerfect Trial Interactive, support sponsors and CROs alike implement new and innovative approaches to TMF management and inspection readiness.
2:30pm – 2:45pm
Break
2:45pm – 3:15pm
Collaborative Approaches to eCOA Licensing and Implementation
![](https://thec3summit.com/wp-content/uploads/2024/08/Megan-Petrylak-300x300.jpeg)
Megan Petrylak is the Executive Vice President of Clinical Operations at Clinical ink. For over 14 years, she held various leadership roles within the pharma industry to drive program and operational excellence. In her most recent role, she leads the global project management teams for Emerging & Growth Accounts, the Project Management Office, and Outcomes Science. At Clinical ink, Megan is tasked with heading up key organizational initiatives to drive better outcomes for patients. Prior to this role, Megan served as Director of Project Delivery at Worldwide Clinical Trials. Through her leadership, her team drove programs to ensure seamless trial execution for pharma customers. At Bioclinica, Megan headed their eClinical division project management team as well as the imaging and eClinical support center. Megan is a career team builder and believes extraordinary customer satisfaction starts with caring for employees.
![](https://thec3summit.com/wp-content/uploads/2024/08/Jill-V.-Platko-300x300.jpeg)
A recognized industry thought leader, Jill brings over 30 years of scientific and 17 years eCOA experience to Suvoda as Vice President of Scientific Services. Prior to Suvoda, Jill led the development of the Scientific Advisory practice at Signant Health and has held leadership positions with Covance and PHT Corporation. Jill earned a bachelor’s degree in biology and mathematics from SUNY, and a doctorate in genetics and development from Cornell University. Suvoda is a global clinical trial technology company that empowers clinical trial professionals to manage the urgent moments in trials through advanced software solutions delivered on a single platform.
![](https://thec3summit.com/wp-content/uploads/2024/08/LPsimas-300x300.jpg)
Dr. Lynsey Psimas is a licensed clinical psychologist with extensive expertise in assessing children, adolescents, and adults. Her professional background spans private practice, therapeutic schools, and academia. Dr. Psimas specializes in the neuropsychological assessment of autism, ADHD, developmental disorders, and learning disabilities. Currently, Dr. Psimas leads business development for the pharmaceutical licensing division at Pearson Clinical Assessments, where Pearson’s highly validated Clinical Outcome Assessments (COAs) are backed by over 80 years of expertise in measurement science.
![](https://thec3summit.com/wp-content/uploads/2024/08/InesSmajic.jpg)
![](https://thec3summit.com/wp-content/uploads/2024/08/TWilliams_20180326-277x300.jpg)
Teresa Williams is the Director of Copyright and Translations at Eli Lilly and Company a global pharmaceutical company that develops and delivers innovative medicines. With 25 years of experience in the pharmaceutical industry, in 2006, Teresa headed a Clinical Outcome Assessment (COA) project and began her career in copyright licensing and translations. Teresa oversees the acquisition of intellectual property rights and linguistic translations for the company’s COAs. Under her leadership, a centralized copyright group and processes were established that streamlined and improved the quality of the workflow of licensing, translations, and eCOA translation migration.
![](https://thec3summit.com/wp-content/uploads/2024/08/Mark-wade.jpg)
Mark P. Wade holds the position of Global Practice Leader and COA SME at TransPerfect Life Sciences, the largest Language translation company globally, where he is the resident SME for all clinical trial processes and translation. Mr. Wade’s 20 years in Life Sciences includes International Regional Director for EMEA at Ethicon and Ethicon Endo Surgery, Johnson
& Johnson companies (NYSE: JNJ). For almost ten years Mr. Wade was Global Practice Leader at another global language translation company. He is a published expert in Electronic Clinical Outcomes Assessments (eCOA) including two eBooks, Clinical Posters and numerous articles in trade journals. He has significant experience and has published in Clinical Services, Patient Recruitment and Site Selection. Mr. Wade has Chaired, presented and published Posters at DIA Annual Symposia and numerous other internationally recognized conferences.
Mr. Wade is currently holds the position of Co-Director of C-Path eCOA Consortium, ISOQOL Digital Health Special Interest Group (SIG), ISPOR Translation and Cultural Adaptation (TCA) SIG and DIA Endpoint Study Group.
3:15pm – 4:00pm
Use of AI in Clinical Trials
![](https://thec3summit.com/wp-content/uploads/2024/08/Scott-Ogden.jpg)
Scott Ogden is the Head of AI Innovation Team at Genmab, a global biotech powerhouse with 8 approved knock-your-socks-off (KYSO) medicines. With a career spanning over a decade in data science and artificial intelligence, Scott has led transformative projects in the healthcare sector. His extensive experience includes roles at Payors and Providers and Memorial Sloan Kettering Cancer Center. Scott is currently pursuing an Executive MBA at Wharton. At Genmab, he drives AI enterprise technical innovation to accelerate drug discovery and development and commercialization, enhancing the company’s mission to improve the lives of patients worldwide.
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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, promoting the industry-leading RBQM/Central Monitoring solution and a growing suite of data-quality related solutions to study sponsors and CROs.
![](https://thec3summit.com/wp-content/uploads/2024/08/John-J.-Doyle.jpg)
John leads a global team of expert consultants across the product development lifecycle, helping clients navigate complex and fast-changing business and regulatory environments — driving productivity and innovation strategies to accelerate drug development that leverage data, technology, and advanced analytics. The team’s solutions include clinical development, regulatory science, and market access strategy, health economics & outcomes research, and real-world evidence. John received his Doctorate and Master of Public Health degrees in Epidemiology from Columbia University and BSc. in Business Management & Applied Economics from Cornell University. Dr. Doyle maintains a faculty position in the Department of Epidemiology at Columbia University.
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Shrividya (Shri) Iyer, is currently with Putnam, Inizio Advisory as Principal, Value Pricing & Access. Prior to current role Shri has 20+ years’ experience in the pharmaceutical industry building and leading global health economics outcomes research (HEOR)/ RWE teams across diverse therapeutic areas. Shri has extensive experience in developing and executing a global evidence strategy meeting the needs of diverse health care stakeholders worldwide and has published extensively in peer reviewed scientific journals. Shri has a PhD in pharmaceutical socioeconomics from the University of Iowa, USA, a degree in pharmacy from University of Mumbai and a Certificate in Business Excellence in Digital Health from Columbia Business School, New York.
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4:00pm – 5:30pm
Networking 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.