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.
Speakers
Agenda
1:00 – 1:30
Welcome & Check-In
1:30 – 2:00
COA/eCOA Innovations – Licensing Hiccups, Linguistic Validation, ePRO Migration, and Best Practices to Ensure FPI
Chris Bowen
Director of Patient Technologies
Pfizer
Chris started with Pfizer in 2000 and has enjoyed a career spanning research, development, and regulatory organizations. He currently leads Pfizer’s Patient Technology strategy, implementing innovative approaches to provide easier access and lessen the burden for sites and patients within Pfizer’s clinical study environment
Jessica Mialkowski
Senior Manager, Clinical Systems
Agios Pharmaceuticals
Jessica Mialkowski, Senior Manager of Clinical Systems at Agios Pharmaceuticals, has more than 18 years of experience in RTSM, eCOA, and UAT across vendor, CRO, and sponsor organizations. In her current role, Jessica focuses on the technology supporting traditional, hybrid, and decentralized trials—primarily eCOA and eConsent—as well as the integration and UAT of digital trial systems. Agios is a biopharmaceutical company and a leader in the field of cellular metabolism pioneering therapies for rare diseases. Agios is focused on hemolytic and acquired anemias, including pyruvate kinase (PK) deficiency, thalassemia, sickle cell disease, and lower-risk myelodysplastic syndromes (MDS).
Bill Barrasso
Chief Compliance Officer
Clinical Ink
Bill Barrasso brings to Clinical Ink years of operational and compliance experience with multiple eCOA service providers. Bill earned his MBA at Northeastern University in Boston and is on hiatus from a PhD program for personal healthcare informatics, also at Northeastern University. Bill is actively involved in regulatory and clinical issues, process quality, and has direct contact with key clients. Throughout his career, Bill has developed effective study management processes to improve delivery quality and connect operational study activities to corresponding regulatory, clinical, and corporate business functions. Through his career, Bill has gained deep experience and knowledge of clinical and regulatory guidance required for successful trial execution.
2:00 – 2:30
Patient Recruitment and Inclusivity – Engagement Strategies for Diversity and Accessibility
Paresh K Shah
President
MindLeaf Tech Inc.
Paresh K Shah is the Founder & CEO of MindLeaf Technologies, Inc., a medical support services and compliance company headquartered in Lowell, MA, with operations in the continental US. Paresh has more than 25 years of experience in healthcare technology, medical administrative services, medical compliance, and consulting. He holds the following degrees and certifications: BS (Northeastern University), MS (Boston University), MBA (Babson College), Patient Engagement and Compliance Expert, and (Feb 2023) NIH/NCI reviewer – Social Determinants of Health.
Tricia Buchheit
Associate Director, Patient Recruitment
Alnylam Pharmaceuticals
Tricia Buchheit has over 25 years of Patient Recruitment, Retention and Project Management industry experience through her work at agencies, CROs, core labs, and biotechnology companies. This vast experience provides a 360-degree perspective of the challenges key stakeholders encounter with recruitment and retaining patients into clinical trials. Currently, Tricia focuses on the development and implementation of thoughtful recruitment and retention strategies and solutions to bring much needed RNAi therapeutics to market.
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.
Nader Daoud
Sr. Manager, Clinical Trial Diversity & Inclusion
Moderna
Nearing a decade of experience in clinical research, Nader Daoud takes a data-driven approach to leading the equitable inclusion of people from all backgrounds in Moderna’s global clinical trials across various therapeutic areas. Moderna’s mission is to deliver the greatest possible impact to people through mRNA medicines. They set out to change the world and make mRNA medicines a reality for humanity. Nader is committed to innovating health technology that is made with and for everyone. With justice at the heart of his work, he cares about how we get to where we are going.
2:30 – 2:40
Break
2:40 – 3:10
Remote Study Team Engagement – Patient Safety, Site Accountability, and Clinical Document Quality
Maria Mancini
Vice President, Head of Clinical Development
Edgewise Therapeutics
Maria C. Mancini, MHP, has 20 years of experience in the biotech industry focusing primarily on clinical trial strategy and operations. Maria is currently employed by Edgewise Therapeutics as the Vice President of Clinical Development Operations. In her current role, Maria provides leadership, strategic oversight, and guidance within clinical development to ensure quality, timeline, resource, and budget goals are met. Prior to joining Edgewise, Maria served as Vice President of Clinical Operations at Catabasis (now Astria) for eight years, and, prior to that, she served in positions of increasing responsibility at Sanofi Genzyme (formerly Genzyme). Maria has held an appointment as an adjunct professor at Northeastern University since 2007. Maria holds a master’s degree in health policy from Northeastern University and a BS in health science from Merrimack College. Maria has earned the US Regulatory Affairs Certification (RAC) designation.
Bill Barrasso
Chief Compliance Officer
Clinical Ink
Bill Barrasso brings to Clinical Ink years of operational and compliance experience with multiple eCOA service providers. Bill earned his MBA at Northeastern University in Boston and is on hiatus from a PhD program for personal healthcare informatics, also at Northeastern University. Bill is actively involved in regulatory and clinical issues, process quality, and has direct contact with key clients. Throughout his career, Bill has developed effective study management processes to improve delivery quality and connect operational study activities to corresponding regulatory, clinical, and corporate business functions. Through his career, Bill has gained deep experience and knowledge of clinical and regulatory guidance required for successful trial execution.
3:10 – 3:55
EU Clinical Trial Regulation: Operational Considerations and Impacts
Pierre-Frédéric Omnes
Executive Director at TransPerfect Life Sciences
TransPerfect
Pierre-Frédéric Omnes, Executive Director at TransPerfect Life Sciences, has over 20 years of experience in global CROs and pharma companies as a regulatory affairs consultant overseeing numerous multinational clinical trial applications globally. Pierre is a subject-matter expert on site startup and regulatory operations in global clinical trials as well as on the EU Clinical Trial Regulation 536/2014 (EU CTR) for corporate readiness, implementation and Clinical Trial Information System. Pierre is part of the EMA-led initiative developing the EU Clinical Trial Information System (CTIS) as Lead Product Owner representing the Industry & Academia since 2019, continuing an engagement of several years in user acceptance testings, workshops and analysis & design sessions related to CTIS development and optimization.
Roxann Pinguelo
Associate Director, Clinical Supply
Black Diamond Therapeutics, Inc.
Roxann Pinguelo has over 15 years of focused and results-driven Clinical Supply Management experience through successful planning, forecasting, and execution to ensure the right supply is at the right place at the right time. Her vast experience spans from small phase I to large global clinical trials across various therapeutic areas at pharma companies of all sizes. Recently, she started her own CS Professional Consulting company. She holds a Bachelor of Science degree in computer science and has coursework towards her Master of Science in regulatory/quality assurance at Temple University.
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.
