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
Remote Study Team Engagement – New Approaches to eLearning Content and Training
Joe Coffie
Director of Clinical Operations
Imago BioSciences Inc., a subsidiary of Merck & Co., Inc.
Joe Coffie has more than 20 years of experience in building and leading highly functional clinical operations teams in small-to-medium-sized companies and a few large companies. His expertise lies in developing and implementing efficient operational strategies that improve clinical trial timelines and quality. Joe possesses exceptional skills in team building, cross-functional collaboration, and project management, which have helped him successfully lead clinical trials from phase I to IV along with clinical operations departments.
Ahsan Awan
VP of Clinical Development and Digital Health
Genlantis
Ahsan Awan is an award-winning clinical development executive with nearly 30 years of global clinical trial experience at the sponsor, CRO, SMO, clinical site and e-clinical vendor levels. He has worked with pharma, biotech, medical device and diagnostics, as well as e-clinical software, mobile and digital health solutions, including the use of AI.
2:00 – 2:30
Patient Recruitment and Inclusivity – Engagement Strategies for Diversity and Accessibility
Daniel A. Perez, CCRP
Director and Global Head of Patient Experience, Diversity & Inclusion
Worldwide Clinical Trials
As Director & Global Head of Patient Experience, Diversity & Inclusion for Worldwide Clinical Trials, Daniel serves as a leader, strategic counselor, and architect for Worldwide’s patient engagement, diversity, and inclusion efforts across 60 countries and five therapeutic areas. His focus is on the geographic and therapeutic expansion of Worldwide’s capabilities to cultivate a thriving ecosystem of investigative sites, clinician investigators, and patients by participating in bid defenses, designing full-cycle clinical operations, engaging first-time clinician investigators, supporting patient recruitment and retention, and leveraging real-world data from global partnership assets.
Shyanne Ali
Vice President Quality Assurance
Aditum Bio
Shyanne Ali has more than 20 years of pharmaceutical drug development experience in the areas of global clinical operations, global clinical development, and quality assurance. Over the course of her career, Shyanne has led the Global R&D Quality organization at Boehringer Ingelheim, Intercept Pharma, and tech startup TrialSpark. Prior to her leadership roles in quality assurance, she held leadership roles in global clinical operations functions at Abbott Laboratories, Novartis Oncology, and Novartis Vaccines.
Aditum Bio is a new model of biotech venture capital, uniquely positioned to rapidly translate scientific discoveries into innovative new medicines. Aditum Bio brings together unmatched scientific and domain expertise with agile operational capabilities. Our unique investment and operating model enables rapid company formation, planning, and execution to advance novel drug candidates into the clinic and accelerate their delivery to patients in need.
Jocelyn M. Ashford
Founder
Rare Advocate
Jocelyn M. Ashford is the Founder of Rare Advocate, a patient advocacy and engagement consulting firm. Jocelyn is a biotech professional with more than 20 years of success in patient advocacy, policy, communications, marketing, sales, relationship management, and analytics. She is a sought-after DE&I thought leader focused on strategies and practical solutions that build and improve equitable healthcare systems. Jocelyn is a respected, enthusiastic, and savvy leader with proven abilities to hear and tell the stories of those with both rare and recognized conditions in a manner that inspires action. She holds a bachelor’s in industrial engineering & economics. She completed her master’s work in engineering management and social & organizational change at Northwestern University.
Marta Schumacher
Executive Director, Global Clinical Operations
Annexon, Inc.
Marta Schumacher is Executive Director of Clinical Operations at Annexon, Inc. Annexon is passionate about bringing game-changing therapies to patients suffering from serious complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders. Marta has more than 30 years of experience working in the biotech, health, and pharmaceutical industries. She has managed and overseen global clinical trials in various therapeutic areas and multiple phases of development.
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
Ahsan Awan
VP of Clinical Development and Digital Health
Genlantis
Ahsan Awan is an award-winning clinical development executive with nearly 30 years of global clinical trial experience at the sponsor, CRO, SMO, clinical site and e-clinical vendor levels. He has worked with pharma, biotech, medical device and diagnostics, as well as e-clinical software, mobile and digital health solutions, including the use of AI.
Rajul Jain
President, Medical Information
ProPharma
Rajul Jain is President of Medical Information at ProPharma. ProPharma is an industry-leading research and consulting organization that helps pharma companies excel at every stage of the pharmaceutical lifecycle by co-creating optimal solutions and models for end-to-end support across the full product lifecycle. Rajul has more than 17 years of experience working in various global leadership positions within medical information, pharmacovigilance, technology, and program management functions. Previously, Rajul was Head of North America Medical Information operations at IQVIA and also led the Technology Solutions group at IQVIA, which enabled the implementation of innovative AI/ML technology solutions for medical information and pharmacovigilance. She has also held several leadership roles in healthcare and pharmaceuticals functions at IBM, Cognizant, and Infosys BPM. Rajul holds an MBA and engineering degree along with several industry certifications.
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)
Ahsan Awan
VP of Clinical Development and Digital Health
Genlantis
Ahsan Awan is an award-winning clinical development executive with nearly 30 years of global clinical trial experience at the sponsor, CRO, SMO, clinical site and e-clinical vendor levels. He has worked with pharma, biotech, medical device and diagnostics, as well as e-clinical software, mobile and digital health solutions, including the use of AI.
Ann Neale
Chief Development Officer
BioAge Labs
Ann Neale is Chief Development Officer of BioAge, where she creates development strategy while driving and building corporate operations and infrastructure for all of the company’s molecules. She has more than 25 years of leadership experience as a biotech executive, leading global multidisciplinary teams to advance molecules through the development pipeline and deliver on strategic objectives. Before joining BioAge, she served as Senior Vice President (SVP) of Development Operations at Principia Biopharma, where she defined operations and resourcing strategy for multiple global early- and late-phase clinical programs while scaling development functions. She holds a BS in nursing from the University of Minnesota.
Emily Hu
Senior Director of Clinical Operations
Nutrafol
Emily Hu is a clinical operations expert with more than 15 years of medical device clinical development experience. She has developed and conducted clinical studies for class 2 medical devices at multiple startups and small companies, but her experience also spans clinical development at large companies, such as Roche and Alphabet/Verily; class 3 medical device companies; and, most recently, human subject research in the health, fitness, and nutraceutical space.
Joe Coffie
Director of Clinical Operations
Imago BioSciences Inc., a subsidiary of Merck & Co., Inc.
Joe Coffie has more than 20 years of experience in building and leading highly functional clinical operations teams in small-to-medium-sized companies and a few large companies. His expertise lies in developing and implementing efficient operational strategies that improve clinical trial timelines and quality. Joe possesses exceptional skills in team building, cross-functional collaboration, and project management, which have helped him successfully lead clinical trials from phase I to IV along with clinical operations departments.
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.
