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 from the lens of real-world experience. Takeaway practical insights and participate ina the discussion during Q&A and the 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
Shyanne Ali
Vice President Quality Assurance
Aditum Bio
Shyanne Ali has over 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 Global R&D Quality organization at Boehringer Ingelheim, Intercept Pharma and tech start-up, 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 speed their delivery to the patients in need.
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 leader, strategic counselor, and architect for Worldwide’s patient engagement, diversity, and inclusion efforts across 60 countries and 5 therapeutic areas. His focus is on 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 & retention, and leveraging real-world data from global partnership assets.
Shyanne Ali
Vice President Quality Assurance
Aditum Bio
Shyanne Ali has over 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 Global R&D Quality organization at Boehringer Ingelheim, Intercept Pharma and tech start-up, 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 speed their delivery to the patients in need.
Jocelyn M. Ashford
Vice President, Patient Advocacy
BridgeBio
Jocelyn M Ashford is Vice President of Patient Advocacy at BridgeBio Pharma. BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat people with genetic conditions and cancers with clear genetic drivers. Jocelyn’s team connects BridgeBio with patient communities around the world. They champion the inclusion of actionable insights in business- and program-level decisions and partner with advocates and other external partners to improve the lived experiences of diagnosed individuals. Jocelyn holds a Bachelor’s in Industrial Engineering & Economics. She completed her Master’s work in Engineering Management and Social & Organizational Change at Northwestern University. Jocelyn has been in the biopharma industry for almost 20 years.
Marta Schumacher
Executive Director, Global Clinical Operations
Annexon, Inc.
Marta Schumacher is an 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 over 30 years experience working in biotech, health and the pharmaceutical industry. 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
Scott McCulloch
Executive Director, Global Clinical Quality Assurance and Pharmacovigilance
ReCode Therapeutics
Scott is currently based in California and has 16 years industry experience. Currently the Executive Director of Global Clinical Quality Assurance and Pharmacovigilance at ReCode Therapeutics and the President of the Pacific Regional Chapter of the Society of Quality Assurance (SQA).
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)
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 over 25 years 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) 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 over 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, and class 3 medical device companies, and, most recently, human subject research in the the health, fitness, and nutraceutical 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.
