Archives: Speakers

Barry Cymerman is a clinical development strategist with a 28-year career spanning pharma, CROs, and clinical technology providers. He brings a rare perspective to clinical-trial sourcing, having worked from both the sponsor and service-provider sides of the industry, giving him a firsthand view of how sourcing strategies, operating models, technology, and external partnerships shape trial execution. Today, Barry works across complex clinical development environments to identify structural misalignment, align stakeholders, and build models that enable complex programs to execute. At OCT New England, he will share his perspective from Daiichi Sankyo’s participation in the Tufts Center for Drug Development research examining clinical-trial sourcing models and their relationship to trial performance.

Experienced clinical research professional with demonstrated expertise in clinical monitoring oversight of global trials, vendor management, and regulatory inspections while fostering strong relationships with internal cross-functional, vendor, and site teams.

Ayat Alsaraby is associate director of biotech relationship management at TruTechnologies, where she partners with sponsors to strengthen site collaboration, clinical trial oversight, and data integrity. She brings over a decade of experience in biomarker operations, clinical data management, and operational compliance optimization. Prior to TruTechnologies, Ayat held senior roles at Repare Therapeutics and Agenus, leading global biomarker operations and driving inspection readiness, vendor management, and operational excellence. With a track record of fostering cross-functional alignment and providing consultative guidance, she combines scientific expertise and strategic insight to accelerate development and ensure compliance in complex clinical trials.

Vimal Patel is executive director of biotech solutions at TruTechnologies, where he partners with life sciences organizations to improve trial oversight and data quality. With more than 15 years in strategic advisory and enterprise sales, he has guided leading companies in adopting technologies that accelerate insights and reduce risk. Prior to TruTechnologies, Vimal held senior roles at AIO, nCino, and Abrigo, helping clients enhance efficiency and growth. Known for his collaborative approach and results-driven focus, he helps sponsors navigate complex challenges and bring critical therapies to patients faster.

As Vice President of Clinical Operations, I lead the global execution of clinical trials with full accountability for strategy, delivery, and performance. My role spans oversight of study design through closeout, ensuring alignment with scope, timelines, budget, and quality expectations. With over 16 years of experience across sites, CROs, and sponsors, I bring hands-on expertise in trial operations and therapeutic depth across analgesia, GI, pulmonary, hepatology, cardiovascular, dermatology, endocrinology, rare disease, oncology, neuro-oncology, women’s and men’s health, infectious disease, and CNS disorders.

I’m a strategic leader who builds and empowers high-performing teams, driving operational excellence across all phases of development. My approach is grounded in a strong medical background and a site- and patient-centric mindset, ensuring safety, ICH/GCP compliance, and data integrity at every step. I have a proven track record of scaling clinical operations, optimizing staff utilization, and delivering complex programs for startup and growth-stage biotech’s.

Beyond day-to-day execution, I actively contribute to clinical development strategy and revenue cycle management, aligning scientific innovation with business outcomes. As a trusted advisor, consultant, and startup enthusiast, I thrive in dynamic environments where collaboration, speed, and adaptability are essential.

I lead with clarity, integrity, and purpose and I’m always open to connecting with fellow professionals, founders, and teams shaping the future of clinical development.

Susan Fitzpatrick-Napier is a biopharma and CRO-focused technology leader with more than 20 years of experience across Asia, the US and Europe. She is the founder of TrialWire, the fastest and most secure precision-AI powered patient recruitment platform built on Salesforce Health Cloud. Her expertise sits at the intersection of data, digital health and clinical development.

A passionate advocate for innovation in clinical research and healthcare, Susan is a frequent speaker at global industry forums, where she explores how AI, automation and data-driven platforms can accelerate trial timelines and bring new therapies to patients faster.

Jake Walton is the Vice President of Quality, Compliance, and Privacy at a leading software company with nearly 20 years of experience across global regulatory, security, and privacy frameworks. His expertise includes FDA regulations (21 CFR Parts 11, 58, 210, 211 and 820) and ISO standards such as 9001, 27001, and 42001.

He leads enterprise-wide programs in quality, AI governance, and information security, aligning AI systems with frameworks like the EU AI Act, ISO/IEC 42001, and the OECD AI Principles. Concurrently, he oversees quality, security, privacy controls based on ISO 9001, ISO 27001, ISO 27701, FedRAMP, NIST 800-53, GDPR, and CCPA to ensure innovation is compliant, secure, and trustworthy.

Jake has led over 350 external audits from customers and authorities including the FDA, MHRA, TGA, Taiwan FDA, and the German Health Authority. A regular speaker at industry conferences, he champions ethical and compliant innovation in technology. He is passionate about helping organizations build ethical, secure, and scalable systems that align innovation with compliance.