COG Bay Area 2025 Meeting Review

The Clinical Outsourcing Group Bay Area conference, held last week, brought together leading professionals from across the San Francisco Bay Area's life sciences ecosystem to address critical challenges in clinical trial outsourcing, operational efficiency, and patient-centric trial design. Under the expert co-chairmanship of Jasmina Jankicevic and Bonnie Bain (both COG Series Advisory Board Members), the two-day event featured insightful presentations, interactive panel discussions, and valuable networking opportunities that illuminated the evolving landscape of clinical research in one of the world's leading biotech hubs.

Paulius Ojeras (VP, Clinical Operations, Perceive Biotherapeutics)

Strategic Outsourcing and CRO Selection

A central theme throughout the conference was strategic approaches to CRO selection and vendor management, reflecting the critical importance of these partnerships for biotech success. Paulius Ojeras (VP, Clinical Operations, Perceive Biotherapeutics) opened the conference with a keynote on "Leadership Insights: Unpacking Current Trends and Looking to the Future of Outsourcing," examining how trial sponsors are navigating leaner teams, increased pressure for speed, and the wave of innovation reshaping biotech operations.

An interactive panel moderated by Jasmina Jankicevic tackled "The (Multi) Million Dollar Question: Should You Choose a Large CRO or Small, Specialised One?" with panellists Dorothy Kwok (Head of Clinical Operations, Bodyport), Gina Morton (Director, Strategic Sourcing and Procurement, Exelixis), David Rhodes (Head of Clinical Operations, Nkarta), and Katharine Grimmer (SVP, Clinical Operations, Sagimet Biosciences) addressing CRO selection challenges from a small company perspective and exploring how to ensure the right organizational fit.

The (Multi) Million Dollar Question: Should You Choose a Large CRO or Small, Specialised One? Panel

Dr Cristina Chang (Chief Medical Officer, Harvest Integrated Research Organization) presented "Strategic CRO Selection: Optimizing Clinical Development Through Intelligent Outsourcing," providing actionable insights on hybrid models, performance-based contracts, and vendor management tools to turn CRO selection from an operational necessity into a competitive advantage.

Rich Polgar (Outsourcing Director, Cellectis) delivered a masterclass titled "A Masterclass on Outsourcing: Keeping your Finger on the Pulse of Small Biotech," demonstrating how to de-risk programs, create CRO accountability, and build governance structures for small biotech while improving company cashflow and preparing for FSP vs. FSO decisions.

Kim Boericke (COO, Veristat) and Hyun Kim (SVP, Clinical Development, AOBiome Therapeutics) jointly presented "Strategic from the Start: Leveraging Your CRO as a True Development Partner," exploring how early, integrated collaboration with CRO partners helps sponsors navigate the full development lifecycle from funding to regulatory approval, with real-world examples of aligned planning and shared risk mitigation strategies.

Drinks Reception - Day 1 Close

Technology, Innovation, and Artificial Intelligence

The conference dedicated substantial attention to emerging technologies and their practical applications in clinical trials. An interactive panel moderated by Bonnie Bain explored "The Unleashing of AI: How Do We Grapple with AI as a Trial Sponsor?" with panellists Judy Yeh (Vice President, Clinical Supply Chain, Gilead), Eduardo Bruno Martins (CMO, Sagimet Biosciences), Peter St Wecker (Clinical Program Director, UCB), and Gajanan Bhat (SVP, Development Lead, TORL BioTherapeutics) discussing whether AI can realistically streamline trials for small-to-mid-sized biotech and how to use AI responsibly on limited budgets.

Hali Beeson (Director of Data Informatics, Evestia Clinical) and Hunter Walker (Chief Technology Officer, Evestia Clinical) presented "Practical AI at a Mid-Sized CRO: Value Now, Agents Later," providing a plain-English playbook for using AI while keeping sponsor data private and service personal, including a realistic roadmap for AI agents.

Hali Beeson (Director of Data Informatics) and Hunter Walker (Chief Technology Officer) from Evestia Clinical

Stacey Lasser (Senior Project Manager, Mednet) delivered a keynote on "Empowering Sites through Simplified Workflows and Unified Technologies," revealing how integrated eClinical technologies like RTSM and monitoring trip reports simplify workflows, enhance communication, and reduce administrative burdens for clinical trial sites.

Walter Boyle (VP, Integrated Solutions, Cytel) addressed "Moving from Data Driven to Data Integrated – How to Create Lasting Impact in a Rapidly Changing World," providing new perspectives on data and analytics strategy by shifting focus from finding the right answers to finding the right questions.

Kevin Haas (Chief Technology Officer, Myriad Genetics) moderated a fireside chat with Stephen Smith (Senior Program Director, Oncology, Corcept Therapeutics) on "Breaking Down Barriers to Harness Real-World Evidence," discussing how small biopharma can overcome obstacles to utilize RWE and gain valuable insights into treatment performance outside clinical trial environments.

Kevin Haas (Chief Technology Officer, Myriad Genetics) with Stephen Smith (Senior Program Director, Oncology, Corcept Therapeutics)

Operational Excellence for Small and Emerging Biotech

Several sessions focused on the unique challenges facing smaller biotech companies in building and scaling clinical operations. Priyanka Mandava (Vice President, Clinical Operations, Generate:Biomedicines) presented "Clinical Excellence from an Outsourcing Standpoint: A Small Company Perspective," addressing how to resource outsourcing functions as a small company, focusing on SOP development, inspection readiness, monitoring, and oversight.

Michelle Wong (Vice President Operations, Octant) shared insights on "Building Clinical Operations While Flying It," demonstrating that early planning, high communication, proactive risk management, and choosing the right partners are key to navigating clinical development for early-stage biotech with limited experience and tight resources.

Fortrea during Networking Break

Kimberly Guedes (VP, Clinical Operations, Intensity Therapeutics) provided "Optimizing Stakeholder Engagement for Timely Completion of Clinical Trials," offering practical approaches for effective communication and collaboration among diverse stakeholders with unique perspectives and priorities.

Caro Unger (Executive Director, Head of Clinical Operations, Asher Biotherapeutics) explored "Navigating Protocol Deviations: Collaborating with CROs for Effective Identification and Follow-Up," demonstrating how focusing on education, quality, and a risk-based approach can help CRAs understand RBM and quality checks to urgently flag only critical protocol deviations.

Dave Borbas (VP, Head of Data Management, Abcuro) addressed "Strategies to Reduce CRO Timelines from 10-12 Weeks to 6-8 Weeks," exploring how to lock databases in multi-year studies efficiently by freezing and eSigning early visits and utilizing detailed timelines for database lock planning.

Katherine Yahvah (Laboratory Manager, Alturas Analytics) presented "PK Lab: Afterthought or Critical Path? Why Early Planning Saves Time, Money, and Regulatory Headaches," highlighting through case studies how early bioanalytical lab engagement helps teams avoid delays, cut rework, and stay on track with compliance.

Q&A

Patient-Centricity and Recruitment Excellence

Patient-centric approaches and recruitment strategies emerged as critical priorities throughout the conference. An interactive panel moderated by Bonnie Bain on "Recruitment Pressure is Rising… What Should We Focus on Now to Target Patients More Precisely?" featured Cem Mangir (Director, Patient Advocacy Relations, Genentech), Stephanie Chuang (Patient Advocate, The Patient Story), Alycia Shilton-Lloyd (Executive Director Patient Innovation & Engagement, Merck), Melanie Klesse (Head of Patient Success, Faeth Therapeutics), and Marc Pangilinan (Director, Health Equity & Community Engagement, Hemophilia Federation of America) discussing best practices for targeted patient recruitment, patient-centric trial designs, involvement of patient advocacy groups, and achieving diversity targets.

Lisa Lea (Director Patient Insights, Merck) presented "Meaningful Patient Engagement in Clinical Trials: Beyond Tokenism to True Value," exploring innovative approaches to integrate patient perspectives into protocol design, endpoint selection, and trial execution in ways that genuinely benefit patients and enhance trial design.

Recruitment Pressure is Rising… What Should We Focus on Now to Target Patients More Precisely? Panel

Sponsor-Site Relationships

COG Bay Area dedicated focused attention to strengthening sponsor-site partnerships. Cecilia Tran-Muchowski (Senior Director, Site Alliances, Genmab) addressed "It Takes 2 to Tango - Strengthening and Managing your Sponsor-Site Relationship," explaining from the sponsor perspective why building strong connections is vital for trial success.

Laurel Brechtel (Clinical Research Manager, Cancer Immunotherapy Program, Helen Diller Family Comprehensive Cancer Center UCSF) provided "The Site Perspective: What We Should All Know," offering the site viewpoint on growing and nurturing the crucial sponsor-site relationship, including discussions around metrics, costs, turnover, and responsibilities.

Meraf Eyassu (Executive Director, Clinical Operations, Terns Pharmaceuticals) delivered a case study on "Navigating a Successful Site Start-Up, Improving Outreach and Starting on the Right Foot," unveiling strategies for rapid study start-up and dynamic outreach through early site engagement, particularly valuable for small biotechs facing challenges due to limited internal support.

FHI Clinical during Networking Break

Strategic Pipeline Management and Financial Planning

The conference addressed critical strategic and financial considerations for clinical-stage companies. An interactive panel moderated by Emily Roberts-Thomson (SVP Development Operations, Onchilles Pharma) on "Leadership Insights into Pipeline Strategy" featured Raj Patel (Chief Operating Officer, ReacX Pharmaceuticals), Mukhtar Ahmed (Director, Project and Portfolio Strategy, Greenstone Biosciences), and Nikhil Dube (Life-Cycle Management Strategy Lead, Biogen) exploring pipeline strategy, portfolio analysis and prioritization, and how cross-functional leadership optimizes development paths.

Gary Johanning (CSO, SunnyBay Biotech) and Feng Wang-Johanning (CEO, SunnyBay Biotech) jointly presented "Clinical Financing, Cash Flow and Raising Funds: A Small Company Outlook," exploring best practices for maximizing cash flow, developing financial roadmaps, and managing funds to avoid trial delays.

Joe Stalder (VP Program Management, Zentalis Pharmaceuticals) discussed "Maximizing Project Success: The Power of KPIs in Tracking, Insight, and Decision-Making," demonstrating how to select relevant, clear KPIs aligned with project goals and present them effectively using visual tools for informed decision-making.

A C-Suite panel moderated by Jasmina Jankicevic on "Navigating Financial Headwinds: The Clinical-Stage Biopharma Investment Outlook" convened Kim Boericke (COO, Veristat) & Dushyant Pathak (CEO, FGH Biotech) to discuss strategic approaches to securing funding, optimizing capital allocation, and maintaining investor confidence in today's challenging capital markets environment.

Global Perspectives

Kento Nakamura (Chief of Staff, Office of COO, CMIC Group) provided insights on "Asia Pacific Clinical Trials Beyond China: Opportunities and Regulatory Updates," exploring the advantages of running trials in the APAC region including access to large and diverse patient populations, cost-effective operations, and increasingly supportive regulatory environments, while addressing key country differences and regulatory updates.

COG Series Quiz Master - Alex O'Leary

Audience Breakdown

The audience was comprised of 80% C-Suite executives, VPs, or director-level attendees, engaged in clinical operations, with strong representation from small-to-mid-sized biotech companies navigating the unique challenges of resource-constrained clinical development.

Charts demonstrating audience split across Job Role Seniority, and Organisation Type

COG Bay Area will return next year! Register now to receive updates.