David Jones- May 2
- 5 min read
COG New England 2025 Meeting Review
The Clinical Outsourcing Group New England 2025 conference brought together leading professionals from across the region’s clinical-stage biopharma to explore cutting-edge strategies in clinical trial outsourcing and management. Under the expert guidance of chair Bonnie Bain (Former President/CEO, Global Healthcare, Ipsos), the two-day event featured thought-provoking presentations, interactive panels, and valuable networking opportunities that shed light on the evolving landscape of clinical research.
Patient-Centricity as a Core Strategy
Patient-centricity emerged as a dominant theme throughout the conference, with numerous speakers emphasizing its critical importance for trial success. The event opened with a powerful CMO panel titled "Putting Patients First: Driving Patient-Centricity in Clinical Trials," featuring Christina Weng (CMO, Pelage Pharma), Mohammed Asmal (CMO, Prime Medicine), Jason Campagna (CMO, Q32 Bio), Jeffrey Bornstein (CMO, Mediar Therapeutics), and Robert Andtbacka (CMO, HiFiBiO Therapeutics). They discussed how patient-centric approaches optimize study designs, meet regulatory timelines, and address recruitment and retention challenges.
Todd Luckritz (Associate Director, Clinical Trial Patient Solutions, Myonex) expanded on this theme with his keynote on "Enhancing Clinical Supply and Logistics to Advance Patient-Centric Care and DEI in Clinical Trials," demonstrating how optimized supply chains can significantly improve the patient experience while supporting diversity and inclusion initiatives.
The rare disease perspective was highlighted in Phill Gallacher's (SVP, Clinical Operations & Program Management, Cullinan Therapeutics) session on "Rare Disease Trial Focus: Strategies for Finding, Recruiting & Retaining Your Patient Population." He shared insights on site activation, patient identification, and addressing the unique considerations of rare disease studies.
On Day 2, Kristine Bernard (VP, Head of Clinical Operations, Astria Therapeutics) delivered an impactful presentation on "Involving Patients in Clinical Trial Decision Making," emphasizing that incorporating patient input during trial design and maintaining clear communication are essential for recruitment and engagement success.
The conference concluded with Allison Kemner's (SVP, Clinical Operations, BoCo Bio Inc) session on "Implementing Diversity, Equity, and Inclusion Initiatives in Clinical Trials: A Patient Centric Approach," which presented case studies and strategies for enhancing diversity in clinical research, including partnerships with Patient Advocacy Groups.
AI and Technology Integration in Clinical Trials
The transformative potential of artificial intelligence and emerging technologies was another key focus area throughout the conference. Quan Doan (VP, Technology Solutions, SDC) set the tone with his session on "Securing AI-Enabled Support: Best Practices for Vendor Assessment in Clinical Outsourcing," providing actionable strategies for evaluating vendor security, mitigating risks, and driving operational efficiency through trusted AI partnerships.
An interactive panel moderated by Bonnie Bain explored "Opportunities and Obstacles with AI in Clinical Trials," featuring insights from Phill Gallacher (Cullinan Therapeutics), Alex Sverdlov (Senior Director, Statistical Scientist, Novartis), and Mary Jo Lamberti (Director and Research Associate Professor, Tufts Center for the Study of Drug Development). The panel addressed the realistic opportunities for AI to accelerate patient recruitment and enhance trial efficiency.
Ernest Odame (Director, Value Management Lead, R&D Data, Digital, and Technology, Takeda) delivered a compelling presentation on "Data-Driven Clinical Trials: Accelerating Site Selection & Patient Recruitment, Reducing Costs, and Gaining More Control," demonstrating how advanced analytics can improve trial outcome predictions and optimize site selection.
The technological theme continued with Ami B Bhatt's (Chief Innovation Officer, American College of Cardiology) presentation on "Revolutionizing Clinical Trials: How AI and Technology Enhance Design, Recruitment, and Regulatory Success," exploring how AI enables more precise patient matching, adaptive study protocols, and real-time monitoring for better efficiency.
Stacey Lasser (Senior Project Manager, Mednet) discussed "Empowering Sites through Simplified Workflows and Unified Technologies," showing how integrated eClinical technologies can streamline site operations, enhance communication, and reduce administrative burdens.
Key Theme 3: Strategic Outsourcing Models and Vendor Management
COG New England featured extensive discussions on evolving outsourcing strategies and effective vendor management approaches. David Jones (Head of Content, The PBC Group), led an interactive debate on "Implementing a Functional Service Provider vs a Fully Outsourced Model from a Small Company Perspective," with panellists Ingrid Abrahamsen (Executive Director, Head of Clinical Operations, Fulcrum Therapeutics), Matthew Weinberg (Director, Clinical Outsourcing and Alliance Management, Intellia Therapeutics), Frank Stout (Senior Director, Global Development Operations, EMD Serono), and Karen Carroll (Clinical Development Consultant) discussing the merits of different outsourcing models for smaller organizations.
Jennifer Bentsen Gordon (VP, Head of Clinical Operations, Editas Medicine) shared gripping insights in her session "How to Position Yourself as a Top Priority for the CRO and Maintain the A-Team Throughout," examining the Sponsor/CRO relationship from initial RFP through project execution and offering strategies for maintaining priority status with CROs.
Jim Lincoln (Senior Director, Clinical Operations & Project Management, Aixial Group) presented on "Asking the Right Questions to Better Qualify CROs," providing guidance on vetting CRO capabilities and experience to ensure proper qualification of vendors for clinical trials.
Douglas Meyer (Senior Director Global Clinical Supply Chain Operations, Vendor Management and Centralized Ancillary Support, Takeda) delivered insights on "Delving into Best Practices for Selecting, Managing and Overseeing Your Clinical Supply Vendors," discussing criteria for vendor selection and strategies for building effective vendor relationships.
The hybrid outsourcing approach was explored by Ajay Sadhwani (VP Operations, Harbor Clinical) in his session "Effective Outsourcing: A Hybrid Approach," highlighting the benefits of combining in-house resources with external partners to optimize clinical trial operations.
A practical workshop led by Meredith Frank-Molnia (VP Clinical Affairs, Vericel Corporation) on "RFP Focus Session: Comparing Apples to Apples" had attendees developing key criteria for assessing vendor qualifications and creating effective RFP templates.
Further Highlights
The meeting featured several other notable sessions that complemented the main themes. Hiroki Matsushima (Branch Manager, US Boston Branch, A2 Healthcare) provided insights on "Japan & Taiwan Development: Regulatory Changes and Effective Patient Recruitment," discussing the emerging opportunities in these Asian markets.
Tufts Center for the Study of Drug Development representative Joan Chambers (Senior Consultant) presented findings from their study on "Evolving Clinical Trial Investigative Site Models and Partnerships," examining new trial execution models and their impact on bringing trials to local communities.
The Quality by Design concept was explored in an interactive panel featuring Stan Russell (VP of Quality, COUR Pharmaceuticals), Sofia Zhidro (Senior Director, Quality, Vigil Neuroscience), Michael Wieczerzak (Associate Director, Clinical Quality Management Lead, EMD Serono) discussing the shift from reactive quality control to proactive quality assurance.
Innovation in specific therapeutic areas was highlighted by Michael Tolentino (Co-Founder, Chief Innovation Officer, Aviceda Therapeutics) with his session on "Global Site Selection & Feasibility Study," and David Sherris (CEO, Attivare Therapeutics) presenting "Innovative Approaches in Immuno-Oncology: A Case Study."
Day 1 of the meeting concluded with a CEO panel on "Fuelling the Future: CEO Perspectives on Funding Clinical-Stage Biotechs," moderated by Darren Rodenhizer (Managing Director, BioBackers) and featuring Dennis Goldberg (CEO, Senex Biotechnology), Andrew Sternlicht (CEO, AISA Pharma), and Jeff Sabados (CEO, Hubble Therapeutics) discussing financing strategies for clinical pipelines.
The networking drinks and canapés reception at the end of Day 1, featuring a rapid-fire team quiz with prizes, provided an excellent opportunity for attendees to build connections and continue discussions in a more relaxed setting. Additionally, the scavenger hunt with prizes during the coffee break on Day 1 added an element of fun and further encouraged networking among participants.
COG New England 2025 welcomed an audience of majority Biopharma executives from across the region. Proudly, the audience was made up of a large proportion of C-Suite executives, and senior directors/ VPs engaged in clinical research.
COG New England will return next year, in April 2026! Register now to receive updates: HERE
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