COG DMV Area 2025 Meeting Review

The Clinical Outsourcing Group DMV Area conference, held at The Bethesdan Hotel in Bethesda, Maryland on May 13-14, 2025, brought together leading professionals from across the life sciences industry to address critical challenges and explore innovative strategies in clinical trial outsourcing and management. Under the expert chairmanship of Bonnie Bain, the two-day event featured insightful presentations, interactive panel discussions, and valuable networking opportunities that illuminated the evolving landscape of clinical research in the DMV (DC, Maryland, Virginia) region.

Effective Vendor Selection and Management Strategies

A prominent focus throughout the conference was strategies for effective vendor selection and relationship management, critical for clinical trial success. Christine Cornwell (Head of Clinical Operations US, AbelZeta) kicked off the event with an opening keynote on "Vendor Oversight Spotlight: Stop Treating it Like a One-Way Street," emphasizing the importance of maintaining and measuring effective communication in vendor relationships, especially for small-to-mid-sized sponsors who rely heavily on outsourcing.

Bruce Smith (Senior Director, Strategic Sourcing and Vendor Management, ADC Therapeutics) shared valuable insights during his on-stage interview about "How to Position Yourself as a Top Priority for the CRO and Maintain the A-Team Throughout the Study," examining strategies for setting boundaries and expectations with CROs from the initial RFP through study execution.

A panel discussion moderated by Beata K. Glogowska (Founder and CEO, Indigo SEA Biotech Solutions) with panelists Azhar Bisle (Senior Manager, Clinical Compliance, Moderna) and Shazia Ahmad (Head of Site & Patient Engagement, argenx) explored "The Critical Role of Effective Communication Strategies in Clinical Trials," highlighting the importance of teamwork, trust, and respect in fostering successful sponsor-vendor relationships.

Jeffrey Hausfeld (Chairman of the Board and Chief Medical Officer, BioFactura) moderated a thought-provoking panel on "The (Multi) Million Dollar Question: Should You Choose a Large CRO or Small, Specialised One?" featuring insights from Anya Derbij (VP, Clinical Operations, Cellphire Therapeutics), Monika Sharma (CMC PML, Clasp Therapeutics), and Christopher Kata (Director of Sales & Marketing, TrialStat). The discussion addressed CRO selection challenges from a small company perspective, examining key considerations for ensuring organizational fit.

Paula Fischthal (Director, Clinical Operations, Takeda) provided practical guidance in her session "Vendor Relationships: How to Fix an Unhealthy Relationship?" exploring root causes of misalignments and collaboration challenges between sponsors and CROs, while offering valuable lessons learned from real-life case studies.

Jennifer Fetterolf (Clinical Operations Director, Gilead Sciences) shared her experience navigating the CRO landscape for oncology trials in an on-stage interview, discussing preferred provider vendor selection processes and day-to-day operational challenges and opportunities when working with vendors.

Patient-Centricity and Diversity in Clinical Trials

Patient-centricity and diversity emerged as critical priorities throughout the conference, with numerous speakers emphasizing their importance for trial success and regulatory compliance. A panel discussion on "Recruitment Pressure is Rising... What Should We Focus on Now to Target Patients More Precisely?" moderated by Bonnie Bain featured Shazia Ahmad (argenx), Elna Narula (US Site Relations and Patient Recruitment Lead, Diamyd Medical), and Holly Patterson (Associate Director, Patient Recruitment & Retention, Takeda) sharing best practices for more targeted patient recruitment processes.

Ricki Fairley (CEO & Co-Founder, TOUCH, The Black Breast Cancer Alliance) delivered an impactful presentation on "Achieving Diverse Clinical Studies: Partnering with Patient Advocacy Groups," highlighting how organizations can work with patient advocacy groups to redesign trial recruitment campaigns to reach underrepresented minority patients.

The conference concluded Day 1 with a powerful keynote panel on "Putting Patients at the Heart of Clinical Trials," moderated by Bonnie Bain with panelists Irina Fish (Group Medical Director, Immunology, Medical Safety Evaluation, AbbVie), Yasmine Hassan (Global Director - Policy, Advocacy and Health Equity, AstraZeneca), Joan Chambers (Senior Consultant, Tufts Center for the Study of Drug Development), and Anna Osinski (Associate Director, Patient Centricity and Engagement Development Unit Lead, Biogen) discussing strategies for enhancing patient-centricity, diversity, and stakeholder collaboration.

Sumaira Ahmed (Founder/Executive Director, The Sumaira Foundation) shared her personal experience with NMOSD in "The Sumaira Foundation Case Study: The Poster Child for Rare Disease Clinical Trials," exploring how Patient Advocacy Groups can be involved in co-leadership of clinical trials and bring the patient voice to study design.

Immo Zadezensky (Head Global Regulatory Policy and Regulatory Intelligence, Moderna) addressed "Clinical Trial Diversity: Challenges and Opportunities for Patient Recruitment and Real-World Evidence in Multinational Trials," providing an overview of the FDA Drug Trial Snapshot program and best practices for improving clinical trial diversity in US trials.

A fireside chat on "Strategic CRO Partnerships for Achieving Diversity in Clinical Trials" with Cynthia Gregory (Team Lead, Diversity Equity and Inclusion in Clinical Research, Takeda) examined the importance of collaboration between CROs and stakeholders to enhance diversity in clinical trials and address barriers to participation.

Strategic Operations and Innovation in Clinical Trials

The conference featured numerous sessions on optimizing clinical operations and embracing innovation in trial design and execution. Vaidehi Agrawal (Sr. Director Clinical Operations at Navitas Clinical Research & formerly Health Program Director, Center for Vaccine Development & Global Health) addressed "Setting up Clinical Operations in the Midst of Staff Turnover," providing advice on handling staff turnover challenges and incentivizing CRO performance while maintaining trial quality.

The conference dedicated a "Tech & Innovation Hour" featuring Bonnie Koo (Fuel Accelerator Strategic Advisor, MPH/MBA Candidate at Johns Hopkins University) discussing "Digital Health Innovations in Clinical Trials" and Jeffrey Hausfeld (BioFactura) exploring "Trial Innovation - Can Smaller Companies Afford to Think This Way?" examining whether smaller companies can realistically adopt the latest advancements in clinical trial innovation.

A panel on "Unlocking the Full Potential of RWD in Patient Referral" moderated by Bonnie Bain with Joan Chambers (Tufts) and Adeniyi Togun (Associate Research Director Global Big Data RWE, Jazz Pharmaceuticals) explored the complexities of patient referral using Real-World Data and proposed strategic solutions to enhance its efficacy.

Chris Bowen (Executive Director Clinical Operations Oncology, AstraZeneca) presented "Optimizing Study Sourcing: AstraZeneca Oncology's Framework for Strategic Decision-Making," detailing their objective framework for deciding which studies to conduct in-house versus outsource, balancing resources, expertise, and strategic priorities.

Beata K. Glogowska discussed "Building a Foundation of Excellence: Fostering a Culture of Quality in Clinical Operations," sharing practical approaches to promote quality behaviors and mindsets among clinical development and operational teams.

Minal Nade-Kulkarni (Director Clinical Operations, AstraZeneca) addressed "Patient and Vendor Selection Criteria in Optimizing Enrollment Strategies – Critical Components to Early-Phase Oncology Trials," exploring how careful vendor selection and partnership is crucial for success in complex early-phase oncology trials.

Biopharma Funding

The conference featured a CEO panel on "Fuelling the Future: CEO Perspectives on Funding Clinical-Stage Biotechs" moderated by Beata K. Glogowska with Christian Walker (CEO, Solaxa), William Stilley (CEO, Adovate), Kristi Jones (CEO, NexImmune), and Ginette Serrero (CEO, A&G Pharmaceutical) discussing strategies for financing clinical pipelines, including venture capital trends, public markets, licensing deals, and cross-border partnerships.

Conclusion & Audience Breakdown

Clinical Outsourcing Group DMV Area 2025 brought together key stakeholders from across the clinical trials ecosystem to address pressing challenges in vendor selection and management, patient-centricity and diversity, and strategic operations and innovation. Through a diverse program of keynotes, panel discussions, case studies, and interactive sessions, attendees gained valuable insights and practical strategies for optimizing clinical trial outsourcing and management.

The event highlighted the DMV region's importance as a hub for life sciences innovation and collaboration, with local expertise complemented by global perspectives to address the complex challenges facing the industry today.

COG DMV 2025 welcomed an audience of Biopharma executives (over 75% of total) 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 DMV Area will return next year, in May 2026! Register now to receive updates: HERE