Past Annual
Meeting Replays

State of the Industry: Forecasts for Biopharma

Dr. Amir Kalali was joined by Josh Schimmer with Cantor Fitzgerald for an opening Keynote on the State of the Industry. The session unpacked why optimism is rising in biotech by examining shifts in investor behavior, market cycles, innovation trends, global forces, and the influence of AI, while framing where the sector is headed next.

State of DCT Adoption

Anthony Costello from Medidata and Manu Aggarwal from Everest Group took the stage for our Global Adoption session. This panel explored post-pandemic recalibration and explore which decentralized methods continue to gain traction, how adoption varies by sponsor size, and what patterns are emerging across technologies.

Leadership commitment to drive adoption of DCTs

Rob Goodwin with Parexel, Suna Avcil with Amgen, and Liz Goodwin from CSL Behring took the stage to share how leaders are sustaining innovation and operational continuity. We examined how companies are adapting trial strategies, balancing efficiency with vision, and redefining partnerships to build resilience in an evolving landscape.

Maintaining Momentum with Regulators

Rasika Kalamegham from Roche, Dr. Molly Klote former VA, and Junko Sato from PMDA myth busted how global regulators are not the barrier to innovation. Instead, they’re actively supporting patient-friendly trials, thoughtful tech use, and resilient pathways for DCT adoption amid industry turbulence.

HCPs in Clinical Research

Erica Coles Jacobsen (Konovo) Shelly Barnes (UCB) and Brittany Niland (Lilly) unpacked how new FDA and ICH guidance, paired with fresh insights from frontline HCPs, are shaping practical, scalable ways to bring local clinicians into research. From oversight models to contracting to workflow fit, the discussion focused on moving from interest to real-world implementation.

How can AI simplify DCTs?

We hosted a discussion on H ow AI can simplify DCTs with Angela Radcliffe (How Mighty We Ventures), James Donohue (Roche), Alison Holland (Medable), and Chris Regan (Microsoft). They took a candid look at what’s actually working, what’s still too complex, and where we may be digitizing chaos instead of reducing it. The big takeaway: AI is helping, but only where it’s solving real site and patient pain points.

Maintaining Momentum Globally

Global trials had become increasingly vulnerable amid regulatory slowdowns, workforce changes, and political uncertainty. Don Harder (Care Access), Katrin Ong (Boehringer Ingelheim), and Jeff Huntsman (EmVenio) highlighted how teams were harmonizing decentralized approaches, strengthening cross-regional collaboration, and shaping a more sustainable, inclusive model for research.

Interactive Town Hall Part 1

Amir Kalali, Craig Lipset, and Jane Myles took the stage to answer live Q&A around managing change, mythbusting whether sites want DCT, and the utilization of HCPs in clinical research.

DHT Tubestop CoLab Presentation

Lauren Tobe (Lilly) and James Donohue (Roche) outlined DTRA’s development of a Digital Health Technologies (DHT) Tubestop to guide consistent, efficient implementation of DHTs in clinical trials. It highlighted how a standardized toolkit can streamline design, improve data quality, support regulatory alignment, and enhance the integration of digital tools across the trial lifecycle.

Site Input to Protocol Planning CoLab Presentation

Caroline Redeker (Advanced Clinical) and Justin Gundelach (Mayo Clinic) joined us to share their team's efforts to strengthen site input early in protocol planning. It highlighted how structured, timely input from research sites can reduce barriers to adopting DCT methods, improve operational feasibility, and ensure site needs are reflected in trial design.

Mayo Clinic: Clinical Trials Beyond Walls Presentation

Rebecca Kottschade and Justin Gundelach from Mayo Clinic took the stage to share about their “Clinical Trials Beyond Walls” initiative and its progress to date. It highlighted how DCT capabilities, such as remote consent, virtual visits, home-based interventions, and remote monitoring, are expanding access, improving inclusion, and accelerating enrollment.

Momentum Forward: New Directions in DCT

Matt Veatch (Navidence), Alexa Berk (Oracle), Lora Black (Sanford Health), Jennifer Miller (Yale), and Kevin Bugin (Amgen) discussed the future of clinical research. As hybrid and digital models become standard and equity and trust grow critical in an AI-driven era, the panel explored integrating pragmatic and point-of-care trials into routine care—and preserving the human element as research moves online.

Interactive Town Hall Part 2

Amir Kalali, Craig Lipset, and Jane Myles took the stage to answer live Q&A around managing change, mythbusting whether sites want DCT, and the utilization of HCPs in clinical research.

Bring Your Own Technology CoLab Presentation

Joe Dustin (Dauntless eClinical Strategies) and Rick Greenfield (RealTime eClinical Solutions) shared about the BYOT initiative, which empowers research sites to use their own technologies to reduce system overload and improve trial efficiency. It highlighted the BYOT Playbook, a GSK eConsent case study, and upcoming work on enabling secure eSource-to-sponsor data exchange and interoperability standards.

Site Insights CoLab Presentation

Patrick Lee (Amgen) and Deena Bernstein (TPS Global) introduced DTRA’s centralized Site Insights Library, built to capture real-world site experiences with DCT elements and use crowdsourced feedback to inform trial design, technology choices, and operational improvements across the ecosystem.