In September 2025, leading professionals across the biotech and pharmaceutical industries will gather and discuss solutions to exchange insights about clinical operations and emerging technologies at the 13th Annual Outsourcing in Clinical Trials Southern California meeting in San Diego, California, US.
Taking place on 23-24 September, the conference will focus on key themes such as AI, partnerships, and evolving outsourcing models in clinical trials.
The meeting will commence with a keynote on the practical applications of AI on pressing industry topics such as patient recruitment, operational efficiency, vendor management, and data integrity. This is followed by a speaker from the clinical research organisation ICON speaking about how AI is already being applied to predict high-performing sites, forecast accurate site activation timelines, improve trial master file (TMF) compliance and reduce costs and accelerate trial delivery.
Attention will then shift to patient recruitment and retention in a presentation by Sagar Vaidya, chief medical officer of Cerevance, who will discuss strategies for identifying the right patient populations. Such themes will be consistent throughout the meeting’s agenda, reinforcing that patient engagement remains key to clinical trial success.
Outsourcing models and technological applications
Later in the day, the meeting will split into two parallel streams - Stream A will focus on outsourcing and clinical operations, and Stream B will centre on clinical trial technology and innovation. Highlights of some sessions include a case study on integrating vendor data for a 360° view of trial progress, a sponsor’s perspective on smarter site partnerships, and a deep dive into patient experience data (PED) strategies from IQVIA, a clinical research services provider.
Considering recent federal budget cuts and regulatory changes, a panel in Stream A on the future of the clinical trial industry will cover funding pressures, shifting US Food and Drug Administration (FDA) priorities, and the evolving vendor and CRO landscape. At the same time, a second panel in Stream B will explore whether sponsors are truly ready for AI, looking at potential risks, data bias, and the need for ongoing human oversight.
Later, the focus will shift to site support and decentralisation, where sessions will explore models that reduce patient and investigator burden and methods to increase privacy, inclusivity and scalability. Janal Urich, clinical development vice president at biotech Atara Biotherapeutics, will outline start-up challenges in competitive environments and overcoming financial constraints with limited budget and resources in Stream A. In addition, biotech WinSanTor CEO Stanley Kim will share lessons learned from when efforts to integrate innovative approaches do not unfold as planned. In Stream B, Michael Murphy, director and legal and associate general counsel of Ionis Pharmaceuticals, will address the complexities of conducting global studies in an evolving environment with shifting GDPR rules and regulations.
The first day will conclude with two panel discussions. The panel in Stream A will examine how to establish constructive, efficient partnerships with contract research organisations (CROs) without compromising patient safety or trial quality, with panellists from Lundbeck Pharmaceuticals and MycoMedica. Simultaneously, the concluding panel in Stream B will dive into the increasingly popular FSP outsourcing model, evaluating its benefits, challenges, and oversight needs.
Overcoming unique challenges of small biotechs
On the second day, during the morning keynote sessions, two perspectives on innovation in clinical research will be showcased. In Stream A, SMSbiotech clinical research director Roger Schechter will share insights from his company’s first-in-human trial outside the US. In Stream B, Murali Pinnaka and Julie Nolte of Arcutis Biotherapeutics will emphasise the role of data-driven insights and cross-functional collaboration in clinical trials. Following this, a panel discussion featuring C-suite executives from Archetype Therapeutics, Crystalys Therapeutics and A28 Therapeutics will talk about fundraising in the real world.
The day will also feature additional panels on how smaller biotechs can scale effectively despite limited resources using boutique providers, and ways to leverage technology to expand capabilities.
The afternoon will continue with a patient spotlight session, focusing on ways in which pharma can work more effectively with advocacy groups. The two-day event will conclude with a panel discussion, featuring panellists from Anaptysio and Neurelis, that will explore how patient engagement throughout the trial lifecycle, through incentives and close collaboration with healthcare professionals, can minimise participant burden, improve enrollment timelines, and enhance trial design overall.
The 13th Annual Outsourcing in Clinical Trials Southern California conference is hosted by Arena International Events Group, a B2B events company owned by GlobalData, the parent company of Clinical Trials Arena and Pharmaceutical Technology.
Click here to read the agenda for the conference for 13th Annual Outsourcing in Clinical Trials Southern California.
