2026年预测的字母汤：GLP-1s、ICH、GCP、CAR-T、AI等

Citeline & industry expertsshare their pharma forecasts By Darcy Grabenstein An Alphabet Soup of 2026 Predictions:GLP-1s, ICH, GCP, CAR-T, AI & more Thought leaders in every industry are making their predictions as to how 2026 will pan out, and the life sciencesis no exception. Read on for forward-looking insights into clinical planning, patient recruitment, clinical trialdisclosure, and more. Clinical considerations what supports sites, and that shift tends to producesmoother studies with clearer data. Throughout the industry, there is a clear push for earlierand cleaner evidence,says Izabela Chmielewska,Citeline Managing Editor, Custom Content. Teams wantto make confident decisions sooner, she says, which isdriving tighter study designs and a stronger focus onwhat can be learned in the first stages of development. Citeline Manufacturing Editor Andrew Warmingtonpredicts contract development and manufacturingorganizations (CDMOs) will become more focused on long-term partnership and full-service offerings, with increasedinvestment in novel modalities. He adds that smallmolecules should remain dominant as first-line treatments. In addition, she says community-based research ismoving from small pilots to something sponsors arewilling to build into their core strategy. The priority nowis proving that it strengthens timelines, retention, anddata quality in a reliable way. Izabela ChmielewskaManaging Editor, Custom Content Controlled models also are gaining attention,Chmielewska notes, because they offer clarity at a pointwhere field trials can be unpredictable. They help teamsrefine programs before they commit to larger, moreexpensive studies. Citeline Andrew WarmingtonManufacturing EditorCiteline Another trend Chmielewska sees is that trial designis becoming more pragmatic. Sponsors are thinkingmore carefully about what is realistic for patients and Patient recruitment the study starts,” he says. “It begins at protocol design/site selection.” Matt Holms, Citeline VP of Sales for PatientEngagement & Recruitment, sees a couple of majortrends taking hold in 2026. First, sponsors will leverageboth data and AI for comprehensive patient matching.More specifically, they will combine real-world data(RWD) and proprietary data with tokenization and AI tolocate hard-to-find patients. Matt HolmsVP of Sales Patient Engagement & RecruitmentCiteline Second, he cites the integration of data as “thefoundational continuum for feasibility as well as patientrecruitment. Successful recruitment doesn’t start once An Alphabet Soup of 2026 Predictions:GLP-1s, ICH, GCP, CAR-T, AI & more Weighty trends “Obesity is definitely having a moment,” saysCitelineSenior Manager Jake Mathon. Yearly new industrytrial starts are up 500% since 2020, a trend heexpects to continue. According to data from Citeline’sPharmaprojects, new drugs in development have hadsteady growth with dramatic increases since 2023 to atotal of 567 individual projects. With about half of thosedrugs still preclinical, he says we can expect to seecontinued new trial growth. see positive cardiovascular outcomes from trials thatare quite large and long, likely negating any advantageto compete on cost. He expects any true GLP-1competitors to have considerable gains in efficacy withbetter tolerability. Median time to approval for obesity drugs from PhaseI to new drug application (NDA) or a biologics licenseapplication (BLA) is just under seven years. Mathon saysdrugs just starting Phase I now could be potentiallygaining approval just before the first wave of genericsfor GLP-1s start hitting the US market. GLP-1 drugs are all the rage, but Mathon cautions thattheir success has been limited by side effects and highcosts. Any new entrants into the space will need tocompete favorably on one or both of these factors aswell as offer equal or better efficacy. Warmington adds: “Obesity/diabetes will become evenmore dominant as oral GLP-1s are developed andprices fall.” Jake MathonSenior ManagerCiteline Mathon notes that the US Food and DrugAdministration (FDA) and prescribers will still want to Indications indicators Based on Trialtrove data, it appears likely that therecent upward trend will continue for clinical trialsin autoimmune diseases involving chimeric antigenreceptor T cell (CAR-T) therapy. Heidi ChenAssociate Director, Research & Commercial SupportCiteline Heidi Chen, Citeline Associate Director, Research &Commercial Support, says, “We wouldn’t be seeing lotsof trials populating in 2026 and 2027, because theseare planned and completed trials. The number of trialswill increase as we progress into these years.” She addsthat sponsors report trials at a later date, creating a lagin the data. An Alphabet Soup of 2026 Predictions:GLP-1s, ICH, GCP, CAR-T, AI & more An Alphabet Soup of 2026 Predictions:GLP-1s, ICH, GCP, CAR-T, AI & more Many of these autoimmune diseases fall into therare disease category, which is poised for an uptickin research.