Accelerating Proof-of-Concept for Complex Early-Phase Studies
About this webinar
Early-phase clinical development is becoming increasingly complex, requiring sponsors to generate robust proof-of-concept data while navigating evolving study designs, diverse patient populations and increasing operational demands. Successfully accelerating proof-of-concept requires more than speed. It demands integrated scientific expertise, strategic planning and effective execution that reduces risk while delivering high-quality data to support critical development decisions.
The featured panelists will discuss practical strategies for designing and executing complex early-phase studies that help accelerate proof-of-concept and position programs for long-term success.
During this webinar, the speakers will explore:
- Strategies for designing efficient early-phase studies that generate meaningful proof-of-concept data
- Approaches to leveraging biomarkers and integrated data insights to inform earlier, more confident development decisions
- Best practices for managing operational complexity while maintaining data quality and regulatory confidence
- Real-world approaches to accelerating timelines without compromising scientific rigor
Whether planning a first-in-human study, optimizing an adaptive trial design or looking to strengthen early development strategy, this session will provide actionable insights to reduce development risk and support faster program progression.
Register for this webinar to learn how proof-of-concept strategies for complex early-phase studies can reduce development risk and support faster, more informed development decisions.
Who should attend
- Clinical Operations leaders
- Clinical Trial Managers and Study Leads
- Patient Recruitment and Retention Specialists
- Site Engagement and Site Management professionals
- CRO and Sponsor Executives overseeing clinical development strategy
- Clinical Innovation, Decentralized Trials and Patient Experience leaders
- Biopharma and biotech professionals focused on improving trial performance and diversity
What you will learn
- Design complex early-phase studies that efficiently generate meaningful proof-of-concept data
- Apply biomarker strategies and integrated data insights to support informed decision-making throughout early clinical development
- Overcome operational challenges while maintaining data quality, regulatory confidence and study efficiency
- Accelerate proof-of-concept through an integrated approach that helps reduce development risk and supports faster program progression
Featured Speakers
Darin Brimhall, DO, FACP
Darin Brimhall, DO, FACP, serves as Vice President, Medical Science and Strategy at Trialmed. A board-certified internist with more than 25 years of clinical experience and 20 years of pharmaceutical industry experience, Dr. Brimhall brings broad expertise in pharmacology, translational medicine, investigative medicine, clinical operations, and regulatory considerations in early drug development.
Dr. Brimhall is an experienced Principal Investigator who has led more than 680 Phase I studies, including first-in-human, drug-drug interaction, proof-of-concept, pilot, pivotal, and first-in-patient studies. His experience also includes Phase III and IV research, significant bioavailability/bioequivalence work supporting FDA regulatory submissions, and lactation studies. He continues to serve as a Principal Investigator while providing medical strategy, feasibility, study-design, and operational guidance to sponsors globally.
Dr. Brimhall completed postgraduate training in Internal Medicine, including service as Chief Resident. He is a Fellow of the American College of Physicians and a Certified Physician Investigator.
Aishwarya Vyas-Lahar, MD
Board-certified Internal Medicine physician with 10+ years of clinical experience and experience across Phase I–III clinical research, currently serving as Associate Medical Director with a focus on early-phase drug development and clinical trial safety.
She has served as a Principal Investigator and Sub-Investigator across early- and late-phase clinical trials, with experience in first-in-human, SAD/MAD, dose-escalation, PK/PD, healthy-volunteer and patient studies, as well as specialized studies in lactating women.
She is experienced in subject safety, dose escalation, adverse event assessment and management, protocol feasibility, safety monitoring, and medical oversight throughout study conduct.
She also has broad clinical and research experience across metabolic and endocrine disease, autoimmune and rheumatologic conditions, hematology, infectious diseases including HIV and COVID-19, women’s health and lactation, and complex internal medicine, with particular clinical interests in rheumatology and women’s health and lactation research.
Partner for this event
Trialmed
Trialmed is the trusted clinical trial partner for patients, trial volunteers and sponsors/CROs. We facilitate clinical research as a care option for patients and healthy volunteers as a part of their health care journey. We create holistic experiences that put the patient first through our welcoming clinics, user-friendly digital technology, and our relentless focus on total quality delivery. Our patient-first approach makes Trialmed the clinical research destination of choice for patients and healthy volunteers. With extensive access to patients in the geographies where we operate, Trialmed ensures reliable enrollment outcomes that consistently meet or exceed sponsor expectations. We offer Home Trial Services for the ultimate in patient flexibility — conducting clinical trial visits where the patient prefers, such as the patient’s home, office or school. Our flexible clinical trial solutions scale to the sponsor’s needs and budget, offering a best-in-class early development services and site network from Phase I-IV.