FIH Trial Trends: How far we’ve come and where we’re going with PK data

Life Sciences, Clinical Trials,
  • Monday, November 06, 2023

Discover an informative webinar delving into pharmacokinetics (PK) in first-in-human (FIH) studies and how it optimizes the data points in clinical trials. In the ever-evolving landscape of pharmaceutical research, it’s crucial to keep a close eye on the changes in PK in FIH trials over the past decade. These changes hold valuable insights that can significantly impact the success of clinical studies.

The influence of PK data on clinical study decision-making cannot be overstated; it serves as a cornerstone in shaping the direction of drug development. Furthermore, comprehending how PK data gathered in FIH trials can be leveraged to optimize data collection in long-term patient studies is paramount. It also enables researchers to streamline the data points collected, enhancing efficiency and reducing the burden on patients while ensuring that the clinical trial remains robust and informative.

Join this webinar to gain insights into PK in FIH trials and how the data is essential for driving innovation and improving patient outcomes.


Sherilyn Adcock, Worldwide Clinical Trials

Sherilyn Adcock, RPh, PhD, Chief Scientific Officer, Early Phase Development, Worldwide Clinical Trials

With a background in pharmacy and clinical operations, Dr. Sherilyn Adcock has dedicated her career to early-phase development. She has been an integral part of Worldwide’s Early Phase business transformation from a small clinical site operation focused on generic compounds to the highly innovative business it is today. Dr. Adcock has been instrumental in expanding the Early Phase business to an integrated 200+ bed, highly flexible, fit for service, clinical pharmacology unit, pharmacy compounding services, specialty pharmacy services and full bioanalysis laboratory renowned for its medical and scientific foundation and its services, staff and accessibility.


Before joining Worldwide, Dr. Adcock served in executive clinical research roles for SCIREX Corporation and Biomedical Research Group (now Premier Research), Phoenix International Life Sciences (now Celerion), HealthQuest Therapy and Research Institute and Pharmaco International (now PPD.) Prior to entering clinical research, she spent several years working in hospital and clinical settings as a pharmacist and development and oversight of specialty pharmacy services.

Dr. Adcock earned her BS in Pharmacy, an MS in Health Science, and a PhD specializing in Community Health and Biostats, all from the University of Texas. She is licensed by the Texas State Board of Pharmacy and holds certifications in sterile product preparation, immunization and pharmacogenomics.

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Jeffrey G. Stark, Worldwide Clinical Trials

Jeffrey G. Stark, PhD, Senior Director, Head of Pharmacokinetics, Worldwide Clinical Trials

As a Director, the Head of Pharmacokinetics for Worldwide Clinical Trials, Dr. Jeffrey G. Stark is responsible for the overall management of staff in the pharmacokinetics department. He provides leadership and uses independent judgment and technical expertise to assist staff in designing studies, preparing data analysis plans, analyzing pharmacokinetic data obtained from clinical and pre-clinical (toxicokinetic) studies, interpreting results from pharmacokinetic analyses and other related activities.


Dr. Stark is a recognized scientific leader and was involved in implementing innovative processes and new scientific opportunities. He authors published literature and is involved in implementing innovative processes and new scientific opportunities. Dr. Stark works closely with Worldwide Early & Late Phase Business Development teams, demonstrating the pharmacokinetic capabilities at Worldwide and advancing business opportunities.

Dr. Stark earned his BS in Chemistry from the University of Texas at Austin, an MS in Chemistry, and a PhD specializing in Pharmaceutical Sciences, from the University of Florida.

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Who Should Attend?

This webinar will benefit Vice Presidents, Directors, Managers, Department Heads, Scientists and Researchers working in early phase trials and clinical pharmacology.

Relevant areas:

  • Clinical affairs
  • Clinical R&D
  • Clinical research
  • Clinical pharmacology
  • Clinical operations
  • Project management
  • Regulatory affairs
  • Medical affairs

What You Will Learn

Attendees will gain insights into:

  • How pharmacokinetics (PK) in first-in-human (FIH) studies has changed over the past decade — and what that means for clinical studies
  • PK data’s influence on clinical study decision-making
  • Understanding how PK data in FIH trials optimize the data points that are collected in long-term patient studies

Xtalks Partner

Worldwide Clinical Trials

Worldwide Clinical Trials (Worldwide) is a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications, from discovery to reality. Our full-service clinical development capabilities include bioanalytical laboratory services and Phase I-IV clinical trials, as well as post-approval and real-world evidence studies – all powered by our talented and accessible team of clinicians, scientists, and researchers who bring their first-hand expertise to each clinical program.

At Worldwide, we understand that each customer and project are unique, so we take a collaborative and personalized approach to identify and meet specific needs and goals. Anchored in our company’s scientific heritage, we are therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. We apply this deep therapeutic knowledge to develop flexible plans and quickly solve
problems in the rapidly evolving clinical development landscape.

Our team of 3,000+ professionals spans 60+ countries, and believes that through collaboration, and a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays an important role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.

For more information on Worldwide, visit or connect with us on LinkedIn.

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