Gene Williams, PhD
Vice President, Clinical Pharmacology
Vested in your success
Much of our clinical pharmacology work focuses on seamlessly integrating preclinical research findings with clinical applications, ensuring optimized therapeutic dosing and enhanced trial outcomes. From strategic planning and complex study designs to meticulous documentation and regulatory submissions, we help transform innovative research into actionable insights. Dive deeper into how we can help move your molecule along development milestones to successful market approval.
Translational DMPK
Bridging the gap between preclinical research findings and clinical application of drugs in humans is critical to understanding how to optimize therapeutic dosing. Allucent scientists have hundreds of years of collective experience in:
- Lead optimization and candidate selection
- DMPK IND-enabling strategy, study designs and oversight
- Interpretation of ADME, DDI and PK/PD findings with clinical guidance
- First-in-human dose selection rationale and protocol design elements
- DMPK clinical development strategy and planning
- Expert representation of subject matter and data to regulatory agencies
Drug Development Strategy
Our clinical pharmacology team includes scientists proficient in navigating complex regulatory requirements to address priorities, reduce burdens, and mitigate risk.
They develop streamlined drug development strategies with robust, best-in-class study designs, industry standard-setting analyses, and insightful interpretation.
Our clinical pharmacology plans address challenges such as bridging adults to pediatrics, formulation switch, clinical data extrapolation, evaluation of diverse populations, and QT waivers.
Clinical Pharmacology Study Design
Allucent has extensive experience designing, analyzing, and interpreting data from each clinical pharmacology study. We work with you to design specialized studies including:
Technical Writing and Regulatory Documentation
Allucent supports your development team by authoring technical documents and regulatory submissions.
Technical Writing
We prepare detailed study protocols ensuring compliance with regulatory requirements and best practices. We analyze and interpret results and provide conclusions through clinical study reports (CSR). And, our experts author analysis plans, reports, manuscripts, and contribute to investigator brochures and waivers (TQT, biowaivers).
Regulatory Documents and Sections
With former regulatory experts and seasoned staff we prepare regulatory documents specific to clinical pharmacology, Model-Informed Drug Development (MIDD), and dose justification in various populations across the development spectrum from pre-IND to registration.
We deliver high quality written deliverables and submission-ready documents to facilitate drug development, messaging, and regulatory approval.
Meet Your A-Team
At Allucent, we’re your trusted partner for navigating the complexities of drug development. With unparalleled expertise and a global perspective, our diverse team of pharmacology experts is here to guide your study to success.
- 25 years in clin pharm strategic planning and drug development
- Worked on broad range of 600 biologic and non-biologic drugs as FDA team leader and 400 as FDA primary reviewer
- Provided consulting for 140 clients on pre IND to NDA/BLA submission and post-marketing
Elizabeth (Betty) Hussey, PharmD
Vice President, Clinical Pharmacology
- 30 years leadership in drug development, clinical pharmacology, and pharmacokinetics
- Therapeutic expertise in dermatology
- More than 50 published manuscripts and 50 abstracts
- Led clinical pharmacology at Stiefel/GSK
Devin Welty, PhD
VP,
Clinical Pharmacology
- 30 years’ experience DMPK
- Expertise in pharmacokinetics, pharmacodynamics, translational medicine, and model-informed drug development
- Formerly served as global head of DMPK at Shire Pharmaceuticals, and head of pharmacology and pharmacokinetics at Forum
- Bachelor’s and Doctoral degrees in chemistry, pharmacy, and pharmacokinetics
We’re Ready to Roll Up Our Sleeves
With a diverse and deep bench of scientists and clinical pharmacologists, Allucent has the expertise and reach to help you meet your objectives and endpoints.
Do you have trouble producing high quality first draft technical documentation?
Allucent’s technical writers will partner with you to produce high quality documents from protocols to regulatory modules.
Do you struggle with successful regulatory interactions?
Allucent’s clinical pharmacologists’ understand the need for a complete clinical pharmacology package with clear and accurate messaging.
Do you need support bringing optimal candidates forward from pre-clinical to clinical development?
Allucent’s translational expertise ensures selection of high-quality drug candidates and efficient development strategies.
Related Topics
Additional Resources
Webinar
Clinical Pharmacology Studies to Support Filing Packages and Labeling
Learn More
Webinar
Translational Clinical Pharmacology in Cell and Gene Therapy
Learn More
Blog
Enabling Patient-Centric Drug Development: Opportunity for Clinical Pharmacology to Leverage Innovation and Advance Diversity and Inclusion in Clinical Trials
Learn More