Drug Development Strategy & Regulatory | Allucent
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Drug Development Strategy & Regulatory

Translating complex data into actionable insights

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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.

“We would not have been successful in this submission without you. Your team has come together to successfully author the PK reports for the Phase 1 studies and the clinical pharmacology and bioanalytical methods Module 2 summaries. We appreciate your diligence and attention to detail during the authoring process.” 

Vice President & Head of Regulatory Affairs Biotech Company

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.

Gene Williams, PhD

Vice President, Clinical Pharmacology

Elizabeth (Betty) Hussey, PharmD

Vice President, Clinical Pharmacology

Elizabeth (Betty) Hussey, PharmD - LinkedIn Page

Fethi Trabelsi, PhD

Vice President, Clinical Pharmacology

Fethi Trabelsi, PhD - LinkedIn Page

Devin Welty, PhD

VP,
Clinical Pharmacology

Devin Welty, PhD - LinkedIn Page

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?

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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?

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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?

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Allucent’s translational expertise ensures selection of high-quality drug candidates and efficient development strategies.

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Partner With the A-Team

Let us know how we can help you bring new therapies to light. Get in touch to get started.

Join the A-Team

Want to help small and mid-sized biotech companies change the therapeutic landscape?

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