october, 2016

20oct11:30 am1:30 pmFeaturedAddressing Development Challenges and Accelerating Timelines from First-in-Human to Proof-Of-Concept


Event Details

Date: 20 October

Venue: Catalyst Restaurant, 300 Technology Square, Cambridge, MA

Time: 11:30 – 13:30

To register simply email Nabil Lally (Nabil.Lally@quotientclinical.com)

Speaker: Kieran Crowley

Presentation title and summary

“Translational Pharmaceutics: Addressing Development Challenges and Accelerating Timelines from First-in-Human to Proof-Of-Concept” Kieran Crowley, Senior Scientific Director, Quotient Clinical

This seminar will describe how Enabled-First-in-Human® programs integrate real-time GMP drug product manufacturing with healthy volunteer and patient clinical testing into a seamless early development plan. The effect is to significantly reduce time to proof-of-concept, minimize up-front investment and simplify supply chains.

Increasing pressure on R&D budgets means the design, speed and precision of early phase clinical programs is critical for success. The traditional staged approach to drug development has involved discrete clinical studies in Phase I and Phase II, separated by decision steps. However, increasingly protocols are being combined or interleaved to accelerate the pathway to POC.

In addition to optimizing the clinical plan, pharmaceutical project teams now also demand more data than ever before to answer key “developability” questions in Phase I. Can we assess the impact of formulation changes on performance and bioavailability? What drug product will we use for Phase II? Is there a valid biomarker to establish an early pharmacodynamics response?  Are there any potential metabolism issues that need to be addressed?

This seminar will present a set of case studies on:

  • Integrated single and multiple ascending dose studies combining healthy volunteer and POC investigations
  • Real-time adaptive GMP manufacturing to enable dose, formulation and product changes within a clinical protocol in response to emerging clinical data
  • Continuous supply of clinical trial material (CTM) to global clinical sites post-Phase I, avoiding the need for tech transfer and scale up prior to Phase II

Presentation Outline

  • Introduction to Translational Pharmaceutics and Enabled-FIH
  • Enabled-FIH experience and case studies from biotech and large pharma
  • Question and answer session

Speaker biography:


Dr Kieran Crowley, Senior Scientific Director

Kieran is a Senior Scientific Director of Translational Pharmaceutics at Quotient Clinical Ltd. He has over 15 years of experience leading Pre-formulation and Formulation Development teams in both innovator and contract manufacturing organisations. His expertise is in selecting and optimising drug delivery systems based on the physicochemical and biopharmaceutics properties of the active ingredient. Oral delivery of poorly soluble compounds is a particular field of experience and interest, in which he has successfully advanced products using hot melt extrusion, nanomilling and lyophilisation, among other techniques. Kieran received his Ph.D. in solid-state pharmaceutics in 1999 from the University of Bradford, U.K. and was a post-doctoral researcher at the University of Wisconsin-Madison, USA from 1999-2001. His responsibilities at Quotient Clinical include the design and implementation of integrated pharmaceutical and clinical development programs, utilizing Quotient’s ability to manufacture drug products in real-time in response to arising human data.

To register simply email Nabil Lally (Nabil.Lally@quotientclinical.com)


(Thursday) 11:30 am - 1:30 pm


Catalyst Restaurant

300 Technology Square, Cambridge, MA 02139