Upcoming webinar

Challenges and Opportunities in Pediatric Product Development

Meeting regulatory and patient expectations in developing acceptable pediatric formulations

SpeakersJenny Walsh & Peter Scholes

  • Jenny Walsh, Director, Jenny Walsh Consulting Ltd
  • Peter Scholes, Chief Scientific Officer, Quotient Clinical

Date / Time

12 October 2017 / 3PM London | 10AM New York

Learning objectives:

  • EU and US regulatory requirements for pediatric product development
  • Formulation considerations in the design of pediatric drug products
  • Benefits of integrated GMP manufacturing and clinical testing to optimize taste and PK performance
  • Real time GMP manufacturing and supply for global clinical trials in pediatric and orphan disease

Over the last decade global regulatory bodies have increased the pressure on industry to develop authorised medicines for pediatric populations in order to improve and protect child health. Frameworks have been put in place to incentivise companies to deliver on their obligations, however how successful has adoption been? What challenges and opportunities remain for development teams?

This webinar will review current EU and US regulatory expectations and processes for the development and approval of pediatric drug products. The reality of today’s “custom and practice” in industry will be described and barriers to success discussed. 

There will be a focus on the unique considerations and requirements for pediatric drug product design in order to develop palatable, acceptable drug products for target age group(s). Strategies and case studies will be shared illustrating how key challenges can be overcome:

  • Formulation development and taste masking
  • Integrated human taste and PK assessments using adaptive study designs
  • Manufacture and supply of drug products for global pediatric trials using a real-time GMP platform

Register now to avoid missing out on this informative webinar on pediatric product development. We hope to see you in the live session!

Register here


On-demand webinars

Pharmaceutical spray drying to overcome poor drug solubility

How integrating pharmaceutical development and clinical testing can maximize Phase 1 success


  • Nikki Whitfield, Vice President, Pharmaceutical Sciences, Quotient Clinical
  • Peter Scholes, Chief Scientific Officer, Quotient Clinical

Learning objectives:Nikki and Peter pic

  • How pharmaceutical spray drying can overcome poor drug solubility
  • How to develop solid oral dosage forms containing spray-dried dispersions
  • The benefits of integrating GMP manufacturing and clinical testing to drive development efficiency
  • Optimising and validating drug product performance based on clinical data

Overcoming poor drug solubility is a common and challenging task facing the formulation scientist today. Over 70% of new chemical entities are reported to have this characteristic which can result in suboptimal oral bioavailability and an inability to demonstrate the therapeutic potential of the candidate drug.

This webinar will focus on the benefits of spray-drying in addressing the solubility challenge, detailing how simple, scaleable systems can be quickly developed to provide drug products for clinical evaluation. Approaches for transitioning spray-dried dispersions to formulated solid oral dosage forms for downstream development will also be described.

The benefits of integrating GMP manufacturing and clinical testing will also be shown in case studies using spray-drying technology. This will illustrate how arising clinical data are used to inform the real-time selection of formulation compositions to be made and dosed in subsequent study periods. Time and cost effective programs can be designed for poorly soluble molecules, to accelerate first-in-human, formulation optimisation and proof-of-concept studies.

Watch the webinar here 


How to accelerate modified release drug product development


  • Peter Timmins, Former Executive Director, Drug Product Science and Technology at Bristol-Myers Squibb
  • John McDermott, Executive Director, Drug Product Optimisation, Quotient Clinical

Learning objectives:

  • Learn about new ways to evaluate formulation performance using clinical data
  • Understand key variables in the development of modified release formulations
  • Examine the relationships between formulation parameters and in-vivo performance
  • Listen to case studies on accelerating formulation optimisation using clinical data

Are you struggling with your drug product development timeline? Are ongoing drug formulation issues leading to escalating costs and missed deadlines?

RapidFACT significantly accelerates the process of optimising modified release drug products, both to improve oral bioavailability and/or achieve targePeter Timmins and John McDermottted GI delivery. Drug products can be optimised within a clinical study by the use of a continuous formulation design space, rather than undertaking cycles of formulation development and multiple clinical PK studies. A range of product performance attributes can also be investigated within a program, by varying the quantitative composition of one or more formulation components in response to emerging clinical data. 

RapidFACT programs have been used extensively by Pharmaceutical Development teams from more than 50 pharmaceutical and biotechnology companies worldwide as a key tool in developing optimised drug products, for all routes of delivery, with over 100 programs now completed. 

The webinar will include a presentation from Dr Peter Timmins, formerly of Bristol-Myers Squibb, describing the key variables that must be considered in the development of modified release formulations, and discuss strategies to understand the key relationships between formulation parameters and product performance using clinical data.

This webinar will showcase case studies and project metrics, illustrating the applications and benefits when developing modified release drug formulations.

Watch the webinar here 



First-in-Human to Proof-Of-Concept: Addressing Development Challenges and Accelerating Timelines


  • Alyson Connor, Executive Director, Exploratory Clinical Pharmacology, Quotient ClinicalAlyson and Ofir Morena
  • Ofir Moreno, Vice President of R&D, MEI Pharma, Inc.

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 and formulation performance? How can we rapidly manufacture GMP product for Phase I? What drug product will we use for Phase II? Is there a valid biomarker to establish an early pharmacodynamics response? Are there any metabolism or bioavailability issues that need to be addressed?

During this webinar, the speakers 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.

This webinar 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

Dr Ofir Moreno, MEI Pharma, Inc will present the design and results of an early development program of a new molecule ME-401, which is in development for the treatment of lymphoid malignancies.

Dr Alyson Connor, Quotient Clinical, will present further cases studies illustrating the applications and benefits of Enabled-FIH.

Watch the webinar


How to Reduce the Time and Cost for Optimizing Drug Product Formulations


  • John McDermott, Executive Director of Drug Product Optimization, Quotient Clinical
  • Kieran Crowley, Senior Scientific Director, Quotient Clinical

webinar peter and kieran

Join industry experts John McDermott, Executive Director of Drug Product Optimization, and Kieran Crowley, Senior Scientific Director, both from Quotient Clinical, as they outline studies and metrics in drug delivery and drug product optimization, illustrating the applications and benefits for a range of drug formulations. 

Real-time flexibility within the clinical study allows product compositions to be varied and performance attributes optimized in response to arising data. The presenters will provide an introduction to Translational Pharmaceutics and how RapidFACT® (Rapid Formulation development And Clinical Testing) accelerates the process for developing and optimizing drug product formulations.

The discussion will include an overview of the first 100 programs, scientific case studies, and several applications of RapidFACT including:

  • Solubility enhancement to improve oral bioavailability
  • Development of Modified Release dosage forms and In Vitro In Vivo Correlations (IVIVCs)
  • Taste assessments

Watch the webinar



Accelerating Timelines from Candidate Selection to Proof-Of-Concept with Enabled-FIH® Programs


  • Alyson Connor, Executive Director, Exploratory Clinical Pharmacology, Quotient Clinical
  • Hazel Hunt, VP of Research, Corcept Therapeutics

Proof-Of-Concept (POC) is a pivotal milestone in the drug development process. Analysis of attrition data from the pharma industry indicates that around 80% of drug candidates continue to fail at, or prior to, POC and do not progress into the later stages of development. Consequently, the early development processes must be re-engineered to improve R&D productivity and shorten project timelines, whilst at the same time allowing a more flexible and interrogative investigation of a drug candidates unique potential.

The Enabled-FIH approach was designed specifically to address these requirements. This webinar will present a set of case studies that will illustrate:

  • Integrated and adaptive clinical protocols combining healthy volunteer and POC investigations
  • Inclusion of POC either at Quotient, or at other sites globally within a single clinical protocol
  • Real time adjustment of drug dose and product composition in response to emerging clinical data
  • Continuity of drug product supply to global clinical sites

Watch the webinar (on demand)


Overcoming the Challenge of Poorly Soluble Drugs – How to Optimize Enabled Drug Products with Rapid Formulation Development and Clinical Testing (RapidFACT®)


  • John McDermott, Executive Director, Drug Product Optimization, Quotient Clinical
  • Gábor Heltovics, CEO, Druggability Technologies

RapidFACT has been proven to accelerate program timelines by at least 50 percent, and deliver significant cost savings. This has been achieved by the co-location of real-time GMP manufacturing and clinical testing, under Quotient’s Translational Pharmaceutics® platform, which enables formulation selection to be based on emerging clinical data. Applications have included assessments of solubility enhancement, modified release, and changes to drug delivery route.

This webinar will showcase studies and metrics from industry experts and users of RapidFACT, illustrating the applications and benefits when developing enabled drug formulations.

Watch the webinar (on-demand)


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