White Paper

Strategies for Accelerating the Development of Modified Release Oral Forms

How do I save >12 months of drug development time?

Quotient is your answer.

Translational Pharmaceutics®

Translational Pharmaceutics® accelerates drug development by integrating formulation development, real-time manufacturing and clinical testing. The platform is unique to Quotient Sciences and has been used over the last decade by global pharmaceutical and biotech companies across over 400 drug programs.

Quotient Sciences' Chief Scientific Officer, Peter Scholes discussed the benefits of Translational Pharmaceutics at Biotech Showcase

Translational Pharmaceutics is significantly faster than traditional drug development, as provide in a recent Tufts CSDD White Paper. On average our customers save >12 months of development time. This translates into R&D cost savings of >$100 million as well as the benefit of getting products to market much sooner.

Unlike traditional drug development, Translational Pharmaceutics integrates a wide array of activities under a single service provider. This reduces the “white space” in development and shortens times between clinical manufacturing and dosing, from months to days.

Simple or complex drug products are manufactured in real-time during the clinical study, with arising human data used to inform the composition of the next formulation to be manufactured and dosed.

Programs are led by a highly skilled cross-functional project manager and science team offering scientifically-rich decision-making to reduce the probability that a drug will fail in later stage clinical testing due to sub-optimal formulation performance.

Where is Translational Pharmaceutics used in drug development?

Translational Pharmaceutics is used to advance molecules across the full development cycle, with programs delivered via all routes of administration. Key applications within development process include:

  • Transitioning molecules from first-in-human (FIH) to proof-of-concept (POC)
  • Development and optimization of clinical formulations including enhanced solubility, modified release and pediatric dosage forms
  • Life cycle management of late-stage and marketed products
  • Evaluation of novel drug delivery technologies

The benefits of Translational Pharmaceutics

  • Reduces timelines

    by 12 months or more

  • Delivers R&D cost savings

    >$9.5 million per month of time saved

  • Conserves drug substance

    by more than 85%

  • Real-time decision-making

    based on emerging human clinical data

  • Provides flexibility

    to adjust formulation composition within a study

  • Streamlines

    vendor management

Overcome your drug delivery challenges

With Translational Pharmaceutics, our scientists help you overcome the drug delivery challenges presented by your molecule for all dosage forms and routes of delivery.

Dosage Forms

  • Solids (tablets, capsules, multiparticulates)
  • Non-sterile liquids (solutions and suspensions)
  • Semi-solids (creams, oil, gels, ointments)
  • Inhalation (DPI/MDI/nebulizers)
  • Parenterals (solutions)

Routes of Delivery

  • Oral 
  • Inhaled, pulmonary, nasal
  • Topical
  • Parenteral (subcutaneous, intravenous)

Using our Translational Pharmaceutics approach, you can streamline your management of outsourced partners. Your program will be led by a single project manager who will manage an integrated cross-functional project team focused on delivering all of the components of traditional CDMO and CRO services — allowing you to capture multiple efficiencies.

What is it like to work with Quotient?

Here's what some of our customers said:

“The company’s ability to integrate manufacturing and dosing really accelerated the conduct of the study and was one of the main reasons that Corcept selected Quotient to undertake the study.”

Hazel Hunt

Vice President of Research at Corcept

01 / 04

“After taking everything into account — the manufacturing costs of a traditional CMO model, creating multiple lots of material that may never get used, etc. — the Translational Pharmaceutics approach was a cost-effective option, especially when we took the additional cost of time saved into consideration.”

Deborah Gouveia

VP Program and Alliance Management, Stealth BioTherapeutics

02 / 04

“Having an integrated way of working is truly innovative and offers a company like Clovis a really efficient option. The entire study was a very positive experience.”

Gillian C. Ivers-Read

Executive Vice President, Technical Operations and Chief Regulatory Officer and co-founder of Clovis

03 / 04

“The understanding we have gained through working with Quotient — in terms of both the formulation development and the manufacturing — will be invaluable.”

Dr David Hava

Chief Scientific Officer at Pulmatrix Inc.

04 / 04

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