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

WEBINAR DETAILS

Date: September 30, 2015 (60 minutes)

Featured Speakers:

 

It has been estimated that up to 70 percent of the drugs entering development possess insufficient aqueous solubility for adequate and consistent gastrointestinal absorption. These molecules consequently exhibit poor bioavailability, significant food effects and high intersubject variability in vivo, necessitating the requirement for enabling formulation technology in order to give the molecule the best chance of achieving the target product profile.

RapidFACT dramatically speeds up the optimization of enabled drug products to improve oral bioavailability. The webinar will include a presentation from Gábor Heltovics, CEO of Druggability Technologies, describing their Super-API technology and how they are using RapidFACT to evaluate enhanced formulations of marketed drugs.

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 optimized drug products, for all routes of delivery, with over 100 programs now completed.

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.

ABOUT OUR SPEAKERS

 

 

John McDermott, Executive Director, Drug Product Optimisation, Quotient Clinical


After gaining a BSc in Analytical Chemistry from the University of Hull, UK, in 2000, John worked in pharmaceutical analysis with Rhone Poulenc Rorer and Covance, before joining Quotient Clinical, (then Pharmaceutical Profiles) in 2001. After fulfilling roles in the development and validation of radiolabelling methods for solid oral dosage forms, and leading Quotients’ Pharmaceutical Analysis function, John was appointed to his current position, in which he has overall responsibility for RapidFACT® formulation development and clinical testing, regional absorption, and gamma scintigraphic services.



Gábor Heltovics
, CEO, Druggability Technologies


Gábor Heltovics is the CEO of Druggability Technologies (DRGT). Headquartered in Malta, DRGT is a proprietary pharmaceutical products business dedicated to the development and commercialization of high-value pharmaceutical products based on the Company’s Super-API Technology.

Gábor Heltovics holds Master's degrees in biology and chemistry, and he is an MBA. He is a seasoned entrepreneurial senior executive with extensive R&D and general management experience in the pharma and FMCG industries in the US, UK and EU. He has a successful track record of innovation management and technology platform development in major multinational corporations such as Procter & Gamble and Coca-Cola, as well as SME Bio-pharmaceutical companies such as SOLVO Biotechnology.

THIS PROGRAM IS INTENDED FOR

EVPs, VPs, Directors, Heads, Managers, Principal Scientists from formulation research and development functions and CMC groups.

OUR XTALKS PARTNERS FOR THIS EVENT

Quotient Clinical offers unique services – based on its Translational Pharmaceutics® – that integrate formulation development, real-time drug product manufacturing and clinical testing, significantly reducing the time and cost of bringing a drug to market.

For more than 20 years, Quotient Clinical has brought innovation to drug product development programs for pharmaceutical and biotechnology customers worldwide. The company is based in purpose-built, fully integrated facilities in Nottingham, UK, where formulation development, real-time GMP manufacturing and early clinical trials are performed in the same facility. It employs over 250 staff, offering a full range of support services, from study set-up right through to data analysis and reporting.

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