Flexible approaches for drug product optimization
Biotech and pharma development teams are under pressure to rapidly advance molecules to the next development milestone and market as quickly as possible. However, progress is often constrained by challenges in drug development complexity, molecule chemistry, rising failure rates and increasing development costs. An example of this would be the prevalence of poorly soluble compounds within the development pipeline. Translational Pharmaceutics® accelerates the development and optimization of drug products by integrating key development functions into a single service provider to reduce “white space” and shorten clinical manufacturing and dosing times from months to days.
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, removing the need to rely on preclinical or in- vitro data which is known to be poorly predictive for many drug molecules. A recent paper by Joseph DiMasi at Tufts CSDD in the Therapeutic Innovation & Regulatory Science (TIRS) Journal, quantified the financial benefits of Translational Pharmaceutics, demonstrating >12 months acceleration of development and multi-million-dollar reductions in R&D costs.
Translational Pharmaceutics has been used in over 400 drug programs by global pharmaceutical and biotech companies to develop all kinds of formulation, from simple capsules to complex formulations to address poor solubility or modify drug release.
Case studies:
This webinar will showcase examples of how Translational Pharmaceutics has been used across all phases of clinical development:
· Optimization of Phase I and II clinical formulations for poorly soluble NCE’s
· Life-cycle management and reformulation of late-stage molecules and marketed products
· 505(b)(2) product development and evaluation of novel drug delivery technologies to address poor bioavailability and suboptimal drug delivery
Presented by
John McDermott,
Executive Drug Development Consultant, Quotient Sciences
John has over 20 years industry experience in roles in pharmaceutical sciences with Rhone Poulenc Rorer, Covance and Quotient Sciences, which he joined in 2001. He has been central to the development of Quotient's integrated pharmaceutical and clinical development programs, utilizing our ability to manufacture drug products in real-time in response to arising human data. John's responsibilities at Quotient Sciences include the design and implementation of integrated pharmaceutical and clinical development programs. In addition, John has a significant body of experience in scintigraphic imaging studies for oral and inhaled dosage forms, including the development and validation of radiolabelling methods.
Chris Roe,
Senior Research Fellow, Quotient Sciences
Chris has over 20 years’ experience across pharmaceutical sciences and biopharmaceutics through a series of technical and leadership roles at Sanofi, Pfizer, AstraZeneca and Walgreens Boots Alliance. His expertise ranges from early pre‑formulation and biopharmaceutical assessments ensuring appropriate new chemical entity selection, through development of a wide range of dosage forms including preclinical and early clinical inhalation, topical, oral immediate release and modified release formulations, to maintenance and life-cycle management of existing marketed products. Chris’ joined Quotient Sciences in 2015 and is involved in designing science-led, robust, clinical study programs which maximise output for clients, in addition to providing scientific support throughout study delivery. Chris holds a Bachelor of Science degree in Medicinal Chemistry from Newcastle University and Postgraduate Certificate in Education from Nottingham Trent University.
