How integrating pharmaceutical development and clinical testing can maximize Phase 1 success
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.
Register now to reserve your spot for this free webinar!
Presented by
Nikki Whitfield,
Vice President, Pharmaceutical Sciences
Nikki joined Quotient Clinical in February 2012 as Senior Director, Pharmaceutical Operations and is responsible for the operational delivery of the formulation development, pharmaceutical analysis and GMP manufacturing groups.
She possesses 23 years’ experience in the Pharmaceutical Industry and has previously held technical leadership positions in Quadrant Healthcare, Quadrant Drug Delivery and Elan where she was responsible for the development, transfer and scale up of both early phase and late phase spray-dried inhaled and topical products intended for both European and US markets.
In her previous position as a Project Director at Vectura, she led the early phase product development for two inhaled, orphan indication products and the late stage development for a novel sterile topical product. Nikki holds a Bachelor of Science degree from the University of Nottingham.
Peter Scholes,
Chief Scientific Officer
Peter read Pharmaceutical Sciences at the University of Nottingham, UK, gaining his PhD in 1993. Peter enjoyed various roles for 3M Pharmaceuticals & 3M Drug Delivery Systems, before joining Quotient Clinical in 2007 to develop and build the Pharmaceutical Sciences group. He has been instrumental in identifying and implementing the innovative and flexible benefits of integrating pharmaceutical development and clinical testing in early research.
Peter was appointed to the position of CSO in March 2013 where he now has responsibility for the scientific strategy and leadership for the organisation. Peter has previously served as a committee member for the UK Controlled Release Society and APS Biopharmaceutics focus group and in 2013 set up a GastroPlus user group with industry colleagues as a discussion forum for PBPK modelling and simulation science.
In 2010, Peter was named one of PharmaVOICE’s 100 most inspiring people in the life-sciences industry. He was appointed as an Honorary Professor in Pharmaceutical Sciences at Nottingham University in August 2015.
