Integrated Early-Stage Drug Development and Manufacturing: Accelerating Molecules to Proof of Concept
Sponsored by: Quotient Sciences
- Drug Development
Date: 10 July
Time: 4PM London/11AM New York
Over the past decade, the pharmaceutical industry has experienced a dramatic increase in the number of companies involved in drug development and the number of candidate molecules in development. Yet although R&D spending has increased enormously, the industry continues to struggle with poor R&D productivity and the majority of molecules entering development will not come close to reaching the market.
To improve R&D productivity, drug developers are continuously seeking new ways of making drug development more efficient and cost-effective through innovation, new technologies and alternative outsourcing models. This webinar will illustrate how our industry is currently configured into outsourcing siloes, with contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) operating in vacuum's from each another. As such, the outsourcing and performance of the corresponding "CMC" and "clinical" development activities are done on a tactical and functional basis, creating create huge inefficiencies in R&D productivity.
The speakers will describe how by breaking down the barriers between traditional outsourcing channels and workflows, drug development activities and key functional groups including formulation development, manufacturing and clinical research can be much more closely integrated to accelerate early-stage drug development, reduce overall expenditure and shorten time to proof of concept.
Join us and learn about how Quotient is innovating drug development and find out how your business can benefit from integrated early-stage drug development and manufacturing.
Vice-President, CDMO Services
Nikki 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 U.S. 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's responsibilities at Quotient Sciences involve building the global formulation and manufacturing services business.
Executive Director and Head, Drug Development Solutions, EMEA
John has over 15 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 Quotients integrated pharmaceutical and clinical development programs, utilizing Quotient's 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, utilizing Quotient's ability to manufacture drug products in real-time in response to arising human data. 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.
Key Learning Objectives
- Holistic formulation approaches driven by the Developability Classification System
- Integration of laboratory and clinical activities to optimize formulations
- Personalized clinical manufacturing: integrating â€œreal-time adaptive manufacturingâ€ with patient recruitment
- Case study - transitioning from FIH formulation to spray-dried Phase II dosage form in record time
- Pharmaceutical & formulation development scientists
- Clinical manufacturing scientists
- Managers and Directors of R&D
- Heads of Outsourcing