Achieving Proof-of-Concept Success Starts in Candidate Selection
Sponsored by: Quotient Sciences
- Polymorph Screening
- Fih Testing
- Patient Trials
Date: 11 September
Days to go: 25
Time: 10AM San Francisco
Building a robust understanding of your API characteristics matched against your development programme goals supports the efficient transition of drug products from candidate selection through to proof-of-concept
Utilizing a data-driven approach during candidate selection is key when trying to develop dosage forms and achieve proof-of-concept success. By applying key strategies in early development such as salt and polymorph screening to select the right API form, pre-formulation characterisation to understand the API, development and assessment of preclinical formulations and screening of technologies for dealing with poorly soluble molecules, you are able to gain a complete understanding of your molecule prior to the first-in-human (FIH) clinical study. This data can then be matched against your target product profile and clinical requirements to effectively guide dosage form development and selection to effectively and efficiently begin FIH testing and then quickly transition through to proof-of-concept (POC) patient trials.
This webinar will explore screening techniques, integrated approaches and phase-appropriate product development strategies. Good science, quality, cost and time are important considerations for drug developers and we will address some key questions: What is a suitable screening package for determining the physical properties of an API and what are the red-flags to watch out for? How can the developability classification system (DCS) be used to streamline my formulation development program? How will in-vitro testing and preclinical evaluation help me guide the clinical formulation? Will a preclinical formulation be suitable for clinical use? Could a simple pharmacy preparation be suitable for my FIH trial or will a manufactured dosage form be required? How can we bridge from pharmacy preparations to GMP solid oral dosage forms that will be robust and scalable? How can you avoid common development pitfalls and ensure future success?
Vice President, CDMO Services, Quotient Sciences
Nikki is the VP of CDMO Services and is responsible for building Quotient’s global formulation and manufacturing capabilities across all of Quotient’s sites. Nikki possesses 25 years’ experience in the pharmaceutical industry and has previously held technical leadership positions in position at Vectura, 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.
CEO, Agility Health Tech
Claire has more than 15 years’ experience in the Pharmaceutical Industry spanning the large multi-nationals GlaxoSmithKline and Pfizer, virtual and Contract Research Organisations. Having taken a range of therapeutic products through clinical Phases 1 to 3, she thrives on translating innovative technologies into healthcare products and shaping technical and organisational strategies.
Claire holds a degree in Biochemistry from the University of St. Andrews and a PhD from the School of Pharmacy,
Key Learning Objectives
- The importance of salt and polymorph screening and prototype selection for pre-clinical assessment
- DCS assignment with in-vitro techniques and modelling data to drive clinical formulation technology selection
- Choosing the appropriate dosage form for first-in-human/Phase I trials (Compounding or GMP manufacturing – how to balance cost, time and dose flexibility)
- Challenges with poorly soluble molecules in early development – what technologies can we deploy
- Manager of Pharmaceutical Development
- Manager of Formulation Development
- Formulation Scientist
- Manufacturing Scientist
- Director of Pharmaceutical Development
- Director of Formulation Development
- Director of Manufacturing
- Director of Clinical Manufacturing
- Director or Vice President of R&D
- Vice President of Pharmaceutical Development
- Heads of Outsourcing
- Chief Scientific Officer