Amplify Analytics: Integrating chemistry and physicochemical analysis for rapid pharmaceutical development
Sponsored by: Malvern Panalytical
- Drug Development
Date: 25 June
Time: 3:30PM London/10:30AM New York
The challenges of differentiated drug product development, increased pressure from generic products, and low rates of return on development costs are all factors driving pharmaceutical companies to seek strategies to accelerate and de-risk their product development. Their ultimate aim is a more rapid realization of pipeline value.
Key to their success is a data-driven, ‘win quick, fail fast’ approach to reduce technical uncertainties faced during the early stages of development by screening candidate NCEs against developability and processability requirements. Application of approaches such as the Developability Classification System (DCS) and Manufacturing Classification System (MCS) helps identify those candidate molecules and formulations which are likely not only to meet bioavailability requirements but also to be successful during scale-up and into commercial manufacturing. These classification systems are enabled through relevant physicochemical analysis approaches which provide the data needed to link decisions made during lead optimization and API salt and polymorph selection to the critical material attributes required to meet both product and process requirements.
In this webinar, we will introduce a unique new service: Amplify Analytics, which has sprung from a partnership between Spectris companies Concept Life Sciences and Malvern Panalytical, and our collective understanding of our customers’ requirements and aspirations relating to drug developability assessment.
This collaboration binds together Concept Life Sciences’ expertise in discovery chemistry, API screening and GMP manufacturing with Malvern Panalytical’s extensive capabilities for detailed solid and morphological form analysis. As an integrated team, we empower our customers to quickly and confidently identify those candidate NCEs which are most likely to meet bioavailability and manufacturability requirements.
The Amplify Analytics service improves pharmaceutical development outcomes by directly linking API selection to both ADMET and microstructural assessments, ensuring developable candidates are rapidly and accurately identified. In addition, the Amplify Analytics team can directly deploy the physicochemical characterization techniques and methods required to ensure process and quality control within our customers’ organizations, supporting scale-up and manufacturing programs. This is a unique partnership which integrates API selection, manufacturing and characterization, accelerating product development to deliver improved development outcomes and a much faster return on investment.
Dr. Paul Kippax,
Pharmaceutical & Food Sector Director at Malvern Panalytical
Paul Kippax is Pharmaceutical & Food Sector Director at Malvern Panalytical, leading a team responsible for business development and marketing. He has a degree in chemistry and a Ph.D. in colloid science, both obtained at the University of Nottingham. Paul joined Malvern Panalytical (formerly Malvern Instruments) in 1997, starting as a technical support scientist and then moving into Product Management before becoming Director of Product Management for Malvern Panalytical’s morphological analysis portfolio. He has spent the past 23 years developing an in-depth understanding of material characterization techniques and their application in solving pharmaceutical industry challenges. A keen believer in the power of collaboration in enabling innovation, he moved into the Pharmaceutical & Food sector team in order to develop closer customer relationships focused on applying analytics to enable innovative product development.
Dr. Ben Cliff,
Vice-President, Strategic Accounts at Concept Life Sciences
Ben is Vice-President, Strategic Accounts at Concept Life Sciences (CLS). Following his Ph.D. in surface mass spectrometry, Ben began his career in scientific instrumentation, then went on to develop significant experience within the Contract Research Organisation (CRO) space, holding both Senior Leadership and Senior Commercial roles. Ben joined CLS in June 2018, initially focusing on Operations within the Analytical and Development Services laboratories, and has been part of the partnership’s leadership team since January 2020.
Key Learning Objectives
- Learn how to optimize your development success through linking API selection with physicochemical characterization.
- Understand the analytics required to support the application of classification systems such as DCS and MCS.
- Learn how an analytical instrumentation company and a contract research organization are partnering to deliver a unique service.
- Find out how Amplify Analytics can help you select and accelerate the most developable candidate drug molecules.
- Formulation Development Scientist
- Analytical R&D Scientist
- Senior Scientist
- Principal Scientist
- Formulation Scientist
- Analytical Scientist
- Analytical R&D
- Regulatory Affairs
- Medicinal Chemist