Medicon Valley Alliance and Quotient Sciences would like to welcome you to a Good Morning Meeting.
In this presentation, Dr. Andrew Parker will discuss transitioning from pre-clinical to clinical stages, covering regulatory expectations and enabling technologies for poorly soluble molecules. He will also showcase solutions developed by our team using the Quotient Sciences Translational Pharmaceutics® platform. This includes assessing amorphous solid dispersions compared to lipidics and size reduction, and how these translate into suitable presentations for oral administration and dose escalation.
Key learning objectives:
• How to identify the best development strategy, technology(s) and candidate(s), demonstrate solubility improvement and stability.
• Justify selection of prototypes as being suitable for testing in animals and potentially improving exposure to meet toxicology multiples required to justify entering a FIH study.
• Where to invest from early stage, modularity of the preclinical screen and how it can be refined based on your needs
Date: Wednesday 12th of June 2024
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub2 Meeting Room: Forrest & Sky
Program
| 8:30 | Networking, registration and light breakfast |
| 9:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:05 | Rationalizing the Preclinical-Clinical Hurdle – How to Overcome the Toxicology Exposure Challenge and enter FIH studies using Translational Pharmaceutics® Dr Andrew Parker, Senior Drug Development Consultant, Quotient Sciences |
| 10:05 | Q&A Session |
| 10:30 | Networking |
| 11:00 | End of Good Morning Meeting |
Speakers
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Dr Andrew Parker, Senior Drug Development Consultant, Quotient Sciences Dr Andrew Parker has two decades of experience in the pharmaceutical industry, spanning from preclinical development, through early clinical formulation development into late-stage development, scale up and commercialization. Andrew has a particular interest in enabling technologies for bioavailability enhancement, characterization of all delivery formats, innovative technologies and understanding drug product structure – drug product function relationships.Andrew’s focus at Quotient Sciences is in Translation Pharmaceutics® and the acceleration in drug candidate progression and associated benefits provided by tighter integration of formulation development, clinical drug product manufacture and clinical dosing activities.Prior to Quotient Sciences, Andrew worked at Cooper Surgical and Healthcare as a Program Director and at Catalent as an Open Innovation Director covering two business units. Andrew also spent 15 years at Juniper Pharma Services and Molecular Profiles CDMO’s in a variety roles combining technical and commercial knowledge, sitting at the operational and business interfaces with external clients. Andrew holds a PhD in physical chemistry from the University of Bristol. |
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