Posted May 07 2021, Filed under Events Back to News Home Page

Quay Pharma Take Part in a Series of Webinars with BioForum Applied Knowledge Center, Israel

About BioForum Applied Knowledge Center, Israel

For over 20 years Bioforum Applied Knowledge Center has been connecting the academy, industry and government – in the field of life sciences. The 20th year of Bioforum, like the ones prior, is a year of strengthening the existent whilst striving to connect with new clients, students and partners, alongside great imagination, adrenaline and new challenges.

Through the generation of countless courses, conferences, and the management of professional societies, these successful projects combined with archived initiatives – led to an enriching, advancing applied knowledge center – a one of its kind in Israel.

Webinar Series: Developing Successful Drug Delivery SystemsFormulation Development from Pre-Clinical to Clinical Supply & Beyond

May 19th
Lipid Delivery Systems

An overview with respect to the rationale for selection and design of lipophilic delivery systems.  Including considerations for in vitro methods and techniques to characterise lipid based formulations.
Case study: lipid strategies that have been used in pre-clinical studies to maximise API exposure.
Formulation options and analytical challenges associated with oral delivery of lipidic dosage forms for first in human studies.
Understanding the potential and limitations for lipid formulations, subject to requirements of the target product profile (TPP) and physicochemical properties of the API.
Case study: Practical considerations and time-lines associated with a typical Phase I drug product development programme

To register for the course https://bit.ly/33o484c Discount code is QUAY15

June 2nd
Paediatric Product Development
Scientific and regulatory overview, including paediatric investigation plan (PIP) & paediatric-use marketing authorisation (PUMA).
PK/PD considerations compared to adults.
Dosage form selection considerations for neonates to adolescents, Excipient & Tox considerations.
Basics for Pre-formulation – Physiochemical characteristics of API and influence on dosage form design.
Setting a TPP.
Formulation route selection – solids, liquids, powders for reconstitution.
Taste masking, antioxidants, osmolality, product specs.
Analytics – Chromatographic considerations for preservatives, specificity, antioxidants, batch to batch consistency.

To register for the course https://bit.ly/33o484c Discount code is QUAY15

June 9th
Live Biotherapeutics
Overview – Definitions, Growth over last decade, Clinical progress, Mechanisms of action
Understanding the drug substance – Fecal Microbiota for Transplantation (FMT), Strains, Consortia, Phages, New modalities
Drug substance development process – Isolation, fermentation, purification, drying. Characterisations methods, specifications. Development risks and challenges.
Drug product development process – TPP, preformulation, robustness, technology selection for target delivery, capsule filling, tabletting, characterisation methods, specifications, packaging.

To register for the course https://bit.ly/33o484c Discount code is QUAY15

Benefits to the Participants

At the end of these three sessions the participants will have an intensive overview and an understanding of:

  • The challenges and pitfalls involved in the development of preformulations for preclinical trials, drug delivery systems for early stage clinical trials, and manufacturing for clinical and commercial supply.
  • The role of a Contract Development and Manufacturing Organization (CDMO) and the benefits of outsourcing the development to a third party that specialise and has the knowledge, experience and scientific capabilities to successfully developing novel, effective, safe and robust drug-delivery systems

To register for the course https://bit.ly/33o484c Discount code is QUAY15