Webinars from the Arcinova team
About this Event
Preformulation characterization of new chemical entities (NCE) can be critical in the selection of the most appropriate drug substance form and formulations to be used in non-clinical and First in Human (FIH) clinical studies. Formulation design should take into account the characteristics of the Active Pharmaceutical Ingredient (e.g. solubility, stability, bioavailability), the intended dosage route and purpose of the study and be appropriate for the stage of development. The goal of preformulation is to establish the physical, chemical, and mechanical properties of a drug substance that provide a roadmap to formulate the molecule into a fit-for-purpose product. The purpose of early FIH clinical studies is often to establish as quickly as possible the safety and oral bioavailability (efficacy assessment may also be possible) of the NCE and suitable formulations can range from simple API (in a bottle or capsule), through to more traditional formulations such as solutions, suspensions, and powder filled capsules or tablets. This panel discussion will provide an in-depth review of preformulation and formulation development, and discuss key considerations and challenges in accelerating drug development from preclinical research to FIH studies.
In this webinar you will learn about:
- State-of-the-art preformulation characterization techniques
- How these techniques can be used to optimize drug substance characteristics that can influence success criteria such as stability, manufacturability (processing and scale-up) and clinical performance
- Factors to consider in the design of formulations for non-clinical and early clinical studies including the information gained from preformulation characterization studies
Please click the image below to view the webinar
Our speakers are:
Dr. Steve Byard, CSci CChem FRSC - Head of Drug Product at Arcinova. He has particularly strong expertise in physical and molecular characterization, formulation development, structure elucidation and materials science. Steve completed post-graduate studies in the Department of Organic Chemistry at the University of Leeds and is a Chartered Chemist, a Fellow of the Royal Society of Chemistry (RSC), and an active member of the RSC Nuclear Magnetic Resonance (NMR) Discussion Group and Chairperson of the RSC Chemistry Community Fund. He received the 2019 Award for Outstanding Services to the RSC, through his commitment to the NMR Discussion Group, and is a visiting professor at the University of Warwick.
- Steve's presentation is available here
Jim Bruno, MS, MBA - Owner, Chemical and Pharmaceutical Solutions and Chemicals Consultant and past president of Drug, Chemical and Associated Technologies (DCAT). He has chaired Rider Universities Scientific Advisory Board and was named to Rider Universities Hall of Fame. Consulting since 2002, focusing on the development of API and dosages for small pharmaceutical companies. He has also consulted for various technology groups looking at implementing new technologies such as flow chemistry. He has published in most of the major magazines in the pharmaceutical industry, looking at the development of new drugs in early development, focusing on both the technical and regulatory aspects of drug development.
- Jim's presentation is available here
Dr. Marcus Stavchansky, PharmD - Executive Director, Global Head Pharmacy Services, Clinical Pharmacology Services for the Covance Clinical Pharmacology Units (CPUs) in North America and the United Kingdom. Marcus serves a lead pharmacy consult on local clinical trials, providing guidance at all stages of design and implementation, including directing pharmacy coverage for clinical studies at all CPUs, ensuring appropriate resource management to meet client needs. As member of the Clinical Pharmacology Services Executive Leadership Team, Marcus develops strategies to help move forward pharmacy services through strategic planning and providing vision for the future of pharmacy services in CPS. Marcus also oversees development and adherence to standard operating procedures, policies and training of global pharmacy staff. In addition to this Marcus leads pharmacy operations in providing quality and integrity of all drug production released in the CPUs.
Our moderator is Masha Kononov, MS, Sr. Director of Business Development at Arcinova. She oversees business development activities for emerging pharma in the US. She has worked in the biotech, pharma and CDMO industries for over 25 years, where she has gained extensive R&D and business development experience.
We had so many great questions during the webinar that we filmed these seperately, please click the image below to view the additional Q&A's