Preclinical Toxicology vs Clinical: Key Considerations in Using Lipids-based Formulations

In this webinar, experts will offer insights into the perceived barriers to developing lipid-based formulation and recent advances in translating them in to useful clinical and commercial products of lipophilic drugs.

Register Free: https://www.pharmtech.com/pt_w/toxicology

Event Overview:

Lipid-based formulation (LBF) can potentially improve the oral bioavailability of challenging molecules. However, when planning for solubility and bioavailability enhancement of poorly soluble drugs, LBF is often overlooked due to a generally poor understanding of LBF technology and the prevalence of preconceived notions about its complexity, especially when transitioning formulations from preclinical toxicology to clinical studies.

In this webinar, experts will offer insights into the perceived barriers to developing LBFs and recent advances in translating them into useful clinical and commercial products of lipophilic drugs. Experts will also discuss lipid excipients from the perspective of dosing in preclinical models for toxicology studies and their safety profile. In addition, the experts will discuss the preformulation considerations of LBF development and the use of PBPK modeling to yield key insights into oral bioavailability. Finally, experts will share approaches from an industrial standpoint on how to transition LBFs from preclinical toxicology to a viable formulation suitable for an accelerated pathway in the clinic.

Key Learning Objectives

• Discuss how lipid-based formulations impart their solubility-enabling benefits.
• Understand the opportunities and limitations of using lipid-based formulations in preclinical toxicological studies.
• Explore key considerations when transitioning enhanced formulations into the clinic.

Who Should Attend

• C Suite
• R&D
• Product development
• CMC
• Discovery scientists
• Consultants
• Manufacturing

Speakers:

Anette Müllertz
Professor
University of Copenhagen
Denmark

Dr. Anette Müllertz is professor at the University of Copenhagen, Denmark (UCPH). She is heading Bioneer:FARMA, a research-based, non-for-profit service provider within the area of pharmaceutical development. She did her PhD in chemical engineering at the Technical University of Denmark and thereafter worked 9 years for Novo Nordisk A/S. In 1998 she joined UCPH, where she is heading the Physiological Pharmaceutics Research Group, focusing on developing predictive biopharmaceutics tools for oral drug delivery and lipid-based drug delivery systems. She has 220 publications in international, peer-refereed journals (h-factor: 59 (Google Scholar 10/1-2021)).

Grace Furman
CEO/President
Paracelsus, Inc.

Dr. Grace Furman received her Ph.D. in Biomedical Sciences with a specialization in toxicology from Northeastern University in Boston, MA (1992). She also holds a B.S. in toxicology (1986) and has been a Diplomate of the American Board of Toxicology since 2000. Dr. Furman is an active member of the American College of Toxicology (ACT) and has served ACT as a 2-term Council member (2009-2011 and 2017-2019), a member of the Nominating Committee (2008), as Secretary (2013-2014), and as co-chair (2017/2018) and chair (2018/2019) of the Education Committee. Dr. Furman is also an active member of the Society of Toxicology and the Southern California Chapter of the Society of Toxicology and has held several Executive Council positions, including President, within the Regional Chapter. Dr. Furman is chair emeritus of the San Diego Biotechnology Discussion Group and a founding member of San Diego’s Women in Biosciences. Additionally, she designed and instructed the “Toxicology” classroom and distance-learning courses offered through University of California/San Diego Extension’s Drug Discovery and Development and AMDET Process Certificate Programs (2005-2014).

Lisa Caralli
Senior Director, Scientific Advisory
Catalent

Lisa Caralli is Science and Technology Director, Pharmaceutics at Catalent San Diego. She has over 30 years of industry experience in pharmaceutical research and development. Lisa's area of expertise is analytical methods and formulation development of small molecules and peptides. In her role, she works with pharmaceutical companies to identify the right development pathway for their early development drug candidates and advances new technical offerings within Catalent.

Register Free: https://www.pharmtech.com/pt_w/toxicology