Fireside chat: Lipids, LNPs and beyond – hot topics and recent manufacturing debates (Episode 1)

Overview

New drug substances and modalities often drive innovation in formulation. Clearly, this was the case for RNA therapeutics when, through the success of the mRNA COVID-19 vaccines, their potential was suddenly realized by the whole world. This success could not have happened without decades of biotechnology research and the discovery of new lipid excipients to enable the delivery of mRNA into cells with lipid nanoparticles (LNPs).

In this series of fireside chats, experts discuss the biggest challenges faced by pharma industry when developing lipid-based delivery systems for novel therapeutics. These discussions cover some of the pharma industry’s most widely discussed topics including manufacturing and formulation challenges as well as robust scale-up and quality aspects. The fireside chat creates a particularly interactive dialogue, involving polls and plenty of opportunity for audience questions.

Discussions in our first episode will touch on:

Challenges in lipid manufacturing
Quality issues concerning lipid manufacturing
Formulation challenges

Experts featuring this session

Dr. Andrea Engel
Global Head, Health Care Growth Projects
Evonik Health Care
Vita

Dr. Andrea Engel joined Evonik’s Health Care business line in 2013 and is currently Director Research & Development.

The team focuses on the development and analytics of new oral and parenteral platform technologies for the pharma and food industry as well as the development of cell culture media. One of the main research areas lies in the formulation and bioavailability enhancement of poorly bioavailable drugs and biopharmaceuticals.

Before taking over the current position she held a position as laboratory head and project manager in Innovation Management at Evonik where she has gained experience in developing complex oral and parenteral dosage forms and handling of highly potent active pharmaceutical ingredients.

She received her degree in pharmacy from the University of Frankfurt am Main and her Ph.D. in pharmaceutical technology and biopharmacy from the University of Muenster where she has specialized on the development of drug delivery systems based on bioabsorbable nanoparticles for cancer treatment.

Moreover, she has authored several research papers and patent applications.

Dr. Thomas R. Tice
Senior Director Technical Global Technical Marketing
Evonik Health Care
Vita

Thomas Tice is internationally recognized for his research and product development of complex parenteral, drug delivery dosage forms based on bioabsorbable polymer excipients. He is known for his accomplishments involving injectable, extended-release microparticles made with bioabsorbable lactide/glycolide polymers designed for systemic and local drug delivery. He was a team leader and core inventor to develop the first commercial, injectable, extended-release microparticle product. This product, a one-month LHRH formulation indicated for the treatment of prostate cancer (Decapeptyl® SR), is still on the market today. He has also served on various US Pharmacopeia expert committees for 17 years, and is currently on the General Chapters Dosage Forms Expert Committee and Excipient Joint Committee.

At Evonik, Dr. Tice, provides scientific support to Evonik’s innovation, sales, product development, research, intellectual property and M&A teams. He earned his BSc in Chemistry and PhD in Biophysics from Syracuse University, New York. He held a postdoctoral fellow position at the University of Alabama at Birmingham (UAB) in Microbiology. He holds 48 US patents with many foreign equivalents and has more than 180 publications, presentations, and invited lectures to his credit. He flew experiments on two Space Shuttle flights.

Dr. Ulrich Klöckner
Global Project Manager
Evonik Health Care
Vita

Dr. Ulrich Klöckner joined Evonik in 2017 and has held several R&D roles within the Evonik Health Care business. In his first positions as a laboratory head he was responsible for the process development and scale up of APIs and lipids. As a project manager in the CDMO business, he managed and led projects focusing on APIs and lipids manufacturing under cGMP.

Since 2022, as a global project manager, Ulrich is responsible for the project management and serves as the technical contact of Evonik Health Care’s lipid business. Ulrich is an organic chemist by education and obtained his PhD from the University of Tuebingen in Germany. As a postdoctoral fellow, holding a DFG scholarship, he went to the University of Urbana Champaign in Illinois, USA. Ulrich is author of numerous research papers and patent applications.

Dr. Michael Parr
Director Formulation and Process Development
Evonik Health Care
Vita

Dr. Michael “Mike” Parr joined the Production & Technology team of Evonik’s Health Care business line in 2021 as director of formulations and process development for the Vancouver site. Mike is responsible for leading multifunctional teams and ensuring the successful execution of a portfolio of complex customer-funded development programs as part of the parenteral drug delivery solutions business.

Mike has more than 20 years of experience in the pharmaceutical industry including roles at Sitka Biopharma, CDRD Ventures Inc., Angiotech and Biogen Idec. His areas of expertise include liposomal drug delivery systems, formulation, molecular biology, GLP, GMP activities and clinical development. Mike holds a B.Sc. Honours and Ph.D. in Biochemistry and Molecular Biology from The University of British Columbia in the laboratory of Dr. Pieter Cullis and he completed post-doctoral studies at Harvard Medical School.