Seminar Program Evonik Health Care

Long-acting, complex drug delivery products, particularly those based on microparticles, nanoparticles and implants, are among the most attractive parenteral products in the pharmaceutical industry. Long-acting injectables that use bioresorbable polymers for systemic and local drug delivery have improved the lives of millions of patients globally, based on successful outcomes for the treatment of schizophrenia, diabetes, substance abuse, cancer, ocular, rare and hormonal diseases. These products have many advantages, such as simplifying the drug regimen by decreasing dosing frequency, helping to improve efficacy and treatment adherence.

In this Fireside Chat, Evonik’s drug delivery experts will continue to share their experiences, backstories and insights on the discovery and development of long-acting injectables, presenting the most advanced polymer-based excipients, products and platforms on the market. They will highlight key properties of bioresorbable poly(lactide-co-glycolide) polymers and explain their relevance to drug delivery formulations.

Together with our special guest for this episode, Prof. James Anderson from Case Western Reserve University, we'll talk about the biocompatibility of polymers used for long-acting injectables, including lactide/glycolide polymer excipients. Prof. Anderson, an expert on the biocompatibility of biomaterials, has worked in the area of biomaterials, medical devices, and prostheses for the past 50 years. Much of his focus has been on cellular and humoral responses to implanted materials.

During our Fireside Chat episodes, our speakers will also discuss GMP manufacturing considerations for both parenteral excipients and drug products. Key areas of focus will be product-by-process manufacturing, ocular implants, microparticles and nanoparticles.

The Fireside Chat creates a particularly interactive dialogue, engaging the audience to take part in polls and asking questions to the speakers.

What the audience will learn during Evonik's Fireside Chat Episodes:

More history and backstories around long acting injectables and polymeric drug products on the market
Overview of key poly(lactide-co-glycolide) polymer properties relevant to drug delivery formulations
Recent application trends, including immuno-oncology and ocular drug delivery
Challenges for GMP-production of implants, microparticles and nanoparticles
Technology transfer and scale-up
Answers to audience questions from past episodes

Experts

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. Whitney Beysselance Moro
Director Strategic & Technical Marketing
Evonik Health Care
Vita

Whitney Moro joined Evonik as part of the acquisition of the LACTEL^® Absorbable Polymers line in 2021. She is currently the Director of Strategic and Technical Marketing for Evonik’s Parenteral Drug Delivery Solutions business.

Prior to the acquisition, Whitney served as the Director of Scientific and Technical Operations for the Lactel group within DURECT Corporation. In this capacity, she was responsible for managing the analytical testing and development for all LACTEL^® products, developing and optimizing manufacturing and purification processes for new products (including glucose star polymer), and bridging the gap between technical and customer support for new and existing clients.

Whitney obtained her PhD in organic medicinal chemistry from the University of Alabama in Birmingham (UAB), USA, which was followed by postdoctoral training at UAB in the discovery of small-molecule antibacterial drugs with activity against novel therapeutic targets for the treatment of biowarfare agents.

Prof. Dr. James M. Anderson
Distinguished University Professor
Case Western Reserve University
Vita

Dr. James M. Anderson received his PhD at Oregon State University in 1967. In 1976, he graduated from the Case Western Reserve University School of Medicine with an MD degree and finished his Anatomic Pathology residency at the Institute of Pathology of University Hospitals of Cleveland in 1979. Following the completion of his residency, Dr. Anderson joined the faculty of the Institute of Pathology at Case Western Reserve University.

Dr. Anderson has worked in the area of biomaterials, medical devices, and prostheses for the past 50 years and his current activities range from the clinical pathology evaluation of retrieved implants from humans to fundamental studies of cellular interactions with biomaterials.

Dr. Anderson is an elected member of the National Academy of Medicine and the National Academy of Engineering. He is a founding member and past president of the Society for Biomaterials and the Controlled Release Society. He is also a founding member of the American Institute for Medical and Biomedical Engineering (AIMBE). He is the Co-Chair of Working Group 1 for the development of the International Standard Organization’s (ISO) Standard on Biological Evaluation of Medical Devices, ISO 10993. He is the Editor-in-Chief Emeritus of the Journal of Biomedical Materials Research.

In 2005, Dr. Anderson received the Elsevier Biomaterials Gold Medal Award given to the individual who has made the most significant contributions to biomaterials science over the 25 year period from 1980 to 2005. He received this award at the Tissue Engineering Science International Conference held in Shanghai, China, in October of 2005. Dr. Anderson is the recipient of the 2006 Chugai Mentoring Award given by the American Society for Investigative Pathology (ASIP) to senior investigators who have distinguished their careers with a dedication to mentoring and education. In 2006, Dr. Anderson was awarded the Honoris Causa Degree (honorary Doctorate of Philosophy Degree) by the University of Geneva, Switzerland. In 2008, Dr. Anderson was elected to the American Association of Physicians. Dr. Anderson was elected Fellow of the American Association for the Advancement of Science (AAAS) in 2011. In 2012, Dr. Anderson was awarded the title of Distinguished University Professor by Case Western Reserve University. He is the recipient of the 2013 Acta Biomaterial Gold Medal for his contributions to biomaterial science and engineering. In 2021, he received the Chandra P. Sharma Award from the Society for Biomaterials and Artificial Organs India (SBAOI) for his outstanding contributions to establishing the immunology concepts in the field of Biomaterials Science, enabling the development of the new generation of implantable materials and devices for human healthcare. In 2022, Dr. Anderson received the Professional Impact Award from AIMBE for outstanding leadership through activities involving impactful research, journal editorship, professional society governance and guidance, and regulatory standards development. He is also recognized for “being way ahead of the times when it comes to diversity and inclusion”.