Diseases of the gastrointestinal tract such as chronic idiopathic constipation, enteric infections, and inflammatory bowel disease affect millions of patients worldwide. Many treatments for these diseases are macromolecule drugs. Many are injected and only a fraction of the administered dose reaches the target sites.
Oral formulation of macromolecule drugs presents numerous advantages over injections, such as better patient acceptance and adherence, easier dosing and better therapeutic profile. A handful of oral peptide and protein drugs are available on the market for local treatment. There are many challenges faced by formulation scientists including the inherent physicochemical challenges of macromolecules and the altered gut physiologies of these disease states.
During this 60-minute webinar, experts will review the physiological changes of gut diseases and discuss how formulation approaches can potentially enable local delivery of macromolecule drugs orally with case studies.
Dr. Claus-Michael Lehr
Professor at Saarland University and cofounder of the Helmholtz Institute for Pharmaceutical Research Saarland
Dr. Claus-Michael Lehr is a Professor at Saarland University and cofounder of the Helmholtz Institute for Pharmaceutical Research Saarland. The focus of his research has been on the biological barriers of the gastrointestinal tract, skin, and lungs. His approach implicates novel cell- and tissue-based in vitro models, mimicking these barriers also in pathophysiological conditions.
In parallel, his team investigates multifunctional nanocarriers that allow targeting the site of action, controlled release of the payload, and being safely biodegraded and eliminated from the body. Prof. Lehr has >250 publications, with more than 4,500 citations. He has been the recipient of numerous awards and accolades including the International Prize of the Belgian Society for Pharmaceutical Sciences (2008), fellow of the AAPS (2010), and honorary member of the French Academy of Pharmaceutical Sciences (2012).
In 2011, his team was awarded the German national research award on alternatives to animal testing. He is coeditor of the European Journal of Pharmaceutics and Biopharmaceutics and regularly involved in the organization of international conferences and programs, such as the biannual international workshop and conference on “Biological Barriers.”
Ronak Savla, Pharm.D., Ph.D.
Scientific Affairs Manager, Catalent Pharma Solutions
Ronak Savla is the Scientific Affairs Manager at Catalent Pharma Solutions and the Catalent Applied Drug Delivery Institute. He earned his Pharm.D. and Ph.D. from Rutgers University. His current research interests include the application of in silico models and simulations to aid in drug formulation design, integration of novel formulation technologies into the industry, and patient centric drug design. Dr. Savla is an author or co-author on over 35 publications including peer reviewed papers, articles, conference proceedings, and posters.
- Understand the physiologic alterations seen in GI diseases
- Understand the challenges of macromolecule oral formulations for local drug delivery
- Learn how formulation and dosage form design protect the macromolecules from stomach and deliver them to targeted area
- Formulation Scientist
- Head of Development
- Head of Pharmaceutical Technology
- Director Formulation
- Director CMC
- VP Pharmaceutical R&D
- Director Formulation Development
- Head of Product Development