Overview

Therapeutic proteins and advanced therapies include different approaches ranging from peptides to large proteins such as coagulation factors to monoclonal antibodies, to cellular and gene therapies. The pharmacokinetic evaluation of such products is important to appropriately select the dose range that can be used in pre- and clinical studies to ensure the safety and efficacy of these therapeutic strategies. An additional objective of the pharmacokinetic documentation is to contribute to assurance of efficacy and safety in all patients, including sub-populations not represented in the Phase III trials. Development of therapeutic proteins and advanced therapies share the same comprehensive goals of safe human investigation, leading to a knowledge that provides compelling information on efficacy and safety in the patient population. 

Specific considerations are needed when assessing the pharmacokinetics of biological products and advanced therapies. The pharmacokinetic requirements may differ depending on the type of protein or cellular or gene therapy and its intended use. Since elimination for some products is largely dependent on target receptor uptake, differences in receptor density between healthy volunteers and target population (e.g. over-expression of receptors in tumours or inflamed tissues) can create important pharmacokinetic differences. Since the intravenous route is very often used, there is no need to always assess absorption. Changes in formulation or in the manufacturing process of the drug substance may alter the pharmacokinetics and the immunogenicity of a compound. The main elimination pathway should be identified. However, for therapeutic proteins, this could be predicted, to a large extent, from the molecular size and specific studies may not be necessary. For cellular therapies, the life span of infused cells should be assessed. Excretion studies are not normally needed. Bioassays should be considered to assess the pharmacokinetic of biological products and cellular therapies.

The webinar will provide an overview of the main topics described above.


Why Should You Attend

Specific considerations are needed when assessing the pharmacokinetics of biological products and advanced therapies. The pharmacokinetic requirements may differ depending on the type of protein or cellular or gene therapy and its intended use. Since elimination for some products is largely dependent on target receptor uptake, differences in receptor density between healthy volunteers and target population (e.g. over-expression of receptors in tumours or inflamed tissues) can create important pharmacokinetic differences. Since the intravenous route is very often used, there is no need to always assess absorption. Changes in formulation or in the manufacturing process of the drug substance may alter the pharmacokinetics and the immunogenicity of a compound. The main elimination pathway should be identified. However, for therapeutic proteins, this could be predicted, to a large extent, from the molecular size and specific studies may not be necessary. For cellular therapies, the life span of infused cells should be assessed. Excretion studies are not normally needed. Bioassays should be considered to assess the pharmacokinetic of biological products and cellular therapies.

The webinar will provide an overview of the main topics described above.


Webinar Takeaway

The webinar will cover the following topics:

  • Underline the specific problems related to the pharmacokinetics of biological products and advanced therapies that need careful consideration during drug development
  • Describe the dissimilarities in pharmacokinetic characteristics between biological products and small molecules drugs affecting the content of the development programe
  • Describe what are the critical steps during the assessment of the pharmacokinetics of biological products and advanced therapies
  • Describe how the pharmacokinetic data of biological products and advanced therapies can be used to extrapolate the human situation.

Who Will Benefit

  • Clinical research associates
  • Pharmacologists
  • Toxicologists
  • Project managers
  • Business development managers
  • Medical writers
FDA Faculty Dr. Stefano Persiani

Faculty Dr. Stefano Persiani 

Internal & External Innovation, Director Translational Sciences and Pharmacokinetics at Rottapharm Biotech

Italy

Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmacy at the University of Milan, Italy and completed a Post-Doctoral fellowship in the Department of Pathology of the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA, and later as a Research Associate in the Department of Pharmaceutics of the University of Southern California, School of Pharmacy in Los Angeles, California, USA. After these academic positions, he entered the pharmaceutical industry at Farmitalia Carlo Erba, Pharmacia, Upjohn, and Zambon Group and in the CRO sector as Scientific Director for Clinical Pharmacology

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