Improving the understanding of biosimilar formulation science through Real-World Training

Objectives

The overall goal of thi project is to provide a fundamental grounding in the physical chemistry,
pharmacology and technology of mAbs-based medicines in oncology, both originators and biosimilars
and the methodology associated with their compounding and handling.

Program

The course comprises both theoretical and remote real-world training on the
pharmacology, toxicology and technology and stability of mAbs, the technology and
rationale of biosimilars and the regulatory aspects of biotechnological medicinal products.

1. Monoclonal Antibodies.
   1. Targeting growth factors and their receptors in cancer (Danilo Norata).
   2. Targeting immune checkpoints in cancer (Danilo Norata).
   3. Mechanisms of action of mAbs in oncology. From antibody-dependent cell-mediated cytotoxicity (ADCC) to complement mediated cytotoxicity (CDC). The role of FCgamma receptor (Danilo Norata).
   4. Immunogenicity of Monoclonal Antibodies: from the first to the fourth generation. (Danilo Norata).
   5. Impact of the manufacturing process on the quality of biological medicines (Paolo Rocco).
   6. Understanding mAbs complexity to optimize formulation and stability: from manufacturing to the bedside (Francesca Selmin).
   7. Preparation of oncology mAb-based medicines in hospital pharmacies. How compounding can address stability, storage and handling issues (Francesca Selmin/Vito Ladisa).
   8. Real-world training @ Pharmacy of the National Center of Excellence for the Treatment of Cancer of Milan. On site filming of the compounding procedure for two different monoclonal antibodies preparations (bevacizumab and trastuzumab) to be used in oncology. Commented by the expert panel with a detailed description of each critical passage, including conservation and shipment to the specific oncological department (Vito Ladisa/Margherita Galassi).
   9. Overview of clinical efficacy of mAb-based therapies in cancer patients (Danilo Norata).
      
      
2. Regulatory Aspects of biotechnological medicines including Biosimilars.
   1. Introduction to EU Pharmaceutical Law (Paola Minghetti).
   2. The Quality of biotechnological medicinal products: relevant guidelines (Paolo Rocco).
   3. Biosimilars: what they are and why they have been introduced (Paolo Rocco).
   4. The Comparability Exercise: molecular and pharmaceutical aspects (Francesca Selmin/Paolo Rocco).
   5. The Comparability Exercise: pharmacological aspects and clinical studies (Danilo Norata).
   6. The regulation of biosimilars at the EU and regional level: authorization, interchangeability and substitution (Paola Minghetti).

 

Scientific Director

Paola Minghetti, Full Professor of Pharmaceutical Technology and Regulatory Affairs, Università degli Studi di Milano

Faculty

Margherita Galassi, Manager Pharmacist, National Cancer Institute of Milan
Vito Ladisa, Hospital Pharmacy Director, National Cancer Institute of Milan
Paola Minghetti, Full Professor of Pharmaceutical Technology and Regulatory Affairs, Università degli Studi di Milano
Giuseppe Danilo Norata, Professor of Pharmacology, Department of Pharmacological and Biomolecular Sciences (DISFeB), Università degli Studi di Milano
Paolo Rocco, Adjunct Professor, Università degli Studi di Milano
Francesca Selmin, Associate Professor, Department of Pharmaceutical Sciences, Università degli Studi di Milano