Day 1 :
Sterne Kessler Goldstein & Fox, USA
Paul A Calvo is the Director of the Biotechnology/Chemical Group at the Washington, DC-based law firm Sterne Kessler Goldstein & Fox which represents a diverse group of US and international companies innovating in the field of biotechnology and pharmaceuticals industries. He provides counsel with regard to global patent portfolio strategy, licensing, patent validity, infringement, and design around strategies. He also has extensive expertise in prosecuting and investigating patents related to bio-production methods and therapeutic formulations. He has extensive technical expertise in the areas of vaccines, therapeutic antibodies, cellular immunology, and bio-therapeutics during his graduate studies and Post-doctoral fellowships at the University of Pennsylvania and National Institutes of Health.
The choice of trade secrets versus patent protection has taken on renewed importance in the biotechnology sector with the advent of biosimilar biologics. From an originator perspective, increasing importance is being placed on secondary patent protection, i.e., patents that cover manufacturing processes, formulations, etc. The goal of these filings is to extend protection of the original composition and method, and use of patents by covering production methods or the commercial formulation. However, there are many originator companies which can bypass filing for patent protection, and the disclosure of their bioprocess that comes with it, in favor of keeping some of their critical processes secret. Factors that weigh in favor of patent or trade secret protection will be outlined in the context of products versus processes.
Sigma Tau SpA, Italy
Rita De Santis has a degree in Biological Sciences and PhD in Experimental Medicine from Rome University and National Institutes of Health, USA, respectively. Since 1999, she directs the group of Biotech Products at Sigma Tau SpA, leading innovative products from bench to clinical trials. She is the author of 70 papers and 20 patents. Her work focuses on the development of the AvidinOX-based therapeutic platform for cancer therapy and looking for collaborations to fully exploit the potential of AvidinOX for targeted delivery of biotinylated drugs in additional therapeutic fields.
We recently discovered that the oxidized version of hen egg white avidin, named AvidinOX, can chemically link to tissue proteins when injected or nebulized, thus becoming an artificial receptor for biotinylated therapeutics. This product is currently under investigation in phase I clinical trials for targeting intravenously administered 177Lutetium-biotinDOTA to inoperable tumor lesions and liver metastases, pre-injected with AvidinOX (ClinicalTrials.gov NCT02053324). Several published and some non-published data from our group indicate that AvidinOX-targeted delivery of the biotinylated version of some marketed monoclonal antibodies turns non-effective doses of such antibodies effective for cancer treatment. Among the antibodies tested, AvidinOX-targeted delivery of biotinylated anti-EGFR cetuximab and panitumumab, and anti-ErbB2/neu trastuzumab and pertuzumab were particularly effective. Molecular mechanisms explaining the improved anti-tumor activity of AvidinOX-anchored biotinylated antibodies have been also described by our group. Overall, our data provide a scientific rational for further pre-clinical and clinical investigation of therapeutic approaches based on the local delivery of AvidinOX (i.e., intra-tumor, aerosol or intra-peritoneal delivery) followed by local or systemic delivery of low dose biotinylated antibodies. The expectation of our AvidinOX-targeted delivery platform is to reduce the cost of cancer treatments and improve tolerability by reaching anti-tumor efficacy with significantly less amount of expensive antibodies.