What does it take to develop a portfolio of immune-oncology candidates? In this fireside chat, Dr. Tom Burt, Sofinnova Partners SAS, will discuss the strategies needed and the path to building a world-class immuno-oncology biotech, along with Dr. Martin Welschof and experts Drs. Christine Power and Björn Cochlovius. During the session, Dr. Welschof, CEO of BioInvent, a clinical-stage company based in Sweden that is developing immuno-modulatory antibodies for the treatment of cancer, and the panel will detail their experiences of the many facets that contribute to building an innovative clinical stage antibody enterprise, including antibody discovery, clinical development, partnership, manufacturing and finance.

The commercialization of innovative antibody therapeutics needs significant capital investments to fund pre-clinical and clinical studies. Many small biotech that are focused on development lack these resources and the infrastructure needed to launch new biologics. Forming partnerships with larger pharmaceutical companies is one strategy that provides access to the resources needed for later stage development but partnering companies will want to scrutinize the data behind the candidate molecule. For this reason, it is crucial for a biotech company to understand the data packages that need to be generated. These will need to show that the biotech company can meet the necessary regulatory requirements but also answer other key questions that potential development and/or exit partners will have. In this webinar, we will provide a general overview of both areas.

It has been reported that approximately 80% of the FDA-approved medicines over the last 10 years were not registered by the originator or patent assignee. Many novel therapeutic molecules and technologies are initially conceived and developed by small biotechnology (startup) companies or universities, but it is usually big pharma and biotech companies that will bring the resulting therapeutics to the market and commercialize the product. In recent years there has been a trend in large pharma companies to reduce in-house research and development activities and increase in-licensing or acquisition of products to fill their pipelines. New technologies are also being developed so rapidly that it is more feasible for pharma companies to rely on startups for the initial drug development in order to acquire de-risked programs at a later stage in development. However, once a potential asset has been identified it is necessary to perform an in-depth scientific evaluation and due diligence in order to increase the probability of a success or dodge a damp squib. In this presentation, I will describe what this process entails with case studies and some of the pitfalls that may be encountered.