Scientific evaluation and due diligence of innovative monoclonal antibody therapeutics

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.

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Start Time:
November 04, 2021 11:00 AM Eastern
10:00 AM Central, 9:00 AM Mountain, 8:00 AM Pacific
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Estimated Length:
1 hour
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14 days, 13 hours
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Free
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Scientific evaluation and due diligence of innovative monoclonal antibody therapeutics

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.

Speaker Information
Christine Power  [ view bio ]
Individual topic purchase: Selected