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Public companies continued to ride the crest of the wave of financing, licensing deals and regulatory approvals, but clouds may be looming on the horizon for the biggest biotech players.
Previous estimates of drug development success rates rely on relatively small samples from databases curated by the pharmaceutical industry and are subject to potential selection biases. Using a sample of 406 038 entries of clinical trial data for over 21 143 compounds from January 1, 2000 to October 31, 2015, we estimate aggregate clinical trial success rates and durations.
For decades, gene therapy has tantalized us with such futuristic scenarios. However, these goals are now coming into focus, and it is the time to consider some of the consequences of success.
The research and development costs of 106 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug and biologics development.
Advances in our understanding of the disease and innovations in basic science have recently allowed biotechnology companies to pursue promising treatment candidates for the disease, but so far, only one drug with limited application has achieved FDA approval. In this case study, we profile the work of an early-stage life sciences company, Solid Biosciences, founded by a father of a young boy with DMD.
Pharmaceutical innovation is risky, and typically investments will only happen when the reward is anticipated to be sufficient to justify the risk. Companies today are faced with the challenge of balancing the substantial investment required to develop breakthrough therapies with the growing constraints on society's ability and willingness to pay for such innovations.
Contrary to widely held perceptions, data on venture returns show that life sciences startups have outperformed other sectors over the past decade.
The pharmaceutical industry is under growing pressure from a range of environmental issues, including major losses of revenue owing to patent expirations, increasingly cost-constrained healthcare systems and more demanding regulatory requirements.
Lipinski's rule of five. Experimental and computational approaches to estimate solubility and permeability in discovery and development settings are described. (Wikipedia article)
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