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Business


The reality of virtual pharmaceutical companies


The vagaries and complexities of bringing a therapeutic drug to market through the Drug Discovery and Development (DDD) process are well known and described.Any company that undertakes such a time-consuming, financially- burdensome, risk-laden task must have access to a myriad of experienced and professional help.The depth and breadth of expertise required includes broad business knowledge, accounting, legal, intellectual property tactics and strategy, scientific discovery, animal models, toxicology, specific disease-domain understanding, regulatory, clinical trials,manufacturing,marketing, sales and distribution skills.Thus, the demands of a modern pharmaceutical company are taxing, and require a cornucopia of employees, as found in medium-to-large pharmaceutical companies. It would appear counterintuitive that aVirtual Pharmaceutical Company (VPC) could succeed in carrying out such a daunting set of inter-connected responsibilities.The currentVPC model requires a small number of experienced core management/advisors/board members to run the company and execute on the production of a therapeutic drug in a specific disease indication.This is achieved by developing an efficient and delineated strategic out-sourcing and partnering plan.Most, if not all, of the major business operations associated with the DDD process need to be considered. We discuss the oxymoronic proposition of aVPC and the typical adopted business model, as well as provide examples of such companies currently trying to undertake this adventurous task.


By Dr Stephen Naylor and


Dr KirkwoodA. Pritchard Jr


H 8


ow much does it cost to bring a therapeu- tic drug to market? The oft-cited capi- talised cost is quoted at $2.87 Billion1!


However, a subsequent study has claimed that “...this analysis lacks transparency and independent replication”, and is a gross overestimation2. Prasad and Mailankody analysed US Securities and


Exchange Commission filings for 10 cancer drugs, and determined the median capitalised cost (7%) of developing a cancer drugwas $757million. Another study by Paul and colleagues estimated that the cap- italised cost (11%) was $1.78 billion. This latter composite figure consisted of ~38% for discovery (target discovery through lead optimisation), ~8%


Drug DiscoveryWorld Summer 2019


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