Prof Hans-Jurgen Federsel, Organic Chemistry, Chemical Biology, Pharmacology, AstraZenaca, Stockholm
Date: 9 December 2015 Time: 15:00 - 16:30
The Quest for Novel Medicines – Chemistry as an Enabling Science in Challenging Times for the Pharmaceutical Industry
Discovering and developing a medicine is a complex, tedious, and a long-lasting endeavour circumvented by many hurdles and risks. At the end of this “journey” covering in most cases 10 or more years only very few of the projects initiated will result in a novel pharmaceutical product – the global average figure is somewhere around 4-5% of successful outcomes.1 Notwithstanding, the challenges in the medical field are enormous and we are facing many therapeutic areas where there are diseases with a high unmet need for better treatment paradigms. Suffice it to mention stroke, cognitive impairment such as Alzheimer’s, cancer in its many appearances, obesity, tropical diseases imposing a deadly threat to vast numbers of people in the developing countries, and orphan (rare) diseases as examples for everyone to quickly realize that we are far from being in the best of all worlds. In parallel, there has been a cost escalation of enormous proportions for developing new drugs strikingly expressed in the rise of investment from roughly $800M in 2003 to the stunning level of $2.600M just 10 years later (at +145% this is far more than what has been caused by the inflation alone).2
Given the fact that the major hurdles for succeeding in bringing a novel medicine to patients are lack of efficacy and an unacceptable safety profile of the drug, chemistry at large enjoys a reputation of being regarded as an enabling science with very few cases of failure to deliver the right compound at the right quality. As a matter of fact, the area of chemical process R&D3 – defined by organic synthesis, analytics, process design and engineering – has an unprecedented track record in meeting ever increasing demands asking for more and more complicated molecules, lower costs associated with their manufacture, escalated quality expectations, and the drive for more environmentally concerned production methods.4 With the radical changes that the entire pharma business has undergone over the recent past, let’s say the 20-year-period since 1995, it is not surprising that this has had a profound impact on the way in which R&D activities are conducted. For chemical development this has brought with it site closures, redundancies, and intense outsourcing alongside an ever increasing array of scientific challenges.
The purpose of this lecture is to provide the bigger picture illustrating the present state of the art in the pharmaceutical industry as well as describing how the crucial task of designing and developing scalable processes is managed.5 Authentic examples will be used to demonstrate the types of problems being addressed and the associated technologies and methodologies available in the tool box to achieve this.5,6
1. (a) Paul, S. M.; Mytelka, D. S. et al Nature Rev. Drug Discov. 2010, 9(3), 203-214. (b) Calcoen, D.; Elias, L.; Yu, X. Nature Rev. Drug Discov. 2015, 14(3), 161-162.
2. Nature Rev. Drug Discov. 2014, 13(12), 877.
3. Federsel, H.-J. Nature Rev. Drug Discov. 2002, 1(12), 1013.
4. Federsel, H.-J. Nature Rev. Drug Discov. 2003, 2(8), 654-664.
5. (a) Federsel, H.-J. Acc. Chem. Res. 2009, 42(5), 671-680. (b) Federsel, H.-J. Bioorg. Med. Chem. 2010, 18(16), 5775-5794.
6. Federsel, H.-J. Green Chem. 2013, 15(11), 3105-3115.
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