Pharmaceutical R&D in the next decade: a perpetually moving storm

The pharmaceutical industry is facing tremendous challenges moving forward into the new millennium. These range from expiring patents on blockbuster drugs, to thin pipelines and stiffer regulatory hurdles, to name but a few; if it sounds like a major crisis then it probably is. In general, crisis management, which involves dealing with threats after they have occurred, is the result of poor risk management or inadequate strategic planning. As a result, the industry has seen an increase in mergers and acquisitions (M&A) activity, which has resulted in job losses, mandatory efficiency campaigns across all R&D disciplines and an explosion in tapping emerging markets through outsourcing and acquisition-based market penetration.

Recently DDT-published reviews depict various facets of, or reactions to the current pharma upheavals, these issues are highlighted in this editorial. In the first of our free downloads Craig Johnstone, Garry Pairaudeau and Jonas A. Pettersson, from AstraZeneca, successfully describe how the combination of lean sigma (LS) and innovation is a possible solution to the much-needed innovation in our business. The authors outline several solutions to innovation through LS by: i) selecting the most important problems to work on and how the ‘5 Why’s can help’; ii) the organization’s attitude towards problems and how LS considers problems a gift or opportunity for improvement; iii) opportunities for cross-boundary solutions through teamwork and anti-silo thinking; iv) capacity and resources to try new things through efficiency gains; v) employee confidence, motivation and engagement as an important component for innovation and how lean organizations report higher level employee engagement; and vi) the need for a supporting infrastructure for innovation and how lean tools can help manage idea progression. They also provide an interesting figure illustrating all of the relationships between innovation and LS, highlighting the potential successful marriage between the two.  

The second download by David E. Clark, from Argenta, reviews the developments in outsourcing lead optimization from 2006 to present. At present the service sector is flourishing because it is taking increasing proportions of R&D out of big pharma and biotechs. The sentiment for outsourcing has grown as a perceived means to improve R&D productivity and it implies a greater confidence in the quality of the services provided and in the business relationships, where trust and confidentiality are of utmost importance. Dr Clark covers three main aspects:
1) Significant market-shaping events: i) M&A activity among CROs, and changes caused by companies entering and exiting the field; ii) continuing rise of outsourcing to Asia and Eastern Europe, primarily fuelled by several large deals with Western pharmaceutical companies.
2) Strengthening of capabilities through: i) alliances between service providers with the aim of expanding their offerings to potential clients; and ii) deals with not-for-profit organizations have become more common and of increasing size.
3) New business models: i) internally:the service providers following a ‘services only’ model and those with a ‘services plus therapeutics’ model. In the latter case, a company uses the revenues generated by its service business to offset the cost of funding one or more internal drug discovery programs; ii) externally: most service providers have operated on a fee-for-service basis (either full time employee (FTE) or task-based) with all intellectual property generated during a collaboration residing with the client company. More recently, ‘risk sharing’ has become an alternative mode of structuring outsourcing deals.
I conclude with my recent review entitled ‘Drug discovery in the next decade: innovation needed ASAP’. I highlight the necessity, and discuss the culture of true innovation in research, ‘not me too’ as a driving engine to prosperity. More precisely, I note that: i) for most big pharma companies increased revenues inversely correlates with new molecular entities or value creation; ii) current outsourcing trends will probably not solve the problem; and iii) integration of current advances in all disciplines harboring drug discovery are viable solutions to pharma’s problems. The perspective that only true innovation will save this industry from the abyssis supported by several examples. Lastly, I introduce a new concept that captures key attributes of an innovative culture in R&D termed ‘Innovation-ASAP’ or ‘iASAP’ (Ask powerful questions, Seek the outliers, Accept defeat and Populate astutely). A combination of focus on new research while nurturing a culture of innovation will help drive new value creation.
Youssef L. Bennani obtained his undergraduate (BSc) and graduate degrees (MSc and PhD) in chemistry from the Universite de Montreal, under the guidance of Professor Stephen Hanessian, and conducted post-doctoral studies at The Scripps Research Institute with Professor K. Barry Sharpless. He also holds an MBA from Lake Forest Graduate School of Management. In the early 1990s, he joined the pharmaceutical industry, as a researcher, and worked for Ligand Pharmaceuticals, Abbott Laboratories and Athersys Inc. Since 2004, he serves as Vice President of Drug Innovation at Vertex Pharmaceuticals, heading both the discovery chemistry and pharmacokinetics departments. He has led programs in immunology, oncology, neurology, metabolic and infectious diseases, resulting in numerous preclinical and clinical molecular entities; and has published over 170 papers and patents in the field of drug discovery.

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