Category: Pharma

A case study of six leading pharmaceutical companies – Amgen, Elan, Lundbeck, Merck, UCB and Wyeth – by Annabeth Aagaard of the University of Southern Denmark points to how the industry might adapt to ongoing pressures from rising R&D costs, depreciating patent value and public authority desire to cut healthcare costs.

“These challenges have increased the focus on shortening development times and the efficiency of Front-End of Innovation (FEI),” explains Aagaard. Writing in the journal IJTPM, she explores how idea management may be applied as a tool to promote pharmaceutical FEI her findings have implications not only for the companies themselves but for policy-makers and how FEI might best be supported and so allow companies to develop strong drug candidates and bring them to market quickly.

Aagaard found that the six companies employ very similar approaches to idea management in FEI, which might suggest that innovation would be stifled and the competitive edge lost. She explains that her contacts at the companies studied pointed out that the similarities in approach are inevitable: “We pretty much all use the same discovery process model, as we have to answer to the same regulations (i.e., FDA) and live up to the same requirements,” one company said. Another stated: “You have to remember, that we (i.e., the pharmaceutical scientists) all go to the same conferences, are more or less educated in the same places and are moving to and between the same companies, so we share a number of similarities and probably think very much alike when it comes to innovation and how to develop a new drug.”

Apparently, skunk work – rule-breaking work by a splinter group within the company – is perhaps the way companies might break the mould in their pharma discovery and development efforts. However, the current regulatory system still leads to low-risk, low-cost approaches to R&D and “me-too” products. Aagaard points out that skunks aside, it might be that a radical shake-up of patent law would be the way forward to new innovation in an industry stifled by expiring patents and desiccating pipelines.

Aagaard A. (2012). Idea management in support of pharmaceutical front end of innovation, International Journal of Technology, Policy and Management, 12 (4) 373. DOI: 10.1504/IJTPM.2012.050138

During the last two decades, India has emerged as a leading player in clinical trials, manufacturing and R&D of pharmaceuticals. Today, the Indian pharmaceutical industry is growing rapidly and ranks third in the world by volume sales (14th by value) amounting to US $20 billion with forecasters suggesting this will double well before the end of this decade. Unfortunately, one aspect of the industry continues to fail – logistics.

According to a report published in the International Journal of Logistics Economics and Globalisation, poor infrastructure, long lead times, multi-layered routes to market because of different state tax systems, and bureaucracy are a blight on this growing industry.

Sandeep Puri and Jayanthi Ranjan of the Institute of Management Technology, in Raj Nagar, India, have looked at emerging business and technological trends in this sector and suggest that there are innovative logistics solutions to many of the infrastructure and other problems India faces. It is increasingly important that such issues are addressed as the nation develops and demand for pharmaceuticals rises particularly given the issues of product degradation when stored and transported in unsuitable – commonly high temperature – conditions. The researchers point out that pharmaceutical products are commonly handled as if they were inert materials not destined for medicine cabinets and patients.

The team also points out that product adulteration, supply-chain corruption and document falsification are rife. Fundamentally, such issues are made easier because of the intrinsic problems of inadequate infrastructure. “Coping with the challenges of streamlining the logistics in India will ultimately benefit the patient and the healthcare industry,” the team says.

Puri S. (2012). Study of logistics issues in the Indian pharmaceutical industry, Int. J. Logistics Economics and Globalisation, 4 (3) 150-161. DOI:

The latest issue of my Cutting Edge of Chemistry report for TR Pharma Matters is now available.

Organic synthesis scheme showcase in this report, we look at a chemoenzymatic approach that shows promise for a more efficient route to synthesize ultra low molecular weight heparins.

Scaffolds on the move – dihydronaphthyridinediones could represent a novel structural class of potent and selective phosphodiesterase PDE7 inhibitors for the treatment of cognitive disorders. Also showcased are antimalarial agents, oncolytic drugs, and drugs to combat HIV.

New molecular mechanisms of action hydroxyacid oxidase 2 (HAOX2, HAO2) inhibitors, integrin alphaMbeta2 (MAC-1) agonists and histone acetyltransferase (HAT) activators, among a range of other compounds, are showcased in this issue.

The starting line – a selection of new molecular entities ready to progress in the R&D arena including pharmacological activity, originator, and chemical structure.

New drugs for old – the search for new drugs is an increasingly costly business. With patents expiring and pipelines drying up it is possible that the pharmaceutical industry is truly at the end of the so-called era of blockbusters. In this article, we look at how the industry is finding ways to reformulate and repurpose old products to new diseases and extracting novel applications for known agents.

The report is available as a PDF here.

The role of the drug discovery chemist has changed significantly over the past 50 years – workflows have been reinvented while the same goals remain to find and test novel molecules that can reach and act on disease targets.

In this, the International Year of Chemistry (IYC 2011), Thomson Reuters offers a timely report, written by David Bradley with research by Robert Slinn, that examines how life in drug discovery has changed and how it will continue to change and adapt in the future. The report analyzes and develops the major themes identified and highlighted by key players in the global pharmaceutical industry. Many of their insights are fully supported by analysis of data taken from the Thomson Reuters Integrity SM drug discovery database for the period 2001-2011.

In this report, we ask who will emerge as the major drug discoverers and the major drug developers during the next decade. What is the driver for change in the industry and will globalization and regulation have far reaching consequences for the role of the chemist? How will the numbers stack up in 2020 when we count the number of new chemical entities (NCEs): will the balance shift from conventional small molecule Pharma products to the burgeoning area of biologicals?

Future skills

We will discuss how the future skills base will evolve and whether or not there will be a shift in the balance of traditional disciplines. We will calculate the ratelimiting steps and ask if that will affect changing role of chemists. Does a dearth of experience in Pharma, biotech, or academia impact on the changes and what role, if any, might the professional bodies play in the future development of the industry.

TR IYC2011 report available as a PDF here.

During the last decade or so (coincident with the development of open access journal PLoS One, as it happens), the paradigm of “open”, as in open innovation, has changed the way R&D is organised and run in countless high-technology firms. However, the open innovation model has to be adapted and modified to fit specific areas. French researchers have now surveyed managers across the UK’s biopharmaceutical sector at the small-medium enterprise (SME) level to identify what needs to be improved to open innovation still further.

Calin Gurau and Frank Lasch of the GSCM-Montpellier Business School, explain that closed innovation is the classical business model, the one in which a company carries out its R&D and market research entirely in secret, allowing no other eyes to see the products heading for patent and locking down any sub-contractors with tyrannical non-disclosure agreements. Open innovation, on the hand, has emerged as markets and technology have changed. The team points out that the biopharmaceutical sector has developed significantly in the last 30 years.

Until the 1970s, innovation was the realm of big pharma, but access by SMEs and academic spin out companies to relatively inexpensive instrumentation and robotic equipment has meant that almost anyone with a small army of PhDs can innovate to some degree. Similarly, as academics turned to wealth creation so many of the brightest individuals in the corporate world jumped ship to create their own start-ups with a similar thought in mind. It was not quite kitchen bioscience, but the post-genomic era gave another boost to SMEs hoping to get on the pharma ladder and nip at the ankles of the multinationals.

Of course, it quickly became apparent, as it did in the dot.com era, that SMEs cannot necessarily cover all aspects of R&D to compete with big pharma. Thus emerged the open innovation concept. The bright young things whether emerging fresh from academia or shrugging off the corporate cocoon began to realise that their skills could be better served and make them more money by engaging in collaborations with big pharma to provide complementary resources to finalise the R&D operations and bring high-value products to market.

Gurau and Lasch suggest that there are four reasons why open innovation was not only inevitable but essential to the ongoing success of the industry as a whole:

1. The complexity of the innovation, necessitating resources that cannot be developed internally by a single organisation
2. The dynamics of competition forces the organisation to accelerate the innovation process
3. The risk of innovation, which requires a combination of expertise and flexibility that can be often realised only through the collaboration of various highly specialised firms in an innovation network
4. The specific innovative conditions that cannot be reproduced in large organisations

The (un)conventional perspective on open innovation in pharma is that it works in a similar way to the open source software movement. This model is already in place. Researchers participate and have the right to use freely the discoveries developed within the group, but also being obliged to make freely available to the group any improvement they make to the initial innovation. The Australian non-profit organisation Cambia is a good example of an open innovator as is Open Notebook Science (albeit with a greater academic focus). The website Innocentive.com, initially an initiative of the pharmaceutical company Eli Lilly about which I wrote in my Catalyst column on ChemWeb.com back in the early 2000s, represents an example of an open market for innovative solutions.

A third approach to open innovation sees adaptation of the value co-creation concept in which value is exchanged as a partnership between two parties evolves. The exchange process can sometimes determine the gradual development of a relationship that transforms the open exchange process into a stable business relationship, the researchers suggest.

“The issue of open innovation is particularly significant for the SMEs from high-technology sectors. In the biopharmaceutical sector, the length and the complexity of the R&D process, coupled with the low level of resources of small biotech firms, forces these organisations to search outside sources of innovative expertise and technology,” the researchers conclude.

Calin Gurau, & Frank Lasch (2011). Open innovation strategies in the UK biopharmaceutical sector Int. J. Entrepreneurial Venturing, 3 (4), 420-434

• Resurrecting the flatlining pharma industry – In 2008, there were 800,000 medical papers published and 21 drugs approved by the FDA. Something of a disparity between amount of effort and productive output, you might say. So, why has drug discovery flatlined and how can we drag it out of the valley of death and revitalise it? Despite significant increases in funding, the advent of genomics, computerized molecular modelling, high-throughput drug screening and synthesis drug submissions (and so approvals) are at an all time low. For a discovery to reach the threshold where a pharmaceutical company will move it forward what’s needed is called “translational” research — research that validates targets and reduces the risk, according to David Bornstein's NYT Opinion piece aimed at fixing the industry.

Selected from the latest science stories to hit DB’s virtual desktop @sciencebase.