EDITOR’S COMMENT by Dr Patricia Lobo |
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WPhN The new forum for global lifescience
Welcome
Welcome to the first edition of World Pharma Network (WPhN) published by Roxby Media as the firm diversifies into the lifescience arena. WPhN offers a single source platform of communication by the industry, for the industry. The pharma sector has been transformed dramatically over the last 5-10 years shaped by global pricing pressures, patent expiry of branded products, amidst a rising tide of more affordable generics, the ever increasing costs of discovery and development in the face of tightening regulatory compliance to ensure safety, efficacy and quality of production, and a diminishing pipeline of new entities. Desperate to deliver value to shareholders, pharma companies have consolidated while looking to outsource anything that can be outsourced in order to save on fixed costs and to return to areas of their core competences in discovery, innovation, sales and marketing.
The current situation
Reflecting these trends and the emergence of stiff competition from the developing economies of India, Asia and South America, this inaugural issue covers a broad spectrum of issues relevant to the pharma sector of the lifescience industry. These fall into three main categories – Research & Development (R&D) focusing on the initial stages of the pipeline from discovery and into development, Clinical Research activities, and Manufacturing operations, including the primary and secondary production of clinical trial batches and test materials, as well as full-scale commercial manufacturing.
WPhN today and tomorrow
With an exciting new format designed to reflect the current needs of the marketplace, WPhN will cover news and current affairs about the industry to provide readers with a snapshot of what has been happening recently and to detect new trends, for example in corporate activity, acquisitions, deals and alliances, new products and technologies and other relevant issues for industry on a global basis.
Our news editor, Charles Horth, who has a grasp of the industry from many years devoted to pharma, biotech and natural products, puts into practice the concept of thinking globally and acting locally. In the first of these news pages (pp 4–7), you can read what industry experts are forecasting for the brave new era as they anticipate a shift towards increased investment in discovery and development, more innovative therapies, including vaccines and biopharmaceuticals, fewer blockbusters, and strategies being adopted by some companies to play both sides of the divide between generics and branded products.
Beyond the smokescreen
There are two certainties in life – death and taxes. Now that Britain has finally grasped or gasped at the ban on smoking in public places it’s worth reflecting on how many decades it took for all the medical statistical research to prove the link between smoking and lung cancer that eventually led to establishing links with other cancers, including bladder cancer, as well as coronary vascular disease. The first published results showing that smoking was the main cause of death was published by Richard Doll and Bradford Hill in 1950. That was just the beginning as more recent research leading up to the smoking ban drove the need to reduce the level of secondary exposure of non-smokers to exhaled smoke and smouldering cigarettes. One has to smile about a recent letter in the press from a commuter complaining about the apparent increase in odour from the feet and bodies of fellow travellers that had been previously masked by smoke – or was it an improvement in sense of smell after quitting? It’s enough to drive even the most dedicated politician to succumb to the urge to snatch a few puffs out of an open carriage window.
I recall, while working for a company with its principal focus on developing and marketing cancer therapies, non-smokers in the offices were the minority, being vastly out-numbered by smokers. Amid complaints about the “Nanny State” interfering in personal freedom to choose one’s own lifestyle, I sense there is more to this ban than appears at first sight. I was discussing with a colleague whether the tax revenues on tobacco were bigger than the costs to the NHS of treating smoking-related diseases. This may well be true, one estimate from ASH suggesting that tobacco taxes earned for the treasury a whopping £10.5 billion compared with the stub of NHS spending on tobacco-related disease amounting to £1.7 billion.
Is the tobacco era about to end?
The argument for taxing tobacco is both to create an incentive to reduce smoking and to raise taxes. Well, every cloud, even a cloud of smoke, has a silver lining. Pharma companies have found a nifty way to take a slice of the revenues that would otherwise go to the treasury and the tobacco giants by marketing products designed to help us to quit the habit and so improve both health and wealth.
The latest buzz on the grapevine borrows pharma’s latest drug delivery technology, a pulmonary (inhalation) device that delivers high levels of nicotine directly into the arterial circulation. This provides, it is suggested, “higher psychoactive effects than cigarettes or any other tobacco product currently on the market.” This might increase the success rate for those trying to quit smoking, but at a cost pitched at a 30% discount to the equivalent cost of a packet of fags, switching to this novel device could become the next best thing to standing outside in the street or leaning out of a train window. It’s claimed that the device is free of carcinogens. Is it so safe that these snazzy gadgets will not carry dreaded health warnings? In time, maybe, they could be formulated with menthol or other flavours so replacing traditional coffin nails in flip-top boxes? Could now be the time to dump shares in BAT?
Clinical trials in Eastern Europe
Since the early 1990s there has been an interest in conducting clinical trials in CEE, starting with Phase III and Phase IV, followed by Phase II and Phase I. In May, I visited Moldova and Ukraine to see at first hand how the health system, CROs, hospitals and Polyclinics operate. On long drives from one country to another, I was impressed that my driver did not touch a drop of alcohol, even at meal times, and preferred to drive at night without getting tired. In fact, driving was not his only job – he also worked as an anaesthetist in a hospital for some nights of the week so was used to sleeping during the mornings and working as a study monitor for a CRO for the rest of the day.
Most of the study monitors or CRAs I met there were trained physicians. The Medical Chief of a mid-sized Polyclinic in Chernivtsi, Ukraine told me there were 35,000 patients registered for a practice involving about 30 physicians covering various medical specialities (Internal Medicine, Social Medicine, Neurology, Ophthalmology, Psychiatry, Surgery, Orthopaedics etc). There are six Polyclinics in Chernivtsi, apart from other hospitals such as the military hospital, railway hospital, various company hospitals etc. Doing a round of the wards of a very large cancer hospital I found it quite different from the teaching hospitals in the UK where I used to help monitoring clinical trials of oncology drugs in development. There were many more in-patients and they came from remote areas of the country and stayed for the duration of their treatment. The consultant oncologist participated as an investigator in many of the major trials with new compounds. See the article (pp 38–40) about InnoPhaR/IPR-EE. In June 2007, I attended a conference in Prague organised by Informa on Clinical Trials in Central and Eastern Europe (CEE), India and China. In the next issue of WPhN, we intend to focus on the Asia-Pacific scene for clinical research.
Clinical trials – trends and technologies
The outcome of cancer trials, as well as those for CNS, cardiovascular and skeleto-muscular, have become a lot more amenable to monitoring using bio-imaging technologies, a subject that Colin Miller and Kimberley Wertz discuss (pp 42–43) with the aim of finding out whether it’s possible to decide on the best method for each type of trial. The development of products for topical (transdermal or percutaneous) delivery is quite different, but still has to comply with stringent regulatory guidelines while meeting the therapeutic needs of clinicians and their patients as reported by Betsy-Hughes Formella and Daniel Bucks of Bioskin (pp 31–33).
Manufacturing-CTM, production, packaging and logistics
Manufacturing, including production of the essential clinical trial materials (CTM) is increasingly outsourced, with the need for strict regulatory compliance extending the scope of GMP compliance. Explaining the dynamics of this niche business (pp 65) Steve Kemp of Brecon Pharmaceuticals considers the gathering pace of strategically outsourcing CTM manufacturing and packaging to specialist CMOs. Beyond production, the need for storage, delivery, temperature control and dispensing are a major challenge for successful trials, confirming an impression that CTM business is a microcosm of the commercial marketplace. Logistics operations for global clinical trials and the challenges are brilliantly exposed by Jonathan Blamey and Chris Tierney of DHL-Excel (pp 57–59). Many of you will be attending CPHI/ICSE in October in Milan – WPhN will be there – and I look forward to meeting many of you again.
Keep them rolling
Our thanks go to all the authors of the interesting and informative articles in this issue of WPhN. In future issues, we plan to review the worldwide market for drug delivery technologies, new developments in biotech, clinical research in Asia/Pacific countries, fine chemicals, and packaging materials. Enjoy this issue as we look forward to receiving your comments and articles.
About the Editor
PATRICIA LOBO, MSc, PhD
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As an independent management consultant for Lifescience Business Solutions, I am honoured to be invited by Roxby Media Ltd to be Editor of World Pharma Network (WPhN).
I have worked in the pharma sector for over 30 years after graduating in Chemistry, Microbiology and Biochemistry and gaining an external PhD in biochemical pharmacology and a business training course. My industrial career in the UK led from the QC department of a generics CMO to the R&D department of G D Searle (now Pfizer), followed by working as a CRA with Stiefel Laboratories, as Senior Clinical Research Scientist with Farmitalia Carlo Erba (now Pfizer), Business Unit Manager with Schering Plough, and for nearly 15 years as a management consultant at Technomark. There I have supported international lifescience clients with assignments in manufacturing, clinical research, development and marketing, providing specialised advice in drug development, outsourcing clinical research or manufacturing, due-diligence, strategic planning and marketing, including advice to corporate finance and equity organisations on M&As, JVs and alliance and investment.
I have published over 20 scientific articles, organised a major conference and exhibition in London, set up a database and directory of Contract Manufacturers, edited the specialist magazine, Pharmaceutical Manufacturing and Packing Sourcer (PMPS) for nine years, while publishing various articles for trade magazines, including GCP journal, PTE, Dose magazine and Scrip.
