WCI Nostrapharmus Feed

The Drug Safety Utility

Tue, 13 Mar 2012 15:45:30 GMT

Against a backdrop of stringent safety requirements and rising cost pressures, global drug safety groups within pharma companies are keenly looking on delivering 'more with less' and refocusing their efforts on what is considered as 'core'.

Traditionally, drug safety groups have operated as drug safety factories, which incurred significant capital expenses in building infrastructure related to technology, processes, people and other operational investments. Technology solution providers also built systems that were licensed to sponsor companies, where internal IT infrastructure groups managed these applications and safety databases. The rapid evolution of the Internet in the late 1990s has changed the business landscape. Although pharma was a little late to adapt to this changing technology, the concept of outsourcing became prevalent. During 2000-2010, global pharma companies spent significant time and effort to outsource several key aspects of drug safety operations. This transition in methodology also forced drug safety database vendors to develop newer models of solution platforms. Software as a Service (SaaS), with superior and secure cloud-based technology spread rapidly to drug safety organisations. Pay-as-you-go models started to evolve. The mind set of 'price per case' was beginning to get discussed in conference rooms more often and marked a paradigm shift for drug safety groups, where refocus happened. Drug safety groups started to emphasise their time and resources on risk management, signal detection, and emerging markets; less was spent on drug safety operational issues, technology investments, and running the factories.

Nostrapharmus predicts that during the next 5-10 years, drug safety operations will become almost completely commoditised. Sponsor companies will demand transactional pricings from their vendors. Vendors will, in turn, benefit from higher case volumes through new media such as social networks, mobile smart phones, emerging nations, and a more aware and educated public who will recognise drug safety issues in a comprehensive manner. The age-old challenge of under-reporting of adverse drug reactions will improve. There will be higher case volumes to be managed. Clearly, technology vendors will further enhance their solutions and offering and become more 'utility' companies than software or technology providers.

If you would like to read the article in full, please click on the pdf link below:

The Drug Safety Utility.pdf

or to read the magazine, follow the link below, the article can be found on page 50:

http://viewer.zmags.com/publication/95ed9af9#/95ed9af9/50

About Pharma Magazine

Aimed at the international pharmaceutical and bio-pharmaceutical community, Pharma magazine covers every aspect of manufacturing from R&D to finished product. With a worldwide circulation of more than 40,000 individuals, it is the first truly global magazine for the pharma industry, bringing together the disciplines of discovery and development, the drug manufacturing process and the resultant business and management issues. For further information visit the Pharma website at www.pharma-mag.com

The complex business of simplification

Thu, 22 Dec 2011 14:31:11 GMT

Nostrapharmus considers how the industry can continue effective global trials and align with a simpler future regulatory landscape

Globalisation of clinical research has presented both opportunities and challenges to the pharmaceutical industry. The logistical challenges of global operations have driven the industry to advocate for consistency and for a reduction in bureaucracy for conducting multinational trials. New initiatives in EU, US, and BRIC (Brazil, Russia, India, and China) countries indicate a move towards simplification, harmonisation and transparency; but despite the best intentions of these initiatives, the immediate future remains complex. So, Nostrapharmus asks: "How can we continue effective global trials and align with a (hopefully) simpler future regulatory landscape?"

As Europe continues to struggle with escalating costs, slow recruitment into trials and the threat from emerging market competitors, a pragmatic update to the EU legislation is much needed. The proposed revision of the Clinical Trials Directive 2001/20/EC aims to harmonise the application for authorisation, with all member states indicating a strong trend towards a single submission process with a co-ordinated assessment procedure. The Commission states that to achieve greater harmonisation and risk-adaptation on the content of the application dossier, "sufficiently detailed provisions could be included in the Annexes to the basic legal act."¹ Although some form of harmonisation is expected, the elements that would be required by the 'harmonised' clinical trial authorisation application remain unclear. The 'revision' is also set to address the classification of investigational and non-investigational medicinal products, sponsorship of clinical trials across EU, emergency clinical trials, and clinical trials performed in third countries. The Commission received 143 responses from stakeholders across the board - there is general consensus with finding a solution to the impediments caused by the EU legislations. It will be interesting to see whether the Commission will hold any further consultation ahead of the proposed legislative changes in 2012.

¹http://ec.europa.eu/health/files/clinicaltrials/concept_paper_02-2011.pdf

If you would like to read the article in full, please click on the pdf link below:

The complex business of simplification.pdf

or to read the magazine, follow the link below, the article can be found on page 58:

http://viewer.zmags.com/publication/2657b02c#/2657b02c/58

About Pharma Magazine

Building emerging markets BRIC by BRIC

Thu, 22 Dec 2011 14:26:43 GMT

With India predicted to be among the top 10 drug producers by 2020 and China well on its way to becoming the third largest pharmaceutical market, just what does the future hold for the BRIC (Brazil, Russia, India, China) nations?

Asia, the world's largest continent, is home to some 4.1 billion people, representing almost 60% of the world's estimated population. It is unsurprising, therefore, that Asia is expected to double its share of global gross domestic product from 27% in 2010 to 51% in 2050.¹

As the wealth of the BRIC nations improves and the ageing population increases, the demand for quality drugs is also boosted. The Asia Pacific pharmaceutical market is predicted to grow at a compound annual growth rate of more than 12% during 2011-2013.²

Pharmacovigilance in Asia is still in something of a development phase and, to a large extent, still varies from one country to another. Yet, drug safety and pharmacovigilance are now very much on the national agenda and are viewed as key components on the journey to becoming a First World nation. China's State Food and Drug Administration (SFDA) recently overhauled adverse drug reaction reporting and monitoring procedures, placing more emphasis on data analysis and evaluation, and putting additional responsibilities on manufacturers. Nostrapharmus believes that further regulations inspired by ICH will be established as SFDA consults with First World regulators, including EMA and FDA. There are already stirrings of a China risk management plan.

¹www.adb.org/documents/reports/asia-2050/asia-2050.pdf

²www.businesswire.com/news/home/20110125006249/en/Research-Markets-Asia-Pacific-Pharma-Sector-Analysis

If you would like to read the article in full, please click on the pdf link below:

Building emerging markets BRIC by BRIC.pdf

or to read the magazine, follow the link below, the article can be found on page 70

http://viewer.zmags.com/publication/947aa6ef#/947aa6ef/70

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The Generic Formulation

Mon, 18 Jul 2011 15:18:01 GMT

Can the generic pharmaceutical industry embrace the principles of Quality by Design to keep risks low and patients safe?

The generic pharmaceutical industry currently has more opportunity than it can handle! Nostrapharmus notes that much of that opportunity will be more concentrated in emerging markets such as India. With $100 billion worth of drugs coming off patent in the next two years, the result will be an increase in the US from 77% of prescriptions in the first half of 2010 to as much as 85% by 2014¹. Indian drug firms, which account for a third of US abbreviated new drug applications (ANDA), could also add $2.5 billion in US sales in the next five years¹.

The threats to acquiring this market share, however, are also increasing on a number of fronts. Competition among generic manufacturers is fierce, and lawsuits are common and increasing in volume. Also, regulators, particularly in the US, are much stricter with many generic companies currently facing compliance issues. The rigour of regulators and the fierce competition is reflected by the current time taken for ANDA approvals, which has increased from an average of 25-30 months a year ago to 30 months².

The challenge for generic companies is to combine science and business acumen. This is partly forced by the regulations as an important section of the Hatch-Waxman Act, which actually encourages generic companies to challenge patents. If a generic company is the first to file its ANDA with a Paragraph IV certification (a patent challenge) and prevails in the subsequent lawsuit, that generic company is granted a period of market exclusivity of 180 days. Most, if not all, generic companies, in both emerging and mature markets, have made the Paragraph IV certification a routine part of doing business. In an industry where profit margins are tight, six months of exclusivity for a product can increase a generic's cash flow exponentially.

¹http://in.reuters.com/article/2011/04/12/idINIndia-56277020110412?pageNumber=1

² http://www.pincmoney.com/Upload/Pharma%20Results%20Preview%20Q4FY11.pdf

If you would like to read the article in full, please click on the pdf link below:

The Generic Formulation.pdf

or to view the magazine, follow the link below, the article can be found on page 58

http://viewer.zmags.com/publication/dc6789fd#/dc6789fd/58

About Pharma Magazine

Keeping the supply chain agile

Mon, 23 May 2011 10:54:46 GMT

Lean thinking works well for the automotive industry, but is it really suitable for pharma supply chains? 'Agile' techniques may be more appropriate and promising for the industry's uncertain factors.

In the wake of cost pressures, Lean thinking has made its appearance within the pharmaceutical industry. Nostrapharmus notes that we were asked to look at, and learn from, other industries that have been under cost pressure for decades. Lean seemed the answer to all our questions: it focuses on eliminating all forms of waste in the supply chain, including spare resources such as inventory and equipment. This works very well in an environment where demand is stable and product variety is low...in fact the very environment in which Toyota developed Lean thinking.

But, does this work for us? Eliminating waste and, thus, fat from the supply chain does cut costs, but with it also comes risk: it makes the supply chain increasingly vulnerable to disruptions and unpredictable events as there is no slack to fall back on. In the car industry that may not be such a problem - all it means is the customer will just have to wait a little bit longer until the car is ready. Patients, on the other hand, have to take their medication immediately; sometimes their life depends on having the product available day to day. We have the moral obligation to guarantee the best possible treatment to the patients, and consequently, securing the supply of medication.

If you would like to read the article in full, please click on the pdf link below:

Keeping the supply chain agile.pdf

or to view the magazine, follow the link below, the article can be found on page 58

http://viewer.zmags.com/publication/b15cb1fc#/b15cb1fc/58

About Pharma Magazine

Navigating the Perfect Storm

Mon, 04 Apr 2011 13:13:52 GMT

Nostrapharmus explores how life science organisations are going to have to navigate the perfect storm to shape the future of patient safety

The origin of our current pharmacovigilance systems can be traced back to the teratogenic effects of thalidomide, first reported as a series of three cases in The Lancet in 1961. Recognition of thalidomide's association with a variety of birth defects and, in particular, limb defects known as phocomelia, led to the drug's withdrawal from the market. Up until this time, the only way of reporting adverse drug reactions was through publication in medical literature. The lessons of thalidomide, 50 years ago, led to the creation of systems to detect, assess, and report suspected adverse reactions.

Early systems for drug safety reporting relied upon a medically qualified person, suspecting a causal association between the event and the medication to report a suspected adverse reaction. Today's PV systems are still built upon adverse event reporting, with over 50% of the resources in a typical drug safety organisation being dedicated to this activity alone. When the requirements to report summaries of the same data in aggregate form are considered, then close to 80% of resources are consumed in performing routine and reactive safety processes.

If you would like to read the article in full, please click on the pdf link below:

Navigating the perfect storm.pdf

or to view the magazine, follow the link below, the article can be found on page 58

http://viewer.zmags.com/publication/68555266#/68555266/58

About Pharma Magazine

Quality Management: Let's make it simpler

Mon, 04 Apr 2011 13:20:54 GMT

Simplification of the supply chain will be key to ensuring future compliance and quality

Imagine that it is your job to sign the form that releases the product to market. You've checked that everything is in place - the batch records, the signatures, the test results - so there's no reason why you cannot sign. The sales people need the revenue, the pharmacists need the inventory, and the patients need the drugs. The supply chain is secure, compliant, and safe. So sign. Are you sure?

Do you really have sufficient confidence in the quality of production throughout the whole supply chain that you can put your signature on the release form? Since globalisation has become a feature of the industry, maintaining that oversight has become increasingly challenging. Between 2001 and 2007 the number of manufacturers in India increased by a factor of twenty five, and in China by a factor of seven. It will almost certainly be true that some of the supply chain will exist in some countries with less well developed regulatory systems than, say, Europe or the US. How do you know what's really going on in your suppliers, or their suppliers, or theirs. Your company probably won't have audited them all - you won't have enough auditors in-house, and renting that kind of capability is expensive. Of course you'll have Quality Assurance Agreements (QAAs) in place for your third party contractors, and those that you have negotiated recently will be good. But, what of the older ones? Do they ensure total transparency? What about your raw material supplier network? Do your suppliers (and theirs, and theirs etc.) fully disclose every Out of Specification (OOS) measurement, every deviation, every change? How do you know? Are you still going to sign?

If you would like to read the article in full, please click the pdf link below:

Quality Management Let's make it simpler not even more complicated.pdf

or to view the magazine, follow the link below, the article can be found on page 58

http://viewer.zmags.com/publication/00b229e7#/00b229e7/58

About Pharma Magazine

Personalised Medicines - the treatment of the future?

Tue, 08 Mar 2011 11:28:55 GMT

Forecasts suggest that personalised medicine will become the future disease management model; a model where treatments will be tailored to a person’s genetic profile. Currently, most available drugs on the market are developed by targeting the patient’s population as a single entity, with limited differentiation of the patient’s genetic make-up. Nostrapharmus asks, how can we change our drug development approach in order to yield the medicines of the future?

Pharmacogenetic vs. Pharmacogenomic approaches

A pharmacogenetic approach demonstrates the development of drugs that are targeted to specific genes. A good example of this approach is research at the University of Southern California where they have identified genetic markers in cancer cells that are able to predict the benefit of a novel cancer drug, PTK/ZK*. The focus of this study was understanding the mechanisms of candidate genes. These genes are associated with a specific group of patients that exhibited significant improvement to PTK/ZK. This approach, if successful, would significantly increase the drug effectiveness in a specific patient group; that is, those who have the correct form of the candidate genes. It may, however, carry a higher risk of commercial failure, because of the increased effort and cost in development, and the risk of investigating the wrong candidate genes.

A Pharmacogenomic approach could be an alternative in developing personalised medicines. With the advance in gene sequencing techniques, it now only takes ten days to sequence all protein-coding genes (about 1 per cent of the genome), which forms a person’s genomic profile, or fingerprint. With this information, researchers could determine association between treatment outcomes and the pattern in the genetic fingerprint. Here, investigators focus on searching for an association between variations in the genome and treatment outcome. No candidate genes are isolated for investigation. To succeed, one must develop powerful analytic tools, using custom built IT solutions and, perhaps, adapting statistical solutions, such as SPSS and multi-level modelling. The tools should be able to effectively group genes into various levels of subgenome, a subset of a genome, which may have a specific function, and determine which subgenome, at which level, are associated with treatment outcomes.

The future model could be a mixture of both pharmacogenetic and pharmacogenomic approaches, dependent on the identification of the candidate gene(s) associated with diseases under investigation and the availability of analytic tools to investigate our genome. Nostrapharmus looks at what we can do now.

To view the article in full, please click on the pdf link below:

Personalised Medicines the treatment of the future.pdf

or to view the magazine, follow the link below, the article can be found on page 74

http://viewer.zmags.com/publication/e9f19faa#/e9f19faa/74

*PTK/ZK, is a VEGF receptor tyrosine kinase inhibitor that is currently under development by Novartis AG and Schering AG as an inhibitor of angiogenesis for the potential treatment of various cancers.

About Pharma magazine

Aimed at the international pharmaceutical and bio-pharmaceutical community, Pharma magazine covers every aspect of manufacturing from R&D to finished product. With a worldwide circulation of more than 40,000 individuals it is the first truly global magazine for the pharma industry, bringing together the disciplines of discovery and development, the drug manufacturing process and the resultant business and management issues. For further information visit the Pharma magazine website www.pharma-mag.com

Natural Attrition?

Tue, 08 Mar 2011 11:25:37 GMT

The pharmaceutical industry's inevitable endgame - that it would become dominated by the need for financial performance - has come to pass

Big Pharma's financial aspiration has been ever present but, 20 years ago, it lived in a more harmonious balance with the desire to save and improve lives. Many of us in the industry still aspire to help people through the development and application of science; but, for most of us, our contexts and the investment decisions are ultimately driven by the numbers. With this in mind, Nostrapharmus asks: what about the minor league, those unmet medical needs, with unattractive financial prospects?

The Payers and the Generics

The financial opportunity for drugs with a relatively modest target beneficiary population was always less attractive than the 'blockbusters'. Now, however, new pressures are upon us, in the form of health funders applying ever-increasing price pressure and the generic manufacturers waiting anxiously for time to pass, to grab the patent, forcing our R&D investment decisions to be based on shorter horizons. One can hardly lay blame for decreasing investment in the minor league at the door of the major players, when they too are subject to these pressures and the need to ensure good share price performance, which is the obligatory foundation stone for investment.

Natural Attrition?

If you would like to read the article in full, please click on the pdf link below:

http://viewer.zmags.com/publication/e54eb7ae#/e54eb7ae/74

About Pharma magazine

Aimed at the international pharmaceutical and bio-pharmaceutical community, Pharma magazine covers every aspect of manufacturing from R&D to finished product. With a worldwide circulation of more than 40,000 individuals it is the first truly global magazine for the pharma industry, bringing together the disciplines of discovery and development, the drug manufacturing process and the resultant business and management issues. For further information visit the Pharma magazine website www.pharma-mag.com

Is a label enough?

Tue, 08 Mar 2011 11:23:56 GMT

Nostrapharmus considers whether a label will be enough or whether educating the populous about how to use drugs will become a key marketing activity by 2020. Do pharma companies owe more to their ultimate customers?

There are many drivers for an improvement in the quality of drug usage information provided by pharma companies:

The pressure of healthcare cost reductions is reducing the time that doctors have to consult with their patients. Inevitably the time available will tend to be spent on making the best possible diagnosis and less will be available for instruction on how to use the prescribed drug
These cost pressures, together with an objective to simplify aspects of regulation in the EU, are creating an environment that is pushing for an increase in the patient's ability to self-medicate. This is exemplified by the recent legislation enabling products to be switched from Prescription Only Medicine (POM) to P ('available in' Pharmacy) status across all EU member states simultaneously. A key foundation for these switches is the establishment of rigorous risk management approaches, principally targeted towards better education of the patient on the appropriate usage of the product.
The requirements to assess safety risk management requirements of new pharma products has led to an increase in formal commitments to the management of risk. Again, this is often achieved through training in drug use and led to an increase in the development of educational programmes for physicians and patients. This legislation has driven a huge rise in the development of medication guides in the US, similar to the EU patient information leaflet (PIL), which aims to provide more information on appropriate drug use.

If you would like to read the article in full, please click on the PDF link below:

Is a label enough?

or to view the magazine, follow the link below, the article can be found on page 44

http://viewer.zmags.com/publication/30a838a6#/30a838a6/44

About Pharma magazine

Aimed at the international pharmaceutical and bio-pharmaceutical community, Pharma magazine covers every aspect of manufacturing from R&D to finished product. With a worldwide circulation of more than 40,000 individuals it is the first truly global magazine for the pharma industry, bringing together the disciplines of discovery and development, the drug manufacturing process and the resultant business and management issues. For further information visit the Pharma magazine website www.pharma-mag.com

Patient Focus – It’s time to listen

Tue, 24 Jan 2012 12:13:35 GMT

To improve the Medical Device Reporting (MDR) submissions process, Nostrapharmus recommends that companies need to put the patient before the product.

The medical device industry is facing increasing pressure from US congress and greater FDA scrutiny owing to several product recalls that have affected patient safety. During a GMP inspection, an FDA investigator usually starts with a device company's MDR files, partly because violations for missed deadlines and failure to report are often easy to spot. Hence, there is a pressing need within the industry to improve the MDR submissions process. Nostrapharmus suggests immediately 'the best place to start is quite simple - listen and focus on the patient.'

If you would like to read the article in full, please click on the PDF link below:

Patient Focus - It's time to listen

or to view the magazine, follow the link below, the article can be found on page 58

http://viewer.zmags.com/publication/6bf9daa9#/6bf9daa9/58

About Pharma magazine

Aimed at the international pharmaceutical and bio-pharmaceutical community, Pharma magazine covers every aspect of manufacturing from R&D to finished product. With a worldwide circulation of more than 40,000 individuals it is the first truly global magazine for the pharma industry, bringing together the disciplines of discovery and development, the drug manufacturing process and the resultant business and management issues. For further information visit the Pharma magazine website www.pharma-mag.com

Data: The root of all...good?

Tue, 08 Mar 2011 11:22:42 GMT

Nostrapharmus suggests that the drug community will share a single data set across research, development, marketing, safety, and more.

Increasingly the ability to store, manipulate, and query vast quantities of data is enabling us to perform key business and medical analysis, without the need for much of the leg work of old.

Not only is it easier than ever to structure and query data, but the advent of data mining has opened up new opportunities to learn from a wider range of data and from older, unstructured data.

The computer ages has prepared us well for this new era. Data has been captured in digitised for for a few decades. As time has progressed, the data set of every business in the sector has grown. This data, newly digitised data, and everyone else's data, now present the chance to unearth new knowledge, hidden within the depths of the hard drive.

If you would like to read the article in full, please click on the pdf link below:

Data: the root of all...good?

or to view the magazine, follow the link below, the article can be found on page 50

http://viewer.zmags.com/publication/cc05a62f#/cc05a62f/50

About Pharma magazine

Aimed at the international pharmaceutical and bio-pharmaceutical community, Pharma magazine covers every aspect of manufacturing from R&D to finished product. With a worldwide circulation of more than 40,000 individuals it is the first truly global magazine for the pharma industry, bringing together the disciplines of discovery and development, the drug manufacturing process and the resultant business and management issues. For further information visit the Pharma magazine website www.pharma-mag.com

No Risk Management or Poor Risk Management?

Tue, 08 Mar 2011 11:26:34 GMT

Nostrapharmus calls for good risk management practice to satisfy regulatory demands and business needs.

'At least we tried' is a phrase unlikely to receive any sympathy when you are held to account for knowing about a risk, but not addressing it appropriately - especially in an industry where public responsibilities are beyond those of ordinary business ethics. Safety is paramount and what you don't know will hurt you.

As Nostrapharmus says, the minimum requirement has to be an explanation of the actions taken, or not, as the case may be. This, alongside evidence to support the decisions made, is a start to exercising the decisions made, is a start to exercising the principles of GRMP (Good Risk Management Practice). Such principles must maximise the benefits of risk management across the business while also ensuring the satisfaction of emergent requirements from the regulators. It is imperative, when implementing risk management, to put mechanisms into place to manage the required actions before getting too excited about where the greatest risks exist in the business.

If you would like to read the article in full please click on the pdf link below:

No Risk Management or Poor Risk Management?

or to view the magazine, follow the link below, the article can be found on pages 49-50

http://viewer.zmags.com/publication/9d1586ab#/9d1586ab/51

About Pharma magazine

Aimed at the international pharmaceutical and bio-pharmaceutical community, Pharma magazine covers every aspect of manufacturing from R&D to finished product. With a worldwide circulation of more than 40,000 individuals it is the first truly global magazine for the pharma industry, bringing together the disciplines of discovery and development, the drug manufacturing process and the resultant business and management issues. For further information visit the Pharma magazine website www.pharma-mag.com

It will all end in multi-tiers!

Tue, 24 Jan 2012 12:12:44 GMT

In reflective mood, Nostrapharmus muses on developments in health and safety and, with the explosion of outsourcing, what the landscape could look like in 10 years time

Nostrapharmus may be all about predicting the future, but let's begin by casting our minds back 30-40 years. Those of you who held line management positions during that time can probably still remember what the UK's Health and Safety regulatory environment was like, or not, as the case may be. The compulsory use of Personal Safety Equipment was creeping into the regulations. Managers spent many hours and disciplinary meetings with employees to convince, persuade, or force the use of safety shoes, glasses, and noise protection. Moving forward a little in time, the Seveso disaster of 1976 was most tragic and left a never fading impression on the people that lived there and survived this catastrophe. The impact on us, the pharmaceutical industry, was enormous. New legislation and regulations were introduced in response. Again, line managers often struggled to get their employees to adhere to the new rules. Other examples, such as the Thalidomide tragedy, and the Devonport Hospital disaster were pivotal in moulding today's regulatory environment. Each incident was responsible for driving new legislation that further, and better, defined the way in which pharmaceuticals should be both manufactured and released.

The regulators have also responded to trends or incidents by tightening the rules and introducing more stringent and far reaching laws. The pharmaceutical industry has responded by implementing the new legislations and, more often than not, creating even tighter self-imposed requirements as well. The efforts to stay compliant have gone up during the years and so too have the costs. Of course, stringent regulation is vital when it comes to protecting the health and safety of employees, the safety of the patients and the environment that are all dependent on our products. Nevertheless, the burden is high.

If you would like to read the article in full, please click on the pdf link below:

It will all end in multi tiers.pdf

or to read the magazine, follow the link below, the article can be found on page 64-65

http://viewer.zmags.com/publication/7c260863#/7c260863/65

About Pharma Magazine

Needs + Opportunity = Collaboration

Tue, 24 Jan 2012 11:17:33 GMT

In the middle of a recession, Nostrapharmus argues that collaboration must continue to grow

In the midst of a global recession, with innovation appearing to be increasingly difficult, and with many unmet patient needs in the world, surely the only way to ensure future success is to get the best out of our individual and collective strengths? In an industry that is so competitive, and with no shortage of tales of adversarial behaviour amongst the players, what chances are there that those involved will change their game? Well, the tide has been turning steadily for quite some time now; there are many good reasons to accelerate change...and no shortage of those who look to the past to justify 'no change!'

Who are we talking about?

We're talking about pharmaceutical companies, large and small, health providers, the medical community, patient groups, regulators, health funds and more. it is not difficult to find examples of these groups working together both within their own communities and across communities. Fundamental to continued and future success will be the ability to get the best out of all parties to deliver individual and collective objects.

Needs-driven collaboration

Necessity and pack mentality alike have inspired, driven, and perpetuated collaboration in this industry. Times of regulatory change have led to industry associations going into a higher gear and standing as a united single body of commercial organisations to resist the scope and pace of changes enacted through the history of this industry. Crisis situations can teach us so much about the power of combining forces to conquer a common enemy. There are many examples; in a recent collaboration, for instance, Pfizer has team up with Mylan and the Clinton Foundation to cut the cost of medication for patients with drug resistant HIV in developing countries. Collaboration is facilitating access to life saving treatment to those that would not have received it.

To read the article in full, please click on the pdf link below:

Needs + Opportunity = Collaboration.pdf

or to read the magazine, follow the link below, the article can be found on page 74

http://viewer.zmags.com/publication/141d4023#/141d4023/74

About Pharma Magazine

Integration to minimise patient risk

Tue, 24 Jan 2012 11:16:34 GMT

Why pharma must integrate R&D, manufacturing, and marketing efforts to minimise patient risk.

Eighteen months ago, Nostrapharmus predicted 'the implementation of processes that enable R&D teams to proactively identify and mitigate risk, coupled with Drug Safety's ability to build 'peer to peer' relationships with clinical colleagues enabling them to take strategic, longer-term views of product risk' was needed to enhance patient safety. Now, more than ever, Nostrapharmus believes that safety's role within pharmaceutical organisations must be one of leading proactive, cross-functional co-ordination of holistic strategies aimed at minimising and monitoring risk from product inception through to market withdrawal and from point of manufacturing through to utilisation.

In the wake of recent court rulings that emphasise the responsibility for product manufacturing, supply, and administration to lie squarely at the foot of the pharmaceutical industry; patient safety and the role the MAH plays in co-ordinating activities to minimise patient risk has again been pushed to the centre of both public and government debate. Add to this the turbulent regulatory environment that continues to move towards risk-based assessments and publication by agencies of product 'watch lists' and there is increasing pressure on the role that safety functions play in pharmaceutical organisations.

To read the article in full, please click on the pdf link below:

Integration to minimise patient risk.pdf

or to read the magazine, please click on the link below, the article can be found on page 50:

http://viewer.zmags.com/publication/f4349e2a#/f4349e2a/50

About Pharma Magazine

Drug pipeline sustainability

Tue, 24 Jan 2012 11:15:49 GMT

What does the drug development industry have in common with every other major industry sector? When it comes to product development, on the surface very little! Nostrapharmus explores this in more detail

In 2006, almost 500 products were launched every day across all other sectors - that's a 50% increase from 2005 and almost 100% from 2004. Yet, in that same period, the combined might of the pharmaceutical industry, the greatest R&D force in the world, both by numbers and dollars spent, launched just 21 active substances. Nostrapharmus notes that what makes this picture even bleaker is the fact that R&D spend has increased annually. The industry spent 100% more in 2006 than 2000, yet launched half the active ingredients. So, is the industry failing to innovate? Are their structural impediments that are driving down the rate of innovation? Or has the industry simply run out of good ideas? Some would argue that all three are true, yet this hides the real truth. Products that are launched are no less successful than in the past; the conversion rate at which actives are taken to market is about the same as in the past, but regulation changes have slowed the pace at which they enter the market. New techniques and methods are appearing: in fact, all the evidence suggests that RNA-based chemistry, computer-modelled drug discovery, or event Raman spectroscopy, with its ability to investigate drug delivery in completely new ways, will open up a new cycle of drug discovery. We are at the beginning of the next wave, even as we end the last one.

To read this article in full, please click on the pdf link below:

Drug Pipeline Sustainability.pdf

or to read the magazine, please click on the link below, the article can be found on page 58

http://viewer.zmags.com/publication/9978d7ea#/9978d7ea/59

About Pharma Magazine

Change as constant

Tue, 24 Jan 2012 11:50:43 GMT

Within 10 years, reporting will be risk-based across a broad spectrum of products, and pharmacovigilance procedures will be an integral part of a product's development plan. Companies must anticipate [this] and build the foundation for processes that easily accommodate change.

The great visionary Buckminster Fuller once said: "To change something, build a new model that makes the existing model obsolete." Increasingly, regulatory agencies in both the U.S. and EU are following this paradigm and constructing a new evaluative model of reporting requirements. For example, we have seen a significant focus on risk management and reporting prioritisation of products based upon their risk profile. Nostrapharmus says "industry must be prepared for this impact, not only on business operations for a traditional product portfolio, but also for medical devices, over-the-counter (OTC) drugs, cosmetics and any animal health products in their portfolio."

Regulatory Change

Both the US and EU have demonstrated an increased focus on risk-based product evaluation and reporting with recent regulatory amendments; the US has done so most notably with the Food and Drug Administration Amendments Act of 2007 (FDAAA), and the EU with proposed legislative amendments to directive 2001/83/EC and regulation (EC) 726/2004.

In the US, the FDAAA establishes that a Risk Evaluation and Mitigation Strategy (REMS) may be required to ensure that benefits will outweigh the risks of a drug. In addition, the emergence of ‘new safety information’ or ‘information necessary to ensure that the benefits of the drug outweigh the risks of the drug’ may prompt the FDA to request a REMS.

To read the article in full, please click on the pdf link below:

Change as constant.pdf

or to read the magazine, please click on the link below, the article can be found on page 49

http://viewer.zmags.com/publication/20ee58e2#/20ee58e2/48

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All change please!

Tue, 24 Jan 2012 12:11:44 GMT

It's all change in the pharmaceutical industry!

Much is written and said about the extent of change going on in the world of the pharmaceutical business. Regulations, new levels of risk aversion, accessibility of information, low-cost generic manufacturers, pricing pressures, to name but a few, are all contributing to the imperative to do things differently. In response we are seeing a shuffling of the deck, as major players create the businesses they believe will deliver success in the ever-changing markets. But it is not just the markets that we play in, and the pipeline that we deliver that will dictate success. The people we have, our organisation and capabilities, together with our ability to work together within, and without, our business are going to be increasingly significant factors.

What we do, and how we organise is moving on and has to move on much further, if we are to thrive. This is best illustrated by example. In research we have extended our skills beyond the laboratory and the clinic and well into the portfolio management arena. Once upon a time, the Head of Research managed a team of scientific researchers. Now, the Head has to consider internal and external research investment, deliver commercial contracts with third parties, and be at least extremely curious about health economics and how it should influence Research decisions.

In manufacturing, we have nurtured capabilities to be excellent in the conversion of raw materials into products fit for consumption. The need to continue to deliver good products continues, as does the imperative to keep manufacturing off the board agenda. But, new skills make the difference between success and failure: third party management, contract management, supplier development, planning and balancing more complex supply chain trade-offs.

The role of sales and marketing is rapidly shifting focus from selling to medical practitioners, to selling to healthcare funders, be these insurers or nationalised health services. The skills, attributes, level of people needed to do this are very different. Perhaps, one of the more significant changes coming our way and likely to impact all areas, is the shift in regulation from “explain” to “prevent”. New skills, new methodologies and, perhaps, most significantly, a new mind set is required.

To read in full, please click on the pdf link below, the article can be found on page 50:

All change please.pdf

or to view the magazine please click on the link below:

http://viewer.zmags.com/publication/e153833d#/e153833d/50

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Are you keeping up with the evolution of the QP role?

Tue, 24 Jan 2012 12:26:39 GMT

Much expectation, and responsibility, has been put on the shoulders of the Qualified Person for Pharmacovigilance (QPPV). The dedication and commitment to the role has, in many organisations, established good oversight of operational processes across pharmacovigilance e.g. QPs have a Detailed Description of the Pharmacovigilance System (DDPS) in place to support the submission process, and operational metrics to ensure compliance to Regulatory requirements.

However, the role has not been fully defined, and its scope is developing as Regulators are pushing towards more enforcement and focus on proactive safety, which in turn is putting more burdens on the legal role of the QP. The role is a continuing evolution, and now is the time to ensure compliance with both immediate and expected requirements of the QP.

Nostrapharmus says: "The publication of Volume 9A - Pharmacovigilance for Medicinal Products for Human Use (April 2007) has certainly made a big impact on the role of the QP. It has clarified the role and specified the areas for which a QP has oversight responsibility and those for which it has direct responsibility." Nostrapharmus predicts that not all companies will grasp the full implications of 9A in establishing the role of the QP and the processes needed for them to succeed. The idea of a single point of accountability requires a radical rethink of governance across functions, competency requirements, reward and recognition, and career paths. Only by taking this holistic approach can the QP be set up to succeed. Some companies will 'get it' from the start, others will respond only after 'prompts' from the regulator.

To read the article in full, please click on the pdf link below:

Are you keeping up with the evolution of the QP role.pdf

or to read the magazine, please click on the link below, the article can be found on page 66:

http://viewer.zmags.com/showmag.php?mid=wqrgrw#/page66/

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Collaborate for competitive success

Tue, 24 Jan 2012 14:36:23 GMT

A while ago, Nostrapharmus predicted that for pharmacos, the ability to attract and build quality relationships with winning partners would increasingly be the key to competitive success. Here, Nostrapharmus looks at a different kind of collaboration: that between companies in the non-competitive space...and discovers that, not only will it make life easier for everyone, it will also benefit both competitiveness and investability.

Nostrapharmus says, ‘Collaboration in the range of non-competitive activities including aspects of manufacturing, development and quality operations will be routine within ten years – and the turning point will come much sooner, as companies and regulators realise that by coming into the arena, they have everything to gain and nothing but pride to lose!’

Non-competitive good?

The level of intimacy of exchange between successful companies will soon be way beyond anything dreamed of or, in many cases, desired by today’s participants. But what is this ‘non-competitive’ space? Are we not talking about something perilously close to collusion? This is the picture I see:

In the competitive space are skills such as portfolio management, investment attraction and forging winning partnerships; business activities including research & development and sales & marketing.

The overlap area is home to activity that I call 'few-to-few' collaboration. Even companies that are in direct competition sometimes see benefits in working together on, for example, the co-development and co-marketing of products.

Finally, in the non-competitive space, are activities in which collaboration poses no threat to corporate interest and in which it will become clear, there is benefit to be derived from sharing and other collaborative activity.

To read the article in full, please click on the pdf link below:

Collaborate for competitive success.pdf

To read the magazine, please click on the link below, the article can be found on page 56:

http://viewer.zmags.com/showmag.php?mid=fftpd#/page56/

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New regulations require new proof of your risk effectiveness

Tue, 24 Jan 2012 14:49:03 GMT

If you work in drug safety you will know that all marketed drugs require an assessment of the need for a risk management plan, the first step of which is to conduct a risk assessment. If there are no important potential risks found as a result, then it is acceptable to perform only routine pharmacovigilance. If the assessment finds either important potential risks, or some missing information, then it becomes necessary to perform either a risk minimisation action, or conduct further studies to find the absent data respectively.

So far, so routine. But are you aware of the extra layer of complexity that new regulations require? From now on all pharma companies conducting risk minimisation actions on marketed drugs are required to prove their effectiveness.

Is this news to you? Well, wait until you have heard the next bit. Although the regulators are seeking enforcement options, including fines, to punish those companies who don’t implement their planned risk management actions, there are no set or recommended models for how companies should satisfactorily achieve or report this.

So, how do you go about tackling this new requirement? Nostrapharmus is not entirely convinced that the agencies appreciate the full extent of what they are asking for yet, and feels at this stage there is only so much that companies can do. However, the first step is surely to look at the different ways to minimise risk and to set the safety objectives for each of them. If, for example, you identified a potential risk to either pregnant women or their foetus, your safety objective would be to prevent pregnant women from using the drug. Your risk minimisation actions might include putting a specific warning advising against this type of patient on the label, setting up an education programme with the pharmacists and physicians who would advise them, an action to make the patient requirements stiffer (‘Do not prescribe this drug unless a pregnancy test has been conducted’), or in the case of higher potential risk, setting up a restricted distribution programme.

To read the article in full, please click on the pdf link below:

New regulations require new proof of your risk effectiveness.pdf

or to read the magazine, please click on the link below, the article can be found on pages 57-58

http://viewer.zmags.co.uk/showmag.php?mid=sgfgh#/page56/

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Time to change

Tue, 24 Jan 2012 14:57:39 GMT

Nostrapharmus predicts that a more strategic and proactive approach to safety will win back consumer confidence

Drug safety in pharma is under extreme pressure right now. Trusted blue chip organisations have been publicly accused of putting profits ahead of patient safety, and negative stories in the media are fuelling public and stakeholder anxiety. Legislators and regulators are feeling twitchy, and are demanding proof from all pharma companies that their teams are building safety risk management into everything they do. The overall result is severe demand on the industry to prove that patient safety forms the nucleus of all work carried out whilst developing a drug from conception to clinical and through to manufacturing and marketing. This means that pharma’s drug safety units are being asked to take a much wider, more strategic look at a drug’s safety profile, starting as early as possible in a product’s life cycle.

This change is not just a tweak to the current ways of working, it is a huge transformation in terms of today’s readily used processes and teams’ mind-sets; and it will require big commitment and determination from the pharma companies to see it through.

To read the article in full, please click on the pdf link below:

Time to Change.pdf

or to read the magazine, please click on the link below, the article can be found on pages 57-58

http://viewer.zmags.com/showmag.php?mid=pfrpd#/page56/

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Tide of change

Tue, 24 Jan 2012 15:05:25 GMT

There is a tide of change in drug safety. Internal and external forces are pushing drug safety to expand its scope of operations; from post-marketing safety monitoring to a proactive stance in the characterisation of safety profiles during the development of new drugs.

With highly public drugs failures, such as Vioxx®; the largest prescription drug withdrawal in history, pharmaceutical companies are under scrutiny from regulators and media alike. All too frequently are companies being accused of putting profits ahead of patient safety, and an increase of stories in the mass media are growing public anxiety. Legislators and regulators have been pushed into an increasingly risk-averse position, owing to little debate or public education on the concept of benefit/risk balance. In the EU, regulators now require new drug submissions to be accompanied by a formal statement of need/lack of need for a risk management plan. The need for global consistency is resulting in submission of similar documentation wherever a drug is to be launched.

The Food and Drug Administration Amendment Act of 2007 describes the requirements for publication of development and post-marketing clinical trial results. The proposed legislation highlights the development of safety signal monitoring processes by the FDA, describing the tightening of enforcement actions if companies don’t follow their own risk management plans.

Where there are outstanding questions from the drugs development phase relating to defined patient populations, the drug’s developer must describe the actions taken to close knowledge gaps. Actions can range from typical post-marketing safety monitoring through to the initiation of targeted clinical or epidemiological studies of safety, which may be accompanied by restrictions on the use of the product until that information is obtained. Where such activities are committed to at submission, the company must ensure appropriate mechanisms are in place across clinical, safety, regulatory and marketing & sales organisations to guarantee that actions are taken and are effective in controlling risk.

To view the article in full, please click on the pdf link below:

Tide of Change.pdf

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Outsourcing: A question of trust

Tue, 24 Jan 2012 15:11:45 GMT

Outsourcing non-critical processes constitutes normal day-to-day business and best practice in industries like Aerospace, Automotive and Telecommunications. Losing the non-value add stuff so that more time and budget is available to spend on the critical? A no-brainer, surely? But this is not yet the case in Pharma, an industry that transforms our lives with modern science, but whose approach to business processes can sometimes be a little lacklustre by comparison.

Outsourcing is not a new concept to pharma per se. Manufacturing capacity and clinical trials are frequently outsourced; and truck loads of documents and paperwork are shipped to Clinical Research Organisations (CROs) on a regular basis. But outsourcing an actual compliance critical process? No way. Take for example Pharmacovigilance; the terror of being sued over incorrect reporting of an adverse event, or putting the business reputation at risk has led the Pharma industry to clutch these processes fearfully to their chest. The processes themselves are needed for compliance reasons and add little in terms of value, but plenty in terms of cost and added stress to the business.

So is it plain foolishness, stubbornness, the fear factor or all three that make Pharmacos ignore the benefits that outsourcing can bring? Well, intense scrutiny and regulatory pressures mean that a culture of extreme caution has developed when it comes to new ways of working.

Many processes in Pharmacovigilance are a burden to Pharma and ripe for outsourcing. In a business making drugs based on, for example, acetylsalicylic acid, a product that has been on the market for well over 100 years, the chances are there is often no new knowledge to be gained from PSURs and single case handling, yet the dogged reporting and analysis still has to take place in order to maintain compliance. The drugs do not contain intellectual property, do not tell the company anything useful and could easily be managed outside of the business. Forward thinking Pharmacos are beginning to wake up to this fact.

To view the article in full, please click on the pdf link below:

Outsourcing A Question of Trust.pdf

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The laws of common sense

Tue, 24 Jan 2012 15:17:59 GMT

A common sense approach to getting things done is being embraced by more heads of pharma. Regulations are progressing towards good sense and basic objectives. The recent welcoming of a more structured approach to managing risk is probably the best recent example of the convergence of the needs of patients (as represented by the regulators) and businesses. Clinical and Safety leaders are using a well thought out risk management framework in order to spot potential risks and tackle them in order of priority. They are then doing suitable things to mitigate them. The regulators acknowledge this, understand that they are managing their business appropriately and leave them to get on with it. It is pure common sense.

Drug development is a place where common sense would suggest that welcoming independent opinion and approval of new products would be highly beneficial. This would mean more people or agencies adopting a role similar to that of the UK’s National Institute of Health and Clinical Excellence (NICE). NICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health. It will currently only approve a drug if it has obvious long term patient benefits and always considers the fuller implications of new products, such as economic viability relative to existing similar products and so on.

The long-term health of patients and community is obviously key – so regulators may well become aligned to this. This could mean that approval decisions are based on longer-term benefits, which would drive requirement for extended clinical trials – to get the data. This would, in turn, make trials more expensive, and slow time to market. This being the case, patent rules would require change, and investment models within the industry would shift. Can you imagine big pharma portfolio decisions being informed by regulators, looking to satisfy specific unmet needs?

Assuming that one day this approach is adopted, what could it mean for pharma companies? Well, they are already working hard for the medium term benefit of the patient and the short term good of the business, so how about changing their model so that they are working hard for the long-term health of both?

To read the article in full, please click on the pdf link below:

The laws of common sense.pdf

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Miracles by design

Tue, 24 Jan 2012 15:25:35 GMT

Imagine working in a place where you and your colleagues help perform miracles every day. Miracles like the blind being given sight for the first time. The deaf handed the opportunity to hear. These are not just hopeful predictions from the crystal ball of futuristic medicine. The very best creative minds are making the impossible possible right now in medical devices.

New technologies are being developed every day to enable the ‘miracle’ cures to become readily available. The sector has a growing customer base in an aging population that is living longer than ever and the pressure to look and feel younger and healthier is rising. The demand for new medical devices to deliver these requirements is white hot.

In developing its products the industry uses a unique blend of creative science, technology and engineering. At present it possesses world-class scientists but accessing the best technology and the right mix of scientific engineering is not easy, especially when speed is of the essence.

Innovative and commercially viable new products are spending too long in the lab due to poor R&D processes, sometimes getting stuck behind a secondary product that isn’t complete or fully tested, or that is waiting on new technology to enable it to move forward. The sector needs to act sooner rather than later to transform the way it works to get the profitable new products to market faster.

However, it is actually pretty hard for medical devices companies to pull together all the different scientific, engineering and technology disciplines needed to ensure that a new product is ready to fly. People working in these areas are experts in their own fields, which is both the solution and the problem! Getting hold of complementary expertise to solve a technical challenge is not easy if you know little or nothing about the latest innovations in an area that is not your own.

And what about the sales and marketing required to take the new product to market? The right expert may not be in-house, and even if they are, where do they fit in the process, and how much influence do they have on the new product design based on their market and customer research and knowledge?

To read the article in full, please click on the pdf link below:

Miracles by Design.pdf

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New year, no risk

Tue, 24 Jan 2012 15:31:20 GMT

Here’s a thing. It is your personal responsibility to spot potential risks in drug safety. If you don’t see them before they become a danger to the patient and a regulator can prove you had the information to mitigate them, you are liable to face the following: closure of your business unit, a prosecution case that could lead to a jail sentence and personal responsibility for the serious illness or death of a patient. Well, Happy New Year, and welcome to the worlds of our stressed Heads of Pharmacovigilance.

But panic not, for Nostrapharmus brings excellent news for the New Year. There is now a tried and tested Risk Management framework that enables you to spot, record and mitigate drug safety risks before they take place, in a structured way. It’s already producing great results in Pharma Manufacturing. And early adopters are trialling it in their UK Drug Safety units now, with a view to rolling it out across the globe.

The new approach merges proven methodologies such as Failure Mode Effect Analysis (FMEA) with best practice risk management in five easy steps. The first is identifying the risk – tracking information gleaned from sources such as questionnaires, audit reports, meetings and conference calls. Step 2 is Analysis – what system/process/component is affected by the risk. Impact – how big is the risk if it happened? Could it harm the patient, the business, or both? Each risk is assessed and scored as to its scale of impact. Calculate the likelihood of it happening by the scale of impact and you have your priorities, and a clear indication of where to focus your resources.

The next step is a plan of mitigation actions to stop the high priority risks turning into anything more serious. This is followed by ‘Control and Report’, which enables you to track and monitor your actions. Monitor the risks continuously as work takes place – is there a chance the risk could return? Take it through a risk cycle until you are sure it is completely mitigated.

How do you know where the risks might spring from? Well, without a crystal ball do the sensible thing: work with safety process experts who know the industry, who have worked on Risk Management with others, who can bring the lessons learnt and the expertise to your own team.

To read the article in full, please click on the pdf link below:

New Year, No Risk.pdf

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Eyes wide shut

Tue, 24 Jan 2012 15:37:51 GMT

Why, in an industry where taking a risk makes you persona non grata, is big pharma insistent on collectively taking a huge one? For by standing still and refusing to learn best practice from other industries, that's exactly what it is doing.

There are areas in Pharma, such as technical operations, which contain processes crying out to be simplified and improved upon, with the time and money saved becoming a cash injection for other parts of the business, such as research and development. Yet Pharma ploughs stubbornly on with bad habits at the back end of the business: sticking to old, cumbersome ways and refusing to grasp the opportunities made available through lean manufacturing.

What gives Pharma its attitude? Well, intense scrutiny and regulatory pressures mean that a culture of extreme caution has developed when it comes to new ways of working. And there is a touch of arrogance – this is Pharma, you know! If our product isn’t top quality it can kill people and destroy the business. If we want to change how we do it, we’ll invent something ourselves.

But Pharma is missing a trick. There is a set of tried and tested lean manufacturing techniques that can be applied to its business to make it safer, simpler and more cost effective.

The Automotive industry followed Toyota when it realised that it had the blueprint for manufacturing the safest, slickest cars on the market. And why not? The quality the organisation had built into its new cars was phenomenal, and the Toyota team had done all the hard work and research around building compliance and excellence into every part of the complex product – something they achieved without inspecting everything to the death!

To read the article in full, please click on the pdf link below:

Eyes Wide Shut.pdf

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Whose agenda is it anyway?

Tue, 24 Jan 2012 15:44:22 GMT

Echoing Sam Goldwyn, Nostrapharmus advises us to 'retaliate first!' Greater coherence across the industy, he predicts we will enable constructive agreement to serve the needs of pharma regulators, clinicians, and patients

What's stopping us?

As the regulatory grip tightens, Nostrapharmus predicted last month, you'll survive only by developing open and transparent collaboration between companies and regulators across the board of pharma activity. Or you could emulate Poor Robin: tuck your head under your wing and hope you're still there when winter's over... Better look at the practicalities!

Pharma needs to improve both its act and its performance. Everyone agrees on that. So what is stopping us? And what can we do to make it happen? We certainly need to be more pro‑active when working with regulators. It is a poor strategy to sit waiting for the worst to happen – and to feel bitterly satisfied when it does. But fighting individually to get your voice heard is no better. I don't think the regulators will be much interested in a Babel of different voices, concerns, issues and solutions! We need to offer them a clear industry position, or they will set the rules by default. Rules that will not be to our liking, nor necessarily contribute to public good.

To read the article in full, please click on the pdf link below:

Whose agenda is it anyway.pdf

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W.L.T.M long term partner for mutually fulfilling relationship

Tue, 24 Jan 2012 15:50:50 GMT

Relationships with other businesses are increasingly significant to pharma success. How can you form and nurture low risk, high reward relationships?

With collaboration of all kinds the signature of the successful pharma of the future, what will these intimate new relationships look like? Nostrapharmus predicts that the closer and more transparent they are, the better it will be for your business. But for the major pharmaco, the awkward question is "How can I learn to be lovable?"

Good relationships – a core competence of the future

Pharma has always bought services from a horde of other businesses. But were these significant relationships or one‑night stands?

There is an accelerating progression away from such commercially‑dominated, single‑point transactions towards greater intimacy and understanding of each other's businesses, greater continuity of contact, involvement and sharing.

Think of a ladder of relationship quality. On the lowest rung people say truculently "you get what you pay for". As we climb, we find businesses share ideas, practice and information. There is an ever‑sharper, ever more continuous focus on performance improvement. Mutual benefit grows. The relationship makes an increasing contribution to the future of both parties. At the top of the ladder are the relationships with real staying power, the ones that survive adversity and success alike. They are characterised by incremental benefits over time beyond the expectation the parties had at the outset: it pays to stay hitched!

But corporate relationships are not the same as personal ones. Are they? Well, they certainly share important features - and don't corporate relationships rather depend on human interaction anyway? I'd say it's about 60:40 between getting a sound business framework for collaboration and getting the people part right. But you have to do both!

To read the article in full, please click on the link below:

WLTM long term partner for mutually fulfilling relationship February 2006.pdf

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Risky business

Tue, 24 Jan 2012 15:59:11 GMT

Big changes, coming soon to a pharmaco near you! Nostrapharmus predicts big changes in the way R&D projects are selected, big changes in the role of the regulator. Very soon, a general adoption of risk management in regulation and in development investment will increase both flexibility and safety, and it will greatly enhance the industry's capacity to develop drugs for future need.

What's driving change?

The present, paper‑heavy system of regulation doesn't stop Serious Adverse Events (SAEs). And when things go wrong, tick the right boxes and your pharmaco's probably off the hook – legally, at least. But the public wants heads to roll. Who's next in line? No wonder the regulators are looking for a new approach!

The tick‑box system doesn't increase safety; so much as encourage risk‑averse investment. Nor does it deliver better or faster drug development – which ought to be a required output. It's a one‑size‑fits‑all, punitive approach that says I can't tell you what to decide, but get it wrong and I'll zap you. That's a regime that saps initiative and makes its victims sneaky, too, as any psychologist will tell you! Hence all those play‑it‑safe 'me‑toos', added‑values and market segmenting. Yet the opportunities are there. Cancer attracts investment aplenty: the pay‑back is clear and as short as it gets. But that leaves a universe of unmet needs that aren't addressed because the one‑size‑fits‑all regime makes them too risky to be prudent business. For most of them, you wouldn't reach payback before the patent ran out. Business decisions are contingent. Must we wait for the pandemic? No wonder pharmacos are desperate to find a way forward.

Shareholders are likely to agree. They don't want to see their shares crashing when somebody dies and the perpetrators get off. No wonder investors are finding pharma less attractive than they used to.

As a patient, I want remedies that are effective, free of side effects, cheap, and simple to use. In that order. The more serious my illness, the more important effectiveness becomes. My decision on treatment is contingent. So if business and therapy decisions are contingent, why not regulatory decisions, too? No wonder I'm looking for a bit more initiative and imagination from pharmacos and regulators alike.

The stakeholders seem to have a shared interest in a more flexible, contingent and sophisticated regulatory process.

To view the article in full, please click on the pdf link below:

Risky Business.pdf

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Are we outsourcing the future?

Tue, 24 Jan 2012 16:06:52 GMT

In the current climate, it is not surprising that the top pharmaceutical companies are busily diversifying themselves of everything they can do without or get done for them by someone else. Meanwhile, the competitors gaze hungrily at them like alpha golden carp in a pool. Is this retrenchment sketching an early picture of the future of pharma?

Certainly, the explosive growth of outsourcing is not just a fashion. There’s a lot to be said for increasing your agility by reducing fixed costs and getting your variable costs into phase with the market. But is there any limit? If the brand isn’t dead (and the reports of its demise seem to have been greatly exaggerated) why not leave it all to the scientists and concentrate on marketing?

Outsourcing transformed the automotive and aerospace industries. Boeing and Airbus leveraged technical excellence in every aspect of aircraft and systems, nurturing a mature supply base and becoming designers and final assemblers. Nissan similarly built a mature supply base and concentrated on design, assembly and marketing. They improved quality while reducing costs year on year; and their financial performance became far less sensitive to sales volume.

So, what should we outsource?

The truth is, you can let almost anything go, except the special skills and knowledge that make you the particular success you are. These are the heart of your business and they will drive your business’s future value. Keep a tight grip on them.

How should we outsource?

When you use someone else’s capacity to smooth the peaks in demand, saving investment, that’s tactical outsourcing. It’s convenient, low‑commitment and pretty safe – it doesn’t touch that ‘essential you’. But the companies that have succeeded through extensive outsourcing have used it to enable them to be what they want to be, to reinforce that very essence, securing and developing their future value to the horizon and beyond. Never cling to activities that you can get others to do better. This is strategic outsourcing - where you get to be great through others’ greatness!

To read the article in full, please click on the pdf link below:

Are we outsourcing the future.pdf

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