Borderline Products

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The borderline between different classes of products has always been a contentious area but arguably in the past it was relatively simple.  Twenty years ago the main areas of difficulty were between medical devices and pharmaceutical products, and between food supplements, herbal medicines and pharmaceuticals.  These borderlines remain but the advance of technology has brought into play a range of other critical interfaces.  We now have nutriceuticals, cosmoceuticals and recently another term of electroceuticals.  The latter is an interesting area where molecules are being developed that will modify electro transmission circuits and/or can be used with mechanical electro stimulation applied either externally or locally to induce physiological changes.  The world is indeed becoming complex. 

The definitions of a medical device and of a pharmaceutical appeared clear and robust.  However, as time has passed, we have come to understand much more about mechanisms of action.  This means that what was once simple is no longer so simple.  Some compounds which appear to act chemically may indeed act physically.  Similarly, some apparent physical effects are really brought about by release of chemical mediators etc.  Does this matter?  The answer is most definitely “Yes”, because there are very different controls for medicines devices with implications on the cost of developing the product, of establishing an authorisation dossier, reimbursement policies and on subsequent maintenance of the licence.  Indeed, some of these disputes have found their way to the Courts and to the European Court of Justice. 

The borderline between cosmetics and pharmaceuticals is also controversial with some products having claims very close to medicinal ones, whilst other products are seeking to take themselves out of the more rigorous medicines controls.  Similarly, the borderline between foods can have enormous economic consequences.  Under the proposed Medical Device Regulation there will be enhanced procedures for giving early advice on the borderline and for making public decisions.  As our understanding and science advances a range of new opportunities are being opened up which are increasingly challenging the neat compartments of the present legislation.  Increasingly these topics are being discussed in MF meetings and will be the subject of specific future conferences and workshops.  This is a topic which will not go away.

Seminars which may be of interest:

The Borderlines Between Medicines and Food – Please click here for more information.

The EU Cosmetics Regulation (EC) No 1223/2009 of the European Parliament and of the Council of November 2009 - Please click here for more information.

Drug/Device and Device/Drug Combinations – to be held on 28 Nov 2013. Further details to follow.

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Benefit – Risk

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The measurement, the evaluation and the communication of benefit risk lies at the very centre of pharmaceutical product development and of medicines regulation.  The same processes apply across the whole field of medical technology.  Benefit risk has become a very hot topic.  Recently we have seen a discussion paper from the FDA and also the lengthy deliberations within the CHMP are coming to a conclusion.  There has been the introduction of new benefit risk templates which the CHMP is using and it is expected that a new guideline and requirements for the clinical overview summary will be published towards the end of this year. 

Progressively, risk management plans are becoming benefit risk management plans (PBRERs).  Within a benefit risk plan it is necessary to set out a full analysis of demonstrated and anticipated risks with clearly defined mitigation programmes.  Until recently benefit risk was a discussion between the regulators and the industry.  This is changing.  Patients are now being brought into the discussion along with healthcare professionals.  This must be right because the final risk being undertaken is by the patient rather than the healthcare provider. 

The patient voice is being heard in the determination of benefit risk.  Patients also have a unique perspective to improve the communication of benefit and risk to the wider public.  Alongside this there are large patient data sets becoming available which allow better tracking and monitoring of benefit and risk in a real world setting.  The European PV Regulation requires that the assessment of risk is not confined to the intended purpose of the medicines but must consider inappropriate off label use, medication errors and misuse of the drug.  This is a rapidly changing picture and it is vital to keep up to date both with the new requirements of the Agencies.  Also of the methodologies which can lead to significant improvements in the development of products. 

Benefit risk discussions are an increasing part of the Management Forum workshops and symposia which are offered on the website.  Benefit risk is no longer a final few paragraphs in the clinical overview section of the dossier.  It is becoming the central evaluation throughout the development cycle of a new medicine.  The need to continue the evaluation of benefit risk throughout a product’s lifecycle poses significant challenges.  We are seeing increased requirements for post authorisation studies, both PASS and PAES.  There is also a need to monitor the effectiveness of any mitigation steps which have been undertaken.  Updates will be taken forward within specific Pharmacovigilance and Safety meetings which we organise.  However, the subject is so pervasive that you will find significant discussions on benefit risk across the whole of our workshops and conferences this year.  This is one topic which will not go away and it is essential for all who work in the pharmaceutical and medical device industry.  Benefit risk is not an optional extra but is a core competency and we can help you.

 

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Innovation

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Innovation is the life blood of the pharmaceutical and the devices industries.  It is also the latest buzz word.  It seems that innovation is everywhere.  We have the Innovative Medicines Initiative (IMI), we hear much talk of pricing for innovation and reward for innovation. (This is a key feature of the present negotiations over Value Based Pricing in the UK.)    There are proposals from the FDA for “innovative regulatory measures” and in Europe there is much work around the proposals for “progressive innovative regulatory approvals and regulatory excellence”.  The MHRA have recently opened an office of Innovation which brings together a number of functions including work on the Early Access Scheme.  The proposal is designed to offer advice and help to SMEs and to encourage innovation and start-up companies.  Across Europe there are Innovation Boards and Innovation Capital Funds being set up to help to drive growth in the Life Science sector.  The timing of all these measures is spot on, since a range of novel technology platforms are becoming available to spur the next generation of medicines and complex medical devices.

With so many references to innovation everything should be rosy in the Life Science garden.  However, this may not be the case.  Whilst everybody is excited by innovation, governments have a very different view of what is an innovative development.  Often they see innovation as a major step change whereas industry considers that innovation occurs incrementally and can often only be recognised many years after a product has come to the market.  The major reason for this difference is that governments are finding it increasingly hard to pay for innovation.  It has been remarked that a product is only innovative if it is affordable.  The lay media do not help by frequently over-hyping innovation and then seeming to revel in the failure of some new technologies to deliver on their early promise.  This leaves the general public confused and can damage trust in the industry. 

What is clear, is that this renewed focus on innovation is good for patients, for industry and for the economy.  So let us hear more talk about this subject.  Many initiatives around innovation will be featured prominently in Management Forum workshops and seminars over the next year.  If you want to be part of the debate and to understand more, look at the website.  You will see how many of the seminars, workshops and conferences are featuring this buzz word.  Innovation matters to us all and therefore we need to understand the changing landscape and maximise the new opportunities being presented.

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Social Media and the Pharmaceutical Industry

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The rapid expansion of social media and mobile IT offers very significant opportunities for the pharmaceutical and life science industries.  However, it also poses a significant number of new challenges and threats.  This is the situation which many face with innovative and disruptive technologies and is arguably no different from the challenges which social media is posing for many other industries.  The rapid development of social media systems presents the pharmaceutical industry with the potential to radically improve the provision of information and to improve compliance and the effective use of medicines.  It is increasingly accepted that the current legislation is inhibiting the effective transmission and communication of information to patients and healthcare professionals.   Most would now accept that the current position is unsustainable and that the legislation is not fit for purpose.  Nobody in Europe wants to see the introduction of US style direct to consumer (DTC) advertising.  However, there is a need for much more authoritative information to be made available to patients and their carers.  Recent developments make it possible for up to date information to be available and provided in a layered manner.   Account always has to be taken of the elderly, the socially disadvantaged and those who are not e-enabled.  However, increasingly, people from across the generations are adopting new communication tools and it is perfectly possible to use recent developments to assist those who are not e-enabled rather than to deny them information as has often been suggested.  Apps provide an excellent way of addressing issues around compliance and ensuring better information on using complex medical technology devices.

Mobile telephony is being used to great effect to enhance healthcare in developing countries.  It sometimes seems that developed nations are lagging behind in how we are using the full potential of social media and websites.

There is, however, another side to the all-pervasive introduction of modern communication.  The recent Pharmacovigilance legislation in Europe changed the definition of an adverse event and reaction.  Previously, safety was considered in terms of the normal conditions of use of the product.  Now, adverse reaction is defined as, “any noxious and unintended reaction generated by the use of the medicine”.  This means that misuse, abuse, off label use and medication errors are part of Pharmacovigilance and safety monitoring.  Companies are required to monitor for abuse and misuse and to identify off label usage.  This means that companies have to regularly scan any sponsored website and sponsored communication tool to identify and record adverse events.  Companies also have a responsibility to scan websites and to identify any emerging problems of misuse or off label usage.  Social media is very much a double edged sword.  It has recently been made clear that companies are not responsible and cannot be responsible for monitoring non-sponsored sites and yet we equally have obligations to ensure the safe use of our products.  Much greater clarity over the responsibilities of the industry towards social media will be required.  It is interesting to see that the regulatory agencies are taking up social media and MHRA has introduced its own Twitter account.

This important and controversial topic will feature in many workshops planned over the next six months and in particular will be addressed during forthcoming meetings on patient safety, Pharmacovigilance and in general review meetings.  It will be interesting to have feedback as to whether a specific workshop on this topic would be valuable.

http://www.management-forum.co.uk

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Medical Device Regulation – The May Workshop

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The introduction of a Scrutiny Committee for high risk medical devices, new rules and procedures for the designation of Notified Bodies, the reclassification of some devices, new rules for re-processing of single use devices, extending the scope of the medical device categories and new rules for combination products are just some of the important subjects covered in the new Medical Device Regulation which is under discussion.  Add in new proposals on transparency, post marketing surveillance and a whole new system for the control of medical device clinical trials and you see the scope of the proposed change.   Surely this is the entire package?  Well, no, there are also interesting proposals on the requirement for a qualified person in regulatory affairs, introduction of a variations procedure for significant changes in the product, and new requirements for registering all classes of medical devices in a new commission database.   All this and much more will be covered in the workshop to be held on the 21st and 22nd May.

This meeting will in addition look at some important areas in the IVD Regulation, in particular proposals on Companion Diagnostics.  The workshop will also assess the likely timescale for the introduction of this legislation.  An update will be given on the current complex negotiations taking place within the Council of Ministers Working Party and also in the Parliamentary discussions.  At the end of February there was in important Parliamentary public hearing with the Environment Committee.  This Regulation is being taken forward through the co-decision process so it is important to understand both the debate in the Parliament and in the Council Working Party.  For those working in industry it is essential to understand where the proposals have reached and to consider the changes which are likely to occur.  Planning is needed now to take on board the implications of these proposals in the development strategy for products.

The Workshop in May is one meeting which is essential and should be a high priority for anyone working or interested in the Medical Device sector.  There is a lot of misinformation circulating at present.  This meeting will give an authoritative position on where discussions have reached, where they are going and discuss the implications.  Much of the public debate has centred on the Scrutiny Committee.  This meeting will look across all the proposals and draw out the key threads.  There is much to learn and understand.

For more information visit the website: http://www.management-forum.co.uk/medical/eventid/2307

Intellectual Property, Patents and Exclusivity

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http://www.management-forum.co.uk/ip

The protection of Intellectual Property is a fundamental cornerstone for pharmaceutical and life science industries.  Without the adequate protection of intellectual property it would be impossible to justify the huge expenditure required to develop a new medicine or an advanced device technology.  The importance of patent and exclusivity protection has been enhanced by the pressures from the so called “Patent cliff”.   Only a few years ago, the erosion of value for an innovative product was relatively slow in many markets.  Today, compounds may lose almost 90% of their sales during the first year of loss of patent or exclusivity.  Indeed, there are examples of many compounds losing value much more rapidly than this.  In response to tough economic circumstances, governments across the world are promoting generic substitution and seeking to maximise the loss of exclusivity.  This makes it all the more important for those working throughout the life science sector to fully understand the current position on patents and on exclusivity.

This is not an easy matter.  There are complex rules concerning supplementary patent certificates and these differ between countries and regions.  In addition, additional patent protection may be granted as a result of a paediatric investigation programme (PIP) in the EU and a paediatric written request in the USA.  Significant new indications may generate additional patent protection or in some regions additional exclusivity.

In some markets, additional protection is given after the first generic is approved.  In others, there may be additional protection in terms of exclusivity for certain new formulations.  Orphan products attract different periods of exclusivity and protection.  In Europe the position is complicated as there is not an operational European Patent Office.  In recent years we have seen the introduction of compulsory licensing for certain “key” health care products in some developing countries.  A clear understand of exclusivity and patent protection is necessary throughout the development cycle.  It is crucial to understand the impact of intellectual property protection upon regulatory strategy and the development proposals.  Timing of the introduction of new indications and of new formulations  is vital.  Many still believe that there is only one patent protection a product, whereas in reality there may be many different patents surrounding and protecting a development.  Court judgments will have an impact as new case law evolves.

A series of webinars and meetings planned this year will keep specialists up to date and give essential information to those working in product development, regulatory strategy and in marketing.  This is an area where ignorance will be expensive.  Understanding the protection of intellectual property has become a core requirement for those working in the life science sector.  Long gone are the days when this topic could be left to patent attorneys and the legal department.

visit our website: http://www.management-forum.co.uk/ip

 

 

 

Business development – when being good isn’t good enough

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A friend of mine runs an advertising agency; one of the big London ones. It handles some huge accounts and has won a pile of awards. Recently, despite its brilliant creative work, it found itself struggling. Reluctant to layoff top talent the agency watched as hungry overheads and salaries started eating up diminishing fee income. I asked my friend what had gone wrong, he said “Being good at what we do isn’t good enough anymore”.

It turns out a few years back the agency had more work than it could handle. So much so that it let its new business development team go. They didn’t need them. Times changed though, clients’ budgets shrank, competitors priced aggressively and the phones stopped ringing. Rebuilding their business development capability is now at the top of the agenda!

It’s a familiar story and one true of many businesses today. Being good at what you do, isn’t always good enough, businesses need to be as good at winning business as they are at delivering it.

Who are the business developers in your company?

As business development is about growing business let’s start by asking who should be doing it.Many companies see it as being just their sales people. Others would widen the net to include staff in client facing roles. Business development in its broadest sense, however, is driven by everyone who can help grow the business through their interactions with prospects, customers and partners. That means everyone from the sales staff right through to the CEO.

What makes a great business developer?

Those at the top of their game excel at two things: their ability to create opportunities and their talent for developing the personal relationships needed to exploit them. These special skills apply whether you’re a salesperson looking to close a big deal or CEO trying to secure an important partnership agreement.

Opportunities in themselves are only of value of course when someone else (prospect, customer or partner) shares your vision and enthusiasm for the desired outcome. And the ability to achieve that is what separates the best from the rest. This requires the business developer to be expert in the art of influence and persuasion. Unfortunately for many this means presenting a list of reasons why someone should take a certain course of action, followed by an openness to negotiate should the other party decline the offer. An understanding of human psychology should tell us that this is the wrong approach. The difference between the often pleasurable act of “buying” (that can be an idea – not just a product or service) compared to the unpleasurable act of being “sold to” lies in the concept of control – namely, who has it.  Losing control (or at least seeming to) is something every professional business developer should be good at doing.

How can I tell how good we are?

One very good indicator is the gap between your top sales performer and the rest. If it’s 20% or more then you need to delve deeper. In some cases there might be plausible reasons, like: the person owning major accounts, having a bigger customer base or selling different products. In the majority of cases though it’s down to the attitude and skills of the individuals.

Attitude comes from within the individual and can be shaped by the organisation. Skills on the other hand need to be learned and practised. Companies that invest in improving the skills of their business developers will reap the rewards many times over.

Paul Holmes

Managing Director, Sellmax

http://www.sellmax.co.uk/index.html

Hear Paul deliver his advice and answer your questions at his Business Development Masterclass

http://www.management-forum.co.uk/managementskills/eventid/2293

Early Authorisation Approvals

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 The need for change in the way drugs are approved and authorised has come centre stage.  This will be a hot topic throughout 2013.  Last year saw a significant increase in the number of drugs approved by the FDA but there was little change in the approval rate for the EMA.  Encouraging signs are also being seen fromJapan.  Many commentators are saying that the present system cannot continue.  The drug development process has become far too expensive and arguably is failing to satisfy clinicians, patients and indeed the payers.  Something, it is suggested, has to change.  The question is what?  Some authorities are looking at early access schemes and the MHRA in theUKhas consulted on such a proposal, with the results of this consultation expected shortly.  A number of scientific groups and industry consortia have put forward proposals for progressive authorisations, adaptive licensing and early or conditional release.  Interestingly in the recent framework issued for consultations about the creation of a joint Australian and New Zealand Regulatory Agency, there are proposals for a provisional approval system.  Under this, products would be approved for a limited time for restricted use.   New methodologies such as the Clinical Research Practice Datalink (CPRD) recently launched in theUKmake it more feasible to collect real world data.  There have already been changes in the way trials are designed and delivered.  The increasing use of biomarkers should help to identify particularly groups of patients in whom it will be easier to determine the effectiveness of the drug.  Quite how all this will link to demands from the payers remains to be seen.  Sir Michael Rawlins, the retiring Chairman of NICE in his TOPRA annual lecture suggested that the current regulatory system was no longer fit for purpose and called for a wider debate with stakeholders.  Key features will be the capture and the generation of more real life data and a series of changes in study design aimed at maximising the potential to demonstrate efficacy and effectiveness whilst at the same time shortening the development process.  A number of workshops are planned this year to look at these inter-related topics.  This is one area which those interested in regulatory affairs, clinical development and post marketing surveillance and HTA and reimbursement cannot afford to ignore.  It is clear that, to quote a phrase “the tectonic plates” are beginning to move.  What this movement will generate remains to be seen but this promises to be an interesting year and perhaps a decisive one.

Management Forum and iSportconnect Agree Partnership For Second Year

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Following on from last year’s success, Management Forum are delighted to announce an event partnership with iSportconnect for the Annual Conference on International Sports Law 2013.
iSportconnect, the world’s leading sports business platform, will become official social media partners for the event taking place at the home of Chelsea Football Club in London on the 28th February 2013.

Following a presentation on the important developments from the preceding 12 months, a panel of experts from the sports industry will consider the key legal and business issues in four separate panel sessions on Integrity in Sport, Digital/Social Media in Sport, Doping in Sport, and Making Sport Pay.

Management Forum’s Marketing Manager Nick Pycraft said “The International Sports Law Conference attracts a global audience keen to hear the opinions and insights of our panel of sports industry experts. We are therefore pleased to be working with iSportconnect again, as delegates are able to discuss the issues pre- and post-conference in our Annual Sports Law Conference group on the iSportconnect website, adding to the conference experience.

iSportconnect’s Marketing and Partnership Manager Xavier Cureau added “The International Sports Law Conference draws in some big names and has proven to be a top class event, so it is great to be working with Management Forum again and hopefully we can continue to develop the relationship between iSportconnect and Management Forum.”

About iSportconnect
iSportconnect is an exclusive online platform that brings together thousands of sports business professionals worldwide.
The site provides news, market data and analysis, columns and features, forums, listings of events and jobs and great opportunities for online networking.
There are no introductory fees and no limits on communication.
The site is complemented by events where attendees can network face-to-face and discuss relevant topics with a panel of experts.

About Management Forum
Now in its 30th year, Management Forum has built its reputation on providing the highest quality conference, seminar and knowledge-based experiences around the world. The latest updates on key issues and new areas of importance are covered by speakers from regulatory authorities, industry and academia. The same expert speakers are also used to deliver the same high standard of experience for in-house training. Management Forum also provide event management services to relieve organisations of the stress of organising and administrating their own events. For more information, visit www.management-forum.co.uk , e-mail info@management-forum.co.uk or tel. +44 (0)1483 730071.

Combination Products

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The development of combination products has become an increasingly important and exciting area for both the pharmaceutical and the medical device industries.   Alongside this companies are exploring the production of linked companion diagnostics and pharmaceutical products.  It has been suggested that a substantial part of industry’s development budget is being directed towards combination products perhaps in excess of 20% of the spend. 

 

The key division is between drug/device products which are regulated as pharmaceuticals and device/drug combinations which are handled through the medical device legislation with the prime mode of action is that of the device with the pharmaceutical having an ancillary effect.  Both the development and the regulation of such products is becoming increasingly complex.  Much of this complexity derives from the recent legislation in the area of Pharmacovigilance and the proposed legislation for Clinical Trials and the Medical Device and IVDs.

 

It is important to understand how such products will be regulated within Europe and how this will fit with a global strategy.  The principles for designating products have been harmonised through the GHTF requirements and are similar between the major regions but in practice there can be important differences and these have to be understood.  It is a field which should only be entered with a clear understanding of the different control regimes and with a very clear development and regulatory strategy.  

 

The Pharmacovigilance legislation which was brought into effect last year needs to be fully understood by those who are coming from a device background.  A number of major new requirements are being introduced which will apply to drug/device combinations such as the need for a Qualified Person in Pharmacovigilance (QPPV), for a Pharmacovigilance Master File, the development of new style PSURs, Risk Management Plans and over time PBERs and Benefit Risk Management plans.  The investigation of adverse events is different between the two fields. 

 

For those from a pharmaceutical background, it is necessary to be aware of the current device legislation and, also given the lengthy development period of the changes which will come into effect, through the new medical device regulation currently under discussion within the European Parliament.  The European Medicines Agency (EMA) will play an increasingly important role for combination products which are in the drug/device category.

 

Management Forum has organised a workshop with prominent speakers including those from Regulatory Agencies and Notified Bodies to bring you up to date in this key area.  The meeting is to be held in London on 20th and 21st February.  Given the recent changes, this is a must attend meeting for those who are working in this area.  The workshop is equally important for those who are considering developing a combination product as part of the life cycle management and improving patient compliance and gaining a better risk profile. 

 

More details can be found on the website at http://www.management-forum.co.uk/medical/eventid/2161