‘How devices can grow pharma profits’ presented at Management Forum Congress

Tom Oakley, Director of Drug Delivery Device Development at Springboard, recently presented at the Management Forum Congress in London on ‘How devices can grow pharma profits‘.

The key challenges facing pharma were discussed, along with real-world examples of how devices can grow pharma profits by:

  • Increasing drug value
  • Giving extended patent protection to drugs
  • Increasing the barrier to entry for generics and biosimilars
  • Using existing drugs for new indications
  • Increasing usability or addressing different user groups
  • Changing the pharma company from a drug manufacturer to an integrated healthcare provider

Please contact Tom Oakley on +44 (0) 1223 422 273 if you represent a pharmaceutical or medical device company. We would be happy to run through the presentation with you.

Judge Business School completes project on bolus injectors

The prestigious Judge Business School presented today their findings from a month-long research project on the market and leading technologies for ‘large volume’ or ‘bolus’ injections.

Springboard sponsored the research and provided industry expertise and contacts.

Tom Oakley, Director of Drug Delivery Device Development at Springboard said, ‘The Judge Business School team has approached the project with great professionalism and energy. They have been able to find very useful information on the new drugs which require large injections, and the market for bolus injectors.’

Many directors of device development and procurement at major pharmaceutical companies were interviewed by the team, and their requirements and predictions for the future have been analysed.

The report concludes with predictions of the potential market size, and an analysis of the strengths, weaknesses, opportunities and threats for bolus injectors.

Please contact Tom Oakley on +44 (0) 1223 422 273 if you represent a pharmaceutical or medical device company which requires bolus injector technology development. We would be happy to present the findings to you.

Springboard at the Drug Delivery to the Lungs conference

Tom Oakley, Director of Drug Delivery Device Development at Springboard, will be attending the Drug Delivery to the Lungs conference in Edinburgh from 11 to 13 December 2013.

As a leading contract developer of drug delivery devices, Springboard can provide turn-key device development, or fit in to an existing project to provide expertise such as:

  • Technology scouting and due diligence
  • Usability engineering
  • Intellectual property navigation, freedom to operate and strategic development for IP
  • Verification and validation plans and protocols
  • Planning and management of the scale up to clinical trials and into production

Please contact Tom on +44 (0) 1223 422 273 if you would like to meet.

Springboard attending Wounds UK in Harrogate

Springboard will be attending the UK’s leading Wound Tech conference in Harrogate from 11 to 13 November 2013.

Wound care is a major sector of the healthcare industry, but with increasing global pressures, many companies are finding that they can no longer compete effectively in a commoditised market.

Well-established companies are increasingly turning to innovation to add value and compete on quality of treatment. Traditional dressings are starting to give way to advanced wound therapy such as negative pressure wound therapy and pressure relief, while prevention and monitoring of infection is increasingly critical. It is in these new advanced spaces where the world’s leading companies will be battling it out for supremacy in the coming years.

Recent examples of commercial activity that is changing the market are Smith and Nephew’s launch of the PICO negative pressure system, and KCI’s acquisition of Systagenix.

The rapidly changing landscape leads to many organisations finding they have to adapt to new technical skills, perhaps by branching out from adhesives knowledge and into electronics or fluid management. Not only does this bring new engineering challenges, but the task must be carried out in a world of increasing regulatory requirements (such as new requirements on usability engineering) and ever-shorter product lifecycles.

Keith Turner is head of medical devices at Springboard, an advanced technology engineering consultancy, which specialises in pushing the boundaries of devices that are sold in regulated markets. If you would like to arrange a meeting at the conference, please call +44 1223 422275.

 

Hot topics in drug delivery to the lungs

Springboard is attending the Drug Delivery to the Lungs conference in Edinburgh on 11 to 13 December 2013.

Drug Delivery to the Lungs is a leading conference and trade show for anyone interested in drug delivery to the airways.

The hot topics coming up in this year’s conference are:

  • Inhaled nanomedicines
  • Inhaled therapeutics for lung cancer
  • Antibiotics delivered by inhalers

Springboard’s team of engineers and physicists has a convincing track record of developing inhalation devices and solving unexpected problems with them.

If you would like to meet us at the conference or any other time, please contact Tom Oakley, Director of Drug Delivery Device Development at Springboard.

Springboard awarded project with Judge Business School

Cambridge University’s prestigious Judge Business School has elected Springboard as their partner for a new research project into an exciting growth area of drug delivery devices.

The project will discover the growth opportunities for large volume injectors and will inform companies how to drive their technology strategy to maximise long-term commercial success.

The precise details will be revealed when the final report is made available in December.

The report will be made available to Springboard’s customers free of charge, and to others for a reasonable fee.

Please contact Tom Oakley if you would like to be notified when the project has been competed.

The Ablation Showdown: Cryo versus RF

Surgical ablation is a technique where energy is used to selectively kill cells and thus bring a therapeutic benefit. It is attractive because it can usually be delivered through long, thin delivery systems such as catheters and probes and thus is less invasive than open surgery. Ablation is used for many indications: tumours can be killed in breast, prostate and liver; lesions can be deliberately created in the heart to treat atrial fibrillation; and nerves can be numbed to prevent pain.

Different types of energy

The energy used can take many forms. The leading method is radio frequency (RF), in which an alternating electric current is directed through the target area. Resistance to the current leads to local heating to above 60°C, which kills the cells. Another prominent technique is cryosurgery, in which intense cold is applied from a cryogenic liquid or gas. This can kill cells through more than one physiological effect. One is cell rupture due to internal ice formation, while another is dehydration due to freezing of the fluid between cells. For cryoablation, the thawing cycle may be every bit as important as the freezing process in terms of ensuring destruction of the cells. Further energy sources include laser and microwave.

Commercial activity in cryosurgery

Cryosurgery has hit the commercial news in recent years, with Medtronic spending $750m on two technologies from Cryocath and ATS Medical in 2008 and 2010. Other activity around the same time saw Endocare bought by Healthtronics and Atricure pick up the Frigitronics product line from Cooper Surgical. These companies and others are now developing their cryosurgery products and markets while their investors wait to find out whether or not they will see a big return.

Who will dominate?

So will cryo or RF dominate the market? Cryo companies often claim “better control”, “longer lasting  effects” or “lower rework rates” compared to RF, but does that claim really stand up to scrutiny? Why should it be easier to control cold than hot, when in neither case can you see what you are doing? On the RF side, supporters point out their ability to use smaller probes without the need for expensive consumables. But does RF produce a permanent lesion?

Ultimately the success of the two technologies will be driven by the physician’s choice, and above all that comes down to patient outcomes.

If you operate in the ablation space, either as a technology supplier or as a clinical user of equipment, we’d love to hear your opinion. You can use the comment form below, contact us, or contribute to the LinkedIn debate.

Springboard invited to present at ‘Synergies Across Life Science’ congress

The ‘Promoting Synergies Across Life Sciences‘ congress promises to be a great meeting of professionals from pharma, medical devices, clinical medicine, government, academia and patient support groups.

We are thrilled that Tom Oakley, Director of Drug Delivery Device Development at Springboard, has been asked by the congress organisers to give a presentation about the pharmaceutical industry’s need for devices.

The presentation will build on Tom’s recent article on ‘How devices can grow pharma profits‘, which generated great interest amongst pharmaceutical executives.

We hope to see you at the conference on 28 – 29 November 2013.

If you would like a face-to-face meeting at the event, please contact Springboard on +44 (0) 1223 422 273.

The presentation will be made available to Springboard’s current and potential clients after the congress so please get in touch if you are interested.

How devices can grow pharma profits

Devices can grow pharma profits in the following ways:

Increase drug value

New drug delivery devices can increase the value of a given drug. For example, sumatriptan is available in:

  • Tablet format (e.g. Imigran/Imitrex),
  • A pre-filled syringe (e.g. Imitrex STATdose),
  • A needle-based autoinjector (e.g. Sun Pharma’s generic sumatriptan in the SHL DAI), and
  • A needle-free autoinjector (e.g. Zogenix DosePro).

We can expect that the injectable versions may justify a higher price due to, for example, faster action. The needle-free version may justify a higher price still for patients that are needle-phobic.

Give extended patent protection

Even if the patent on the drug has expired, there could be features in the drug delivery device, or production methods, which could be patented, thus protecting the product value for a longer time.

Increase the barrier-to-entry for generics

Some drug delivery devices are very difficult to copy. For example, GSK’s patent on the blockbuster drug for asthma and COPD, Advair/Seretide, expires in Europe in 2013, but it has proven very difficult to achieve the same pharmacokinetics using a different device.

The nearest competitor is perhaps the ElpenHaler, but the user must place each dose into the device, rather than having 60 doses preloaded as in the Advair Diskus device.

Use existing drugs for new indications

Drug delivery devices could deliver existing drugs in new ways, thus allowing new applications. An example is the corticosteroid dexamethasone which was previously  available as an oral tablet, but is now available as an intravitreal (eye) implant as Ozurdex by Allergan.

Increase usability or address different user groups

Different user profiles may need different drug delivery devices. An example where a drug’s value has been maximised, and generic competition tackled, by offering a range of drug delivery devices is Merck Serono’s blockbuster drug for multiple sclerosis, Rebif. In this case, the drug is available in:

It may well be the case that offering a range of devices to meet different user profiles may increase adherence and therefore improve patient outcomes and increase drug sales volume and value.

Become an integrated healthcare provider by developing other medical devices

Some pharmaceutical companies are changing from ‘drug manufacturers’ to ‘integrated healthcare partners’, a transition that may be necessary as some payers are proposing to drop the ‘pay per dose’ model and use a ‘payment by results’ model.

For example Sanofi manufactures the leading long-acting insulin for diabetes mellitus (Lantus). In 2012 it launched the blood glucose monitors BGStar and iBGStar, which is a major step in its path to becoming a provider of all the healthcare needs for people living with diabetes.

Summary

Devices have the ability to increase and extend the value of drug products, to give competitive advantage and increased usability, and to help strategic positioning as an integrated healthcare partner.

If you have found this interesting, or would like to share your views, please use the comment form below, or contact us.

Growth opportunities for pharma

The big pharmaceutical companies must overcome significant challenges if they are to grow.  In this article, Tom Oakley, Head of Drug Delivery Device Development at Springboard, identifies the main challenges and opportunities for growth.

Challenges facing pharma

Everybody associated with the pharma industry knows about the patent cliff of patent expiries for the blockbuster drugs. Another USD 50 billion worth of drugs will lose patent protection in throughout 2014, although some of these are not trivial to copy due to their complex biologic nature or delivery devices.

The top-selling drugs which are likely to lose patent protection in 2014 include Roche’s Rituxan (indicated for some cancers and rheumatoid arthritis), Sanofi’s Lantus (for diabetes mellitus), Lilly’s Cymbalta (for depression), and Novo Nordisk’s NovoRapid and NovoLog (for diabetes mellitus).

The patent cliff continues in 2015 with about USD 34 billion worth of sales losing patent protection.

In addition to the patent cliff, healthcare budgets across the world are being squeezed. In Europe, where much drug spending comes from national healthcare budgets, sovereign debt is reducing drug budgets. European countries are delaying payments to drug companies by up to 3 years, which is effectively using the pharma companies as sources of credit but without paying any interest.  Merck has had enough and is no longer supplying the cancer drug Erbitux to Greek hospitals, with Roche and Novartis amongst the big pharma companies considering whether to restrict supplies.

If that was not enough, the requirements of regulatory authorities tend to become more onerous rather than less, and the number of new drugs coming to market has reduced.

Opportunities for growth

Despite the challenges listed above, there is upward pressure on the value of the pharma industry as described below.

Demographic changes

People in the developed world are living longer and therefore require more medical intervention.  For example, people over the age of 65 typically need 4 times more medical services and products than younger people.

Living with chronic diseases

People are living with one or more medical conditions for longer.  The success of drugs for chronic conditions such as diabetes and AIDS means that patients often live with these conditions, and their co-morbidities, for many years. Chronic conditions such as diabetes, asthma, cancer and heart disease are on the rise in both developed and developing countries.

Emerging economies

People in emerging economies are demanding improved healthcare, and leading less healthy lifestyles (increased sugar and fat in their diets, and less exercise), both of which are driving increased healthcare spending.

Generic drugs

When drugs lose their patent protection there is a corresponding sales opportunity for generic drugs.

Biologics

Biologics are difficult to produce and therefore difficult to copy. In addition, the US Food and Drug Administration has not yet decided how to approve generic copies of biologics (called biosimilars).

High value indications

Some indications are not well-served, and/or may need repeated drug doses for long periods of time. An example of a high value drug is Gilead’s Sovaldi for chronic hepatitis C, which sold an astonishing USD 2.27 billion in its first quarter.

Oncology, immunology and diabetes remain popular targets for high value drug developments due to their prevalence in the population and long-term nature of most treatments.

Payment by results

Some healthcare payers have been asking to move from a “pay per dose” to a “pay by results” model. For example, rather than paying per dose of salbutamol (or similar), the payer may pay according to a reduced rate of emergency hospital admissions with an asthma attack.

According to this payment model, the pharmaceutical company is likely to become more of a whole patient care provider. For example, a payer may pay the company to handle an asthmatic’s whole treatment regime, from diagnosis to training to monitoring and support. If this happens, the company will be incentivised directly to tackle issues such as adherence to the drug regime.

Diversification

Pharma companies may diversify even if payment by results does not become widespread. For example, Sanofi has launched the BGStar and iBGStar blood glucose meters to complement its range of drugs for diabetes.

Other pharma companies may diversify into diagnostics, delivery devices and interventional devices in order to increase their market share.

Summary

This article gives a snapshot of the challenges facing the pharmaceutical industry, and ways in which the pharma companies can tackle those challenges in order to achieve growth.

If you are from a pharmaceutical or medical device company and are interested in finding out more, please contact Tom Oakley.