New Heads for Genzyme’s MS and Rare Diseases businesses

by emma 11. November 2011 15:54

Pharma Industry News

Biopharmaceutical company Genzyme, part of Sanofi, has appointed William ‘Bill’ Sibold as Head of Multiple Sclerosis and Rogério Vivaldi as Head of Rare Diseases.

These two businesses make up Genzyme’s core focus following its integration with Sanofi.

David Meeker, Genzyme’s President and CEO, commented: “These appointments are a critical step in launching the new Genzyme. Bill and Rogério are dynamic leaders with the experience, energy, vision and commitment to patients needed to move us forward.”

Bill Sibold has worked in the biopharmaceutical industry for two decades, primarily in commercial roles – including responsibility for the MS drugs Avonex and Tysabri. In eight years at Biogen Idec he rose to become Senior Vice President of US Commercial. He joins Genzyme from Avanir Pharmaceuticals, where he was the Chief Commercial Officer.

“Our goal is to build a world-leading multiple sclerosis franchise,” said Meeker. “Bill’s substantial commercial experience and his deep knowledge of the MS field will be critical to the launch of Lemtrada and Aubagio, two investigational therapies with the potential to transform the lives of people living with MS.”

Rogério Vivaldi joined Genzyme in 1997; his roles have included President of the company’s Renal and Endocrinology Business and President of Genzyme Latin America. As a doctor, he became a recognised expert on the rare Gaucher disease and its treatment.

“Rogério’s experience as a physician treating Gaucher patients in Brazil and his subsequent work in building our rare disease business in Latin America will provide both continuity and an energising new beginning for our global rare disease business,” noted Meeker.

Based in Massachusetts, US, Genzyme specialises in biopharmaceutical therapies for rare and debilitating diseases. As part of Sanofi, it benefits from the commercial reach of a leading global pharmaceutical company.

Diary of a self-confessed NHS budget-holder

by emma 11. November 2011 14:47

Diary of a self-confessed NHS budget-holder

In Part III of his diary, Omar Ali discusses the significance of process mapping and the wide reaching influence of health technology assessments and regulatory bodies.

1.10pm: GP CONSORTIA/CCG – RESPIRATORY ASTHMA PROCESS MAPPING & FORMULARY

I’m trying to step into the main meeting room but one of the CCG/GPs pulls me aside. It’s a mixture of a low-key signal and a discreet ‘thumbing’ to pull away from the group. He wants a quiet word and it’s clear that there are some key issues, agendas and directions that are on the table for this asthma meeting.

The process mapping event takes some four hours – evaluating everything and anything that ‘leads to an asthma admission’, followed by everything and anything that occurs after the admission and leads to discharge – which is then followed by QIPP ‘bottlenecks’, where re-admissions and inefficiencies occur.

It’s always a challenge having so many viewpoints – nurses, physicians, pharmacists, budget holders, and of course patients and carers who often change the whole paradigm when we hear about their experience, expectations and concerns around ‘choice’.

Thoughts for pharma

Respiratory is big. Whether on prescribing budgets, healthcare priorities, implementation of national guidance or QIPP streamlines. Companies haven’t yet got their act together on process mapping of care pathways, but it’s the only way to invest in prescribing up-front drugs for potential ‘return to the QIPP baseline’ over the next three to five years. Needless to say, whilst the NHS talks QIPP, pharma is getting used to it and patients are still puzzled by it.

Asthma

With so much behind National Guidance/BTS, QoF and commissioning cycles, some companies are indeed getting into the mix with Clinical Commissioning Groups and supporting process mapping. That support is vital, as not only does it bring pharma in as key stakeholders, but more importantly there is a level playing field here in the same room bringing the cause back on track.

So often in the NHS we have silo budgets chasing after silo savings. Process mapping brings us out of our silos into the bigger picture and into the ‘process map’. Seeing it happen is a wonderful thing.

COPD

Given we make such a fuss around the cost of drugs, in truth we know two things: the most expensive drug is the one that is not being taken, and the tariff for an admission for COPD at £3,400 is more expensive than the annual price of the most expensive inhaler!

So where’s the issue? It goes like this. Pharmaceutical companies come to us quoting the costs of admissions in COPD then tell us how amazing it would be to reduce these hospitalisations.

They then tell us how amazing their COPD product is and tell us that we would be crazy to not buy their inhaler, which is a fraction of the cost of COPD burden/admissions. The GPs, nurses and patients love it and want it and state they ‘need it’. Medicines Management then look like the bad guys for not funding the said branded inhaler.

4.15pm: DRIVING BACK TO NHS BASE CAMP – CHECKING VOICEMAILS

One of the big five companies has asked me to come and present to their European heads-of-country on ‘payer issues’ in the UK and the influence of HTAs.

It’s a bit short notice and I gather the VP for Europe, Middle-East and Asia will be there. Times are tough and I see this as an example of how the EU can join forces on some of the key payer issues beginning to filter through.

I have one question back to these pharma companies. What is your data on reducing these expensive hospitalisations in COPD? Because in truth, with the data, I buy the story.

In most cases pharma will then spin another story around how compliance is great, or a patient support programme is excellent. But given all the spin that has come on how much COPD costs me in hospitalisations, it’s a shame many of the companies don’t have the evidence to help me.

They have marketing but not the evidence. Show me the money. And the formulary will be yours.

Thoughts for pharma

There is no doubt that the UK is ‘different’, but I don’t imagine global HQ for any of the pharmaceutical companies readily accepting that – especially when the targets are high and sales may not be so. It sometimes takes global agencies to hear about payer issues ‘from the horse’s mouth’.

This was the quote stated to me regarding this piece of work/event. From my work abroad – at NICE I informally interact with a number of contacts in other countries who belong to their residing equivalents – I can’t stress enough the importance of NICE, the SMC and similar bodies.

The last SMC decision on pain management was quoted verbatim within two weeks by three different countries within the EU. I’m also aware from my US/value-based pricing work that when NICE rules on a drug the impact on the US healthcare system is far reaching.

Insurance companies download the information – they can’t believe NICE do all this work transparently and then leave it freely available for anyone to download – and the US agencies then use this information on deciding what percentage they will ask patients to pay.

So, if NICE say no and SMC say no, somewhere a butterfly flaps its wings and then a patient in the US, who has paid extra funds into a private insurance policy, will be told that this particular brand is not covered and that the patient will have to make an additional payment if they want the drug.

To be continued...

omarali Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust and sits on the External Reference Group for Cost Impact Modelling for NICE. He may be reached on omar.ali@sash.nhs.uk.

Takeda restructures business operations

by Emma 8. November 2011 15:53

 

Takeda Pharmaceutical Company has created several new positions as part of its “Transformation into a New Takeda”, restructuring the company’s business operations.

The new roles include Chief Medical and Scientific Officer (CMSO) and Chief Commercial Officer (CCO).

The CMSO is set to replace the existing post of Chief Scientific Officer, to be filled by board member Dr Tadataka Yamada, a medical doctor and scientist with strong experience in pharmaceutical R&D.

The CCO will be responsible for the company’s global sales structure, replacing existing positions in International Operations in the US, Europe and North Asia.

Takeda’s Chief Executive Dr Frank Morich will claim this position, who will lead sales strategies in the US, EU and key emerging markets.

The restructuring of the company is said to relect Takeda’s recent acquisition of Nycomed, which the firm described as “another significant step towards globalisation”.

Takeda fully acquired Nycomed in October in a cash deal worth €9.6 million.

Lundbeck appoints two VPs of R&D

by emma 28. October 2011 12:15

Jens Peter Balling

Lundbeck has appointed Jens Peter Balling and Iman Barilero as vice presidents in its R&D organisation.

The new appointments follow Lundbeck’s recent consolidation of its R&D activities into one organisation, creating a new unit.

Peter Balling (pictured, right) has been appointed as Vice President of the new unit, which will focus on regulatory product support, patient safety and quality assurance of clinical research.

Barilero (pictured, below) will be responsible for increasing Lundbeck's strategic efforts to build and maintain constructive cooperation and dialogue with national and international regulatory authorities.

Iman Barilero Anders Gersel Pedersen, Executive Vice President of R&D at Lundbeck, said: “The regulatory and safety areas are an increasingly important prerequisite for this. The creation of one new unit and the increased focus on the other gives us a strong position in these areas.”

Peter Balling joined Lundbeck in 2006 as divisional director of global pharmacovigilance, previously working at Novo Nordisk and Nycomed.

Barilero began work for Lundbeck in 2007, when she served divisional director of regulatory development, strategy and policy, with previous experience at Hoffmann-La Roche and Johnson & Johnson.

Search for careers at Lundbeck.

New CEO at Genzyme

by emma 25. October 2011 13:39

David Meeker

Sanofi has appointed David Meeker as CEO of Genzyme to incorporate its Rare Disease and Multiple Sclerosis franchises.

He will join the company’s Group Management Committee, reporting to Sanofi’s CEO, Christopher Viehbacher.

He said that David’s “medical and business experience will be essential to move Genzyme’s broad portfolio of products forward and deliver much-needed therapies to patients”.

Mr Meeker joined Genzyme in 1994 as medical director to work on the company’s Cystic Fibrosis Gene Therapy programme. He has since held various positions at the company, including President of Global Rare Disease Business, and was promoted to Chief Operating Officer in 2009.

Sanofi is a global healthcare provider, which develops and distributes therapeutic solutions in diabetes care, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health.

EKR appoints new independent director

by emma 24. October 2011 14:19

Pf Industry News

EKR Therapeutics has appointed Robert Roche Jr as an independent director to its Board.

John Bailye, President and CEO of EKR Therapeutics, said that Mr Roche “brings a wealth of operating and management experience to our company at a time when we are working hard to expand our business”.

Mr. Roche currently works as Independent Director of NuPathe in Conshohocken, Pennsylvania. His previous positions include executive vice president of Worldwide Pharmaceutical Operations at Cephalon as well as various sales and marketing roles at SmithKline Beecham.

EKR Therapeutics is a pharmaceutical company that provides acute care products to the hospital marketplace.

Senior management changes at Lilly

by emma 12. October 2011 14:47

Pf industry news

Eli Lilly has appointed key appointments to its senior management team after the retirements of Bryce D. Carmine, Senior Vice President and President of Lilly Bio-Medicines, and Frank Deane, President of Manufacturing Operations (both pictured below).

The two will step down at the end of the year with Dave Ricks, President of Lilly USA, replacing Mr Carmine and Maria Crowe, Senior Vice President for Global Drug Product Manufacturing, succeeding Mr Deane.

John C. Lechleiter, Chairman, President, and CEO, Lilly, says the outgoing pair have been “pillars of the company who have had a lasting, worldwide impact”.

Mr Deane, who has let the Bio-Medicines division since 2009, and Mr Carmine, the leader of global manufacturing since 2007, have a combined 69 years of experience at the company.

“We’re grateful for their dedicated service,” said Mr Lechleiter. “We'll certainly miss Bryce and Frank and the extraordinary leadership they provided.

“At the same time, we're very fortunate to have talented leaders who are well-prepared and ready to step into these critical roles.”

As a result of Mr Ricks’ promotion, Alex Azaz is being promoted to President of Lilly USA.

Bryce Carmine Bryce Carmine

Frank Deane Frank Deane

Roche appoints new head of department

by emma 11. October 2011 12:11

Pf industry news

Roche has appointed Dr Harsukh Parmar as Head of Translational and Experimental Medicine (TM) of its Inflammation Discovery and Translational Area (DTA).

Dr Parmar will be responsible for the strategy and implementation of early clinical progress in Inflammation as well as collaborating with Discovery and Clinical Development to ensure high quality of compounds used throughout drug production.

Dr Jacques Banchereau, Head of the Inflammation and Virology Discovery and Translational Areas, said that Harsukh is recognised as “an expert in respiratory, inflammation, immunology and oncology, and possesses the right combination of experience for this pivotal position”.

Dr Parmar joins Roche from AstraZeneca in the UK, where he worked as Early Development Director, Vice President and Global Head of Early Clinical Development in the Respiratory and Inflammation Therapeutic Area. He also previously served at Roche as Global Clinical Science Leader and Director in Oncology, Immunology, Virology and Transplantation.

“Having previously worked for Roche and recognising the rich heritage of innovation that has come from the pharma business in small molecules and biologics, I was excited to rejoin a company that has been a leader in many of its respective fields,” said Dr Parmar.

A winning formula

by emma 7. October 2011 15:00

A winning formula

In the pharmaceutical industry one of the biggest challenges is to manage large events which require certain levels of privacy, whilst also ensuring they are hosted in professional and accessible venues. Simon Hunter shares his knowledge on how to make the most of your venue and event.

A high profile venue is a prominent, well known, iconic space which has a range of facilities to offer, and a reputation for hosting annual industry exhibitions or summits for international brands.

Discretion and privacy are key attributes of hosting events at high profile venues. If there are well-known guests present or sensitive intellectual property being shared – a new scientific discovery or drug, for example, then this kind of venue is ideal.

 

Experience pays

Other advantages of high profile venues include a proven track record in hosting different sizes of events in-house. For example, Chelsea Football Club manages fixtures attracting 42,000 guests who need to be managed onsite and this translates to the events team and experienced in-house security. The higher profile the venue or the bigger the event brand, the more strategies will already be in place which can help.

With regards to security, trust the staff and the in-house teams; they will have the benefit of experience organising private events, managing arrangements for high profile guests, and advising on the best way to utilise facilities. A good venue will take you through all stages of the event and should ask in advance of any special requirements, schedules or VIP attendees.

Ensure that all channels of communication are left open during the event itself so that staff  know of any last minute alterations. This will also guarantee that event organisers look professional, with the additional help of the venue’s catering, service and after-care.

 

Deciding outcomes

Knowing your audience and the objectives you want to achieve from any event will be a great help in selecting a venue. It is therefore vital to outline these clearly before approaching any venues for suggested briefs. Following this, there are some useful points to bear in mind which will make selecting a suitable venue easier.

Consider the components of your event to make sure you select somewhere that can accommodate them all. For example, consider whether the event will be an annual conference with a gala dinner and accommodation; whether you need separate facilities for VIP guests; and the possibility of needing to bring in equipment for demonstrations or exhibitions.

Venues which offer numerous events spaces, like a music venue, accommodation, restaurants and an exclusive spa can be ideal for organisers wishing to combine many activities within one event. It will also reduce the need for a separate transport budget to transfer guests from between conferences and seminars, for example.

Every event organiser should be constantly focussed on how to get maximum results for minimum cost. Look for a venue that whilst impressive, offers a range of packages and choose the one that suits your audience and your budget.

 

Simon Hunter Simon Hunter is the Head of Venue at Chelsea Football Club.

Laying the foundations

by emma 30. September 2011 16:29

Pharma Field - Laying the foundations

After working within the industry and the NHS for the last two decades, John Fletcher uses his inside experience to explain how the shift to Foundation Trusts will affect hospitals, how completion may change the NHS, and the opportunities for the pharma.

Despite recent ‘backtracking’ by the Government, the 2010 White Paper on Health and the subsequent Health & Social Care Bill will bring both challenges and opportunities for NHS hospitals.

Clearly, financial constraints will cause the biggest problems in terms of care delivery, both for existing services and for newer ventures; however, acute trusts may also benefit if they can change and develop their services in such a way as to satisfy local needs better than their competition – be that private providers, neighbouring acute trusts or community providers.

Trusts need to develop pathways that are efficient, yet profitable, in conjunction with their commissioners. They must minimise their unprofitable emergency work, and maximise their income through the more profitable work, elective care.

Foundation Trust status

The Government has stated its desire to see all acute trusts become Foundation Trusts (FT) by 2013. In essence, a Foundation Trust has more freedom to adapt its services according to local needs, and is free from the control of SHAs. FTs are also able to re-invest their surpluses in local developments, and indeed borrow from commercial banks to support their plans, should they wish to do so.

The fate of trusts that fail to reach this FT status is at present unclear, but it is likely that they will be either subsumed by neighbouring, successful FTs, or, as in the case of Hinchingbrooke in Cambridgeshire, franchised out to a private provider.

The Trust I recently left achieved FT status, having been authorised by the regulator Monitor on 1 February. Given the problems associated with Mid Staffordshire Hospital FT, Monitor is ever more rigorous in its approval process, and it is by no means assured that all trusts will make the grade.

As a result, it can be expected that many trusts will fail in their aspirations, and the approvals process will be slow, given that many Trusts have not had their plans signed off by the DH, and Monitor will be snowed under with requests.

However, the drive towards a complete conversion to FTs will mean that every trust in the country will be its own discrete business, accountable to its local GPs and patients, overseen by a board of governors, and regulated by Monitor on its finances, and the CQC on its clinical quality. Each is also subject to ‘free market’ conditions, and can therefore ‘fail’.

Challenges for trusts

1. Competition: recent years have seen the number of competitor organisations to acute trusts rise considerably, and this is set to continue, although the Government has recently discouraged the undercutting of National Tariffs on the grounds that it may erode quality.

This keeps trusts in a stronger position as they can preserve their income, and there is less temptation for commissioners to seek alternative, cheaper suppliers of healthcare. Nonetheless, competition comes from a number of sources:

  • Neighbouring acute trusts
  • Private hospitals/organisations bidding for NHS work
  • Community providers
  • GP organisations (providing, for example, cataracts or endoscopy)

In order to stimulate further competition, there are an increasing number of tenders appearing from PCTs for ‘Any Willing Providers’ to provide various services. This work is only offered at reduced tariffs compared to acute providers, often in the region of 75%. Furthermore, such work may only be delivered in a community setting.

Despite Government moves to allay fears about private competition, the likely result of this will be many more players entering the market, particularly for services that have a relative lack of complexity, with either low lengths of stay required in hospital, or ease of delivery in community/day-case settings.

The loss of work and/or the lower tariffs may cause severe income loss for some trust departments – ophthalmology and endoscopy have already been mentioned, but there is scope in many other specialties, either medical or surgical.

2. Efficiency requirements: although the NHS has been given a further year to deliver its £20 billion efficiency savings, all NHS bodies are working towards efficiency savings of 3.5% this financial year, and 4% thereafter.

Put simply, this means doing the same level of work for less, or doing 3.5-4% more work with the same resource. Given the levels of competition, gaining activity growth on profitable services – usually elective care – is going to be much tougher, and indeed trusts will be subject to various demand management schemes instigated by commissioners.

Reductions in national tariffs this year of 1.5% will reduce income further, and given inflationary cost pressure of at least 2%, it is not difficult to see the challenges ahead in order to achieve the required efficiency, or essentially become insolvent.

To make the challenge even harder, emergency admissions over and above 2008-09 levels now only attract 30% of the full tariff, and such admissions show no sign of declining – my own trust is 4% higher than last year, and considerably above the 2008-09 levels.

A recent report from Monitor, their Annual Plan Review 2011-12, showed that the number of trusts having high risk scores for their finances moved from four in 2010-11 to eleven. In other words, trusts themselves are forecasting tougher times.

Trusts will need to adopt strategies that enable them to either grow their way through the challenge, or cut unprofitable services, or reduce wards/staff numbers. Some trusts have indeed already started trimming their staff numbers. There may be cases for mergers, bringing some economies of scale.

3. Targets: despite much rhetoric around moving to more outcome-based targets, trusts will still face daunting goals in terms of A&E where 95% will have to be seen in four hours; two week wait for cancer patients; 18 week referral to treatment, plus MRSA & C.Difficile infection rates, to name but a few.

There is one new target which could also present a challenge for trusts, and that is re-admissions within 30 days. On the surface, the target may seem reasonable, but the reasons for readmission are often more to do with the lack of community care, rather than poor hospital treatment.

Many targets will be included in contractual negotiations, or appear as ‘CQUINs’.

There is not enough space within this article to go through every target, but suffice to say that the target culture remains, and there are penalties associated with failure, both financial and regulatory.

Opportunities for trusts

Foundation Trust

Thus far, it would appear that the poor old NHS hospital is well and truly under the cosh. Whilst there are clearly major hurdles to overcome, there are also tremendous opportunities to exploit. Trusts have many inherent strengths, and not all shared by their competition – they have significant estates, they have significant diagnostic capabilities, and they have significant expertise.

In some cases, they may have developed good relationships with their commissioners and GPs, and many have strong reputations in their communities. Successful acute trusts will take advantage of these strengths.

1. Community provision: whilst it is true that across all areas there are Community Units covering services such as district nursing, health visitors, and running community hospitals with step-up and step down beds for those patients not requiring acute care, the advent of competition will enable any provider to bid to provide these services. Some may not be attractive to trusts, but some may be of great benefit.

Given the pressure to keep emergency admissions down, and to ensure readmissions are minimised, a trust taking control of some elements of community provision may help to achieve this – for example, running community hospitals, or providing Chronic Disease Management teams to help prevent acute exacerbations.

2. GP commissioning: whilst the Health & Social Care Bill is yet to be approved by the House of Lords, it seems likely that PCTs will be abolished by 2013, and commissioning will pass to Clinical Commissioning Groups. Indeed, a timetable for the handing over of powers to commissioning groups has been issued from the DH in August.

There will be a far greater emphasis on local care through these groups, and trusts that build up strong working relationships with their GPs will be in a much stronger position to defend their markets. Some services may well be decommissioned, particularly if GPs feel they can provide them cheaper, but trusts would still be able to keep their core services profitable.

3. Private income: the Health Bill also brings a possible opportunity for trusts to engage in more private work. Some time back, levels of private work were capped as a percentage of income; this cap is to be removed, opening up the private market fully.

Whilst such work cannot interfere with a trust’s ability to see its NHS patients according to the relevant targets, there are means of gaining such work, either as a separate ward in the trust, or in partnership with another private provider.

Private work in a recession may not sound like a big market – which explains why private hospitals ‘mop up’ their spare capacity with NHS work, but recessions come and go, and private work will increase.

4. QIPP: the QIPP agenda is essentially a mechanism for increasing efficiency, and decreasing cost, whilst maintaining the highest quality of care. Those trusts with the greatest ability to innovate safely will be better placed to weather the storm.

5. Section 52: some FTs may fall foul of this clause within the National Health Service Act, 2006. In essence, it gives Monitor the power to formally intervene in the running of the trust, including sacking the board, if it deems that there has been significant breaches in the trust’s terms of authorisation.

These terms include both governance – as in the case of Mid Staffs – and finance. Whether a hospital would be declared bankrupt is open to debate, but Monitor does have the power to force through whatever solution they feel appropriate. Cost pressures will undoubtedly raise the spectre of this event in the minds of many trust CEOs.

Opportunities for pharma

Given the landscape that trusts operate in, there are several opportunities for pharmaceutical companies to help:

  • Development of drugs/formulations and treatments that decrease length of stay in trusts – this will help increase bed-utilisation, or indeed cut the number of beds required resulting in big savings.
  • Development of drugs/formulations that enable more efficient treatment in the community, particularly for conditions that regularly translate into emergency admissions – this will reduce a trust’s exposure to lower emergency tariffs, and save the community money.
  • Development of tools that enable commissioners and trusts to understand the impact of any intervention on the patient pathway, particularly cost, but also other quality parameters. These tools have to show VALUE – evidence is the key, and must be robust enough to persuade the stakeholders to amend the current pathway.
  • Bringing GPs and hospitals together in a single forum to assess the primary and secondary care pathways as one, rather than two separate entities. Undoubtedly, there can be an adversarial feel to trust-commissioner relationships – bringing single solutions to joint problems is the only real way to maintain and improve patient care with no additional resource. Pharma could facilitate this in various disease areas.
  • Share expertise – most staff within the NHS, including management, have never worked in the ‘cut and thrust’ of the commercial world. Expertise from any part of a pharmaceutical company may help the NHS innovate, and it will certainly build greater rapport for a more fertile commercial relationship.

John Fletcher now works for Pathway Communications, developing patient pathway simulation models and enabling pharmaceutical companies to assess the value of their treatments.

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