D2 Digital by Design: service delivery innovation award runner-up

Service users are sent personalised messages of support by the Response Prevention Project team. Photograph: Jason Lock/Jason Lock Photography

Text messages that support people recovering from alcohol misuse has significantly cut the number of people who relapse and have to be referred back to services.

Daily personalised support messages – which prompt a service user who has recently completed an alcohol misuse programme to reflect on their recovery – are delivered automatically as part of the Bolton Response Prevention Project called Shine.

The questions take into account the user's triggers to drink, such as the time of day they are likely to crave alcohol and also what motivates them to stop drinking such as their relationships with their family.

Service users are also asked whether they feel OK, or are struggling and need more support, and are sent appropriate messages.

Project manager Renate Kalnina at digital technology company D2 Digital by Design in Manchester, which is behind the initiative, says: "If they respond 'OK' we send them back a congratulatory message; if they are 'struggling' then the personalised intervention messages come into play.

"If they say that they need more support then the services get notified within 15 minutes and they get in touch with the client."

Service users are also sent a reminder via text message for appointments as part of the project, which ran from April 2010 to December 2012 in partnership with alcohol misuse services in Bolton.

Only 2.2% of Shine service users had to be re-referred for treatment, compared to 9.5% of non-Shine service users; a significant" reduction according to an analysis of the project.

Clients' attendance rates for relapse prevention programmes improved – rising from 42% to 72% in tier three services (medical intervention and psychosocial support) and from 17% to 72% in tier two services, which offer less intensive support and aftercare, the analysis revealed.

It is estimated the initiative has saved between £68,260 and £399,150, depending on individual client need.

D2 Digital by Design is in discussion with Public Health England about using the same model to support opiate users.

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Department of primary care health sciences, University of Oxford: winner, service delivery innovation award

Daniel Lasserson, senior clinical researcher, and Maggie Webb, unit manager, in the emergency multidisciplinary unit.

An emergency unit designed exclusively for old and frail patients is keeping them out of acute hospital and helping to prevent bed-blocking.

The emergency multidisciplinary unit (EMU) established at Abingdon community hospital in Oxfordshire is hoped to become the national model for the future of emergency care for older people.

Patients can be referred to the EMU, which is seen as an alternative to an acute hospital A&E, by either their own GP, a community nurse or ambulance paramedic.

The unit, which is open seven days a week from 8am-8pm on weekdays and 10am-4pm on weekends, is not available for patients who have suffered a stroke or a heart attack, who would still be taken to the local acute hospital's A&E. The majority of the 5,500 patients it has seen arrive with chest or bladder infection or heart failure. The average patient age is 89.

Staffed by elderly care physicians, GPs, nurses, healthcare assistants, therapists and social workers, the unit can quickly assess a patient. It has point of care blood testing with rapid results and X-ray facilities so the unit can guarantee speedy diagnosis.

The EMU has five hospital beds available for patients who may need to be kept in for a maximum 72 hours. A "hospital at home" nursing team is also available to provide support to patients who are sent home to recover.

"I would say that the EMU is more than just a casualty for older frail patients – it's more intensive because we aim to provide care for the episode at the time or for a number of days," says Dr Daniel Lasserson, a GP and senior clinical researcher at the department of primary care health sciences, University of Oxford, who helped design this new model of care.

Lasserson adds: "Its aims to deliver an acute care pathway for frail older patients that does not rely on bed-based care, yet can still provide appropriate medical, nursing and therapist treatments within an individually tailored care plan as close to the patient's home as possible.

"It was designed to challenge the existing urgent care pathway of admission to an acute hospital with its associated harms of unfamiliar and physically challenging environment and loss of independence."

The EMU, he says, addresses the dilemmas of how to best care for a growing elderly population with complex needs and multiple chronic conditions and to provide an alternative to "office hours" general practice or acute hospital bed-based care.

According to the EMU audit, 65% of patients who are assessed by the unit are able to stay in their own home – only 17% of patients need acute hospital care.

Lasserson says this new way of working, known as "interface medicine", is challenging the traditional medical training and care. Oxford has created an Interface Medicines Fellowship and is in discussions with Health Education England about how it can be developed nationally.

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Moorfields eye hospital: service delivery innovation award runner-up

Nurses at Moorfields administer a third of all eye injections. Photograph: Moorfields eye hospital

Nurses at Moorfields eye hospital NHS foundation trust in London have been trained to give eye injections to patients in a groundbreaking move, which is changing professional practice and benefiting patients.

The hospital decided to teach senior nurses how to administer the drug Lucentis as an injection in the eye because of increased patient demand, following new national clinical guidelines and a lack of ophthalmologists to carry out the procedure. New guidelines from the National Institute for Health and Care Excellence (Nice) recommended that Lucentis should be injected into the eye to treat patients with diabetic maculopathy.

The decision put more pressure on the hospital because its doctors were already busy administering 10,000 Lucentis eye injections every year to patients with the wet form of age-related macular degeneration.

Moorfields decided to train its senior nurse to give the eye injections, even though it was opposed by the Royal College of Ophthalmologists because Lucentis is only licensed in the UK to be administered by a doctor.

Hospital lawyers were consulted and a special patient consent form was drawn up. The NHS Litigation Authority also guaranteed the nurses the various liability cover they needed.

So far, 15 Moorfields nurses have given 3,000 eye injections, representing 33% of the hospital's eye injection workload. Moorfields has also been able to run 15 extra eye injection sessions a week because of the new skills mix.

Moorfields fellow Joanna DaCosta says: "This model of working is instrumental in removing professional barriers, increasing job satisfaction and providing a cost effective healthcare system."

The success of the initiative is illustrated by the decision in May taken by the Royal College of Ophthalmologists to issue new guidelines that non-medically trained professionals can administer eye injections, provided they have appropriate training and supervision.

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Strike out bureaucracy: barriers to choice in public service delivery

From GP appointments to school timetables, more flexible systems will give people more choices Photograph: Custom Medical Stock Photo / Ala/Alamy

At the start of this year, I finished my work for the UK government as an independent reviewer on barriers to choice.

Someone from outside government was needed to look dispassionately at the way people were using their choices in public services and decide what barriers there were to prevent them.

I listened to a dizzying number of roundtables and must have spoken to well over a 100 service users face to face, and almost as many professionals.

But one person in particular stands out. She had muscular dystrophy and had to see her consultant every six months, which meant a two-hour round trip plus 30 minutes or more in the waiting room. It meant going over a large river and paying a toll. And all she said to the doctor when he asked her how she she felt was: 'I'm fine'.

What this woman really wants is to check in occasionally by phone, and see him when she's not fine. But she can't, because his slots are full seeing people who are also fine.

What struck me most forcibly was that she was asking for something quite simple, though important to her as a long-term patient. It was a 'choice' about her treatment, in a sense, but not one that is recognised currently by the system in the UK.

The new emphasis would be less about choosing between regulated options, and more about making services flexible enough to suit individuals better – closer to the 'personalisation' agenda in social care, where service users can get budgets they can (theoretically, at least) use in ways they believe are best suited to their needs.

The best approach may be to find ways to give service users the confidence to ask for something different, and perhaps provide duties on service providers to consider this. I imagine this would be like a 'right to request' flexible service delivery.

In each case, the provider would not be obliged to provide flexibility if it is impossible, but they would be obliged to explain why and make that explanation public.

This would help people cut through systems or bureaucratic arrangements. Perhaps they want a consultant who won't mind them asking lots of questions, or to study Spanish at A-level when all that prevents them is their school's time-tabling system, or to go to bed later than 5pm when their carer comes round. 

This is basic flexibility which articulate people can often get now by being assertive, but which others can't.

There are possible objections to this kind of approach. Patients may choose badly. They may fail to take responsibility for the wider system, by misusing the flexibility they are offered.

There may also be higher costs from treating people more individually, and the costs will come before the potential savings are available. Financial innovations that tie professionals too closely to narrow numerical outcomes, like the current experiments with payment by results, may also make flexibility more difficult to achieve.

More flexibility would require up-front investment and mean fewer set systems, but more human connection.

David Boyle is the author of The Human Element: Ten new rules to kickstart our failing organisations (Earthscan) and a range of other books. This article is based on a piece commissioned by the British Council for its Equality Exchange forum on public services

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Halozyme: Drug Delivery Specialist With Multiple Near-Term Catalysts

Halozyme Therapeutics (HALO) (Q2 2013 conference call transcript, a source for many of the projected catalyst time frames outlined below) develops enzyme-based (hyaluronidase) products for a wide variety of conditions, which include diabetes, cancer, autoimmune disorders and cosmetic medicine (cellulite).

CLINICAL AND REGULATORY CATALYSTS:

Below is a summary of the Company's clinical development pipeline which includes collaborations with Roche (RHHBY.OB), Pfizer (PFE) and Baxter (BAX) in addition to an FDA approved product, HYLENEX (human recombinant formulation of hyaluronidase), which improves the absorption and dispersion of drugs injected under the skin (subcutaneously) (e.g. insulin) on a temporary basis (approximately 24 hours) with plans to increase sales through a recently initiated post-marketing study in Type 1 diabetes using insulin pumps.

1.) Herceptin-SC (trastuzumab) and MabThera-SC (rituximab) (novel subcutenous injected rHuPH20 formulations) are currently pending European Medicines Agency (EMA) decisions in the form of line extension applications for new formulations of approved anti-cancer drugs. In late June, partner Roche received a positive CHMP opinion for EU approval of Herceptin-SC with final EU approval expected approximately two months later by late August-early September.

Partner Roche filed a MabThera-SC line extension application in December 2012 with the next CHMP meeting scheduled for September 16-19 and a meeting update to follow on Friday 9/20/13. The May Pharmacovigilance Risk Assessment Committee (PRAC) meeting minutes posted in June (page 40-41) indicated that both line extension applications are acceptable with Herceptin-SC subsequently receiving a positive CHMP opinion in late June.

In addition, Roche has two ongoing Phase III clinical trials to evaluate patient preference and support pending European marketing efforts upon final approval for both Herceptin-SC (ClinicalTrials.gov ID NCT01810393) and MabThera-SC (ClinicalTrials.gov ID NCT01724021) compared to the standard, longer IV infusion delivery route for these products.

2.) HyQvia (novel subcutaneous injection formulation of immune globulin) received a Complete Response Letter (CRL) in August 2012 for a Biologics License Application (BLA) seeking approval as a novel formulation of immune globulin for subcutaneous injection due to elevated anti-rHuPH20 antibody titers and partner Baxter expects to submit additional data to the FDA by year-end 2013 to support potential FDA approval by mid-2014 to H2 2014 (Baxter Q2 2013 conference call transcript). In May, HyQvia received EU approval with the initial product launch ongoing.

3.) HTI-501 (recombinant human cathepsin L) (lysosomal proteinase) is currently being evaluated in a Phase II clinical trial and in late June HALO presented interim Phase II results from 12 of planned 34 evaluable patients in a fully enrolled Phase I/II clinical trial for the treatment of cellulite with the last patients dosed in July and final follow-up results through six-months post-treatment expected in early 2014.

4.) ClinicalTrials.gov ID NCT01839487 is the identifier for a Phase II clinical trial with results expected during Q3 2015 in a study evaluating PEGPH20 (PEGylated form of rHuPH20) in combination with nab-paclitaxel and gemcitabine for the first-line treatment of metastatic pancreatic cancer.

HALO will present more complete Phase IB data at the EU Cancer Congress on 9/30/13 following initial results presented at ASCO 2013 (42% overall response rate) and the Company is also developing a companion diagnostic with a planned start of a Phase II pancreatic cancer trial by Southwest Oncology Group by the end of Q3 2013.

5.) ClinicalTrials.gov ID NCT01848990 is the identifier for a fully enrolled Phase IV post-marketing clinical trial evaluating HYLENEX (rHuPH20 hyaluronidase human injection) in combination with rapid-acting analog insulin in Type I diabetics using insulin pumps with results expected in early 2014. HYLENEX is FDA approved to facilitate subcutaneous fluid administration for a variety of indications (e.g. hydration and to increase dispersion of other drugs as illustrated in the pipeline above).

6.) In December 2012, HALO announced an agreement with Pfizer to develop and commercialize biologic agents using Halozyme's Enhanze (hyaluronidase-based) drug delivery technology in up to six targets. Pfizer paid HALO an initial cash payment of $8 million for the initial two targets along with the right to add four more targets (additional fees apply) and the deal also includes potential regulatory and sales-based milestone payments of up to $507 million plus royalties.

FINANCIAL STATS (Q2 2013 results press release):

- On August 12 & 14, director Kathryn Falberg purchased a total of 100,000 shares of HALO on the open market at an average price of $6.82 increasing her stake to 280,000 shares (SEC filing link) while CEO Gregory Frost exercised options into 20,000 shares of common stock which increased his large ownership stake to approximately 3.6 million shares (SEC filing link).

- On 8/14/13, Swiss BB Biotech reported a 5.1% ownership stake (5.75 million shares) in HALO (SEC filing link).

- HALO currently has a high percentage of insider and institutional investors which account for nearly 70% ownership of outstanding common stock and includes major holders such as Randal Kirk / Third Security (combined ownership stake of 23.3 million shares which equates to a 20.6% ownership stake) and Baker Brothers (6.5 million shares).

- Randal Kirk is a billionaire biotech entrepreneur who recently netted over $1 billion on the highly successful IPO for Intrexon (XON) (Forbes overview article) and he also serves on the Board of Directors for HALO.

- As of 6/30/13, HALO reported $76 million (M) in cash and equivalents with $11.4M in cash used to fund operations during Q2 2013.

- During 2Q13, HALO reported revenue of $14.5M vs. $7.8M in the year-ago period.

- As of 8/5/13, HALO reported approximately 113M shares of common stock outstanding with $29.7M in total debt as of 6/30/13 ($26.1M classified as long-term debt which reflects a term loan from Oxford Finance and Silicon Valley Bank with a maturity date of 12/1/16).

- HALO has provided guidance for potential to be cash flow positive in 2014 (PR link) based upon key partner product launches that include HyQvia, Herceptin-SC and MabThera-SC in Europe with adequate cash to fund operations into late 2014 based upon the current cash and burn rate with an expected decrease over time as additional revenue offsets R&D expenses for the Company's three wholly owned programs (HTI-501 for cellulite, Hylenex for use w/ insulin pumps and PEGPH20 for pancreatic cancer).

TRADE SUMMARY & OUTLOOK:

With final European approval for Herceptin-SC due any day now and a very likely (90%) positive CHMP opinion for MabThera-SC in the near-term; I expect shares of HALO to fill the gap-down in the chart if positive news comes in as expected in the coming weeks with the potential to reach low double digits during H2 2013 ($10-12 target) as additional catalysts approach and the Company continues narrowing the cash burn with a goal of becoming cash flow positive by next year.

I believe the decision by ViroPharma (VPHM) to discontinue development of Cinryze-SC will have no impact on other programs as discussed by HALO on the most recent quarterly conference call and the enzyme-related antibodies have never been linked to any side effects with no clinical impact observed to date for an issue that was known in summer 2012 and being addressed by Baxter as part of plans to resubmit a BLA for HyQvia which is already being marketed in Europe following approval earlier this year.

In addition, HALO spiked by approximately $2 earlier this year on both Phase 1b pancreatic cancer data for PEGPH20 and again in late June on the positive CHMP opinion for Herceptin-SC so there is potential for another $1-2 upside each for upcoming Phase 1b data being presented on 9/30 and an expected positive CHMP opinion for MabThera-SC.

Other recent bullish developments include a recent open market insider/director buy for nearly $700,000 and bullish trading in the September $7.50 and October/December $10 call options so in the short-term, I expect the positive uptrend in the six-month chart below to continue with an upper $7-lower $8 short-term swing / run-up target with key risks being potential for an overall market correction and unexpected bad news on any of the upcoming regulatory or clinical trial catalysts which would have the potential for downside risk that is similar to the upside targets outlined earlier.

(click to enlarge)

Disclosure: I am long HALO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Strike out bureaucracy: barriers to choice in public service delivery

From GP appointments to school timetables, more flexible systems will give people more choices Photograph: Custom Medical Stock Photo / Ala/Alamy

At the start of this year, I finished my work for the UK government as an independent reviewer on barriers to choice.

Someone from outside government was needed to look dispassionately at the way people were using their choices in public services and decide what barriers there were to prevent them.

I listened to a dizzying number of roundtables and must have spoken to well over a 100 service users face to face, and almost as many professionals.

But one person in particular stands out. She had muscular dystrophy and had to see her consultant every six months, which meant a two-hour round trip plus 30 minutes or more in the waiting room. It meant going over a large river and paying a toll. And all she said to the doctor when he asked her how she she felt was: 'I'm fine'.

What this woman really wants is to check in occasionally by phone, and see him when she's not fine. But she can't, because his slots are full seeing people who are also fine.

What struck me most forcibly was that she was asking for something quite simple, though important to her as a long-term patient. It was a 'choice' about her treatment, in a sense, but not one that is recognised currently by the system in the UK.

The new emphasis would be less about choosing between regulated options, and more about making services flexible enough to suit individuals better – closer to the 'personalisation' agenda in social care, where service users can get budgets they can (theoretically, at least) use in ways they believe are best suited to their needs.

The best approach may be to find ways to give service users the confidence to ask for something different, and perhaps provide duties on service providers to consider this. I imagine this would be like a 'right to request' flexible service delivery.

In each case, the provider would not be obliged to provide flexibility if it is impossible, but they would be obliged to explain why and make that explanation public.

This would help people cut through systems or bureaucratic arrangements. Perhaps they want a consultant who won't mind them asking lots of questions, or to study Spanish at A-level when all that prevents them is their school's time-tabling system, or to go to bed later than 5pm when their carer comes round. 

This is basic flexibility which articulate people can often get now by being assertive, but which others can't.

There are possible objections to this kind of approach. Patients may choose badly. They may fail to take responsibility for the wider system, by misusing the flexibility they are offered.

There may also be higher costs from treating people more individually, and the costs will come before the potential savings are available. Financial innovations that tie professionals too closely to narrow numerical outcomes, like the current experiments with payment by results, may also make flexibility more difficult to achieve.

More flexibility would require up-front investment and mean fewer set systems, but more human connection.

David Boyle is the author of The Human Element: Ten new rules to kickstart our failing organisations (Earthscan) and a range of other books. This article is based on a piece commissioned by the British Council for its Equality Exchange forum on public services

• Want your say? Email us at public.leaders@guardian.com.

To get our articles on policy and leadership direct to your inbox, sign up to the Guardian Public Leaders Network now.

Looking for your next role? See our Guardian jobs site for senior executive jobs in government and politics.

• For the latest on public services leadership, follow us: @publicleaders

View the original article here

Strike out bureaucracy: barriers to choice in public service delivery

From GP appointments to school timetables, more flexible systems will give people more choices Photograph: Custom Medical Stock Photo / Ala/Alamy

At the start of this year, I finished my work for the UK government as an independent reviewer on barriers to choice.

Someone from outside government was needed to look dispassionately at the way people were using their choices in public services and decide what barriers there were to prevent them.

I listened to a dizzying number of roundtables and must have spoken to well over a 100 service users face to face, and almost as many professionals.

But one person in particular stands out. She had muscular dystrophy and had to see her consultant every six months, which meant a two-hour round trip plus 30 minutes or more in the waiting room. It meant going over a large river and paying a toll. And all she said to the doctor when he asked her how she she felt was: 'I'm fine'.

What this woman really wants is to check in occasionally by phone, and see him when she's not fine. But she can't, because his slots are full seeing people who are also fine.

What struck me most forcibly was that she was asking for something quite simple, though important to her as a long-term patient. It was a 'choice' about her treatment, in a sense, but not one that is recognised currently by the system in the UK.

The new emphasis would be less about choosing between regulated options, and more about making services flexible enough to suit individuals better – closer to the 'personalisation' agenda in social care, where service users can get budgets they can (theoretically, at least) use in ways they believe are best suited to their needs.

The best approach may be to find ways to give service users the confidence to ask for something different, and perhaps provide duties on service providers to consider this. I imagine this would be like a 'right to request' flexible service delivery.

In each case, the provider would not be obliged to provide flexibility if it is impossible, but they would be obliged to explain why and make that explanation public.

This would help people cut through systems or bureaucratic arrangements. Perhaps they want a consultant who won't mind them asking lots of questions, or to study Spanish at A-level when all that prevents them is their school's time-tabling system, or to go to bed later than 5pm when their carer comes round. 

This is basic flexibility which articulate people can often get now by being assertive, but which others can't.

There are possible objections to this kind of approach. Patients may choose badly. They may fail to take responsibility for the wider system, by misusing the flexibility they are offered.

There may also be higher costs from treating people more individually, and the costs will come before the potential savings are available. Financial innovations that tie professionals too closely to narrow numerical outcomes, like the current experiments with payment by results, may also make flexibility more difficult to achieve.

More flexibility would require up-front investment and mean fewer set systems, but more human connection.

David Boyle is the author of The Human Element: Ten new rules to kickstart our failing organisations (Earthscan) and a range of other books. This article is based on a piece commissioned by the British Council for its Equality Exchange forum on public services

• Want your say? Email us at public.leaders@guardian.com.

To get our articles on policy and leadership direct to your inbox, sign up to the Guardian Public Leaders Network now.

Looking for your next role? See our Guardian jobs site for senior executive jobs in government and politics.

• For the latest on public services leadership, follow us: @publicleaders

View the original article here

Physicists discover theoretical possibility of large, hollow magnetic cage molecules - potential for targeted non-invasive drug delivery

Main Category: Biology / Biochemistry
Article Date: 02 Aug 2013 - 1:00 PDT Current ratings for:
Physicists discover theoretical possibility of large, hollow magnetic cage molecules - potential for targeted non-invasive drug delivery

Virginia Commonwealth University researchers have discovered, in theory, the possibility of creating large, hollow magnetic cage molecules that could one day be used in medicine as a drug delivery system to non-invasively treat tumors, and in other emerging technologies.

Approximately 25 years ago, scientists first made the discovery of C60 fullerene - better known as the Buckminster Fullerene - a molecule composed of 60 carbon molecules that formed a hollow cage. Due to its unique hollow cage structure the molecule offers serious technological potential because it could hold other atoms or small molecules inside, and therefore, be used in applications such as drug delivery.

That potential has since spurred worldwide interest among scientists who have been searching for similar molecules. Although some hollow cage structures have been found, none of them is magnetic. Magnetic properties of the structure are of particular interest because a hollow magnetic structure carrying an embedded atom or molecule can be guided by an external magnetic field and may serve as an effective vehicle for targeted drug delivery.

In a new study, published online on July 22 in The Journal of Chemical Physics, two VCU scientists employing state-of-the-art theoretical methods show that magnetic hollow cages larger than the original C60 fullerene that carry giant magnetic moments are possible. A magnetic moment refers to the measure of the magnetic strength of a cluster.

An illustration of the VCU discovery also is featured on the cover of the July 28 print issue of the journal.

"The potential benefit of this finding is that it provides a route to the synthesis of molecular magnets with colossal magnetic moments," said co-lead investigator Puru Jena, Ph.D., distinguished professor of physics in the VCU College of Humanities and Sciences. Jena collaborated with Menghao Wu, Ph.D., co-author of the paper and a postdoctoral scholar in the VCU Department of Physics.

"These molecules can be used for targeted non-invasive drug delivery. When assembled, the molecules can also form new high strength magnets for device application," Jena said.

According to Jena, the pair of VCU researchers demonstrated the magnetic moment of the molecule by focusing on hetero-atomic clusters consisting of transition metal atoms such as cobalt (Co) and manganese (Mn) and carbon (C) atoms. In particular, Co12C6, Mn12C6, and Mn24C18 clusters consisting of 12 cobalt and six carbon atoms, 12 manganese and six carbon atoms, and 24 manganese and 18 carbon atoms, respectively, carry magnetic moments as large as 14, 38 and 70 Bohr magnetons. In comparison, the magnetic moment of an iron (Fe) atom in crystalline iron is 2.2 Bohr magnetons.

According to Jena, the team is still early in its discovery process.

"There is a long way to go. Experiments first have to be carried out to prove the predictions of our theory," said Jena.

"Ways must be found to synthesize large quantities of these molecules and study their magnetic properties once they are assembled. Finally, these molecules need to be functionalized by embedding desired atoms/molecules for practical applications."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our biology / biochemistry section for the latest news on this subject.

This research was supported in part by the U.S. Department of Energy grant number DE-FG02-96ER45579.

Menghao Wu and Puru Jena, Magnetic hollow cages with colossal moments, Journal of Chemical Physics, doi: 10.1063/1.4813022

Virginia Commonwealth University

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