Pharmacy education centre awarded new NHS contract

A new contract between the NHS and the University of Manchester has secured the future of the Centre for Pharmacy Postgraduate Education (CPPE).

NHS North West, on behalf of the NHS as a whole, signed up to the contract with the University, safeguarding the organisation’s future funding through the Multi-professional Education and Training levy: part of the Department of Health’s investment in education and training.
Based at The University of Manchester, CPPE offers continuing professional development opportunities for pharmacists and pharmacy technicians providing NHS services in England. The organisation was described as a “centre of excellence” in 2008 following a review led by the Chief Pharmaceutical Officer, Keith Ridge, and the completion of an independent evaluation carried out by the University of Birmingham.
Neil McLauchlan, Assistant Director for Education and Commissioning, NHS North West, said: “This new arrangement gives a chance for the contract to be closer to service and engage more effectively with the wider NHS education and training networks. The new Contract Management Board will add to the robust governance arrangements that have supported CPPE when being managed by the Department of Health.”
The review recommended greater involvement of the NHS in the operation of the Centre to reflect the role, remit and funding of CPPE as part of the NHS investment in the healthcare workforce.
In the current financial climate, CPPE, like all education and training providers across the NHS, will face pressure to ‘do more for less’. The new contract provides for the Centre to develop and commercialise the intellectual property it creates in the course of delivering learning for pharmacists and pharmacy technicians.
This will include opportunities to develop partnerships with The University of Manchester and other higher education institutions. Income generated by the Centre will be reinvested in the learning programmes delivered by CPPE and will support the delivery of NHS services across England. Learning will continue to be delivered free of charge to pharmacists and pharmacy technicians in England. The Department of Health will continue to retain the copyright on all learning developed by CPPE.
Professor Dame Nancy Rothwell, the University’s Vice Chancellor and President, said: “The University recognises the importance of continuing professional development for today’s professionals and is extremely pleased that Manchester, through CPPE, is able to be at the forefront of this for the two pharmacy professions.”
Professor Ian Jacobs, Vice-President and Dean of the Faculty of Medical and Human Sciences, added: “We are delighted that the University has secured the future contract for CPPE and look forward to the opportunities and mutual benefits this will provide.”
Keith Ridge, Chief Pharmaceutical Officer, said: “I am delighted to see the final steps in securing the future of CPPE as an integral part of the NHS education and training infrastructure are in place.
“As plans to establish Health Education England and local education and training infrastructure take shape, it is important that CPPE’s commitment to working with employers, pharmacists and pharmacy technicians, across community, primary care and NHS Trusts, goes from strength to strength.
“Whilst stability and continuity in the provision of learning is as crucial now as it has ever been for pharmacy and the patients it serves, CPPE will also need to adapt quickly to support the transformational change necessary to support the quality and value that the public will demand from health services and the professionals that provide them.
“Improving outcomes through medicines optimisation, delivered in a healthy living environment, will need a level of both engagement with the public and patients, and collaboration across and within professions, not previously seen and CPPE will be an important player in supporting this new agenda.”
For information about CPPE and the learning opportunities it offers, visit www.cppe.ac.uk.

Independent pharmacy figures out how to set itself apart

THE CHALLENGE
The corner drug mart was becoming a rarity as grocery stores and megastores increasingly captured a larger share of the prescription, drugstore products and specialty gift lines of business. Competitors’ costs and prices were lower and their advertising budgets were higher. The independent corner drug mart was finding it more difficult to succeed in the shadow of these powerful competitors.

Rob Heaton, a pharmacist and owner of Cambrian Pharmacy in Calgary, realized that a change in strategy was required if his business was going to remain viable.

THE BACKGROUND

Cambrian Pharmacy opened in 1959 in a new neighbourhood in central Calgary. In 1996, Mr. Heaton purchased the store from a pharmacist-owner he’d known since high school and with whom he’d worked since 1990.

Shortly after assuming sole ownership, Mr. Heaton realized that continuing to operate a traditional drugstore was no longer viable. Change was essential for survival.

Big-box stores, like Wal-Mart Stores Inc., had a strategy of ensuring they had the best price on everything from a case of diapers to a children's book. Young families watched their money carefully and were compelled to get the best price.

Traditional drugstores also carried a significant inventory of giftware and home accessories. The opening of stores like Pier 1 and Rafters, part of the Liv Canada Gift Groupmade it difficult to compete with the drugstore's limited product lines.

As a result, Cambrian Pharmacy faced an identity crisis of sorts. Before establishing a new identity and business strategy, Mr. Heaton felt he had to answer two key questions: What are we? What's our business?

He saw himself as a health care professional, leading him to conclude that Cambrian Pharmacy's business was health care. He then had a focus for his strategy.

THE SOLUTION

In 2002, Cambrian began to offer a compounding service, essentially custom-tailoring prescriptions, in precise dosages and forms. Standard products don't work for well for some patients with a unique combination of symptoms, diseases and tolerance levels.

The compounding service started out small, with a small counter space and a simple, new piece of equipment, an ointment mill.

To create awareness of the service, Mr. Heaton held meetings with physicians to discuss their most puzzling patients. “You dream it and we'll find a way to do it,” he told them.

Working with physicians created an awareness of the value of the service and helped with word-of-mouth marketing.

The creation of individual treatment plans resulted in a holistic approach to health.

Patients were requesting natural ingredients and fewer chemicals and dyes. They were also were routinely conducting research into their ailments. After validating holistic plans, the pharmacist could work with a patient and his or her physician to develop a treatment plan.

Mr. Heaton also identified a competitive advantage that pharmacists had over their main competitor: health food stores, whose knowledge was limited to naturopathic products. Pharmacists could understand both homeopathic and prescription drug remedies and the complex interactions that might result.

THE RESULT

The role of being a “medication problem solver” is very challenging and satisfying, and fits the business's focus.

As a result, two of Cambrian’s pharmacists have pursued specialties relating to their passions and interests, one in diabetes and the other in hormone balancing and reproductive therapy.

The compounding service grew in response to customer demand and Mr. Heaton’s increasing experience allowed him to identify additional opportunities.

Over the past decade, new equipment and training have allowed the compounding service to grow from six square feet of counter space to a pharmaceutical lab occupying 400 square feet, and it is able to prepare the most complex and sterile medications (for instance, eye drops and injections).

To increase trust in its products, Cambrian voluntarily sends all of them for testing to ensure quality control. It has also developed a collection of scholarly articles and studies that can be used by physicians considering a novel treatment protocol.

Cambrian’s relationship with physicians continues to flourish as it provides unbiased information on new developments and products in the industry.

Cambrian is the pharmacy with the largest selection of homeopathic and complementary remedies in Calgary. It now has three or four pharmacists on each shift, up from one in 1996.

Mr. Heaton has demonstrated a clear strategic vision of a pharmacy providing health care choices and solutions that is built upon four key services: compounding, supplements, natural products and the pharmacy.

His motto of “If you decide to do something, do it right,” and having a passion for what he does will continue to allow Mr. Heaton to be creative and innovative.

In addition to providing superior customer service by developing individualized treatment plans, Cambrian will continue to allow patients to make informed choices about their health.

Parents, pharmacists: Crucial attention-deficit drugs scarce

Seven million people who have been prescribed drugs to battle the unmanageable cacophony that attention deficit hyperactivity disorder brings to their minds now face another hurdle: getting those drugs at the pharmacy.
Lake Park pharmacist Nirav Patel finds himself fielding nearly a dozen phone calls a day from patients frantically trying to fill prescriptions.
The owner of Robalo Pharmacy says his suppliers give him only enough to fill one or two a day.
"It's rationed out. The problem is big. It is huge," Patel said. "This is one of the biggest shortages right now."
And health authorities nationally expect the problem to worsen through the holidays and into the new year.
Th e shortages were first seen last spring, when one of the most commonly prescribed medicines, Adderall, went generic, said Ruth Hughes, chief executive of the national advocacy group Children and Adults with Attention Deficit/Hyperactivity Disorder.
"There were lots of problems: distribution issues; issues of production involving the active pharmaceutical ingredient," she said. "We talked to a number of people at the time who thought it was going to be a short-term problem, but it has continued over the summer and recently it got worse."
Walgreens and Publix pharmacies confirm that they are experiencing some shortages in these drugs. Sometimes the drug is available, but not in the prescribed dose. For example, the shorter-acting drugs seem to be a bigger issue, Hughes said.
Adderall has been listed among those in shortage by the U.S. Food and Drug Administration off and on since 2009, said Erin Fox, who tracks the shortage data as manager of the drug information service at the University of Utah.
Then this month, the active ingredient in Ritalin and its generic counterparts, methylphenidate, joined the list.
The reasons for this shortage, like the reasons for the myriad of other drug shortages nationally, are difficult to pinpoint, Fox said. Companies cite increased demand, problems in distribution and tight Drug Enforcement Administration rules on how much of the active ingredient each maker can use in a given year.
"It's a very complex problem, and I have to tell you that I'm not seeing many easy answers," said Hughes, the ADHD advocacy group official.
Drug shortages have plagued the medical field for at least the past year, but most of the drugs in question have been intravenous ones used by hospitals or drugs that catered to a very specific illness, such as a brain cancer.
The population relying on these ADHD medications is vast, Hughes said. An entire generation of children with the disorder have grown up with the option to address their problems with these drugs.
They are, however, powerful drugs.
The DEA classifies them as Schedule II substances, which means they carry a "high potential for abuse" that "may lead to severe psychological or physical dependence." As such, the federal government sets limits on how much of these drugs can be manufactured each year.
Some might shrug at the situation - after all these are not life-saving cancer drugs that are in short supply - but Hughes would have them think again.
"It's not a shrug," she said. "If my teen goes out and is driving without his medication, the likelihood of him having a very serious car accident is three times higher than it was before."
For some teens, coping with ADHD in the long term without medication can contribute to alcohol or drug abuse, lead to criminal behavior and increased teen pregnancy rates, Hughes said, referring to more than a decade of research.
Younger children use these drugs to help keep them on task in school and to curb those impulses to act out at unexpected triggers.
But while children are more often prescribed drugs to cope with this disorder, there are at least 3.2 million adults taking these medicines to help them focus at work and at home, Hughes said.
Doctors and pharmacists are struggling to meet the demand.
Barry Paraizo, who owns Winships Prescription Center in North Palm Beach, says he also recalls having supply problems at the end of last year.
"You get patients bouncing around stores; they've tried Walgreens or CVS," Paraizo said. "But if I can't take care of my patients, I can't supply other pharmacies' patients.
"It gets frustrating," he said.

---

What to do?
If you experience difficulty in filling an ADHD prescription :

• Ask your pharmacist if the medication is available from another location, especially if you use a large chain pharmacy.
• Contact the manufacturer to help locate a pharmacy that has your medication in stock .
• Contact the doctor who prescribed the medication to request samples .
• Ask your pharmacist about the availability of other medications used to treat ADHD.
• As a last resort, discuss with your prescribing physician whether or not any of these available medications might be appropriate for you or your child.
• Finally, if you still can't get a prescription filled due to a medication shortage:

Tell the FDA: Send an email to drugshortages@fda.hhs.gov or call 888-INFOFDA or 888-463-6332 .
Tell CHADD: 800-233-4050 .

FDA commish outlines plan to speed new drug development

That blast from the NVCA today is just the latest example of the growing chorus of criticism from lobbyists and political opponents over the regulatory process faced by drug and device developers. The regulatory burden had grown too cumbersome and too uncertain, they claimed, which was threatening to throttle innovation and cost the country some much-needed jobs. And yesterday FDA Commissioner Margaret Hamburg outlined a plan intended to appease the critics.
Innovative new drugs targeted at serious unmet medical needs, she said, will be provided an "expedited drug development path." A new deputy FDA commissioner will be charged with overseeing the regulatory process for drugs, biologics and cell-based treatments. Personalized meds will be given a top priority. And the country's top biotech entrepreneurs will be sought out to offer insights on how the agency can do better.


"The Obama Administration is committed to encouraging the entrepreneurs and businesses that are modernizing and strengthening our health care system," said HHS Secretary Kathleen Sebelius. "The innovation blueprint is another part of our effort to help businesses grow and keep Americans healthy."
Will it prove enough to satisfy the critics? Some are taking a wait-and-see approach on whether the FDA can walk the talk.
"Many in the private sector-especially investors in medical technologies-say America is beginning to lose its competitive edge in this arena, as many innovative start-up companies are choosing to commercialize, and hence create jobs, overseas," notes Timothy Hay, who writes the Venture Capital Dispatch for the conservative Wall Street Journal. "One of the most oft-cited reasons for the phenomenon is the unpredictability at the FDA."

Venture Firms Reduce Biotechnology Investment on FDA Risk

Oct. 6 (Bloomberg) -- Venture capital firms are investing less in experimental drugmakers and medical device makers because of what they say are regulatory hurdles, a survey found.

Almost 40 percent of 150 venture capital firms that responded to the survey have decreased their investment in life sciences during the past three years, the National Venture Capital Association said today in a statement. The same proportion expect to continue to reduce their spending on these companies over the next three years, a potential $500 million loss, the association said.

“The process has gotten to be so long, and the capital required so deep, that it’s becoming more and more difficult to generate venture-type returns and therefore make it worth your while to do it,” said Terry McGuire, co-founder and general partner of Polaris Venture Partners and past chairman of the association, in an interview.

Venture firms have shifted their investments overseas, where McGuire says regulatory approvals come quicker. More than one-third of survey respondents said they would increase their spending in Europe and 44 percent in Asia, compared with 13 percent saying the same for North America.

The U.S. Food and Drug Administration is taking steps to address some of the industry’s concerns, Commissioner Margaret Hamburg said yesterday in a statement. The agency plans to streamline regulations and speed up the approval process for some drugs, among other changes.

The agency approved 25 new drugs as of Sept. 15 and at that pace, by year’s end, would clear the most new drugs in since 2004, according to Bloomberg data.

--With assistance from Anna Edney in Washington and Catherine Larkin in Indianapolis. Editors: Andrew Pollack, Donna Alvarado

Campbell med school takes step forward

The planned Campbell University    School of Osteopathic Medicine took a big step toward being accredited after the Commission on Osteopathic College Accreditation awarded it pre-accreditation status.
The need for more doctors has been well documented, and Campbell University leaders want to see their graduates fill the gap. http://www.bizjournals.com/triangle/print-edition/2011/07/15/campbells-med-school-aims-to-help.html
Gaining pre-accreditation status does not mean the school is fully accredited, of course, but is seen as a key step in that direction. The university will next seek provisional accreditation, awarded to schools that meet the standards for accreditation. Campbell hopes to achieve this status and begin recruiting students for the fall of 2013.
A ground-breaking ceremony for the 97,000-square-foot medical school facility will be held by early 2012. The school will be on U.S. 421 in Buies Creek about one-quarter mile from the main Campbell University campus. The medical school will cost more than $60 million for building construction, equipment and other startup requirements.
Nationally, enrollment in osteopathic medical colleges has grown to 20,600, a 6.5 percent increase from 2010, according to the American Association Of Colleges Of Osteopathic Medicine. More than 20 percent of new U.S. medical students are attending osteopathic medical schools, the association reports, a number it expects to grow.
Graduates from osteopathic medical colleges receive a DO degree, not an MD degree as from traditional medical colleges like the University of North Carolina at Chapel Hill or Duke University. Physicians with DO degrees have all the same latitude as those with MD degrees.

AdverseEvents: Why Big Pharma Is Scared Of This Startup

By taking lists of potential side effects out of the hands of the drug makers, the startup is letting people know what their pills might be doing to them in a more open way than big pharmaceutical companies ever have.

Last week during a Republican debate, as you may have heard, Michele Bachmann claimed that the HPV vaccine Gardasil can cause mental retardation. Prozac and other antidepressants are often linked to suicide. Ambien is rumored to cause amnesia in some patients. Which of these things are true? And how could we ever really know since the list of side effects that comes with medication never gives detailed statistics?
AdverseEvents, a California-based startup, is pushing the debate out into the open with a centralized database of how many side effects are happening from what drugs and what the patient outcomes are--and according to cofounder Brian Overstreet, "it scares the crap out of the pharmaceutical companies."
"The FDA has some of this [side effect] data, but it's unstructured, not searchable, and not standardized," explains Overstreet. AdverseEvent's proprietary algorithm, which took 18 months to build, takes into account data from the FDA, direct patient reporting, and even information from social media sites (AdverseEvents analysts are alerted to side effect discussions on patient discussion boards, for example, and try to extract data).
AdverseEvents also has an internal alert system, so that the company can track potentially dangerous side effects and alert the FDA if necessary.

The result: a clean, easy-to-read database for both health-care professionals and patients. Pictured above is the Prozac top 10 side effect list--and sure enough, suicide is on there. But Gardasil? Mental retardation isn't on the list, though the most common side effect is "drug exposure during pregnancy."
Pharmaceutical companies are, as you might imagine, not thrilled that AdverseEvents exists; they're used to controlling side effect information. "First they freak out about it, then they look in greater depth and say 'Wow, it's
really interesting and we could see how to use this but we're not ready.' And we explain that the data is coming--your customers are going to have it,
insurance companies and doctors are going to have it, and you need to be part of
the conversation," says Overstreet. Fast Company contacted Pfizer for comment, but we have not yet heard back.
AdverseEvents went live this month. It's free for patients, but the startup has a subscription based model for insurance companies, hospitals, and eventually pharmaceutical companies. AdverseEvents is also working on a mobile app.
"I think people are going to be horrified," says Overstreet. "That's the only reason I'm doing this--because it scares me a lot."

Twitter 'offers world mood clues'

Researchers have trawled through more than half a billion messages on Twitter, looking for changes in people's mood across days and seasons.

They said people start off brightly in the morning, but mood deteriorates throughout the day until a boost late in the evening.

Unsurprisingly, they found people tended to be happier on Saturdays and Sundays than during the working week.

Changes in the hours of daylight also had an effect.

It has been difficult for scientists to investigate changes in mood. The authors of this study argue that traditional laboratory tests are limited as they are based on university students self-reporting their mood.

Some academics have begun looking at social networking sites to gather data on a wider and more diverse group of people.
Mood rhythm

The team at Cornell University, New York, argued that monitoring Twitter provides a real-time reflection of mood.

They looked at messages from 2.4 million people's public tweets from 84 countries and used language detection software to score positive and negative feelings.

Positive feelings started high, but began to fall in mid-morning and then picked up again in the evening. Generally, positive words appeared more at the weekend than during the week.

However, the researchers say work is not necessarily to blame as the shift in mood pattern "was similar on weekends and weekdays" which instead "points to sleep and the biological clock" as the cause.

Negative feelings were lowest in the morning and increased throughout the day. The researchers said: "This pattern also suggests that people may be emotionally refreshed by sleep."

Researchers said day length affected positive tweets, but not negative ones suggesting "that winter blues is associated with diminished positive affect but not increased negative affect".

bbc.co.uk

A Start-Up Takes On Procter & Gamble Over a Name

A light bulb went off for Christy Prunier while giving her 8-year-old daughter, Willa, a bath. The girl complained that she didn’t like “babyish” soaps anymore.
Ms. Prunier got to work, and after three years of research, introduced a line of skin care products aimed at preteenage girls. The name? Willa, of course.
With lip balm, facial masks and lotions in whimsical purple and white bottles, Willa caught the attention of Target, J. Crew and trendy Upper East Side boutiques like Blue Tree, owned by the actress Phoebe Cates.

Procter & Gamble noticed Willa, too, but wasn’t so enthusiastic. It sent Ms. Prunier a letter demanding that she drop the name Willa, or it would resort to “lengthy and expensive alternative measures.” Willa, contends Procter & Gamble, sounds too much like Wella, its own brand of hair care products, and consumers would be confused.
Instead of changing the name, Ms. Prunier chose to fight back. The battle between Ms. Prunier and Procter & Gamble — or Willa versus Wella — goes to court next month.
“There’s no chance here that anyone is going to be confused,” said Ms. Prunier, 43, a former film executive who lives in suburban Connecticut. “They have nothing to lose. They are intent on shutting me down.”
Andrew Sullivan for The New York TimesProcter & Gamble contends that Willa, Christy Prunier’s skin care line, is too similar to the name of its Wella hair care products. Ms. Prunier is not the first small-business owner to claim harassment by a large corporation over its name. After some small businesses complained about what they call “trademark bullying,” Congress mandated a study of the issue.
In introducing the study, which was released in April, Senator Patrick Leahy, Democrat of Vermont, said, “I am concerned that large corporations are at times abusing the substantial rights Congress has granted them in their intellectual property to the detriment of small businesses.”
The senator noted a “spurious” trademark claim from 2009 against a Vermont business, Rock Art Brewery. Hansen Beverage, the makers of Monster Energy drinks, objected to the brewery’s Vermonster beer. Hansen dropped its claim provided Vermonster was not sold as an energy drink.
In another case, from last August, the Maya Archaeology Initiative fought claims by Kellogg that a bird depicted in the organization’s logo is too similar to Toucan Sam, the bird on the Froot Loops cereal box. The two sides have since reached an agreement allowing the Mayan group to use its mark.
Facebook, meanwhile, has sued Teachbook.com, a Web site for teachers, for using the word “book” in its name. A Facebook spokesman declined to comment.
“The big corporations often send these cease-and-desist letters and issue threats regardless of the merits of the claims,” said Erik M. Pelton, a trademark lawyer in Alexandria, Va. “They then use their endless resources and legal firepower to get the result they want: the small businesses often go away because they can’t afford to fight back.”
But Alan C. Drewsen, executive director of the International Trademark Association, said, “Just because trademark owners are big doesn’t mean they’re bullies. Major brands must have a carefully considered enforcement strategy in order to protect their intellectual property.”
Indeed, the government’s study found that evidence of widespread trademark bullying was inconclusive, suggesting that disputes “may be best addressed by the existing safeguards in the litigation system.”
The report effectively killed any momentum for a legislative fix. Instead, regulators have urged the private sector to provide free or low-cost legal counsel to small businesses engaged in trademark disputes, a remedy that some small businesses and lawyers have criticized as being woefully inadequate.
Like many large corporations, P.&G. fiercely protects its intellectual property, and company lawyers routinely search for potential conflicts. Procter’s lawyer contacted Ms. Prunier in January after she received government approval to use the Willa name.
For Ms. Prunier, the trademark approval was the end of a nearly three-year process of working with chemists and dermatologists to develop the Willa line. Her goal, she said, was to provide a natural alternative to the “Miley Cyrus, made in China, bubble-gum flavor products” currently on the shelves.
For instance, among her products is a face wash that “is meant to smell like a girl in the summertime who takes a shower outside,” she said.
The natural personal care category is big business, estimated at $5 billion a year in sales in the United States alone, according to Organic Monitor. A few one-time start-ups have made a killing, too; Tom’s of Maine was purchased by Colgate-Palmolive for $100 million in 2006, and Burt’s Bees was bought by Clorox for $925 million a year later.
Ms. Prunier said she developed Willa with help from her baby sitter, Francesca Harrell, a recent graduate of the Parsons School of Design, and Willa herself. Focus groups consisted of Willa’s classmates from the Spence School, a private school on the Upper East Side, who sampled products and jotted their reactions on a clipboard. (The family moved to Connecticut this summer.)
Ms. Prunier was picking Willa up at Spence on Jan. 31 when she received a call from her trademark lawyer informing her of the Procter cease-and-desist letter. P.&G. gave her less than two weeks to confirm that she was “taking the necessary steps to comply with our client’s demands.”
Instead, she sought advice from Willa’s best friend’s father, a lawyer, who urged her to stand up to Procter & Gamble. Eventually, Ms. Prunier sued, asking a court to rule that Willa does not infringe upon the trademark for Wella, a German hair care brand that P.&G. acquired in 2003 for $7 billion.
Procter has since demanded the hard drive from Ms. Prunier’s computer to search for incriminating documents. And it issued subpoenas to Ms. Prunier’s potential customers, including Ms. Cates, according to Ms. Prunier’s lawyer.
“If you were the owner of this boutique, why would you want to get involved in this fight?” said William A. Brewer III, Ms. Prunier’s lawyer. “It basically stops the forward thrust, or opportunity, for our client.”
Jennifer J. Chelune, a spokeswoman for Procter & Gamble, said, “We believe that a range of hair and related products called ‘Willa’ would be too close to our Wella brand name. This risks consumer confusion and is important to know that it could set a precedent that other companies could exploit to try and infringe our Wella trademark.”
She said that the company’s trademarks were “how we build consumer trust in our brands over many years” and needed to be protected. “Especially in today’s Internet world, the size of the company makes little difference.”
The case goes to trial in Federal District Court in Manhattan on Oct. 12. It is likely to hinge on whether a jury finds a “likelihood of confusion” among customers of Willa and Wella, a rather squishy legal standard that focuses on factors including the similarity of the marks and products, and whether they are sold in the same channels.
Ms. Prunier argues that Wella sells only hair care products, while Willa’s line is broader. In addition, she said Wella is primarily sold in hair salons, while Willa would be offered in retail stores and boutiques.
Given the strain of the lawsuit and the estimated $750,000 in legal fees, Ms. Prunier said she had thought about changing the name. But she said the story of Willa was crucial to the brand and any other name lacked “authenticity.”
Willa’s middle name, Price, doesn’t work either. “The first thing I think of when I think about ‘Price’ is cost,” Ms. Prunier said.
For Willa, now a smiley 11-year-old with braces, the family start-up has provided all sorts of lessons about the business world, not all of them pleasant. As she watched her mother break down in tears during an interview at her kitchen table, Willa struggled to maintain her composure.
“I think it’s going to work out,” Willa said. “It’s just a lot of stress for my mom.”

Analysis: Open-access R&D one answer to drug industry woes

(Reuters) - Drug companies are learning how to share.

In a bid to save both time and money, some of the industry's biggest names are experimenting with new ways to pool early-stage research, effectively taking a leaf out of the "open-source" manual that gave the world Linux software.

If it takes off, the approach could break the mold of current drug research and speed the development of tomorrow's life-saving medicines for diseases from cancer to autism.

At the University of Oxford on Wednesday, two more companies -- Pfizer and Eli Lilly -- signed up for the first phase of the concept by joining existing backers GlaxoSmithKline and Novartis in an unusual public-private research partnership.

As supporters of the international Structural Genomics Consortium (SGC), the rivals give cash and scientific resources for work into the three-dimensional structure of proteins -- important for drug discovery -- even though all the findings are made available to scientists worldwide without restriction.

In all, the SGC has secured $49 million in new funding.

Next year, a far more ambitious scheme is slated to take cooperation to another level by promoting open-access, patent-free research right up to mid-stage "proof of concept" clinical trials, known as Phase II.

The bold idea calls for drugmakers to trade exclusivity for the chance to get in on the ground floor of new therapies. After the initial sharing phase, companies could cash in by developing their own versions of any new medicines.

"HORRENDOUS WASTE"

Patents may be the life-blood of the drugs industry but a growing band of rebels believe the current system of building walls around the science is counter-productive because companies end up working in parallel and duplicating research.

"It's a horrendous waste of money, a horrendous waste of resource and waste of peoples' careers," says Chas Bountra, the SGC's chief scientist, who is also a founder of the new project to take open-access research into the clinical arena.

"There is also an ethical and moral dilemma here because the way we are currently doing drug discovery means that we are exposing patients to molecules that other groups know are destined to fail. That is tragic."

Bountra, who knows the industry well after working for nearly 20 years at GSK, is convinced that no one company can fully grasp the myriad genetic and other factors behind complex diseases like cancer.

Stephen Friend -- another founder of the patent-free drug development project known as Arch2POCM -- is also an industry veteran, having founded Rosetta Inpharmatics and gone on to head Merck & Co's cancer research, before shifting to establish the non-profit group Sage Bionetworks in Seattle.

Friend told Reuters the new project, whose name derives from "archipelago" and "proof of clinical mechanism," was on track to launch in 2012, with an initial focus on cancer and two areas in neuroscience, autism and schizophrenia.

A meeting is planned with drug companies in November to hammer out details on the oncology program.

Friend hopes to have at least three companies on board in cancer, each putting in $4 million a year in cash and "in-kind" expertise, with extra funding from public and private bodies giving a total budget of around $150 million over five years.

The neuroscience program, which is running a couple of months behind, would be of a similar size, making the overall venture significant, though still a side bet by comparison with the $68 billion Big Pharma spent on research last year.

RADICAL DEPARTURE

It amounts to a radical departure for an industry used to playing its cards close to chest.

But Keith Blundy -- who has a ringside seat as CEO of Cancer Research Technology, which strikes alliances with drug firms on behalf of Britain's leading cancer charity -- believes global drug companies are thinking outside the box these days.

"What people are prepared to entertain now is a long way away from what it was a couple of years ago," he says. "Industry has pulled all the levers it can and new models have got to be considered."

The stark fact is that current returns on drug research are dismal, prompting the first decline in R&D spending in 2010, after decades of relentless increases.

How far drug companies are prepared to go in embracing the Arch2POCM model remains to be seen.

Friend argues they would have two bites of the cherry to make a commercial drug -- either by buying exclusive rights to data generated from any successful unpatented drug or, more significantly, by using the research as a jumping-off point for developing their own proprietary molecules.

Patrick Vallance, head of medicines discovery and development at GSK, says the new approach makes sense in principle but commercial decisions by companies on when they need to secure intellectual property (IP) will inevitably vary.

"I think going through to Phase II with everything in an IP-free environment is not going to happen," he says.

"But there may be some areas that really benefit. For example, everyone is struggling with trying to understand aspects of neuroscience -- having a few more molecules that probe specific pathways could be really beneficial for the whole field and for industry."

Sanofi tackles $3B acne market with UC San Diego pact

Acne may not rank up there with, say, cancer in the area of unmet medical needs. But with a $3 billion market at stake, it's serious enough to grab the attention of Sanofi Pasteur, which today announced a collaboration deal with investigators at the UC San Diego School of Medicine on a new vaccine that promises to control the skin eruptions associated with extreme teen angst.

"This investigational vaccine and treatment may lead to a better solution for the many who suffer from this skin disease," said Sanofi R&D chief Elias Zerhouni. None of the financial terms were disclosed, but Sanofi noted that the deal includes a two-year research collaboration with Dr. Chun-Ming Huang and his associates for further R&D work.

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Acne may not make many headlines in the drug development world, but the market covers an estimated 50 million people. Sanofi notes in its release that the current treatment of mild acne revolves around bactericidal agents like benzoyl peroxide as well as oral or topical antibiotics. Long-term use of antibiotics, Sanofi adds, also leads to resistant strains.

Employees Are Key in Emerging Markets

When I meet other executives here in Shanghai, both through work and socially, we talk about similar challenges. Most of us have moved here to set up operations for multinational companies or to help drive them into their next growth trajectory.
So what do they worry about?

Recruiting and retaining talent is high on the list, but mostly they fret about sustaining operations on “auto mode” so that they can focus on growth. I looked into this and found that these companies had made significant investments in rolling out proven systems and processes that should have helped standardize and stabilize operations. So how come companies that have a massive presence in other parts of the world and run very sophisticated business operations in those countries but end up struggling with relatively smaller projects in China?

The insight that I got from all my discussions is that the real problem stems from a fundamental issue. We call it the “Jim and Bob theory.” Jim is any employee that has spent over five years in your company – he has a better view of the larger organization, is well networked within the company, feels empowered to make decisions when faced with hurdles, and often is the kind of person who is responsible for continuous improvement. Let’s call everyone else “Bob.” If you look at the ratio of Jims in your home market they are likely to comprise up to 40 percent of the work force, assuming your company is headquartered in a developed economy. This ratio is more likely to be lower than 10 percent in emerging economies. Why? Operations in these countries have been around for fewer years compared to home markets and are growing at a higher growth rate. Higher churn reduces the tenure rate, thus resulting in a majority of employees who have been with your company for less than 5 years – that is, your Bobs.

Because the Jim ratio is low, a number of things that worked smoothly in our home market do not work nearly as well in the emerging market or stop working altogether. The explanation? Mentoring is not as effective; too few Jims are teaching the new hires; institutional knowledge has not yet become common sense; fewer people are available to effectively troubleshoot problems; systems that seem to work well elsewhere receive too many complaints; compliance is low and so on.

I feel that studying successful companies that originated in emerging economies can provide some useful tips on how your operating model has to change to factor in this shift in personnel makeup. They have always have had to deal with higher growth trajectories, relatively high attrition, and consequently lower Jim ratios. I think these companies would have intuitively developed systems and processes that allow them to operate and scale in a similar environment.

Boardroom Lessons from a Social Media Misstep

Board members need to understand the factors that impact their businesses. Economics, politics, and sector shifts are all vital issues on the agenda in the boardroom. But the agenda needs to keep pace with what is influencing business, and amongst the things that board members need to fully appreciate is the growing influence and power of social media. It is not just about political uprisings any more.

Let me illustrate with a real world experience that has confirmed some of the discussions I've been having around the boardroom table:

On the morning of Monday, Aug. 1, I woke up to a Groupon offer in my mailbox. The headline was "Fatboy Buggle Up Beanbag 60% Off". I'm a big fan of Fatboy's offbeat beanbags — we have several in our house — so I clicked through to see more. But looking at the website, and clicking through to the supplier, I didn't see any reference to the Fatboy brand. Further examination led me to realize that this wasn't a real Fatboy, but rather a knockoff.

Usually I would simply delete the email, but it really made me cross. So, for the first time in recent memory, I wrote two tweets about a consumer issue: The first: "Is it false advertising if @Groupon_UK sends email clearly stating @Fatboy_original Buggle Up Beanbag 60% off, clicking thru it is knockoff?" and the second: "Clearly states Fatboy Buggle Up Beanbag for £89 from ILocal Furniture in @Groupon_UK email, but then BigDaddy Beanbag on @Groupon_UK site". Both were posted early in the morning.

I might have left it at that, but I began to wonder if there were any of the consumer advocacy agencies on Twitter, so I tracked down the Office of Fair Trading and I discovered the existence of Which? Conversation, a community website run by Which?, a UK consumer organization. I sent a follow-up tweet to both. A few people who follow me online joined in with their thoughts, including a patent and trademark attorney, and some other knowledgeable consumers.

Mid-morning, Groupon's Twitter team tweeted back that "We can confirm this deal is legitimate, if you have any question please call..." They clearly had not realized the true seriousness of the issue. You can read the details of how the day progressed on Which? Conversation's website. It turned out that the first couple of tweets that I sent in the morning had set things rolling: Fatboy's lawyers got in touch with Groupon; Which? was not just in touch via Twitter, but actually called Groupon over the phone.

In the end, Groupon withdrew the deal, refunded the customers (which set off further complaints about the time it took for the refund to process), and wrote an apology on their website, and responded to the story Which? Conversation wrote on their website. All of this was done by close of business the same Monday.

With one tweet, I was able to link up all the impacted and potentially useful organizations: Fatboy, Which?, and the Office of Fair Trading, and let them get on with addressing the issue. Except for decent Klout and Peer Index ratings (which I'm not even sure any of the parties knew), I was essentially any person on the street. I had no particular pull, no previous interaction with any of the parties, am not even a member of Which?, and to date have never even spoken to anyone involved on the phone.

What is the lesson we can take away as board members?

With the growth of social media and the barrier to entry for points of expression getting lower every day, anyone can start a movement or write about their concerns, and if it captures the attention of enough people, it can quickly spread. It doesn't require a mainstream newspaper taking up the cause either, so it changes the public relations dynamic as well.

For organizations like Groupon, a reputation for integrity and fair trading is much of what their business is predicated upon, especially now that others are nipping at their heels in the world of discount deals and looking so carefully at their corporate structure as Groupon prepares for its IPO.

Social media is a frontline service. It is not a place where you can funnel people into siloed areas via "choose option 1, 2, or 3" telephone lines. It encounters a multiplicity of queries be it marketing, customer service, legal issues, and more. It therefore should be managed by someone who is empowered in the organization, with the authority, or access to someone with authority, to make things happen in a decisive manner. Also, though this example is a customer issue, the influence and speed of social media touches a broad array of stakeholder related issues, be it a community rising up about an oil spill or unearthing poor labor practices in the third world. No sector is immune.

The more companies operate at a distance, where brands are based on reputation and documented actions, the more companies need to respond in a transparent way. It is not only for the sake of accountability but it also helps to enhance a sense of trust and reliability. In other words, we need to show our math.

As a board member, by asking the question knowledgeably and bringing my experience and expectations as an end user or consumer into the boardroom, I help shape the agenda for the company and help ensure the company is future proofing itself.

The board is not responsible for putting the mechanisms to address this issue in place — that is the role of the executive team. But we are responsible for asking the questions about how the company is integrating this new factor into the business, and harnessing it in positive and powerful ways. Is the company addressing the issues of the increased expectations of speedy response? Does it understand the power of opinion that can be quickly massed? Is the company using social media as a means to receive as well as transmit data? We as board members are also responsible for knowing if the answers we are given ring true.

If a couple of savvy tweets can do this, then imagine what a sea of tweets can do. That's the power of social media and we need to address it in the boardroom now.

Bristol CEO says "pure pharma" strategy paying off

(Reuters) - The Chief Executive of Bristol-Myers Squibb Co said the company intends to remain "100 percent" in prescription medicines and is prepared to use its $10 billion cash hoard to gain new drugs through moderate size deals with other drugmakers.

Lamberto Andreotti also told scores of industry executives and analysts that the company's recently approved Yervoy medicine for metastatic melanoma continues to generate good initial sales.

"We will continue to remain 100 percent pharma," Andreotti said at the Pharmaceutical Strategic Alliances Conference in New York. He said it was beneficial to have "the entire management team strictly focused on one business."

"We can continue to be successful as 100 percent pharma," said Andreotti, whose company is deemed by many analysts to have the strongest lineup of recently approved drugs and medicines in the late stages of development in the industry.

The 153-year old company now focuses completely on prescription medicines after having divested its consumer product, medical devices and nutritional products divisions. Its former brands include Excedrin and Bufferin headache medicines and Convatec wound-healing products.

Two years ago the company spun off its majority stake in Mead Johnson, a leading nutritionals company that sells Enfamil baby formula, to focus on traditional prescription pills and sophisticated biotech drugs.

Meanwhile, big rivals such as Pfizer Inc, Merck & Co Inc, Novartis AG, Johnson & Johnson and Sanofi SA say they get more reliable profit growth from an array of product lines, including animal health, consumer healthcare products and low-cost generics.

And unlike larger drugmakers such as Pfizer and Merck that have grown by gobbling up rivals through huge deals, Andreotti says Bristol has avoided going down that path.

"We didn't have to go through the disruption of mergers," he said, noting that the 1989 Bristol-Myers tie up with Squibb was many years before his time at the helm.

Bristol-Myers has captured attention for Yervoy, a biotech drug that spurs the immune system to fight advanced melanoma -- the deadliest form of skin cancer. It was approved in March and some analysts expect it to eventually generate annual sales of $6 billion as the first approved drug shown to extend survival of such patients.

Yervoy, which costs $120,000 for a full course of treatment, chalked up second quarter sales of $95 million -- its first quarter on the market.

Andreotti declined to discuss Yervoy sales for the third quarter, but said the drug "continues to do well."

Bristol-Myers acquired Yervoy through its $2.4 billion purchase of Medarex Inc in 2009. The company generates more than half of its revenue from deals it has made with other drugmakers, most far less costly than the Medarex transaction.

Andreotti noted that earlier on Thursday the company announced a collaboration with Ambrx Inc for an upfront payment of $24 million that gives Bristol-Myers access to drugs for type 2 diabetes and heart failure that he called "potential best-in-class" medicines.

Bristol-Myers has about $10 billion in cash with which to forge other deals.

"It feels very good to have $10 billion," he said, flashing a big smile. "And it feels good to have it in the U.S."

GE offers $100M challenge, $1B in R&D cash for new cancer tech

GE knows how to make a splash. This morning it was making waves in the cancer diagnostics field with its plan to join hands with four leading life sciences venture funds to offer a $100 million global challenge to developers of advanced cancer diagnostics, a $1 billion plan to beef up R&D investments in cancer detection and treatment over the next 5 years and a "super database" billed as a central repository on clinical, pathology, therapy and outcomes data that can help drive new products.

Kleiner Perkins Caufield & Byers, a well-known admirer of disruptive technologies, Venrock Associates, Mohr Davidow Ventures and MPM Capital will put up half of the $100 million, with GE contributing the rest. They plan to initially target breast cancer diagnostics with a special focus on personalized treatments.

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"We envision a day when cancer is no longer a deadly disease," said Jeff Immelt, the CEO and chairman of GE. "When you add our cutting edge cancer detection technologies to the innovative ideas of our new partners, it's a powerful formula for tackling cancer and helping doctors and researchers improve care."

GE's big initiative includes seed funding for academics, who stand to earn $100,000 of support for their work. And the tech giant and its VC partners rounded up a blue ribbon committee that includes former U.S. FDA Commissioner and National Cancer Institute Director Dr. Andrew Von Eschenbach to help parcel out the cash.

Most Annoying Things That Tech Companies Need To Fix

Without question, it's awesome to be alive right now thanks to all the amazing technology we have in our lives.

Instant access to every piece of information, every song, every movie, and just about anything else we want is right in our pocket thanks to our iPhone. It's pretty hard to get lost thanks to the iPhone, too. We get instant, simple contact with friends from Facebook, Twitter, and email.

And yet, for all of the incredible things the big brains (mostly) in Silicon Valley have thought up, there are one or two small things they forget. Maybe it's because they just don't realize the problems of us normal folks, or perhaps because they don't think it's important, or perhaps they just can't solve certain problems.

Whatever the reason, these forgotten features are the things that annoy the heck out of us in the world of tech.

Why your child's care should be moved

By Dr David Shortland Vice-president of the RCPCH
Boy in hospital Fifty children's wards 'might close'

Every parent wants the best care for a sick child.

But - as this government makes its first decision about restructuring hospital care - Dr David Shortland, vice-president of the Royal College of Pediatricians and Child Health says being treated further away from home might be necessary to get the best.

As changes within the NHS and the financial squeeze start to bite, hospitals are looking again at the affordability of keeping skilled pediatricians available on call 24 hours a day in small hospitals where there are similar services within about 30 minutes drive.

There are many units operating with dangerously low levels of staff, and trainee doctors being left to manage wards because there are just not enough senior consultants.

There is increasing pressure from the government to reconfigure children's services so that senior pediatricians are located in more specialist inpatient units, with smaller hospital wards closing or being converted to daytime-only units staffed by specialist nurses and visiting consultants.

It is likely that up to 50 of the existing 218 inpatient wards would need to close in the UK.

Many of these units will have experts on site to see children during the day rather than taking in-patients as they do now.

Although A&E departments don't only provide pediatric services, we are all aware that they are all under the same pressures.
Closures 'inevitable'

It is completely understandable that parents are worried about their local services moving away, but these changes are important so specialist units can achieve and sustain the necessary excellence and quality.

If we want our health service to protect health outcomes and safeguard children and young people, then parents have to face traveling further for treatment if their child needs an overnight stay.

As a parent, I would expect and want my child to have the highest quality care possible - and it is crucial the standards of care are not comprised in any way.
Continue reading the main story
“Start Quote

If your local unit can't meet the minimum standards of care for your child - wouldn't you rather drive that little bit further to one that can?”

These changes will allow doctors and nurses to be more readily available to the sickest children whilst continuing to offer the local service for early diagnosis and observation.

The new changes proposed will ensure that children are seen by senior trainees and consultants with better expertise and experience in a set period of time.

It's also important to highlight that it is not just pediatric services that are feeling the strain on services - we have seen opinion divided over children's heart surgery centers in recent weeks.

The government is also considering reducing the number of units locally and focusing on the regional centers for providing better care and outcomes for patients with a decision to be made by the end of this year, and changes implemented in 2013.

No matter which units are under scrutiny, the quality of care must remain or it only right those who cannot meet minimum standards should be closed down.

But any change should be solely on the basis of ensuring that the right standards of care can be met and children's health is paramount, taking into consideration the implications of longer journeys and transport arrangements.

Closure and changes to children's services are inevitable, but the reasons should be completely about the quality of care and support so children get better.

If your local unit can't meet the minimum standards of care for your child - wouldn't you rather drive that little bit further to one that can?