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Posts Tagged ‘Eli Lilly’


Reporter and Curator: Aviva Lev-Ari, PhD, RN

WOEST (What is the Optimal Antiplatelet and Anticoagulant Therapy in Patients with Oral Anticoagulantion and Coronary Stenting): Get Rid Of The Aspirin In Triple Therapy

According to current guidelines and clinical practice, PCI patients already taking an oral anticoagulant generally end up on triple therapy comprising the anticoagulant plus clopidogrel and aspirin. However, there is no supporting evidence base for this approach and the triple therapy regimen is known to increase bleeding complications. Now a new study– the first randomized trial to address this situation, according to the investigators–  may have a large impact on clinical practice by demonstrating that the omission of aspirin in this context appears to be safe and may reduce adverse events.

Results of the WOEST (What is the Optimal Antiplatelet and Anticoagulant Therapy in Patients with Oral Anticoagulantion and Coronary Stenting) trial were presented by Willem Dewilde at the ESC in Munich today. Investigators in the Netherlands and Belgium randomized 573 patients to triple therapy or dual therapy of an anticoagulant plus clopidogrel for at least one month after implantation of a bare-metal stent or one year after a drug-eluting stent. Two-thirds of the patients were receiving oral anticoagulation for atrial fibrillation.

The primary endpoint, the total number of bleeding events, was dramatically reduced in the dual therapy group at one year:

  • 44.9% in the triple therapy group versus 19.5% (HR 0.36, CI 0.26-0.50)

There were 3 intracranial bleeds in each group. Most of the difference in bleeding occurred in TIMI minor and minimal bleeding. The difference in TIMI major bleeding (3.3% versus 5.8%) did not achieve statistical significance.

Clinical events, the trials’s secondary endpoint, were numerically lower in the dual therapy group. The difference in mortality achieved statistical significance.

  • Mortality: 7 deaths (2.6%) in the dual therapy group versus 18 deaths (6.4%) in the triple therapy group, p=0.027
  • MI: 3.3% versus 4.7%, p=0.382
  • TVR: 7.3% versus 6.8%, p=0.876
  • Stroke: 1.1% versus 2.9%, p=0.128)
  • Stent thrombosis: 1.5% versus 3.2%, p=0.165

“The WOEST study demonstrates that omitting aspirin leads to less bleedings but does not increase the risk of stent thrombosis, stroke or myocardial infarction,” said Dewilde in an ESC press release. “Although the number of patients in the trial is limited, this is an important finding with implications for future treatment and guidelines in this group of patients known to be at high risk of bleeding and thrombotic complications.”

David Holmes said the trial addressed “an incredibly important issue” and predicted that it would “change the way we practice medicine, it will change practice right away.” Keith Fox said that the evidence base prior to WOEST was extremely limited and that the trial showed that there was no hazard in doing without aspirin. The ESC discussant, Marco Valgimigli, said the trial showed it was safe to drop aspirin and provided another demonstration that “we have hit the wall” with anticoagulation.

Republished with permission from CardioExchange, a NEJM group publication.

http://www.forbes.com/sites/larryhusten/2012/08/28/woest-get-rid-of-the-aspirin-in-triple-therapy/

European Society of Cardiology: Prasugrel Can’t Top Clopidogrel in ACS

 By Todd Neale, Senior Staff Writer, MedPage Today

Published: August 26, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

MUNICH — For patients with unstable angina or non-ST-segment elevation myocardial infarction (non-STEMI) who do not undergo revascularization, increasing platelet inhibition may not improve outcomes, a randomized trial showed.

Added to a background of low-dose aspirin, prasugrel (Effient) did not significantly reduce the rate of MI, stroke, or cardiovascular death compared with clopidogrel (13.9% versus 16%, HR 0.91, 95% CI 0.79 to 1.05), according to Matthew Roe, MD, of Duke University in Durham, N.C.

The risk of severe bleeding was similar with both drugs, although minor and moderate bleeding were increased with prasugrel, Roe reported at the European Society of Cardiology meeting here. The findings were published simultaneously online in the New England Journal of Medicine.

“I think the outcome is a bit surprising because we think usually that more aggressive antiplatelet therapy, conceivably, in the face of an acute coronary syndrome and non-ST-elevation would lead to lesser adverse outcome from acute myocardial infarction or death,” said William Zoghbi, MD, from Methodist DeBakey Heart Center in Houston and president of the American College of Cardiology.

But he said clinicians need to respect the data “and start thinking about pathogenesis and what we’re trying to do with any of our new interventions.”

In patients with unstable angina or non-STEMI, practice guidelines call for angiography within 48 to 72 hours with provisional revascularization. Many of these patients do not ultimately undergo revascularization, placing them at greater risk compared with those who have their arteries opened with percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).

Recommended medical therapy is with clopidogrel and aspirin, which is an approach that will not change from the current findings, Zoghbi said.

The purpose of the TRILOGY ACS trial was to explore whether using a more powerful platelet inhibitor — prasugrel — would improve outcomes compared clopidogrel (Plavix) in this high-risk patient subset.

The primary analysis involved 7,243 patients younger than 75 (mean age 62) who were receiving aspirin and were randomized to prasugrel 10 mg daily (or 5 mg daily for those weighing less than 132 pounds) or to clopidogrel 75 mg daily. The researchers recommended a daily aspirin dose of 100 mg or less.

A secondary, exploratory analysis involved 2,083 patients, 75 or older, who were randomized to prasugrel 5 mg daily or to clopidogrel 75 mg daily.

The lack of efficacy seen in the primary analysis of patients younger than 75 remained when patients of all ages were combined. There were no between-group differences for any of the components of the primary endpoint.

A prespecified secondary analysis taking multiple recurrent ischemic events into consideration showed a lower risk of MI, stroke, and cardiovascular death with prasugrel in the younger patients (HR 0.85, 95% CI 0.72 to 1.00, P=0.04), a finding consistent with the main results of the TRITON-TIMI 38 trial, which involved patients treated with PCI. The apparent benefit appeared after 12 months of treatment.

“Although this observation is exploratory, it raises the question of whether investigation of the multiplicity of ischemic events is warranted in future secondary-prevention trials, rather than solely analyzing the time to the first event, as has been traditional in studies involving patients who have had an acute coronary event,” the researchers wrote.

Rates of GUSTO severe or life threatening bleeding and TIMI major bleeding — as well as intracranial hemorrhage — were similar in the two groups in both the younger patients and in the overall study population. When minor and moderate bleeding events were added, the bleeding rate was higher with prasugrel.

There were no widespread differences between the groups in rates of nonhemorrhagic serious adverse events, but heart failure was more frequent with clopidogrel (1.8% versus 1.3%, P=0.045).

Douglas Weaver, MD, of Henry Ford Health System, said that he does not think the findings will have any impact on the use of prasugrel, which is not indicated for the patient population included in the study.

“It just doesn’t pass muster in improving value over clopidogrel,” said Weaver, a past president of the American College of Cardiology.

From a clinical perspective, he said, an important message from the study is the evidence of the safety of a reduced dose of prasugrel in the patients 75 and older, which is a consideration when prescribing prasugrel for patients undergoing PCI.

In comments following Roe’s presentation, Raffaele De Caterina, MD, PhD, of the G. d’Annunzio University in Chieti, Italy, provided context about how the findings fit in with the rest of the literature.

He compared the current results to those of a substudy of the PLATO trial, which involved ticagrelor (Brilinta).

In that trial, ticagrelor significantly reduced vascular death, MI, and stroke (HR 0.85, 95% CI 0.73 to 1.00, P=0.045) — the primary endpoint — and all-cause death (HR 0.75, 95% CI 0.61 to 0.93).

He then highlighted the ESC guidelines on treating patients with acute coronary syndromes without persistent ST-segment elevation.

In those, ticagrelor is recommended for all patients at moderate-to-high risk of ischemic events, regardless of initial treatment strategy and including those pre-treated with clopidogrel, and prasugrel is recommended for those who have not taken another P2Y12 inhibitor, who have a known coronary anatomy, and who are proceeding to PCI.

“I believe such statements and recommendations of the guidelines should not be changed,” De Caterina said.

TRILOGY ACS was funded by Eli Lilly and Daiichi Sankyo.

Roe reported relationships with Daiichi Sankyo, Eli Lilly, AstraZeneca, Bristol-Myers Squibb, Janssen Pharmaceuticals, Merck, Hoffmann-La Roche, and sanofi-aventis. The other authors reported numerous relationships with industry.

Primary source: New England Journal of Medicine

Prematurely halted ALTITUDE trial showed When added to monotherapy with either an ACE inhibitor or an angiotensin receptor blocker (ARB), aliskiren (Tekturna) did not improve outcomes in patients with type 2 diabetes who had high cardiovascular and renal risk

ESC: Aliskiren Onboard No Help in T2D

By Todd Neale, Senior Staff Writer, MedPage Today

Published: August 26, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

MUNICH — When added to monotherapy with either an ACE inhibitor or an angiotensin receptor blocker (ARB), aliskiren (Tekturna) did not improve outcomes in patients with type 2 diabetes who had high cardiovascular and renal risk, the prematurely halted ALTITUDE trial showed.

Through an average follow-up of 32 months, a composite of various cardiovascular and renal outcomes occurred in 17.9% of patients receiving the direct renin inhibitor and 16.8% of those receiving placebo (HR 1.08, 95% CI 0.98 to 1.20), according to Hans-Henrik Parving, MD, DMSc, of the University of Copenhagen and Aarhus University in Denmark.

As a Hot Line presentation European Society of Cardiology meeting here, Parving reported that there were no significant differences on any of the individual components of the endpoint — cardiovascular death, resuscitated sudden death, MI, stroke, unplanned hospitalization for heart failure, doubling of baseline serum creatinine, and onset of end-stage renal disease — or all-cause death.

The rate of stroke — mostly ischemic stroke — was numerically higher with aliskiren, although the result fell short of statistical significance (3.4% versus 2.8%; HR 1.25, 95% CI 0.98 to 1.60,P=0.07).

Thus, Parving said, using aliskiren with ACE inhibitors or ARBs in these high-risk patients “is not recommended and may even be harmful.”

The data monitoring committee for the ALTITUDE trial decided to stop the study early in December 2011 both for futility and for adverse events. Then, earlier this year, the FDA issued a warning about using aliskiren with ACE inhibitors or ARBs and changed the drug label to reflect a contraindication for such combinations in patients with diabetes or renal impairment.

The trial included 8,561 patients with type 2 diabetes who had a high risk of cardiovascular or renal disease who were randomized to aliskiren — at 150 mg daily for 1 month followed by 300 mg daily thereafter — or placebo in addition to monotherapy with either an ACE inhibitor or an ARB (but not both).

Adding aliskiren did not improve outcomes, and in fact, may have caused harm, Parving said, as indicated by the apparent increase in stroke risk.

He said that could be explained by the impaired autoregulation of patients with diabetes or by chance, as there are no indications of a stroke risk in other studies of the drug.

Johannes Mann, of Friedrich Alexander University in Erlangen, Germany, and McMaster University in Hamilton, Ontario, who served as the discussant following Parving’s presentation, agreed that it could be a chance finding, but said that it could also be a direct effect of aliskiren itself.

He concluded that the stroke risk was not explained, however, by dual renin system inhibition, because such a signal was not seen in the ONTARGET trial, which compared the combination of ramipril (an ACE inhibitor) and telmisartan (an ARB) with each drug as monotherapy.

As noted when the trial was halted last year, adverse events were more frequent in the aliskiren group.

The percentage of patients who had a potassium level of 5.5 to less than 6.0 mmol/L was greater with active treatment (21% versus 16%), as was the percentage of those with a potassium level of 6.0 mmol/L or greater (8.8% versus 5.6%).

Aliskiren carried higher risks of hyperkalemia (38.7% versus 28.6%), hypotension (12.1% versus 8%), diarrhea (9.6% versus 7.2%), and falls (2.8% versus 2.6%). There was one death caused by hyperkalemia.

Douglas Weaver, MD, of the Henry Ford Health System in Detroit, said that the findings were disappointing, but that they likely wouldn’t change how aliskiren is used in practice.

“I don’t think this is going to have a negative or a positive effect on it,” said Weaver, who is a past president of the American College of Cardiology.

ALTITUDE was sponsored by Novartis Pharma AG.

The executive committee and other investigators or their institutions received a consultancy fee. Some of the authors are employees of Novartis and therefore eligible for stock and stock options.

Primary source: European Society of Cardiology
Source reference:
Parving H-H, et al “The Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE)” ESC 2012; Abstract 399.

Aliskiren

From Wikipedia, the free encyclopedia
Aliskiren
Systematic (IUPAC) name
(2S,4S,5S,7S)-5-amino-N-(2-carbamoyl-2,2-dimethylethyl)-4-hydroxy-7-{[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-8-methyl-2-(propan-2-yl)nonanamide
Aliskiren (INN) (trade names Tekturna, U.S.; Rasilez, U.K. and elsewhere) is the first in a class of drugs called direct renin inhibitors. Its current licensed indication is essential (primary) hypertension.

Aliskiren was co-developed by the Swiss pharmaceutical companies Novartis and Speedel.[1][2] It was approved by the U.S. Food and Drug Administration in 2007 for the treatment of primary hypertension.[3]

In December 2011, Novartis had to halt a clinical trial of the drug after discovering increased incidence of non-fatal stroke, renal complications, hyperkalemia and hypotension in patients with diabetes and renal impairment.[4]

The following recommendations are being added to the drug labels for aliskiren-containing products as of 4/20/12:

I) A new contraindication against the use of aliskiren with ARBs or ACEIs in patients with diabetes because of the risk of renal impairment, hypotension, and hyperkalemia. II) A warning to avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (i.e., where glomerular filtration rate [GFR] < 60 mL/min).

Mechanism of Action

Renin is the first enzyme in the renin-angiotensin-aldosterone system which plays a role in blood pressure control. Renin cleaves angiotensinogen to angiotensin I, which is in turn converted by angiotensin-converting enzyme (ACE) toangiotensin II. Angiotensin II has both direct and indirect effects on blood pressure. It directly causes arterial smooth muscle to contract, leading to vasoconstriction and increased blood pressure. Angiotensin II also stimulates the production of aldosterone from the adrenal cortex, which causes the tubules of the kidneys to increase reabsorption of sodium, with water following thereby increasing plasma volume and blood pressure.

Aliskiren binds to the S3bp binding pocket of renin, essential for its activity.[5] Binding to this pocket prevents the conversion of angiotensinogen to angiotensin I.
Aliskiren is also available as combination therapy with hydrochlorothiazide.[6]

Many drugs control blood pressure by interfering with angiotensin or aldosterone. However, when these drugs are used chronically, the body increases renin production, which drives blood pressure up again. Therefore, doctors have been looking for a drug to inhibit renin directly. Aliskiren is the first drug to do so.[7][8]

Aliskiren may have renoprotective effects that are independent of its blood pressure−lowering effect in patients with hypertension, type 2 diabetes, and nephropathy who are receiving the recommended renoprotective treatment. According to the AVOID study, researchers found that treatment with 300 mg of aliskiren daily, as compared with placebo, reduced the mean urinary albumin-to-creatinine ratio by 20% (95% confidence interval, 9 to 30; P<0.001), with a reduction of 50% or more in 24.7% of the patients who received aliskiren as compared with 12.5% of those who received placebo (P<0.001). Furthermore, the AVOID trial shows that treatment with 300 mg of aliskiren daily reduces albuminuria in patients with hypertension, type 2 diabetes, and proteinuria who are receiving the recommended maximal renoprotective treatment with losartan and optimal antihypertensive therapy. Therefore, direct renin inhibition will have a critical role in strategic renoprotective pharmacotherapy, in conjunction with dual blockade of the renin−angiotensin−aldosterone system with the use of ACE inhibitors and angiotensin II–receptor blockers, very high doses of angiotensin II−receptor blockers, and aldosterone blockade.[9]

Adverse effects

  • Angioedema
  • Hyperkalemia (particularly when used with ACE inhibitors in diabetic patients)
  • Hypotension (particularly in volume-depleted patients)
  • Diarrhea and other GI symptoms
  • Headache
  • Dizziness
  • Cough
  • Rash
  • Elevated uric acidgout, and renal stones
  • Rarely: allergic swelling of the face, lips or tongue and difficulty breathing

Contraindications

  • Pregnancy: other drugs such as ACE inhibitors, also acting on the renin-angiotensin system have been associated with fetal malformations and neonatal death[10]
  • Breast feeding: during animal studies, the drug has been found present in milk.[10]

Aliskiren has not yet been evaluated in patients with significantly impaired renal function.

Drug interactions

Aliskiren is a minor substrate of CYP3A4 and, more important, P-glycoprotein:

  • Reduces furosemide blood concentration.
  • Atorvastatin may increase blood concentration, however no dose adjustment needed.
  • Possible interaction with ciclosporin (the concomitant use of ciclosporin and aliskiren is contraindicated).
  • Caution should be exercised when aliskiren is administered with ketoconazole or other moderate P-gp inhibitors (itraconazole, clarithromycin, telithromycin, erythromycin, amiodarone).
  • Doctors should stop prescribing aliskiren-containing medicines to patients with diabetes (type 1 or type 2) or with moderate to severe kidney impairment who are also taking an ACE inhibitor or ARB, and should consider alternative antihypertensive treatment as necessary.[11]

References

  1. ^ Gradman A, Schmieder R, Lins R, Nussberger J, Chiang Y, Bedigian M (2005). “Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients”. Circulation 111 (8): 1012–8. doi:10.1161/01.CIR.0000156466.02908.EDPMID 15723979.
  2. ^ Straessen JA, Li Y, and Richart T (2006). “Oral Renin Inhibitors”Lancet 368 (9545): 1449–56. doi:10.1016/S0140-6736(06)69442-7PMID 17055947.
  3. ^ “First Hypertension Drug to Inhibit Kidney Enzyme Approved”CBC. 2007-03-06. Retrieved 2007-03-14.[dead link]
  4. ^ Healthzone.ca: Blood-pressure drug reviewed amid dangerous side effects
  5. ^ “Chemistry & Biology : Structure-based drug design: the discovery of novel nonpeptide orally active inhibitors of human renin”. ScienceDirect. Retrieved 2010-01-20.
  6. ^ Baldwin CM, Plosker GL.[1]doi:10.2165/00003495-200969070-00004. Drugs 2009; 69(7):833-841.
  7. ^ Ingelfinger JR (June 2008). “Aliskiren and dual therapy in type 2 diabetes mellitus”N. Engl. J. Med. 358 (23): 2503–5. doi:10.1056/NEJMe0803375.PMID 18525047.
  8. ^ PharmaXChange: Direct Renin Inhibitors as Antihypertensive Drugs
  9. ^ Parving HH, Persson F, Lewis JB, Lewis EJ, Hollenberg NK. “Aliskiren Combined with Losartan in Type 2 Diabetes and Nephropathy,” N Engl J Med 2008;358:2433-46.
  10. a b Drugs.com: Tekturna
  11. ^ European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines.

External links

 http://en.wikipedia.org/wiki/Aliskiren

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Reporter: Aviva Lev-Ari, PhD, RN

Will ‘gamifying’ drug R&D win more than Facebook fans for Boehringer?

By Tracy Staton, FiercePharma, August 22, 2012

Lots of computer games enlist players in quests to save the world. But how many would-be saviors are developing drugs? We can’t think of any–until now. Boehringer Ingelheim is on the verge of launching Syrum, a Facebook game of test tubes and titrations, not crossbows and assault rifles.

 “The health of the world is in your hands,” Boehringer’s director of digital, John Pugh, tells PSRK, in what could be a voice-over for a YouTube promo video for the game. “And you’re the only one who can save it.”

 Players have to solve a problem–e.g., a pandemic–via drug development, all the way from early discovery through clinical trials and launch. They can enlist help from Facebook friends, and advance in the game by checking into locations via the social network’s mobile app. “It wasn’t built with a view to being an educational platform,” Pugh says. “It’s very much a game which is meant to be engaging and entertaining … In the same way that Farmville doesn’t just appeal to people who like farms, Syrum isn’t just for people who like the pharmaceutical industry.”

But it was education that drew Pugh and his team into the project; as he points out for PSFK, the industry does a lot of it, whether that’s “educating” doctors about products, or teaching patients how to take their meds properly. Just because the game isn’t designed as an educational platform doesn’t mean it can’t educate, in a stealthy, backhanded way.

Syrum has been in development for two years. On Sept. 13, Boehringer will unveil a beta version at a London conference, aiming to get feedback from players for future iterations. “[T]he game will grow and evolve as more people play it,” Pugh says.

He also says Syrum is a “very unique offering from a highly regulated industry.” True. Whether it will remain unique depends, in part, on how Syrum actually fares. Will it attract a following? And if it does, will gamification of drug development actually benefit Boehringer’s business? Image? Relations with patients? Pharma’s social media advocates (and skeptics) will be watching.

John Pugh, Director of Digital for Boehringer Ingelheim, talks about driving innovation in his large organization with the forthcoming game Syrum – which he will launch at PSFK CONFERENCE LONDON on September 13.
 
 
 
 
By Tim Ryan on August 21, 2012.
  • John Pugh is the Director of Digital for Boehringer Ingelheim GmbH – a group of pharmaceutical companies that specialize in research and development for prescription medicine products. He spoke to PSFK recently about driving innovation in a large organization with his forthcoming game Syrum – which he will launch at PSFK CONFERENCE LONDON on September 13.

Your company has a new game, Syrum. What is it – and why is a pharmaceutical company like Boehringer Ingelheim involved in it?

What really sparked my interest in the potential of gaming is that a lot of what we do in pharma is around educating and teaching people; whether that’s teaching doctors about specific products, educating the general public and patients about diseases and healthy ways to live, or teaching people how to take their medication.

Gaming seems to be a useful way and effective way for us to do that. I basically began the journey to try and work out what I could do in gaming that wasn’t an arcade or platform based game — but was something a bit more immersive.

Syrum has been in development for at least two years. At the beginning, we called in lots of experts from different industries, different locations in countries, and with different skill sets. We had various leaders, from specialized futurologists to branding experts, from pharma people to gaming people, and even young entrepreneurs who’d made a million dollars by the age of 17.

We really worked together to create a vision of the future, and one of the strong things that came through was the influence of gaming and gamification.

After two years of hard work, the result is that we are about to launch Syrum, the pharmaceutical industry’s first social game.

syrum-boehringer-ingelheim

Can you tell us a little more about the gameplay in Syrum?

Syrum is a social game. The health of the world is in your hands, and you’re the only one who can save it. In each chapter, you have to solve a particular problem, which could be a disease or a pandemic that is sweeping the world. The player’s goal is to discover cures, create a stable drug, and then create a clinical trial so that you can launch the drug and cure the disease.

It’s a social game, because you can collaborate with friends or other people, and you can give them gifts, even headhunt their staff. As the game progresses, it gets more and more complicated.

syrum-boehringer-ingelheim-game

What do you think people will get out of it?

First, it’s a fun game. It wasn’t built with a view to being an educational platform or anything like that. It’s very much a game which is meant to be engaging and entertaining to play. In the same way that Farmville doesn’t just appeal to people who like farms, Syrum isn’t just for people who like the pharmaceutical industry. It’s for anyone to play.

It’s built on Facebook because that’s the world’s biggest gaming platform. What we really wanted to do was try to use a lot of the features of Facebook. For example we leverage Facebook Places, a service where people can check into locations. It’s really bridging that offline/online world. Places helps players market the products they make. Wherever the players check in through the Facebook mobile app, that data gets integrated into the game and you get rewarded accordingly.

syrum-boehringer-ingelheim-game

When will it be available?

September 13. We are taking a Silicon Valley approach, where we know we have got a really good game that’s stable but we’ll launch a beta version. We really want to make it so that we get lots of feedback from the people who are playing.

We’re offering rewards and prizes for people to give feedback so that we can really create the duration of the game, and develop it, and have more of a crowdsourced collaborative effort to develop the future stages of it, so the game will grow and evolve, as more people play it. This is a very unique offering from a highly regulated industry.

Can we finish by understanding your role within the organization – and how you drive change.

My job is anything which is connected to digital, so that includes apps, mobile, websites, gaming, crowdsourcing, and so forth. Our goal is to find applications for all of that. I bring to this company new ideas and I inspire them, educate them, cajole them, prod them to try new things, particularly in digital. I want BI to stretch out beyond the traditional marketing activities because in pharmaceuticals, and particularly at Boehringer, we’re still very traditional in what we do.

Thanks John!

Come see John talk about the launch of Syrum at PSFK CONFERENCE LONDON.

Syrum / @johnpugh / Boehringer Ingelheim

Click the banner below to purchase tickets and find additional information about this year’s event.

 

via PSFK: http://www.psfk.com/2012/08/pharma-social-game-psfk-london.html#ixzz24IgR5ZEm

http://www.psfk.com/2012/08/pharma-social-game-psfk-london.html

How Sanofi Is Writing The Social Media Rules For Big Pharma Without Running Afoul Of The FDA

BY BEN PAYNTER

 | 

AUGUST 20, 2012

After a Facebook PR meltdown two years ago, Sanofi has emerged as a social media leader with a robust community for diabetics. Here’s how they are writing #TheRules while the FDA catches up.

About This Series

#therules

Follow Fast Company’s roadmap to social media: surefire rules, data, and expert wisdom guaranteed to show why this market is completely unpredictable.READ MORE

The biggest challenge to treating patients with diabetes isn’t doling out medications, it’s making sure that people control their habits. Poor diet and lack of exercise generally create complications with the disease. To combat the problems, researchers in the diabetes division of Sanofi US took an unusual step for Big Pharma: they went social, jumping into online networking with a Facebook page, Twitter presence, and eventually three different engagement platforms.

“Treatment is an important aspect to blood sugar management, but it isn’t the only aspect,” says Laura Kolodjeski, Sanofi’s diabetes community manager, who has become the virtual face of the company. “There is a huge community of people already that live with diabetes and are connecting and sharing [online] to improve each other’s experience with the disease.”

 

Laura Kolodjeski

 

Sanofi now helps direct and police those interactions online. The company won’t release total visitor numbers, but it has about 4,000 followers on Facebook and another 4,000 on Twitter, all of whom are sharing links to broader content. And for better or worse that community is going to grow: About 8 percent of Americans or roughly 26 million people have diabetes, and the Centers for Disease Control predicts that as many as one third of us could have the disease by 2050.

But the social frontier is potentially prickly for Sanofi because the FDA has not yet written the rules about how pharmaceuticals are allowed to engage with potential customers and patients. The only guidelines came out in a December 2011 advisory statement declaring that while allowing virtual comments about things like off-label uses isn’t technically illegal, it’s shady territory; basically, pontificate at your own risk. “We are working on the area and it’s something we feel is important but we don’t have a specific timeline right now,” says Ernest Voyard, senior regulatory council at the FDA’s Office of Prescription Drug Promotion.

For Sanofi, drawing up their own social media strategy is also a defensive move: In 2010, the company’s cancer division suffered a PR nightmare after a patient, who claimed to have experienced permanent hair loss from one of their treatment drugs, posted complaints and photos on that group’s unmonitored Facebook page. John Mack, the editor of Pharma Marketing News, which tracks shifts in the pharmaceutical industry, says such hits are common anytime you try to pioneer a new space. “They’ve had some rough times, but they are learning a lot,” he adds.

Mack considers Sanofi a leader in the category, especially compared with the offerings from other companies. Diabetes juggernaut Novo Nordisk sponsors IndyCar driver Charlie Kimball to tweet @racewithinsulin, including when he injects with their products. And Pfizer’s ThinkScienceNow blog about developments and advances in research is wonky but not exactly customer friendly.

Sanofi has created a template they hope will eventually be deemed both acceptable to the FDA and cool for customers. The lessons they’ve learned in the last two years is a valuable addition to The Social Media Roadmap from our current issue.

Be Transparent

When she took over as social media director, one of the first things Kolodjeski did was post a bio with a photo of herself online at DiscussDiabetes to show who was moderating. She also disclosed that she wasn’t diabetic. Why? To build trust, the kind community members might not have for a faceless company run by mostly non-diabetics. The message: “If Laura is going to work every day to solve [issues] on our behalf, then others must be doing the same,” Kolodjeski says.

Rather than just explain the rules of their forums in a jargon-y “terms of use” agreement Kolodjeski also tapped Mark Gaydos, head of the company’s U.S. regulatory affairs for marketed products division, to do a Q&A about how the sites would function. For instance, anytime someone on the site mentions a product, they are technically promoting it, so there needs to be fair balance of potential benefits and risks explained alongside that per FDA guidelines. That means many posts get quarantined internally before posting, so the company can add additional links or annotations to more information. Sanofi only wants to allow discussion of FDA-approved uses for products–any mention of possible side-benefits or bonuses from tweaking the usual dose regimen is prohibited. To make sure everything meets these requirements, there is often a delay–sometimes up to 24 hours–between when users make comments and those comments become publicly visible.

To explain their business interest, Kolodjeski also interviewed Dennis Urbaniak, the head of the company’s U.S. diabetes business unit to explain what he calls the “360-degree partner” principle–an effort to inspire others to talk more and tap into that as a focus group for new ideas.

Let Users Shape Expansion

Sanofi launched their diabetes Facebook and Twitter handles in September 2010 mainly to offer news updates about the company and its offerings. On Facebook, any clinical questions were directed to a separate tab and often answered privately. On Twitter, medical concerns were covered via direct message. What was missing was a way to collect various poster’s lifestyle tips and inspirational messages all in one place. In January 2011, the company launched DiscussDiabetes to address that. They also run their own stories about successes, including highlights from A1C Champions, another company sponsored group of diabetics who have maintain the best or “A1C” target range of blood sugar levels.

By March of this year, the company took a look at the discussions that were being generated and realized that terms like A1C weren’t actually as universally understood as they once thought. To speed that learning curve, they launched Diabetepedia, which provides both simple definitions and links to other sites showing how terms are actually used in other online conversations.

The final step: After noticing how activity at Diabetepedia was spiking, Sanofi launched another site collecting lots of the content they were already linking to all in one place. The DX, which launched at the end of May, hosts daily dispatches by both Kolodjeski and stable of already popular bloggers (none of whom are paid directly) that include everything from a diabetes related comic strip to mommy blogs for parents with diabetic kids. “We really allowed the community to help identify what might be useful to them and where they might go next,” Kolodjeski says.

Give Users Even More Control

The medical glossary at Diabetepedia doesn’t just provide standard definitions to complex terminology, users are encouraged to submit their own entries, creating a sort of slang dictionary that makes complicated stuff more relatable to newcomers. For instance, glucoaster: that’s shorthand for “a rollercoaster of blood glucose levels, with blood sugar lows followed by blood sugar highs.” User contributions have helped the database grow by 30 percent to include more than 150 terms, all of which make it easier to users themselves to better convey thoughts in future postings.

The company also considers each media outpost an exclusive “channel,” which means there is lots of cross-posting of content from different platforms to make sure users who only tune into one place are being best served. “We certainly have people that overlap but for the most part people have selected which channel they feel represented by and communicate through,” Kolodjeski says. But at each stop, the company still tries to crowdsource bigger ideas.

This year, they asked users to help set priorities for the company’s annual Data Design Diabetes Innovation Challenge, which asks individuals, businesses and non-profits to create new initiatives for using big data to help others struggling with the disease. To help brainstorm for that, Sanofi’s social media troop was given the chance to visit a competition homepage and answer questions about what aspects of life with the disease might be consistently overlooked or ignored. Their answers were used to shape a final guideline for contestants that solutions must address the overall wellness and family life of patients, not just symptom mediation. The winner: a program created by the n4a Diabetes Care Center that matches people with certain cost or risk profiles directly to the services they might need to slow the progression or expense of the disease. Mood problems can be addressed by better disease management, hopefully cutting into the 18 percent of all diabetics who require hospitalization each year.

After realizing just how open users are to sharing and connecting, Sanofi also launched their own new product, the iBGStar, a personal blood glucose monitor that plugs directly into an iPhone or iPod Touch with an app that saves data and maps correlations between blood sugar levels and meal times, carb and sugar intake, and physical activity. Users can share results with their family or email them to health care providers. But the product, which hit the market in May 2012, wasn’t just inspired by early community actions; ensuing reviews and comments in their own forums will help refine future updates. “It’s a big hit with the online community,” Kolodjeski says. “It’s also given us a great opportunity to prove back to them that if we hear someone comment about something, we have the ability to engage in a public manner.”

Correction: An earlier version of this article said that iBGStar came on the market in 2011, it was released in May 2012.

http://www.fastcompany.com/3000457/how-sanofi-writing-social-media-rules-big-pharma-without-running-afoul-fda

Lilly to develop company-wide social media strategy

11 Jul 2012

 
Nearly two years after launching its first major foray into the world of social media in the shape of its LillyPad corporate blog, Eli Lilly is developing a company-wide social media strategy.

Lilly has so far had strict rules about who can use social media on behalf of the company, authorising just a handful of people in corporate communications and government affairs, but now wants to empower other departments to do so.

“There are a lot of parts of the company that are getting interested in social media so I’m working on a strategy that will keep these aligned with one another,” Lilly’s director of corporate communications Greg Kueterman told SMI’s Social Media in the Pharmaceutical Industry conference on Monday.

“We don’t want to have eight different social media platforms that all look and sound very different from one another. So we’re going to try and do something where they all have their own identity but are still consistent within the company.”

Kueterman acknowledged LillyPad, launched September 2010, and the company’s Campaign For Modern Medicines, a US health policy initiative Lilly founded last year that uses Twitter, Facebook and YouTube, were set up “before we had a full blown strategy”.

“But sometimes that is important,” he said. “Because you have to know what you have, before you can make it even bigger.”

The company’s Clinical Open Innovation team, a group working to improve the drug development process, also began using social media earlier this year, with a blog and Twitter account.

The next stage for Lilly will be to continue its expansion of LillyPad (as previewed herein March), following the launch in May of a Canadian version of the corporate blog.

“We’ve started to go global with LillyPad and we’re working with a number of our affiliates to do this. Lilly Canada has been the first one out of the box to do that and they’re off to a nice start,” Kueterman said.

Discussions are underway with the company’s European affiliates in the UK and Belgium along with its operations in Mexico. “Hopefully some of those are going to be launching this year, although we don’t have firm dates yet,” Kueterman said.

“We’re excited that this is a programme that’s going to start picking up momentum. Looking ahead there are still things that we can do much better. I’m never really satisfied with the way things are going with LillyPad – I’m happy, because I think we’re doing things the right way, but I also believe that we can be even more proactive than we are.”

• Links to Lilly’s social media presences can be found in the Pharma Social Media Directory‘s blogsTwitterFacebook and YouTube sections 

http://www.pmlive.com/digital_intelligence_blog/archive/2012/jul_2012/lilly_to_develop_company-wide_social_media_strategy

What Else Can We (Really) Do?

by Greg Kueterman 07/10/12 


On Monday, I had the pleasure of presenting Lilly’s social media history and strategy at a conference in London. The history part was easy: LillyPad — our first major platform — has been around for 22 months. We’re not experiencing the Terrible Twos just yet, but we’ve still got plenty to learn.

The London audience — consisting of European and U.S. communicators and marketing experts at the Social Media for Pharmaceutical Industry conference. — warmly embraced our strategy of addressing issues such as public policy and medical innovation. And the reception was not unusual. Over the last two years, we’ve talked LillyPad in live settings from London to New York to Indianapolis to San Francisco — and our peers typically offer two thumbs up for the good work.

For that, we are grateful. But it’s a good reminder about a couple questions we need to ask more often:

What else can we be doing? What else should we be doing?

As our loyal readers, you know what we offer — and you know what you need to become more informed. We would love to hear more from you: the good, the bad, and the ugly. We’re always looking to enhance LillyPad, and we’ve taken a lot of steps in recent months to do so (more video, more guest blogs, and — we think — clearer, more conversational writing). And while we will remain a non-product communications vehicle, we’re open to any and all ideas that make your LillyPad experience even better.

From London (where I’ve seen more rain in three days than my backyard has seen in two months) thanks for reading!

http://lillypad.lilly.com/entry.php?id=1736

 

 

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