Walmart coming to healthcare! How do we ensure we have the agility, insight & execution in order to survive in this period of rapid healtcare change?

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

I've done extensive work within the healthcare sector over the last many years; this is one industry where the rapidity of scientific driven change is simply unprecedented. Think about what is really happening around us, and about what needs to be done:

A transformative shift - Personalized medicine drives the agenda: the big picture item is that we are in the midst of a fundamental, significant shift in healthcare philosophy and medical research: from a world in which we “react” to disease and illness after it has happened, to one in which we will be doing far more to “prevent” health care problems through highly personalized medicine.

This is primarily coming about because of furious rates of discovery related to genomics. This more than anything will dominate the health care / pharmaceutical research / delivery agenda through the next years.

Knowledge growth becomes exponential; pace of innovation / discovery picks up: medical knowledge is now doubling every eight years. Expect it to be doubling every two years by 2010 -- with the result that medical professionals will be struggling to an even greater degree in keeping up than they are today. Research taps out practical results faster than ever before.

The key for everyone is tapping into global collaborative discoveries / keeping up / developing agility for rapid innovation, response, development, and implementation. For pharmaceutical and health care suppliers, it's about rapid development and rapid time to market.

Discovery moves offshore: for a good chunk of the pharmaceutical industry, the proces of R&D, approval and application will increasingly move offshore, particularly to China / India, due to different regulatory requirements (or lack thereof). Also, such things as stem-cell research limitations, US visa policies and other factors play a factor in the diminishing role of the US as a pharmaceutical industry hub.

The pharmaceutical industry will continue to spend a huge amount of time learning to work within the new shifting zones of influence in the world of research.

Theory into practice becomes the primary focus; operational excellence is key: already, health care can’t keep up with the rate of scientific discovery: “Because of the rapid discovery of new medical knowledge, you'll get the most up to date treatment today only 50% of the time” is one key stat to remember. Tomorrow, the prime focus in the medical community will be how to ingest and incorporate this new knowledge into practice.

In terms of the pharmaceutical industry, the key goal will be “operational excellence,” i.e. ….from the Financial Times 6 Jun article on Roche, “…the Avastin story also highlights a central issue for innovation-led companies: how to make sure advances in the laboratory are brought to market quickly and efficiently.” There’s a whole line of thinking emerging in that article and elsewhere that puts into perspective that collaborative excellence in managing complex teams is quickly becoming a key and critical success factor.

Skills fragment and a battle for skills drives decisions: hyper-growth in knowledge and new medical discoveries means that every medical profession is becoming more specialized, leading to a greater degree of niche-oriented medical skills than we see today. In the pharmaceutical industry, small biotech companies will continue to dominate the research agenda over big-pharma, by focusing on ever tighter niche markets, as well as by discovering disease-oriented drugs based on specific genetic markers. Skills fragmentation results in challenges, but so does the looming baby boomer retirement wave.

A war for medical talent drives much of the agenda of the industry by 2010, and the battleground is global in scope.

Complexity partnerships take on an increasing role: because of the skills crisis, rapid discovery, need for operational excellence, knowledge growth and discovery, big/medium the pharmaceutical industry will continue to look to shed additional component pieces of the discovery / regulatory approval process; outsourcing takes on a whole new meaning.

Bio-informatics emerges, core competence becomes critical: Microsoft estimates that at least 50,000 people worldwide are working in the field of bio-informatics – the folks who are developing the highly sophisticated computer databases and computational methodologies that can do the billions of measurements on an individual patient that is leading us into the era of personalized medicine.

Bio-connectivity becomes the next big thing: a new generation of intelligent, Internet-connected medical devices flood the industry, providing new opportunities for monitoring and management of difficult health care conditions. Furious pace of innovation occurs here as consumer tech trends (collapsing product lifecycles) come to medical devices and medical technology.

Hospitals get “de-physical”, customer service comes to the industry: today, a health care institution is thought of as the building or campus that makes up its constituent parts. Tomorrow, it will be defined by the reach of its virtual network, and the hospital will be thought of as the extended community network by which a good portion of its services are provided.

Walmart is coming to health care; the Minute-Clinic business model and others like it mean that we are seeing a revolution in customer service come to the industry.

Generational attitude transforms the system: the entrance of Gen-Y -- kids who are in 2005 aged 15 -- into the health care system -- will bring a flood of new ideas, innovation and new ways of thinking helping to break some of the organizational sclerosis that has clogged up the opportunity for change in the world of health care.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Workplace Incivility on the Rise: What Can We Do to Stop It ?

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma corporate culture, news, views and data.

There is a disturbing trend in Corporate North America. Despite increased talk about improving corporate culture, there is a civility problem in the workplace. It is wreaking havoc on employee relationships and workplace morale, as well as the bottom line. And few leaders are doing anything to stop it.

According to The Cost of Bad Behavior by Christine Pearson and Christine Porath, it is far more widespread than people realize—and incivility in the workplace has devastating effects. Here are just a few of the statistics from their research study of 800 employers:

· 96 percent have experienced incivility at work.
· 48 percent of employees claim they were treated uncivilly at work at least once a week.
· 10 percent said they witnessed civility every day.
· 94 percent of workers who are treated uncivilly say they get even with their offenders.

What is Incivility in the Workplace?

Pearson and Porath define incivility as “the exchange of seemingly inconsequential inconsiderate words and deeds that violate conventional norms or workplace conduct.”

In essence, what is considered “uncivil” is based on an individual’s perceptions of actions or words.

Sometimes it is blatant, like:

· losing one’s temper or yelling at someone in public
· rude or obnoxious behavior in the workplace
· badgering or back-stabbing in the workplace
· withholding important customer/client information
· sabotaging a project or damaging someone’s reputation.

And others times it may be a bit more subtle, like:

· arriving late to a meeting
· checking e-mail or texting during a meeting
· not answering calls or responding to emails in a timely manner
· ignoring or interrupting a colleague in the workplace
· not saying “please” or “thank you”

Incivility does not just happen between coworkers. About a quarter of the customers/clients they surveyed believe disrespectful behavior is more common today than it was five years ago, and 40 percent said they experience rudeness from employees at least once a month! So much for all the talk and advertising about great service and a positive customer experience.

Why Does it Matter?

It can have a devastating impact on your employees, as well as the organization as a whole. When incivility is prevalent in the workplace, stress levels increase and performance suffers. Employees will become less engaged, which means they can also become de-motivated, apathetic and even angry. They put in less effort, produce lower quality and can even burn out. Perhaps you’ve seen these telltale signs. They lead to losses in productivity, efficiency and of course, profitability.

According to Banishing Burnout by M.P.Leiter and C. Maslach, the annual cost of job stress alone due to incivility at U.S. corporations is $300 billion.

What Can We Do About it?

1. Increase Awareness:

The first step is to recognize that incivility is an issue that can debilitate an individual and an organization. Educate employees about the cost and impact of uncivil behavior. Most people don’t even realize the trend or know the cause of their malaise or frustration in the workplace. Define what it is and what it looks like. And, share the research on the impact of continued incivility in a community to increase the sense of urgency to address it.

2. Create Workplace Standards and Value Civility:

Agree to set a clear, written standard for behavior, noting what is acceptable and what is not. The first step must begin by setting down guidelines of corporate governance by the management board followed by strict implementation of the laid out principles by HR and respective heads of the departments.

Leadership needs to be not only involved in the process, but committed to modeling civility and reinforcing its importance. Communicate the standards with all associates so they understand how to consistently demonstrate respect and concern for others. Consider making civility one of your core values, a principle that guides the internal conduct at your organization.

Be sure to recognize and reward employees who model it, so all employees see it’s a serious commitment—a value of the business, not just words on a wall or plaque. Equally important is addressing incidents and complaints, and taking corrective action so your employees see it is not condoned or tolerated.

3. Provide Internal Training and Coaching:

Some people in the workplace may not even realize they exhibit uncivil behavior—the employees figure this is “not about me.” Well, chances are they lack self-awareness (like some of the perpetrators) and/or have no idea how to change behavior that may be ingrained. Training employees on your new standard will help create an open, friendly and accepting environment.

Ideally, the internal training would be experiential and include realistic skill practices that are videotaped, so employees can see themselves and hear how they sound. This helps associates see the impact of their behaviors on others and allows them a chance to practice in a safe environment. When the employees experience progress in the training and receive developmental coaching to maintain the change, the employees are more likely to continue their newfound behaviors.

4. Encourage Open Communication and Feedback:

To sustain the new culture, put systems in place that encourage open communication so that it becomes the norm. Organizational leaders need to lead responsibly and create a safe environment so employees are not fearful when sharing concerns or reporting incidents.

Promote constructive and open feedback so employees learn how to demonstrate respect and common courtesy, really listen to each other and be more accepting of each others’ ideas and opinions. Continue the dialogue and engage employees in the process by gathering their input and ideas. Share progress along the way so all employees can see the impact of their efforts and celebrate successes.

Why Bother?

It makes sense to cultivate a climate of civility and a culture of openness and inclusion. According to P.M. Forni, the co-founder of the Johns Hopkins Civility Project and author of Choosing Civility:“Encouraging civility in the workplace is becoming one of the fundamental corporate goals in our diverse, hurried, stressed and litigation-prone society.

A civil workplace is good for workers, since the workers’ quality of life is improved in such an environment. But a civil workplace is also good for the customers, since the quality of service they receive from happier and more relaxed service providers is improved.”

And, it is the right and most civil thing to do...

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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Starting Metformin Within Three Months Of Diabetes Diagnosis May Increase Drug's Efficacy.

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

Starting Metformin Within Three Months Of Diabetes Diagnosis May Increase Drug's Efficacy.

According to a study published in the March issue of the journal Diabetes Care, "starting patients with metformin within 3 months of their diabetes diagnosis increases the drug's efficacy." After studying "the electronic records of 1,799 patients with type 2 diabetes who received metformin as their first antihyperglycemic medication," researchers found that "a lower rate of secondary failure occurred in those who began metformin soon after their diagnosis." In addition, "patients who started the medication with an" A1C "level of less than 7% failed at an adjusted rate of 12.3% per year."


Somaxon Receives FDA Approval For Insomnia Drug.

Development-stage biotech company Somaxon Pharmaceuticals Inc. said Thursday the Food and Drug Administration approved its delayed insomnia drug Silenor [doxepin]." The agency "approved the drug to treat short term and long term insomnia," but it "did not schedule Silenor as a controlled substance, as expected." Regulators delayed "decisions on the drug...in 2008 and again in February of 2009" seeking "more information on the drug."


Adding Cilostazol To Dual Antiplatelet Therapy May Not Improve Outcomes In DES Patients.

A study presented at the American College of Cardiology meeting. reported that "adding cilostazol -- an antiplatelet approved in the US for treatment of intermittent claudication -- to standard dual antiplatelet therapy did not improve clinical outcomes in patients receiving drug-eluting stents," Researchers found that, "six months after the procedure, patients who had received cilostazol in addition to standard therapy had significantly lower platelet reactivity, compared with those receiving dual antiplatelet therapy alone." But, the investigators found, "that addition did not translate into a significantly lower rate of cardiac death, myocardial infarction, ischemic stroke, and target lesion revascularization, the primary endpoint."


Gender-Based Drug Research Has Yet To Lead To Tailored Treatments.

Time magazine that while "an estimated 12 million American women are routinely prescribed statins...there is little evidence that they prevent heart disease in women." In fact, when researchers "analyzed the data on healthy female patients in" statin trials, they "found that the lifesaving benefit, which extends to men, does not cross the gender divide. What's more, there's evidence that women are more likely than men to suffer some of the drugs' serious side effects." Time notes that although gender-based research has grown and "has begun to reveal crucial information about how the development of diseases -- such as heart disease, lung cancer, and autoimmune disorders -- may affect women in markedly different ways from men," the practice "has not taken the next step: tailoring treatments according to gender-specific data."


Drug Combination Meets Key Milestone In Cancer Trial.

According to Abraxis BioScience, Nanoparticle albumin-bound paclitaxel (Abraxane) "met a key milestone in a non-small cell lung cancer clinical trial." In "a multicenter phase III study of 1,052 patients, the drug showed a significant improvement in overall response rate, compared with solvent-based paclitaxel (Taxol)," the drug's maker said. The company said "the study compared both forms of the drug, in combination with carboplatin, for first-line treatment of patients with advanced non-small cell lung cancer," and that the "response rate was assessed by independent radiologist review." MedPage added that "the data from the trial are to be submitted as a late-breaking abstract for the June meeting of the American Society of Clinical Oncology in Chicago, the Los Angeles-based company said in a statement."


Minocycline May Help Halt HIV Progression In T Cells.

According to a study released online in advance of publication in the April 15 print issue of the Journal of Infectious Diseases, minocycline (Minocin), "a cheap acne drug that's been used for decades, appears to target infected immune-system cells in which HIV lies dormant before coming back to life and spreading infection”. Johns Hopkins University researchers "said minocycline targets immune cells known as T cells and makes it harder for them to reproduce. That, in turn, makes it harder for HIV to spread and eventually cause AIDS."


Twice Weekly Tacrolimus Ointment May Be Safe, Effective For Children With Atopic Dermatitis.

According to research presented at the American Academy of Dermatology meeting, "tacrolimus 0.03% ointment applied twice weekly is effective and safe for children with moderate to severe atopic dermatitis (AD)." In a study of 153 children with moderate to severe AD who were "randomized to apply either tacrolimus 0.03% ointment twice weekly on areas of usual flare (maintenance therapy, n = 78), or to a standard reactive tacrolimus regimen (standard therapy, n = 75)," researchers found that "the maintenance group experienced significantly fewer major flares than those in the standard group (P < .001), with 46.2% experiencing no major flares at all (compared with 21.3% of those in the standard group)."

New Form Of Inhaled Insulin May Be Less Risky Than Exubera.

According to research presented at a chemical society meeting, Afrezza (insulin human [rDNA origin]), "a new form of inhaled insulin, appears to help people with diabetes who must use insulin, with fewer potential risks than" Exubera (insulin inhaled), "an earlier form of inhaled insulin that is no longer on the market." Afrezza, "which is awaiting approval from the US Food and Drug Administration, works faster, keeps blood sugar levels at a closer to normal level, and has less risk of causing low blood sugar levels (hypoglycemia) than currently available injectable insulins, researchers say. It also appears to have less risk of causing lung problems than...Exubera."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.


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Strategies To Prevent Heart Attacks In Type 2 Diabetes Patients May Be Ineffective, Harmful, FDA To review study.

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

The New York Times reported that, according to studies presented at the American College of Cardiology meeting and to be published online March 18 by the New England Journal of Medicine, "aggressive treatment strategies doctors had expected would prevent heart attacks among people with type 2 diabetes and some who are the verge of developing it have proved to be ineffective or even harmful." Still, some experts, such as Dr. Daniel Einhorn, said that the results of these studies "would not necessarily dissuade him from taking such intensive measures with individual patients." He conceded, however, "It's hard to make a case for a public health recommendation.

The Wall Street Journal reported that the ACCORD study of a subset of 5,518 patients found that treating hypertension to levels currently lower than recommended in practice does not lower the risk of stroke, heart attack, or death in type 2 diabetes patients. Moreover, researchers also found that Abbott's drug TriCor (fenofibrate), even though it did lower triglyceride levels, did not stop patients from having strokes and heart attacks. In another study, the drug Starlix (nateglinide) did not stop patients at high risk for type 2 diabetes from eventually developing the condition.

The ACCORD study findings "provoked a sharp response from Abbott vice president Eugene Sun, who said in a statement that" in patients with "abnormally high triglycerides or low levels of good cholesterol," combining "fenofibrate and simvastatin reduced heart attacks, strokes, and deaths by 31% over simvastatin alone." Meanwhile, cardiologist Steven Nissen, MD, of the Cleveland Clinic, pointed out the risk of a "higher incidence of kidney failure and other serious side effects" revealed when "doctors examined the benefits of intensive blood pressure lowering in diabetic patients and found that it failed to reduce deaths, heart attacks, and strokes taken together."

A decade ago, the federal government launched the three-part study to see whether intensely lowering blood sugar, blood pressure, or fats in the blood would reduce heart attacks and strokes in diabetics. The first piece of the study -- about blood sugar -- was stopped two years ago, when researchers saw more instead of less risk with that approach." As for what to do now, cardiologist Clyde Yancy and other experts advised diabetic patients to "focus on healthy diets and lifestyles, and take tried-and-true medicines that doctors recommend now to control health risks."

One report focuses particularly on TriCor's failure "to cut the risk of heart attacks, strokes and cardiac deaths in diabetics." In a related piece, Bloomberg News reported that "Novartis AG's top blood pressure pill Diovan (valsartan) failed to prevent heart attacks, strokes or deaths in high-risk patients, while its diabetes drug Starlix didn't protect them from developing heart disease or diabetes." HealthDay 3rd March issue, also focused on the Diovan and Starlix study conclusions.

In an editorial accompanying the studies, the Los Angeles Times "Booster Shots" blog reported that "Dr. David Nathan, of Massachusetts General Hospital, wrote that the 'prevention of diabetes remains a critical public health priority, but for now we should steer away from" Diovan and Starlix, "'and use effective lifestyle interventions" or metformin."

Tthe findings come from the huge National Heart, Lung, and Blood Institute-funded Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial which, overall, involved more than 10,000 patients with type 2 diabetes at risk for heart disease.

FDA To Review ACCORD Study.

In a related story, The FDA said it will conduct a full review of findings from a study which concluded that neither aggressive lipid-lowering therapy nor tight blood pressure control reduced cardiovascular events in persons with diabetes." The study found the "addition of fenofibrate" to statin therapy "did not reduce cardiovascular events." MedPage Today noted that an FDA "spokesperson said the agency planned to include a review of the labeling and indications for fenofibric acid (Trilipix). It should, however, be noted that the trial used fenofibrate (TriCor)."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Insulin patch is on track for clinical trials. Is needle free insulin dependent treatment round the corner ?

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

FDA Devising New Guidelines To Expedite Testing, Approval Of Multidrug Regimens.

The Wall Street Journal reported that the FDA is creating new guidelines aimed at expediting the testing and approval process for multidrug regimens that include new, experimental drugs for some deadly diseases. The agency normally requires each treatment in a drug cocktail to be tested and approved separately. FDA Commissioner Margaret Hamburg said the move "represents a bigger issue -- the strengthening of regulatory science" to include scientific advances.


FDA Changing Rules For Testing Tuberculosis Drugs.

Bloomberg News reported that the Food and Drug Administration is now "changing rules for testing tuberculosis drugs to enable Johnson & Johnson, Sanofi-Aventis SA, and Pfizer, Inc. to speed up approval of new combination treatments by decades." In a March 18 statement, the "Global Alliance for TB Drug Development, a research group funded by the Bill & Melinda Gates Foundation and national governments," announced that "at least 10 companies agreed to work together to test experimental tuberculosis treatments simultaneously in new combinations," instead of developing "each component of a therapy...independently," a process that requires "24 years to make novel combinations."


Insulin patch is on track for clinical trials.

Phosphagenics Limited’ s TPM (Targeted Penetration Matrix) insulin project should begin human trials in the first half of 2010. For this product, the company has adapted the patch technology that it had developed for its oxycodone program. The company also has achieved dose optimization that reduces substantially the amount of insulin required for a therapeutic dose and has demonstrated through tests on animals that the product lowers glucose levels.


New Study Aims To Identify Effective Breast Cancer Treatments Quickly.

"Breast cancer researchers say they could cut years off the time required to test new drugs for treating certain kinds of tumors under a study about to begin at the University of Minnesota and the Mayo Clinic." The study is designed to help researchers "quickly identify which drugs are effective for different groups of patients, based on the genetic or molecular makeup of their tumors." The "drugs that show no benefit can be quickly dropped, without wasting years and millions of dollars on further study."

Three companies have joined the government in the "$26 million trial set to last five years," The trial includes five drugs, which "the FDA is now involved in fast-tracking...but says it is important to find the right drug for the right patient." Dr. Anna Barker, deputy director of the National Cancer Institute, "says that as a result" of the study, "life-saving drugs will get to patients much faster."

There are reports that patients will be matched to the drugs based on their DNA, and the drugmakers agreed to share information on predicting patient response using their genes. The study will include Abbott Laboratories' veliparib, Amgen's conatumumab and AMG 386, and Pfizer Inc.'s figitumumab and neratinib.


Different Pediatric Asthma Cases Do Best With Different Step-Up Treatments.

Researchers at the University of Wisconsin have discovered that "different kids do best with different step-up treatments" once they find that their "regular steroid inhaler fails to prevent asthma attacks."

According to the paper in the New England Journal of Medicine, the "drugs with the best chance of success -- 45% -- are long-acting beta-agonists," however, "safety concerns limit the use of these agents." Investigators also discovered that approximately "30% of kids...do best either with a leukotriene-receptor antagonist, or by doubling the dose of the child's current inhaled steroid medication," but there is "no clear winner," and "there were few clues to predict which kids were most likely to do best on which step-up treatment."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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What is the Future of medicine ? What are the lessons from 60 years of pharmaceutical innovation?

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

It’s the title of a very insightful analytical paper by Bernard Munos (Nature Reviews, Dec-2009). He applied statistical analysis techniques to the aggregate inputs and outputs of the pharmaceutical industry.

The most stunning insights from his analysis are:

1. Average annual output of the industry is constant and has been so for 60 years, despite consistent increase in R&D investment ($50 billion/year). Practically, it means that the output of the industry is not depressed, as commonly thought, but simply reflects the innovative capacity of the established R&D model. In this light,new approaches, such as the open innovation paradigm, public-private partnerships and industry consortia hold a lot of promise.

2. If the NME (New Molecular Entity) output is constant, the only way to grow is to increase the number of companies, which goes contrary to the 2009 wave of large mergers & acquisitions (M&As). However, Bernard Munos’ analysis shows that, broadly speaking, the impact of M&A in the pharmaceutical industry on R&D is “1+1=1″, which is consistent with other analysis (Grabowski, Kyle in “The Economics of Corporate Governance and Mergers”, p.262-287, 2008). A more nuanced view reveals that for small companies nearly 80% of acquisitions increased the NME output while for large companies the proportions were roughly reversed: 70% of acquisitions reduced NME output whereas 30% of acquisitions increased NME output.

3. Let’s forget the rate of innovation and focus on sales instead. After all, customer knowledge, efficient sales infrastructure and disease expertise are the core competencies of major industry players. Every commercial decision and development step that can be codified and turned into a predictable process already has been done. However, sales forecasts for new products are inaccurate nearly 80% of the time and portfolio management techniques have failed to protect the industry from patent cliffs. Munos’ analysis shows that the probability that an NME will achieve blockbuster status is about 21%, a success rate that has not changed in 20 years.

Solution? Bernard Munos’ recommendations point to the need to rethink process and culture.

Quoting CEO of GSK, Jean-Pierre Garnier: “The leaders of major corporations have incorrectly assumed that R&D was scalable, could be industrialized and could be driven by detailed metrics and automation. The grand result: a loss of personal accountability, transparency and the passion of scientists in discovery and development.”

Igniting passion for discovery is a tricky task for a large corporation. However, I am confident the veritable fireworks of passion for medical discovery will very soon be a realty if research breakthroughs and promise of NME R&D successes have to be recorded often.

How do we bring in passion for discovery? Is it through good HR practises? Certainly not... and it doesn’t need management to pump in dollars either !

The answers are available for those interested to bring in a wave of change to their R&D’s systems, functioning and culture....

For detailed FREE white paper on this topic, register at http://www.drshrutibhat.com/

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Expert at Leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.

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Can vaccines be preserved without refrigeration? new technology revelations-

Dr.Shruti Bhat, a Generics & specialty pharmaceutical expert, brings to you some highlights from current pharma business news-

Technology may allow vaccines to be preserved without refrigeration.

A new technology, developed by British firm Nova Bio-Pharma Technologies and tested at Oxford University, may represent a sea change in vaccine preservation -- minimizing the need for long-term storage in refrigerators or freezers, and improving access and global health as a result." The study, published in the journal Science Translational Medicine, found that "the technology, which utilizes special membranes stabilized with a sugar compound, was shown to preserve two different types of virus-based vaccines for four months at a temperature" of 113 degrees Fahrenheit or 45 degrees Celsius "with no degradation."

The researchers also found the vaccines could be stored for a year or more at 37 degrees Celsius with only minimal losses of vaccine.

Watson To Pay $47 Million For Drug To Prevent Premature Birth.

Watson Pharmaceuticals Inc. press reported that it will pay $47 million upfront for a Columbia Laboratories Inc. drug that is being developed for the prevention of premature birth." Watson will pay $45.5 million more if the drug, currently marketed as Crinone and Prochieve, "succeeds in clinical testing, gets approved, and reaches the market." The companies also are working "on a late stage clinical trial of Crinone for the prevention of premature birth in women with a short cervix."

Bristol-Myers Has 60 Potential Drugs In Its Pipeline.

Executives at Bristol-Myers Squibb Co. told analysts at a business briefing that the drug maker has 60 potential drugs in development, seven in late-stage studies." Bristol-Myers "said it expects future revenue from those medicines and growing sales from existing drugs to help offset an expected plunge in Plavix sales in 2012." The key drugs in development "include the blood thinner apixaban, organ transplant drug belatacept, cancer drug brivanib, diabetes drug dapagliflozin and skin cancer drug ipilimumab."

Glaxo Looks To Expand In India.

The Wall Street Journal reports that GlaxoSmithKline PLC seeks to expand in India through both acquisitions and core business growth, Glaxo CEO Andrew Witty said, "Opportunities will be evaluated based on a variety of factors, including the strategic nature of the fit."

Synta Pharmaceuticals To Restart Development Of Skin Cancer Drug.

Synta Pharmaceuticals Corp. announced that "it will restart development of its skin cancer drug candidate elesclomol," a decision reached "after consulting with the Food and Drug Administration." The company "said it expects to start at least one new clinical trial in the second half of 2010." The drug is designed to treat metastatic melanoma. The company halted a trial of elesclomol due to safety issues and an increased number of deaths among those on the medicine.

Roche Expects Increase In Sales From China.

Bloomberg News reports, "Roche Holding AG expects sales of drugs in China to account for about half of all pharmaceutical revenue from the Asia-Pacific region within three years, spurred by higher incomes and the nation's health reforms." Roche "is benefiting as higher incomes and cancer rates in the world's most populous nation spur demand for its Herceptin [trastuzumab] and Rituxan [rituximab] oncology drugs." Roche may also benefit from rising rates of heart disease and diabetes in the region if late-stage patient studies of two experimental drugs are successful.

Perrigo To Buy Orion Laboratories For $48 Million.

Perrigo Co., a maker of the over-the-counter drugs, "said it would buy Orion Laboratories for $48 million in cash, expanding its market in Australia and New Zealand." Perrigo "said the addition of Orion," which makes and distributes pharmaceutical products to hospitals, "will boost annual sales by more than $30 million and add to earnings in the first year."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.

Cabazitaxel May Improve Metastatic Prostate Cancer Survival...many more updates.

What efforts go behind the scene till a new drug hits the market? Do patients benefit ? Are they cured? How do we control health care costs? What are the new drugs in the making? To know more, visit http://www.drugsinthemaking.com/

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

Heartburn Drug Renamed To Avoid Medicinal Mix-Ups.
Press reports that, Takeda Pharmaceuticals will change the name of a heartburn drug that has repeatedly been confused by pharmacists with drugs meant to treat cancer and other ailments." The drug, Kapidex (dexlansoprazole), has been mistaken for "Casodex [bicalutamide], a prostate cancer drug, and Kadian [morphine extended-release], a narcotic pain reliever." The newly-named Dexilant will "begin appearing on store shelves in late April 2010.

Cabazitaxel May Improve Metastatic Prostate Cancer Survival.
According to a study presented at the Genitourinary Cancers Symposium, "cosponsored by the American Society for Clinical Oncology (ASCO), the American Society for Radiation Oncology, and the Society of Urologic Oncology," the Sanofi-Aventis prostate cancer drug cabazitaxel "increased survival by 30%...compared with the standard therapy of mitoxantrone" when "used as a second-line therapy" in men with metastatic disease. Researchers found that "men in the cabazitaxel group had a median survival of 15.1 months, compared with 12.7 months for men in the mitoxantrone group." The researchers noted that cabazitaxel's overall survival benefit was "consistent across subgroups."

FDA Approves Mylan Generic Gastrointestinal Drug.
Mylan Pharmaceuticals Inc. has received final Food and Drug Administration approval for 300-milligram Ursodiol capsules, the generic version of Watson Pharmaceutical's gastrointestinal drug Actigall."

Hydroxychloroquine May Help Delay Skin Damage In SLE Patients.
According to a study published in March issue of Arthritis Care & Research, "treatment with hydroxychloroquine (Plaquenil) may help delay the occurrence of skin damage in patients with systemic lupus erythematosus (SLE)." In a study of "580 patients who had not yet developed skin damage at baseline," researchers found that use of hydroxychloroquine "was associated with a longer time until integument damage -- defined as scarring alopecia, extensive skin scarring, and skin ulcers -- was present." Moreover, "the cumulative probability of damage at five years was 5% for those taking hydroxychloroquine, compared with 24% for those who were not on the drug."

FDA Approves Pre-Filled Injection Pens Of Somatropin.
The FDA approved pre-filled injection pens of the endogenous growth hormone disorder drug somatropin (Norditropin) for adult and youth patients." The Norditropin FlexPro "produces an audible click that tells patients the medication has been dispensed," and is a single-use device and does not require reconstitution to administer. The drug is indicated for children who have growth failure attributed to insufficient endogenous growth hormone, short children with Noonan or Turner syndrome, children born short who have not grown enough by two to four years, and adults with growth hormone deficiency due to pituitary disease, hypothalamic disease, surgery, radiation therapy, trauma, or those with childhood-onset growth hormone disorders.

FDA Approves Weekly Immune-Replacement Therapy.
CSL Ltd., the world's second-biggest maker of treatments derived from blood, won US clearance to sell Hizentra (IgPro20), "a weekly immune-replacement therapy for people with genetic disorders that lead to frequent infections." The drug "contains 20 percent immunoglobulin, or antibodies, and is intended as a replacement for CSL's older Vivaglobin product, which contains 16 percent and was previously the only self-administered immune treatment approved in the US." An FDA letter said that the drug Hizentra "did not raise concerns or controversial issues" that would warrant a review by outside advisers.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.


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Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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Is there a break through? Six Genes May Help Predict Paclitaxel's Effectiveness In Cancer Patients.

Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

Leading the news...
Six Genes May Help Predict Paclitaxel's Effectiveness In Cancer Patients.
According to research published in The Lancet Oncology, "Scientists have developed a gene test which predicts how well chemotherapy will work in cancer patients." In a study of "829 genes in breast cancer cells," researchers "whittled down the possibilities to six genes which had an impact on whether a drug worked." The study "showed that these genes could be used to predict the effectiveness of paclitaxel in patients."

Researchers found that "if any of the six genes are 'faulty,' paclitaxel does not work and the tumor cells continue to divide uncontrollably, just as they would without treatment," The lead researcher Dr Charles Swanton, from the Cancer Research UK charity's London Research Institute, said that the "research shows it is now possible to rapidly pinpoint genes which prevent cancer cells from being destroyed by anti-cancer drugs and use these same genes to predict which patients will benefit from specific types of treatment."


"Painless" Vaccine Delivery Method Introduced In Japan.
Japanese researchers have unveiled a "painless new vaccine delivery system" consisting of "as many as 300 micro needles" that do not need to penetrate the dermis layer of skin. Professor Kanji Takada, of Kyoto Pharmaceutical University, said the "patient feels no discomfort and there is no bleeding”. It is hoped that the use of the microneedles, which dissolve after being pressed into the skin, will help alleviate some patient's fear of getting shots.


Scientists Say TB, Antiretroviral therapy should be administered concurrently to co-infected patients.
Clinicians with patients who have both HIV and tuberculosis infections should not defer antiretroviral therapy until TB treatment has been completed. In fact, the "benefit of concomitant treatment was so striking that a data safety monitoring committee stopped the sequential arm of the study within two months of completion of enrollment," according to researchers in South Africa. The findings published in the New England Journal of Medicine add "weight to World Health Organization guidelines," which favor "integrated therapy."


Genentech Says Avastin Failed.

To Extend Survival Of Patients With Advanced Stomach Cancer.
Genentech reported that the combination of its blockbuster cancer drug Avastin [bevacizumab] and Xeloda [capecitabine] did not meet a late-stage goal of extending the lives of advanced stomach cancer patients." Genentech "said it will submit the data and hopes to present full results...at the 2010 American Society of Clinical Oncology's annual meeting." But, Genentech pointed out that the study did not reveal any new safety issues with Avastin.


Impax Receives FDA Approval For Generic Flomax.
Drugmaker Impax Laboratories Inc. reported that the Food and Drug Administration gave final approval to its generic version of the enlarged prostate treatment Flomax [tamsulosin hydrochloride]." The company "plans to start shipping the drug immediately." Impax "said it had reached a legal settlement last October with Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals Inc." to launch its generic version.


FDA Rejects Ranbaxy's Generic Flomax.
Daiichi Sankyo Co., which controls 64 percent of Ranbaxy Laboratories Ltd., reported that the " FDA rejected its Indian unit's application for approval to sell the generic version of Flomax. The company was expected to launch its generic version March 2 under a patent settlement.

Reference-

http://www.drshrutibhat.com/2/category/drug%20research%20and%20technology%20updates/1.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
Do you have questions for the author?

Marketing Your Career -- Become a Proactive Job Seeker, know what is personal branding.

The global economic crisis has hurt all of us in various ways. If you’ve been laid off in recent months, or are unhappy with your present job or keen on a change of job, then you're feeling recession’s effects very directly. It’s discouraging to try to get a job while the news reports continue to announce massive new layoffs, and the resumes you send out lie buried in stacks on hiring managers' desks.

However, your job loss can be an opportunity to reassess your career, figure out what you want to do next, and take more control of your future.

Clearly, the days are gone when one company took care of you from graduation through retirement. While you may still meet people who’ve worked for one company for 30 or 40 years, their situation has little in common with ours. In fact, today’s average worker changes jobs every 3 years. Furthermore, hiring managers now prefer the worker who has changed jobs every 3 years. In the manager's eyes, that's the worker with broad experience. The worker who’s stayed with one company for 30 years is now a questionable bet, unless he or she moved around within the company, continuing to learn and grow.

Since you can't rely on a company to manage your career, you have to manage it yourself.

Coz..."If you don't have a plan, someone else will make your plan." And forming that plan for your career is a critical first step in creating the future you want. You need a strategy for the short term and the long term.

In essence, you need to figure out what you want to become, and develop a plan that will get you there. Your plan may change, but you do need one. That's strategy.

Now what about strategy execution? What do you do to get the job you really want? The answer? Marketing/ branding.

Marketing yourself, or proactive job searching, starts with identifying (1) what you can offer, (2) what distinguishes you from your competition, and (3) who your target market is. Marketing yourself is no different than marketing a product, but the product is you.

To effectively market yourself, you must develop a good understanding of your assets--your skills and personal traits. If you know your strengths, you can market yourself more effectively and with greater confidence, making your strengths available to companies that are looking for them.

You also need to understand the marketplace for people with your skills. This requires research. You may find that you need to go back to school or that people with your skills are employed in industries you hadn't thought of.

When you know your skill set and your market, your job search should rely on two important techniques: informational interviewing and networking.

One technique to apply to your job search is the informational interview. In the informational interview, you contact people who work in a field or company that interests you, and ask them questions to increase your knowledge and understanding. The interview can be done on the phone or in person. You can take this approach: "I'm exploring the kind of work I want to do, and I’d like to learn more about you and your work."

The informational interview is an extension of the research you’ve already done. These interviews should help you learn more about your field of interest and intelligently craft your career plan. You might make a connection through interviewing that leads to a job, but don't approach it that way. Instead, be a researcher. Always thank your interviewees for taking time to help you. If they’re interested, keep them updated on how things work out.

The second key tactic used by the proactive job searcher is networking. Networking is about meeting people--lots of them--and staying in touch. You should focus your networking on people who are in your field of interest. A good way to do this is to attend professional association meetings in your target field. Attend the meetings of these and similar organizations. Use the meetings to develop relationships with the members, and you will gradually build a powerful professional network.

Why do you need a professional network? Because the people in your network care about your success, just as you hopefully care about theirs. Many of them also recognize that helping each other is far more fruitful than treating others as hostile competitors.

Read full article...click http://www.drshrutibhat.com/2/category/personal%20branding/1.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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Innovative Strategies and Models for R&D Success.

Over the last quarter of the twentieth century, medical research made substantial advances in defining our understanding of diseases, their etiologies, and the biochemical pathways through which they were mediated. Our understanding was further augmented by human genome research. As the pathways of disease were clearly identified, pharmaceutical research largely focused on a “lab to market” approach, which involved identifying/synthesizing molecules that could mediate a disease pathway, characterizing their various attributes, and then commercializing them. In several cases, new molecules had characteristics that were marginally different from others already on the market, and therefore, did not address any unmet clinical need. Commercial success was often determined by the intensity of the sales and marketing effort behind the product, which resulted in an “arms race” (a battle for maximizing share of voice by investing in larger and larger sales teams) and the emergence of “blockbusters.”

The last 10 years have seen a seismic shift in the dynamics of pharmaceutical sales and marketing. The return on investment in sales force expansion is shrinking, causing almost all major pharmaceutical companies to reduce their head counts. Further, it is increasingly evident that the market and regulators are interested in new therapies that address an unmet need rather than yet another product in an existing class of molecules with little or no clinical or economic benefit.

Over the last few years, most of the innovations in pharmaceutical development have been only incremental — for most indications, there are significant therapy options available and it is unlikely that a radically better “wonder drug” will become available soon. Consequently, a disproportionate amount of ongoing research and development (R&D) effort has gone into products already in the market to expand the spectrum of indications where they can be used. A look at the number of drugs approved by the US FDA over the years indicate 35 new drugs approved in 2005 as against only 20 last year.. The decline in approvals is a clear indication of how difficult it will be for pharmaceutical companies to continue to show revenue growth in future.

As they grapple with shrinking pipelines, stricter safety requirements of the regulator, and spiraling costs to bring a product to market, pharmaceutical companies need to ensure that their products genuinely fulfill an unmet market need. Therefore, it is imperative that the R&D effort follow a “market to lab” approach—one that reverses the conventional approach used over the last few decades.

Aligning the organization to the Goals of Clinical Development-
Clinical R&D is a complicated process involving several steps and multiple stakeholders, both internal and external, in a pharmaceutical organization. Over the last 50 years, the journey of a product from laboratory to the market has not only become more arduous and time-consuming, but also more risky. Furthermore, since more and more clinical development plans (CDPs) include global, multi-centric clinical trials, their formulation and execution are broken into several sub-elements, each of which have become the responsibility of different functional silos in a pharmaceutical company. Consequently, clinical R&D at present involves stakeholders from the strategic, marketing, sales, medical, R&D, clinical operations, regulatory affairs, documentation, and health economics teams.

Given that the collective objective of all the teams involved in the CDP is to achieve a desirable Target Product Profile (TPP) and therefore a superior product label, pharmaceutical companies must ensure that all stakeholders are aligned and share a common line of sight to the end objective. This is not always easy, but is a critical challenge that must be overcome. Failure to do so runs the risk of a CDP not being in step with current and future market needs, and oblivious to the competitive scenario in the future.

The essence of “claims-based R&D” lies in taking a backward “market to lab” approach so as to ensure that the CDP is designed to address specific unmet market needs. It also involves the systematic benchmarking of a product’s CDP to current and future competition while continuously evaluating scientific and market threats and opportunities. It involves the integration of multiple inputs to develop the CDP and then prospectively simulate the likely TPP of the product and a SWOT analysis vis-à-vis its inline and pipeline competitors.

The Process of Developing a CDP-
The process of claims-based R&D is iterative since it attempts to temper the desire to develop an “ideal” product with scientific and operational feasibility. With the ever-growing volume of information and data available in the secondary domain, it is now possible to pursue claims-based R&D to a far greater level of granularity than before. It also enables TPP simulation on a near real-time basis as pivotal information becomes available.

Customer Insights-
In an earlier era of pharmaceutical development, unmet market needs were determined almost exclusively from the opinions of physicians and medical key opinion leaders (KOLs). In the modern era, however, there has been a significant shift in the level of influence exerted by different stakeholders (customers) on the patterns of pharmaceutical consumption. These stakeholders (customers) include the patient, the payor, and the regulator.

While pursuing claims-based R&D, it is critical to ensure that the insights and opinions of all the key stakeholders (customers) are accurately captured so that the product(s) developed can genuinely claim to deliver a clinical and/or economic benefit.

These insights are most often captured through primary research and intelligence initiatives, which include engagement with physician groups, patient and caregiver groups, insurance agencies, etc. However, such initiatives can be effectively complemented by research of secondary sources of information such as online patient discussions boards and transcripts of regulatory proceedings.

Full article... http://www.drshrutibhat.com/2/category/business%20news/1.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.


Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
Do you have questions for the author?