 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. http://www.pharm-education.com/2010/03/walmart-coming-to-healthcare-how-do-we.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.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.Do you have questions for the author?
 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 CivilityAgree 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 CoachingSome 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 FeedbackTo 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.Full article at http://www.pharm-education.com/2010/03/workplace-incivility-on-rise-what-can.html Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. Do you have questions for the author?
 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. Also at http://www.pharm-education.com/2010/03/starting-metformin-within-three-months.html Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.Do you have questions for the author?
 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. More at http://www.pharm-education.com/2010/03/strategies-to-prevent-heart-attacks-in.html Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. Do you have questions for the author?
 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.comExpert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. Do you have questions for the author?
 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.... Reference- http://www.pharm-education.com/2010/03/what-is-future-of-medicine-what-are.html For detailed FREE white paper on this topic, register at www.drshrutibhat.comDisclaimer- 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.
 Dr.Shruti Bhat, Generics and Specialty Pharmaceutical Expert.
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... 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... 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... 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... 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...
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... Full article at http://www.pharm-education.com/2010/03/can-vaccines-be-preserved-without.htmlDisclaimer- 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.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.
 Dr. Shruti Bhat, Generics & Specialty Pharmaceuticals Expert. In their quest for new and more potent drugs, pharmaceutical companies look to their scientists for inspiration. Once a discovery is made, there is often a rush to patent as much of the discovery as it allows and then some. Patent practitioners seek to protect new compounds by filing patent applications in which, once granted, broad genus claims protect not only the compounds actually made by the scientists, but also other compounds of similar chemical structure, which, if they are made, would be predicted to have similar properties. This type of broad claiming generally rewards the discovery of a hitherto unknown class of compounds identified by a common chemical structure and can protect many hundreds of thousands of compounds. However, available human and financial resources often limit the number of compounds claimed that can actually be made and tested. Given that the Patent Act confers on an inventor the right to a monopoly for 20 years, where should the line be drawn in terms of extending claim protection beyond the initial discovery? Check out full article at http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/03/selection-patents-new-business.htmlDisclaimer- 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.comExpert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS.
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 Health Canada says Accutane may cause potentially deadly skin reactions. The Canadian Press reported that in an advisory from, Health Canada warned consumers that rare but potentially deadly skin reactions have been reported with the use of Accutane [isotretinoin] for the treatment of severe acne. ... Diabetes drug may increase fracture risk in women. According to a study published in the Journal of Clinical Endocrinology & Metabolism, women with type 2 diabetes who take a commonly prescribed drug for the problem are at a higher risk of bone fractures. Researchers found that women taking "a class of medicines called thiazolidinediones, or TZDs... Syringes with detachable needles may play role in hepatitis C incidence among drug abusers. The Los Angeles Times reported, "The high incidence of hepatitis C infections among drug abusers may be due in part to the use of syringes with detachable needles...FDA unveils risk-management plan for anti-anemia drugs. The Los Angeles Times reported that Physicians who want to prescribe Amgen Inc.'s anti-anemia drugs for cancer patients will have to register and undergo special training under a risk-management plan unveiled by the FDA... Antibiotics may be overprescribed for ear infections. The Wall Street Journal reported that many physicians routinely prescribe antibiotics for ear infections in young children, even as current guidelines only recommend the treatment for the youngest and sickest of patients... Drug counterfeits continue to plague Middle East. Syria is reportedly aiming to reduce the use of counterfeit drugs as the problem remains widespread in the Middle East. A recent seizure of millions of dollars worth of breast cancer, leukemia ... 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. Read full article... http://www.qa-expert.com/2010/03/diabetes-drug-may-increase-fracture.html Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.Do you have questions for the author?
 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." ...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%... 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)." ...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...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)...Details of above topics/ data at http://www.pharm-education.com/2010/03/cabazitaxel-may-improve-metastatic.htmlDisclaimer- 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.comExpert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. Do you have questions for the author?
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