DNA targeting could pinpoint early cancers or deliver radiotherapy straight to the tumor. U.K. researchers have found a way to test for a protein that could become a biomarker for many different types of cancer
. The DNA damage-signaling protein, γH2AX (gamma-H2AX), signposts the points where both strands of the DNA double helix have broken, one of the first steps in development of cancer (known as tumorigenesis).
The team from Oxford University's Gray Institute for Radiation Oncology and Biology has built an imaging probe that targets this protein. The probe is in three parts--an anti-γH2AX antibody that targets the biomarker, a peptide (TAT) that penetrates the cell, and 111In, a radioactive marker used as an imaging agent.
To test out the concept, the researchers used the probe and SPECT imaging to find DNA damage in a type of genetically modified mice that tend to develop breast cancer lumps that can be felt after around 17 weeks. The test spotted potential cancers in mice up to 5 weeks before they developed these lumps. The same marker is also seen in lung
, skin, kidney and bladder cancer.
Katherine Vallis of the institute told BBC News
: "If larger studies confirm this, the protein could provide a new route to detect cancer at its very earliest stage--when it is easier to treat successfully."
As well as being a biomarker for many cancers, this finding could also lead to a way to deliver radiotherapy directly to the damaged cells and monitor its effects, treating established tumors or even heading off cancers almost before they start. As Vallis explained to BBC News
, the system is "self-amplifying" because the radiotherapy will cause further damage to the cells, therefore attracting more antibodies that will deliver more radiation, eventually killing the cancer cells. However, the technology has only been studied in mice so far, and it is a long way off use in humans.
We are in the midst of third quarter earnings reports, and they show with stark detail what the tsunami of patent losses means to the financial underpinning of drugmakers. It's a serious problem that will erode earnings for years to come. Pharmaceutical researcher EvaluatePharma
estimates there are $290 billion of sales at risk from patent expirations between this year and 2018.
Companies are trying to put the most positive spin they can on the impact, but the effects can take your breath away. For example, Sanofi , suggested in their company's most recent earnings call that things are looking up because its new full-year projection is for earnings to drop only 12% this year, not the 15% projected earlier. Sanofi lost protection for three drugs. Megablockbuster Plavix
, a blood thinner, alone saw sales drop 70%.
And the patent cliff pain continues. In 2013, patents will expire on drugs that currently have sales of $29 billion annually. The research firm expects more than 70% of that total will be lost to generics. Falling revenue is usually tracked by a falling share price, but the firm points out that patent cliff problems, when a wave of big-ticket drugs lose protection, generally show up several years in advance with a stalling stock price.
The implications are, of course, huge. But is it all bad? "The patent cliff is generally portrayed as a bad event for the Industry, but it may turn out to be a good event, with companies feeling liberated from the mega-blockbuster curse of replacing aging cash flow
That depends, on how companies respond. Too often, spurred by the feeling they need to raise their share price--and perhaps made overconfident by the success of aging blockbusters--they blow it. They take excess cash from those aging cash cows and overindulge on "risky, late-stage, in-process R&D assets in seemingly high-priced and speculative in-licensing deals and company
Even those companies that say they are dedicated to finding their future with R&D don't always seem to know how. Statistics points out the industry has plunked down $1.1 trillion, in the last decade on research and development--and too often with very poor results.
So what are the drugs that top the 2013 patent expiry list? Presented here the top 15, out of about 120, that will see patents expire next year. It is led by Eli Lilly's anxiety and depression drug Cymbalta
, which last year generated $4.9 billion in sales for the company. It includes Purdue Pharma
, which sold to the tune of $2.4 billion last year, and tails off with the Novartis osteoporosis
, which generated $612 million.
While the overall losses are less than this year's, which will see patent protection stripped away on about $67 billion, they will keep some companies in a vise grip of indecision. Others, perhaps, will free themselves and find their way to smart investments and drugs that provide benefits to patients and returns to shareholders.
New cancer drugs are a top priority for most pharmaceutical companies these days, but the sector's sales trajectory has flattened as key medicines lose patent protection and new breakthrough products prove scarce.
U.S. sales of oncology drugs increased just 3.5 percent in the first nine months of this year, according to pharmaceutical market information company IMS Health.
The sector saw sales growth of 23 percent in 2006, after Roche Holding AG's Avastin was launched. It grew by 14 percent in 2007 and 9 percent in both 2008 and 2009.
"This is an unprecedented slowdown," IMS representatives said at the Reuters Health Summit. "Growth is largely being driven by pricing increases," as well as the entrance of lower-cost generic drugs. Read more...
Drug recalls reached a record high 1,742 in 2009 — more than four times the amount in 2008. Bowman Cox, managing editor of the Gold Sheet told CNN Money that in light of the 296 recalls issued in the first six months of 2010, there could be 600 or more recalls this year. Why So Many Recalls? Analysts and legislators are examining the recall statistics to find sources and solutions to the pharmaceutical safety issue. 1. Drug repackaging :Advantage Dose, a now-defunct Shreveport, LA based drug re-packager, was responsible for more than 1,000 of the 2009 recalls. Companies like Advantage Dose repackage and re-label drugs into smaller units for resale or distribution to health care facilities. After excluding Advantage Dose from the count, there still remains a 50% jump in recalls from 2008 to 2009. 2. The generic rush : Gold Sheet’s Cox suggests that generic manufacturers cut drug design costs in their rush to be first to market after a branded-drug’s patent protection expires, decreasing quality. “The first generic applicant typically gets the lion’s share of the business for the new drug…the 180 day exclusivity… So they get the application. They make and market the drug, but they could still have problems down the road if they haven’t really understood the optimum way to make that drug(product).” One example of a design failure is Caraco Pharmaceutical Laboratories’ “tablet thickness” recalls in March 2009. 3. Manufacturing lapses: Some experts say the biggest culprits include the quality of raw materials and contamination. Some months ago, HealthReformWatch.com reported in Pharmaceutical Outsourcing: Trading Quality for Lower Costs? that India’s largest pharmaceutical manufacturer had been cited several times in recent years for manufacturing violations. Additional recalls include vaccines produced by Shantha Biotechnics for Sanofi-Aventis and injectible drugs made by Claris Lifesciences for Pfizer. The FDA stated its intent on May 5, 2010 to “propose stronger regulation for pharmaceutical companies that outsource manufacturing, putting more responsibility on the companies to ensure the purity and safety of the products…” 4. Increased FDA scrutiny of manufacturing facilities: Which came first, the chicken or the egg? Increased FDA oversight may or may not have led to the increased number of recalls; however, the recalls will probably lead to increased FDA regulatory power.As Jennifer Jascoll reported, Senator Michael F. Bennet (D-CO) proposed the Drug Safety and Accountability Act of 2010 on August 3, 2010. According to Bennet’s press release, “[t]he bill would strengthen manufacturer quality standards, enhance the USFDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.”Currently, the FDA is empowered to issue warnings and recommend that a manufacturer issue a recall. According to CNN Money, the FDA has not identified any alarming pattern. FDA spokeswoman Elaine Gansz Bobo stated, “[s]ince every recall situation is unique, it would be difficult to assess whether there are any trends or increases in recalls this year… At this time, however, we have not identified any trends.” Despite the FDA’s lack of concern, other federal agencies are interested in the practices of pharmaceutical companies. Further Federal InvestigationsAccording to the N.Y.Times, federal prosecutors and securities regulators are investigating pharmaceutical companies for potential violations of the Foreign Corrupt Practices Act (FCPA). The FCPA is an anti-bribery law which bars companies from offering foreign government officials items of value for profit. For instance, Pfizer disclosed in April “that it paid $35m over six months to 4,500 doctors in private practice for education and the development and marketing of new drugs.” Although this practice is legal in the U.S., such payments are illegal in many foreign countries where physicians are employed by the government. On November 17, 2009, Assistant Attorney General Lanny A. Breuer stated that the Department of Justice intended to focus its attention on the pharmaceutical industry: In some foreign countries and under certain circumstances, nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product may involve a “foreign official” within the meaning of the FCPA. The depth of government involvement in foreign health systems, combined with fierce industry competition and the closed nature of many public formularies, creates, in our view, a significant risk that corrupt payments will infect the process. Our remarkable FCPA unit and our terrific health care fraud unit will be working together to investigate FCPA violations in the pharmaceutical industry in an effort to maximize our ability to effectively enforce the law in this high-risk area. “Corrupt practices” under the FCPA are not limited to cash in envelopes. Inappropriate payments for lavish hospitality, consulting, licensing agreements, and even charitable donations may raise red flags for government investigators. Could bribery be contributing to decreased quality and the sudden rise in recalls? According to the Financial Times, the DoJ is focusing its efforts elsewhere: [T]he DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 percent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial. It appears that the DoJ’s scrutiny of clinical trials is not without merit. The N.YTimes reports that “[l]ast month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events.” The clinical trials for Avandia included many foreign trial sites, which were submitted in support of the drugs’ application to enter and remain on the U.S. market. GlaxoSmithKline, the trial’s sponsor, has not been accused of fraud. According to recent regulatory filings, the following companies are under investigation for possible violations of the FCPA:
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- Merck is cooperating with a federal investigation of company activities in multiple foreign nations.
- Medtronic is cooperating with investigations of company activities in Greece, Poland, Germany, Turkey, Italy, and Malaysia.
- Eli Lilly is cooperating with the investigations of subsidiaries in several countries, including Poland.
- Federal investigators are looking into improper payments related to the sale of Zimmer products abroad.
- Johnson & Johnson voluntary disclosed the possibility that company subsidiaries abroad had made improper payments to government officials in two countries relating to the sale of medical devices.
- Pfizer and Bristol-Myers Squibb have also disclosed that they are subject to federal investigations. AstraZeneca, GlaxoSmithKline, and Baxter SciClone have also received inquiries from federal enforcement agencies.
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"Two drug makers with sometimes stormy pasts, Biovail and Valeant Pharmaceuticals International, said Monday that they had agreed to merge in a $3.2 billion deal." The new company "will retain the Valeant name," and "will focus on four areas, including treatments for the skin and for neurology, and is expected to have more than $175 million in savings by the second year." Up "to 20 percent of the workers of the combined company will lose their jobs." The AP also adds that Biovail's "most advanced" drug "is Staccato loxapine, which is designed to treat agitation in patients with schizophrenia and bipolar disorder. The Food and Drug Administration is scheduled to make a ruling on the drug in the fall." The new company, which will be based in Mississauga, Ontario, also will focus on specialty drugs for the central nervous system and dermatology, in addition to branded generics in Canada and in emerging markets. Biovail CEO Bill Wells told that the deal solidified the company's position in specialty neurology, adding, "We've achieved with this deal what I only hoped we'd be able to do in 10 years." References-http://www.nytimes.com/2010/06/22/business/22drug.html?src=busln http://www.forbes.com/feeds/ap/2010/06/21/business-health-care-providers-us-biovail-valeant_7706755.html http://online.wsj.com/article/BT-CO-20100621-709413.html?mod=WSJ_World_MIDDLEHeadlinesAmericas http://www.bloomberg.com/news/2010-06-21/valeant-pharma-canada-s-biovail-corp-agree-to-merge-in-stock-transaction.html http://www.pharm-education.com/2010/06/pharma-industry-updates-biovail-and.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.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author?
Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moieties, brings to you some highlights from current pharma and clinical business news, views and data.
Glaxo CEO Plans To Announce Two "Small" Acquisitions Soon. GlaxoSmithKline Plc Chief Executive Officer Andrew Witty plans to announce two 'small' acquisitions soon, after walking away from five potential purchases or partnerships since October. In an interview on Friday with Bloomberg News, Witty "said prices are still being pushed up by competition. He declined to elaborate on the planned acquisitions." In addition, "the drug maker will continue to defend keeping Avandia [rosiglitazone] on the market at a July meeting of a US Food and Drug Administration advisory board, Witty said." He stated, "The only thing I ask for is that qualified scientists with the right evidence and data calmly look at the information." Cheap Inhalable Measles Vaccine May One Day Replace Syringes. A cheap inhalable measles vaccine, developed by scientists at the University of Colorado-Boulder, "could soon be available to families that could pave the way for an end to treatment by syringe for children." Within a few weeks, "human trials of the treatment are scheduled to begin," and they "could lead to inexpensive vaccines for illnesses ranging from tuberculosis to cervical cancer." The researchers are "also hope the trials, which come after five years of development, could reduce the need for painful injections." Teva Poised To Dominate Generic Drug Industry. The New York Times reported on Teva Pharmaceutical Industries, "an Israeli enterprise that, despite not being a household name, is the biggest generic drug maker in the world." The Times added, "Teva's size gives it huge advantages." In fact, "it has enough cash to buy up a strategically located rival generic maker about every other year." It also "has the bravado, and muscle, to mount patent challenges against name-brand drug makers and wring favourable settlements from them." Still, the Times notes that FDA regulators "raised concerns about bacterial contamination of generic propofol, an intravenous anesthetic used in surgery, made at" one of its US plants, and though "Teva recalled thousands of vials of propofol last year," the "regulators said the company hadn't adequately ensured that the problem wouldn't repeat itself." Pfizer, Merck Post Large 1Q Revenue Increases, Lower Income.Net The world's two largest drug makers, Pfizer Inc. and Merck & Co., posted big revenue jumps but lower net income for the first quarter, as they enjoyed new revenue from big rivals acquired last year but absorbed billions in severance pay and other costs." The AP adds that their "relatively upbeat profit forecasts for this year and beyond are a sign the acquisitions are starting to pay off." In addition, both "companies beat Wall Street profit expectations widely and edged out revenue expectations, partly due to favourable currency exchange rates." Eli Lilly & Co. Sues Watson Pharmaceuticals To Block Generic Version Of Osteoporosis Drug. The Indianapolis Business Journal reported that "Eli Lilly and Co. sued Watson Pharmaceuticals Inc. to prevent the sale of a generic version of its osteoporosis drug Evista [raloxifene] in the United States." In its application for Food and Drug Administration "approval to sell a low-cost version of the Lilly medicine," Watson asserted that Lilly's "patents are invalid, unenforceable, or not infringed, according to a complaint filed by Lilly on May 3 in federal court in Indianapolis."
Expiring Patents, Price Controls Expected To Slow Drug Sales. Pharmaceutical sales growth worldwide will slow this year due to expiring patents for blockbuster drugs and tighter price controls imposed by European governments." In fact, according to "health industry data firm IMS Health...global prescription drug sales growth" may "slow to between 4 percent and 6 percent compared with 7 percent in 2009. Pharmaceutical companies are expected to "face new competition from lower cost generics" for "drugs worth more than $142 billion." Meanwhile, "European governments will tighten price cost controls to manage increasing healthcare expenses of aging baby boomers." As increasing demand in developing countries offsets price drops tied to generic competition," drug sales "may grow at least 5 percent worldwide...according to IMS." Emerging markets, including those in "China and India, are expected to grow by as much as 17 percent a year, helping offset the $136 billion a year worth of medicines that will lose patent protection." Notably, "the top disease areas for growth will be in diabetes, cancer, HIV, and multiple sclerosis, IMS said." http://www.pharm-education.com/2010/05/pharmaceutical-r-business-news-updates.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.
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Abbott Labs Completes Purchase Of Starlims. "Abbott Laboratories said Monday it completed its purchase of Starlims Technology" for $123 million, or $14 per share. Abbott said that Starlims will "increase its position in the diagnostic testing market. WHO: Drug-Resistant TB Killed 150,000 In 2008. The New York Times reported that the WHO announced data last week showing that "drug-resistant tuberculosis killed about 150,000 people in 2008, and half of all the world's cases are thought in be in China and India." The report found that "progress has been made in parts of Siberia, but in another region of Russia, more than a quarter of all cases are drug-resistant. And in Africa, a vast majority of cases have probably not even been diagnosed, the report said." Transgene Sells Novartis Option On Rights To Experimental Cancer Vaccine.
Bloomberg News reported that French biotechnology company Transgene SA "sold Novartis AG an option on rights to the experimental TG4010 cancer vaccine in a deal that may fetch as much as $960 million." Under the terms of the agreement, "Novartis will pay an initial $10 million for a worldwide license...Transgene said." The vaccine received FDA "fast-track status" in December. For its part, "Transgene will fund the next phase of the product's development and retain control of it until early 2012, when the first results of the trial emerge." At that point, "Novartis will...have 90 days to exercise its option, Transgene said." Pharmaceutical Industry Prepares For New Business Under Health Reform Law.
The US drug industry fended off price curbs and other hefty restrictions in President Obama's healthcare law even as it prepares for plenty of new business when an estimated 32 million uninsured Americans gain health coverage. Noted provisions that may help the industry include: "brand-name biotech drugs won 12 years of protection against cheaper generic competitors," Medicare beneficiaries' drug "price cuts plus gradually rising federal subsidies will mean more elderly people will purchase more drugs," and lobbyists "beat back proposals to allow importation of low-cost medicines and to have Medicare negotiate drug prices with companies." FDA clears Vytorin and Zetia of suspected link to cancer.
The Los Angeles Times blog reported "Booster Shots" that after examining two previous studies, a Food and Drug Administration review committee has determined that it is "unlikely" the cholesterol-lowering drugs Vytorin and Zetia "increase the risk of cancer or cancer-related deaths." The agency said the trials were expected to be finished in 2010 and 2012, and advised physicians "to use their best judgment in evaluating potential risks and benefits of the drugs" until they are completed. Roche Seeks Acquisitions To Boost Its Research Programs.
Roche Holding AG Chief Executive Officer Severin Schwan said he seeks acquisitions that will bolster the company's research programs, rather than 'mega-mergers' designed to add immediate revenue." In addition, the company "is interested in partnerships or acquisitions that would strengthen" its position as the "world's biggest maker of cancer medicines," and "expand its work on Alzheimer's disease and diabetes, Schwan said in an interview." He added that Roche's drugs to treat melanoma and "good" HDL cholesterol could change the treatment of cancer and heart disease. Roche To Introduce At Least Six New Drugs By 2015.In a separate story, Roche also expects to introduce "at least six new medicines by 2015." Roche "wants to expand" the use of its cancer drugs "by testing them in different tumors and earlier in the disease." The company "also is seeking to expand beyond cancer and tap markets for conditions such as diabetes and diseases of the central nervous system." Pharmaceutical Thefts Becoming More Common.
The $75 million heist at" Eli Lilly's "warehouse in Connecticut was just the most audacious example of a growing phenomenon: Thieves are stealing large quantities of prescription drugs for resale on the black market." The increase is blamed on "spotty security and high drug prices," while Freight Watch spokesman Ron Greene also blamed thefts on "a fragmented supply chain." FDA spokesman Tom Gasparoli said, "Some of these thieves completely redo labels, and they pass muster if no one's looking too closely." In response, "drug makers are taking steps" and "the FDA has stepped up its own efforts, issuing alerts to the public, working with manufacturers, wholesalers, pharmacies and law enforcement, and publishing lot numbers of stolen drugs on a website." http://www.pharm-education.com/2010/04/who-drug-resistant-tb-killed-150000-in.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.
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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?
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.
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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. Scientific Insights-The volume of scientific research has been growing at an astounding rate. A search on www.pubmed.com (the online index of the National Library of Medicine) reveals that approximately 725,000 articles were published over the last year alone. Journal articles and congress presentations constitute a wealth of information about cutting-edge scientific developments. A thorough analysis of such publications and academic congresses is critical at the time of developing a CDP and simulating the TPP because:It serves as an advanced warning system about novel scientific developments that could threaten to make obsolete a particular product It could reveal alternate approaches to addressing the unmet clinical need at an early stage, and therefore throw up opportunities for partnerships or ideas for developmentIt presents the successes and failures of competitive development programs, thereby sparing a lot of unnecessary effort and investmentIt is a good source to unveil new information about the epidemiology of a disease and therefore the size of the addressable market opportunity. Competitor Insights-Ultimately, pharmaceutical R&D needs to be viewed in the context of competition because of the underlying commercial objectives associated with the process. Consequently, an understanding of the development, licensing, and marketing strategies of the competition constitutes a critical input into the development of the CDP. It is important to note that competition needs to be viewed not merely in today’s context but also in context of what lies ahead. Therefore, it is recommended that any CDP and its derived TPP be benchmarked to the claims and positioning strategies of competitive products already in the market as well as the likely claims and strategies of pipeline products. Fortunately, substantial amount of information about clinical trials—completed and ongoing—is available in the public domain through sources such as product labels and clinical trial registries. The main source for clinical trial information is www.clinicaltrials.gov (the official site of the US FDA), which contains several essential details about all registered clinical trials. Although the information is accessible through sources such as the ones cited above, it is essential to note that deriving insights, simulating competitive claims, etc., is an exercise that requires substantial human expertise. The Ideal Target Product Profile-As a first step of an iterative process to design a CDP, it is recommended to build an “ideal TPP.” To do this, one would need to integrate the various insights and inferences described above and evolve a TPP that would address all the unmet needs of the market while also yielding superior marketing claims across all product attributes. Therefore, an “ideal TPP” would represent best-in-class performance for efficacy, safety (ideally, would result in no adverse effects), tolerability, convenience, drug and food interactions, and perhaps, even cost. In addition, the “ideal TPP” would cover a wider patient population than all competitors. The Real Target Product Profile (TPP)-Much as we may aspire for an “ideal TPP,” it is necessary to recognize that in the real world, we cannot get every product attribute we desire. Therefore, we must modify the “ideal TPP” by prioritizing the attributes and claims that the CDP must focus on and compromising on others to arrive at the “real TPP.” This can be done by classifying the product attributes in the “ideal TPP” as either essential or desirable. The essential features of the TPP would represent a set of product attributes that represent either superiority over competing products or, at the very least, non-inferiority to competing products. Without these features, the product would enjoy no unique selling point when launched. The desirable features of the TPP would represent additional product attributes that could enhance the product’s marketability. These additional attributes could include some side indications, tolerability improvement, application for specific subpopulations, or even improved product stability. They all represent features that are not absolutely mandatory for commercial success but would certainly amplify the claim of superiority. Full text article is available to interested readers as a Free technical white paper. To register click here. 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.
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