Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data.Resveratrol May Help Prevent Age-Related Deterioration Of Eyesight. Resveratrol, found in particularly high levels in grape skin (and consequently red wine)," may help prevent age-related deterioration of eyesight, according to a study published in the American Journal of Pathology. "The substance...is believed to work because it protects against abnormal angiogenesis -- the formation of damaged or mutated blood vessels," a condition which "is linked to cancer, heart disease, and eye diseases, such as age-related macular degeneration." http://www.telegraph.co.uk/health/healthnews/7851772/Drinking-wine-could-protect-your-eyes.html
Pfizer Suspends Clinical Trials Of Tanezumab As Potential Osteoarthritis Treatment. Pfizer Inc. Spokesperson said Wednesday it has suspended clinical trials of its drug tanezumab as a potential osteoarthritis treatment, after some patients' conditions worsened." The drugmaker "said it halted the worldwide program following a request by the Food and Drug Administration after reports of a 'small number' of patients experiencing more severe osteoarthritis that led to joint replacement." FDA has also asked the company to show data on potential effects in clinical studies of the drug among patients with cancer pain, interstitial cystitis, chronic low back pain and painful diabetic peripheral neuropathy, Pfizer said." The FDA "will then decide whether to halt Pfizer's remaining trials of tanezumab after reviewing company data." However, "trials for other conditions haven't reported similar adverse events, MacKay Jimeson, a Pfizer spokesman, said."The drugmaker recently reported that patients using the drug for knee pain related to osteoarthritis had positive responses. http://www.forbes.com/feeds/ap/2010/06/23/business-health-care-us-pfizer-halts-study_7714952.htmlhttp://www.bloomberg.com/news/2010-06-23/pfizer-suspends-trial-of-tanezumab-for-osteoarthritis-pain-at-u-s-request.htmlhttp://online.wsj.com/article/SB10001424052748703900004575325320800502744.html Glucosamine, Chondroitin Sales Remain Strong Despite Evidence They May Be Ineffective. Despite a 2006 study published in the New England Journal of Medicine that suggested that "for most people, glucosamine and chondroitin do not soothe knee pain much better than a placebo," Americans nevertheless "spent $838 million on glucosamine and chondroitin in 2008," according to the Nutrition Business Journal. Rheumatologist Sean Whelton, MD, who "attended the American College of Rheumatology meeting where" results of the NEJM study were presented, tells his osteoarthritis patients that the products are safe, but also points out that they may not be "particularly effective."SSRI Antidepressant Use Associated With Cataracts. According to a study published online in the journal Ophthalmology, "SSRI antidepressants raise the risk of cataracts by about 15% -- enough to cause 22,000 extra cataract cases in the US each year." After analyzing "data collected from 18,784 cataract patients and 187,840 comparison patients between 1995 and 2004," researchers found that risk for cataracts was associated with the antidepressants Luvox (fluvoxamine, 39%), Effexor (venlafaxine, 33%), and Paxil (paroxetine, 23%), while overall "use of any SSRI antidepressant raised cataract risk by 15%." The authors theorized that SSRI antidepressants may cause more serotonin to be deposited into receptors in the lens of eye, over time making the lens more opaque. http://www.pharm-education.com/2010/06/resveratrol-seems-to-be-promising-drug.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.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.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 moeities, brings to you some highlights from current pharma and clinical research news, views and data.Antiretroviral Therapy Treatment May Reduce Perinatal AIDS Transmission. According to studies published June 17 in the New England Journal of Medicine, "AIDS transmission to babies was blocked in 99 percent of cases when breastfeeding mothers infected with the HIV virus took triple-drug combinations." In fact, one study in Botswana of 730 pregnant women with HIV found that "virus transmission fell to 1.1 percent when mothers were assigned to one of three combination regimens initiated before birth and continued through six months of pregnancy." But, "without the drugs, the infection rate would be at least 25 percent." The second study, which took place in Malawi, "found that giving babies an antiretroviral drug once a day during their first six months of life reduced the transmission rate to 1.7 percent." Researchers came to that conclusion after giving 2,369 "HIV-positive mothers...either antiretrovirals after delivery and while breast-feeding, or" instructing them "to give their babies a single vial of the drug nevirapine daily." Meanwhile, "infants in a third control group received a single dose of nevirapine and seven days of two other antiretroviral drugs." According to accompanying editorial "debate over which regimen is best 'should not be used to justify inaction.'" Rather, "the choice of regimen is secondary to identifying, caring for, and treating HIV-positive women and their infants."http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aTKRE8oVsUVghttp://consumer.healthday.com/Article.asp?AID=640176http://content.nejm.org/cgi/content/full/362/24/2271http://www.medpagetoday.com/HIVAIDS/HIVAIDS/20717Experimental Colon Cancer Treatment Fails To Meet Goal In Midstage Study. A potential colon cancer treatment failed to meet its goal in a midstage study." The research "was conducted by Curis' partner Roche and that company's Genentech unit." A drug, a so-called hedgehog-pathway inhibitor, combined with the Avastin [bevacizumab] tumor drug and chemotherapy didn't keep the disease at bay or extend lives of patients compared with those given standard treatment." This "study of 199 patients was the biggest yet for the hedgehog treatment," known as GDC-0449. http://www.bloomberg.com/apps/news?pid=20601202&sid=aJxiB1BIwgUMhttp://www.forbes.com/feeds/ap/2010/06/16/business-health-care-us-curis-mover_7694092.htmlhttp://www.reuters.com/article/idUSSGE65F0G020100616 After 12 Months, Aspirin OK Without Plavix For Patients With Stents.
Giving aspirin alone to patients who have had stents implanted seems just as good as giving aspirin along with the blood thinner Plavix [clopidogrel]," according to a study presented at the American College of Cardiology annual meeting. Researchers discovered that, after an initial year receiving the dual anti-clotting therapy, patients who went off Plavix and just took aspirin had the same rate of heart attacks and death as those patients continuing on the two drugs together. Dr. Gurpreet Sandhu, an interventional cardiologist with the Mayo Clinic, cited ACC guidelines, saying, "In general, this fits with current guidelines, so it's not going to be practice-changing, per se." Investigational Implantable Sensor May Reduce Risk Of Hospitalizations For Heart Failure. A study being called the start of a revolution in the management of heart failure." Among heart failure patients with moderate to severe disease, six months of monitoring with an investigational implantable sensor that measures pulmonary artery pressure was associated with a 30% relative risk reduction in hospitalizations for heart failure," according to the research, presented at the Heart Failure Congress. Investigators found that, "after six months there were 83 hospitalizations for heart failure among the 270 patients randomized to treatment guided by hemodynamic measurements from the CardioMems Heart Sensor, compared with 120 heart failure hospitalizations in the 280-patient control arm." One of the researchers "said the data suggests that using the pulmonary monitoring device to guide treatment in just eight heart failure patients for six months would result in one less hospitalization for heart failure." FDA Seeks More Information On Inhaled Insulin Drug. MannKind Corp.allegedly "failed to win approval from US regulators to market its inhaled insulin drug, Afrezza, for people with diabetes." The FDA "asked for more information about the medication and the inhaler patients will use, MannKind said today in a statement," and although the agency "didn't cite any safety concerns, they requested updated safety data." The FDA questioned whether the inhaler used in clinical trials was similar to another one the company created and wants to market with Afrezza. Related links-http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm215515.htm http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216214.htm http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216218.htm http://www.medscape.com/viewarticle/723988http://www.pharm-education.com/2010/06/investigational-implantable-sensor-may.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.
Introducing a new blog Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.Do you have questions for the author?
Dr.Shruti Bhat, Leader Pharmaceutical R&D and specialist in hiTech formulation development and quality-by-design, brings to you some of her personal experiences and highlights from her reading on topics of personal branding and career development...
During course of my writing my book on “ Experiences of a job seeker in a depressed economy”, I have interviewed scores of professionals, grad students, senior executives in transition, who volunteered feelers about their experiences, most importantly impressions about their interviewers. Summarizing my findings, presents, five well- identified interview styles so that next time you are escorted into the interview room you can identify them quickly and react in a way that helps you stand out in a good way- Style 1. The Careful - This style is found in people who are new to interviewing, are below your level or will be reporting into the role you for which you are interviewing. They show their careful quality by asking really simple questions. Almost apologetic. Here is an opportunity- To lead the interview and to create raving fans within the interview team. Because “the careful” want to do a good job. But they also are nervous about asking tough questions to their future boss. So ask them of yourself . One successful technique might be “You might be wondering how I like to lead a team. What I am like to work for”. And then it would give you a feeling like” you were interviewing yourself”. Asking questions that lead to the real concerns that could be answered with ease. And you become more confident as the interview progressed. Feels good? Style 2. The Brash – Brash is often associated with “young”. And sometimes that is true. Sometimes it is also just someone who feels that being on the interview team gives them the ability to be especially confident. These can be a bit tricky. Few of my volunteers for the my book interview stated “The last time I interviewed, I was introduced to a person who would be my direct report in the role. He happened to be young. Just a few years out of school. Very smart I could tell. He hit me with question after question. Biting. Almost smirky smile. I marveled how he could do this to a potential future boss. No fear of ramifications? My strategy with him was to respond with strength and detail. As best I could without playing the “future boss” card. Because I wasn’t yet. And I think that this person wants to see strength in return. A tip I gave myself, oil your conflict resolution strategies, this employee could have the potential to be difficult also to his colleagues ! and thank your stars if there aren’t any complaints waiting for you to tackle them. However, train yourself not to be biased or prejudiced. Style 3. The Unprepared – Sometimes people get busy the day before or the day of an interview. They may have just been added to the interview team. Or maybe they are just unprepared. They walk in late, can’t find your resume, need time to clean their desk. And finally after a few minutes look up and say “OK, let’s hear about you”. To their defense, most companies are really bad about preparing their teams (circulating resumes, sharing a job description, and identifying specific hiring objectives). But interviewing is one of the most important roles you can are asked to play. The right new hire is crucial. So the good ones prepare on their own. Interviewing with this group is an opportunity. For you to lead the charge by asking great questions, sharing situations in which you had a big impact and leaving the interviewer feeling like they did a pretty good job. Despite their lack of preparation. Style 4. The Talker – Some interviewers just like to hear themselves talk. And some really want you to understand the complexities of their product line, industry, department, etc. But it can be a challenge to communicate your unique value when the interviewer seems to be honing their own. I’ve fallen into this trap before as an interviewer when the position is new to our company or when it is early in the interview process. Sometimes those first few interviews are an opportunity for the hiring manager to sound out a few new responsibilities for the position. But a few minutes can last longer if the candidate seems happy to just sit there and listen. A mutually beneficial process here might be, is to engage the interviewer. To interrupt the flow after a few minutes and ask a question that shows you are listening. But that also allows you to share something about yourself. Something that shows you appreciate the complexity the interviewer is trying to get across. Very few people do this. They are afraid of interrupting. Style 5. The Heroic - A cousin of the talker, the heroic spends the first 15 minutes introducing you to the strengths of their company and their department. Oh, and they like their own work pretty well too. They will tend to set the bar extremely high for new employees. Both in terms of your dedication and your weekly hours (i.e. “everyone here works 50+ hours because we believe in the cause”). Now your job is to determine if you believe in it. Because if 50+ is really 60+, you need to decide whether that really fits into your life’s plan. This style is designed to weed people out. People who aren’t dedicated. People who will complain at the first sign of overtime. While it is hard to get past the bravado, usually a few good questions can help you determine whether this is a place you’d like to work (a great, hard working, close-knit team) or a sweat shop. Research, research, research well about the company, people, culture, financial strength, HR processes WELL before accepting the offer. Further reading …20 habits of highly effective job seekers http://www.drugsinthemaking.com/19/post/2010/06/first-post.html Finding a culture fit for career success http://pharmaceuticalcareerdevelopment.blogspot.com/2010/06/evaluating-cultural-fit-for-success.html 8 ways by which an interview can take a turn for the worse http://www.drugsinthemaking.com/6/post/2010/05/8-ways-a-job-interview-can-take-a-turn-for-the-worse.htmlhttp://timsstrategy.com/7-interview-styles-youll-face-as-the-candidate/http://pharmaceuticalcareerdevelopment.blogspot.com/2010/06/knowing-interview-styles-essential.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.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do 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.
"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?
Informational Interviews:Informational interviews are excellent tools for gathering intelligence: about a company or a particular role in terms of its purpose and scope, to assess the caliber of your competition, or to get a better feel for key personalities and company culture. Such interviews are initiated by YOU. They can occur in places you already work and want to advance further. You can outreach to people in organizations of interest to you. Informational interviews can occur in person, on the phone, by e-mail - and can be as short as 5 minutes or last over an hour. In any case, you need to listen far more than you speak in an informational interview scenario. This is an exercise in information gathering, not selling yourself. You don't know how best to sell your own talents until you know what their needs are. Don't jump ahead. The goal is to gather enough information so that you can follow up with your resume and cover letter, making a case for them to consider you for current and future positions of particular interest. Be specific, not general, in that second-phase outreach. Casting a wide net within a single organization actually dilutes your efforts. Phone Screens: Phone screening is a common interview technique. It saves both time and money while helping to narrow down the applicant pool for an open position. You need to prepare for a phone screen as much as you would for a formal interview. It starts when they call you to set up a mutually convenient time. Always be at the ready: have a professional tone of voice when answering calls; have a short and professional outgoing message on your voicemail (no music). If you don't recognize the number calling and are actively job searching, let the call go to voicemail to ensure you respond appropriately. Keep a listing handy of where you've applied and for what position so you can reference it quickly and with confidence. Know your calendar. Once scheduled, do as much research as possible in addition to preparing yourself to answer questions. Look up the company website, understand their mission, and read the position description very carefully to note which items are strengths or weaknesses for you. Rehearse your answers to all common interview questions (widely available online). During the call, take advantage of the ability to have materials in front of you to reference at any point. The phone screen's objective is to clarify that you have the qualifications required (and desired) for the job, including work ethic and personality traits. Your goal is to convey that your skills are exactly what they are looking for, right now. If you are successful in doing so, they will talk to you about the next interview phase - either that day or within a few days of the screening call. Formal, In-person Interviews:This will be scheduled in advance. During the scheduling call, learn about dress code, what materials to bring with you, who you will be meeting with and their role, directions to their location, and how much time to expect to be there. Is your interview primarily with HR or will the hiring manager also be there? Will potential team members and co-workers be present? The more people you are scheduled to meet, the better your chances of success because they would not coordinate that many people if your qualifications were in question. Your goal is to be well-versed in the position details, to give concrete examples of previous successes that have prepared you for this role, and to come across as intelligent and likable. There are numerous sites online dedicated to helping you prepare for formal interviews; check them out! This includes not only how to best answer questions, but to sketch out your success stories in advance, and to ensure your presentation style is as free from flaws and distractions as possible.
Final Round:This may be the second or third time you connect with HR, the hiring manager, and potential colleagues within the prospective organization. You may meet them individually, in small groups, or as a larger panel - be sure to ask in advance what to expect. It is possible, especially for entry-level positions, that your first formal interview will also constitute the final round. What you ultimately want to convey is that the position description is well understood, and that you have the necessary resources to succeed in the role. And if you do not have all the resources you think you will need, negotiate for them during the offer phase. Beyond that, make it very clear that you are ready, willing, and able to do the job - and that you are eager to get started. With any type of interview, be sure to genuinely thank each person who took time out of their day to meet with you. A personal, hand written note is still an extra nice touch. To do so, collect the business cards of everyone you meet. Make it a habit. You can do this! Good luck! http://pharmaceuticalcareerdevelopment.blogspot.com/2010/06/ace-interview-meet-objectives-at-every.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.
Teva Announces Positive Results from a Study Assessing a New Formulation of Copaxone(R). Significantly less pain and fewer injection site reactions were reported by patients receiving the new lower volume injection. Teva Pharmaceutical Industries Ltd. announced positive results from a study assessing a new lower-volume injection of Copaxone(R) (glatiramer acetate) containing the currently approved dose in half the injection volume. The SONG study ('Study of New Glatiramer Acetate Formulation') explored the safety and tolerability of a 20mg/0.5mL injection of Copaxone(R) versus the current formulation of 20 mg/1.0mL. These findings were presented at the 24th Annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in San Antonio, Texas. "Copaxone(R) has proven long-term efficacy, safety and tolerability with more than one million patient years of treatment," said Dr. Ronald Murray, FAAN, a lead study investigator and Director of the MS Clinic of Colorado. "We are encouraged by these data as they suggest that a 0.5mL dose of glatiramer acetate may enhance patients' experience with the most frequently prescribed MS therapy."
http://www.marketwatch.com/story/teva-announces-positive-results-from-a-study-assessing-a-new-formulation-of-copaxoner-2010-06-04?reflink=MW_news_stmp Starpharma Plans Effectiveness Studies On Herpes-Killing Gel For Women. Bloomberg News reported, "The world's first herpes-killing vaginal gel may go on sale within two years, said its developer Starpharma Holdings Ltd., which plans to start patient studies on its effectiveness." Starpharma CEO Jackie Fairley said her company is discussing the trials of VivaGel with "a number of groups," noting that it's the only microbicide designed to stop herpes from spreading. The company also "plans to study the product's effectiveness against bacterial vaginosis, the most common vaginal infection in women of childbearing age, later this year, it said" in March. http://www.bloomberg.com/apps/news?pid=20601202&sid=aqEEau5hBC6Q
Bevacizumab May Improve Some Outcomes In Advanced Gastric Cancers.MedPage Today reported that "bevacizumab (Avastin) may improve some outcomes in advanced gastric cancers, but it did not benefit overall survival, according to a major international clinical trial reported" at the American Society of Clinical Oncology annual meeting. Researchers found, "in the phase III AVAGAST clinical trial, conducted among more than 770 patients," that "adding the monoclonal antibody bevacizumab to standard chemotherapy tended to be associated with a 13% reduction in risk of death from any cause, but the two-month survival advantage was not significant compared with chemotherapy alone." But, "bevacizumab produced significant benefits in progression-free survival and response rates," the researchers reported. http://www.medpagetoday.com/MeetingCoverage/ASCO/20582 Erlotinib May Prolong Survival In Older Women With Advanced Non-Small Cell Lung Cancer. MedPage Today reported that "the targeted agent erlotinib (Tarceva) prolonged survival by 26% in older women with advanced non-small cell lung cancer, but did not benefit men with the disease," according to research presented at the American Society of Clinical Oncology annual meeting. Investigators found, "in the randomized clinical trial, conducted among 670 patients (median age 77)," that "erlotinib also markedly extended the time before relapse in women." However, "men in the study saw no benefit either in overall survival or progression-free survival." http://www.medpagetoday.com/MeetingCoverage/ASCO/20581 Mapatumumab Fails In Midstage Study. "Human Genome Sciences's potential cancer drug mapatumumab failed in a midstage study. The company found "no difference in disease response or progression-free survival rates between patients receiving the drug for multiple myeloma and the control group. The drug was studied in combination with bortezomib for the study. http://www.forbes.com/feeds/ap/2010/06/09/business-health-care-us-human-genome-sciences-study_7672784.html http://www.reuters.com/article/idUSSGE6580FL20100609
Rosiglitazone, Metformin Low-Dose Combination May Reduce Progression To Type 2 Diabetes. The Los Angeles Times reported, "A combination of low doses of the diabetes drugs Avandia [rosiglitazone] and metformin can reduce the progression to type 2 diabetes by two-thirds in people who are at high risk of developing the disease," according to a study published online in The Lancet. In fact, "the benefit is greater than with either of the drugs used alone, and the combination has fewer side effects." For the study, researchers at the University of Toronto "enrolled 207 patients with impaired glucose tolerance, randomly assigning half to take the combination and half to take a placebo," then followed them for almost four years. HealthDay reported that not only did the study find "that the risk of developing type 2 diabetes was reduced by two-thirds in those taking the drug combo compared to those on placebo," but also that "using half of the maximum dose was extremely effective for preventing type 2 diabetes." Moreover, "the drug combination appeared to counteract the weight gain that's common with Avandia therapy alone," and with relatively few side effects. "The dosages used in the study were 2 milligrams of Avandia plus 500 milligrams of metformin. There is no evidence whatsoever that lower doses of [Avandia] are 'safe’. Any suggestion that serious cardiovascular toxicity can be avoided by using a small dose represents pure speculation at best." According to MedPage Today , an accompanying editorial also "cautioned that the 'larger issues that have cast doubt on use of drugs to prevent diabetes are not addressed by the'" study. 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.pharm-education.com/2010/06/rosiglitazone-metformin-low-dose.html Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Shruti has initiated a new blog Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.Do you have questions for the author?
Dr. Shruti Bhat, is a Leader in Pharmaceutical R&D and QbD specialist presents few salient points regarding the latest quality systems expected by regulators from the life science, more particularly pharmaceutical industry. But first, a brief chronology of evolution of quality systems. Definitions and scope of quality systems in pharmaceuticals has evolved over a period of time. The “Thalidomide babies tragedy” prompted the concept of continuous or cGMP. With cGMP came into existence the concept of Quality Assurance or “Zero defect”. QA advocated that quality cannot be created at the end of processing, but has to be in-built into a product at every step of manufacturing process. Further improvements in quality systems throughout the 1990’s and beyond brought about concepts of internal audits, documentation and validations. Y2K improved quality systems further...introduced 21CFR part 11 compliance measures. Year 2010 and beyond promises further refinement in quality systems- Quality-by-Design (QbD). What is quality by design? Quality by designmeans designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality at the end of the manufacturing process.Where to implement quality by design? Quality by design implementation targets the following departments within a pharmaceutical company-Management, Procurement, R&D, Manufacturing, Testing, Quality control, Quality assurance, Regulatory, Logistics, Sales, Warehouse/ Supply chain including vendors facilities, CRO and CMO. Principles of quality by design?QbD scope assume that problems can be anticipated and their occurrence prevented by reviewing data and analyzing risks associated with operational and quality system processes and by keeping abreast of changes in scientific developments and regulatory requirements. The central goal of a quality system is the consistent production of safe and effective products and ensuring that these activities are sustainable. A robust quality system will promote process consistency by integrating effective knowledge-building mechanisms into daily operational decisions. When fully developed and effectively managed, a QbD system will lead to consistent, predictable processes that ensure that pharmaceuticals are safe, effective, and available for the consumer. Framework of quality by design?Quality by design integrates quality systems and risk management approaches into its existing programs with the goal of providing the necessary framework for implementing quality by design (building in quality from the development phase and throughout a product’s life cycle), continual improvement and risk management in the drug manufacturing process and also for post development changes and optimization.Quality risk management (governed by CAPA- corrective actions preventive actions) is a valuable component of an effective quality systems framework. Quality risk management can, for example, help guide the setting of specifications and process parameters for drug manufacturing, assess and mitigate the risk of changing a process or specification, and determine the extent of discrepancy investigations and corrective actions. CAPAfocuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. QbD system models discuss CAPA as three separate concepts, all of which are used in this guidance:• Remedial corrections of an identified problem. • Root cause analysis with corrective action to help understand the cause of the deviation and potentially prevent recurrence of a similar problem. • Preventive action to avert recurrence of a similar potential problem.Review outcomes typically include: • Improvements to the quality system and related quality processes. • Improvements to manufacturing processes and products.• Realignment of resources. The results of a management review would typically be recorded. Planned actions should be implemented using effective CAPA and change control procedures. http://www.qa-expert.com/2010/06/quality-systems-approach-to.html To be continued...
The economy and job market have made a sea change. Things aren’t the same as they used to be. The marketplace has changed. The job market has changed. Now many more people are looking for the jobs that are out there. So it’s critical that you stand out in a crowded market. If you do, you can take days off of your job search. LinkedIn is one of the best ways to do that and to be successful in finding a job. You can take days off of your job search when you use LinkedIn. The first step is to join LinkedIn and set up your LinkedIn Profile. Your LinkedIn Profile is your presence on LinkedIn. You can’t do anything until your Profile is up. Your LinkedIn Profile is not the same as your resume. One of the biggest mistakes people make is to simply copy and paste their resumes into their Profile. And make them backwards-oriented like a resume. Your Profile is a sales and marketing piece for you. And it’s like your personal Web site. Search engines find your LinkedIn Profile when it’s complete, and you’re not limited in space or format the way you are with your resume. It’s the first impression someone has of you, and they decide to connect or not based on what they see in your LinkedIn Profile. LinkedIn members are helping people in their networks find jobs. For example, the Susan Todd of the NJ Star Ledger wrote on March 15, 2009 about Abby Kohut’s LinkedIn Success Story: “Abby Kohut got LinkedIn. And then she got work. After creating a detailed profile and shamelessly collecting recommendations, the 42-year-old staffing consultant landed contract work with a non-profit organization and a major publishing group. “The two jobs found me as opposed to me finding them,” Kohut said. “And the people who found me, hired me after barely interviewing me.” When she joined the social networking site LinkedIn, she was looking for a job, but the contract work gives her more flexibility, more variety, more connections. And there’s another benefit: “I don’t have to worry about being downsized,” Kohut said. Networking online isn’t new, but it’s getting a big boost from the growing numbers of unemployed searching for work with the help of new digital tools. Although more and more adults are joining the social networking site FaceBook, the more staid LinkedIn is still considered the serious site for professional networking. The two are different — think of it as going to a party and going to a work party. At the end of last year, LinkedIn had 33 million members, and there were signs many were stepping up their activity. The amount of time individuals spent online increased 22 percent since the start of the year and the number of recommendations soared 65 percent, according to Kay Luo, a spokeswoman for LinkedIn. A recommendation and referral like this definitely helps. Even with a referral, recommendation or LinkedIn Introduction, your LinkedIn Profile still must show that you’re qualified and the best person for the job. Here’s what happens when a recruiter or hiring manager is looking for someone to fill a position: They do a search on LinkedIn for qualified candidates based on their criteria, such as job titles, keywords, and geographic location. Then a list of people who meet those criteria comes up in the LinkedIn results list. They skim- and-scan the list of Profiles to find people they want to follow up with, and eliminate those that they don’t want to contact. They choose based on what they see in your Profile. Imagine what they see. Pages of names, photos (or not) and what I call your professional headline. That’s the few words below your name at the top of your LinkedIn Profile. How do they select the ones to follow up with? When they skim-and-scan the results list: 1) If there’s no photo, they skip right over the Profile and go somewhere else. Gone. 2) If your professional headline catches their attention and is compelling, they click on your name to see your entire Profile. They skim-and-scan your entire Profile. (They don’t read it.) If they like what they see in the Summary section, they move down to look at your credentials. 3) If they like what they see in your credentials, you go on their list of people to follow up with. 4) If your Profile doesn’t catch their attention and show how you’re the best candidate for the job, they skip over you. You’re out of the running and still in the job pool. So your LinkedIn Profile has two critical jobs to do for you:1. Come up in the search results list. Be found. 2. Show that you’re the best person for the job. Show you have what they’re looking for, and how you stand out from other candidates who do similar things. That means that your LinkedIn Profile must have the best keywords built in. It shows who you are as a person and shows you as someone they want to work with. And the Summary section must show your “DNA Expertise” – what you’re known for and that differentiates you from other people who are in the running for the same position. If your LinkedIn Profile does these two critical jobs well, you’ll take days off your job search. http://pharmaceuticalcareerdevelopment.blogspot.com/2010/06/how-to-take-days-off-your-job-search.html
Researchers have scored the first big win against melanoma, the deadliest form of skin cancer. An experimental drug significantly improved survival in a major study of people with very advanced disease.The results, reported Saturday at a cancer conference, left doctors elated. “We have not had any therapy that has prolonged survival” until now, said Dr. Lynn Schuchter of the Abramson Cancer Center at the University of Pennsylvania, a skin cancer specialist with no role in the study or ties to the drug’s maker.The drug, ipilimumab, (ip-ee-LIM-uh-mab), works by helping the immune system fight tumors. The federal Food and Drug Administration has pledged a quick review, and doctors think the drug could be available by the end of this year. “People are going to have a lot of hope and want this drug, and it’s not on their doctors’ shelves,” although some may be able to get it through special programs directly from its maker, Bristol-Myers Squibb Co., Schuchter said. Melanoma is the most serious form of skin cancer. Last year in the United States, there were about 68,720 new cases and 8,650 deaths from the disease. Worldwide, more than 50,000 people die of melanoma each year. “The incidence is rising faster than any other cancer,” said one of the study’s leaders, Dr. Stephen Hodi of Dana-Farber Cancer Institute in Boston. “When it spreads to vital organs, it’s almost always fatal.” Doctors also reported Saturday at the conference that an experimental drug for lung cancer patients with a certain gene showed extraordinary promise in early testing. The drug, Pfizer Inc.’s crizotinib, (crih-ZAH-tin-ib) targets a gene that promotes tumor growth and is found in about 4 percent of lung cancers, especially among younger, non-smokers. Nearly 220,000 new cases of lung cancer are diagnosed each year in the United States alone, and it is the world’s top cancer killer. Two other gene-targeted treatments, Tarceva and Iressa, help about 20,000 lung cancer patients annually in the U.S. The skin cancer study involved 676 people around the world with advanced, inoperable melanoma who had already tried other treatments — a very grim situation. They were given one of three treatments: ipilimumab by itself, with another immune-stimulating treatment, or the immune-stimulating treatment alone. After two years, 24 percent of those given the drug alone or in combination were alive, versus 14 percent of those given just the immune-stimulating treatment. Average survival was 10 months with ipilimumab versus just more than six months for the others, which worked out to a 67 percent improvement in survival for those on the drug, said one of the study’s leaders, Dr. Steven O’Day of the Angeles Clinic and Research Institute in Los Angeles. Doctors hope the drug can provide more benefit if given earlier in the course of the disease and to less sick patients. Ten percent to 15 percent of patients on ipilimumab had serious side effects related to the drug’s actions on the immune system. Most were treatable with high doses of steroids, but 14 deaths were thought to be related to the treatment. That’s still far fewer than deaths due to the cancer. The study was funded by Bristol-Myers and Medarex Inc., a company that co-developed the drug and was bought by Bristol-Myers last year. A spokeswoman said Bristol-Myers has not yet set a price for the drug, but similar treatments for other cancers cost several thousand dollars a month or more. Results were reported at the American Society of Clinical Oncology’s annual conference in Chicago and published online by the New England Journal of Medicine. References Online:Cancer meeting: www.asco.orgNational Cancer Institute: www.cancer.govNew England Journal of Medicine: www.nejm.org http://www.pharm-education.com/2010/06/first-big-win-against-skin-cancer-drug.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.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Shruti has initiated a new blog Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.
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If you’ve ever found yourself in a company that doesn’t value your skills, then you’ll appreciate the discussion on finding the right corporate culture for the skills and talents you bring to an organization. In this post, we’ll take a quick look at how you can overcome a very common barrier for moving your career to the next level. A big issue for many working professionals is in finding a good fit for success within a company. Fit is usually broken up into two factors: job and organization. Job fit is fairly easy for the company and the individual to figure out; that is, you have the skills for the job or either the company feels they can teach you what you need to know. Organization or culture fit is much more difficult. It is essentially the alignment of beliefs and values of you and the company. Yes, the company has their own set of values. Why? Because companies are usually run by people and these people have values. When companies interview candidates for hire, one would hope that they are asking questions that will assess both fits. Unfortunately, many companies don’t know what their values are. It’s fairly safe to say that many people that get involved in the interview process don’t fully understand their own company’s culture. Assessing whether you will fit or not is too difficult for most interviewers and usually doesn’t happen. The problem is that the interviewer will assess you with their own values. If there is a gross mismatch, they won’t recommend you. Even if there is a match, the interviewer’s values may not be the same as those in higher levels of the organization. This is important if you want to move up in an organization. Defining your values. It is useful for you to have a good understanding of why you work. Sure, we all work for the money. But do you work for increasing technical challenge, higher levels of authority, or high visibility? One thing most highly educated professionals value is graduate degrees. I know you are saying to yourself, of course they do. They’ve spent a lot of time and effort into obtaining the degrees so they want to get a good return on it. The advanced degree is a tool for supporting the desire to do higher level tasks. Other values that professionals seek are affiliation, autonomy, intellectual challenge, managing people, power, influence, prestige, recognition, security, variety and so on. If you want to achieve higher levels of success within someone else’s organization, you have to know your values and how you will use them. For example, I have a highly technical background. No matter what position you put me in, I will use analytical methods to resolve issues and perform my work. Now, consider putting me in a management position. Will my analytical skills be necessary? Maybe, but I will use them anyhow because it’s who I am. I can’t turn that off. To know what type of environment that you would thrive in, you must first understand what you value. If your values are not present in your environment, you won’t be happy. You’ll become restless and will make a change. Sometimes this change is a conscious move to another company or it can be a subtle transformation to self-defeating behavior that drives a wedge between you and the company, forcing them to remove you. Aligning your values. As mentioned earlier, ascertaining the values of a company from an interview is a big challenge. So maybe it isn’t the best place to look. You should consider your career goals to define the location for a values assessment. Let’s say you just completed your MBA and are looking to leave your current company to find a middle management position in another company. How do you determine if management will value your MBA? The best way is to evaluate their backgrounds. If management doesn’t have graduate degrees but possess many years of work experience, they most likely won’t see much value in your advanced degree. At all levels of management, values are different, but most managers strive to be similar to the managers at the highest levels of the organization. Henry Mintzberg defined the Ten Managerial Roles in 1973, outlining the typical behavior for CEOs. Later on, Pavett and Lau (1983) performed similar studies of lower and middle level managers and found that they emulated the higher level managers. One might think that managers desiring to be part of the executive groups will mimic their behavior so that they resonate with them and will increase their chances of being accepted into the group.One of my clients struggled with achieving even the smallest levels of success in his organization because of a misalignment of values. My client held three advanced degrees, mostly because he wanted to differentiate himself from his competition. Unfortunately, with such high levels of education, he differentiated himself from his management. He appeared more as a threat to them. Management is about competitive advantage, to some extent. Those that sit at or near the top won’t value things that they don’t have. No one would intentionally rule themselves out of the competition. Therefore, to align your strengths and skills with an organization, you need to align them with the values of higher level management. If they value what you have, you will be more successful. If they don’t value it, you’ll have a difficult time becoming extremely successful. After all, people don’t like to change, especially if they value security. Reaching your career goals in someone else’s organization is a difficult task. We often find ourselves in groups that don’t appreciate our unique skills and abilities. Of course, we don’t know what kind of culture we are in until we are neck deep in it. At that point, it can be painful and waste a lot of time trying to get out of the company and into a new one. You are better off taking the time to align your values with those that will be promoting you to higher levels. You can do that by aligning your values with their values. http://blog.happen.ca/?p=1440http://pharmaceuticalcareerdevelopment.blogspot.com/2010/06/evaluating-cultural-fit-for-success.html