Current Affairs Pharmacy

Investigators at the University of California, Los Angeles worked with the experimental drug NVP-BEZ235. This drug is an imidazoquinoline derivative and Phosphoinositide 3-Kinase (PI3K) inhibitor that inhibits PI3K and mammalian Target of Rapamycin (mTOR) kinase activity by binding to the ATP-binding cleft of these enzymes. PI3K and mTOR are members of a molecular signaling pathway, which once activated promotes ovarian cancer growth. Tumours with this pathway are more aggressive and more likely to metastasize. The   investigators   described   the drug's effect on cell proliferation in 18 ovarian cancer cell lines, including four pairs of  syngeneic  cisplatin-sensitive and cisplatin-resistant cell lines. They also evaluated the in vivo effects of NVP-BEZ235 on established tumour growth using an immunocompetent, transgenic murine ovarian cancer model. Results revealed that NVP-BEZ235 decreased cell proliferation in all ovarian cancer cell lines assayed and sensitized Cisplatin-resistant cells to the cytotoxic effects of cisplatin. Oral administration of NVP-BEZ235 resulted in significantly longer survival of the mice with ovarian tumours compared to control animals that were not treated.

US Marshals, at the request of the US Food and Drug Administration (FDA), recently seized more than $6 million in products distributed by Triad   Group, Inc, at the company's facility in Hartland, Wis. Triad Group and H & P Industries are owned and managed by the same parties. Several drug products were seized, which included povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, haemorrhoidal wipes, in-process drugproducts and raw materials. The action was taken due to the continued failure of Triad Group and H & P Industries to comply with the FDA's current Good Manufacturing Practice (cGMP) regulations, which are   intended to assure the safety, quality and purity of manufactured drugs. Through this seizure, FDA seeks to prevent the company from distributing products that were manufactured in violation of federally mandated manufacturing requirements. Dara Corrigan, Associate Commissioner for Regulatory Affairs, FDA, said, "We took this action to stop Triad from continuing to distribute products, which may pose a risk to public health."

454 Life Sciences, a Roche company,  and NuGEN Technologies, have recently announced the development of a unique  sample preparation method and high-throughput sequencing solution for small   and degraded RNA samples. The collaboration leverages 454 Life Sciences' capabilities to construct sequencing-ready cDNA libraries from RNA samples and NuGEN's experience and innovation with genomic sample preparation solutions. This collaborative effort provides researchers an end-to- end solution for transcriptome profiling using their most precious sample types. "NuGEN's innovative sample preparation solutions provide a unique and powerful tool that will enable researchers to obtain    high-quality data from their less abundant samples. Together with 454 sequencing: Systems, the research community can perform whole transcriptome profiling on samples with as little as 500 pg of total RNA. Being able to collaborate with a leading NGS platform provider such as Roche, enables customers to leverage NuGEN's linear amplification technology while obtaining long and highly accurate sequence reads," said Elizabeth Hutt, CEO, NuGEN Technologies.

Waters Corporation has introduced its Waters9 Biopharmaceutical System solution. The new biopharmaceutical system brings together UPLC®/MS characterization technology with UNIFI™     Scientific comprehensive software biotherapeutic analyses high-resolution analytics across the development process continuum. The combination of Ultra Performance Liquid Chromatography (UPLC®), mass spectrometry and bioinformatics technologies results in efficient flow of data and information. It also conforms to biopharmaceutical quality guidelines and regulations. Focused on task-specific workflow design, the Biopharmaceutical System features automated data processing and simplified results validation. Leveraging UNIFI's architecture, the intuitive user interface can be configured for the roles and   capabilities   of   the   scientists throughout an organization. Critical to biopharmaceutical organizations is reliance on an analytical system that supports Good Manufacturing Practice (GMP) and compliance tools all with underlying secure database technology.

...says Rakesh Aggarwal, Director - Operations, Cole-Parmer, India. Explaining the business model, he discusses the strategies planned to achieve growth in the next few years in the life sciences segment. Meghna Mukherjee & Arshia Khan   How is your business performing? We are a knowledge and solutions- based business and deal with most of the industries in the scientific and process community. The premier channel through which we reach customers to offer our wide portfolio of products is our product catalog and website. We have an India-specific catalog, which contains more than 2,600 products and a biennial general product catalog with more than 10,000 new products listed. In India, we have a strong field sales and service team, which covers the length and breadth of the country and reaches customers with our value-added solutions. We also have a dedicated applications team based in  Mumbai, which provides exceptional technical support and customized solutions, assists in selecting suitable products and helps with troubleshooting. We also organize various road shows and seminars, and participate in trade shows to meet with customers and understand their business requirements. Our strategy remains in tine with our mission to excel as the premier global source of instrumentation to meet individual customer needs. It also underscores our reputation of bringing the latest products to customers, and re-stresses our mantra of 'Delivering Solutions You Trust'.    Please tell us about your product portfolio. With a mix of proprietary products and   strategic   partnering   with leading manufacturers, Cole-Farmer's business is highly diversified across a spectrum of products, consumables, services and solutions. Cole-Parmer offers a wide range of products for needs ranging from R&D, pilot plant and production; specializing in  providing scale-up  assistance- With  more than  50 years  of experience, Cole-Parmer is one of the global leaders in supplying fluid handling,   life   science,   general laboratory products, instrumentation and equipment. What is Cole-Farmer's strategy for growth? Our parent company has made a number of strategic acquisitions over the years, large and small. We always look for appropriate opportunities whenever they present themselves. Cole-Parmer has been m India for more than 15 years with a direct presence in the last five years. We have a strong presence in the biopharma and bioservices markets. Today, around 40 per cent of the business comes from biopharma, while the remaining 60 per cent derives from food & processing, chemical,   automobiles,   dyes   & pigments industry and government- owned research labs. What are the recent developments at Cole-Parmer? Our biennial 2011-12 general catalog recently launched in India contains 10,000 new items with approximately 2,500 brand new products mainly catering to the pharmaceutical. Academics, food and agriculture sectors. Our website in India is in the nascent Stage and does not represent our full capabilities. So, we have a plan to develop our website, giving it a local perspective based on the feedback received. Every year, we pursue several initiatives to increase customer awareness of the latest technology and trends. The objective is to meet customers and provide them with answers to their demanding application needs.   What are the strengths more...

Development of a new drug/molecule begins with a lot of ideas and interest and then it enters the long dark tunnel of risks and uncertainties. Pharma companies invest enormous amount of money and time for the development of a drug and bringing it into the market, but it is not without proper risk analysis and assessments that they do so. In most industries around the world, risk analysis and decision- making tools arc relevant. In times of recession, patent products expiration, lack of novel technologically advanced skills, pharma companies are relying on sophisticated specialization for analyzing the risks and uncertainties prevalent in the market. This will not only help them achieve their desired targets but will also ensure   or   predict the huge stumble or roadblock that their product might face in the long run. By necessity, experts in the Held garnering varied solutions are preferred, and    Protivitri    is one   such   leading business    consulting firm    catering    to the    demands    of this sector. Businesses   around the     world     are facing   extraordinary challenges. In India, Protivitri commenced its   operatic ns   in October 2006 and have offices at NCR, Mumbai and Bangalore. We have rendered services ranging from value added internal audits. Information Technology   (IT)   effectiveness   & control, risk and compliance, finance and accounting excellence, and cost &   working   capital   optimization across   industries   ranging   from health care & life sciences, telecom, industrial products, infra structure, etc.  Pharma industry: Present and future The pharma industry in Indian is poised for a rapid growth over the next few years. Patents for several blockbuster drugs (estimated at over $250 billion in sales) will be expiring between 2011 and 2015, which will lead to an opportunity for the generic manufacturers in India. Once the drug loses patent protection, the market price of the product falls drastically by around 80 to 85 per cent. Even on a conservative basis of 10 per    cent,    the    market for these drugs over the next five years would be in the range of $25 to 30 billion. Indian companies are leaders in generic manufacturing and have    set    up    state-of-the-art manufacturing facilities   in   India that   are   US   Food   and Drug Administration    (PDA)    approved. The US PDA has stringent regulatory standards     for     manufacturing of"   pharmaceuticals   products   in the world. Considering the low cost of manufacturing in India, there seems to be a tremendous opportunity for the Indian drug makers. Over the past few years, we have seen several alliances/ takeover between Indian drug maker and foreign MNCs; the latest being the joint Venture (JV) between Merck and Sun Pharma that was formed with the idea to sell branded generics   in   emerging   markets. Some of the companies that are affected by loss or patent protection Would be Pfizer, £Ii Lily, Johnson &. Johnson, Merck, etc. Since the non-patent protection regime for such products   if   not   lucrative, the best way to retain the market share of this products by these foreign MNC's would be to share the technology/IP with a generic manufacture on a                profit share more...

While much effort is spent in optimizing commercially operating plant, getting the process 'right first time' can be far more efficient. Real-time analysis of process parameters provides substantial support during development, streamlining and accelerating the evolution of successful process designs. A case study for investing in real-time process measurement for pilot studies is discussed. Real-time process analysis systems      are      used increasingly   within   the manufacturing environment. Automating   analysis   dramatically reduces    operational    variability and its associated inefficiencies- Automation can pay big dividends by improving product quality and at the same cutting the cost of production. These   savings   quickly   offset installation   costs,   strengthening the economic argument in favour of investment. The financial case for automation at the pilot scale may be less easy to make. Here, potential   benefits are not so immediately obvious,   and   can   be difficult to quantify, but are nonetheless   considerable. The   scope   for   more consistent operation, and the efficient correlation of 'cause and effect', accelerates and   improves   product and process development alike,    bringing    faster and     more     efficient commercialization.    This drives   down – Research &   Development   (R&D) spend an important goal in many sectors. Pilot plant trials As a product moves through early stage research towards commercialization,      the impetus is to develop a robust process that will secure consistent, profitable production over the long term.  Pilot scale trials often have an important role to play. Operating small scale units, which replicate part or a!! of a proposed or existing full-scale plant, is a relatively inexpensive   way   to   experiment towards the best processing solution. The term 'relatively inexpensive' is, however, used advisedly here, since pilot scale trials are often associated with     significant     expenditure. Furthermore, they are an upfront investment, cash spent now in anticipation of future, rather than immediate    reward.    Maximizing efficiency is essential. In considering the contribution that real-time analysis can make, it is worth examining possible goals of a pilot scale study. These might include: • Identifying the most cost-effective process design • Proving the feasibility of a new technology • Preparing representative samples for product testing • Defining the process operating envelope; the range of conditions that will result in a product that meets the defined specification • Developing an effective control strategy Reaching these goals in a timely way demands rapid acquisition of understanding. The pilot scale may follow directly on from fairly basic lab work, designed to simply prove the viability of a product. Little may be known about the feasibility of different manufacturing options and it is important to learn fast. The role of real-time measurement The real-lime measurement of key process or product parameters eases pilot plant control and increases experimental efficiency. Consider the example of a trial designed to establish optimal muling conditions. When milling, particle size is a defining characteristic of the product so it is useful to examine what happens when using periodic particle size measurement compared with applying real-time analysis. Periodic, off-line analysis provides a snapshot of the process each time a sample is taken. Material is extracted from more...

The recent launch of version 7.0 of Argus Safety database application, by Oracle Software shows how Information Technology (IT) has become a crucial part of the healthcare system worldwide. This new updated version is a cloud-based product that allows healthcare firms to report and manage data from adverse drug events. This updated version will help healthcare companies keep a track of the adverse effects of drugs and will also help in efficiently running clinical trials. Oracle also has other software like Clinical, Remote Data Capture and Thesaurus Management System, but how many of them are being used in India? "In India use of specialized software like Argus is very rare. Unlike the US Food and Drug Association (FDA), in India too much emphasis or stress is not given to organized documentation of database. There are hardly any drug safety audits done in India and since no one asks for documentation of progress achieved at every level of a drug's development, companies do not invest in specific software like Argus," said Dr Arun Bhatt, President, ClinInvent Research Pvt Ltd. He continues, "We do use Oracle Clinical, but except that right now in India there are hardly any specialized software’s that are being widely used. And on top of that, the high cost of such software is another hindrance to its widespread use. All work done by Argus can easily be done in Microsoft Excel sheet and with very little stress given on organized documentation in India; Ms Excel can easily perform the task." There are various data management software used by various companies and hospitals, but in specialized software progress is yet to be done. Few multinational companies such as Pfizer can use such specialized software but India is yet to fully utilize the power of such specialized software. And this will only be possible once the regulatory bodies set forward some hard and fast rules regarding drug safety and clinical trials, giving more emphasis on documentation and organized database. 

Over the last few years, Electronic Data Capture (EDC) has strengthened its usage and it is predicted that it will replace paper for capturing clinical trial data. Will we see a paperless world in the near future, or certain obstacles such as not realizing the true value of EDC will act as a barrier? Clean, high-quality data is one of the most critical elements of any clinical trial and to obtain this most companies engaged in clinical research have a robust Clinical Data Management System (CDMS) in place. CDMS is a tool used in clinical research to manage the data of a clinical trial and can be broadly divided into paper-based and EDC system, historically, the collection of clinical trial data has been a very manual, paper-based process. The clinical trial data is gathered at the investigator site in the Case Report Forms (CRFs) and sent to the company for Which trial is being performed or to the Contract Research Organization (CRO) that is managing the trial for a company. The data on forms is transferred to the CDMS tool through data entry. This can be by single or double data entry. The most popular method is double data entry where two different data entry operators enter the data in the system independently and both the entries are compared by the system. In case the entry of a value conflicts, the system gives an alert and verification can be done manually. The data in CDMS is then transferred for data validation to check for logical errors. An example is a check of the subject's age to ensure that they are within the inclusion criteria for the study. These errors are raised for review to determine if there is an error in the data or clarification from the investigator is required. Also, in these systems, during validation the data clarification from sites are done through paper forms, which are printed with the issue description and sent to the investigator site and site responds by answering on forms and mailing it back. This process is labour intensive, slow and involves extensive use of  paper forms.                           Paradigm shift Given the fact that the pharmaceutical industry is under extraordinary economic pressure and the demand to quickly deliver therapies to market intensifies, there is a growing need to implement technology solutions such as EDC to control operational costs and expedite time-lo-market. Clinical trials are the most expensive and critical part of drug development and EDC has the potential to significantly decrease time to market and clinical trial costs. In EDC, traditional data management roles have changed, as it is the site staff that enters data into the system and the programmed edit checks will trigger queries at the time of entry or immediately after submitting the data. This instant validation provides a higher level of data quality at reduced cost and without delay- Clinical Data Management (CDM) no longer makes data changes in the system based on site query responses, but rather site more...