Intellectual Property rights

Intellectual propert rights from aartisoni12

Pharma Quality Control and Quality Assurance

Pharma Quality Control and Quality Assurance from aartisoni12

Distance Learning Program

Distance learning program in pharma from BII Noida

SYSTEM PHARMACOLOGY

A comprehensive strategy to transform drug discovery by convening researchers from an unprecedented range of disciplines to explore together how drugs work in complex systems. This defines System Pharmacology. It comprises of personals from a broad array of disciplines, including systems biology, cell biology, genetics, immunology, neurobiology, pharmacology, medicine, physics, computer science and mathematics, drawing on expertise from the Quad and our distinguished affiliated hospitals and research institutions.

Therapeutics is being created with two broad goals: first, to increase significantly our knowledge of human disease mechanisms, the nature of heterogeneity of disease expression in different individuals, and how therapeutics act in the human system; and second—based on this knowledge—to provide more effective translation of ideas to our patients by improving the quality of drug candidates as they enter the clinical testing and regulatory approval process, aiming to increase the number of efficacious diagnostics and therapies reaching patients.

This Initiative in Systems Pharmacology reframing classical pharmacology and marshaling its unparalleled intellectual resources to take a novel approach to an urgent problem: The alarming slowdown in development of new and lifesaving drugs.

A better understanding of the whole system of biological molecules that controls medically important biological behavior, and the effects of drugs on that system, will help to identify the best drug targets and biomarkers. This will help to select earlier the most promising drug candidates, ultimately making drug discovery and development faster, cheaper and more effective. A deeper understanding will also help clinicians personalize drug therapies, making better use of medicine. The initiative will support both new approaches in translational science, such as failure analysis on unsuccessful drugs and use of chemical biology to develop probes of biological pathways. It will also include a new educational program, one that develops a new generation of students, postdoctoral fellows and physician-scientists, the future leaders in academic and industrial efforts in systems pharmacology and therapeutic discovery.

The initiative will be led by Marc Kirschner, the John Franklin Enders University Professor of Systems Biology and chairman of the HMS Department of Systems Biology; Peter Sorger, professor of systems biology; and Tim Mitchison, Hasib Sabbagh Professor of Systems Biology and deputy chairman of the Department of Systems Biology

Bashah Javed

Faculty of Bioinformatics.

Bioinformatics Institute of India.

Noida.

Characteristics of Indian Pharmaceutical Industry

The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registered units. It has expanded drastically in the last two decades. The leading 250 pharmaceutical companies control 70% of the market with market leader holding nearly 7% of the market share. It is an extremely fragmented market with severe price competition and government price control.


The pharmaceutical industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals and injectibles. There are about 250 large units and about 8000 Small Scale Units, which form the core of the pharmaceutical industry in India (including 5 Central Public Sector Units). These units produce the complete range of pharmaceutical formulations, i.e., medicines ready for consumption by patients and about 350 bulk drugs, i.e., chemicals having therapeutic value and used for production of pharmaceutical formulations.


Following the de-licensing of the pharmaceutical industry, industrial licensing for most of the drugs and pharmaceutical products has been done away with. Manufacturers are free to produce any drug duly approved by the Drug Control Authority. Technologically strong and totally self-reliant, the pharmaceutical industry in India has low costs of production, low R&D costs, innovative scientific manpower, strength of national laboratories and an increasing balance of trade. The Pharmaceutical Industry, with its rich scientific talents and research capabilities, supported by Intellectual Property Protection regime is well set to take on the international market.


Why India…?


Competent workforce: India has a pool of personnel with high managerial and technical competence as also skilled workforce. It has an educated work force and English is commonly used. Professional services are easily available.

Cost-effective chemical synthesis: Its track record of development, particularly in the area of improved cost-beneficial chemical synthesis for various drug molecules is excellent. It provides a wide variety of bulk drugs and exports sophisticated bulk drugs.
Legal & Financial Framework: India has a 53 year old democracyand hence has a solid legal framework and strong financial markets. There is already an established international industry and business community.


Information & Technology: It has a good network of world-class educational institutions and established strengths in Information Technology.

Globalisation: The country is committed to a free market economy and globalization. Above all, it has a 70 million middle class market, which is continuously growing.


Consolidation: For the first time in many years, the international pharmaceutical industry is finding great opportunities in India. The process of consolidation, which has become a generalized phenomenon in the world pharmaceutical industry, has started taking place in India.


Steps to strengthen the Industry


Indian companies need to attain the right product-mix for sustained future growth. Core competencies will play an important role in determining the future of many Indian pharmaceutical companies in the post product-patent regime after 2005. Indian companies, in an effort to consolidate their position, will have to increasingly look at merger and acquisition options of either companies or products. This would help them to offset loss of new product options, improve their R&D efforts and improve distribution to penetrate markets.
Research and development has always taken the back seat amongst Indian pharmaceutical companies. In order to stay competitive in the future, Indian companies will have to refocus and invest heavily in R&D.


The Indian pharmaceutical industry also needs to take advantage of the recent advances in biotechnology and information technology. The future of the industry will be determined by how well it markets its products to several regions and distributes risks, its forward and backward integration capabilities, its R&D, its consolidation through mergers and acquisitions, co-marketing and licensing agreements.



RITU PAL
Marketing Executive

A Successful Presentation of BII for Research collaboration with Dr.K.N.Modi institute

A big day just passed for BII, but had left its impressions; 4-MAY-2012 was very special to everyone in BII, what was so special in it? Specialty was the Research collaboration proposal between two institutes. Now not making you wait I will tell you we have got very special guests in our premises, Dr. K.N.Modi Institute of Pharmaceuticals Education & Research represented by their faculties & students have come for a visit.

Guests have arrived at 1200 Hrs, we welcomed them with open arms. As it was a sunny day, we arranged refreshments before the commencement of any proceedings of the day. Round 1230 Hrs. our COO Mr. Anshul Gupta & Technical Head Mr. Ranjan Kumar expressed the warm welcome on the behalf of BII.  Now we took off for the technical part of the day; first we had “Cheminformatics session” took by our Bioinformatics faculty Mr. Bashah Javed which last for one hour. The guests were taking every bit of information from the presentation. After it, we moved to the Lunch break for all our guests and students.

Post lunch was even more exciting for all, as it had got demonstrations in it. We divided the students from Dr. KN. Modi into two batches. First batch took the demonstration of Drug Designing & analyzing software V-Life on the other hand second batch was on an exciting ride of instrumentation in the Biotech Lab with Ms Aditi Banerji. Then we swapped the batches for the demonstrations. Meanwhile our Guests faculties were with our Management in Directors’ Chamber on the academics discussions and interestingly on the research collaboration which will take place.

After the insightful technical sessions we all assembled at one place and our Honorable CEO Mr. Shivendra Misra thanked our guests for their eminent presence. And then our Honorable guest Mr. Vijay Sharma (HOD-Pharm. Chem.) expressed his views on the day, then we call for the day.

I would like to express my gratitude to the Director, members of BII, ICIS and our marketing team member Ms. Ritu Pal and Mr. Yash Srivastava for such a wonderful arrangements and presentation of BIII would also like to give special thanks to Ms Aditi Banerji for live demonstration of molecular biology experiments in front of faculty and students and last but not the least for such a tremendous and extra ordinary work of our junior division staff which are essential part of our organization thank you for bringing us at a successful commencement of the day.

 Author

Gourav Kumar

Faculty cum Research Associate

Biotechnology BII

Piramal Healthcare signs agreement with Bayer Pharma

Piramal Healthcare Limited has inked a pact to purchase worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG via its newly developed arm – Piramal Imaging SA.


The portfolio consists rights to florbetaben, which is presently in the final stages of its Phase 3 clinical trials. First Phase III results will be unveiled in New Orleans at the American Academy of Neurology Annual Meeting on April 25.

Florbetaben is a PET tracer used for the detection of beta-Amyloid plaque deposition in the brain. It is believed that the detection of beta-Amyloid depositions is likely to lead to early diagnosis and more specific treatment of Alzheimer’s disease.

Ajay Piramal, Chairman Piramal Group, said, “This is the second acquisition of late stage assets after our acquisition of assets of BioSyntech in 2011, where we have recently received the European CE mark approval for an innovative bio-orthopaedic product for cartilage repair, BST-CarGel, which enables the company to commercialize BST-CarGel in all of the countries in the European Union. We plan to build a promising portfolio in the Pharma space, including our newly acquired Molecular Imaging assets, which will help us create a global branded Pharma business.”

According to the pact, Piramal will be having the intellectual property (consisting patents, trademarks and know-how), worldwide development, marketing and distribution rights of the lead compound florbetaben.



Ritu Pal
Marketing Executive
BII

SCHOTT AG & KAISHA joint venture in Pharmacy :

MAINZ, Germany and MUMBAI, India, SCHOTT AG and KAISHA Manufacturers Private Ltd., an Indian company, announce the formation of a joint venture, SCHOTT KAISHA Private Ltd. The new joint venture will manufacture primary pharmaceutical packaging made of glass for the Indian market. The joint enterprise will have operations in Mumbai and Daman.

"With this double-digit million euro investment, SCHOTT continues on its course to growth and quality leadership. Udo Ungeheuer, Chairman of the Board of Management of SCHOTT AG.

SCHOTT, the technology group based in Mainz, Germany, will hold a 50 percent share in the company and contribute its technological expertise in manufacturing high quality ampoules, vials, syringes and cartridges in a global environment. KAISHA will bring in its existing sites and manufacturing capacities.

SCHOTT and KAISHA have worked successfully for many years in a buyer-supplier relationship. SCHOTT supplied the pharmaceutical glass tubing to Kaisha for converting them into primary pharmaceutical packaging products

The pharmaceutical packaging market in India is growing by approximately 10 to 15 percent per year, particularly in the higher quality segments, according to industry analysis. India has the largest number of U.S. Food and Drug Administration approved plants outside of the United States, for example. The joint venture will support Indian pharmaceutical companies in upgrading products for international markets by supplying pharmaceutical packaging at an international quality level from the Indian production site. For this purpose, SCHOTT KAISHA will build production capacity for Standard Line ampoules and vials, which will be in production in the fourth quarter 2009.

SCHOTT Pharmaceutical Packaging is one of the world's leading suppliers of parenteral packaging for the pharmaceutical industry. More than 500 production lines in 11 production sites worldwide produce more than 6 billion syringes, vials, ampoules, cartridges and special articles made of tubing glass or polymer. All production sites of Business Segment SCHOTT Pharmaceutical Packaging operate in a GMP environment and the products comply with the international standards USP, EP and JP.

Author

Yash Shrivastava

Marketing Executive

GENE EXPRESSION ON ARRAY TOOLS

Microarray is an important part of life science domain to analyze the expressions of genes and this is due to the rapid progress of Human Genome Project and Biotechnology. The use of gene expression profiling has increased dramatically but serious problems are in the analysis of such data. Valid analysis of DNA microarray experiments requires substantial statistical knowledge but statisticians with expertise in microarray methods are in short supply and not available to many laboratories.

BRB-Array Tools was developed in an attempt to broadly share the knowledge gained by biostatisticians of the Biometric Research Branch of the National Cancer Institute in a decade of involvement in collaborative microarray investigations and in the development of statistical methodology for microarray data. The primary objectives of BRB-Array Tools are:

(1) To provide scientists with software that guides them to utilize valid and powerful methods appropriate for their experimental objectives without requiring them to learn a programming language.

(2) To encapsulate into software the experience of professional statisticians who read and critically evaluate the extensive published literature of new analytic and computational methods.

(3) To facilitate education of scientists in statistical methods for the analysis of DNA microarray data.

BRB-Array Tools is an integrated software system for the comprehensive analysis of DNA microarray experiments. It was developed by professional biostatisticians experienced in the design and analysis of DNA microarray studies and incorporates methods developed by leading statistical laboratories. The software is designed for use by biomedical scientists who wish to have access to state-of-the-art statistical methods for the analysis of gene expression data and to receive training in the statistical analysis of high dimensional data. The software provides the most extensive set of tools available for predictive classifier development and complete cross-validation. It offers extensive links to genomic websites for gene annotation and analysis tools for pathway analysis. An archive of over 100 datasets of published microarray data with associated clinical data is provided and BRB-Array Tools automatically imports data from the Gene Expression Omnibus public archive at the National Center for Biotechnology Information. So anyone who is working for expression of genes can go for it.

Author Name

Bashah Javed

Faculty Bioinformatics

Bioinformatics Institute of India

Marketing Trend in Biotechnological concept:

With vast amounts of information being generated due to advancements in biotechnology, there arises a need to effectively control and manage the information so generated. Information Technology provides a mechanism more popularly known as bioinformatics, which facilitates this process. Information technology has become a critical factor in pharmaceutical research and development .Bioinformatics is the computer assisted data management discipline that helps us gather, analyze, and represent information in order to educate ourselves, understand life’s processes in the healthy and disease states, and find new or better drugs. This field has exploded out of the world of molecular biology and the Human Genome Project. Pharmaceutical companies are achieving increased research efficiency by the introduction of new approaches to the design, synthesis, screening and optimization of drug candidates. IT is an important support function for all of those activities and there are certain functions and operations that cannot be performed without IT. Informatics represents the deployment of Information Technology to manage, analyze, and store biological data. Beyond data management, informatics represents the only way to analyze large pools of genomic information. Informatics finds application in Target Validation, Lead Optimization, Exploratory development etc.

Bioinformatics plays a key role in functionalities such as gather, store, classify, analyze, and distribute biological information derived from sequencing and functional analysis projects. In Bioinformatics, the real long-term value lies in converting the data into useful therapeutics and hence efforts are on to make the bioinformatics tools as standardized and easy as possible, which is similar to the development of standardized computer operating systems. Most publicly held informatics companies had initial public offerings in the second half of 2000. Since then, the biotechnology index has suffered a major setback, and informatics stocks have reacted in sympathy mostly to the downside. Growth in the informatics industry is largely contingent on continued spending on drug discovery. The market for Bioinformatics isn’t large enough to support a company built around one or two high-cost software programs targeted to a relatively small user group. As we assess the market or potential market of Bioinformatics we must consider the strategies effective to reach different, or all, parts of the potential market. Strategies focused at the high margin big Pharma market (limited in opportunities) or strategies designed to embrace all biological scientist (but of reduced or variable margin). Also, certain bioinformatics-based companies are leveraging their technologies to become fully integrated drug discovery operations. Other bioinformatics companies are merging with drug discovery companies, resulting in a substitute technological approach to drug development.

The convergence of biotechnology and computing has already resulted in a number of alliances, which could result in mergers between previously distinct industries. In future, we may see a combination of pharmaceutical and computing firms bringing together their research as well as IT capabilities. In future we may see alliances between pharmaceutical, software as well as firms, which have strong marketing capabilities. The field would also witness the entry of new players such as computing and telecommunication firms. The challenge facing bioinformatics researchers is simply making sense of the plethora of genomic data while constantly refining their technology, research approaches. The real opportunities are in finding out how all the shards of information relate to one another, and what this means for real world applications. Recognizing bioinformatics as central to accelerating drug discovery, big pharma and biotech firms are expected to invest heavily in internal capabilities, or meet their needs through outsourcing. As the market matures, collaborative industry initiatives may drive even more bioinformatics demand. Innovation will depend on the integration of databases across functions and across companies.

Ritu Pal

Marketing Executive

Ranbaxy launches Atrovastatin in Australia

It feels great when  an Indian pharmaceutical company i.e. Ranbaxy Laboratories has announced that its subsidiary, Ranbaxy Australia has launched Atrovastatin in 10mg, 20mg, 40mg, 80mg in Australian market. This has been approved from Therapeutic Goods Administration, the regulatory authority in Australia. The brand was introduced under the name, ‘Trovas’ through retail pharmacy chains. Basically Atrovastatin is a cholesterol reducing drug and it is the most prescribed medicine in Australian pharmacy market. Atorvastatin is the largest selling pharmaceutical product in Italy with sales of US$ 377 Mn (IMS MAT Dec., 2011). The market size for Atorvastatin in the Netherlands is US$ 164.4 Mn (IMS MAT Dec., 2011) and in Sweden is US$ 55 Mn (IMS MAT Dec., 2011) and is the largest selling Statin product in these two markets.

 Alex Evans, Managing Director Ranbaxy Australia, said that Ranbaxy is the first Indian generic company in Australia to introduce Atrovastatin under the brand name, ‘Trovas’. The continent is important strategic market for Ranbaxy, which entered in Australian market in 2006. Australia has distinct business philosophy committed to empowering community pharmacies and improving access to quality medicines. Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 46 countries and manufacturing operations in 7 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence.

     YASH SHRIVASTAVA

     MARKETING EXECUTIVE

                                                                                   

    BIOINFORAMATICS INSTITUTE OF INDIA 

Career Spotlight: Pharma Regulatory Affairs

Pharma regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry.

Those working in pharma regulatory affairs jobs not only work in the initial application phase for a new or generic drug, but also in the licensing and marketing stages – making sure all operations and products meet required safety and efficacy standards.

Professionals must combine knowledge of the business, legal and pharmaceutical industries to determine if regulations are being followed and in many cases form the link between pharma companies and regulatory authorities, such as the Food and Drugs Agency (FDA) and the European Union.

Regulatory affairs jobs in the UK and further afield are generally within the pharmaceutical, chemicals, biotechnology, medical devices and cosmetics industries. Organisations such as the FDA, also provide roles for those interested in working in the field.

As biotechnology plays an increasing role within drug development and the pharmaceutical industry, growing numbers of biotech regulatory affairs positions are opening up. Inspection of biotechnology facilities requires a high level of technical knowledge due to the ever advancing systems being used.

Pharma regulatory affairs jobs

Professionals working in pharmaceutical regulatory affairs roles will be required to handle a number of different tasks; from keeping on top of the latest developments within the industry to writing product labels and patent information.

As well as collecting and collating large amounts of information and preparing licensing submissions, pharma regulatory affairs jobs also include liaising with doctors and scientists, conducting clinical trials and negotiating with regulatory authorities.

Workers may also be tasked with undertaking and managing regulatory inspections within the company and reviewing practices when required to meet with new or updated regulatory requirements.

Opportunities for regulatory affairs consultants offer professionals the chance to work in a number of fields, which requires high levels of knowledge of multiple industries.

Jobs in pharma regulatory affairs generally require a background in the applicable industry, business knowledge, great oral and written communication, good attention to detail and strong IT skills.

The international scope of many companies working within the pharmaceutical industry mean that a second language is generally desirable, as it previous work experience within a clinical or pharma setting.

Pharma regulatory affairs jobs in India

Asia has emerged as a strong growth region for the pharmaceutical industry in recent years, in particular India which is fast becoming a preferred location for clinical trials and research and development activities.

The creation of a new product patent system in 2005 was a driver of this growth, which is expected to increase as the domestic market in India further opens up.

This growth has also helped facilitate an increasing number of pharma regulatory affairs jobs in India. A number of companies have set up in the most populous city in the country, creating a number of regulatory affairs jobs in Mumbai.

Figures from a companiesandmarkets.com report show that by the year 2012 the market for clinical trials in India is expected to grow to $630 million (£404 million), helped by the fact that the cost of conducting research in the country is sometimes less than half that in more developed nations.

The United Arab Emirates (UAE) is another country looking to expand its appeal to the pharmaceutical industry, increasing the number of pharma regulatory affairs jobs in Dubai.

A report by RNCOS suggests that compound annual growth of 17 per cent will take place between 2010 and 2013 and that the UAE is ripe for investment for pharmaceutical manufacturing operations.

Pharma Regulatory Affairs

Pharma Regulatory Affairs (12 Months Program)

The industry program aims to prepare aspirants for regulatory affairs positions in the pharmaceutical, biopharmaceutical and medical device industries i.e. to equip them with the educational foundation that will help them advance in the regulatory affairs profession. The course will provide the student with the fundamentals required in both regulatory affairs and quality operations. This course is designed to give industry level education in field of legal and regulatory issues. These issues are very critical to Pharma companies, Clinical Research Organization, Bio Tech companies. The course focuses on regulatory affairs concept which the Pharma companies must comply to sell their drugs both domestically and in the international market.

The course has been framed with the following objectives

• To decipher a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.
• To create experts in the field of RA documentation and research
• To help students build their career in RA and become RA professionals.
• To provide students with a global knowledge of Regulatory Affairs.

Career Opportunities

As regulatory processes increase in complexity and scope, and globalization occurs within the field, there will be continuing industry demand for people with a strong foundation in regulatory affairs. The students of the program will have an understanding of the regulatory processes involved in biotechnology, medical device, pharmaceutical and food products. Students will become eligible for occupations involving drug or medical device submissions and quality assurance functions and roles. The individuals who are interested in pursuing a career in regulatory affairs would get a thorough understanding of current regulations and their application to the development and commercialization of drug, biologic and biodevice products. The Regulatory Affairs program provides professionals with the specialized knowledge required to help biotechnology, medical device, pharmaceutical and food companies manage regulatory processes. The course would facilitate the participants with the understanding of th e areas of regulatory affairs and quality operations to give students a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.

• Pharma Regulatory Affairs Consultant
• Regulatory Officer

For further details and enquiries
Call:0120-4320801/02
Mob:09810535368,9818473366
E-mail : info@bii.in,