Clinical Trial of a Cancer patient

I am writing a little bit about Clinical trials on cancer patients. These trials are performed to figure out the best way to treat cancer. In the early phase of clinical trials, patients that are diagnosed with cancer have to sign a treaty that they are participating in the clinical trial to help with their pain. The pain from the cancer is severe. Patient will be told about the medication , the side effects , and the potential benefits. Then patient will sign the consent form. In this trial they have to  keep a diary on how much pain is controlled  and how much different doses of the medicine took. The patient will receive a box of pain meds and it will contains pills of different strengths. Then 30 minutes, 60 minutes, 90 minutes after medication  the pain level  has to be note down each time. If the pain improves and is well controlled then the dose have to be taken when it is needed. If this doen’t work then an increased dose has to be given next time. This will figure out the best way to treat cancer pain. In first phase of pain medication trial a very low dose will be given which will show effect or not, depends. Now to get relief from pain the dose has to be increased may be four times and that gives a relief from pain but with sleep. So controlling  most of the pain that has to be done with lowering the dose and without falling asleep. If the pain for the cancer become worse so the highest dose can also be given.

Bashah Javed

Faculty of Bioinformatics

BII, Noida.

Novartis wants U.K. to quash off-label Avastin use

Novartis is taking up arms against British eye doctors who use Roche's Avastin. Novartis markets Lucentis, a much pricier treatment for wet age-related macular degeneration. Lucentis is licensed for that use. It's recommended for that use by the U.K.'s cost-effectiveness gatekeepers. Avastin is not.

Some local National Health Service operations are repackaging Avastin, a cancer drug that's actually related to Lucentis, into syringes for eye use. While quite expensive as a cancer treatment, at such tiny doses, Avastin costs a tiny fraction of Lucentis' price. Novartis is asking a U.K. court to review NHS reimbursements for off-label Avastin treatment.

The U.K. debate mirrors another in the U.S., where repackaged Avastin has been broadly used by eye doctors. Recent head-to-head study data suggested that Avastin was as effective at treating wet AMD as Lucentis, but the cheaper drug presented a higher risk of side effects. The off-label Avastin use also got some negative publicity last year after several clusters of eye infections, some of which led to vision loss, were linked to the drug.

Novartis is using Avastin's side-effects risks to bolster its case for Lucentis. "It is unacceptable to put the safety of patients at risk through the widespread use of an unlicensed treatment when a licensed medicine is available," Novartis said in a statement. "It undermines the regulatory process that was introduced to safeguard patients."

The local NHS operations, however, say that Avastin is safe, the BBC reports. "Avastin is internationally recognized as an effective treatment for AMD, and, for example, over 50% of AMD patients in the United States are treated with Avastin," officials said.

With its top-seller Diovan facing generic competition, Novartis is leaning on newer products such as Lucentis to take up the slack. As Reuters points out, the eye drug's sales jumped by 30% in the first quarter, to $567 million.

Yash shrivastava

Marketing Executive

BII

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

Biotechnology in Pharmacology

Starting with the last paragraph where we have finished with DNA structure Now it’s obvious that DNA looks a very attractive molecule for life processes. Thanks to Henri Becquerel discoverer of radioactivity, Its gives a perfect way to Alfred Day Hershey and Martha Cowles Chase to prove DNA on protein as a genetic material. DNA Which have ability to move forward for Transcription process which finally lead to synthesis of new polypeptide chain (a unit of protein) with process known as translation.
Proteins are considered as body building material, and as all enzymes are protein, it makes proteins very essential for metabolic activities. So discovery of DNA as a genetic material reveals the secrets of life i.e. how conservation of species and their phenotypic character is possible.

Factors required for transcription

A. Prokaryotic

1. RNA polymerase (enzyme that catalyzes the synthesis of RNA from a DNA template).

a) Core enzyme = 3 different types of subunits (2a; 1b; 1b’)

(1) b - binds incoming nucleotides
(2) b’ – binds DNA
(3) a - helps with enzyme assembly; interacts with other transcriptional activator proteins; recent work demonstrated that a also interacts with some DNA sequences

b) Holoenzyme = core + s factor (recognizes the promoter)

c) s factors – Initially, people thought that there was only one s factor that functioned to direct RNAP to the promoters of genes. Later, different classes of s factors were found. Each s factor directs RNAP to a different type of promoter (differentiated by a specific DNA sequence in the promoter).



2. Accessory transcription activator proteins
a) IT have ability to bind with specific DNA sequences and help RNA polymerase to initiate transcription via protein-protein interactions or by altering the structure of the DNA.

b) Transcription of some promoters requires an accessory transcriptional activator; at other promoters, the activators just increase the rate of transcription but are not absolutely required.

3. Template DNA containing gene or genes to be transcribed

4. Promoter - The regulatory element that determine when a gene “turned on” (transcribed) or “turned off”. The promoter DNA is located upstream of the gene and contains a sequence which is factor of RNAP and other transcription factors bind. Different classes of promoters have different DNA sequences. Deviations from the consensus sequence decrease the level of transcription.

5. Weak promoters (ones that have poor sigma recognition sequences) have additional sequences to which transcriptional activators can bind.

6. NTPs, Mg2





Gourav KumarFaculty cum Research associate
Bioinformatics Institute of India

Cheminformatics: An Emerging Field

Cheminformatics is an emerging field that uses information technology to a range of problems in the field of chemistry as well as drug discovery. Cheminformatics is a fast growing field and there is a lack of qualified scientific professionals who can use computers and databases for chemical compounds or drug development. Basically it is the application of information technology to chemistry. The efficient search of such stored information includes topics that are dealt with in computer science as data mining, information retrieval, information extraction and machine learning. The applications are the Chemical data collection, analysis and management, chemical data representation, database design, chemical structure prediction, compound library, database mining, QSAR/ QSPR, Statistical models and descriptors. The various aspects are the Information Acquisition i.e. methods for collecting data from the source or from various theories, Information Management i.e. storage and retrieval and Information use i.e. analysis, correlation and application to problem. The methods that included are force fields, molecular dynamics, QSAR, molecular docking and pharmacophore. The software that used are Amber (use for protein and DNA), OPLS (Optimized Potentials for Liquid Simulations), Charmm (C-22 for protein and C-27 for DNA, RNA, and Protein). These in silico techniques are used in pharmaceutical companies in the process of drug discovery. These methods can realize its immense potential, the chemical and pharmaceutical industries are now going in for qualified and trained staff in cheminformatics. New career avenues have also opened up for IT as well as computer-proficient science graduates for acquiring, managing, or utilizing chemical information with the help of computer software. The aim of Cheminformatics is to provide comprehensive understanding of this fast growing field in science and technology starting from basic principles to the point of application in various fields of chemistry, biotechnology, drug development and drug designing.

Author: Bashah Javed

Faculty Bioinformatics,

BII.

Parkinson’s disease|Bioinformatics Institute in Noida

Parkinson’s disease is a neurological illness named after Dr. James Parkinson, a physician who was the first to describe in his essay “An essay on the Shaking palsy” 1817. Parkinson‘s disease is a disorder caused by the gradual loss of cells in a small part of the brain called the substantial nigra. The loss (death) of these cells produces a reduction in a vital chemical called “dopamine”, which causes symptoms that may include loss of facial expression, reduction in speech volume and clarity, change in size of handwriting, dry skin, constipation, urinary difficulties and depression. It is a progressive disorder; hence these symptoms worsen with time. Parkinson’s disease belongs to a group of conditions called movement disorders. It is characterized by muscle rigidity, tremor, a slowing of physical movement (Bradykinesia) and in extreme cases, a loss of physical movement (Akinesia). The primary symptoms are the results of decreased stimulation of the motor cortex by the basal ganglia, normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary symptoms may include high level cognitive dysfunction and subtle language problem. Most people with Parkinson’s disease are described as having idiopathic Parkinson’s disease (having no specific cause). There are far less common causes of Parkinson’s disease including genetic, toxins, head trauma, cerebral anoxia, and drug- induced Parkinson’s disease. In recent year, a number of specific genetic mutations causing Parkinson’s disease have been discovered, including in certain population (Contursi, Italy). These account for a small minority of cases of Parkinson’s disease. Someone who has Parkinson’s disease is more likely to have relatives that also have Parkinson’s disease. However, this does not mean that the disorder has been passed on genetically. There is also recent evidence that a common gene defect contributes susceptibility to both Parkinson’ disease and Alzheimer’s disease.

Author Name Mr. Ranjan Kumar

HOD, Bioinformatics Institute of India

INDIAN PHARMACEUTICAL MARKET- REVIEW

Today I feel enthusiastic while writing this article as Pharmaceutical market is a big ocean; and I had tried my best to hold few drops on Indian economical face.

The Indian pharmaceutical market is highly competitive and remains dominated by low-priced, domestically-produced generics. Despite having the second largest population in the world and a growing middle class with high healthcare expectations, India accounts for less than 2% of the world pharmaceutical market in value terms. In one of the world's better performing economies, spending on pharmaceuticals accounts for less than 1% of GDP and average per capita spending remains one of the lowest levels in the region.

India’s biopharmaceutical sector is currently experiencing double digit growth and this is expected to continue, driven by the vaccines market. Growth drivers include education and increased awareness of disease prevention, increases in disposable income and government participation in immunization programmes. Continued growth is also expected in the diagnostic and therapeutic segments, including cancer and diabetes.

The Indian Pharma industry is responsible for around 10% of world pharmaceutical production. Over the last few years, a number of Indian pharmaceutical companies have been targeted for foreign acquisition. Concerns have been raised that this trend could adversely affect generic drug prices in India. The need to maintain low prices for essential medicines has been addressed in the government’s draft National Pharmaceutical Pricing Policy (NPPP), released in 2011. The proposed NPPP focuses on the National List of Essential Medicines (NLEM), which is periodically revised. The headline major change is a move from the principle of cost-based pricing to a market-based pricing model. The Department of Pharmaceuticals argues that market-based pricing would result in more transparent and fair pricing, as well as increasing competition in the marketplace. Price regulation will encompass all drugs listed in the NLEM, as well as formulations containing combinations of drugs listed in the NLEM; this will include combinations comprising listed drugs and unlisted drugs. If the NPPP is implemented, around 60% of the drugs currently available in India will come under price control.

Ritu Pal

BII

BII offers short term courses:-

· Professional Designation in Clinical Trials Data Management

· Professional Designation in Medical and Scientific Writing

· Professional Designation in Clinical Trials

· Professional Designation in Computational Biology

· Professional Designation in Intellectual Property Rights and Patents

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Biotechnology in Pharmacology|9810535368

Finding a chance to write on the blog of BII is a subject of honor for me. I am just trying to make reader familiar with the world of Biotechnology/life sciences and there relation with Pharmacology, Here I am trying to set some epic of DNA which is most fascinating thing in health care system as per my view. After the discovery of nuclein (nucleic acid) by Johannes Friedrich Miescher in 1869 which is one of most remarkable work in the world of Life Sciences. It initiate a new era in Life sciences especially in molecular biology. In the initial of 20^th century when protein is regarded as the most complex structure as well as genetic material, DNA comes as a medicine. Structure of DNA reveals how the characters are transferred from parents to offspring and transcript the information from genotype to phenotype via RNA and Protein. Writing anything is looks less as per broad view of DNA but 5’ to 3’ end always attract me so I will try my level best to sum-up maximum stuff about DNA and its relation with pharmaceutical industry in my this and upcoming next blogs.

Structure of DNA is very important because it is the key role for remedy of viral, bacterial and mutational problems. As its chemical structure elaborate with addition of pentose sugar purine, pyrimidine and tri phosphate molecule. Where sugar molecule deoxygenate at 2’ no of carbon while Nitrogenous bases are at 1’, when we talk about phosphate structure its added at 5’.That whole compound is regarded as nucleotide, and every new nucleotide join at 3’ end and constitute a new DNA.

Source: Mr. Gourav Kumar

Faculty:Bioinformatics Institute of India

Molecular Connections Ranked Number 24 Fastest Growing Technology Company on the Deloitte Technology Fast 50 India 2011 | Molecular Connections

Molecular Connections Ranked Number 24 Fastest Growing Technology Company on the Deloitte Technology Fast 50 India 2011 | Molecular Connections

BII Exam Notification

BII EXAM NOTIFICATION

BII's Exams would be held on 23rd & 24th April 2010 at the following cities Ahemdabad, Kottayam, Chennai, Hyderabad, Bangalore, Mumbai, Pune, Kolkata, Lucknow, Noida, Chandigarh, Bhopal & Bhubneshwar.

Changing Pharma Education in India: Join BII Pharma Programs for the New Paradigm of Pharmacy Profession in India

Due to the mushrooming of the pharmacy institutions, quality pharmacy education has faltered. As a result various institutions are finding it difficult to fill the approved quota of seats. Many institutions have a scant regard for maintaining education standards.

Pharmacy education in India had its beginning in mid of 19th century in Madras Medical College with introduction of pharmacy classes to impart pharmaceutical skills for the students qualifying for medical degrees or diploma or hospital assistance ship. Later it was helpful for the students who intended to qualify as chemist and druggists. Duration of study was increased to two years and entry qualification was made matriculation. The classes didn’t receive popularity and there were only a few students who used to opt for it. However, the course remained in operation and received Government sanction for its continuation. But the pharmacy education gained popularity only when Prof. M. L. Schroff with the consent of Madan Mohan Malviya introduced Pharmaceutical Chemistry and Pharmacognosy as one of the subjects for B.Sc. Degree in July 1937 in Banaras Hindu University. Then onwards there was no looking back. Pharmacy became a full pledged course with introduction of Diploma in Pharmacy and Bachelors of Pharmacy. Later Master of Pharmacy in various specializations was introduced. It is said that the first ever Pharmacy course was introduced along with the medical course in 1842 at the Old Portuguese school known as "Escola Medica de Goa" and later named as "Escola Medica Cirurgica de Goa". The Pharmacists (farmaceuticos) and Doctors (Medica Cirurgiao) were educated and trained in the same medical school and they had almost the same status in the Goan society.

Pharmacy education played a very crucial role in the economic development of the country. Now Pharmaceutical Sector is considered to be one of the very important sectors which significantly contribute to country’s economy. Although the pharmacy education has its enormous contribution for the development of pharma industry, its contribution for the development of pharmacy practice was modest with just a Masters programme in Pharmacy Practice. Hence, it was decided that there is a need to start a full-pledged course which would impart sufficient knowledge to student to practice the profession of pharmacy. And then the birth of Pharm D in India took place with the untiring efforts of a few visionaries. Doctor of pharmacy is patient-oriented whereas, bachelors of pharmacy is industry — oriented. The students are shaping to enter with pride and knowledge to take up the challenges of patient care.

In general, there should be a re-look at the pharmacy courses. Diploma in Pharmacy course, as a prerequisite to run a pharmacy (medical shop), is said to be outdated and only a few students opt for the course. Bachelor in Pharmacy needs an update to adapt to the advanced technology at which pharmaceutical industry is operating. Although been criticized, there should be a second thought to be given to introduce specialization at bachelor’s level. There should be an amalgamation of a few specializations at post graduate level as there are various offshoot specializations, which have come up in recent past for just commercial purposes. Instead there should be an initiation of courses in Pharmaceutical Management, Intellectual Property Right, Regulatory Affairs, Pharmacoeconomics, Pharmacovigilance, Clinical trial data management and Nanopharmaceuticals.

There should be self-regulation by pharmacy teachers. Being in very pious profession, they should update themselves with recent happenings and maintain high professional standards. They should enthuse students to take up challenges of the industry and profession of pharmacy.

Future strategies for pharmaceutical education

Curriculum design and reorganisation of the degree programme requires a ‘visionary’ approach. We should try to imagine, what is most likely to be happening in about 10 to 15 years in the future at any point of time. It is necessary to prepare the student for tackling problems and situations of the future rather than for the current state. Present will be outdated very quickly. The state-of-the-art is not a static state but is very much dynamic. The concept of the state-of-the-art itself implies a parallel and constant change in our endeavour to keep pace with the rapid changes taking place in technology, basic sciences and information. A student needs the past and present states-of-art only as basis for his future states. Attempts to do this sublime approach of jumping to the future from the past without going through the present have not yielded satisfactory outcomes. Students and the educators tended to see the ‘present’ more clearly than visualise the future possibilities. Skepticism has always been responsible in delaying progress. We exist in a social and educational system that has limited vision and consequently limited goals of achievement. Our attention and focus have been distorted by the numbers of students involved rather than the quality of education. Every student has to necessarily learn many new concepts and skills just to be able to remain in the profession of the future. We should prepare students with the right skills to learn new states-of-the-art with less effort! Nobody can visualise the entire future and design a strategy suited for that. But we could concentrate on incorporating the mental skills in the educational activities that are more permanent and provide the student a capability for learning new concepts.

Strategy in education should shift to ‘concept’ approach from the present ‘content’ approach. All content should be chosen to demonstrate and strengthen a ‘concept’ with an objective that is basic to the topic. The approach should reflect in curriculum design, its implementation and evaluation areas of education. All evaluation methods like written, oral, practical, assignments, seminars, projects, discussions etc. should be concept oriented. A student will benefit most with orientation of educational process to such mental skills like observation, analysis, correlation, application, evaluation or judgement etc. Such a system will go a long way to lessen the effort required by the students to acquire such skills all by themselves.

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Collagen manufactured from transgenic tobacco plants has great commercial promise for Hebrew University

A scientist at the Hebrew University of Jerusalem’s Robert H. Smith Faculty of Agriculture, Food and Environment has succeeded in producing a replica of human collagen from tobacco plants – an achievement with tremendous commercial implications for use in a variety of human medical procedures. Natural human type I collagen is the most abundant protein in the human body and is the main protein found in all connective tissue. Commercially produced collagen (pro-collagen) is used in surgical implants and many wound healing devices in regenerative medicine.

The current market for collagen-based medical devices in orthopedics and wound healing exceeds US $30 billion annually worldwide. Currently, commercial collagen is produced from farm animals such as cows and pigs as well as from human cadavers. These materials are prone to harbor human pathogens such as viruses or prions (mad-cow disease). Human cadaver is scarce, and for certain indications possesses serious ethical issues. Producing human recombinant type I pro-collagen requires the coordinated expression of five different genes. Prof. Oded Shoseyov of the Robert H. Smith Institute of Plant Sciences and Genetics in Agriculture has established the only laboratory in the world that has reported successful co-expression all the five essential genes in transgenic tobacco plants for the production of processed pro-collagen. For this work, Shoseyov was one of the recipients of a Kaye Innovation Award during the Hebrew University Board of Governors meeting in June. Shoseyov’s invention on has been patented, and the scientific findings behind it were published recently in the journal Biomacromolecules.

A company, CollPlant Ltd., has been established based on patents and technology that were developed in Shoseyov’s laboratory. It has raised US$15 million to establish the first commercial molecular farming company in Israel and is already manufacturing collagen-based products that have attracted collaborative commercial interest from companies in the US, Japan Europe and Israel. Yissum, the technology transfer company of the Hebrew University, is one of the shareholders of CollPlant. CollPlant is a public company traded in “TASE”, and the potential revenue for the Hebrew University from this invention is estimated to reach into the multi-million dollar range. The Kaye Awards have been given annually since 1994. Isaac Kaye of England, a prominent industrialist in the pharmaceutical industry, established the awards to encourage faculty, staff, and students of the Hebrew University to develop innovative methods and inventions with good commercial potential which will benefit the university and society.

Genes? It's complicated
The advance heralded a decade ago in mapping human DNA is yet to lead to the answers we craved

Ten years ago the $10bn Human Genome Project announced it had completed the first draft of the blueprint for human life. It was hailed as a huge scientific advance, comparable to putting a man on the moon. President Bill Clinton declared: "We'll go from knowing almost nothing about how our genes work to enlisting genes in the struggle to prevent and cure illness. This will be the scientific breakthrough of the century, perhaps of all time."

The project at last laid bare the entire human genetic code – 22,000 or so genes (the precise number is still uncertain) – that make us into the people we are. Several decades of research into the cause of diseases before the project had firmly identified genes as a significant cause of many important diseases.

The first haul of genetic diseases was of those fairly rare but devastating inherited diseases, such as cystic fibrosis and haemophilia, that are caused by single genes. Most of the genes responsible for those had been fished out of the genome long before the sequencing project hauled in its net. But the project was expected to find genes for various far more common conditions, such as cancer, diabetes, heart disease, autism, depression and schizophrenia, because most of these conditions tend to run in families. Studies of families in which these diseases were common, particularly of twins, had established a level of heritability for each condition, and the levels were high. Autism comes out at a whopping 90%, indicating that most autism is caused by faulty genes (and certainly not by faulty vaccines). The heritability of schizophrenia was about 80% whereas conditions such as heart disease, diabetes and cancer came in anywhere between 30% and 70%.

And it wasn't just diseases that were caused by genes. Many behavioural studies indicated that intelligence, personality, sexual orientation and even voting preference seemed to be highly heritable. If genes were so powerful, it should be straightforward to identify the culprits in the genome.

But a decade later these expectations have not been fulfilled. The project that promised so much has, so far, delivered very little. Very few genes have been found that account for more than 1% of the risk of any of those common diseases. And even the most significant intelligence gene yet found is responsible for variation in individual intelligence equivalent to less than one IQ point. The scientists who went in search of whoppers netted only a host of minnows. Where are the missing genes?

Like most things in life, it turns out that genes are more complex than we thought. Those genes responsible for single-gene defects such as cystic fibrosis and haemophilia are the low-hanging fruit. Common diseases, and such attributes as intelligence, are not caused by single genes or even handfuls of genes, but probably by networks of hundreds or even thousands of genes.

To understand these networks, we need to look, not at the branches, but at the roots of the genetic tree. Genes form tangles of interactions with each other such that the effect of chopping one or another is unpredictable and depends on the connectivity of the whole network. Finding a gene responsible for a disease is mostly like finding a root responsible for maintaining a tree.

The task of unravelling the roots of biology is the new science of system biology, in which biologists work with mathematicians and computer scientists to build models of complex networks. This is where the causes of heart disease, diabetes and autism are now being sought. To paraphrase Winston Churchill, the genome project was not the end. It was not even the beginning of the end. But it was, perhaps, the end of the beginning in the search for our genes.