Clinical Trials

Clinical Trials: Medical clinical trials plays an important role in development of new drugs. These trials are conducted in three phases. Introduction Clinical trials are a means of developing new treatments and medications for diseases and conditions. There are strict rules for clinical trials, which are monitored by the National Institutes of Health and the U.S Food and Drug Administration. Clinical trials are also called clinical studies, research protocols or medical research and often compare one drug against another to see which is more effective, or the medicine or procedure in a specific demographic group or for a specific disease. About Clinical Trials Why Participate in a Clinical Trial? Participants in clinical trials can play a more active role in their health care, gain access to new research treatments before they are widely available and help others by contributing to medical research. Where Do the Ideas for Trials Come from? Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and/or in animal studies, the treatments with the most promising test results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work. Who Sponsors Clinical Trials? Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions,foundations, voluntary medical-related groups and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health, the Department of Defense and the Department of Veteran’s Affairs. Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices or community clinics. What is a Protocol? A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people can participate in the trial; the schedule of tests, procedures, medications and dosages; and the length of the study. While in clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. What is a Placebo? A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment. What is a Control or Control Group? A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo. What are the Different Types of Clinical Trials? Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicine, vitamins, vaccines, minerals or lifestyle changes. Screening trials test the best way to detect certain diseases or health conditions. Quality of Life trials (or Supportive Caretrials) explore ways to improve comfort and the equality of life for individuals with a chronic illness. Classification of Clinical Trials There are three types of clinical trials – phase I, phase II and phase III – each one is designed to learn something different about a new medical treatment. Phase I Trials A phase I trial is the first test of a new treatment, and it uses the fewest number of patients (20-30 patients is typical). A phase I trial for a new drug is designed to determine the safety of the new drug, how to best administer it and the correct dosage (i.e., one that will minimize undesirable side effects). Because investigators are very interested in how the drug behaves in the body, patients in a phase I trial undergo frequent monitoring of their vital signs. Although drugs being tested in a phase I trial have shown promise in the laboratory, there is no guarantee that the drug will have any positive effects on a patient. Patients participating in a phase I drug trial help advance basic medical knowledge; they may or may not reap any personal benefits. Phase II Trials After a phase I clinical trial has determined the safe dose of a drug, it can enter a phase II trial, which begins the process of determining the drug’s effectiveness in treating a specific type of disease. Because a phase II trial involves more patients than a phase I trial, physicians also have a chance to observe any less common side effects associated with the drug. In a phase II trial, which can involve 100 patients or more, physicians carefully monitor patients for a drug effect. For example, in a clinical trial testing a drug to increase the number of platelets in the blood, patients would have frequent blood samples taken, but they might also undergo several physical exams and other tests. The high level of patient monitoring in a phase II trial can be very time-consuming, so patients should take this into account when considering a phase II trial.

GSF2013

The National Geographic Society is one of the world's largest nonprofit scientific and educational organizations. Founded in 1888 to "increase and diffuse geographic knowledge," the Society's mission is to inspire people to care about the planet. It reaches more than 400 million people worldwide each month through its official journal, National Geographic, and other magazines; National Geographic Channel; television documentaries; music; radio; films; books; DVDs; maps; exhibitions; live events; school publishing programs; interactive media; and merchandise. National Geographic has funded more than 10,000 scientific research, conservation and exploration projects. For more information, visit www.nationalgeographic.com. As the non-commercial, educational outreach arm of the National Geographic Society, National Geographic Education pursues two primary goals: to bring National Geographic's rich resources for learning to the largest possible audience of educators worldwide; and to catalyze educational change that will bring National Geographic's vision of a geo-literate society to life. National Geographic Education creates compelling resources for teaching and learning, provides educators with transformative learning experiences, and advocates for improved education in geography, the environmental sciences, and the other disciplines that are critical to geo-literacy. Join the 5.5 million annual visitors at NatGeoEd.org to learn more about National Geographic Education and get involved in building a more geo-literate society & Scientific American is at the heart of Nature Publishing Group's (NPG's) consumer media division, meeting the needs of the general public. Founded in 1845, Scientific American is the longest continuously published magazine in the U.S. and the leading authoritative publication for science in the general media. Together with scientificamerican.com and 14 local-language editions around the world, it reaches more than 5 million opinion-leading citizens, public and private sectors influential, educators and scientists. Scientific American won a 2011 National Magazine Award for General Excellence. Other titles include Scientific American MIND in the US and 14 local-language editions worldwide. Scientific American is committed to promoting science, technology, engineering and mathematics (STEM) education, and to promoting wider engagement among the public and scientists. In September 2010 NPG became a member of Change the Equation, a CEO-led initiative to cultivate widespread literacy in STEM in the U.S., as part of President Obama's "Educate to Innovate" campaign. In 2011 Scientific American launched several programs in support of the initiative's goals. Bring Science Home, an ongoing weekly program, provides parents and school age children with simple projects that explain basic science principles they can do at home in just a few minutes. In Citizen Science, Scientific American has created an online platform for children and adults to participate in ongoing scientific research conducted by major research institutions. Scientific American, in partnership with The Zooniverse,launched the whale-song project, Whale FM, which enables "citizen scientists" to help marine researchers better understand how killer whales and pilot whales communicate. With the 1,000 Scientists in 1,000 Days program, Scientific American has created a portal where educators can connect with scientists who have agreed to volunteer their time to benefit STEM education, perhaps by volunteering in a classroom or explaining the latest in research. To encourage science-literacy in children, Scientific American launched our popular blog, Budding Scientist, lead by editor Anna Kutchment. Scientific American is also a media sponsor and participant in the biennial USA Science & Engineering Festival. In 2012, Scientific American launched the annual Science in Action prize, powered by the Google Science Fair. This prize honors a project that could make a practical difference by addressing an environmental, health or resources problem in the lives of a community.

Ion exchange resin and its application in pharmaceutical dosage forms, and drug delivery systems.

Ion exchange resins are cross linked polymers of polystyrene, up on which a negatively charged or a positively charged functional group can be added to get an anion exchange resin (Resin- )or a cation exchange resin Resin +(Resin + Or Resin- ). When these resins are mixed with drug molecule which has a negative charge in its one or more functional group as a result of polarity, or as in salt form, or as a result of resonance, such a drug can form a complex with a resin as follow.

1.) Resin + Drug-
2.) Resin- Drug+

*The resulting resin drug complex stability depends on how strong are the acidic or basic functional groups on resin, stronger functional group result in to formation of very stable resin drug complex, and vice a versa , both has its applications in sustained release drug delivery systems, a resin with strong acidic or basic functional group tend to provide a much more delayed drug release, where drug release is bit faster with weak acidic and basic functional group resins.

When Resin- Drug+ or Resin + Drug- complex (drug resinate ) comes in contact with acid(in stomach) or base(in intestine), it start releasing drug molecule in exchange of similar charged ion for example if drug molecule is positively charged, then it is released from Resin- Drug+ complex when it come in contact with Hydrogen Ion( H+) , similarly a Resin + Drug- or basic drug resin complex will start releasing drug when it comes in contact with basic ions ( in intestine ) OH – NH3- .
Release of drug molecule from Resin +Drug complex takes place due to higher concentration of replacing ions (H+ , or OH – NH3- ).


Masking Taste of drug with ion exchange resin:
There are some drugs which are very bitter in taste like Bromhexin and Quinine, patients has very low acceptability for such drugs some time patients vomit and expelling all of the consumed dose which may result in to dosing error, therefore when such drugs are formulated with ion exchange resins which binds such drugs they do not release drug on taste buds over tongue as a result taste of drug is masked, and when it come in contact with gastric acid bromhexin is released in to gut.

Sustained-release drug delivery system:
Ion exchange resins may not alone give capability to formulate it in to a sustained release dosage form , to make it a good sustained release drug delivery system , proper selection of resin is important a resin with strong acidic or basic functional group provides strong complexation with drug therefore are good candidates for delayed drug release, likewise when early release is intended a weaker acidic or basic functional group resins are useful . Drug resinate is also required to be coated with semipermiable film forming polymers, as drug resinate complex can not be solely relied up on for the intended use. ( ethylcellulose ). In order to maintained the sustained release property of ion exchange resin drug complex it is pretreated with polyethylene glycol so that it do not swell and break open the film coating when it come in contact with gastric juice.

Ion exchange resins are required to be washed with, suitable organic solvent, to remove residual organic or chemical impurities in ion exchange resin, followed by washing with purified water, and regeneration if required, before using for actual process. Ion exchange resin are required to comply with requirements listed in 21 CFR 173.25 by US FDA.

Ion exchange resins have many other applications in pharmaceutical dosage form and drug delivery systems like , localized drug release, stabilization of drug molecule for chemical degradation .
Ion exchange resins are widely used in pharmaceutical industry for purification or raw water and in preparation of water for pharmaceutical use.

-Rajarshi Nareshkumar Patel

Novel Drugs: Cancer Chemotherapy Using Nanoparticles developed with Nanotechnology May Reduce Harmful Side Effects of Antineoplastic Agents.

Chemotherapy for cancer is most of the time associated with one or the other harmful side effect of antineoplastic drugs as these chemotherapeutic drugs themselves are very cytotoxic, i.e. they damage normal cells too.
Antineoplastic drugs bring about their anticancer action by inhibiting cancerour cells growth by virtue of alkylation of nucleotides in cancerous cells or by inhibition of folic acid uptake by cancerous cells or by inhibiting cell division by binding with tubulin and microtubulin in a cancerous cells, it is likely that these drug are also absorbed in to normal tissues, leading to untoward serious cytotoxic effects , like kidney damage and nerve damage in chemotherapy with cisplatin, a drug of choice in most of anticancer chemotherapies.

A new drug delivery technique is being studied which uses Nanotechnology to deliver a cytotoxic drugs specifically directly in to the cancer cells , such drug delivery technique will be able to provide an efficient cancer chemotherapy that do not have much side effects as they pose today , it was observed that with nanoparticle drug delivery system the concentration of drug required to kill the cancerous cell is lesser than required in conventional chemotherapy therapy. As the drug is absorbed efficiently in to targeted cells and also drug is protected from degradation in blood stream , certain class of the anticancerdrugs are very unstable and stay in plasma for a very little time, therefor to achieve the required effect a higher concentration of drug may be required to be administrated.

Nanotechnology drug delivery system involves placing an anticancer drug in to a tiny particles known as nanoparticles which recognize cancerous cells and deliver the drug only to cancerous cells , as nanoparticles are very minute particles (1 nm to 100 nanometer) , the dose of drug required to kill the cancerous cells were also found to be very low as compared to conventional therapy . As the required effective dose it self gets reduced than conventional therapy , the harmful effect of anticancer drug are also likely to be reduced.

A team of scientists from the Massachusetts Institute of Technology and Brigham and Women's Hospital conducted study. They stored an prodrug of cisplatin (which is used in most of cancer chemotherapies) within nanoparticles which they developed to target a specific protein in cancerous cells in prostate gland.
After these prodrug loaded nanoparticles were absorbed by cancerous cells the prodrug was released in to the cancerous cells and was converted in to an active form . The team demonstrated that these prodrug carrying nanoparticles were able to kill cancer cells in culture more efficiently than the drug alone.

Study was conducted by researchers, led by Dr. Omid Farokhzad and Dr. Stephen Lippard, to study nanoparticle drug delivery system for an effective and safer option for chemotherapy in living animals. Their research work is published in Proceedings of the National Academy of Sciences, in Jan 2011 issue of the journal, the study was funded in part by NIH’s National Cancer Institute (NCI) and National Institute for Biomedical Imaging and Bioengineering (NIBIB).

By applying this drug delivery by nanoparticles they were able to shrink tumors in mice with smaller doses of the drug to reduce harmful side effects. Only 30% of the dose of prodrug of cisplatin was required to diminish the tumor by using the drug carrying nanoparticles, than that of standard dose of cisplatin as such.
Researchers initially studied different doses of nanoparticle bound drug in rats and mice, both the types of animals maintained their body weight and survived at higher doses of the drug when drug was delivered using nanoparticles than when injected without nanoparticles. It was also found that the kidney damage was less in rats which received the nanoparticle bound drug.

Also it was found that binding nanoparticles provided greater stability of cisplatin prodrug in blood stream than that of injected alone , after one hour about 77 % of prodrug was found in blood stream when it was delivered using nanoparticles compared to only 16% available drug in case of drug delivered without nanoparticles, cispaltin is very unstable drug and remains in blood for very short time , which calls for more dose to get the desired effect.

Rajarshi Patel

Kidney transplant will see more success rate than earlier.

Patients suffering from kidney failure are required to go for treatment like regular dialysis and kidney transplant, and that to be not all kidney transplants are successful , 1 out of every 3 kidney transplants are rejected by patients body (because of patients immune system) , it is because of the human body recognizes difference between its own body tissue and other persons body tissue and human body reject others persons body tissue by producing antibodies against the transplanted tissue , ultimately damaging and rejecting the transplanted kidney.

Dr. Robert A. Montgomery and his team from the Johns Hopkins University School of Medicine have found new technique , which has shown promising method which has greatly lowered the kidney rejection and has done kidney transplants successfully with their method.

They identified that there is an antigen on cells in human called as human leukocyte antigen, a person sensitized by human leukocyte antigen (HLA sensitized ) help human immune system to identify its own body tissue and incoming foreign tissue and trigger antibodies against transplanted kidney transplant and further leads to kidney rejection.

Therefore they developed a method to desensitize patients by filtering out anti-HLA antibodies they removed the anti-HLA antibodies from patient’s body by process of plasmapheresis. Patients were given
Low-dose intravenous immune globulin (antibody preparation made from pooled donor blood) as substitute for anti-HLA antibodies. The procedure of plasmapheresis was repeated several times before the actual kidney transplant was done , these patients were also given other immuno suppressant drugs which are normally given before kidney transplant.

More than 80% of the patients which received kidney transplant and plasmapheresis treatment were still alive after 8 years. Compared to observed lower life period for patients on either dialysis or HLA compatible kidney transplant ad dialysis.
The method is bit costly but is cost effective compared to the total other costs of regular dialysis are considered in kidney failure patients, and success rate.

What is plasmapheresis:

Plasmapheresis is a method of removing toxic or unwanted component from blood , by removing part of blood out of body and processing it in centrifuge to separate blood cells and plasma , the plasma containing toxic or unwanted antibodies is discarded and is replaced with donor plasma , albumin , or 70% albumin and 30% saline , a suitable anticoagulant drug is given to patient before the plasmapheresis procedure .

'India ready to make it big in outsourcing of medical devices'

'India ready to make it big in outsourcing of medical devices'



India is now in the limelight for its expertise in the medical devices space. The industry's inherent engineering strengths is being recognized by global majors who are looking to tap the emerging market opportunities to augment growth. This is where Bangalore-based MedVed sets up an advanced facility here, which has designed and developed high quality, reasonable priced implantable medical devices for cardiac rhythm management. The company's 'Stellar' brand for single and dual pacemakers, cardiac leads, pacing system analyzers will now revolutionize the heart surgery management. Dinesh Puri, chairman and managing director, MediVed Innovations Pvt Ltd provides an overview of the opportunities, business potential in the segment in a discussion with Nandita Vijay. Excerpts:

How do you see India emerging as a hub for contract design, manufacture of medical devices?
India is well placed in the outsourced contract design, development and manufacturing space because of its engineering capabilities in a wide spectrum of areas. Typically, there are two market opportunities in contract design and development of medical devices. One is that companies in the US and Europe can offload a whole range of existing medical device products to India to maximize the cost advantage. India has been proving to be a reliable and dependable source for this capability. The second is that global companies can look at India as a hub in the Asian region to undertake contract design, develop, manufacture and package the medical devices.

What according to you are the visible trends in this space?
A visible trend is that all international companies in the wake of the global economic slow down are looking to tap opportunities in the emerging markets. These are the markets of the future. Companies in the West are transforming business models to cater to the needs of the emerging markets which make up 4/5th of the global demand.

In the wake of these opportunities, what are the efforts taken by global cos to make the most of the situations?
The companies have begun to re-device the business strategy primarily because emerging markets are price sensitive. Therefore companies would look at alliances and joint ventures with Indian enterprises in these regions. In the US, the issue is 'performance over price' as against India where it is 'price over utility'. Therefore international companies need to look at the 'design-to-cost' factor to make medical devices available in India. This is where global majors will now have to look at design and manufacturing hubs in Asia and India, in particular, to tap the quality-cost advantage which will help improve gross margins. There is need for innovative thinking and India is now building its capability to be a platform for such prospects.

What are the challenges before medical devices cos to generate business?
The challenge for medical device companies is to raise funds and be able to repay within a realistic time frame. In this business, cycle time is longer. Therefore, both the investor and management have to be patient. There is also the issue of global sourcing of raw materials and dealing with imports because of inconsistent levy of import duty on raw materials which is higher than the finished products. Therefore, we need to be able to raise investments with a realistic time frame and calibrate expectations of time.

Could you tell us how MediVed has grown since its inception two years ago?
MediVed is in the league of the top six world-class medical devices companies. It has the advanced infrastructure and technical competence to offer services at a competitive cost. Our capability covers design, development of electro mechanical diagnostic and therapeutics devices besides implantable devices and active implantable like pacemakers. The company is currently doing five pilot projects for customers in the US. The assignments are in various phases of development. The projects are proving to test the capability in development of complex devices ranging from surgical to dental and diagnostics equipment apart from implantable devices. But, since pilots take a long time to convert into revenues, we are keen to tap the contract business space. By 2011, we hope to garner a turnover of Rs 150-crore which will be generated with contract assignments and the 'Stellar' brand pacemakers. The two opportunities could chip in a 50:50 revenue generation. The business opportunity in medical devices globally is close to $200 billion.

How is MediVed positioned to tap the opportunities?
MediVed has the expertise in medical device engineering, design and prototype. It can provide the proof of concept in the lab study and later scale up manufacture.

We are gearing up to offer our expertise across all segments in medical devices from electrical-electronics-mechanical engineering to software. These include high precision machining of components, sub assemblies to printed circuit boards assembling, sourcing of implantable grade materials and sterile packaging, global sourcing of bio gradable materials which are implantable grade materials steel, noble metals, novel biomaterials like nitinol, polymers, silicones, epoxy of medical grade. This is possible because of our state-of-the-art ISO 13485 compliant in-house multi disciplinary engineering and manufacture infrastructure that includes micro electronics, polymer sciences, bio mechanical, laser welding-hermetic sealing which is supported by 100,000 class clean room and complex device assembly areas. We have the expertise to provide the required regulatory compliance documentation for medical devices manufacturing quality management systems.

What is the future of medical devices industry?
The future holds immense potential for the medical devices industry. This is because of the strong growth of the healthcare space. India can score over China in the medical devices space and grab the contract design and development orders. The country has a sound record in adherence to IPR which is vital for medical devices because it follows English law which is also referred to as the contract law of the Commonwealth countries. International Courts uphold the English law.

There is multi-disciplinary R&D efforts and engineering capability in multiple sciences of electronics, chip design, software mechanical and medical engineering which are complex. The country has already made a mark in pharmaceuticals, development of new chemical entities and clinical research. The time has now come for India to take its place in the medical devices space. This medical device engineering opportunity is bigger than the Information Technology (IT) boom and we need to capitalise

India-Canada to foster joint R&D projects in biotech, health research, medical devices

India-Canada to foster joint R&D projects in biotech, health research, medical devices


Under the Canada-India agreement for scientific and technological cooperation, India and Canada will soon foster joint research and development (R&D) projects in areas of biotechnology, health research, pharmaceuticals, medical devices and nanotechnology as it applies to these sectors.

The key objectives of this joint programme are to encourage domestic competitiveness through the transfer of technology and knowledge resulting from international S&T partnerships; to foster international S&T partnerships and collaborative research with an emphasis on industrial outcomes; to accelerate the commercialization of R&D that would benefit Canada and the partner country, through international partnerships, with a focus on small and medium-sized enterprises; to access international technologies for Canadian enterprises; to promote Canadian R&D capacity and Canada as a destination for foreign technology-based investments; to encourage the mobility of researchers and to promote Canada as a career destination for foreign researchers and highly qualified personnel; and to strengthen overall bilateral S&T relations.

The Department of Biotechnology (DBT) will be the implementing organization on the Indian side, while the International Science and Technology Partnerships Canada (ISTPCanada), a non-governmental organization will be implementing the project on the Canadian side.

This Canada-India programme aims to foster and support the development of collaborative R&D projects that bring together companies, research organizations, academics and other collaborators from both countries for the joint development of innovative products or processes. It aims to stimulate innovative R&D projects (engaging small-to-medium-sized companies and/or larger, well established firms) that address a specific market need or challenge; demonstrate high industrial relevance and commercial potential; and aim to deliver benefit to all participants, and more broadly, to both nations. These projects help participants to become more competitive by developing global research-based alliances with the potential to foster increased or expanded international R&D collaboration.

Eligible Indian applicants for this programme include researchers and managers of Indian companies, academic institutions, research hospitals or other R&D institutions (including not-for-profit research institutes recognized by DBT) that are headquartered and operate in India.

Eligible Canadian applicants must be researchers or managers of for-profit companies that operate and are headquartered in Canada. Canadian subsidiaries of companies headquartered outside of Canada are typically not eligible for support. However, as ‘benefit to Canada’ is a key objective and among the most important selection criteria, ISTPCanada may grant an exception to such subsidiaries if they have R&D facilities in Canada and can demonstrate that Canada will accrue clear economic benefit from the bilateral R&D project. Academic institutions, research hospitals, other institutes or research associations are strongly encouraged to participate in the projects as co-investigators.

Each proposal must include an eligible lead from Canada and India. Although it is not mandatory, projects that engage a technology developer and a technology end-user/first customer are strongly encouraged.