Cimeio Therapeutics and University of Pennsylvania Collaborate on CD45 CAR T Cell Therapy for Blood and Bone Marrow Cancers

Cimeio Therapeutics, a key player in the field of innovative therapeutics, has made a significant announcement regarding a preclinical research collaboration with the University of Pennsylvania. 

This collaboration, spearheaded by Saar Gill, M.D., Ph.D., an esteemed associate professor of medicine and a researcher at the University’s Center for Cellular Immunotherapies, aims to delve into the realm of universal immunotherapy. 

The objective is to create a potential treatment modality for various types of blood and bone marrow cancers. The collaboration capitalizes on the unique strengths of both entities, leveraging Cimeio Therapeutics’ proprietary epitope-editing and CD45-targeting technologies in tandem with Penn Medicine’s epitope-editing and CAR T cell technology. 

The ultimate goal is to design a revolutionary CD45-targeting CAR T cell therapy coupled with epitope-edited hematopoietic stem cells (HSCs). CD45, being prominently present on the surface of a wide array of blood cells, is a pivotal receptor that holds promise for the development of a universal CAR T cell therapy tailored for blood cancers. 

Recent breakthroughs in epitope editing have shown promise in effectively editing CD45, a receptor ubiquitously expressed on the surface of both healthy HSCs and numerous blood and bone marrow cancers. 

This collaboration builds upon the research and findings that have demonstrated the potential to shield healthy HSCs while making malignant cells susceptible to a CD45-targeting therapy, presenting a promising avenue for drug development. In addition to this groundbreaking research, Cimeio Therapeutics is advancing its efforts in the field by also working on the development of a CD45-directed antibody-drug conjugate. 

The company has a strategic vision to develop this therapy utilizing CD45 epitope shielded cells, not only for blood cancers but also for autoimmune diseases and various other indications.

FDA Guidance Documents Update

The US FDA have released the following guidance documents recently.


1. Guidance for Sponsors, Investigators, and Institutional Review Boards: Questions and Answers on Informed Consent Elements,21 CFR § 50.25(c) (Small Entity Compliance Guide)

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf

2. Guidance for IRBs,Clinical Investigators,and Sponsors: IRB Continuing Review After Clinical Investigation Approval

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf

3. Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf

4. Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers, Final Guidance

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM295372.pdf

Virtual Clinical Trials - Pfizer leads the race

I was very much interested to know what this is all about when I saw the Program of "Partnerships in clinical trials" conference that started yesterday at The Marriot World Cener, Orlando, FL, USA. Really interesting idea.

How about running clinical trials at a subject's home ?! Yes, that is all about Virtual Clinical Trials.

Pfizer have become the forerunner of this new approach in clinical trials. They have decided to leverage the advantages that the digital world provides to overcome the difficulties faced while conducting a usual clinical trial. Difficulties range from finance, logistics, partnering, enrolling patients, labs, ethical and legal issues, storage, dispensing of IP, etc. in a clinical trial. If not all the difficulties, many of those seems to be overcome in virtualtrials (which has limitations of its own!)

Pfizer began the first ever virtual clinical trial, REMOTE (Research on Electronic Monitoring of OAB Treatment Experience) to determine whether the results of the pilot ‘virtual trial’ can replicate those of a previously completed Phase IV study with tolterodine tartrate (Detrol LA)

• 600 patients from around 10 states across the US
• Screening is online
• Consent online using video/multimedia
• Subjects will manage their own trial activity and report results directly to a trial investigator,
• Study drugs will be shipped to the subjects' homes rather than to study sites
• Study participants will get $25 for each online assessment and/or laboratory visit completed, up to a total of US$175.
• No study site visits

Potential advantages would be real time and reliable data collection, a lot of time, money and effort saved. A lot of paperwork is eliminated and of course audit findings will be clear.

“Studies like REMOTE could make biomedical science much more accessible to people who have long been excluded from or under-represented in clinical trials,” said Dr Freda Lewis-Hall, executive vice president and Chief Medical Officer of Pfizer.

But to train almost 600 people on the systems to use, procedures to follow will be tough job for Pfizer and the advent of technology is itself a limitation of its use. And the main disadvantage of this would be that this system is more applicable to conditions where there are a lot of patient reported outcomes and those that does not involve any complex diagnostic or treatment procedures. That again raises a concern of the scalability of this system. Moreover, I cannot imagine something like this to be a reality (at least in half a decade) in an African country or a developing nation where the cost of healthcare is still a economical burden on the patients.

Least, this does spice up the clinical trial experience for trial personnel and subjects who are tech savvy!

Here is the program at "Partnerships in Clinical Trials" confernence. No wonder Pfizer dominates this  session. They lead the race with no visible competitors.

Monday, March 5, 2012—Executive Summit Day and General Session Kick-Off 9:30 Chairperson's Opening Remarks,PFIZER INC. 9:45 Virtual Trials— what are They? - PFIZER INC. 1030 Making a Study Different: What is Truly Innovative About the Virtual Trial Approach? - GENENTECH (ROCHE) 11:00 Break 11:30 Case Study: New Results From Pfizer's Mobile- Powered Virtual Clinical Trial Outsourcing Pilot Program, PFIZER INC. 12:30 Lunch 1:30 Assess the Legal Risks and Considerations of Virtual Trials, GORDON & REES LLP. 2:15 Examine Collaboration of Technology Companies Needed to Support the Virtual Trial Model 2:45 Industry Collaboration: How Should We Approach and Work With the FDA to Create a Regulatory Process for Virtual Trials? - PFIZER INC. AND JANSSEN 3:30 Summits End

Researchers create a healthier cigarette

From a health care perspective, the best cigarette is no cigarette, but for the millions of people who try to quit smoking every year, researchers from Cornell University may have found a way to make cigarette smoking less toxic.

Using natural antioxidant extracts in cigarette filters, the researchers were able to demonstrate that lycopene and grape seed extract drastically reduced the amount of cancer-causing free radicals passing through the filter. The research will be the 1500th article published in the ground-breaking Journal of Visualized Experiments (JoVE), the only peer-reviewed, PubMed indexed video-journal.

"The implications of this technique can help reduce the hazardous effects of tobacco smoke," said Dr. Boris Dzilkovski, who co-authored the paper, "because free radicals are a major group of carcinogens."

Scientists have tried to make safer cigarettes in the past. Haemoglobin (which transports oxygen in red blood cells) and activated carbon have been shown to reduce free-radicals in cancer smoke by up to 90 percent, but because of the cost, the combination has not been successfully introduced to the market.

JoVE Content Director, Dr. Aaron Kolski-Andreaco, is very excited to be publishing this article as the journal's landmark 1500th article.

"Practically, this research could lead to an alternative type of cigarette filter with a free radical scavenging additive," said Kolski-Andreaco. "It could lead to a less harmful cigarette."

The watch the full video article, please click here: http://www.jove.com/video/3406/a-protocol-for-detecting-and-scavenging-gas-phase-free-radicals-in-mainstream-cigarette-smoke

Source: EurekAlert!

CCMB scientists discover different set of gene mutations in Indian population

In a recent finding at Centre for Cellular and Molecular Biology (CCMB) in Hyderabad, scientists have discovered that Indian population carry a different set of mutations in the genes responsible for irregular lipid metabolism and type-2 diabetes.

“This is a major finding that could help trace the human origin and genetic basis of diseases in the Indian population. It will also be useful in designing strategies to intervene or cure diseases,” says CCMB director Dr Ch Mohan Rao.

The CCMB has also found that India has two sets of ancestral populations. One related to south and west Asia, Middle East, and the Caucasus, while the other is not related to any group and confined to south Asia. The late group is responsible or more than 50 per cent of ancestry in Indian populations.

The scientists have also found novel genetic mutations associated with certain neuro-generative disorders, cardio-myopathies and male infertility in Indian population. The mutations have been found in mitochondrial DNA which is inherited from the mother, unlike the chromosomal DNA, inherited from both the parents. Mitochondrion plays an important role in cellular energy metabolism. In the past decade, genetic variations in mitochondrial DNA have been linked with various disorders, particularly neurological.

Dr K Thangaraj who led the team of scientists at CCMB conducted the study in collaboration with the University of Tart, Estonia, the Chetindad Academy of Research and Education, Chennai, and the Banaras Hindu University, Varanasi.

Earlier in 2007, Dr K Thangaraj had received the first Major UK-India Education and Research Initiative (UKIERI) Award. The UKIERI award is aimed to promote the innovative research and academic excellence between the two countries India and UK.

The team reported the new genome-wide data for 142 samples from 30 ethnic groups of India. The researchers found that genes like MSTN, DOK5 and CLOCK have potential implications in lipid metabolism and type-2 diabetes. “The elements of population structures and genes are likely to bear relevance for medial genetic studies on population of South Asia, which harbours one-sixth of the human population,” revealed the researchers.

Over the past few years, CCMB has been undertaking studies on population genetics to trace human origin and genetic basis of diseases in Indian populations.

Weight loss as Symptomatic Treatment for Knee Osteoarthritis

A research study conducted by Henning Biddal et al at the Parker Institute, Denmark whose results were published in the Annals of Rheumatic Diseases has shown that weight loss program was successful in lessening the pain in patients with Osteoarthritis.

The study was a 1-year randomized controlled trial conducted to evaluate 1-year symptomatic improvement in obese patients with knee osteoarthritis (OA) on an intensive low-energy diet (LED) maintained by frequent consultations with a dietician compared to minimal attention. The LED programme consisted of group therapy with dietary consultations and two periods of a low-calorie diet of 810 kcal/day during weeks 0–8 and weeks 32–36. The control group only received dietary instruction and attention for 2 h at baseline, and at weeks 8, 32, 36 and 52. Primary end point (total Western Ontario and McMaster Universities (WOMAC) index) was assessed as the mean group difference during and after 1 year. After 1 year, mean weight loss in the LED group was –10.9 kg (11%) versus –3.6 kg (4%) in the control group. There was no difference between the groups in total WOMAC index (p=0.11), although both groups improved. However, the LED intervention resulted in less WOMAC pain (7.7 mm), with a group mean difference of 7.2 mm. After one year 14 (32.8%) responded to LED versus 7 (15.6%) to control, with an absolute benefit of 16.3%. Continuous reinforcement of a weight loss programme can be successful over a year in obese knee OA patients. Weight loss was statistically reflected only by a reduction in pain.

Ref: Ann Rheum Dis 2011;70:1798-1803 doi:10.1136/ard.2010.142018

Middle East to be the Future in Clincial Trials

Global pharmaceutical companies are currently seeking emerging markets to conduct clinical trials due to the increase in drug development costs and the demand to advance drugs faster.

The Middle East is forecasted to be one of the fastest growing markets for clinical research outsourcing based on availability of the required infrastructure, access to necessary patients, faster timelines and lower costs compared to other markets.

Clinical Trials Partnership Middle East Summit will assemble all stakeholders from leading research sites, clinical research organisations, regulators, government organisations and pharmaceutical companies to provide strategies and knowledge on critical issues such as regulatory compliance, optimising clinical trials, overcoming clinical trials challenges and identifying business opportunities in the Middle East region.

Taking place between 28^th & 30^th November 2011 in Dubai, this three day summit is a must for all executives, senior level directors or directors from the pharmaceutical, biotech, clinical research organisations and clinical investigators who are looking to discuss the advances of the regions clinical trials market.

Clinical Trails Partnership Middle East Summit kicks off with an essential interactive workshop on day one, looking at a comprehensive overview of 'Good Clinical Practice' in relation to the regional and international guidelines for conducting clinical trials.

The next two days are packed full of exciting and innovative discussions, crucial networking opportunities and exciting round table discussions where delegates will be able to share their views and knowledge on subjects such as 'Improving the quality of clinical trials by using standardised performance metrics'.

Event Director for Clinical Trails Partnership Middle East Summit, DoaaSaid, described the conference as'A vital event for the increasing success and on-going improvement and competitiveness of the regions clinical trials market.'

Delegates in the field will come away from the summit with all the tools needed to better their practices, making them more competitive and efficient. They will also have the chance to make vital relationships and connections in the scheduled networking periods.

Registration for this event is now open on the website http://www.clinicaltrialsmena.com. Delegates booking before 19th September 2011 will receive a discount of up to $450.

For more information about the Clinical Trails Partnership Middle East Summit please contact Jihan Mohammed,

Marketing Manager,

IQPC Middle East,

Email enquiry@iqpc.ae

call +971-364-2975

Eating Nuts Such as Peanuts Improves Diabetes Control Without Weight Gain

An important new study released in the August issue of Diabetes Care shows that replacing carbohydrates with two ounces of nuts, such as peanuts, everyday improves blood glucose control and blood lipids in people with type 2 diabetes.

David Jenkins, MD, PhD, DSc, Principal Investigator and a pioneer in the area of glycemic control for diabetics said, "Nuts, including peanuts, can make a valuable contribution to the diabetic diet by displacing high glycemic index carbohydrates and replacing them with vegetable fats and vegetable proteins which have been shown in the long term to be associated with better cardiovascular health and diabetes prevention."

Peanuts have more protein than any other nut and are a source of mono and polyunsaturated oils. The paper reports that, "increased proportions of fat and protein, especially of plant origin, may confer metabolic benefits and reduce the risk of developing coronary heart disease and diabetes."

The study, "Nuts as a Replacement for Carbohydrates in the Diabetic Diet", was conducted at the University of Toronto. During the study, 117 men and women with type 2 diabetes were randomized into three groups where they received either a full portion of mixed nuts including peanuts, a half portion of both nuts and muffins, or a full portion of muffins. The muffins were made of healthy whole wheat with protein from egg and skim milk powder. Participants' fasting blood glucose were tested every other week.

After three months, participants receiving the full portion of nuts showed the biggest decrease in glycated hemoglobin (HgA1c), a measure of blood glucose control. The difference was significantly more than the decrease shown in the participants receiving the half portion of nuts and muffins, and in those solely receiving muffins. Peanut and tree nut intake also decreased total cholesterol and bad LDL cholesterol in the blood compared to the other groups. It is notable that reductions in HgA1c and LDL cholesterol were achieved even though the majority of the subjects were already on antihyperglycemic medications and statins that lower cholesterol.

The authors conclude that nuts, such as peanuts, "may be used to increase vegetable oils and protein intake in the diets of type 2 diabetic patients as part of a strategy to improve diabetes control without weight gain."

The article says that weight maintenance could have occurred in nut eaters for a few reasons including increased resting metabolic rate, enhanced satiety resulting in decreased intake of other foods, or incomplete absorption of energy. Studies done specifically on peanut eaters have demonstrated each of these factors.

This new clinical trial is an important milestone demonstrating glycemic control and builds on an earlier population study published in JAMA in 2006. Researchers at the Harvard School of Public Health concluded, "Our findings suggest potential benefits of higher nut and peanut butter consumption in lowering the risk of type 2 diabetes in women."

Peanuts are the most commonly eaten nuts in America. Combined with peanut butter, peanuts comprise over two-thirds of U.S. nut consumption according to USDA data. Numerous studies have shown that consumption of peanuts and peanut butter is beneficial in keeping blood glucose stable, improving satiety and decreasing hunger, maintaining weight, and reducing risk of heart disease.

The 2010 U.S. Dietary Guidelines called for Americans to shift towards a more nutrient-dense, plant-based diet. Peanuts, peanut butter and nuts are foods to encourage daily. This may be particularly useful in preventing the onset of diabetes. Diabetes prevalence is growing at a dangerously rapid rate. Worldwide, the number of people with diabetes has increased over 40% since 1980.

The study was funded in part by The Peanut Institute, the International Nut Council, and the Canada Research Chairs Endowment Fund.

Source: PRNewswire

ACRO to launch campaign to allay negative public image about CROs

Enraged over the negative propaganda that the Indian subjects, especially the poor and the illiterate, are being used as guinea pigs by the Clinical Research Organizations (CROs), pharmaceutical companies and other organizations involved in the clinical trials and bioequivalence studies, the Association of Contract Research Organizations (ACRO) will soon launch a publicity blitzkrieg to allay the misconceptions about the CROs in the country.

During the last two months there has been misleading reports about the role and responsibility of the CROs and pharmaceutical companies involved in the clinical trials in India, an ACRO leader said.

ACRO, in the interest of the general public and the CRO industry would soon be coming up with the facts and figures for apprising all concerned on the objectives of the clinical research industry, the key role it plays in aiming at the general population health and in bringing the expensive drugs within the reach of the common man, the leader said.

Ever since the drug authorities raided and unearthed irregularities at Hyderabad-based CRO, Axis Clinicals, in which the company is alleged to have conducted clinical trials of a breast cancer drug on nearly 30 illiterate agriculture labourers after luring them with Rs.10,000 each, there has been a public criticism that the Indian subjects, especially the poor and the illiterate, are being used as guinea pigs by the CROs.

Under this background of growing public criticism against this dubious activities, the ACRO held an emergency meeting on July 29 in Mumbai which was attended by over over 35 CROs, pharmaceutical companies engaged in clinical research and representatives from Confederation of Indian Industries (CII).

Condemning the recent events which have been misrepresented without fully presenting all the facts, the ACRO decided to come out with a detailed information and a clarification regarding all the issues concerned. ACRO pledged its support to undertake initiatives that would create positive impression amongst participating volunteers and subjects in clinical research. “Clinical research is important for the development of drugs and it is our responsibility to build a strong scientific foundation in the interest of billion lives. Outcome of research should be used in positive and meaningful discussion for deriving better healthcare benefits to the nation,” an ACRO leader who actively participated in the meeting said.

He added that ACRO has pledged in supporting these initiatives and work closely with all stakeholders in ethical conduct of clinical research. All ACRO members conduct studies only after obtaining all the required approvals including from the DCGI and Independent Ethics Committees.

Source: Pharmabiz

India attracting more investments in BioPharma R&D

More than 70 per cent of the 40 global BioPharma executives in a recent survey are satisfied with their R&D alliances in India, and three out of four expect to increase their R&D activities in India. Despite such positive appraisals, India continues to play a relatively small role in BioPharma innovation, according to a new report by The Boston Consulting Group (BCG).

The report, which was commissioned by the USA-India Chamber of Commerce (USAIC) and based on in-depth research, interviews, and a quantitative survey with over 40 R&D decision makers, released on June 23 at the annual USA-India BioPharma & Healthcare Summit in Cambridge, Massachusetts.

Over the past 10 years, India has made a concerted effort to capitalize on the globalization of R&D investments. US BioPharma companies spent 24 per cent of their R&D budgets in foreign countries in 2009, up from 17 per cent in 2002. Over the same period, India’s share of these foreign expenditures increased tenfold to about $500 million.

Emerging markets have benefited from the growth of overseas investments, while the share of US-funded BioPharma R&D conducted in Western Europe, Canada, and Japan declined from 2002 to 2009. “We expect this trend to continue,” said Simon Goodall, a BCG partner and a co-author of the report. “Global BioPharma companies are intent on finding more efficient ways to develop new drugs, and emerging markets hold a distinct cost advantage.”

Despite this trend, India still accounts for only about 1 per cent of the overseas R&D investments made by US BioPharma companies - similar to China’s share (also about 1 per cent), but much smaller than the share of Eastern Europe (about 8 per cent) and Latin America (about 4 per cent). “We feel that India’s research sector still has tremendous opportunities for growth, particularly with BioPharma companies struggling to resolve the crisis in R&D productivity,” said Bart Janssens, a BCG partner and a co-author of the report.

R&D productivity, the report explains, is a function of “value generated” (the number of new drugs launched) divided by “value invested” (the resources required to bring a single drug to market). Over the past ten years, the global BioPharma industry has seen a steady decline in value generated, along with a steady rise in R&D costs - and hence value invested.

India can help companies improve both parts of this equation - but only if BioPharma companies and Indian stakeholders move beyond the prevailing model, which revolves around low-cost sourcing. “Costs are critical, and India can play a significant role in increasing R&D efficiency over the short to medium term,” said Kim Wagner, a BCG senior partner and a co-author of the report. “But collaborative partnerships, compared to traditional vendor relationships, can have a much more substantial impact on a company’s ability to create new and innovative products.”

To lower the cost element of the equation—value invested—BioPharma companies should work with India’s research sector on several fronts:

Generate greater value from collaborations: There is growing recognition that the transactional R&D sourcing model, while often effective in lowering costs, is wholly inadequate for spurring innovation. Strategic partnerships are gaining traction, both globally and in India. In these relationships, the partners exchange knowledge and work toward shared goals, which sometimes include building or enhancing capabilities.

Expand the scope of sourcing: Indian research companies have invested heavily in broadening their services, giving multinationals an opportunity to increase both the depth and breadth of activities sourced from India. Several BioPharma companies in the survey had sourced early discovery activities from India and were satisfied with the results.

Establish clinical hubs - Approximately 1,300 clinical trials have been conducted in India since 2005. The cost per patient is half of what it is in Western countries, and the process of recruiting patients is four times faster. Companies can conduct twice as many proof-of-concept trials in India as they could for the same cost in Western countries.

Develop niche-busters - The current R&D model makes it uneconomical for companies to pursue niche-busters—drugs designed to combat diseases that affect a relatively small population. India, with its 60 percent cost advantage relative to the traditional R&D model, can allow global BioPharma companies to develop such drugs cost-effectively.

Leverage research capabilities in emerging technologies - BioPharma companies should look for opportunities to capitalize on India’s growing interest and expertise in specific research areas. India was one of the first countries in the world to establish a nationwide bioinformatics network. Its Biotechnology Information System Network (BTIS) now connects 57 key research centres, covering the entire country. In addition, the Indian government is fostering a research ecosystem to support the development of nano biotechnology. It is also coordinating its own efforts to advance stem cell research.

To realize the full potential of R&D in India, a range of stakeholders - including global BioPharma companies, local biotech and pharma firms, and academia- will all need to be involved and willing to make a long-term commitment. “Successful relationships are ones in which the partners invest in building capabilities and trust,” Janssens said. “Such partnerships have been able to move beyond low-cost sourcing to deliver fundamental improvements in productivity.”

The BCG report was based on proprietary research and in-depth discussions with over 40 key R&D decision makers in India, Europe, and the United States. It was complemented by a survey of Western BioPharma companies and Indian research companies. The survey focused on measures to enhance R&D activity in India and increase local innovation.

The Boston Consulting Group (BCG) is a global management consulting firm and the world’s leading advisor on business strategy. We partner with clients in all sectors and regions to identify their highest-value opportunities, address their most critical challenges, and transform their businesses.

ICMR improving quality of project audits for timely, tangible results

The Indian Council of Medical Research (ICMR) is further equipping the existing system to improve the quality in auditing of on-going intramural projects with a view to ensuring timely and tangible results of the projects taken up under its different institutes.

As part of a three-tier system in place for auditing, a scientific advisory committee (SAC), comprising of subject related experts, assists each ICMR Institute and the centre. The SAC oversees the research activities including review of on-going projects and clearing new project.

The ICMR now is adding new parameters to improve the quality of auditing like assessment of promising leads and ensuring of basic translational research at the institute levels. The ICMR is also seeking further technical and financial resources for the SAC.

There is also a Scientific Advisory Board (SAB) comprising 21 members representing different institutions and disciplines, as specified in the Rules and Regulations of the ICMR, to review the reports. It also recommends advisory groups and offers advices to the ICMR.

The recent meeting of the SAC reviewed the progress made in developing a vaccine against AIDS among other projects recently. “A phase I HIV vaccine trial using the prime boost approach was initiated in NARI, Pune and TRC, Chennai. The enrolment for the trial has been completed and the volunteers are now being followed,” sources said.

New proposal on “ICMR- Indian National Diabetes Study-Phase I,” has been initiated at three states and one Union Territory with the aim to understand prevalence of diabetes and pre-diabetes along its association with the genetic aspects, the meeting was told.

Guidelines on Management of buccal mucosa and cervical cancer have been finalised. As part of a multi-centric Management of Acute Coronary Event Registry project, a web-based questionnaire had been designed and is currently being validated by entering data from patients registered by MACE registries at different centres.

DBT plans to broadbase SBIRI for benefit of more pharma, biotech units

The Department of Biotechnology (DBT) is planning to modify and expand the public private partnership programme 'Small Business Innovation Research Initiative (SBIRI)' based on the report of an ongoing expert review and suggestions from different stakeholders.

The DBT has invited applications from the companies for funding through loans and grants under the 15th batch of the SBIRI, even as it is keen to further modify the scheme to take the gains to wider sections of the industry, sources said.

The DBT has already entrusted the task of review with the IIM, Bangalore and is waiting for the report so that the programme can be modified accordingly. The Department has collected suggestions from different stakeholders to broadbase the scheme as per the industry preferences, it is learnt.

As per the latest records, the DBT has cleared 81 proposals so far for single industry projects and
collaborative ventures and extended soft loans and grants. The application for the current batch will close on February 28.

Sources said apart from expanding the base, the DBT is planning to monitor the projects initiated in the past in a better manner to ensure progress and development of products and processes. The SBIRI on-line system will be monitored for its effectiveness. Emphasis would be on innovation and validation and scaling-up of the proof-of-concepts obtained in various projects supported under this scheme. Some new ideas and concepts in different areas of biotechnology would be generated and new entrepreneurs will be encouraged further, sources said.
According to the announcement of 15th batch, proposals are being invited from pharma and biotech companies for 'for support of early stage, pre proof-of-concept research and development of research leads towards commercialization in all fields of biotechnology.'

The SBIRI assists small and medium business units including new enterprises with not more than 500 employees in R&D, offers phase I funding for early stage, pre proof-of-concept innovative research and provides Phase II funding towards commercialization of research leads.

Expert inspection panel on clinical trial on Bhopal gas tragedy victims finds deficiencies

The expert committee which went into the allegations of engaging the victims of Bhopal gas tragedy for clinical trials has cited some ‘deficiencies’ in the procedures and the Health Ministry has asked for clarifications from the principal investigator Dr Pradeep Bhattacharya and the Bangalore-based firm involved in the matter, Quintiles Ltd.

The inspection of Bhopal Memorial Hospital and Research Centre was carried out in the month of October by a team of experts set up by the Central Drugs Standard Control Organisation (CDSCO) for a clinical trial titled “A phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Pneumonia with a Focus on Patients with Infections Due to Methicillin Resistant Staphylococcus aureus’’ (Protocol No. 0015).

“Findings of the inspection showed some deficiencies for which principal investigator Dr Pradeep Bhattacharya and Quintiles Ltd., Bangalore (CRO) were asked to explain their position. Quintiles., Bangalore has already submitted its reply,’’ sources said, without giving further details into the deficiencies reported by the panel and the reply given by the investigator or the CRO.The reports claimed that the patients suffering from various ailments following exposure to Methyl-Iso-Cyanate in the Bhopal tragedy in 1984 were being used as guinea pigs at the BMHRC to test different unapproved medicines by multinational drug firms, and the issue has created furore across the country.

The research centre, set up in 2000, was also reportedly carrying out studies on long term effects of Methyl-Iso-Cyanate (MIC) poisoning, thus raking up suspicions about clinical trials by multinational companies. It was also alleged that the required code of ethics for conducting trials was being violated. The drugs allegedly used in the trials included telavancin (patented by US company Theravance), tigecycline (Wyeth), prasugrel, fondaparinux (GlaxoSmithKline) and fixed-dose combination of cefoperazone with sulbactum (Magnex) sold by Pfizer in India.However, it is not clear whether the inspection panel has listed out the names and drugs of the companies cited in the media reports.

The CDSCO authorities still maintained that they did not get any complaints, but the inspection was ordered following the media reports.

GVK Biosciences receives AAALAC Accreditation

GVK Biosciences Private Limited (GVK BIO), Asia’s leading Contract Research Organization today announced that it received full accreditation from the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International for its animal facilities.

The accreditation demonstrates GVK BIO’s commitment to high standards of animal care. AAALAC commended the organization for promoting a productive research environment that ensured high standards of humane care and use of research animals.

The AAALAC certification will help in furthering GVK BIO’s growth in the areas of Pharmacology, ADME/DMPK, Exploratory toxicology and Animal Models. GVK BIO is the first organization in Hyderabad and only the 6th one in India to receive AAALAC certification. The endorsement is a validation of GVK BIO’s abilities to deliver world class solutions.

GUIDANCE ON CLINICAL TRIAL INSPECTION

Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare has released the guidance document on Clinical Trial Inspections

The purpose of this programme is to provide direction to inspectors/CDSCO officers for conducting inspection of site of clinical trial, sponsor / CRO’s facilities involved in clinical trial and information to investigators, sponsor/ CRO’S about procedures for inspection and follow up
of action.

This Clinical trial inspection programme will cover all clinical trial sites and sponsor /
CRO’s facilities involved in clinical trial of drugs including biological and medical device covered under Drugs & Cosmetics Act.

CDSCO HQ will issue instruction to the CDSCO Officers /Inspectors to conduct the inspection identifying the Clinical trial, name, address, contact number of clinical trial site, sponsor /
CRO’s facilities to be inspected. It may also identify the type and purpose of the inspection and provide background materials like study protocol, CRF etc.

Inspection can be carried out as a routine surveillance or for any specific cause(s).Study may be selected for inspection based on, but not restricted to the following criteria:

1. Nature of study
2. For regulatory decision based on clinical trial data
3. Data irregularities
4. Complaints
5. Vulnerability of subjects
6. Number of CT including number of subject enrolled at a particular site

Training Programme on Proposal Development & Report Writing for Development Projects

Excella Orbit, the training division of Sambodhi Research & Communications Pvt. Ltd., is organising a Training Programme on Proposal Development & Report Writing for Development Projects to be held at New Delhi from 05 – 06 March, 2010.

The course aims to facilitate a shared understanding of importance of structure, organization and articulation in proposals and report writing and enhancing knowledge for developing clear, concise and high-impact proposals. This course also provides trainees with an augments skills for organization and presentation of contents of event report and research/study reports perspective on professional. This also enables students in building greater confidence in producing effective written communication.

The programme brief is discussed below.
The course shall provide:
• 16 hours of tutorial
• Reading Material and aids
• Rigorous hands on practice
• Complementary advisory and troubleshooting support services through electronic media.

Interested people can send an email requesting for the flyer and registration form. Discounts available for group registration. Last date for registration is 25th February, 2010.

Contact:
Excella Orbit
Sambodhi Research and Communications Pvt. Ltd.
O2, 2nd Floor, Lajpat Nagar
New Delhi -110024
Phone :+91-11-40560734/ 65492502
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Record Number of Medicines In Development to Treat Diseases Affecting Women

America’s pharmaceutical research and biotechnology companies are working on nearly 1,000 life–changing medicines for diseases affecting women, according to a new report released by the Pharmaceutical Research and Manufacturers of America (PhRMA). The medicines are awaiting approval by the U.S. Food and Drug Administration or are in human clinical trials.

In the U.S., diseases that disproportionately affect women include diabetes, which has reached epidemic proportions and affects 11 million women nationwide. Autoimmune diseases strike women three times more and anxiety and depression two times more women than men. The number one killer of American women is heart disease.

The report lists 969 new medicines in development. They include 112 new treatments for breast cancer, 86 new treatments for obstetric/gynecologic conditions, 76 for asthma, 114 for autoimmune diseases, 155 for diabetes, 131 for arthritis, and 80 for Alzheimer’s disease.

One medicine in the report is a potential cutting–edge treatment that attacks the cause of Alzheimer’s disease rather than merely treating its symptoms. Currently, treatment options for Alzheimer’s disease are limited. This groundbreaking medicine holds the potential to slow the progression of the disease and could vastly improve quality of life for Alzheimer’s patients. Women account for 70 percent of Alzheimer’s deaths.

click here to read the report

Senior Research Fellowship at NIPER, Ahmedabad

Applications for a post of Senior Research Fellowship are invited from candidates with first class marks in M. S. (Pharm.) (Medicinal Chem.)/M. Pharm.(Medicinal/Pharmaceutical Chem.) or M. Sc. (Organic Chemistry) with two years of research experience in organic synthesis on a project entitled “Computer Aided Design and Synthesis of New Chemical Entities Targetting the Hemaglutinin of H1N1 Virus,” under the joint supervision of Prof. Asit K. Chakraborti and Prof. Prasad V. Bharatam,Department of Medicinal Chemistry, NIPER, S. A. S. Nagar, Punjab.

The duration of theproject is for one year. The position is purely temporary. The candidates need to appear for a walk-in-interview at 12-00 noon on Aug 28, 2009 in the Conference Room, Secretariate Block, NIPER. The candidate should bring an application form, a CV,original and one set of photocopies of the relevant certificates at the time of appearing theinterview. Age relaxation for reserved category is as per GOI rules. CANVASSING IN ANY FORM WILL BE TREATED AS DISQUALIFICATION FOR THE POST. Director NIPER reserves the right to cancel the recruitment without assign any reasonthereof. No TA/DA will be given for attending the interview.