ICMR publishes Code of Conduct Guidelines for Research Scientists

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Indian Council of Medical Research
Indian Council of Medical          Research (Photo credit: Wikipedia)

Bioethics has emerged as a new discipline over the past couple of decades and is poised to become a multidisciplinary specialty. Institutional review boards/Institutional ethics committees have evolved as conscience keepers of professionals with the view to safeguard the welfare of members of society against any possible harm from scientific advances. Bioethical discussions and debates provide perspectives on the relevance of

new as well as existing processes to human values, enabling appropriate decisions by the
different stakeholders.
Advances in laboratory technologies in the recent times have created new and complex
ethical dilemmas in their wake. Laboratory services are an integral part of disease
diagnosis, treatment, response monitoring, surveillance programmes and research.
Therefore, personnel working in clinical and/or research laboratories should be aware of
their ethical responsibilities. It is necessary to comply with the ethical code of conduct
prescribed by national and international organisations, and address the emerging ethical,
legal and social concerns in the field of biological and biomedical sciences. The basic
principles enshrined in the codes and guidelines followed by different countries are:
1. Autonomy – Respect for persons including informed consent, privacy and
confidentiality
2. Beneficence – Fruitful result, Do good
3. Non-Maleficence – Do no deliberate harm
4. Justice – Ensure equitable distribution of risks and benefits
The aim of the code of conduct for scientists is to ensure that all research activities involving microbial or other biological agents, or toxins whatever their origin or
method of production, are only of types and in quantities that have justification for
prophylactic, protective or other peaceful purposes.
Source : ICMR
Read the Entire Guidelines on Code of Conduct for Research Scientists engaged in field of Life Sciences HERE
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Merck, Samsung Bioepis ink pact to develop & commercialize insulin glargine candidate for diabetes

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Merck, known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd., have expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293, an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes. Phase III clinical studies in type 1 and type 2 diabetes will begin soon.

“We look forward to collaborating with Samsung Bioepis on this insulin glargine candidate, as diabetes is a top priority for the company,” said Matt Strasburger, senior vice president, diabetes, global human health, Merck. “Merck is strengthening its leadership in diabetes through our own work and in collaboration with others, and this agreement will help build our portfolio across the spectrum of the disease.”

“Samsung Bioepis is very pleased to extend the partnership with Merck to the field of diabetes,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “This collaboration will bring better access to patients with diabetes worldwide.”

Under the terms of the agreement, the companies will collaborate on clinical development, regulatory filings and manufacturing. If approved, Merck will commercialize this candidate. This collaboration builds on the agreement made by the two companies in February 2013 to develop and commercialize multiple biosimilar candidates.

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, aims to develop affordable and high-quality biopharmaceutical and biosimilar products.

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions.

Source: PharmaBiz

 

USFDA to hold workshops across India on quality requirements

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Commisioner of the United States Food and Drug...
Commisioner of the United States Food and Drug Administration Margaret Hamburg. (Photo credit: Wikipedia)

The US health regulator plans to conduct workshops across India in the next one year in order to sanitise Indian drug companies about the changing quality requirements in the American market.

 

 The matter came up during a meeting between chief executives of various drug companies and US Food and Drug Administration (USFDA) Commissioner Margaret A Hamburg.

 

 Wockhardt Chairman Habil Khorakiwala said the plan to conduct workshops in India is part of the USFDA’s strategy to let Indian companies be more aware about the changes happening in the US in terms of the requirement for quality.

 

 “One of their (USFDA) objective is to sensitise here in India about these changes. In fact, the USFDA is planning a workshop over the next one year at 3-4 locations to clarify what are the new requirements and what are the expectations of the USFDA”, Khorakiwala told reporters here.

 

 During the meeting, which was attended by chiefs of pharma companies including Ranbaxy CEO & MD Arun Sawhney, Sun Pharma Founder & MD Dilip Shanghvi and Khorakiwala, the Indian delegation asked USFDA team to continue with the high level interactions.

 

 “The second suggestion which was made and she (Hamburg) accepted is that this dialogue at the highest level should continue,” Khorakiwala said.

 

 She also accepted the proposal that a delegation of leaders and scientists from India should have interaction with larger group in USFDA so that the issues could be discussed at length, he added.

 

 Hamburg, said the USFDA is in the process of reorganising its structure and speeding up the process of approvals.

 

 She added that this would help clear the backlog of inspection for Indian drug manufacturers who have applied for approval from USFDA to export their products to the US.

 

 The USFDA has taken a series of actions against Indian pharmaceutical firms, restricting their shipments to the US, their largest export market.

 

 The US health regulator on January 23 banned the import of products manufactured by Ranbaxy Laboratories at its plant at Toansa. This was the company’s fourth plant to face regulatory action from the USFDA, after Mohali, Paonta Sahib and Dewas plants.

 

 In 2013, Ranbaxy had agreed to pay a fine of $500 million to US authorities after pleading guilty to ‘felony charges’ relating to manufacture and distribution of certain adulterated drugs made at the Paonta Sahib and Dewas units.

 

 Another Indian firm, Wockhardt, had its two plants put under import alert by the USFDA.

 

 India’s pharma exports increased 10% to $14.6 billion during 2012-13, with shipments to the US accounting for about 26% of the total.

 

 India is the largest exporter of generics to the US by volume, with supplies from 35 companies in the country. The nation has around 320 USFDA-approved pharma facilities, the largest number outside the US.

 

Source: Business Standard

 

 

 

FDA approves pediatric use of Dexcom’s G4 Platinum continuous glucose monitoring system

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The U.S. Food and Drug Administration today approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older.
Diabetes is a serious, chronic metabolic condition in which the body is unable to adequately manage blood sugar levels. An estimated 25.8 million people – about 215,000 of them under age 20 – in the United States have diabetes. If left untreated, high blood glucose levels (hyperglycemia) can lead to serious long-term problems such as stroke, heart disease, and damage to the eyes, kidneys, and nerves.
A continuous glucose monitor (CGM) is a device that includes a small wire-like sensor inserted just under the skin that provides a steady stream of information about glucose levels in the fluid around the cells (interstitial fluid). When used along with a blood glucose meter, CGM information can help people with diabetes detect when blood glucose values are approaching dangerously high and dangerously low levels.
The FDA has not approved the use of CGM values alone to determine dosing of diabetes medications. CGMs must be calibrated by blood glucose meters, and treatment decisions such as insulin dosing should be based on readings from a blood glucose meter.
The G4 Platinum System is an externally worn system that continuously displays an estimate of blood glucose levels and the direction and rate of change of these estimates. The device is intended to be worn by a single patient for up to seven days. It requires a prescription and is meant to complement, not replace, information obtained from standard home glucose monitoring devices.
The previously approved G4 Platinum System is for insertion of the sensor in the abdomen only. The new G4 Platinum (Pediatric) System, the first approved CGM system for use in patients 2 to 17 years of age, includes the upper buttock in addition to the abdomen as sensor insertion sites. The device system components (sensor and transmitter) are unmodified from the previous system.
“This device can provide valuable glucose trend information to children with diabetes and their families, but it is important that those using this device understand the expected performance of this device compared to blood glucose meters, especially for detecting low glucose, in pediatric patients,” said Alberto Gutierrez, Ph.D., director, Office of In Vitro Diagnostics and Radiological Devices in the FDA’s Center for Devices and Radiological Health. “This approval for expanded use is part of the FDA’s work to meet the needs of children living with diabetes.”
Before the approval, the FDA reviewed data from a pivotal clinical study of in-clinic and home-use patients to assess the accuracy and precision of the system. One hundred and seventy-six patients ages 2 to 17 wore the G4 Platinum (Pediatric) sensor for seven days (168 hours). The accuracy of the system’s glucose readings was evaluated by comparing them to a clinical laboratory reference method (for patients ages 6 to 17) and to results obtained from finger stick samples on a blood glucose meter (for patients ages 2 to 17).
The pivotal clinical study demonstrated that the G4 Platinum (Pediatric) System performance in pediatric subjects was not as accurate as the performance of the same device in adults. In addition, the performance of the hypoglycemic detection alert in the pediatric study was poor relative to that seen in the adult study, particularly at blood glucose concentrations below 70 milligrams per deciliter of blood. Despite these limitations, the study did demonstrate that the device is effective for tracking and trending to determine patterns in glucose levels, and for alerting patients when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels.
To communicate the reduced accuracy in pediatric patients to users, two warnings are included in the labeling, and are displayed on the receiver screen when a new sensor session is started or the alert thresholds are changed:
  • In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decisions.
  • In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on CGM alerts to detect low glucose.
Research on CGMs is underway as part of a developmental artificial pancreas device system (APDS) for people with type 1 diabetes, a device that includes a CGM and an insulin pump. An artificial pancreas system would monitor glucose levels and automatically pump the appropriate amount of insulin as determined by a computer algorithm.
The G4 Platinum (Pediatric) System is manufactured by Dexcom, Inc., located in San Diego, Calif.
Source : USFDA

Johnson & Johnson hands over clinical trial data to Yale University to be publicly accessible

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NEW DELHI: The campaign to bring all clinical trial data into the public domain got a shot in the arm with Johnson & Johnson making all its drug trial data available to Yale University.

J&J is the first company to hand over all its trial data to a completely independent third party, the Yale University Open Data Access (YODA) project. Pharma giants like GSK, Pfizer and Roche had earlier announced that they would make their trial data available, but only on their own web portals where researchers would have to apply to be given access to the data. Harlan Krumholz, principal investigator on the YODA project has stressed that YODA’s advantage lay in its credibility as an independent body that would not impede access to data, but would ensure its responsible use.

The slow and cautious opening up of clinical trial data to public scrutiny is the result of a long campaign that has insisted that all trials past and present ought to be registered and the full methods and results reported. The AllTrials project campaigned for all governments, regulators and research bodies to implement measures to achieve this. The project’s goal is “all trials registered, all results reported”.

Slowly but surely the screws seem to be tightening on the pharma companies to disclose trial data. Recently, the new clinical trial regulation, which would require anyone conducting a clinical trial to register it and publish a summary of results in a publicly accessible EU database, was approved by the Public Health Committee Members of the European Parliament. Under this regulation, full clinical study reports will have to be published after marketing authorization of the product or if the marketing authorization is withdrawn. These stipulations are to be enforced through fines on anyone who does not adhere to the new transparency rules.

Pharma has been fighting this move towards greater transparency. Last year in May, two pharma companies had sued to prevent European Medicines Agency from releasing clinical trial documents claiming that releasing the data would compromise ‘commercially confidential information’. The EMA argued that it did not consider clinical trial data to be commercially confidential . The case has moved to the General Court of the EU and in the meantime EMA cannot make public any document covered by the claim.

In a recent editorial in British Medical Journal, Dr Ben Goldacre, founder of the AllTrials campaign called for a routine audit of all currently used medical treatments. The audit is expected to identify if the clinical trials on which the treatment is based were registered, what trial and research data was available, which company manufactured the drug and who were the investigators involved in the R&D. This data is expected to help identify the best and worst treatments, companies, researchers and inform patients and doctors before making all-important life-or-death decisions.

According to the AllTrails website, thousands of clinical trials have not reported their results and some have not even been registered. “Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine and trials being repeated,” stated the AllTrials website.

Glen Willmott, the UK MEP was quoted as saying that for too long, unflattering studies on new medicines have gone undisclosed. “Around half of all trials are never published, usually with negative or disappointing results. It is vital that we know about negative outcomes—otherwise trials can be conducted repeatedly before it becomes public knowledge that some products are ineffective, or even dangerous,” said Willmott.

Source: Times of India