Steve Eaton jailed in pre-clinical trial data scam

Steven Eaton, a former employee of Aptuit was found guilty at Edinburgh Sheriff’s Court in March following a prosecution under the Good Laboratory Practice Regulations 1999, was today sentenced to three months in prison for altering pre-clinical trial data designed to support applications to perform clinical trials. - The first time the Medicines and Healthcare Products Regulatory Agency (MHRA) has successfully used these regulations to bring a prosecution.

The case came about when Aptuit informed the MHRA that they had identified serious irregularities in pre-clinical data generated to support human clinical trials and the registration of new medicines.

The irregularities involved changing or providing false analytical data that would be used to determine the concentration of medicine that could be given to clinical trial subjects used to assess the safety and efficacy of a new medicine.

The MHRA launched an investigation to identify the number of studies affected and the impact the data irregularities would have on the interpretation of important safety data. The investigation concluded that Mr Eaton had selectively reported analytical data over a number of years, dating back to 2003. During this period he selectively reported data which was used to assess whether analytical methods were working properly or to assess the concentration of the drug in blood. The data manipulation ensured an experiment was deemed successful when in fact it had failed.

The actions led to the review of many hundreds of safety studies assessing the impact of the data manipulation and to ensure that the compromised data was not used in future submissions to relevant authorities without their knowledge.

The development of a number of new medicines were significantly delayed and considerable cost to the study sponsors was incurred as a result of the delay due to the fraudulent activities of Eaton.

Following a full assessment by the MHRA’s inspection team and assessors it was concluded that the data integrity issues did not invalidate the results of the clinical trials that were affected.

Merck Opens New Manufacturing Facility in Hangzhou, China

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the opening of its new pharmaceutical manufacturing facility in Hangzhou, China. The facility, located in the Hangzhou Economic and Technology Area (HEDA), will package Merck medicines for China and the Asia Pacific region and will become a critical part of Merck’s global supply chain.

 

The new facility – a nearly US$120 million investment by Merck – deepens Merck’s growing research and development (R&D), manufacturing and commercial presence in China. Merck also has an R&D Center in Beijing, three manufacturing facilities throughout the country, a marketing and sales organization headquartered in Shanghai, and employs more than 5000 employees in China.

“Merck built its first China plant in 1994 in Hangzhou,” said Pam Cheng, president, MSD China. “Today, 20 years later, we are celebrating this new plant in Hangzhou that marks another milestone in our commitment to invest in China and further demonstrates the importance of China to Merck.

 

Facts about the new Merck manufacturing facility in HEDA

“The new facility in HEDA joins an integrated, interdependent network of 72 Merck facilities that supply medicines and vaccines to more than 140 countries,” said Mr. Deese. “The HEDA facility is one of the most advanced and largest packaging facilities in China and the region.” 

The new facility is 75,000 m² and is capable of holding up to 16 high speed lines to package pharmaceutical tablets and sterile Merck medicines that are used to manage diabetes, cardiovascular, infectious, respiratory and bone diseases. Packaging capacity is currently estimated at more than 300 million packages annually. Products used in Merck’s clinical studies and in its commercial activities to support future new product launches also will be packaged at the new HEDA plant. 

The new facility is fully compliant with the rigorous quality, environmental, safety and compliance standards that all Merck manufacturing facilities worldwide meet. The HEDA facility received a current Good Manufacturing Practices (cGMP) certification in January 2013. Protecting the environment was also a critical consideration in the facility’s construction – special air, waste and water management procedures and systems were built into the facility. 

BITS Pilani acquires its Dubai campus

BITS Pilani has acquired the infrastructure of its Dubai campus from its long term partner ETA LLC Group, ending a 12-year collaboration. Birla Institute of Technology and Science, Pilani made the announcement adding that all the statutory requirements for acquisition had been met.

 

BITS had set up its only international branch in Dubai in 2000 in collaboration with ETA LLC Group. Under the agreement, the latter provided infrastructural facilities and administrative support while the former managed the academics.

 

“BITS Pilani brand is looking forward to strengthening its Dubai campus by expanding programme offerings, student enrolment, faculty strength, research and community outreach activities, with a view to attracting best of talents,” added Professor Ravi Kant Mittal, Director of Dubai campus.

 

Currently, the Dubai campus offers seven undergraduate programs in Engineering besides several postgraduate and doctoral programmes, with a student strength of over 1500. (No Pharmacy Courses though :( )

Clinical Trials in India plummet after stringent norms - Article from The Hindu

Clinical trials of drugs in India have seen a drastic fall this year after toughened norms were introduced following Supreme Court directives.

 

Not only have the number of trial approvals in the country reduced, there has also been a significant

reduction in the number of sponsoring pharma firms applying for such approvals.

 

Official Health Ministry data shows that until January 31 this year, only six trials had been approved. Even these pertained to older applications where the Drug Controller General of India had asked the applying firms to make some amendments.

 

Sources say until April, only around 12 approvals have been granted by the DCGI for trials of drugs in India. Pending applications for trials as of today are just 70.

This is in sharp contrast to the past when the number of Global Clinical Trials (GCTs) approved for conduct in India was in hundreds

 

Though in 2008 the DCGI had granted just 65 approvals for trials, the number in 2009 rose sharply to 391. The trend continued with a whopping 500 GCTs being allowed in 2010 and 325 in 2011 followed by 262 approvals in 2012.

 

Admitting that there has been a drastic fall in fresh applications for conduct of global clinical trials of drugs in the country, DCGI GN Singh told PTI, “The safety and well being of Indian subjects participating in clinical trials is the foremost in our minds.

 

“This is why the Government has tightened the norms putting the onus of safety of participants on firms conducting the trials. It is for the first time that such norms have been put in place.”

As many as 2,262 people died in these trials during the past five years, leading to a public outcry and Supreme Court intervention for stricter norms for holding drug trials. The apex court had rapped the Health Ministry for allowing Indians to be used as “guinea pigs” in the conduct of drug trials.

 

Also before the new rules were put in place, the average compensation awarded per death was a meagre Rs 2.2 lakh as per Health Ministry data.

 

The Government recently notified new rules for the conduct of drug trials in India, making it mandatory for investigators and sponsors to address issues of serious adverse events such as death of subjects involved in trials and fixing a formula for grant of adequate compensation in such cases.

Pharma firms, the sources say, have been discouraged to apply for new trials due to recent stringent norms which the Government has notified as a precondition for grant of approvals.

 

The new rules which came into force this year, for the first time, propose a formula for minimum compensation to be paid by the sponsoring firm in case of serious adverse events such as death or injury of the trial participant.

 

New rules also require the setting up of independent ethics committees under medical institutes to monitor ongoing drug trials.

 

These committees must now be registered with the DCGI prior before the conduct of clinical drug trials.

 

In the older system, pharma company hosting the trial could set up its own committee and have its own investigators for inquiring into serious adverse events.

 

Currently pegged at USD 500 million, India’s clinical research market was projected to more than double and cross USD one billion mark by 2016 driven by a large and easy-to-access population with much lower cost than in the developed world.

 

Source: The Hindu

GSK signals a new journey with Electroceuticals

Pharmaceuticals, Nutraceuticals and now Electroceuticals!!

 

Glaxosmithkline (NYSE:GSK) have announced their entry into a new field of medicine known as Electroceuticals. The company have entered into academic institutions and encourage research on developing new therapeutics which can treat diseases via electrical signals. The company is crowdsourcing for this venture has announced a prize money of $1 million for an innovative treatment option.

The company is nterested in projects that begin detailing how nerves in the body are related to particular diseases, understand the firing patterns of those nerves, and explore new technologies that will enable to interface with multiple individual nerve fibres.  As a first step, the company has put up an Ideation challenge via Innocentive with a prize money of $ 5000

Details of the Ideation Challenge:

Bioelectronic medicines or “electroceuticals” promise to treat disease by modulating neural electrical impulses. Which specific disease has a major peripheral neural control component and would be the best proof of principle for such medicines?

You do not need to perform any experiments, only to describe the conceptual approach and need in a total of 3 pages!

This is an Ideation Challenge with a guaranteed award for at least one submitted solution. Solvers can also be considered for research funding.

GlaxoSmithKline (GSK) will also be convening an international conference for the bioelectronic research community in December 2013, encouraging researchers to meet, build relationships and share early findings.

A commentary on Nature is quite fascinating read and I’m certainly interested to know more about and I have more to post on this subject in the near future… Watch out for more….

Bristol-Myers Squibb – On a balancing act?

Bristol-Myers Squibb (NYSE:BMS), is making its final move in the Amylin acquisition by announcing the closure of the headquarters facility at La Jolla, California. The work being done here will be moved to other BMS sites and the site closure is expected to be complete by Q1 2015.

On the other hand, BMS made a recent announcement regarding two new manufacturing facilities at Devens, Massachusetts. These two facilities are expected to be completed in 2015 and one of these is dedicated to a group that designs processes for early production of investigational biologics medicines.

With several Biologics/BioPharmaceuticals in the early stage pipeline, the move by BMS does make sense and show that the company is preparing to march into a brighter future.

Roche launches new test for diagnosis and monitoring of Thyroid Cancer

Roche has announced the global launch (except US) of Elecsys Calcitonin, a new laboratory test for the diagnosis and lifelong monitoring of medullary thyroid cancer patients after thyroid surgery. This test is based on Calcitonin, a specific tumour marker that can help diagnose medullary thyroid carcinoma early, as elevated concentrations of calcitonin in the blood are associated with the onset of this type of cancer.

 

Designed for use on Roche’s cobas modular analyser platform, Elecsys Calcitonin offers healthcare professionals an integrated solution for accurate diagnosis and reliable patient monitoring, significantly improving medical decision-making and treatment planning.

Click here for more info

 

DCGI office Organizational Structure

Here is the Organizational Structure of the Drugs Controller General of India office.