Malaysia Spearheads Stem Cell Research

Read more contents from CRM Bulletin Issue 14. Download here!

The Ministry of Health (MOH) Ampang Hospital is embarking on a pioneering stem cell research exploring the use of mesenchymal stem cells (MSCs) in acute graft-versus-host-disease (aGVHD). While this innovative treatment has already been approved in several countries, it has so far only been used as salvage therapy after failing steroids and other immunosuppresants, and rarely employed as a front-line therapy. Steroid refractory aGVHD has a dismal prognosis with mortality in excess of 90% and no viable second-line options.1Working in collaboration with Cytopeutics®, a local company with an impressive track record of basic and clinical trials in stem cell, this Phase I-II double blind randomized clinical trial has been approved by the Medical Research Ethics Committee (MREC) and the National Stem Cell Ethics and Research Sub-committee (NSCERT). More centres are expected to participate in the trial locally and abroad including Singapore and Australia. The success of the treatment will provide a real chance of the patient surviving against the odds as well as put Malaysia on the map in the field of stem cell advances.

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Kuala Lumpur Sports Medicine Centre (KLSMC) On Stem Cells Research And Therapy

Read more contents from CRM Bulletin Issue 13. Download here!

Articular Cartilage Repair and Regeneration

Articular cartilage is the soft tissues that surround the bones in the knee joint enabling smooth movement of the knee. Anyone who has suffered or is suffering from damaged cartilage will know just how painful it can be. This can also seriously impact their quality of life and daily function. Regeneration of damaged cartilage has long been thought impossible due to the nature of its tissues. The conventional way of treating cartilage damage often involves complex surgery and is limited to small areas. Even so, the success rates were variable and inconsistent. Often the treatments result in the formation of scar tissues, which cause the cartilage to breakdown faster than normal healthy cartilage; and eventually lead to revision of surgery, higher medical care cost, and little to no improvement in quality of life.

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My Personal Experience in Conducting Trials in Sabah and Sarawak

By Soon Wen Xian

Soon Wen Xian, a medical graduate of Volgograd State Medical University, is currently a Clinical Research Associate at an international pharmaceutical organization based in Malaysia.


When I was a young boy, Sabah and Sarawak have always had an air of mystery about it. Despite both being the largest and second largest state in Malaysia, I never had a chance to visit them. And that was until I joined the clinical research industry.

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CRM’s Quality Improvement Plan

At clinical research sites, Standard Operating Procedures (SOPs) help define the study team standard practices and daily processes to assure execution of study tasks are in accordance with the requirements. SOPs should contain enough detail to guide the study team through a particular procedure and thereby establish uniformity in the everyday functions of each site.

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Esketamine Trial – A Success Story in Patient Recruitment

Written by Chan Wei Quan, Site Manager at Janssen

 

Of all the illnesses out there today, which one would you say is the leading cause of disability around the globe? The answer may surprise you.

It’s depression, which affects more than 15 million adults in the U.S. and more than 300 million worldwide, according to the World Health Organization (WHO). It can cause the affected person to suffer greatly and function poorly at work, at school and in the family. At its worst, depression can lead to suicide. Close to 800 000 people die due to suicide every year.

All existing antidepressants work on the same premise by increasing the brain levels of serotonin and/or norepinephrine—neurotransmitters. However, only about half of the patients receive an adequate response from them, which typically takes four to eight weeks or longer for someone to start feeling better. When you are that depressed and possibly on the point of contemplating suicide, 4 to 8 weeks is a long time….

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Biosimilars: Are they generics?

Article contributed by Shaun Lee Chia Choon.

Shaun Lee is an aspiring clinical research professional with an interest in drug safety and development. He graduated with a Masters of Pharmacy qualification from The University of Bath UK and at the time of writing, is a study coordinator at Kuala Lumpur Hospital.


The short answer is no and here is why.

Generics are conventionally small-molecule drugs, commonly produced via synthetic methods. They are interchangeable with the reference innovator products as their approval depends on the fulfilment of regulatory requirements to be both bioequivalent (comparable pharmacokinetics) and pharmaceutically equivalent (identical active substance). In other words, generics are therapeutically equivalent carbon copies of the reference innovator products.

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Overview of the Medical Research & Ethics Committee’s (MREC) Industry Sponsored Research (ISR) Performance Statistics, 2014 – 2016

Gurpreet K*, Asha T*, Sharina MN*
*Medical Research Ethics Unit, NIH Secretariat, Ministry of Health Malaysia

MREC was formally established in 2002, with the purpose of safe guarding the rights, welfare and safety of subjects participating in research in Ministry of Health (MOH) facilities. It is the sole ethics committee for Ministry of Health facilities and may act as an Independent Ethics Committee for facilities outside the MOH.

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Investigator’s Corrective Action Plan Fails to Satisfy FDA

Following an FDA inspection, the agency lists identified deficiencies in a Form FDA 483, Inspectional Observations, and in the FDA Establishment Inspection Report. There is no regulatory requirement for the inspected party to respond to the Form FDA 483. Nevertheless, a well-reasoned, complete and timely response is generally in the inspected party’s best interests, not least because it may mitigate a decision for further action and demonstrates commitment and intent to comply, which will establish credibility with the FDA. When the inspected party chooses to provide a written response, any subsequent FDA warning letter is likely to include a judgement on the appropriateness of that response. From a review of even a small number of FDA warning letters, it is evident that the agency often finds that the corrective and preventive actions (CAPAs) proposed by inspected parties are inadequate. One such case is described below.

MISSED LABORATORY EVALUATIONS

An investigator participating in two oncology trials failed to perform a large number of protocol-required laboratory tests, including coagulation profile laboratory tests for four out of five subjects on up to 15 occasions. In addition he failed to perform liver function tests for all five subjects on at least three occasions. In his written response to these violations, the investigator confirmed that the protocol-required laboratory tests were missed for subjects enrolled in the two studies. He indicated that, as a part of his corrective action plan (CAP), he had added a “clinical trials link” to the site’s electronic medical record (EMR) to

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