GenoMed Inc. (GMED)

[mingwan0]

Who will Phenomed collaborate with?

Some relevant text from their website:

http://www.phenomed.net/

PhenoMed is a development-stage disease management and medical and pharmaceutical therapeutic company using genomic-based diagnostics to assist health practitioners in their efforts to improve patient outcomes.

Working closely with its U.S. partner, Genomed, Inc., along with research labs in the region, PhenoMed is building a network of physician and health services organizations to quickly expand its medical and therapeutic services offerings throughout the Asia-Pacific region.

http://www.phenomed.net/news1-26-04.htm

Phenomed Sdn Bhd Initiating Clinical Trials Program for SARS and other Infectious Diseases

Physicians and Health Care Groups Encouraged to Participate in Clinical Trials

KUALA LUMPUR, Malaysia – January 26, 2004 – Phenomed Sdn Bhd, a development-stage disease management and medical-pharmaceutical therapeutic company, announces the initiation of its clinical trials program for infectious diseases.

"Phenomed is announcing that it will begin collecting information from government agencies, physicians and individual patients interested in participating in the company's clinical trials program. We are working closely with our US partner, Genomed, Inc., and that company's CEO and Chief Medical Officer, Dr. David Moskowitz in helping to sign up interested parties," said Ezehan Reza Kamaluddin, Phenomed's interim Chief Operating Officer. "There is a worldwide need for disease management and targeted pharmaceutical therapeutics directed at infectious disease. Malaysia's disease management needs are ever-present and Phenomed wants to do all it can to help in meeting the country's healthcare needs in fighting these persistent scourges. The immediate concern over avian flu highlights this need."

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How do you identify people that will be involved in the clinical trials program? One way is to look at people that have previously been involved in similar work in conjunction with the Phenomed principals. Here I identify one such individual.

Here are a couple of quotes from a press release of January 12, 2002:

http://www.bioenterprise.org/dengue-NUSpressRelease(HTML).htm

AP Genomics to Launch Innovative Dengue Diagnostic Kit Based on Home-Grown NUS Technology

"The need for a more effective and practical approach to diagnosis of dengue is so great - we immediately recognized the immense public health potential of A/Prof Chow's primers, and its use for accelerating diagnosis of the disease." said Dr. Gurinder Shahi, Interim CEO for AP Genomics and CEO of BioEnterprise Asia, the accelerator facilitating technology and business development for AP Genomics."

Dr. Nor Shahidah Khairullah, Head of Virology at the Infectious Diseases Research Centre, Institute for Medical Research in Malaysia, is anticipated to oversee the testing for field validation of the dengue diagnostic technology. "The development of this test represents a major advance in dengue diagnostics, and will also be a boon for studying the molecular epidemiology of the disease - it could have substantial public health significance" she said "We believe it will be only the first of many innovative diagnostic tools we are planning to develop and validate with AP Genomics."

Dr. Nor Shahidah Khairullah, of the IMR in Malaysia, said, "the availability of such a product will greatly facilitate molecular epidemiology and diagnosis of dengue. IMR is planning to work with AP Genomics and is proud to be associated with the development effort for this exciting new product, and we look forward to many years of cooperation and collaboration in product and technology development with AP Genomics."

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Apart from being the Head of Virology at the IMR, Dr. Nor Shahidah Khairullah is also a member of the Medical Research & Ethics Committee (MREC), Ministry of Health Malaysia:

http://www.imr.gov.my/MREC.htm

Here is a Malaysian Ministry of Health presentation:

http://webjka.dph.gov.my/aids/bss/1workshop/MALAYSIA.ppt

This bit:

http://webjka.dph.gov.my/aids/bss/1workshop/36

is concerned with HIV Diagnosis in Malaysia. The presenter was Dr Nor Shahidah Khairullah MBBS, MSc, FRCPath, FAMM, Head of Virology and Director National AIDS Reference Laboratory.

She regularly takes part in conferences and workshops. Here she is at the Intracom conference in October 2003:

http://www.ninpv.org/5thIntracom/201003.htm

Special Lecture
Integrated Medicine – Addressing the Gap
Dr Nor Shahidah Khairullah

Here she is giving a presentation on clinical trials:

http://www.bpfk.gov.my/tcmconferenceprogramme.htm

Clinical Trial of T/CM Product Towards Compliance to GCP
Dr. Nor Shahidah Khairullah, Consultant Virologist and Head of Virology Unit, Infectious Diseases Research Centre, Institute for Medical Research, Malaysia

The presentation itself contains a nice overview of the clinical trials process in Malaysia:

http://www.bpfk.gov.my/pdfworddownload/21.ppt

Finally, here is an article on her work with SARS:

http://www.orifresh.com/NEWSFLASH.htm

Testing time for researchers
in Malaysia

Scientists in Malaysia are quietly studying the SARS virus and are achieving some positive results. Audrey Edwards speaks to Dr Nor Shahidah Khairullah of the Institute for Medical Research to piece together the puzzle

DR Nor Shahidah Khairullah is probably facing the challenge of her lifetime as she and her staff at the Institute of Medical Research (IMR) work tirelessly to conduct tests on specimens suspected to contain the SARS virus.

“It is a tough but exciting job. And I like challenges,' she says simply.

Ever since the IMR's P3 laboratory was activated in mid-March to work on the SARS outbreak, Dr Nor Shahidah, who also heads the Institute of Medical Research (IMR) virology unit, and her team of 20 comprising scientists, doctors, research officers and technicians have been working non-stop testing the specimens that have been referred to them by various hospitals and institutes throughout the country. This is the first time that the laboratory is being used for a real viral outbreak, reveals Dr Nor Shahidah who is on a two-year contract with IMR, which ends this August.

It is also one of two P3 labs in the country, the other being at the Veterinary Research Institute in Ipoh. (A P3 lab undertakes work on viruses such as HIV and Hepatitis.)

“I’m very proud of my lab. I think we are doing a lot. The staff is on call every day,” she says.

A very hands-on person, Dr Nor Shahidah is also involved in the testing process, performing tests such as studying the immuno fluorescent slides and doing cell culture.

“I verify and look at the tubes myself. Even if you are the head, you have to be hands on,” she says. “You cannot just be an administrator, you must be the driving force.”

A typical day for her begins at 7.15am and ends about 10pm. She spends the day doing a host of things including looking through the number of specimens received the previous day, repeating tests, screening pending cases, attending ministry meetings, teaching and doing administrative work.

“I have a very close relationship with my staff but I will keep tabs on them and what they are doing. They have to be trained to be detailed in their work,” she says.

She is lucky if she gets five hours of sleep daily, she says, but the adrenaline and the passion for work keeps her going.

“Viruses intrigue me. It infects a person and you study the outcome on humans and their immune system. Another passion for me is looking at the potential of herbal medical products on viral diseases.”

The scale of activities at the lab since it was co-opted in the fight to contain the outbreak of SARS in the country has affected the personal life of everyone involved here, she says.

Going to work early in the morning and coming back late at night, you do not get to see daylight at all, she relates. “My three children are complaining that they do not see me anymore.”

So when she has time to spare, she and her family watch movies and play with their menagerie of cats, terrapins, turtles and fish.

“We go to the zoo, movies or just sing together. I have simple needs and I want my children to learn from my commitment so they will do the same later on,” she says.

One of her staff, senior research officer Ravindran Thayan, 38, finds the current project in the P3 lab quite exciting. “You feel that your work is important and there is a huge responsibility because people are depending on you. Initially, I was a bit worried (to work in a P3 lab) but if you don’t do it, then who will?” he states.

“You are happy if you get results because it is frustrating when you don’t produce anything.”

After more than a month, he says, they had become “experts” in changing from their normal working clothes to the Tyvex suits.

“We used to take about 10 minutes but now we can do it in three minutes. And we have taken the necessary precautions,” he says, adding that his wife and family were supportive of his job.

Another research officer, Fauziah Md Kassim, 39, is also finding the job exciting but hectic.

“You are on call and what time you get to leave depends on the number of specimens there are to process,” says Fauziah who also had to learn how to handle some of the equipment being used in the work.

“As I am not used to working in a P3 lab, I initially felt clumsy handling the specimens. The size of the glove (attached to the casing) was too big,” she says.

Like their counterparts in hospitals who are involved in containing the SARS outbreak, the team at the IMR P3 lab also know they are working with a dangerous virus.

“My husband was initially worried that I might get infected, but he didn’t say no to my working in the lab because he knows that I will be okay if I follow all the advice,” says Fauziah. “And anyway, I think this job cannot compare to those medical staff who have direct contact with the patients. They are in a riskier position.”

Medical technician Mohd Shamsuddin Mohd Zain, 26, admits that he was initially frightened when he began to work at the P3 lab. “You do feel a bit tense because you really have to concentrate on what you are doing. Sometimes, you have to bring specimens from the P3 lab to be tested downstairs. And you need to know what to do.

“The safety suit and mask can make you feel suffocated in the beginning, but it is okay once you learn how to breathe properly. My family and friends always remind me to be careful. I’m still scared now but it will be fine as long as I am careful,” he says.

The following is Dr Nor Shahidah’s outline of the various aspects connected with specimen testing and the work of the team at the IMR’s P3 lab.

Transporting specimens

Guidelines on the correct way of transporting specimens have been given to hospitals and institutions that obtain specimens from patients.

Specimens include organs, sputum, throat and nasal swab, and excretions.

“The specimens are transported to us in ice. Before transportation, the specimens are packaged in three layers,” Dr Nor Shahidah explains.

“Swabs are put in a viral transport medium. This is to preserve the specimens and make sure spillages don’t occur to protect the person transporting it.”

However, processing could run into problems when specimens are not labelled properly, contaminated, arrive late, sent without adequate information or when wrong specimens are sent, she says.

“The doctors in charge have to take care when sending specimens because we don’t want to take repeat specimens. And they should send more specimens to us when the patient’s condition worsens,’’ she adds.

The lab setting

The high containment lab is set at negative pressure (where air from outside would flow in when the door is opened and not vice versa).

Strict standard operating procedures also need to be observed by staff working there. These include making sure that the pressure in the lab is correct, maintaining the equipment and cleaning up after they leave. Everyone also has to wear Tyvex suits (full body suits), double gloves, N100 face masks and goggles.

Dr Nor Shahidah says the lab is divided into three sections: reception, changing room, which has an attached airlock, and the lab itself.

Specimens are passed to staff in the high containment lab through a “pass box”. They then start to sort them out.

“They see what specimens have been sent, and look at the form to make sure the labels on the specimen match the one on the form. If the wrong specimen has been sent, then it cannot be processed,” Dr Nor Shahidah says.

Once all this is verified, they write out a work sheet and fax it to the operations room in IMR. Nothing that goes into the P3 lab comes out unless it has been decontaminated and autoclaved, she said.

Her staff in the P3 lab work on a rotation basis and practise a “buddy system”.

“In case something happens, they will always have back-up so no one is allowed to go in alone,” she explains.

The tests

The type of tests done depends on the specimens used.

Five tests: cell culture, electron microscopy, immuno fluorescence antibody technique (IFAT), polymerase chain reaction (PCR) and real time PCR are carried out in three labs at the IMR. The labs are electron microscopy, cell culture (where IFAT is also done) and molecular diagnosis (PCR and real time PCR).

To confirm that a specimen is positive for SARS, at least two kinds of tests are needed, Dr Nor Shahidah says.

“This can be PCR and IFAT. Even then, we repeat the tests twice. We also test all specimens that come to us.”

They achieved a triumph of sorts when they obtained seven positive isolates, which meant they could proceed to do other experiments.

“When there is a positive isolate (cultured virus), we have to go through the whole battery for confirmation as sometimes you get a citopathic effect that is due to different kinds of viruses. So you have to confirm whether it is SARS or not,” she says.

But a negative result also does not mean there is no SARS virus, she cautions.

“Once you have confirmed that you have the SARS virus, then you can grow it. You can do sequencing of the coronavirus (which is the biggest RNA virus) and when you get that, you can compare this isolate with those from other countries and see if ours is the same as theirs.

“You can also get virus antigens, which can be used in diagnostic tests.”

Malaysia is also trying to standardise its own test kit in real time PCR and IFAT, and the IMR is evaluating the Artus kit (a German diagnostic kit).

The misconception

One major misconception among people, including doctors, was that test results would be quick, says Dr Nor Shahidah.

“They must understand that it is a process. The fastest it takes to get a result is three to four days, which is through IFAT, molecular diagnostics or electron microscopy. Cell culture takes two weeks.

“Sometimes it is frustrating to get calls from doctors who ask why there are no results and who say they need the results to determine what to do next. They shouldn’t stop dead in their tracks (of treating patients) while waiting for the results,” she says, pointing out that SARS was diagnosed clinically and that lab testing was done just to confirm the clinical diagnosis.

Patients who come in after two days of illness and have been warded for about three days, says Dr Nor Shahidah, do not produce antibodies yet.

“Don’t expect their antibodies to be at a level where it will test positive for immuno fluorescent. It could be positive later on, though, and this would require a second serum specimen.”

All said and done, Malaysia is doing its fair share of work to stem the spread of the killer virus, whether in public health measures, precautionary measures or testing. The Star

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Looks like she could be a very useful person to be associated with Phenomed's work given her expertise in areas such as HIV, SARS, clinical trials, etc.; not to mention her role at the Ministry of Health.