Category Archives: Clinical Development

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Competition among generic pharmaceutical companies to gain market advantage is increasing day by day. The sooner they bring the drug to market, the larger the market capture. USFDA also encourages this approach to bring down the overall expenditure on health care cost. The agency rewards the company making first to file ANDA applications with 180 days exclusivity. However, Bioequivalence studies are complex and involve Planning, resourcing, timeline management, technical capabilities, coordination and decision opportunities, which make improving performance a multidimensional challenge.

If a study is not designed properly, execution breaks down, leading to loss of opportunities for the client. We at Veeda understand this and have designed special task force to carry out such time sensitive and intensive planning & coordination demanding studies.

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We at Veeda take pride to state that we have the technical capabilities, required resources and proven track record in helping our business partners to make their first to file programs successful. We are capable of getting required regulatory permission well ahead of the study execution, shortest possible time to enroll required number of subjects and highest number of LCMS/MS machines as compared to any other Indian CRO to help you with your file to file ANDA applications.

Some of the highlights of our capabilities and achievement are as listed below:

  • Excellent regulatory network with proven track record to get approvals in time
  • Good database of healthy subjects and an excellent enrollment team capable of recruiting over 250+ subjects with a merely 24 hour advance notice
  • Team of over 750+ personnel to meet the timeline expectations of the project
  • Dedicated task force for clinical execution, data review, Bioanalysis, PK statistical analysis and report writing to handle first to file projects
  • Highest number of LCMS/MS machines as compared to any other Indian CRO

For 59-year-old Ashok Kumar, living with Parkinson’s disease (PD) for the last 12 years was nothing less than an ordeal. Kumar who formerly served as a general manager in a private firm, had been leading an active and productive life until he was diagnosed with PD. The progressive neurological disorder brought his life to a standstill and what followed was years of futile treatment and fading hope. However, recently his decision of undergoing stem cell therapy for PD turned out to be one of the most favourable decisions of his life.
Kumar recalls, “I couldn’t walk, stand or sit. I would fall forward and my body constantly suffered from tremors, postural instability and rigidity. I had lost all hope of recovery but Plexus Neuro and Stem Cell Research Centre reignited my hope. Within four months of undergoing stem cell therapy at the centre, my speech, writing ability, posture and body balance have improved drastically and I no longer take any medications for Parkinsonism.
Dr Naeem Sadiq, neurologist and director, Plexus Neuro and Stem Cell Research Centre (PNSRC) says that Kumar would recover completely in the next few months. Kumar is one of the many Parkinson’s patients who have got successfully treated at PNSRC. The centre, which has over 25 years of clinical experience in treating neurological disorders, offers stem cell therapy for neurological, psychiatric and orthopaedic disorders as well as several other incurable diseases.
Previously, medications and certain surgical procedures were the only treatments available for parkinsonism. Whilst medications in the long-term lack effectiveness and may cause side-effects, surgery is not always feasible or fruitful. In recent years, the application of stem cell therapy for treating PD has turned out to be a boon for the patients. Stem cells are like mother cells which originate from the developing embryo and differentiate into different types of cells, for example- heart muscle, liver, brain, skin, bone etc.
They are also known as progenitor cells since they lead to creation of new cells. Dr Sadiq explains, “Stem cell therapy for Parkinson’s disease involves collection of stem cells from the patient’s own bone marrow. The cells are isolated under CGMP conditions and after quality analysis in the laboratory, the isolated stem cells are re-injected or transplanted into the patient’s body. The stem cells then migrate to the affected area of the brain, get attached there and transform themselves into healthy tissue, thereby replacing the damaged cells”.
After the procedure the patient is discharged the next day. Regular follow-ups are essential and depending upon the severity of disease, a patient may need subsequent doses of stem cell transplant. “The doses and the route of administration of stem cells varies from disease to disease, and from patient to patient. The improvement pattern may also differ for every patient as per the patient’s overall health status and duration of disease.
In case of Kumar, two doses of stem cell transplant in four months period worked effectively,” adds Dr Sadiq. PD which afflicts about 7 to 10 million people worldwide is characterised by tremors, stiffness of limbs, slowness of movement and impaired balance and coordination. Later stages of Parkinson’s are highly debilitating. As the disease progresses, there is loss of dopamine producing brain cells in the substantia nigra region of the brain. Dopamine, a brain chemical plays key role in regulating coordination and movement of the body.
Till date, the exact reason behind the loss of dopamine cells in parkinsonism has not been elucidated. Dr Sadiq informs that every week, approximately ten patients are diagnosed with PD at Plexus Neuro Centre. These patients are in different stages of PD. He asserts, “Early detection and timely treatment of parkinsonism is imperative for positive treatment outcomes. General public lacks awareness of Parkinson’s disease. The initial stage of PD which usually begins as mild tremors on one side of the body is either neglected by patients or misdiagnosed.”

With rising temperatures, swine flu cases — which crossed the 4,000 mark this year in the capital— seem to have subsided. On Saturday, only five patients tested positive for the H1N1 virus out of a total nine patients.

flu

Dr Charan Singh, nodal officer for swine flu in the Health department, said, “Every year, with a rise in temperatures, the virus tends to recede. This is why we are seeing fewer cases now. Cases would have come down in February, but we continued to see cases due to the unseasonal rain.” Continue reading

The American Association of Clinical Endocrinologists (AACE) has released new, comprehensive clinical practice guidelines and an updated diabetes algorithm to aid clinicians in the medical management of patients with diabetes mellitus (DM). The 2015 guidelines have been substantially modified since the previous guidelines with the focus going beyond glycemic control to address multiple DM risk factors.

Diabetes-mellitus

The diabetes management algorithm is presented as an illustrated treatment pathway and includes all FDA-approved medication classes for diabetes. The treatment algorithm is based on initial A1c, with medications listed in a suggested hierarchy of usage. For example, recommendations for type 2 diabetes include the following: Continue reading

While there is still a row going on about the size of pictorial warnings on the cigarette packs, a new study claims that warnings in images as well as text are more likely to motivate people (especially young adults) to quit smoking, making them understand the various dangers and the effects of smoking.

According to a new research by the Washington State University, Vancouver, published online in the Annals of Behavioral Medicine, pictorial warnings or warnings with images and texts are more effective and influential in quitting smoking.

Although more and more evidence support graphic warnings in discouraging smokers, there has been very less research to show how smokers learn from the warnings, generally people with rotting teeth, facial scars and people dying in hospital beds. Continue reading

Beginning Monday, sale, purchase, storage and manufacturing of all forms of chewable tobacco including ‘guktha’ and pan masala containing tobacco are banned in the national capital. Delhi Government has decided to run campaigns on a large scale to educate the masses about the ban and harmful effect of chewable tobacco.

'Mouth Freshener' Tobacco Fueling Rise Of Oral Cancer In India

The AAP government has issued a notification banning all products of chewable tobacco in all forms. “We have put a ban on purchase, sale, manufacturing and even storage of all forms of chewable tobacco from today (Monday) in city. To implement the ban, several teams of Delhi Police, MCD and Food Adulteration will conduct surprise raids,” Health Minister Satyendra Jain said in New Delhi. However, no such ban will be enforced on cigarettes in the capital. Continue reading

Clinical trials market in India-Will the same pick up in India?

This is the key question with analysts, investors and all stakeholders who have been observing this market in the recent times. The clinical trial industry since the year 2006 has been expected to grow in double digits because of its vast patient population.

However, things have not been bright for the industry particularly since 2009.

Data available at the Clinical trial registry of India has witnessed a step hike in clinical trial registration since it came into inception. On an international level, data at the Clinical trials Gov. site has also captured this aspect. Continue reading

Clinical Trial Market in India is in serious danger today. Day by day , the dangers are on the rise .  The supreme court coming out with a ruling that the CDSCO ( DCGI) cannot approve clinical trials till the laws are in place.

This decision is coming at a time when the industry needs “growth boosters.” This decision has come without keeping the real and the broader picture into perspective.

The questions now arise was this preplanned, or the same  has been just to  keep the industry professionals or regulators on the guard . Whatever may be the reason , the future Continue reading