Medical device clinical trials

Unlike Pharmaceutical technologies, there are no dedicated established centers- MEDICAL DEVICE CROs in ample amount which could satisfactorily facilitate a medical device product evaluation and commercialization nor clinical evaluation guidelines in medical devices sector i.e. ISO-14155, ICH-GCP in adaptation oriented towards medical devices are taught in institutions so as to enable the students take such projects and come up with an excellent guideline document for producing local, national or global impact.

Medical device related health economics: The education could be imparted with Intended Learning Objective (ILO) of providing insight to economic evaluation of clinical effectiveness or diagnostic accuracy of medical devices with respective cost dimensions. This may comprise projects like preparation of costs database, estimation of budget for reimbursement schemes on medical device failure and so on.

Medical Technology Surveillance: There is little guidance available in field of post-marketing surveillance of medical devices especially in India. Unlike PvPI and hemovigilance, no such programme is available for medical devices. A model or strategy for the same could be invoked for purpose of brainstorming in students.

Regulatory Affairs and Standardization: Understanding how to put boundaries to innovations while their diffusion is something highly expected to be taught. It is fact that MATLAB,LABVIEW related digital image processing projects are promoted always but no project is seen which might have explored ethical issues related pros and cons associated with image processing i.e. violation of PNDT act, misdiagnosis of any abnormality or disorder. Moreover, there is less education provided on CE marking, Medical device standards, Medical device testing.

Intellectual Property Rights: No course I came across so far incorporates this aspect from project perspective i.e. project on assessing IPR issues faced by device manufacturers, comparison of device patentization framework of different countries, petty patents.

Bridging translational gap: It is hard fact that even after outstanding project model, there is no support in terms of how to accelerate it for professional growth with commercialisation purposes. Most of projects are just for sake of completion and not with realization and/or continuation of further journey. Such lacking in system is also proposes threat of plagiarised projects (ready-made models/circuits in markets) or “frog-in-well” approach during project.

I believe if this type of thinking could be done "apriori", then biomedical engineering’s value could be realised like never before. And also I believe that these aspects, when ingrained in curriculums, it would be “pride” rather than “speechlessness” or “cluelessness” when somebody would ask the reason for choosing this branch.

I would be happy to see as many as comments and suggestions for this post.

Let's start our journey for evidence-based-medical device research and development !!

Genelife Clinical Research: 5th Anniversary

As Genelife Clinical Research is growing 5 year old on February 26, 2015, with the steadfast confidence of Clients, Consultants and employees have shown to Genelife Clinical Research by entrusting to her services. When our company was founded in 2010 with a very small team, we could hardly foresee our growth to an international company with a staff of 32 within this short span of time. Many people predicted we will not last a year in the industry because we were too idealistic and simple to cope with business environment. Fortunately, we survived not only the initial phase but also the most difficult phase of Indian Clinical Research industry. When I started this organization I had a clear vision for success. I wished to create an amazing environment and hire the smartest people. Together we will build a beautiful system to delight the customers and makes the world just a little bit better. I started working night and day to make my vision “to be most respected CRO” reality, but the things did not go as planned due to some external and financial issues. Fortunately, we came out of that with some unexpected luck and trust of our clients. Every member of Genelife team have worked hard to make sure Genelife’s success and celebrate 5th anniversary.

Five year is long time as well as short time, compared to a big companies like Quintiles, we are still adolescent. On the other hand, five years in a sector that is constantly and rapidly advancing is an achievement, we can be proud of. It means we have managed to establish ourselves in this sector. We have claimed our rightful place here. This reflects with the kind of work we are doing. Currently we are having maximum approved studies in India with one of the best operations tools to run these projects. Deliverability has been our strength for retaining all business we have.

Since inception Genelife Clinical Research capitalized on the company's vision “to become the most respected CRO”. In these 5 years we have translated our knowledge into a full portfolio of drug development which empowers clients to close the gap between their requirement and regulatory needs. In near future, we aim to expand our horizons into the field of BA/BE, Pharmacovigilance as well as studies conducted in other Regulated market in and outside India. Keeping past experiences as well as future dreams in our mind, Genelife Clinical Research shall strive hard to reach the highest peaks with positivity, quality and excellence and make a noteworthy contribution in the field of Clinical Research. 

Genelife Chem

Genelife Clinical Research is starting its division Genelife Chem. Genelife Chem will be a collaborative drug discovery partner based out in, Pune, India. Like Genelife Clinical Research the Vision of this Genelife Chem will be “To be the most respected partner". We are setting up this new venture with state of art infrastructure and one of best talent in Asian subcontinent to partner with innovators in their early drug discovery and development programs etc. We have experiences Chemists to devise the synthetic strategy and deliver the desired molecule with excellent purity and structural integrity.  

With this note, we would like to introduce you with the services we are offering in drug discovery & development space under flexible business models. At present our main focus is chemistry that is the backbone of most of the life science programs.

Services: Structure-based design; Fragment optimization; hit to lead; Synthetic organic chemistry; Library design and multiple parallel synthesis; Synthesis of reference compounds; Non-GMP and GMP scale-up synthesis; Route scouting; optimization of reaction conditions and critical process parameters.

In 1st week of inception only, Genelife Chem has entered into a joint drug discovery collaboration with one of the biotechnolgy company based in USA to develop kinase inhibitors. Genelife chem will be responsible to provide synthetic and medicinal chemistry expertise while the collaborator holds the responsibility of biological screening of new chemical entities against a kinase panel.

Genelife Chem is looking forward to serve the client in best possible way in order to earn same trust, faith and support which its parent company has achieved. 

Kind regards,

Dhirendra V. Singh

Medicinal Plants In Health Management

The struggle of a man against disease and death is as old as the history itself. On the basis of skill, knowledge and practices based on the theories, beliefs & experiences indigenous all civilizations has developed their own treatment system which is now called as traditional treatment system. The base of almost all such treatment system is plants. Various as scholar and medical men, since the vedic period dawn to the present century, have contributed a lot on the use of medicinal plants in health care.

Plants are the most ancient source of drugs and the plant based medicaments, the countrymen’s prime therapeutic weapon, are still is front line today for treating a large number of diseases. According to Professor N.R. Fransworth the plants are “The sleeping giants of drug development today and will represent in future as first class source for new medicaments.

The most established traditional system is Ayurveda. The objectives of Ayurveda are Dhatu Samya, Swastha Vritta and Atura Vritta. Proper cure of a disease entirely depends upon rational interaction of four limbs of therapies or chikitsa chatushpada and drug is one of the components of therapy. The material Media of Ayurveda is very vast. It comprises of Plants, animals and metals and aquatic products but plant drugs occupy a large area for the prevention and promotion of health and treatment of Disease.

It may be noted that Ayurveda (sanskrit Ayur : life, Veda : science, Knowledge) is the ancient Indian system of health management which is still widely practiced in the sense of “holistic’ approach, especially for metabolic disorders. Ayurvedic medicines are mostly based on plant materials. The entire mountainous region of the country is considered a vast repository of medicinal herbs. It has been estimated that the sources of 80% Ayurvedic medicines are found in the western Himalayas.

A medicinal plant is any plant which is one or more of its organs substances that can be used for therapeutic purposes or which are precursors for chemo pharmaceutical semi-synthesis. The definition makes it possible to distinguish between the medicinal plants that are already known whose therapeutic character or a precursor of certain molecular have been established scientifically and the other plants which are regarded as medicinal but have not yet been subjected to thorough scientific study. Researches for the identification, development and utilization of plants should be given high priority for the development of Indigenous system of health care in order to reduce drug bills and develop more acceptable and more readily acceptable to the people and with better coverage.

The following are the some of the examples of plants which are used in primary health care extensively specially in the Rural Area:

1	Tulsi	Ocimum sanctum	Promotes immunity
2	Bhallatak	Semicarpus anacardium	Anti-cancer agent
3	Ashwagandha	Wiothania somnifera	General nervine tonic
4	Amalaki	Emblica officinals	Rejuvenate (resayana)
5	Manookharni (Brahmi)	Hydsrocotyl ariatica	Improves memory and intelligence
6	Shankhapushpi	Convulvulus pluricalis	Improves memory and intelligence
7	Vacha	Acorus colamus	Improves speech in children
8	Jyolishmati	Collesterus pariniculala	Improves mental health
9	Arguna	Terminalia Arjuna	Most effective cardio tonic
10	Shirish	Albebia lebeck	Anti-asthma
11	Haridra	Curcuma longum	Anti-Allergic
12	Katuki	Picrorrhiza Kurroa	Jaundiced Hepatitis
13	Punarnawa	Boerhavia diffusa	Kidney disorders
14	Varuna	Gitavia deligiosa	Bladder disorders
15	Kapikachu	Mucona Pruriens	Impotency
16	Shatavari	Asparagus racimosus	Galactogogue
17	Bala	Sida cardifolia	Baby tonic
18	Japakusum	Haviscus Rosa cyanosus	Antifertility agent
19	Vijaysar	Ptericorpus Marsupium	Ant diabetic
20	Kutaj	Holerene Antidysenterica	Colitis

Some of the drugs which have come to light in our experience to have significant action and the observation have been also supported. Scientific observations are as follows

Psychotropic drugs : A group of drugs which have been observed as medhya drugs and few others have shown to have definite action on brain called as psychotropic drugs e.g.

• Shankhapushupi      -           Convolvulus Pluricaulis choisy
• Mandukharmi           -           Centella Asiatica
• Brahmi                      -           Bacopa – monnieri
• Ashwagandha          -           Withania somnifera Dunal
• Vacha                        -           Acorus calamus
• Jyotismati                  -           Calastrus paniculatus
• Jatamansi                  -           Nordostachys Jatamansi

The drugs have a true tranquilizing effect on brain without inducing any hangover or dullness of brain. These are helpful in inducing sleep and freshness of brain for better performance, thus improving the intellectual activity and memory also. These plants also help as to come out of severe complexes, depression and antisocial trends e.g. suicide, hemisuidal, homicidal etc.

By their virtue of having effect on psychic they are also effective for the management several psychosomatic disorders. Heart disease, hypertensions peptic ulcer, ulcerative colitis are some of the notable disease of this group. These drugs have also anabolic effect on general metabolism. Cardio vascular drugs: cardio vascular disease is a great cause of mortality like cancer in the western countries. But the developing countries are no more exception. The incidence of high B.P., heart disease, and obesity is in increasing in China and India. Usually the people have a feeling that it is disease of affluent society and the treatment as only possible by the modern drugs. But none of them is true; there is description of this disease in Ayurvedic literature which is referred to be a contribution of 500 B.C. The treatment of heart disease is still in practice in Indian system of medicine. The effective drugs of cardiovascular system are as follows:

Arjun                          :Teminalia Arjuna

Gugulu                       : Balsamodendron mukul

Pushkarmula             : Inulr Recemosus

Shalpharmi                : Desmodium gangetiun

Karbir                         : Theretia Nereifolia

Kutha                          : Holerrbena – Antidysenterica

Rasona                       : Alliun – Sativum 

Thus a good number of cardio vascular drugs are in our urmamentorium of medicinal plants which can be developed as potent drugs in future.

Respiratory System:

According to Ayurveda respiratory system is the chief site of Kapha hence the disease also produce the symptoms of Kakha. Vata is also involved simultaneously in some disease as Bonchial Asthma. It is a well-known fact that if is a disease having ofstruction branch opathy. Obstruction may be because of the Oedoma/ inflammation of the mucosa or due to bronco – construction, forma is allergic inflammation due to excess of histamine like substances and the latter is because of the predominance of anticholenergic substance. Allergic manifestatias may produce several symptoms of respiratory tract disorder e.g. Allergic Rhinitis, Nasopharongitis Brynchitis etc. The following drugs have been found to be useful for amelioration of the above pathology.

Tulsi                   :Olimum sanctum

Sirisha               :Albizzia Leffeck benth

Kantkari             :Solan um xanthocarpum

Vasa                   :Adhatoda Vasca

Madhuyasti        :Curucuma Longa

Sunthi                 :Zingiber Feivale

Bibhitaka           :Terminalia Belerica

Tulsi is supposed to be most pious plant in Indian culture. No worship is complete without offering the tender leaves to God and then same is distributed among the masses for beneficial effect on health. The evidences are in favour that it is an immunostimulant thus providing increased general resistance for the prevention of disease. It is antipyretic, antinflamatery, expectorant and milid bronchodiloty thus of great help to the patient of upper respiratory and bronchial disease. Sirisha is known as an established drug for allergic disorders and branchal asthma. Charak has described it to be most effective vishghna (antitoxic drug). On Pharmacological study it is found to be antihistaminic and steroidogenc, plasma cortisol is increased within a week after the administration of the drug Active Principle is known to be a Saponin.

All above drugs may be used alone or in combination for the treatment of several types of respiratory system disease. Shirisadi compounds containing Shirisha, Kanthari, vasa and Madhyuasthi is popularly used as shiristi chey (tea). Sunthi.

Gastro – Intestinal: Statistics is evident that the incidence of gastro intestinal diseases in India is maximum. Broadly these can be classified in two groups (i) psychosomatic disease (ii) parasitic infection and a third group can be idiopathic. Among the first group peptic ulcer (parionon shula) irritable bowel syndrome and colitis are the common clinical entities available in our country. Ion the second group amoebiasis, giardiass and other worm infections are common e.g. round work, Hook worm, thread worm. There is a concept of Jatharagni in Ayurveda. Apart from that it also seems to help the absorption and metabolism. In case of hyperseoretion/Hyposecreation absorption becomes poor and the metabolism registers at a lowereble. So the malsecretion and malaobsoption syndrome are related to each other and produce several disease of G.I. tract which are often known as adiopathic e.g. Amlaphita, graham etc.

A good number of drugs have been worked out and found to be useful for the treatment of these disorders or follows :

Patola –    Gastritis

Nurikela – Pepticulcer

KLutaja –  Colis

Karanj –    Amoebiasis

Bilwa –      Amoebiasis

Palas –      Beeja – worm infections

Most of these drugs stimulate and digestive and help in regeneration of villi for a better absorption which leads to acceleration of metabolism. Some of the drugs are proved to be antihelimenthic and antiparasitic others offer symptomatic relief to the gastro intestinal symptoms.

Liver Dis-function:

The most common disease of liver is infective hepatitis (kamala) Though it is a fact that it is a self limiting disease and takes about 4 weeks to become alright but it has got a very deterimented effect on health, if the pathology continues come residual symptoms perrists it may turn into cirrhosis of liver which is fatel in due course of time.

Otherwise of the infection is fulminating it may take acute turn and patient may pass towards acute hepatic failure characterized by anasarca, hemorrhage, renal and curdic failure and the patient may succumb in no time.

Even in the normal course of the disease there can be four stages on the first week there is no jaundice, there is fever and loss of appetite and general weakness usually the cough and cold may be present with the beginning of the process. In the second week Jaundice is marked urine, stool, skin, nails, eyes everything becomes yellow, in the third week there may be inflammation of file canaliculi colangitis leading to intrapepaic obstruction and regurgitation of file in the blood producing a more deep Joundice and whiteclay colourd stool, in the fourth week the pathology may resolve  or pass to the stage of complication. Otherwise also, it the resolution is not complete the lesion may perrist as residual pepatitis. The following drugs hae been found to have a cholaratic effect and helping in the complete resolution of hepatitis, so these drugs have preventive as well as curative effect in patients of hepatitis.                                                                 
Kalmegh – Androgaphis panculata 
 Bhringraj – Eclipta alba
Amalaki – Emblica officinalis
Sarpankha – Tephrosia purpurea.

In clinical trial all these drugs in combination or as single drug can be used kalmegha and Amalaki combination are under clinical trial in our medicinal plants unit serum bilirubin comes down to normal range within to 2-3 weeks hepatitis is improved and there is no chance of having residual hepatitis in the end.

The discussion could be extended to any length but it is concluded with an optimistic note that India with its rich heritage of herbal medicine, its wealth of medicinal flora and necessary expertise in all relevant area would be able to offer leadership in the development of herbal medicine. It should, however be kept in mind that tomorrows citizens of India will have a better scientific temper and attitude and will not be satisfied to know merely that it works they will question how it works? Our development should be equipped to answer this questions.

Dhirendra V. Singh

4th Anniversary of Genelife Clinical Research

Not so long ago, on 26 Feb 2010 we started Genelife Clinical Research, after years of planning and analyzing the cost & expenses. On this day our dreams took-off with a lot of enthusiasm, promise and hope in the back drop of recession and limited resources. We knew that if we will survive that period we would have no limits. During those days we had to survive not only the recession but also against mighty established players. We survived that period and emerged as a winner in our own way. The first year was a very emotional year. We had gone through lots of pain and turbulence before we reached our 1st anniversary. But why I am talking about that now.. because this was an equally challenging year.

This year we will be remembering as the year of “reform and regret”. Across the country the quality of care of patients and clinical research was decreasing considerably. The necessary quality standards were available as standard in some places and were unavailable in others. Our regulation which was developed in a piecemeal fashion over a period of time was not able to manage the things properly and industry was in desperate need for reform- which finally happened this year. However, the planning, developing and implementation of this reform took almost a year, which almost killed the Clinical Research industry of India. Many competitor companies including some giants pull their curtains down; some changed their mode of operations. This changed the entire complexion of Clinical Research market, which to some extent is positive because now only those seriously involved companies are left in this serious business.

Everybody in healthcare industry was affected by this “silent” phase and we were no exception. However, with the confidence in our system and support of clients, friends and well-wishers we came out of this period. This could have been even better if we would have not lost some US FDA projects due to this regulatory complication. I still regret that decision of taking those projects in such an unstable regulatory environment. It was hard for us, but even larger concern and my deep apology to those sponsors whose time, energy and money wasted during this tenure.

Since inception, Genelife Clinical Research has focused on strong customer relationship with a vision "To be the most respected partner in providing product development and clinical research needs." The effort of giving the best is a kind of self-motivating mantra which probably separates us from the rest. And probably this is the only thing which helps us to emerge excellent from any given situation.

Looking back at the development of the entire year; it gives me a sense of achievement. We started the year on high note and anticipated a greater growth; however, with all the hiccups, what we achieved is remarkable growth not only in terms of project but also in terms of reach. We now have a global presence and soon we will be operating globally. We have implemented electronic CRF and looking forward to implement CTMS.

I would like to to attribute this year’s success to my team, which stuck to the basics & kept me away from taking any imprudent decisions. The secret of our success this year is not just doing the right thing but doing the right thing in customer centric way cost effectively. Very basic principle we understood our sponsor’s requirement and planned according to their requirement.

On this auspicious occasion, I sincerely appreciate the faith of clients on our ability. We are looking forward to deliver that trust in best possible way. I am greatful to all those who have directly or indirectly helped us to shape our dream and vision. But my greatest thanks to my colleagues and consultants for their commendable effort and believing the ideology of Genelife Clinical Research. This year belong to them and I feel proud to be a part of this excellent team.

I am looking forward for the same kind of trust, faith and support from everyone in future. I know if we perform this good, we will evolve even better in the coming year.

Thank You.

Kind Regards,

Dhirendra V. Singh