January 25, 2011
Rajesh Kher discusses the intricacies of the clinical trial outsourcing trend, and what it means for India. Listen in, and understand why India's patient pools and outsourcing talent are top-tier. Examine key success factors to leverage cost-savings and scale.
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See Summary and Notes Below:
Reader-submitted follow-up question:
"Does he [Rajesh] consider increasing regulatory requirements for approval to be speedbreaker in number of NCEs coming up in market, diverse clinical use open plethora of usage avenues eg Aspirin, Thalidomide, Improvisation on current entities with minor issues shd be considered"
Rajesh:India does not have a well defined regulatory framework in conducting clinical trials although great progress has been made of late in addressing this deficiency. Infact the need of the hour is to provide guidances and a stricter regulatory environment to conduct trials. Barring a few most of the Indian Pharma giants have not shown great interest in spending on discovery research involving NCEs as they have been quite successful in generics; Carrying out Phase 1's on NCEsdiscovered out of the country has regulatory restrictions and the regulators, political class and intelligensia must be discussing pros and cons of removing the restrictions.
1. Can you comment on the strength of the current clinical outsourcing trend?
2. Do you believe a strong value proposition exists for outsourcing the pharmaceutical supply chain?
3. Do you personally believe that the increase in clinical trials is a good thing for patients in India?
4. What is the effect of the naivety of the patient pool?
5. What are the implications of India's mixed therapeutic Profile?
6. When outsourcing medical writing, what are you looking for in a potential partner?
7. Can you give us an example of a time when you had to discern a key skill and pass it on to your partners?
8. How is the digital age affecting medical writing? (Submitted by www.pharmaphorum.com)
9. Why are you so excited about what you do?
10. What is the biggest hurdle to improved access to medicine?
Can you comment on the strength of the current clinical outsourcing trend?
Rajesh: 0:00- Clinical trial and data processing outsourcing remain robust, especially for the top tier companies and global CRO market leaders.
2:20 Different CROs have different supply chains and use outsourcing in different ways, but smart pharmaceutical companies are beginning to outsource their supply chains in order to focus on their core competencies.
3:10 Indian CROs are seeing significant business in pre-clinical R&D, bulk manufacturing and API
4:20 Lots of data outsourcing happening by the big players.
5:20 Top global CROs control most clinical trial outsourcing, as big pharmaceutical companies want to avoid risk.
Do you believe a strong value proposition exists for outsourcing the pharmaceutical supply chain?
Rajesh:6:00 – A strong value proposition does exist.
7:20 – India presents a much more attractive patient pool. Patients are naïve and compliant. There is also significant cost-savings.
Do you personally believe that the increase in clinical trials is a good thing for patients in India?
[Editor's Note: Awaiting further updates on this question from Rajesh.]
Rajesh:8:20 – The increase of clinical trials is a good thing and a bad thing. Good for patients who may not have access to best in class drugs. Bad in case there are not proper checks and balances to see that trials are conducted as per global standards. Clinicians and trial personnel must be better trained in conducting clinical trials. They need more experience and regular training, so that patients in India are consistently getting access to good clinical trials.
9:10 – Phase 3 and 4 trials, as well as for patients who are terminally ill, maybe be of benefit for people in India who are poor and otherwise would not receive any access to medicine. There are still other considerations where things must improve.
11:35 – An increase in multi-central trials would also benefit unique patients.
12:05 – Middle-class Indians are well-educated about clinical trials. Patients are also much more compliant than in American and Europe because Indian patients don’t ask as many questions and see the Doctor’s as experts.
What is the effect of the naivety of the patient pool?
Rajesh: 13:00 – This is mostly the poor people who have not been exposed to medication at all. They have typically not even been diagnosed.
13:30 – Naïve patient pool allows you to effectively test new generation drugs.
14:30 – Presumably, naïve patients are more compliant as well because they are receiving medicine for the first time.
What are the implications of India's mixed therapeutic Profile?
Rajesh: 16:40 – Non-Profit organizations will be spending more and more money doing trials in India on TB, cholera, diptheria
17:10 – Oncology and diabetes patients are found in urban areas.
17:40 – Pharmaceutical companies are also investing money in new molecules to fight infectious diseases, it is hard to tell if this is a big business case or a matter of social responsibility.
18:25 – The emerging market strategy is in use by all pharmaceutical companies, it sees them importing previously shelved molecules at low margins to increase market share and brand awareness.
19:30 – To further leverage the emerging market strategy, manufacturing can be outsourced to a local partner to further reduce costs.
When outsourcing medical writing, what are you looking for in a potential partner?
Rajesh: 22:20 – I cannot speak for my company, of course all opinions are only personal, but when it comes to medical writing, good communication practices are critical. The partnership must also be profitable for both parties. It is important to treat vendors as true partners, with equal financial compensation, and not only service providers. This is the only way it can run.
23:20 – I invest a lot of my time in training people that have been hired by partners. I understand the requirements in India and America and am able to bridge the gaps. This is especially important when it comes to regulatory writing, because India does not have strict regulatory authorities. The partners must be trained so well that they are extensions of ourselves. It is important to be transparent.
26:20 – Because I am highly involved across geographies I am able to train people and give them the necessary confidence that they are exactly like us. This is important because of how knowledge-intensive medical writing is, it is also a quickly evolving field in India. I try to bring people and cultures together, the latter being a very important part. I try to talk about American culture with Indian counterparts and vice-versa, I travel between USA and India quite a bit.
28:25 – I also worked with Canadian partners. I try very hard to pass on the skills I have learned to the partners.
Can you give us an example of a time when you had to discern a key skill and pass it on to your partners?
Rajesh: 29:00 – Restroom toilet paper example.
30:00 – A communication failure.
30:15 – Remarkably different outcome with contextual framing.
31:05 – What Indian and global community understand can be different, based on cultural lens. A communication plan that is understood by everyone is crucial. These small things are important when you are managing an alliance so that everyone else understands and there is no failure in communication.
How is the digital age affecting medical writing? (Submitted by www.pharmaphorum.com)
Rajesh: 32:20 – Digital technology cannot replace someone’s mind, but they can help in data collation, collection and processing.
33:00 – Things are much faster and efficient in the digital stage. But analytical skills of people are far too important in medical writing.
35:20 – Regulators only want to see things automated up to a point. Regulators want to see a brief narrative report that cannot be digitized.
Why are you so excited about what you do?
Rajesh:I moved from bench research to clinical research, which was a big challenge, but it was important to me because I wanted to come back to India and make a difference, to see that good quality of medicine and research is coming to Indian patients. And at the same time, see that global patients continue to benefit from trials . There is a global aspect and local aspect. This came from my experience in doing 13 years of research, and not being sure what fruit was born from it, or what good came from it.
I am really excited that there is a hope for new medicines, even against infectious diseases like TB. That helps keep me going. I wanted to see my expertise and experience go to good use in India.
What is the biggest hurdle to improved access to medicine?
Rajesh: 40:30 – Corruption. This is a long topic that we must discuss another day. There is a lot of growth and things are improving. People are indirectly effected by middle-men everywhere.
41:00 – There is corruption everywhere, but it is less obvious and happens in higher levels. In India, you have to grease palms from the bottom up.
42:00 – Corruption is the dark side of the growth.
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