Fountain Medical Development: Clinical trials, government involvement and China's future




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Video title: Fountain Medical Development: Clinical trials, government involvement and China's future
Released on: October 29, 2009. © PharmaVentures Ltd
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In this interview, filmed at BioPharm in San Francisco, Dr Fintan Walton speaks with Joanne Jiang, Executive Vice President at Fountain Medical Development, a new contract research organisation in China

They discuss:

• the nature of FMD's work in clinical trials
• assisting clients with drug development
• clinical trials inside and outside China
• how FMD's government grant allows them to use hospital space for research
• China's role in clinical trials over the next 3-5 years, and how business is done differently
• Working with experienced and less experienced partners
• MNAs, CROs and innovation as part of China's future
The nature of FMD's work in clinical trials.
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here in San Francisco at BioPharm America. On this show, I have Joanne Jiang, who is the Vice President at Fountain Medical Development, Welcome.
Joanne Jiang:
Thank you.
Fintan Walton:
Joanne, Fountain Medical Development is a company that is operates within China and around the Asia region including places like Taiwan and Korea. What exactly is Fountain Medical Development?
Joanne Jiang:
Well we are a company that have been founded two-years ago by a group of attorneys from US originally from China, but studied and trained and worked in large CRO's and pharma in US and they returned China, established a contract research organization which is Fountain. And we conduct clinical trials for biotech and pharmaceutical companies. And our main clients come from US, Europe and other regions of the world. And we conduct these trials in hospitals in China, Hong Kong, Korea and Taiwan for these clients.
Assisting clients with drug development.
Fintan Walton:
Very interesting. So clearly then your company is very close to what is happening in the Asia Pacific area but also in particular in China, so as you said you conduct clinical trials primarily through your contract research organization?
Joanne Jiang:
Right.
Fintan Walton:
So from a outsider's [ph] point of view a company that's looking to do clinical trials in China what do they need to consider?
Joanne Jiang:
They need to find a very strong partner to work with. I know different companies take different approaches, most of the multinational and pharmaceutical companies have established local subsidiaries to support their activities in China, in Asia, but most of the clients like medium and small size of you know biotech and pharmaceuticals they do not have the luxury of having their own on ground team in China so they often collaborate with companies such as us through a partnership setup. And we have been able to helping our clients to from the start where they design a protocol we provide a feedback on that and we even go up to the whole development program and give advice on how to best tailor program based on China particular culture. So that has been the very important piece that as co-founders we feel very proud of that we are not only the implementation team for the trial but we call ourselves intelligent CRO's because we are a drug developers originally before we founded a company so we were able to be part of the drug development process for a lot of our clients.
Clinical trials inside and outside China.
Fintan Walton:
So, you assist in clinical trials in human trials?
Joanne Jiang:
Yes.
Fintan Walton:
Effectively. So what are the differences that one can expect between doing clinical trials outside China and within China?
Joanne Jiang:
It's actually quite different, because the variety of geographic areas that exist in China, so your on one hand that's a plus because then give you a wealth of choice of all that different sites and different weather zones, so some of the disease prevalence are very, varies from time from zone to zone so you have a choice of which, where to go to do your study, the flipside of it the drawback would be the regional regulations, provincial regulatory agencies as well as the central SFDA the Chinese regulatory authority�
Fintan Walton:
Sure.
Joanne Jiang:
Have their own way of operation. So having a strong partner that's present in China have a strong team and experience of dealing with various regions area as well as the central agency would give you the leverage of getting the trials implemented smoothly, per time line with high quality, otherwise people find themselves either concentrating on the major cities in China the tier I city we call and then really lose the benefit of using the second tier to third tier city were they also have very well build medical centers and have a greater population patients to choose from.
Fintan Walton:
Right.
Joanne Jiang:
So I think it's the diverse culture and it's the different regulation, it's the people, the characters that vary some much in the country that gives you both advantage but also challenges.
How FMD's government grant allows them to use hospital space for research
Fintan Walton:
Okay. So your organization not just only helps them to perform the clinical trials, plan them and so forth project management, but also help them guide through all the regulatory issues not necessarily at a clinical level but also at a governmental level, regional level where you know you have to have influences on certain hospitals and so forth, is that correct?
Joanne Jiang:
Exactly, because we are very unique, we are the only CRO in China that have our own people operating a Phase I centre and our central laboratory. And some of the global CRO players such as Quintiles, Covance and you know they also have their team in China in different Asian countries however they do not have the access to a direct managing of Phase I centre there in China, so that's because of the administrative regulation in the Country. And we are lucky enough to be chosen by Chinese government as a recipient of a major grant for clinical research platform. So therefore we are allowed to use a local hospital as our collaborator and have that several hundred square meter space 74 bed Phase I facility. So we are very lucky and our companies past performance actually reflects a good integration of our expertise we brought from overseas and our venture capital support from US venture company integrated with local expertise of how to partner with Chinese government and getting the grant support so that we would have this facility and staff ready for companies that are trying to do trials in China.
China's role in clinical trials over the next 3-5 years.
Fintan Walton:
Okay. So you're coming into this some of the strategic issues here, because have you seen a change in which pharmaceutical companies have taken in terms of their planning and their strategic planning in particular about how they do clinical trials worldwide, because in the past probably China was looked at the rest of the world rather than as a real opportunity, so are we seeing major pharmaceutical companies now looking at China as part of their overall integrated clinical development program?
Joanne Jiang:
Yes definitely. I have a large pharma background myself, so thinking back about three, five-years ago China is still not a key player in that global drug development program at all. But right now it's definitely that main piece that's coming arising every program I've heard about major development program from main multinational pharma's have to include China in Phase III program unless the disease is not present in China, but otherwise most of the programs have to include this piece of development piece in there. So that's a major change and that's actually very encouraging because not only China will become one of the key markets that delivers revenue eventually, but having China program moved up into part of the global development early on in Phase I you know Phase II not only Phase III as compared to before makes a difference in that, the China development time line would also benefit from it. So it's not only the global program benefit from China as a piece of contributor, but the time line alone in China being getting on the Chinese market which would be top three in about three, five-years as predicted by the major consulting companies.
Fintan Walton:
Right.
Joanne Jiang:
So the time lines in China would definitely be improved, because the government in China encourages innovation, so if it's a drug in development they would treat it very in a very accelerated fashion as compared to a post marketing drug.
Fintan Walton:
So a drug that is for an example in clinical trials elsewhere in the world
Joanne Jiang:
Yes.
Fintan Walton:
They will be lot more comfortable taking those products through much more quickly, but if it's just a product purely for China it may be a little bit slower?
Joanne Jiang:
Yes if it's already launched in US or Europe against [ph] others regions of the world and then they are coming to add China into that market then they would activate a longer reveal time line, it's a regular reveal time line
Fintan Walton:
Sure.
Joanne Jiang:
But if it's a part of the multi country, multi centre global trial then you have the benefit of possibly accelerating the time line.
Fintan Walton:
Okay.
Joanne Jiang:
Yes.
Cultural differences and how business is done differently in china.
Fintan Walton:
So one of the other things that you've mentioned a couple of times is you know the obviously the differences, but we are also talking about the cultural differences and you've had the experience of working in a major western type pharmaceutical company and so you are very familiar with the way things have done, when people go to China what differences are there or are there any differences in the way business is done in China?
Joanne Jiang:
Yes, it's actually very different, lot of the executives in pharma are very familiar with Japan throughout the past 20, 30-years of exploring that market and become mature. And then when they come to China they often feel that it's very different in some aspects it's easier to deal with Chinese company as compared to Japanese company and culture, because I think Chinese companies initially would be very similar to eastern culture where it would be very polite and calm and no issue, but then as we progress then the issue will start to come up and then they are more vocal in terms of disagreement or argument and that's not a bad thing, so I wanted to really bring that out in the picture and see and let helping our western partners to realize that there is a Chinese power if you don't fight you don't become a family [Foreign language] so it's a very famous proverb and it's actually very truthful in terms of dealing with Chinese companies. So let the issue come out and by all means discuss it and question each other back and forth and that's what part of Fountain's role is to bring that question upfront instead of really leaving it buried in the contract and then later on you go into really the bad the challenges in the mid of implementation you better identify on the table right now. So, and that's especially true when you work with metropolitan cities like especially Shanghai as you know the Southern China culture is more tuned in that kind of practice, but in the Northern China culture more and more is changing, so peaceful people are more business oriented. And then I actually have been working with projects that are implemented in US, Europe compared to China and I feel that in the past Chinese time line was lagging behind, but right now it's catching up in an incredible speed.
Fintan Walton:
Right.
Joanne Jiang:
Actually the lot of projects and sites we can open in China much faster than compared to US and Europe once we identify and do the proper planning in the beginning, so.
Fintan Walton:
Okay. So just going back to the basically the management of the alliance or management with the deal. So once you've entered into a partnership with another company or an organization within China clearly communication is really important and preparedness for open discussion about issues that's a key message that you are putting across�
Joanne Jiang:
Yes, yes.
Fintan Walton:
To our audience?
Joanne Jiang:
Yes.
Fintan Walton:
And so, as you've already mentioned you know China is evolving very, very quickly, things are changing another thing that often comes to people's minds outside China is the quality of the work that's done, the quality of the technology and so forth. And again you know with your experience from the west and going into China how what comment would you make about that, is that a correct view or is it an incorrect view?
Joanne Jiang:
I would say it's a combination, there is a very accurate survey report that I saw coming out of Cambridge House Institute last year and they evaluated vendors for pre clinical they just picked that area because there are the CRO's in pre clinical area in China has the highest numbers compared to the other area. And they found that the distribution curve of quality is very widely distributed so you have a bell shaped curve where on the top there are two, three or five that are really top performers where you've got the best quality, moderate cost but then on towards the you know the other end you have a majority of the vendors are still learning it's not like they don't want to perform they probably just don't know the expectations because of the lack of experience, so they just doing the catching up learning curve if you will.
Fintan Walton:
Sure.
Joanne Jiang:
And I would say that would properly reflects all aspects of partnerships in China that if you choose to feel strong ones one to three in each area you have to find those top-notch companies to work with and that's not to limit your choices, because if you for some reason or a strategic issues and stuff picked a other company that's are less experienced then it just means you have to put more, lot more effort of spelling out your expectation just start from basic level, do not assume they know anything just as long as you're upfront and spell it out people you know definitely would meet it, but if they have a difficulty they will let you know. So I think it's all communication going back to what you've just mentioned.
Fintan Walton:
Sure.
Joanne Jiang:
But I think, yes there is definitely a wide distribution of different level of expertise and experience in China, so people have to be careful who they work with.
Fintan Walton:
Right.
Joanne Jiang:
Yeah.
M&As, CROs and innovation as part of China's future
Fintan Walton:
So that comes back to Fountain Medical Development obviously you're there to facilitate some of that
Joanne Jiang:
Yes.
Fintan Walton:
And to identify the suitable bodies to work with, but then looking at China and how China is going to evolve, we are going into the future and looking at China which is rapidly evolving, what do you see as the key changes that we were gonna see within China over the next five-years?
Joanne Jiang:
I think you would see we would see lot of M&A's definitely in the CROs and in the pharma world in China, because the strong team would continue to perform and really climb to the top very quickly and then they would expand quite fast too, because these top leadership that I could see from these Chinese companies are very, very ambitious which is good. And then they would and they're actually already actively licensing in a lot of compounds from the West and doing very well. And also in the CRO arena you would see a lot of integration as well people you know companies that are good will grow fast and then it makes a lot of sense, because then they kind of take the little ones under their wings and then implement the same kind of (indiscernable) SLPN [ph] processes and then help them you know become part of the main stream which is the continuing improvement. And then also I would like to see I think it would happen also with a very high probability is that innovation coming out of China, because from my fellow attorneys that I talk to I have already been observing that drugs discovery effort which is pretty difficult and could take up to a 10-years to get a good drug out, but it's been six, seven years that these group of chemists and biologist that are trained in the west have returned to the country so I would expect in the next two to three-years we will see compounds start coming into IND enabling stage going into Phase I, which is really we are ready to support you know we really want to in addition to our western client group add on the innovators from China, the Baltics and you know the smaller drug discovery groups. And we are ready to deliver their compound into FDA, into EMEA for filings.
Fintan Walton:
Joanne Jiang, thank you very much indeed for coming on the show.
Joanne Jiang:
Thank you for having me. Thank you.
Joanne Jiang
Executive Vice President
Dr Jiang has been working in the pharmaceutical industry for 14 years. She started her career in preclinical pharmacology area at Bayer pharmaceutical and Eli Lilly, working as research scientist, lab head and project leader. She further developed expertise in drug development and project management through her tenure as global project manager since year 2000. From year 2000 to 2007, at Aventis and then Daiichi Sankyo, she managed drug development and life cycle management projects, encompassing preclinical to phase IV activities. She especially focused on clinical trial planning and management, integrating marketing plans and regulatory strategy that enables optimal trial design. Effective implementation of the clinical studies delivered best data quality and timeline. Dr. Jiang also has working knowledge of building and managing high performing project teams that deliver break-through results. Dr Jiang co-founded Fountain Medical Development, a contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services for multinational clients conducting clinical research in Asia.Dr. Jiang holds a PhD in pharmacology and toxicology from Indiana University and an MBA from University of Michigan, Dearborn.
Fountain Medical Development
Fountain Medical Development Corp. is a contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services for multinational clients conducting clinical research in China. The management team of Fountain has decades of combined experience working with the world's leading CRO's and drug developers. In the Chinese CRO market, they fill the void of a service provider that balances high quality with moderate cost. Fountain's extensive global experience in multiple therapeutic areas is unmatched by other local CRO's, and lower operational costs allow them to pass significant savings on to its clients