2011 marks the 10th anniversary of the company. Over that time you’ve enjoyed notable success including being the first Asian CRO to attain OECD GLP accreditation. Talk us through your proudest achievements?
First of all we want to make clear that Info Kinetics was never a local company. It has been set up and is geared for international business. It takes guts, pragmatic skills and risk acceptance to accomplish this. Our first 10 years represent a phase of growth, and it has not been easy to lay down the processes and gain acceptance within the industry. Today Info Kinetics is seen as benchmark for Malaysia, from a regulatory and governmental perspective. We are proud to have now reached this stage.
Info Kinetics is not the first entity I set up, as I started one in Australia before, as well as the CIC within the University of Malaya, thus I have an understanding of the need in order to be geared for international business, with clear objectives and aiming for international acceptance. We were ahead of time recognising that the Malaysian market was not big enough and that we would need to look beyond its borders to be successful as a company.
Aside from establishing the reputation of Info Kinetics, this year we are celebrating “10 years of clinical research”. Info Kinetics’ tag line is “connecting research with people” which is why every celebration we have is linked with people. For our fifth anniversary, we launched an operation with underprivileged kids in orphanages; this time around we will work with education programs for teenagers in the Penang area.
However it is true that Info Kinetics is Penang’s home grown Clinical Research Organisation (CRO). We had several options to choose from as a base for Info Kinetics’ Head Quarters, namely Malaysia (Kuala Lumpur and Penang); Australia where I had worked for eleven years and had established a strong network; and Singapore where the Economic Development Board (EDB) is very active. We chose Penang which, besides business and life style consideration, was offering great support from the previous Chief Minister.
As you mentioned we have gained the accolade of international accreditation and worldwide data acceptability, but this is no reason to become complacent. What we are proud of is that we pioneered as the nation’s first and only accredited commercial Clinical Research and Drug Analysis facility. As a commercial entity, Info Kinetics is always innovating and leading the way forward.
As Malaysia ventures into International arena, the NPCB (the Malaysian equivalent of FDA) is fast to adapt. We have been adopted as the benchmark and the showcase facility. The most recent event is the inspection of GCP using the recently launch Oct 2010 GCP Inspection Guides, we are proud to be the first in this nation to collaborate with the government and to have been inspected, of course we like to thank Dr Kamaruzaman and Mr Selva for having confidence in us.
What we are now interested in is moving more towards East Asia, and are now creating partnerships with Yongsai, Korea and Kitasato and Mitsui in Japan. This will be graced by our Health Minister as well as respective country regulator. This is in line with Prime Minister’s vision to focus on the East Asian economies. As far as European sites are concerned, they are amazed to find a Malaysian Centre of research that is technically competent and involved in Phase 1.
One of the most interesting things about Info Kinetics is the niche you work in. We interviewed Dr. Goh Pik Pin of CRC and she said that Malaysia’s strength lay in phase 3&4 trials. Yet Info Kinetics is a phase 1 specialist (‘phase 1 Malaysia’). Why have you chosen this niche?
Compared to other countries, Malaysia is not strong in R&D. Very rarely in our country will you see a business entity take the lead and their spending is usually minimal and not consistent. However Info Kinetics consistently ploughs back its earning into R&D. After gaining the international acceptance, we will move to our second objective which is to take the lead and strengthen R&D. Hence, it is not true that Malaysia is neglecting the early phase study although Info Kinetics has been earmarked to take the lead. I was personally involved on behalf of Info Kinetics in discussing early phase research at the NKEA lab conducted by Pemandu. We are now working on our Business-to-Government partnership, particularly with the federal and Sarawak government.
Do you foresee any other company following your route and offering more phase 1 and R&D in Malaysia?
I am confident that Info Kinetics will take the lead, but it is not easy to see whether others will follow or not. I am trained in clinical pharmacology and pharmacokinetic, and feel confident going into this area. You have to understand the distinction between clinical trials, which concerns phase 3 and 4, and clinical research, the early phase studies which require more scientific research. A lot of CROs are unable to carry out such research as they are based on more business orientated models, and of course they are complementary to what we do. Info Kinetics has been re-investing in its platform, resources and we made sacrifices to achieve pre-eminence in this area of research.
Together with the Prime Minister’s vision of One Malaysia, the Health Minister has consented to the concept of “Phase I Malaysia”. This will be launched this year and it is a niche market that we have presented in Japan Phase 1 conference late last year.
Malaysia is well know being multi-ethnic. This covers the ethnic groups like Malay, Indian and Chinese. There is another term we created recently and shared at the Japan Phase I conference in Okinawa: “Human Research Expedition Subjects”, where the particular ethnic group will fly to Penang to do ethnic specific studies. This is a totally new business that we have developed quite well. The subjects can have cultural exchange, relax on the Penang Island resort as well as learn clinical pharmacology knowledge for medical and science students. This is applicable also for Caucasian population who is already undergoing education exchange program in Malaysian Universities. This is in line with our company tag line “Connecting Research & people”.
Partnership is clearly crucial for a company like Info Kinetics and you have been successful in creating strong links with hospitals and clinics including Pantai and Gleneagles and with local industry. How do you persuade these groups to choose Info Kinetics as a partner?
Basically, we are bringing the services closer to the door, with a complete platform and standard operating procedures, and this is our expertise. We are considered as the sub-speciality of the hospital. Our partnership started since we established at the very beginning, and the partnership is still strong. With the new Gleneagles Medical Centre Penang expansion, we are going to acquire more space from them in order to grow together. Over the year we are expending more and more, now we have overseas requests for partnerships as well.
It is an exciting time for biotech in Malaysia. Companies like Inno Biologics are seeing their first contracts whilst companies like CCM are looking into biosimilars. But the industry is very young in Malaysia. Do you feel that this constrains your BABE business growth as a company or can you look to international sponsors?
Bioequivalence or not, I am a firm believer in quality medicine, irrespectively of whether they are branded or generic drugs. A stringent test is definitely needed in all cases. This is further augmented by strong and effective surveillance system. Of course there is a need of balance with business perspective. Only then will the whole spectrum of pharmaceutical services and delivery gain confidence. This is the wish of the current Health Minister too.
I am personally involved in regulatory aspects, as a technical chairman in drafting up the Malaysia BABE Guide with Cik Fudziah and Dato Zain, and we laid down the foundation for Malaysia to lead within ASEAN’s ACCSQ PPWG in BABE. I am still part of this team today. As a committee member to Ministry of Health on BE as well as advisor to the Minister. There are several positive step is in the cooking from the Minister to gain extra confidence of local and export user. Such as BE study site pre-inspection and inspection, internal surveillance i.e. conducting random BE studies on product selling on the market.
In Info Kinetics, one of our products is called “BE, the Same”. We have local and international clients. Data is accepted by EU, Australia, and Asia, and we are proud to be the first and still the only one in ASEAN which has been inspected by respective governments and whose dossier has been accepted. Strategically, we are continuing to create value to be the global vendor for the MNC generic companies. We learnt a lot from international players such as Sandoz who moved around the region (Korea, Taiwan, Singapore and Australia) looking for globally approved vendors and they gave us the highest ranking.
There’s no doubt that big pharma has its sights set on Malaysia and other pharmerging markets in SEA. However, Albert Liou of Parexel said that they had a preference for large CROs because they can quickly conduct trials across the region. How can Info kinetics remain competitive in this landscape?
We need to be modest and cannot say we outdo these international players. Info Kinetics’ philosophy is to work together. In this regard Parexel is one of our very close collaborators, and every CRO operating in Malaysia works with us! We are now working closely to grow together as an industry. Moreover Info Kinetics has its own niche, i.e. early phase trial as well as running a chain of private hospitals or non-governmental sites such as SMO, which is why we are not “threatened by” or “competing with” multinational CROs. This is still the missing link for multinational CRO.
Info Kinetics has a proven research facility and is able to provide services beyond the conventional trials and testing. The system developed by Info Kinetics is something highly sought after, and Info Kinetics has been called upon by governmental agencies from Malaysia to Vietnam, Cambodia, Indonesia and the Philippines to provide technical training. We meet the timelines and have a good quality system, which is why many of them want to work with us. Recently we started working with a English company, which wasn’t considering us at first but then asked Info Kinetics to be its CRO. CRO will not be our core area and we are mostly willing to do what we are good at, together with the rest of the industry, but we are willing to do it for some partners. We have often rejected studies because we prefer putting more energy in what we are much better at in order to develop a reliable reputation.
Our strategy is also in line with that of the Prime Minister’s and the Health Minister’s statement that the time has come for Malaysia to create a bigger cake in line with the economic transformation programme and venture beyond our traditional norms. In fact, several middle-sized Western CROs started to align with us to jointly conduct some trials in the ASEAN region.
The Government aims to expand the number of clinical trials tenfold by 2020. However, with organizations such as the CRC encouraging international CROs and sponsors to Malaysia what needs to happen for local industry to conduct more clinical trials? Is Info Kinetics the ideal partner?
As a participant in the NKEA lab, I personally assume responsibility for the ETP target of 1000 trials per year. I believe this is achievable. Looking at several countries in Asia Pacific, they have been doing this for decades. Looking at our new partner Yongsai, they achieved more than 1000 trial per year at a single site, so we need to move even higher and have bigger targets.
The challenge is who is the champion driving this goal forward? We recently discussed this subject with the Health Minister Liow, and he can see this weak point clearly. I am impressed that he is drafting a proposal and is determined to take the necessary steps to look for an industry leader, with local knowledge, international exposure and who is savvy with government policy to take up this challenge.
Where are we likely to see Info Kinetics at its 20th anniversary and what are your 2020 ambitions?
Info Kinetics has passed through the first decade with a few trials and tribulation, the next decade will be even more challenging and rewarding. We are the solution provider for the West; “To connect your research with people in Asia”. Ten years ago no one cared about us, but today the timing is right. We are definitely looking at expanding, and our representative offices in Singapore and Australia will be soon aligned with our current offices. We need these different offices as we are trying to create a sample of the world’s population and Australia gives us access to the Caucasian population.
We do not see why not Malaysia cannot be the clinical trials hub within APAC region in the future. With the plus point deliberated before by others as well as the government commitment, especially DG of Health. This is an attainable goal. We definitely want to be noticeable and collaborate with the government. Our Info Kinetics solution to the West is connecting research with people in Asia. We can speak Chinese, English, Malay and Tamil, are able to go anywhere in Asia!
Info Kinetics collaborates with BiotechCorp in the framework of their BEST program to develop human resources in Malaysia. What do you see as the role of Info Kinetics in developing the human resources crucial for the CRO industry?
We were not the first company to participate in this program. This program had been going on for one year with partners other than Info Kinetics, before BiotechCorp came to us and gave us one month to deliver a proposal. It is a service for the country, which does not give us business or revenue, but my board finally agreed as we needed stable human resources to grow the company and the country. Today a significant portion of Malaysians migrate to Singapore or Australia, and thanks to my network I even help them find positions abroad if they are determined to move!
It is for this reason that we chose Kuching for further development, as Sarawak as a region is full of human resources that isn’t given enough opportunities locally. As a company, we provide resources for chemists/ scientist and pharmacists to come back to Malaysia, we then oriented them for at least six months. We should think countrywide and many of the collaborations we have are participated in are with a view to helping the country grow.
Like the CEO of InnoBio Ventures, I’ve read that you prefer your lab coat to your business suit. Do you feel that in Asia there is more respect for knowledge over business savvy and consequently more space for a scientist at the head of a company or are you an exception?
I believe it all depends on how long one stays in the business and how successful we are. Today I am happy as a businessman as I can help grow the country more than as a scientist. Although it should be said that the core of our business is built around integrity and knowledge.