Sample Size Expansion
InClinica finds clinical research opportunities in Malaysia, as well as the region
Drug development is a long and rigorous process that is both time consuming and requires a large investment. It may take up 12 to 14 years to complete research and development (R&D) for one drug. From the time a molecule is covered to the time the drug enters that market, the entire process can cost a company anywhere between US$800 million (mn) to US$1.4 billion (bn).
Therefore, clinical research is a necessary component when developing a new drug; more than just to see if they are effective, it is to ensure that they are safe. These are done in a series of steps or phases as industry players like to call it.
Devoted to clinical development in support of pharmaceutical and biotechnological companies attempting to get new drug approvals in North America, Asia and Europe, InClinica is a global contract research organisation (CRO) that has made headways in the segment.
It provides support services such as laboratory services and analytics, management of clinical trials and relevant components including bio statistical management, data management, medical writing, and clinical operations support.
Business Today speaks to Jeffrey Yablon, Executive Vice President & General Manager of InClinica, about its expansion into Asia Pacific with the opening of its regional office in Kuala Lumpur last year, as well as some of the current clinical research landscape.
A LUCRATIVE SECTOR
The global CRO business is a US$20bn industry and has an annual growth of 7% to 10%. It is interesting to note that most major global CRO players have offices in Malaysia – a location that InClinica seeks to explore as well due to its growth opportunities.
The company provides everything from pre-clinical to post-approval services, and aims to use Malaysia as its operation hub to coordinate its activities, which deals mainly in clinical research in areas of oncology, cardiovascular, metabolic and inflammatory diseases, GI disorders and infectious diseases.
To effectively conduct clinical research programmes, the organisation needs a population and volunteers who would take part in the trials. It has staff scattered throughout Asia that are running clinical trials at the site level.
On this end, it is no wonder InClinica sees the region as a lucrative one.
Before drugs enter into human beings, CROs oftentime have to test them on animals in the laboratory to rule out toxicity issues. Then based on the safety and tolerability, the project enters Phase I or early phase clinical trials on normal healthy volunteers to further monitor its safety and tolerability in humans, the results of which are noted through blood samples and adverse reactions such as cardiac abnormalities and skin rash.
Yablon further explains: “Phase 2 involves testing the drug on patients with particular conditions for efficacy and safety. In Phase 3, we conduct multi-centre clinical trials across multiple nations and continents, the results of which are useful for regulators to gather information on stability, quality, efficacy and safety.”
Such clinical trials may require a sample size of anywhere between 300 to 30,000 people. In the final phase, CROs compare the reactions of various populations to collect data on which patient populations it is more effective and which populations it is less effective.
“Malaysia has 30 million people, but then you start looking further afield at Indonesia, Vietnam and Australia. In ASEAN alone, there is in excess of 600 million people, “adds Yablon.
GENERICS FOR ALL
The diverse opportunities in Malaysia has also piqued the interests of InClinica. The country is trying to promote the use of generic drugs as part of the government’s economic transformation initiative.
“InClinica is a relatively new market entrant and we are seeing the benefit of growth here in Malaysia. We are doing clinical trials at Malaysian and regional sites. PEMANDU has taken us in an Entry Point Project (EPP) 2 to bring 1,000 clinical trials into the country by 2020,” shares Yablon.
“There is the advantage of cost, quality and efficiency that exists here. Malaysia has an abundance of talented, well-qualified human capital who are English speaking.”
There are numerous companies that are looking at bringing in new generic drugs so the opportunity for clinical research is to do bioavailability and bioequivalence (BA/BE) studies. This is to make sure that generic drugs manufactured here are similar as possible in terms of quality, stability and purity to the former innovator drug. The primary concern of the government is to make sure that drugs entering the market are safe and benefit Malaysian patients.
As such, organisations such as Clinical Research Malaysia (CRM) are playing a key role in the development of the ecosystem and the promotion of the country as a key clinical trial site.
He adds: “Moreover, under the leadership of the International Medical University (IMU) president, Tan Sri Dr Abu Bakar Suleiman, they have created a Phase 1 governance committee to advise the government on policies that should be established, so we can do Phase 1 first-in-human trials in Malaysia. For now, Malaysia has only permitted Phase 2 to Phase 4 trials.”
The Malaysian government is currently looking at guidelines and regulations to support Phase 1 clinical trials. Two key institutions that have been identified to do early phase research in Malaysia are Hospital Ampang and Sarawak General Hospital. Aside from that, InClinca is also involved in projects with the Malaysian Investment Development Authority (MIDA) and the Malaysian Biotechnology Corporation.
“There is an opportunity for pharmaceutical players to work more collaboratively with universities to do primary science, which could lead to curing and medicines developed here in Malaysia,” he opines.