basic research as well as drug discovery & devel- opment, information
management systems and clinical data processing. He has been integrally
involved in the ...
REVIEW
An ICON in Clinical Research Dr Malcolm Burgess took up the role of Executive Vice President with ICON Clinical Research in 2011 with special responsibility for Asia Pacific. Previously, he was responsible for the global Clinical Research strategy. He has over 30 years experience within the Pharmaceutical sector having held various Research and Development positions within Novartis, Hoechst Marion Roussel and SmithKline Beecham. Dr Burgess has a wealth of global experience in basic research as well as drug discovery & development, information management systems and clinical data processing. He has been integrally involved in the discovery and development of several high impact pharmaceuticals during his years in the industry, in addition, he has also played a key role in numerous significant regulatory submissions. Having played an active role in establishing offshore support organizations for both pharmaceutical companies and CROs, he was instrumental in the establishment of a Statistics and Programming unit in Mumbai in 2000, and more recently he established two multi-discipline offices in Chennai and Trivandrum. Currently, ICON has over 500 staff deployed across these two offices.
33
REVIEW APBN interviewed Dr Malcolm Burgess, Executive Vice President of ICON Clinical Research amidst his very busy schedule. APBN: What unique development services does ICON provide to pharma and biotech industries? MB: ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. We have the operational flexibility to provide development services on a standalone basis, functional service provision or as part of an integrated “full service” solution. We work in close collaboration with our clients to fully understand the unique requirements of each study and match these requirements with tailored resourcing models and we have the experience and knowledge (scientific, therapeutic and regulatory) to solve the challenges that arise during any development project. We believe our project management governance structure with strong oversight from ICON senior management sets us apart from other service providers. Our use of strong collaborative tools, processes and systems is also a critical component in providing a quality service to our pharma and biotech clients. APBN: What are the milestones of the company since it started its operations in 1990? MB: From it’s inception in Ireland in 1990 by Drs Ronan Lambe and John Climax, ICON’s story has been one of almost unbridled growth. The very location chosen immediately gave ICON a challenge – after all not many clinical studies are run purely in Ireland, even back in the 1990’s. So ICON’s history is full of many landmarks – within the first 7 years we had expanded our service provision and become global, opening offices in mainland Europe, USA and Japan. In the next 7 years, we further expanded our service provision to become a full service CRO (including Medical Imaging) as well as expanding our geographic coverage across all 6 inhabited continents. Over the last 7 years, we have expanded our service provision to include Bioanalytical and Biomarker services. In recent times, we have seen Japanese pharmaceutical companies expanding their activities into the U.S., Europe and other markets and at the same time, more and more multinationals are discovering the potential of the Japanese market. We have recently announced an alliance between ICON and ACRONET and this has strengthened our presence across the globe. ICON now has almost 8,000 employees in 77 offices spanning across 39 countries – it takes many significant milestones to achieve that. APBN: What are its plans for Asia Pacific expansion? Any new areas it is targeting. MB: At ICON, we are constantly evaluating our footprint in different parts of Asia Pacific, we currently have over 1,000 staff based in 14 countries across the region. Our geographic coverage of AsiaPac is matched by only one other global CRO. We have a broad strategy to grow 34
REVIEW all of our capabilities in Asia Pac and at a country specific level, we are constantly monitoring the success of this strategy and making amendments driven by our client requirements. We continue with ICON’s tried, tested and successful model of organic growth and development from within the organisation. But we have also agreed alliances with key players in the region to ensure we have flexibility in the services we offer. For example, our alliances with Tigermed and ACRONET allows us to tap in to their extensive coverage in, and knowledge of, both China and Japan respectively. These alliances also give access to an additional 700 plus experienced staff in the region. APBN: What do you think sets ICON apart from other CROs in the region? MB: I think the thing that sets ICON apart from other CRO’s is our culture. From the formation of the company we have focused on being the best CRO, not necessarily the biggest one. Our focus on People, Performance and Clients has enabled us to grown from 5 people back in 1990 to almost 8,000 staff (with over 1,000 of those based in AsiaPac). For many years, ICON spent very little on advertising and simply relied on our reputation to sell for us, and that approach has engendered a high degree of trust within our client base. Developing a drug is not a ‘quick hit’, it requires a partner who can be relied upon for the duration, regardless of any obstacles or bumps that are encountered. While these may seem to be ‘soft’ attributes our desire to provide service of the highest standard to our clients permeates everything that we do and our clients know that their projects are in safe hands with ICON. I think these attributes are critical for all of our clients, but even more so for emerging biotech companies. APBN: How has data processing technology changed over the last five years. What technologies are you very excited about? MB: The landscape has changed radically in the last 5 years – and will probably do so again in the next 5 years. The use of Electronic Data Capture (EDC) opened the door to real time data processing but it has only been in the last 5 years or so that it had gained almost universal acceptance as the optimal way to collect and process data. Part of the reason for the delayed acceptance was that other data processing tools were also needed to bring the full value to EDC to the fore. Collecting the data more efficiently only led to problems further downstream in terms of processing and understanding of the huge amounts of data in a timely fashion. The recent technology developments that enable rapid pooling of data across different data repositories coupled with the advances in portal technology have really revolutionised clinical drug development by making that same data available in an easy to understand manner so that decisions can be taken almost in real-time. This is now the ultimate goal of our clients – rapid access to data to enable real time decision making in order to shorten drug development timelines. At ICON, we have completed over 500 EDC implementations and we have an integrated data repository that enables our clients to access their data using state of the art portal technology regardless of the EDC system used to capture the data. This enables more informed decisions to be made throughout the cycle which leads to increased efficiency in development programs. APBN: What multi-language challenges are faced by CROs in the Asia-Pacific region and how are they overcome? MB: As with many regions of the world the diversity of languages and cultures in AsiaPac can pose challenges when a business operates on a global level. ICON overcomes this by focusing on the very skills needed to overcome these barriers to smooth and efficient global communication. Our staff that are involved in global project teams have strong English language skills. The larger challenge I think is that posed by the many different cultures across 35
REVIEW AsiaPac. A successful global company like ICON learns to understand and appreciate these cultural differences so that they can harness the cultural diversity and in so doing design optimal global project plans. Understanding and appreciating different cultures also has a huge impact on staff motivation and retention. ICON’s attrition rate globally is well below the average for the CRO industry, and this remains true in AsiaPac. APBN: Any local regulatory challenges faced by the company in Singapore. Are they any different from UK or other parts of the world? MB: The Singapore regulatory process is very straight forward in terms of review cycle time and document requirement. They accept a standard CTD format for IND packages and their study document requirements are quite simplified (protocol, ICF, IB and other study related documents). HSA review and approval takes about 4-5 weeks and the import license will take a further 1-2 weeks. Import license application forms needs to be completed with the clinical trial certificate (HSA approval). The more challenging part to manage clinical studies in Singapore is the EC approval and contract negotiation process which can be a challenge. APBN: What are the opportunities for the clinical trials industry in Asia Pacific? MB: The industry increasingly recognizes the contribution that AsiaPac can make to global and regional trials across all clinical trial phases. Western companies acknowledge the significant populations of relatively treatment naïve patients that are keen to avail themselves of new medicines. Additionally, the cost of doing business tends to be lower than in Western countries but I think that this is now becoming very much a secondary factor compared to patient availability (mentioned earlier). As a result, these companies are developing strategies for AsiaPac and looking to CRO’s to help them access the patients across the region, particularly those companies that have a relatively small presence and infrastructure across the region. In addition to this, indigenous pharma companies in Japan, Korea and Taiwan are looking to expand their activities beyond their local markets. The Japanese Regulatory Authority is now accepting data from other ethnically similar countries while Korean and Taiwanese companies are looking to the European and US markets. These factors combine to create a new surge of activity in AsiaPac driven from multiple directions. ICON recognises the importance of offering our clients’ services where they need them, and has therefore, devised a specific strategy to grow our regional presence in AsiaPac significantly over the next few years. APBN: Is Asia Pacific considered an attractive region/location for clinical trials? MB: Yes, for many of the reasons already given above. While regulatory timelines can be a challenge, with a CRO that knows how to minimize these hurdles, there are still huge benefits to be had in terms of patient availability and recruitment rates. Failure to recruit patients is still the number one cause of clinical development delays, judicious use of AsiaPac investigators can minimise or eliminate these potential delays. APBN: Today, more study sponsors are starting to consider Asian locations for critical early clinical studies. If you were a pharmaceutical client, what kind of clinical trials would you conduct in Asia Pacific and why? MB: The same formula applies for evaluation of Asian countries for inclusion into clinical studies as for any other country being considered. The study duration, disease prevalence, number of available patients that fit the protocol parameters and the ease of access to those patients are the key drivers – these have to be set against the time taken to get investigator sites up and running in order to meet development timelines. While some countries like China do have very long start up times for longer studies this can easily be overcome by the very large number of patients available once the sites come on line, especially if your protocol requires treatment of naïve patients which are becoming harder and harder to find in developed countries. Remember that over 50% of the population of the Earth live in this region, that’s a pretty strong reason for consider AsiaPac! 36
