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Navigating Oncology Trials in Asia:
How a Regional CRO can Deliver on a Global Project

WEBINAR DETAILS

Date: May 19, 2016 (60 minutes)

Featured Speakers:

Worldwide, there were an estimated 14.1 million new cancer cases in 2012 (American Cancer Society). Almost half of these occur in Asia with almost one quarter of the global burden in China. The top three cancers in women are breast, lung, and cervical cancers. In men the top three cancers are lung, stomach, and liver cancers.

Availability of large patient population, high quality medical facilities and the relatively low cost of running clinical trials have helped Asia emerge as a prime location for conducting Oncology trials.

However, for most sponsors conducting oncology trials in Asia, navigating the maze of trial logistics, local regulatory requirements and cultural differences can present major challenges without the expertise of a regional CRO.

Cultural Requirements

Asian countries are a melting pot of different ethnic groups and cultures. The variety in ethnic groups may be beneficial from a data perspective, but it is imperative that cultural differences across countries are respected and followed. The key to the success of a trial is to utilise the knowledge of local clinical trial personnel in each country. For example, whilst conducting in-depth feasibility by phone or email is common practice in Western countries, in many Asian countries this can only be accomplished if conducted in person.

Effective communication is vital to the success of any trial. Special emphasis on effective site management is a vital ingredient in promoting patient enrolment and ensuring high quality data.

Patient Demographics

Prevalence of various oncology indications can vary widely both between Asia and western countries, as well as between different Asian countries. Together with possible differences between standards of care in different countries, as well as availability of comparators, the value of local knowledge expertise when considering Asia for inclusion in global oncology trials cannot be overstated.

Regulatory Requirements

Regulatory requirements can differ widely across countries in Asia, and this can have a major impact on study start-up. Before initiating a trial, it is essential to have a thorough understanding of regional requirements, as well as specifics of each country’s local regulations. Familiarity with documents and processes ensures timelines can be shortened and sites can be activated quickly.

Site Selection

Selecting the right sites is fundamental to the success of any clinical trial. Asia boasts a number of first class oncology centres staffed by world renowned investigators, whose inclusion in a study can have a major influence on regional enrolment. When evaluating sites it is important to consider the ability of the site to recruit patients, staff availability and the competitive clinical trials environment.

Keywords: Clinical Trials in Asia, Biotech Sponsors

      ABOUT OUR SPEAKERS

      Dr. John Moller

      Dr. John Moller, Chief Operating Officer - Asia, Novotech


      A qualified physician, John has in-depth knowledge of the health services sector and is adept at developing innovative strategies, and achieving complex business outcomes quickly. Prior to joining Novotech, John was Managing Director of IVF Australia and a Director of the parent company Virtus Health. The business employed over 400 staff and included a number of day hospitals and advanced diagnostics laboratories.

      John was previously a management consultant with the Boston Consulting Group and Partners in Performance specialising in supporting private equity transactions and implementing growth and operational improvement initiatives.

      In addition to his medical qualifications, John also holds a Masters of Business Administration degree from University of Oxford (UK) and a Bachelor of Arts (Advanced Logic) from University of Canterbury (New Zealand).

      Andrea Jeffrey

      Andrea Jeffrey, Senior Project Manager, Novotech


      Andrea Jeffrey is a Senior Project Manager at Novotech, where she is responsible for the planning and management of all contracted responsibilities for assigned clinical projects.

      With more than 24 years of experience, Andrea has extensive clinical research knowledge having managed a vast range of highly complex studies across varied therapeutic areas and multiple Asia Pac regions.

      Andrea holds a degree in Pharmacy from the Victorian College of Pharmacy (Australia).

      Chin Wee Tan

      Chin Wee Tan, Clinical Operations Manager - Singapore, Novotech


      Chin Wee provides management oversight and leadership to a team of experienced SCRAs, CRA and other support staff. He works closely with the feasibility team and ensures that clinical trials are conducted according to all applicable Good Clinical Practice (GCP) guidelines, regulatory requirements, Standard Operating Procedures (SOPs) and the project agreement.

      Chin Wee brings more than 10 years of clinical experience to the role, joining Novotech in 2014. He has previously held senior positions at regional and global CROs.

      Chin Wee graduated from National University of Singapore with a Bachelor of Pharmacy degree.

      THIS PROGRAM IS INTENDED FOR

      • Senior Clinical Development/Clinical Operations Personnel
      • Heads of R&D
      • Outsourcing Executives

      From biotechnology and pharmaceutical companies

      OUR XTALKS PARTNER FOR THIS EVENT

      Novotech
       

      Established in 1996, Novotech is the largest independent CRO in Australia. With operations in Australia & New Zealand, China, Hong Kong, India, Malaysia, the Philippines, Singapore, South Africa, South Korea, Taiwan and Thailand, Novotech’s service offering has come to be recognized for its quality both by our clients, as well as industry analyst groups evident from being awarded the “CRO Best Practice Award” for the third time in recent years by Frost and Sullivan. The demand for global clinical outsourcing services continues to grow at a rapid pace, with Asia providing the new frontier. Headquartered in Australia, Novotech is the ideal gateway for expansion of clinical programs into the region.

      Our comprehensive range of services extends the full spectrum of clinical drug development needs. Our Australian Head Office is situated in Sydney, with regional offices in Melbourne and Brisbane providing easy access to the most important population centres in Australia. Supported by regional staff across the country and in New Zealand, our coverage of the Australia/New Zealand region is second to none.

      With Asian services launched in 2007, Novotech’s operations provide access to the most dynamic and fast growing clinical research hubs in the region.

      Our company philosophy is focussed on hiring experienced professionals with local environment expertise. Both in Australia and internationally, the company boasts some of the most experienced full time Project Managers and CRAs in the markets it operates. Our vision is to be recognised as the CRO of choice by all our clients in the Asia Pacific, something that we are well on the way to achieving.

      In addition, through key external partnerships and strategic alliances we offer worldwide reach to our clients, including the USA, Canada and Europe. This combination of a relatively small, flexible CRO, coupled with the ability to confidently manage very large projects allows us to move a project from initial planning stage to recruitment with dramatic speed.

      We have developed excellent relationship with key opinion leaders (KOLs) having been managing clinical trials for over 20 years. On average, Novotech staff have relationships with 85% of the top 50 investigators and 90% of the top 20 sites in each of its countries. Novotech Sydney is ISO 9001 certified and is regularly audited not only by clients, but external quality endorsement organisations as part of maintaining ISO credentials.

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