FEBRUARY 2015 D. Lee Spurgin, Jr., PhD

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1 FEBRUARY 2015 D. Lee Spurgin, Jr., PhD

2 Resources - Publications Little Advisor ICH-GCP, Investigational Site - English Little Advisor ISO 14155:2011, Sponsor Responsibilities - English Little Advisor ISO 14155:2011, Investigator Responsibilities - English Little Advisor ICH-GCP Guidance for In-Vitro & Investigational Product Trials - English Little Advisor ICH-GCP Investigational Site - Mandarin ISO 14155:2011, ICH-GCP, and Diagnostics site reference booklets Little Advisor ISO 14155:2011, Investigational Site French Little Advisor ISO 14155:2011, Investigational Site - German A Guide to Country Selection in Asia- Pacific for Medical Device Trials 2

3 Medical Device in Asia Pacific Paper CRF s are the standard of practice in Asia - FALSE Device is not reimbursed in China - TRUE With Asia countries developing their economies, so is their expertise in research and development improving. Estimates show that by 2015, over 50% of growth in global clinical trials will be directly attributed to the offshoring of clinical trials to emerging markets. The challenge is to understand why to go to Asia and What to watch out for. Patient retention is a concern in Asia - FALSE Intellectual property laws are a concern - - TRUE Use of traditional medicines are common - TRUE There is a lack of awareness of the availability of clinical trials - TRUE

4 Introduction To The Region Facts about the region - 48% of the world s population lives in the AP region and growing Fastest growing region in the world for clinical trials - i.e., China, Korea, Taiwan, Japan English is a common second language in the larger cities Leading physicians often receive their medical training in Australia, Europe or North America Industry facts - Every major global pharmaceutical & medical device company is investing in regional R & D centers, and looking to sell more of their branded products in the region (i.e., mega centers in Shanghai Boston Scientific, GSK, Bayer, Sanofi, Roche, etc.)

5 Why Go to Asia Outsourcing in Asia can reduce the trial cost by 50% or more

6 Attributable Facts Aging Population Increasing Life Expectancy Increasing Incidence of Major Disease Increasing Health Consciousness Higher Disposable Income Over 30% of new expenditures on healthcare worldwide are attributable to Asia. Page 6

7 Incentives to Asia Lower cost due to looser regulations in some countries Less conservative stance by some governments Less complicated regulatory regimes = faster approval timelines Genetically diverse population Many have never received medications Allows companies to assess success more accurately Less access to medical care Willingness to participate in trials to receive access to care that otherwise could not be afforded

8 Cost Summary Some AP countries are expensive Japan, Australia (as expensive as US) Singapore, Hong Kong, Taiwan, Korea (50-70% of US) Lower cost countries Malaysia, Philippines, Thailand (40-60% of US) China, India (30-50% of US)

9 SELECT COUNTRY BY COUNTRY REVIEW

10 Pros & Cons Of China China Positives: Significant savings - ~1/3 less cost than the US Trials are compliant with ICH GCP and draft regulatory guidelines exist for medical device trials Less trials, less competition for patients Chinese investigators are well educated and motivated to run trials Investigator sites are certified by SFDA Leading research is CV, oncology, HEOR trials Tax exemption on qualified new technologies Downsides: Up to twelve months to obtain CTA approvals Device import and testing can take 8-12 weeks prior to CTA and EC approvals Devices are not currently standard of practice nor currently reimbursed Transparency of government Con-meds often include local Chinese medicines and complicate coding 10

11 Pros & Cons Of Japan Japan Positives: High quality data and technology meets or exceeds Western standards Leading academic and clinical trial professionals are abundant Large patient pool and market potential Leading research oncology, cardiovascular, environmental research, economic outcomes Downsides: High cost of conducting clinical trials Complex regulatory requirements Limited English proficiency Culture/local behavior 11

12 Pros & Cons Of South Korea South Korea Positives: Large patient population Abundant of qualified medical facilities Less regulatory start-up requirements/ongoing efforts are being made to improve and align requirements with FDA and other Asia regulations Less expensive than other Asia countries Downsides: Complex import requirements Limited ICH GCP understanding Limited English proficiency Inconsistency of requirements between KFDA and local government authorities 12

13 Pros & Cons Of the Philippines Philippines Positives: Shorter timeless for regulatory reviews and approval, regulatory and EC done in parallel Qualified site review and registration requirements Less expensive than other Asia countries Immunology and infectious disease are leading in research English proficiency in larger cities and medical facilities due to long presence of US military installations in the Philippines Downsides: Lack of government transparency Liability insurance Regional difference between islands Inconsistency of requirements in regulatory and import process 13

14 Pros & Cons Of Taiwan Taiwan Positives: Shorter timeless for regulatory reviews and approval, regulatory and EC done in parallel State of the art medical facilities Abundance of trained investigators; most are Western trained Ongoing regulatory inspections with a high commitment to quality English proficiency Downsides: Liability insurance/trial insurance is required and the cost of conducting a trial is higher than China and South Korea Variance between regulatory and IRB s standards not seen in other Asia countries Smaller patient pool Devices are not standard of care, but they are being used off label 14

15 Pros & Cons Of Singapore Singapore Positives: Well established regulatory environment; leads all other Asia countries in standards development State of the art medical facilities English is the official language Investigators are Western trained Ongoing regulatory inspections with a high commitment to quality Highly values Intellectual Property Rights Key Therapeutic research is oncology, cardiovascular and transplant Government encourages foreign investment Downsides: Limited patient population Expensive to conduct clinical trials, however, there are some tax deduction benefits. But note, it is a rich country and patients are limited. 15

16 Pros & Cons Of Malaysia Malaysia Positives: English is a second language, and commonly used Short regulatory approval process compared to other Asia countries Access to multi-ethnic populations Western trained physicians Downsides: Limited patient population Limited experience of investigators Although regulatory timeline is short, timeline can be uncertain based on limited reviewers 16

17 Pros & Cons Of Thailand Thailand Positives: Ongoing government review to promote local research Less intellectual property law concerns than any other Asia country Infectious disease is the primary focus of research Large patient population Government encourages foreign investment Downsides: Limited experience of investigators Lack of skilled medical facilities Unstable politics 17

18 Pros & Cons Oceania Australia/ New Zealand Positives: One of the most matured healthcare environments in Asia Pac Australian regulatory guidelines align with those of the EMEA; note New Zealand regulatory timeline is shorter than Australia, but less patients available Strong academic and institutional network of sites English speaking, diverse ethnic population Trials are compliant with ICH GCP Seasonal difference allow year around study conduct for seasonal studies i.e., influenza Leading research is immunology, CV, transplant Downsides: EC submission streamlined increases time to EC approval upwards of 9 months Smaller population than other Asia countries (although a large country in size of mass of territory, the population is ~25million) Highest cost of clinical trials vs. other countries Competing trials, reduces the number of patients available Reimbursement is limited 18

19 D. Lee Spurgin, Jr., PhD SVP & General Manager, Medical Device & Diagnostics