Increasing Agility and Innovation in the Clinical Supply Chain for Cost Optimization Connect with us to connect with Asia CTS East Coast Oct 19 th, 2011 Philadelphia
Introduction Zuellig Pharma Asia Pacific Asia Pacific s leading distribution solutions provider for healthcare products Privately Owned (80/20) Established over 90 years Sales 2010: US$ 6.9 billion 14 countries and regions in Asia Pacific 9,000 employees
Introduction ZP Specialty Solutions Group Wholly owned affiliate of Zuellig Pharma Offers logistics & supply chain management solutions HQ in Singapore since 2009 Core businesses: Clinical Reach (IMP services suite) Specialty logistics for IMP and supplies Own depot network across 13 APAC countries Transport solutions (International courier and domestic) Comparator drug sourcing & labeling 1,000 clinical studies over 5 years (40% cold chain) Pharma Bio-Logistics (regional distribution of commercial drugs) Anti-counterfeit Solutions (combining serialization and SMS technology)
Our Network, Your Clinical Reach Features a unique network of storage Depots for IMP covering 14 locations Seoul Beijing Kobe Bangladesh Shanghai Taipei Mumbai Bangkok Hong Kong Manila Sri Lanka Kuala Lumpur Ho Chi Minh Singapore Jakarta Central Depot (2) Sydney New Zealand Local Depots (12) New Local Depots 2012 (2 planned)
Agenda Changing environment The role of Asia Evaluating supply chain models Case study on cost optimization Innovation in the clinical supply chain
The backdrop Cost pressure in R&D and demand for higher ROI greater than ever Trend to greater, more holistic collaboration Pfizer Parexel / ICON GSK Parexel / PPD BMS Parexel / ICON Eli Lilly Parexel (for Asia) Eisai Quintiles Takeda Global strategic partnership with Quintiles / Covance Sanofi A. Covance (10 year strategic deal) Merck PPD Sponsor CRO Reduced number of service partners higher contract value Shift in risk/reward sharing approach (outcome based remuneration)
The emerging challenge Low innovation rate in clinical trial supply chain management Is your service provider a potential liability for you? What are the incentives for logistics service providers to innovate? Is single source and volume leverage the (only) route to greater cost savings in clinical trial logistics? More dominant role of procurement Logistics? Sponsor CRO
What drives clinical research The Threat: Patent cliff (top-line challenge) Between 2010-2015, $142 bln sales of patented products face generic competition (IMS) Speed to market The Opportunity: Increased Revenue Closing gap between research and markets (e.g. Asian specific diseases) Stakeholders: Increasing regulatory requirements Larger trials required (more patients across more countries, genetic diversity) Internal: Rising cost of clinical trials & low R&D productivity High cost of drug development (est. 800M 1B USD per drug) Unsatisfactory return on R&D investment
The role of Asia
The Asian attraction Better access to patients Low clinical trial density (CT per million population) China (0.4), India (0.7), South Korea (9.5), USA(120), Germany (51) Faster recruitment rates 85% of clinical trials in traditional markets experience delays due to patient recruitment Lower costs per patient (40-60% cheaper) Asia (excluding China) is up to 60% of the cost in US/Western Europe Population with genetic, therapeutic and demographic advantage Hospitals increasingly experienced in conducting global multinational trials Talented workforce (qualified investigators and site support) Large number of drug naïve population
Asia's growth 10000 New Clinical Trials (2007 2010) by region 1200 CRO Market Size in USD million (Asia) 8000 6000 4000 2000 0 2007 2008 2009 2010 North America Europe Asia Pacific Source: Clinicaltrials.gov Growth in studies (2008-2010): North America 55% Europe 94% Asia Pacific 95% 1000 800 600 400 200 0 2004 2005 2006 2007 2009 Source: Frost & Sullivan 65% of FDA-regulated clinical trials will be conducted with sites outside of US by 2013 (http://csdd.tufts.edu)
Evaluating Supply chain models for Asia Modifying supply chain tactics according to clinical study dynamics
Approaches to IMP shipment 1/3 Central Depot Model IMP source US, EU Central Depot Thailand Site 1 Site 2 Site n Advantage Relatively low IMP needed Standardized external processing Simplicity for IMP source Efficient shippers to Central Depot Centralized kitting, labeling option Taiwan Site 1 Site 2 Site n Disadvantage Highly dependent on courier service Highly dependent on shipper performance High transit risk, excursion risk High international shipment /packaging cost IMP recall, return & destruction challenging/ impossible and costly
Approaches to IMP shipment 2/3 Local Depot Model IMP source US, EU Advantage Local validated and efficient shippers Shortest lead time to site (same or next day) Most responsive to site orders Lowest cost (local transportation) Same time zone / language as site Recalls, returns, destruction is localized Local comparator drug sourcing option Local expiry date re-labeling saves IMP cost Disadvantage More IMP needed Forecast based supply ( recruitment) Higher depot fix cost, storage & mgmt cost Quality management/ qualification of depots Local Depot Korea Site 1 Site 2 Site n
Approaches to IMP shipment 3/3 Hybrid Depot Model IMP source US, EU Central Depot Thailand Site 1 Site 2 Site n Taiwan Advantage Reasonable complexity for IMP source Most adaptable, supply strategy can change during study Shortest lead time (1-3 days) to Site High responsive to Site orders Optimum cost (Inventory vs. local transport) Same time zone / language as site Suitable for adaptive trial designs and competitive recruitment strategies Disadvantage Local Depot Korea Site 1 Site 2 Site n Site 1 Site 2 Site n Complex project mgmt Forecast based supply to depot Higher depot fix cost, storage & mgmt cost
The ultimate supply chain challenge To do this Have the right kit at the right time at the right site in the right quality for the right patient while minimizing waste of time cost drug/materials Your supply chain needs agility to adapt to changing requirements (known) and circumstances (unknown).
Case study
Case Study Project Challenges & Key Logistics Figures Global Phase III study, 36 months 7,000 subjects (1,755 for Asia) IP (2-8 C) IP Kit valued at 121.00 USD Local sourced comparator drug Return and destruction of IP at project end A surprise element unknown to all parties at time of RFQ. Several states 7 countries Indonesia Malaysia Philippines Singapore Taiwan
Case Study Key Transaction Figures 2 inbound per year 12 outbound per site 1 return per site No. of sites by country: Malaysia 5 Philippines 20 Indonesia 2 Taiwan 15 Singapore 3 Central Depot (benchmark) Taipei Hybrid Model (alternative) 387,000 USD Thailand Manila 240,000 USD Malaysia Singapore Indonesia
Case Study Key Transaction Figures 2 inbound per year 12 outbound per site 1 return per site No. of sites by country: Malaysia 5 Philippines 20 Indonesia 2 Taiwan 15 Singapore 3 Central Depot (benchmark) 387,000 USD Courier -146,000 Additional IP (20%) + 42,000 Packaging Box - 36,000 Project Mgmt + 19,000 Return/destruct. - 12,000 Hybrid Model (alternative) 240,000 USD Other Benefits Local comparators saved additional USD 55,000 (drug, transport & duties) 3 depots managed by single provider for Asia PH, TW: Re-usable shipping containers (no disposal at sites needed) Zero IP loss due to temperature excursion (no hidden cost) No complications with project close-out (returns & destruction)
The Project Manager s Office
May 6 th, 2011 The surprise element arrives 약사법시행규칙 75 조 ( 의약품의표시및기재사항 ) 6 법제 56 조각호외의부분단서에따라임상시험용의약품의용기나포장에는다음각호의사항을기재하여야한다. 다만, 법제 31 조제 2 항및제 3 항또는법제 42 조제 1 항에따른허가를받지아니하거나신고를하지아니한사항은기재하지아니한다. " 임상시험용 " 이라는표시 제품의코드명또는주성분의일반명 제조번호및사용 ( 유효 ) 기한또는재검사일자 저장방법 임상시험계획승인을받은자의상호와주소
Translation Announcement of regulatory change issued on 6. May 2011 According to the revised Pharmaceutical Affair Law 56, IND holder s name and address has to be included on each pack of IMP. (Effective date: 6. May 2011 ) Investigation medicinal products Product code of general name of API Batch no and expiry date or retest date How to store / storage condition IND holder s name and address IND (investigational new drug)
... Effect I don t like to hear about problems, I want solutions!
... The solution 16 customers using that depot representing 35 sponsors affecting 200 studies requiring 85,000 kits at the depot to be re-labeled How we solved the problem: we printed label locally we provided a local GMP compliant labeling service we ensured there were no disruptions to IP supplies to sites all for a bargain of just USD 0.65/IP kit. 5 months later Still, most incoming shipments are received non-compliant. IP either already manufactured or it is easier to apply label in Korea than change the label at source. Key conclusion: Working with the right vendor is the key to being able to respond to unexpected local challenges and to have flexibility.
Innovation in the clinical supply chain
Eye on innovation Versatile supply chain models as driver of cost avoidance Biological specimen collection process (consolidation & packaging) Tax & duty recovery for IP that has been destroyed Simplified fee structure
Summary Asia s role is increasing and Asian countries are becoming more frequently part of US FDA controlled clinical trials. To harness greater cost saving opportunities, supply chain models and execution will need to become more sophisticated. Assess with an open mind the viability of new emerging solutions alternatives and scrutinize current alliances to ensure continued value creation through innovation.
Thank you!