Clinical Trial Trends Outline Complexity for Supply Chain. Scott Ohanesian, VP Commercial Operations APAC

Transcription

1 Clinical Trial Trends Outline Complexity for Supply Chain Scott Ohanesian, VP Commercial Operations APAC 29 May 2013

2 Biotechnology Sales on the Rise Source: EvaluatePharma (29 MAY 2012) 29 May 2013 Industry Snapshot 2

3 R&D Spend: Slow But Steady Growth Worldwide Total Pharmaceutical R&D Spend Source: EvaluatePharma (29 MAY 2012) 29 May 2013 Industry Snapshot 3

4 Success in Biologics Higher success rates for large molecules Source: KMR Group, April May 2013 Industry Snapshot 4

5 The Biologics Patent Cliff Source: Pharmaceuticals, May 2013 Industry Snapshot 5

6 Pipeline Growing Again Source: Citeline May 2013 Industry Snapshot 6

7 Biologics Growth: Orphan Drugs The Expanding Global Orphan Drug Market Source: Journal of Pharmacy And Bioallied Science, May 2013 Industry Snapshot 7

8 Biologics Growth: Neglected Diseases Growing R&D pipeline for neglected diseases, by industry Pharma's commitment to fighting neglected diseases is reflected by a growing R&D pipeline: 132 compounds in development. Source: IFPMA, May 2013 Industry Snapshot 8

9 Funding for Neglected Diseases Total funding by funder type Pharmaceutical R&D investment reached USD million in 2011, an increase of 4.2%, even as public and philanthropic funding decreased. Source: IFPMA, May 2013 Industry Snapshot 9

10 A Bright Future for Complex Drugs Nanotechnology The market is projected to reach close to a trillion dollars by 2015 Biomarkers Usage increased by more than 280% over the last three years Personalized Medicine US market is currently $232 billion with a projected annual growth of 11% Source: Tufts Center for the Study of Drug Development, 2012 Sources: Cientifica Oct 2011; Regulatory Focus, Oct 2012; PricewaterhouseCoopers Dec May 2013 Industry Snapshot 10

11 Growth in Cold Chain Spending The temperature control industry continues to grow at a fast pace The majority of growth is in Asia and other developing countries Source: Biopharma Cold Chain 2012 Sourcebook 29 May 2013 Industry Snapshot 11

12 Slowing Growth for Clinical Trials Estimate of spending for transport and packaging logistics in phase I-IV biological and drug trials This is based on two assumptions Prices will stay steady Quantities will go down Source: Biopharma Cold Chain 2012 Sourcebook 29 May 2013 Industry Snapshot 12

13 The Global Face of Clinical Research Clinical research is becoming more global, but also more complex Density of Clinical Trials Worldwide Average Number of Countries Participating in Global Trials Sources: Tufts Center for the Study of Drug Development, 2012; Nature Biotechnology, Jan May 2013 Industry Snapshot 13

14 116 Biopharmaceutical Professionals Were Asked How great of a challenge are the shipping/logistics of supporting a more global clinical trial supply? What emerging market region are or will be involved in your clinical trials? Source: UBM TechWeb / Wipro, May 2013 Industry Snapshot 14

15 Avoca Group Quality Survey Market research conducted by The Avoca Group on quality in the delivery of clinical supply chain services Respondent by Market Sector Respondent by Region Source: Avoca/Marken Survey, May 2013 Industry Snapshot 15

16 Quality Challenges in Emerging Economies China Export, import and storage Consistency to global SOPs Local partners Specialized couriers Cultural differences Geopolitical risks Source: Avoca/Marken Survey, May 2013 Industry Snapshot 16

17 Quality Challenges in Emerging Economies Japan Consistency to global SOPs Regulatory issues Expertise in a centralized location Extreme quality requirements Expensive Source: Avoca/Marken Survey, May 2013 Industry Snapshot 17

18 Quality Challenges in Emerging Economies Asia Other than China, India, & Japan Export, import and storage Consistency to global SOPs Local partners Specialized couriers Cultural differences Geopolitical risks Source: Avoca/Marken Survey, May 2013 Industry Snapshot 18

19 Quality Challenges in Emerging Economies Eastern Europe Rural pick-up and delivery Consistency to global SOPs Drug import authorization Logistics challenges Regulatory challenges Customs issues Third-party depot issues Lack of extensive trade agreements Complex local regulations Geopolitical issues Source: Avoca/Marken Survey, May 2013 Industry Snapshot 19

20 Quality Challenges in Emerging Economies Latin/South America Rural pick-up and delivery Consistency to global SOPs Drug import authorization Logistics challenges Regulatory challenges Customs issues Third-party depot issues Lack of extensive trade agreements Complex local regulations Geopolitical issues Source: The Avoca Group, May 2013 Industry Snapshot 20

21 Quality Challenges in Emerging Economies Africa Rural pick-ups and deliveries Consistency to global SOPs Logistics challenges Regulatory challenges Source: Avoca/Marken Survey, May 2013 Industry Snapshot 21

22 Quality Challenges in Emerging Economies India Customs Rural pick-ups and deliveries Consistency to global SOPs Expert carriers Source: Avoca/Marken Survey, May 2013 Industry Snapshot 22

23 Increased Regulatory Scrutiny New EU GDP Guidelines 92/25/EEC Impact on logistics vendor selection due to license requirements for purchase, receiving, storage and export of drugs for human consumptions New requirements for controlled room temperature USP Chapter <1083>: Good Distribution Practices Focus on Supply Chain Integrity Technical and Quality Agreements become crucial FDASIA: Food and Drug Administration Safety and Innovation Act (July 2012) Supply Chain Title VII enhances FDA s inspection authority and the drug supply chain New authority concerning drug shortages FDA wants to increase use of Biomarker and pharmacogenomic data for more efficient trials 29 May 2013 Industry Snapshot 23

24 Why FDASIA? One of the most important provisions in FDASIA is Title X, which addresses the issues associated with drug shortages Sources: FDA, Oct 2011 & Jan 2013; Premier Healthcare Alliance, Aug May 2013 Industry Snapshot 24

25 Quality Survey Key Findings Respondents who knew of new regulations and guidelines affecting clinical supply chain management: said at least one of these regulations had already affected, or was anticipated to, their quality management practices: did not know if their quality management practices would be affected by new regulations: Source: Avoca/Marken Survey, May 2013 Industry Snapshot 25

26 Awareness of Regulatory Guidelines Less than 50 percent of respondents were aware of the top 6 regulations that affect their business every day Source: Avoca/Marken Survey, May 2013 Industry Snapshot 26

27 The Quality Gap Among the respondents Source: Avoca/Marken Survey, May 2013 Industry Snapshot 27

28 Content of Quality Agreements When your teams do use Quality Agreements, please describe how frequently each of the following is covered. Monitoring and tracking (TAT, communication path, issue escalation process) Shipment requirements and turnaround time Shipping processes Customs/regulatory handling (roles and responsibilities) Security systems Shipping package design/validation Source: Avoca/Marken Survey, May 2013 Industry Snapshot 28

29 Content of Quality Agreements When your teams do use Quality Agreements, please describe how frequently each of the following is covered. (continued) Oversight of third party vendors Crisis response systems Qualifications of staff Supply chain management processes Proactivity/Risk Assessment and contingency planning Investigative site report Source: Avoca/Marken Survey, May 2013 Industry Snapshot 29

30 Standardization of KPI Metrics Would you be in favor of the creation of industry-wide standards for key performance indicator metrics in clinical supply chain services? Source: Avoca/Marken Survey, May 2013 Industry Snapshot 30

31 Standardization of Quality Agreements Would you be in favor of the creation of an industry-wide standard for Quality Agreements in clinical supply chain services? Source: Avoca/Marken Survey, May 2013 Industry Snapshot 31

32 Time is Running Out If you were audited today, would you be ready? 29 May 2013 Industry Snapshot 32

33 Time is Running Out If you were audited today, would you be ready? Do you understand the full impact of increasing supply chain complexity and new quality regulations? 29 May 2013 Industry Snapshot 33

34 Time is Running Out If you were audited today, would you be ready? Do you understand the full impact of increasing supply chain complexity and new quality regulations? 29 May 2013 Industry Snapshot 34

35 Time is Running Out If you were audited today, would you be ready? Do you understand the full impact of increasing supply chain complexity and new quality regulations? 29 May 2013 Industry Snapshot 35

36 Time is Running Out If you were audited today, would you be ready? Do you have the knowledge to identify the changes needed to address additional complexity and regulations? 29 May 2013 Industry Snapshot 36

37 Time is Running Out If you were audited today, would you be ready? Do you have the knowledge to identify the changes needed to address additional complexity and regulations? 29 May 2013 Industry Snapshot 37

38 Time is Running Out If you were audited today, would you be ready? Do you have the knowledge to identify the changes needed to address additional complexity and regulations? 29 May 2013 Industry Snapshot 38

39 Time is Running Out If you were audited today, would you be ready? Do you have the internal capacity needed to implement these changes? 29 May 2013 Industry Snapshot 39

40 Time is Running Out If you were audited today, would you be ready? Do you have the internal capacity needed to implement these changes? 29 May 2013 Industry Snapshot 40

41 Time is Running Out If you were audited today, would you be ready? Do you have the internal capacity needed to implement these changes? 29 May 2013 Industry Snapshot 41

42 Time is Running Out If you were audited today, would you be ready? Do you have the budget to cover the costs associated with an internal initiative? 29 May 2013 Industry Snapshot 42

43 Time is Running Out If you were audited today, would you be ready? Do you have the budget to cover the costs associated with an internal initiative? 29 May 2013 Industry Snapshot 43

44 Time is Running Out If you were audited today, would you be ready? Do you have the budget to cover the costs associated with an internal initiative? 29 May 2013 Industry Snapshot 44

45 Thank You 29 May 2013