Best Practices for Comparator Sourcing

Transcription

1 Best Practices for Comparator Sourcing 1

2 CLINICAL TRIALS GLOBALLY Expect growth and increase in India, China (4-fold growth), Eastern and Central Europe (30% growth), Africa and Latin America By 2020, the emerging market (BRIC: Brazil, Russia, India and China - but really.india/china, Brazil and Russia) will equal that of the US and EU combined Regulatory harmonization has made global trial execution more manageable between the US and ROW

3 A UNIQUE COMMODITY Short Expiry Dating Varied Regional Specification Requirements Complex Logistics and Distribution Requirements Uncertain Lead Times Further Manufacturing Requirements Limited Availability Clinical Trial Supplies Volatile Prices Major factors impacting sourcing activities: Geographical spread of trials Market Supply requirements Varied obstacles requiring situation specific solutions 3

4 OVERVIEW OF NEW / EMERGING MARKETS Expect higher prices; and expect that all sales in country will be in local currency Assess the availability of both product, documentation and supporting vendors Considered real or supposed quality issues: Counterfeit or substandard local product Does product have necessary marketing authorizations? Has product been stored and shipped in accordance with GMP? Availability of both product and supporting vendors: Can product be purchased in desired volumes? Are packaging and labeling vendors available or must product leave country? Can it come back? Do you trust local logistics providers? 4

5 SOURCING CONCERNS IN GLOBAL MARKETS Availability Import/Export Considerations Accessibility Customs Regulations Product Manipulations Regulatory Agency Requirements Sustainability Local Representation Authenticity Local Knowledge Logistics 5

6 REALITIES Drug is available with restrictions Disclosure is being required but anonymity is preferred Pedigree is becoming a requirement Solutions to drug shortages is being demanded Import/export concerns are addressed with knowledge In country landscape information is needed, reality-check on expectations Specification requirements are more unique Documentation is still in demand Alternatives are being considered Market intelligence is sought after 6

7 EXPECTED OUTCOME Right Material Right Amount Right Place Right Time Right Manner 7

8 SECURING SUPPLIES WITH INTEGRITY 8

9 SOURCING TECHNIQUES Who What When Where How 9

10 FULL SERVICE SPECIALIST PROVIDERS Where services include: Logistics Market Intelligence Sourcing Strategies Procurement Project Management Re-Supply 10

11 AVENUES FOR PROCUREMENT External Business Partners Provides: Transparency Cost control Accountability Added quality systems Project management Unbiased advisement Requires Inclusion of external team members Disclosure of information Relinquishment of control Vendor management 11

12 ASSESSMENT OF INTERNAL VS. EXTERNAL Determine in-house capabilities Understand offered logistics and distribution services Question if sourcing comparators/clinical trial supplies is a core business function Realize extensive procurement options exist through global network Evaluate accessibility to information, data banks, sample provision and knowledge support Consider project timelines 12

13 AVENUES OF PROCUREMENT Trial Sites Innovator Companies Traditional Wholesalers CMOs Lead time Steady supply (accessibility to large quantities) National presence National & International presence Limited control of budge Stable prices < 40 Million USD < 40 Million USD Expiry Steady supply - less control over stock Single lots Expiration and availability Large quantities Reliable quality systems (recall tracking) Focus is not on clinical trial supply comparators Labeling at each site Feasibility- local regulations Accountability Global inventory and documentation Disclosure of trial information Focused on single country/region - no globally operations Clinical trial supply is not main business Provision of documents Limited global network Flexibility in keeping procurement separated Licensed, no importation Lack of central co-ordination with HQ many affiliates in many countries Mainly indirect sourcing Mainly indirect sourcing 13

14 AVENUES FOR PROCUREMENT Specialist Provider International presence > 100 Million USD Core business Market preferred sourcing via direct sourcing Thorough analysis of local markets and availability Early support in planning stage of trial Extensive global network Global support 14

15 ASSESSING CHECKS AND BALANCES 15

16 TRUST BUT VERIFY Who you are working with What you are getting Expectations of timing and specifications Source of supply Supply chain options 16

17 ASSESSMENT OF MATERIAL Sponsor and partners are held responsible for the trial including the quality of trial supplies GMP standards Manufacturing Policies and procedures Genuine materials where quality is defined by GMP standards; beware of counterfeiting Trusted source Transparent and reliable distribution to trial sites Pedigree 17

18 ASSESSMENT OF MATERIAL Storage and transportation Established and reliable distributors Temperature monitoring devices, insulated shipping containers Proper documentation Recall Tracking Timely communication Inventory Management Reconciliation Destruction 18

19 MANAGE EXPOSURE 19

20 STORAGE, TRANSPORT & DISTRIBUTION

21 CASE STUDY: HUMIRA IN LATIN AMERICA Project: Supply of single pack quantities of Humira for analytical purposes within Latin America Countries involved: Argentina, Colombia, Brazil, and Mexico Requirement: How: Security of several lot numbers Exclusion list management Management of temperature-controlled shipments Logistic management within Latin America Export management for onward shipment final EU destination Timely delivery (6 wks from receipt of PO) Proactive planning Collaborative regional support Result: Execution of the 5 Rs Re-order requests 21

22 CASE STUDY: BACKGROUND TREATMENT Project: Global trial for an expensive oncology cold chain product Central sourcing requirment Countries involved: Russia, Ukraine, Japan, Korea, Taiwan, China, Hong Kong, Singapore, Brazil, Argentina, Mexico, Chile, Peru Challenges: Competitive enrollment and small number of patients per country Requirement: How: Supply contracts with manufacturers Direct supply to sites from manufacturers warehouse Management of temperature-controlled shipments Timely delivery (6 wks from receipt of PO) Proactive planning Collaborative regional support Result: Shift supplies to local procurement for cost and flexibility considerations Execution of the 5 Rs Re-order requests 22

23 CLINICAL TRIAL SUPPLY OVERVIEW The process of securing clinical trial supplies has become increasingly difficult. The procurement of drugs and ancillary supplies has become more complex worldwide. Specifications are more stringent. Availability of supply and documentation is uncertain. Increased demand is needed globally regardless of market restrictions. Quality and supply chain standards and expectations are increasing. Collaboration across multiple sponsor departments and third party vendors are required. Clinical trial supply management can make or break a clinical trial. 23

24 OPTIONS IN A GLOBAL MARKET 24

25 IN SUMMARY Search for expertise in global clinical trial supply Require fast handling and decision making Require a multinational presence and flexible option solutions that consider total cost impacts Require access to qualified staff with global reach along with supporting information intelligence Insist on the most direct purchase method Assess both centralized and local sourcing Provision of all requested documentation (CoA, MSDS, BSE, Equivalency Statements, etc.) Source single lot with long expiration date Identify the most appropriate worldwide depot network and assess depot solutions in various countries Direct to site distribution JIT distribution to clinical sites Source single lot with long expiration date 25

26 CONTACT Lekishia White Vice President, Multipharma Group Managing Director, Multipharma, Inc. USA Phone: Fax: