CHALLENGES OF GLOBAL CLINICAL TRIAL SUPPLY SOURCING SOME SPECIFICS FOR EMERGING MARKETS

Transcription

1 Clinical Trial Supply 28 th 29 th October 2014 Princeton, NJ - USA CHALLENGES OF GLOBAL CLINICAL TRIAL SUPPLY SOURCING SOME SPECIFICS FOR EMERGING MARKETS 1

2 Agenda The challenges associated with various clinical trial materials being sourced 2 The increased importance of emerging markets 4 The planning process points to consider 7 What happens when the sourcing process begins? 11 Clinical trial supply quality considerations when working in emerging markets 15 Questions? XX 18 2

3 Type of clinical trial materials being sourced? Whether a trial is local or global, the classification of the clinical trial materials required will often determine the complexity and strategy of the trial. IMP: A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization, but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form. (Source: Directive 2001/20/EC, Article 2(d)) NIMP: A Non-Investigational Medicinal Product (NIMP) is a medicinal product not defined within the description of an IMP and may be considered a background, challenge, concomitant, endpoint, escape, or rescue medication dosed for preventive, diagnosis, or therapeutic reasons. NIMP is EU terminology, but has been accepted globally within the pharmaceutical industry. (Source: European Commission: Definitions of IMPs, NIMPs) Comparator: IMP by definition because one gains information concerning the effectiveness of the comparator to itself or relative to another medicinal product. 3

4 Agenda Type of clinical trial material being sourced? 2 Increased importance of emerging markets 4 The planning process points to consider 7 What happens when the sourcing process begins? 11 Clinical trial supply sourcing in emerging markets: Quality considerations 15 Questions? 18 XX 4

5 Increased importance of Emerging Markets Pharma clinical trials services revenues by regions [in $ bn, CAGR in %] Rationale for Emerging Markets 74.1 Double-digit growth of trials in Emerging Markets USA (10.4%) Europe (10.5%) Japan (10.6%) BRIC Nations (20.6%) Others (17.9%) Projected Compound Annual Growth Rate of 20% for CTS in Emerging Markets, based on: Regulatory requirement for local trials Increasingly important end-markets Access to large treatment-naïve patients BRIC >40% of the world s population Significantly lower costs trials (up to 60% lower compared to established markets) Consider a strategic partner with a strong footprint in the Emerging Markets Source: visiongain (2013), Pharma Clinical Trial Services World Market

6 The ever changing and timesensitive sourcing landscape Situation Implications Changes in regulations Distribution models Availability Originators set their own sales strategy Regulations in some markets are regularly changing and may be inconsistent. Close monitoring or access to such information through thirdparty providers is advisable. Changes may facilitate or impede market access Direct distribution by manufacturer Appointed Distribution Authorized Exclusive Wholesale Market size, Shortages, Discontinuity, Profitability Global players behave differently across regions Every market is unique and needs to be monitored for changes 6

7 Agenda Type of clinical trial materials being sourced? 2 Increased importance of emerging markets 4 The planning process points to consider 7 What happens when the sourcing process begins? 11 Clinical trial supply sourcing in emerging markets: Quality considerations 15 Questions? 18 XX 7

8 Language / Culture / Distance 8

9 Japan: A unique example? Situation in Japan Gentlemen s Agreement not functional Sponsors in need of alternatives Japanese Market is changing: Independent sourcing partners are speeding up sourcing process: Reducing lead time to one month or less No disclosure of protocol, although handing out limited trial information might be necessary in certain cases. Original manufacturers satisfied to let third party handle the process as it eases their internal coordination work.

10 Considerations when working with strategic partners in emerging markets Can they assist in laying the foundations and managing complex relationships with external providers of different cultural backgrounds? Can they assist in overcoming potential language and cultural barriers? Is there consistent open feedback between partners - trusted communication? Particularly as a sponsor organisation is arguably further away in a trial that is globally spread. A potential partner needs to be carefully chosen and relations actively managed and developed 10

11 Agenda Type of clinical trial material being sourced? 2 Increased importance of emerging markets 4 The planning process points to consider 7 What happens when the sourcing process begins? 11 Clinical trial supply sourcing in emerging markets: Quality considerations 15 Questions? 18 XX 11

12 Value of strategic partners with local experience in emerging markets Preparation of the sourcing process Actual sourcing process Logistics -outsourced- Market Intelligence Development of sourcing strategies Procurement management Project management May be particularly important in new regions as for example presentations and strengths of product may differ or may not be marketed Re-supply Development of optimal sourcing strategies for each individual project. 12

13 Getting ready to start From the Sponsor Inform on possible comparators concerning markets, timelines, prices Communicate project limitations and boundaries Advise development of the protocol with regards to choice of IMPs and NIMPs and markets Share information on past experience From the Provider Discuss the expected outcomes Ask for all known specifications before starting the research Investigate on all potential strategies Verify the appropriateness of the decision based on market situation Actively ensure the feasibility of the project Ensuring quality support / documentation Suggestion of the optimal supply strategy Early communication between all parties is important 13

14 Recent Projects Phase II, effect of IMP on the blood/urine tests The Test Kit Minimum sensitivity of at least 25 IU/L. Kits measuring total human chorionic gonadotropin (hcg). Supply of test kits, direct to site distribution to 142 sites out of 11 depots in the following countries: Argentina, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Finland, France, Germany, Italy, Israel, Korea, New Zealand, Poland, Spain, Thailand, USA. Risk assessment and test of supply routes before carrying out trial distribution suppliers, depots and logistics providers require a similar level of attention 14

15 Agenda Type of clinical trial materials being supplied? 2 Increased importance of emerging markets 4 The planning process points to consider 7 What happens when the sourcing process begins? 11 Clinical trial supply sourcing in emerging markets: Quality considerations 15 Trying to understand if you understood! 18 XX 15

16 A Secure Supply Chain All services must be executed under GMP and EU GDP standards. Whenever possible, purchase medicinal products directly from manufacturers To support remaining sourcing requirements, have a compliant and reliable worldwide procurement network at your disposal. 16

17 Management of contracted partnerships - Examples Partner Relationships A B Central warehouse in EU Cold chain, Narcotics and IMP storage Labeling and repackaging (manufacturing) Distribution to customers or sites with qualified third parties Manufacturer in China, GMP certified by CFDA Primary and secondary packaging and labelling for CT purposes German consultant (QP) on site for CT projects to ensure quality C Authorized Distributors e.g. South Africa, Peru, Argentina, Chile Successfully passed audits Applies our global quality management systems Long-standing and close relationships, continuously monitored and managed for quality

18 Agenda Type of clinical trial materials being sourced? 2 Increased importance of emerging markets 4 The planning process points to consider 7 What happens when the sourcing process begins? 11 Clinical trial supply sourcing in emerging markets: Quality considerations 15 Questions? 18 XX 18

19 Thank you Edoardo Madussi Executive Vice President Multipharma Inc. Hoboken, NJ Phone Direct