• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
Bio presentation   counterfeiting & serialization
 

Bio presentation counterfeiting & serialization

on

  • 1,476 views

 

Statistics

Views

Total Views
1,476
Views on SlideShare
1,458
Embed Views
18

Actions

Likes
0
Downloads
43
Comments
0

2 Embeds 18

http://www.slideshare.net 13
http://www.linkedin.com 5

Accessibility

Categories

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

    Bio presentation   counterfeiting & serialization Bio presentation counterfeiting & serialization Presentation Transcript

    • Counterfeiting and Serialization - the implications for biotech businesses UKTI Presentation BIO 2010 Dr Hugh Burchett, Director, Defence and Security Business
    • Presentation context This presentation was given on the UK Trade & Investment stand at the BIO2010 Convention in Chicago, USA – http://convention.bio.org/ Cambridge Consultants also hosted a panel session at BIO2010 entitled “Phony Drugs, Real Solutions: Practical anti-counterfeiting considerations” – http://www.cambridgeconsultants.com/news_pr269.html UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 2
    • Introduction to Cambridge Consultants Cambridge Consultants is one of Europe’s leading design and development houses, established for 50 years We provide a complete development capability from feasibility through to New Product Introduction (NPI) We employ around 300 staff in our Cambridge, UK and Boston, US offices UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 3
    • Introduction to Cambridge Consultants We work across a wide range of medical technologies Surgical & Sensing & Drug Delivery Diagnostics Wireless Medical Interventional Imaging Inhalation and Injection and Nasal Reconstitution Transdermal Dose Counters Nebulisers Needle Free UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 4
    • Introduction to Cambridge Consultants ..and across a wide range of security and brand protection technologies Authentication Disposable Vulnerability Brand Protection Smart Packaging System Design Authentication Analysis Strategy Distributed Secure Software Reader System Data Analysis Secure Systems Communications Architecture Development Integration UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 5
    • Counterfeiting and Serialization – the implications for biotech businesses Counterfeit medicines - why should we be worried ? Patient safety is key to biotechnology businesses Biotech industry must put in place systems to protect against counterfeiting This is as important for small biotech companies as it is for big bio – Anti-counterfeit strategy is becoming increasingly important in the acquisition process “Estimated that 15% of medicines sold worldwide are fake, rising to 50% in Africa and Asia” Source: WHO 2006 “50% of medicine supplied by on-line pharmacies which conceal their physical address are fake” Source: MHRA “Pharmacists and wholesalers have identified fake drugs targeting: anti- cholesterol, anti-inflammatory, anti-platelet, anti-psychotic, erectile dysfunction, prostrate cancer, appetite suppressants, chronic asthma, alopecia” Source: MHRA UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 6
    • Counterfeiting and Serialization – the implications for biotech businesses Counterfeit medicines – what can we do about it? Requirements and Complexities – Understanding what needs to be achieved – Understand the risk vs. threat Anti-tamper – Serialization – Authentication – Understanding the levels of protection provided by each Technology Considerations – A systems approach is required – “A system is only as strong as it’s weakest point” – A layered approach is required UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 7
    • Counterfeiting and Serialization – the implications for biotech businesses Counterfeit medicines – understanding what we can control and what we can’t Risk ( Likelihood x Severity ) versus Threat ( Intent x Capability ) Opportunity  Deterrence Patient safety,  Financial  Skills Mitigations,  and financial  brand value,  Gain vulnerabilities  gain financial loss and  assumptions Counterfeiter  Product specific Counterfeiter  Solution  specific specific specific UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 8
    • Counterfeiting and Serialization – the implications for biotech businesses Anti-tamper - Serialization - Authentication These approaches provide different levels of mitigation and detection of adversary behavior Anti-tamper and tamper-evident packs – Detection of insertion of counterfeit product into manufacturers packaging, or alteration of serialization or authentication features Serialization – Detection and prevention of mass duplication of counterfeit product and insertion into the supply chain at Point of Dispense (PoD) – Supports accurate re-imbursement, recall of product and removal of out-of-date product Authentication – Detection of counterfeit product within the supply chain through authentication of packaging or the product formulation – Different features support end-users, supply chain and litigation, as well as deterrence UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 9
    • Counterfeiting and Serialization – the implications for biotech businesses Anti-tamper - Serialization - Authentication In practice, the approaches have limitations and assumptions which need to be understood Anti-tamper – Predicated on the real pack being difficult to counterfeit, and the users and supply chain aware of the legitimate pack design and overt authentication features Serialization – Predicated on the real product reaching the PoD before the counterfeit, and serial number generation being truly random – Serialization does not equal authentication Authentication – Authentication is only as good as the reader (!) – Technology dependent and compromise between uniqueness, reader complexity and cost UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 10
    • Counterfeiting and Serialization – the implications for biotech businesses UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 11
    • Counterfeiting and Serialization – the implications for biotech businesses Summary 1. Brand owner carries the risk of poor system performance, not the system or technology provider – Responsibility resides with you 2. Assess your balance of risk versus threat for your products – Develop a plan and approach to manage this 3. Avoid becoming the target – Anti-tamper, serialization and overt authentication provide a deterrence 4. Serialization will not prevent counterfeit products being dispensed – Authentication is required to achieve this 5. Serialization does substantially reduce the likelihood that this will occur – Provided it is implemented well UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 12
    • Phony Drugs, Real Solutions: Practical  anti‐counterfeiting considerations Track:     Global Biotechnology Issues (Session ID: 4929) Date/Time: Wednesday 5th May 8:00am ‐ 9:30am Location:            Room S403B, Level 4 UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 13
    • We will be publishing a white paper to accompany the panel session To register for this please contact: Ruth Thomson +44 1223 420024 ruth.thomson@cambridgeconsultants.com 14
    • Questions ? 15
    • Contact details: Cambridge Consultants Ltd Cambridge Consultants Inc Science Park, Milton Road 101 Main Street Cambridge, CB4 0DW Cambridge MA 02142 England USA Tel: +44(0)1223 420024 Tel: +1 617 532 4700 Fax: +44(0)1223 423373 Fax: +1 617 737 9889 Registered No. 1036298 England info@CambridgeConsultants.com www.CambridgeConsultants.com © 2010 Cambridge Consultants Ltd, Cambridge Consultants Inc. All rights reserved. UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 16