1. Counterfeiting and Serialization
- the implications for biotech businesses
UKTI Presentation BIO 2010
Dr Hugh Burchett, Director, Defence and Security Business

2. 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

3. 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

4. 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
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5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. Counterfeiting and Serialization – the implications for biotech businesses
UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010 11

12. 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

13. 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

14. 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
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15. Questions ?
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16. 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