bio presentation counterfeiting & serialization

UKTI Presentation BIO 2010 Dr Hugh Burchett, Director, Defence and Security Business

Counterfeiting and Serialization- the implications for biotech businesses

2UKTI Presentation, BIO 2010 © Cambridge Consultants Limited 2010

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

Presentation context


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

Introduction to Cambridge Consultants


We work across a wide range of medical technologies

TransdermalReconstitution Dose CountersInjection and Needle FreeNasal

Surgical & Interventional

Sensing & ImagingDiagnostics Wireless Medical


Drug Delivery

Inhalation and Nebulisers


..and across a wide range of security and brand protection technologies

Data AnalysisSecure Communications

System Integration

Reader Development

Distributed Secure Systems

Disposable Authentication


Authentication System Design

Software Architecture

Smart Packaging Brand Protection Strategy

Vulnerability Analysis


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

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



Counterfeit medicines – understanding what we can control and what we can’t

Risk ( Likelihood x Severity ) versus Threat ( Intent x Capability )

Mitigations, vulnerabilities

and assumptions

Solution specific

Patient safety, brand value, financial loss

Product specific

Opportunity and financial

gain

Counterfeiter specific

Deterrence

Counterfeiter specific

SkillsFinancial Gain



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



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



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



Phony Drugs, Real Solutions: Practical anti‐counterfeiting considerationsTrack: Global Biotechnology Issues (Session ID: 4929)Date/Time: Wednesday 5th May 8:00am ‐ 9:30amLocation: Room S403B, Level 4

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We will be publishing a white paper to accompany the panel session

To register for this please contact:

Ruth Thomson

+44 1223 [email protected]

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Questions ?


Contact details:

Cambridge Consultants Ltd Cambridge Consultants IncScience Park, Milton Road 101 Main StreetCambridge, CB4 0DW Cambridge MA 02142England USA

Tel: +44(0)1223 420024 Tel: +1 617 532 4700Fax: +44(0)1223 423373 Fax: +1 617 737 9889

Registered No. 1036298 England

[email protected]

© 2010 Cambridge Consultants Ltd, Cambridge Consultants Inc. All rights reserved.

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