Prisym Compliance

Drug and Device Labeling Control Chris Miller 310-265-3618

Industry Drivers: Changing R&D Process Rising costs and length of R&D process More collaborative development; more outsourcing; more inlicensing Changing Regulatory Environment Global compliance – EU, MHRA (& equivalents), FDA Global standards – GS1 Reduce Medication Errors, anti-counterfeiting, traceability Rise in Number of Mergers & Acquisitions Expansion of product portfolios Multiple languages Managing readability for multiple destinations Increase in contract packaging and manufacturing Disparate manufacturing sites Increased focus on brand identity

What Keeps You Up at Night? How can we ease compliance to regulatory authorities? How can I ensure safety down to patient level? Is my data secure ? How can I mitigate losses from piracy ? What will it take to integrate our labeling with other system systems? How can I optimize my clinical supply chain? How can I lower Operational costs ? How can I drive global business ? Am I getting a long term cost effective solution ? How should I interact with my business partners ?

PRISYM Life Science Work with 70% of Major, Global Life Science Companies Specific Domain Expertise in Life Sciences The world’s only label design and production software specifically developed to meet FDA 21CFR Part 11 and GMP requirements Works in a "hands-on" manner to implement relevant solutions that meet all of the local, national, international operational and regulatory requirements of your company More than a decade of experience in rigorous Life Science Biotech and Medical regulatory environments, PRISYM has developed an integrated software solution that combines industry best practices with the flexibility to meet every customer’s unique needs

Compliance and Security Only purpose designed GMP & 21 CFR part 11 Compliant labelling system Fully compliant label printing and management system Easy to user label design system Automatically manage all label designs centrally Manage the approval processes centrally Automatic, secure event & version history logging Manage all user permissions centrally Full lifecycle documentation IQ, OQ and PQ testing available

Signature to record linking (electronic) Proven date and time stamping Password protected records (encrypted) Time elapsing, two component passwords Automatic anti-tamper detection Custom validation of installed system Custom software development and integration Custom database design and integration Custom maintenance and servicing Custom support and training Compliance and Security

Validation Support: Developed, tested and documented in accordance with strict FDA and GAMP guidelines GAMP based life cycle documentation to provide evidence of the design controls and development history URS and FRS documents can be produced by PRISYM LS

Industry Drivers: The label is arguably one of the most critical elements of any product It is used to: educate the user about how, where & when to use (or not use), help achieve compliance to local governance, display compliance to appropriate standards, reassure that the product is genuine, track and trace the product from warehouse to consumer, and to promote your brand, values, and mission Yet, labelling is Number One on the FDA recall list

Patient Risk Wrong medication packed and shipped in patient kits Inconsistent processes for tracking and tracing from patient kit to API and backwards Potential wrong information in emergency labels or emergency letters Improper label context in regards to Direction for use Warning phrases Expired material Lack of drug at sites is a risk to patient health

Clinical Trial Risks: Inherent risks to the security of study data with clinical supply activities Insufficient Randomization algorithm could lead to a biased assignment of patient/kits to treatments The missing quality of clinical labels, especially for re-supplies, could cause unblinding of patient blocks or a whole study Uncontrolled access to data, especially Randomization data, is a threat to keep the blinding

Mitigating Clinical Trial Risks: Extensive Randomization capabilities reduce risk Proper Randomization is required to generate unbiased comparison groups in controlled trials Management of several Randomization per study Symmetric and asymmetric Randomization Consecutive and non-consecutive Randomization Multiple patient sets Stratification Integrated Labeling tools reduce risk Automated tracking and allocation of printed labels for the packaging process ensures the use of the “right” labels Simple re-reprint capabilities for re-supplies lowers unblinding risks

Counterfeit Drug Challenge Much like computer software, music and movies the cost of pharmaceuticals is largely in their development not manufacture Unlike the others, pharmaceuticals are consumed repeatedly creating a much more lucrative opportunity for counterfeit Fortunately fake pharmaceuticals are more difficult to manufacturer than copying a CD or DVD, though not much While building slowly in the US, counterfeit pharmaceuticals are already a major problem in the developing world http://www.fda.gov/oc/initiatives/counterfeit/report/interim_report.html#IIA

Counterfeit Drug Challenge Loss of life in China due to counterfeit medications has been estimated to be 200,000 to 300,000 people per year. 2.5 million people were harmed in 1999 due to counterfeit medications For some drugs in China as much as 50% of the product on the market is counterfeit (FDA Task Force report) The true extent of U.S. counterfeit drugs in not known FDA investigations are up from 5 per year in the late 1990’s to 20 per year since 2000 Some estimates are less than 1% With Internet pharmacy proliferation, these estimates are likely low Sources: South China Business Journal , 2002; WSJ , 2005 WHO estimates that counterfeit drugs comprise 8% of the world market.

Counterfeit Viagra Counterfeit Viagra was found in the Summer of 2004 in two retail pharmacies in California. Bottles were for 100mg, 30-counts. Cost $270/bottle Cost < $1/bottle

Counterfeit Ponstan Ponstan is an anti-inflammatory product. This counterfeit was found in Columbia. The yellow powder consisted of boric acid, floor wax, yellow highway paint. Pressed into tablets and placed in foil packs with labeling. Source: Pharmaceutical Manufacturer Research Association

Counterfeit Mitigation Advanced PrisymLS bar coding (i.e 2D), PrisymLS RFID technologies and PrisymLS Hologram Labeling enable efficient electronic pedigree There are two possible approaches Adding lot number, expiration date and other information to the bar code or RF-ID tag Mass serialization where each package has a unique id number assigned by the manufacturer RFID is emerging as the preferred solution for package level tracking Printed 1-D or 2-D bar codes is the preference at the dose level PDF417 High data density Rugged 2-D RSS Stacked Limited space “ 1.5-D” Example RFID Labels Example Hologram

PRISYM Life Science Applied Across Functions Research Development Clinical Trials Manufacturing Distribution Auditable security protocols and life cycle documentation based on the GAMP V Model Can help in meeting GLP, GCP, GMP and ISO requirements for sample/material/product labeling and record keeping

PRISYM Life Science Integration with ERP, MES, WMS, legacy and custom systems Visibility throughout; can provide useful information to decision makers at all levels of a global organization Real-time production reports History records Supply chain connectivity Modular, flexible and scalable You can start small and work your way up– from a stand-alone work station, to a global enterprise Allows labels to be securely designed then transmitted to another site anywhere in the world for approval or printing

PRISYM Life Science Software solutions - provide a secure, auditable and collaborative environment allowing central control of label designs whilst allowing easy access to label designs and data for production purposes. allows collaboration within a secure environment Web based technology - can provide a clientless application which enables an auditable ‘routing system’ for the management of approved label designs making approval and control of label designs easier and faster XML support- allow you to port labels and product documentation to new systems and software packages more easily. current requirement for SPL information to the FDA Integration - between production systems, ERP systems and databases allows for increased automation within the label production environment Reducing errors, increasing efficiency

Benefits: Fully-compliant label printing and management Secure event logging Automatic version history logging Signature to record linking (electronic) Proven date and time stamping Password protected records (encrypted) Time elapsing, two component passwords Automatic anti-tamper detection Full product life cycle documentation

21CFR Part 11 Compliance: Secure event log Accurate and complete records Protection of records Limited system access Signature/Record linking Control over record editing and deletion Reliable record retrieval History file attached to record

Proven time and date stamping Two component signatures Unique combination of user identification and password Signature Usage Re-using of signatures Passwords unknown to system administrators Signatures directly attributable to an individual Unsuccessful access attempts recorded 21CFR Part 11 Compliance:

PRISYM ClinTrial is a feature rich module that combines with other products to provide a safe, accurate and traceable labeling environment for clinical trials. Clinical trials labeling Trial materials storage and transfer Proven to help in meet GLP, GCP and ISO requirements for clinical sample/material/product labeling and record keeping PRISYM ClinTrial Application:

Secure access, event and audit logging Four (4) Print time variables – allowing user defined criteria to control the label printing process Trial specific “static” variables – to include in labels Auto randomization facility – configurable by visit, allowing weightings and mirroring Import facility – via ODBC / OLEDB Connection String / DSN or CSV files Export facility Full product life cycle documentation PRISYM ClinTrial Features:

Unlimited number of patients* Stratification of patients into discrete groups Enabling / Disabling of patients within the trial Multiple Study Centers Multiple visits Multiple Treatments - expressed by code and description Customization of user-define variable Randomization based on treatments and stratification PRISYM ClinTrial Benefits: * given adequate memory and disk space

Identifies, tracks and reconciles raw materials/ingredients /child parts and/or products from goods in through processing or R&D to dispatch all the way to the customer’s door Used as a stand-alone system or as module within PRISYM Medica to: enable the safe tracking and auditing of research, trial and manufacturing materials commercially packaged products and general physical assets PRISYM IM Application:

R&D materials/asset tracking/auditing Clinical trials sample tracking/auditing Hazardous material supply chain management Pharmaceutical manufacturing supply-chain management Medical Device manufacturing supply-chain management Contract packaging labeling and distribution Package labeling and distribution PRISYM IM Features:

Increased R&D Spending with Less Output Increase of R&D costs by 400% over the last 20 years Decreasing output of approved new drugs Spending per new drug significantly increased Failing studies become more expensive

Increasing Number and Complexity of Trials Number of clinical trial per NDA doubled over the last 20 years Number of needed patients tripled Clinical trials have trended steadily higher in both cost and complexity Clinical Supplies have to handle more and more throughput

Integration with Supply Chain Accelerating a product launch by 2 years could increase the revenue by $600 million An effective Clinical Trial Inventory Management can help to improve the product launch date

Goods Traditional Supply Chain

Goods Customs Traditional Supply Chain

Port of Departure Port of Arrival Supplier Distribution Center Distribution Center 1 st Mile Last Mile Goods Customs Active RFID reading + state sensing Active RFID reading + state sensing Passive RFID tagging + reading Active RFID reading + state sensing + de-associate Passive RFID reading Active RFID tagging + reading + association w/passive tags Enabled Supply Chain Visibility

Enabled Supply Chain Visibility Active RFID reading + state sensing Active RFID reading + state sensing Passive RFID tagging + reading Active RFID reading + state sensing + de-associate Passive RFID reading Active RFID tagging + reading + association w/passive tags Port of Departure Port of Arrival Supplier Distribution Center Distribution Center 1 st Mile Last Mile Goods Customs

Goods Port of Departure Port of Arrival Supplier Distribution Center Distribution Center 1 st Mile Last Mile Authenticity Specificity Productivity Visibility & Location State & Security Reliability Productivity Active RFID reading + state sensing Customs Passive RFID tagging + reading Active RFID reading + state sensing + de-associate Passive RFID reading Active RFID tagging + reading + association w/passive tags Enabled Supply Chain Visibility

Full Traceability of all ingredients, raw materials and finished products Automated reporting on stock value and location Supports barcode or RFID methods Supports range of data capture devices (PDT’s, PC’s, Scanners etc) Operates over Wi-Fi or narrow-band RF Real-time proof-of-delivery, asset location Public IP addresses give operator independence PRISYM IM Benefits:

Reduces the need to hire more people Reduces counterfeits Eliminates the costs associated with printing, copying and filing paper documents Eliminates packaging and shipping costs involved with multiple facilities Employees in all departments spend less time managing processes or documents and more time on higher priorities Decreases the cost associated with outsourcing and remote management Lowering Costs:

Increases speed to market Streamlines critical processes Implements product enhancements more quickly Improves product quality Impresses customers, prospects and auditors Increasing Revenue:

Enhances and enforces quality standards throughout your company Compliant with 21 CFR Part 11 Meets or exceeds expectations of auditors and inspectors – makes audits go smoothly Extends collaboration, communication and approvals to include multiple facilities, suppliers and customers, regardless of geographic location Reducing Risk:

Enhances and enforces quality standards throughout your company Tracking, Reporting and Troubleshooting Allows decision makers to get a real-time/ anywhere, high-level view of progress Identifies weaknesses in processes, training and personnel Shows history and trends Collects and summarizes multiple processes throughout the entire organization With PRISYM Medica Web it is accessible via the Internet anywhere in the world Tracking and Reporting:

Streamlines common processes within and between multiple functions throughout your company including engineering/R&D, clinical, regulatory, manufacturing, quality control, distribution and all the way to POS. Manages processes and documents throughout the entire product lifecycle Interfaces with other third party applications such as ERP, MES, WMS, software, legacy or custom systems, etc. Global Solution:

Price vs. Features PRICE FEATURES Loftware Seagull Teklynx Teklynx NiceLabel Standard Series NiceLabel SE NiceLabel Enterprise Series Prisym Medica

Conclusion Achieve compliance with regulatory authorities Proven to help with 21CFR Part 11, GLP, GCP. ISO and GMP requirements Ensures safety down to patient level Data IS secure mitigate losses from piracy Integration support and experience Optimization of clinical supply chain? Lower Operational costs Drive global business ROI, competitive advantage, risk mitigation Enterprise solution enables collaboration with all stakeholders

Prisym Compliance

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