TRACEABILITY AND THE DRUG QUALITY AND SECURITY ACT CONFERENCE

4TH ANNUAL

EXECUTIVE SUMMARY

CONTENTS

INTRODUCTION 3

PRESENTATIONS 4

FOR MORE INFORMATION 8

3

INTRODUCTION:

If you weren’t able to join us this year, here is what you missed at ExL Pharma’s 4th

Annual Traceability and the Drug Quality and Security Act Conference…

With the latest on how to enhance supply chain processes to protect brands and

comply with global serialization, pedigree, and track and trace regulations, this

annual summit, which was held May 15-16 in Philadelphia, brought together some of

the most experienced industry experts to assess the Drug Quality and Security Act

(DQSA) and its impact on the industry. Presenters offered best practices designed

to optimize and protect supply chains via relevant industry-specific case studies and

examples.

Topics covered at the conference included meeting new requirements requirements

of the Drug Quality and Security Act and how the DQSA affects supply chain

processes, best practices to create and enhance traceability and verification

programs, an introduction to the FDA’s secure supply chain pilot program, an update

on global developments and regulations as well as collaboration with wholesalers

and dispensers and putting long-term strategies into place.

In addition, the conference shared FDA draft guidance for the industry on how to

enhance supply chain security, how to leverage serialization as a corporate asset,

implementing risk mitigation strategies to prevent counterfeiting and diversion, and

more.

Following are session summaries and highlights from the 2014 conference…

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PRESENTATIONS

Highlighting recent developments in the regulatory landscape, “Understand the

Impact of the Drug Quality and Security Act and How it Affects Supply Chain

Processes” clarified differences between DQSA and CA requirements. Presented

by Gabrielle Cosel, Pew Charitable Trusts, and Bill Fletcher, Pharma Logic Solutions,

the session helped attendees outline processes that need to be in place for 2015

and highlighted the new deadlines for lot traceability, verification, serialization and

requests for information. The duo encouraged trading only with authorized trading

partners and offered clear definitions and dates for upcoming changes in the

industry.

The presentation “Best Practices to Implement a Global Serialization Program

and Handle Multiple Mandates” by Bob

Celeste of GS1 discussed the company’s

data exchange, which easily allows product

information to flow through the supply

chain and reminded that businesses

of all sizes need a common language,

possible through the use of standards. He

encouraged companies to “go fast by going

slow,” which entails getting the basics right

and thinking holistically. Increased visibility

can lead to a wealth of benefits.

“Work Closely with Wholesalers and Dispensers to Meet New Requirements and

Put a Long-Term Strategy in Place” was a panel discussion moderated by Carl

Accettura of PharmoRx Therapeutics with the following panelists: Mike Daly of

Valeant Pharmaceuticals; Dick Rogers of Rx Trace; and Priya Gopal of Novartis.

The panelists highlighted the expectations of wholesalers, discussing some of the

letters manufacturers have received from several wholesalers recently, as well as the

benefits of paper vs electronic and the challenges that the notification requirements

entail for manufacturers. The panel addressed how to capture transaction

information, history and statements as well as the importance of developing

verification and notification procedures for suspect products and the ability to retain

samples of these products upon request. They also covered details on laying the

groundwork for an interoperable, electronic tracing of products at the package level,

and strategies for capturing and exchanging data efficiently.

© GS1 US 2013

ACCRUING BENEFITS EPCIS - GS1’S ANSWER TO INCREASED VISIBILITY

36

The results are:

visibility efficiency security collaboration

convenience value safety satisfaction

for business for patients

5

“Outline the FDA Draft Guidance for the Industry on Methods to Enhance Supply

Chain Security” from Gabrielle Cosel of the Pew Charitable Trusts and Dick Rogers

of RxTrace explained the recent FDA

draft guidance with regards to suspect

and illegitimate products. The duo’s

presentation also outlined processes and

outlined steps to implementation while

detailing a variety of guidance expected

in 2014. According to an industry survey,

improving supply chain visibility is the

biggest benefit of implementation while

a variety of challenges, both internal and

external, exist, in particular, costs and lack

of standard architecture.

Carl Accettura shared a case study from Braeburn Pharmaceuticals “Capturing

Strategic Business Value: Designing a New Product’s Supply Chain to be the ‘Safest

in the Market.’” He outlined how the company leveraged serialized track & trace

data commercially to support the business brand and a secure supply chain while

designing a traceable web-based event repository solution to enhance the new

Rx launch, creating an end-to-end commercial brand solution. With serialization

initiatives in particular, he discussed piloting an intuitive, user-friendly serialization

system to create a secure distribution model to generate a virtual chain of custody

with serialized ePedigree while enhancing physician practices and enrollment.

SESSION SUMMARIES

InvesIgaIon,  verificaIon,  and  noIficaIon  

‘‘  SUSPECT  PRODUCT.—The  term  ‘suspect  product’  means  a  product  for  which  there  is  reason  to  believe  that  such  product—    ‘‘(A)  is  poten)ally  counterfeit,  diverted,  or  stolen;    ‘‘(B)  is  poten)ally  inten)onally  adulterated  such  that  the  product  would  result  in  serious  adverse  health  consequences  or  death  to  humans;    ‘‘(C)  is  poten)ally  the  subject  of  a  fraudulent  transac)on;  or    ‘‘(D)  appears  otherwise  unfit  for  distribu)on  such  that  the  product  would  result  in  serious  adverse  health  consequences  or  death  to  humans.    

“  ILLEGITIMATE  PRODUCT.—The  term  ‘illegi)mate  product’  means  a  product  for  which  credible  evidence  shows  that  the  product—    ‘‘(A)  is  counterfeit,  diverted,  or  stolen;    ‘‘(B)  is  inten)onally  adulterated  such  that  the  product  would  result  in  serious  adverse  health  consequences  or  death  to  humans;    ‘‘(C)  is  the  subject  of  a  fraudulent  transac)on;  or    ‘‘(D)  appears  otherwise  unfit  for  distribu)on  such  that  the  product  would  be  reasonably  likely  to  result  in  serious  adverse  health  consequences  or  death  to  humans.    

DefiniIons:  Suspect  and  IllegiImate  Product  

6

Bill Fletcher of Pharma Logic Solutions presented a regulatory and strategy

supply chain master class on “Making the Right Business Decisions in Light of

the Drug Quality and Security Act (DQSA)” to help prepare organizations for

item-level serialization and traceability and provide the latest information on

requirements. He noted that global trade will drive counterfeiting to areas of the

world that lack traceability regulations and that packaging alone does not thwart

counterfeiting. Variations in product identification/uniqueness in other countries

necessitates some agility in data systems. Key elements of the new law are that it

defines supply chain participants and their requirements for managing and passion

transaction information; it establishes rules for providing transaction information

for investigations and suspect product notifications as well as rules for trading

with “authorized” supply chain participants. DQSA also adds a new requirement

to uniquely identify prescription drug products and their shipping cases using

serialization and defines steps that will be taken to move the industry to certified

chain of custody pedigree within 10 years. The right strategy, vendor selection and

functional design are key to successful implementation.

“Beyond The Drug Quality And Security Act - why this Legislation Falls Short of

a Safe and Secure Supply Chain” by Walter Berghahn of the Healthcare Packaging

Council shared his organization’s mission to advance the use of compliance-

prompting packaging to improve medication adherence and patient health outcomes.

In general, packaging is designed to protect

patients and help them take medication,

protect the product from the environment,

protect the product and patient from

unscrupulous players in the supply chain,

and protect our healthcare system from

unwanted costs and unnecessary patient

harm. Supply chain security is all about the

right patient, right drug, right dose, right

time and safe drug. Even a 1 percent error

rate among 4 billion prescriptions means

40,000,000 potential impacts. Functional

packaging is critical to getting it right.

SESSION SUMMARIES

The  99%  good  � Manufacturers  � Distributors  � Physicians  � Pharmacists  

� But  1%  bad  in  a  system  of  4  billion  prescriptions  means  40,000,000  potential  impacts  

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“Implementing the FDA’s Secure Supply Chain Pilot Program” was the focus of

a session offered by Brad Elrod of Pfizer. In a typical pharmaceutical supply chain,

many transport assets and people are involved in getting pharmaceuticals from cradle

to table, which is why the FDA launched its Secure Supply Chain Pilot program to

implement aspects of the FDA Safety and

Innovation Act. The program is designed

to create regulatory/entry simplification

and process improvements that eliminate

“may proceed” time and increase supply

chain predictability. It was also intended to

provide a measurable reduction in inventory

through decreased lead time in supply

chain agreements and decrease double

handling at logistics centers as well as faster

resolution of issues around short supply

compounds.

SESSION SUMMARIES

1

Pharmaceu)cal  Supply  Chain  

Many Transport Assets and People Are Involved in Getting Pharmaceuticals From Cradle to Table???

Finished  Product  Manufacturing/Packaging  

Road    

Customs  

Port  of    Departure  

Warehouse/  Logis<cs  Center  

Interna<onal    Ocean/  Air/Road    Port  of    

Arrival  

Customs  

Road  

Warehouse  

Warehouse  /    Customer  

API    Manufacturing  

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UPCOMING EVENTS:

5TH TRACEABILITY AND THE DRUG QUALITY AND SECURITY ACT CONFERENCE May 5-6, 2015 in Philadelphia

www.exlevents.com/traceability

Join us in Philadelphia at our annual conference to make sure you have everything in place

to be able to respond to FDA inquiries within 48hrs to avoid high fines and work effectively

together with your wholesalers and dispensers. Our expert speaker faculty of leading supply

chain experts provides valuable insights what processes to put in place now to comply with

the requirements in 2017 and leverage serialization benefits to secure an advantage in the

market place. Hear how they have managed to provide business value through serialization

and pedigree beyond regulatory compliance.

This interactive forum discusses best practices for track and trace and lessons learned

from implementing an integrated global supply chain security program, which improves

transparency, secures your supply chain and protects your brand, while leveraging business

benefits.

Do you want to spread the word about your organization’s solutions and services to

potential clients who attend this event? Take advantage of the opportunity to exhibit,

present an educational session, host a networking event, or distribute promotional items

to attendees. ExL works closely with you to customize a package that suits all of your

needs. To learn more about these opportunities, contact, Matthew Halvorsen, Business

Development Manager at 917-258-5163 or mhalvorsen@exlevents.com