8 Myths That Can Derail Your e-Pedigree Traceability Project

8/3/2019 8 Myths That Can Derail Your e-Pedigree Traceability Project

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8 Myths & Lessons Learned:Serialization & e-Pedigree

Presented by: Michael Stewart

Track & Trace Projects


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Seria lization & e-Pedigree

Agenda

Pha rm Tec h

8 Myths or Lessons Learned

Opportunities

Next Steps Q&A


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Esta b lished in 1995

FDA regula ted industry foc us

Pharmac eutica l, M ed ic al Device & Biote c h

Hea d q uartered in suburb a n Chic a go , IL

Emp loyee ow ned

Ac c ess to 100+ resources na tionw id e

Av erage e xp erience:

Projec t M a nage rs 10 yea rs

Assoc ia tes 6 yea rs

ASQ Certified Qu a lity Aud itors Certified Sup p ly Cha in Professiona ls (CSCP)

Qu a lity Eng ineers IT Personne l

PharmTec h Overview

People

Background


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PharmTec h

ROI

Trac eabilitySyste m s


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Trac k & Trac e Projec tsPha rmTec h has been working w ith lea d ing pha rmac eut ica l manufa c turers sinc e theint roduc tion of the Ca lifornia leg isla tion and ha s been inv olved in p rojec ts suc h a s:

Ev a lua ting solutions p rov iders

Seria lized da ta sha re and systems interop erab ility

Sta nd ards imp lementa tion (GS1 sta nd ards)

Pilot ing for seria lized p roduc t and trades

Mapp ing current & future sta te p roc esses

Long -range p lanning & Impac t ana lysis

Sup p ly c ha in integ ration

Rev ising strategy in response to leg isla tion and ind ustry shifts


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TERMS & LEGISLATION


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Trac eability Defined

Trac eability is the ab ility to TRACK FORWARD, (item levelserialized produc t), the m ov em ent throug h spe c ified stag e(s) o f

the extend ed sup ply cha in and TRACE BACKWARDS the histo ry,applic ation or loc ation o f tha t whic h is under c onsideration

GS1 GTSH 1.0.0 Feb-2009


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California

Serialization & e-PedigreeItem leve l seria lization, sm allest distribute d unit

Elec tronic pedigree , passed in interop erable fo rm at for eac h

transaction of ownership change

50% of a m anufa c turers produc ts by Jan. 1, 2015100% of a m anufa c turers produc ts by Jan. 1, 2016

Wholesalers and re-pa c kagers must ac c ep t and forwardproduc ts w ith e -Pedigree by July 1, 2016

Pharm ac y and pha rm ac y wa rehouses m ust ac c ep t and p asse-Pedigree by July 1, 2016

Non Com plianc e?Civ il fines, injunc tions and / or c rimina l p rosec ut ion

Fines up to $5,000 PER OCCURRENCE*

*Eac h sa leab le unit is co nsidered an o cc urrence.


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8 MYTHS & LESSONSLEARNED


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Lesson:

Cross func tiona l, ho listic v iew

Myth #1 Its a (fill in the b lank) Projec t


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Lesson: Don t p ic k a solution until you know the p rob lem.

Choose stra teg y before tac tic .

Myth #2 Pic k a c ard, any c ard


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Could vs. Should

Over-stretched sta ff

Time, tra ining and temperament Ramp up time vs Next Step

Myth #3 Internalize strategy development projec ts

Lesson:Leverag e industry expe rienc e and knowledg e


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3 Phase Trac eability Readiness

Strat eg y

Planning

Implementation

Gap Analysis

Process Mapping

Business Process Analysis

Current State/Future State Evaluation

Review Commercial Relationships

Strategic Impact Analysis

Cost-Benefit Analysis

Business Value Propositions

Traceability Architecture Development

Strategic Solutions

Systems Recommendations

Solutions Provider Analysis

User Requirements

Functional Requirements

Long Term Planning & Forecasting

Solutions Provider Selection

Project Management

GS1 Standards Conversion

Internal Test & ValidationTrading Partner Connection

Piloting


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Lesson:

Beg in w ith the end in mind. You w ill get the system you p lan for.

Myth #4We just need to get c ompliant,then well find value.


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Real World : Real Value

With inc reasing c osts o f drug de velopm ent, find ing ways to b oost m arket shareof existing brande d drugs whic h have gone o ff pa tent w as of prim e c onc ern, as

brand ed drugs hav e highe r prem ium tha n c om pe ting g ene ric s.

Challenge: Flat sa les and generic equiva lents Current system too c ostly. Need seria lization c om patib ility

Scope of Work: System rep lac em ent Item leve l seria lization Identify business value


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Real World: Real Value

Results:Seria lization m itigated future regulatory c onc erns

700 Clinic Pilo t

Authentication achieved

Autom ated softw are for d ispenser,Direc t b illing to Med ic areInventory fulfillm ent

Patient Sc he dulingReduc ed c ustom er serv ic e staff 40%

3% inc rease in overa ll m arket sha re

Extensib le to othe r produc ts and div isions


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Lesson:

Dev elop a stra tegic business p lan

Understa nd c ost, imp act a nd w orkflow c hanges effec ted

Stra tegy to full implementation 6months-3 yea rs

Myth #5 Time is on my side


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Myth # 6 Virtual Manufac turer

My timeline is shorter.

Less time? Mayb e.No owne rship of line s to seria lize.

Contingencies: Are the CMOs/ Pac kag ers on your tim eline? When w ill the y be ready to p ilot? Test? Integ rate? What so lution w ill ea c h CMO go w ith? Who is responsible c ontrac tua lly for seria lization? How do you want to rec eive the serialized prod uc t d ata ?

How do the y wa nt to send the serialized prod uc t da ta? (All of them ?) How im portant is your business to the m ? Them to you? Are they w illing to be guide d by your c om pa nyi, or do you have to ac c ep t

their solution? Ca n yo ur system s seam lessly integrate w ith 40+ tec hno log y system s

Has yo ur c omp any c onducted aTrac k & Trac e Readiness Ana lysis?

Yes

NoUnsure


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Wa iting onCa lifornia de laying a 3rd t ime

Universa l st and ards

FDA guidelines

Technology

Big pha rma

TPCM/ TPCP

A w hit e unicorn

Lesson:

The ac tiv ities from stra tegic business planning are evergreen.

Oppo rtunities are found when you are looking for them .

Myth #7We need more c larity on


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Identify new value in projec ts

ReceiveIngredients

BulkDrug

Proc essingPackaging

DistributionCenter


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Reduc e Days on Hand Inventory

Challenge:Nee d to red uc e Days on Hand (DOH) costsassoc iated w ith exc essive inv ento ry in the wronglocations.

Business Value:Nea r rea l tim e inte rna l view of ingredients and produc t in p rogress andhistoric al d ata

Monitoring of key proc ess c hanges as they oc c ur, exped iting thec onfirm ation of the ena c ted im prov em ents

Red uc tion in site spe c ific invento ry to m atc h prod uc tion level de m and

Decrease in manufacturing times and reduction in warehousing space


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Lesson:Id entify and quantify the non-com pliance benefits

Insta lling a business system, not a compliance p ro jec t

Myth #8 Leadership wont fundthe projec t until they have to

"In a wo rld w here outc om es c ount for ev erything, its notm olecules that c rea te value but, rathe r, the ability tointegrate d ata , p roduc ts and serv ices in a c oherentbusiness o ffe ring .

- Pw C, Pha rma 2020: Sup p lying t he Fut ure


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Immediate ROI OpportunitiesAsset V isib ility, Tracking & Utiliza tion

Issue Resolut ion and Opportunities

Rea l Time Response

e-Ped ig ree & A uthentica tion Cap ture

Lev erage Captured Data for Improv ements in;Rev enue Ga ins in Sa les & Ma rketingInv entory Cont rolCyc le time reduc tions

Log ist icsSeria lized return & cha rgeb acksSpeed import/ export ap prova lsSup p ly Cha in Q AHuman workflow mana gement

Recall Management

Ident ifica tion of Div ersion & Counterfeiting


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Improved AdherenceChallenge:Ma nufa c turer losing o pportunities in a self-injec tab le b etw een Physic ianRec om m endation & Dec ision Day (b y pa tient) as well as the tim e linebetween Prior Autho rization & Bene fit Ve rific ation.

Physician Rec ommendat ion

Decision

Day Patient

PriorAuthorization Insuranc e

Denial

BenefitVerification Approval

Delivery Adherence

30-60 Day Cyc le


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Improved Adherence

Business Value Highlights;-Provided w eb ba sed educ at ion and financ ial assist anc e t o pat ient t o acc elerat e Decision Day choice

-Integ rated w it h EHR s and Third Party Providers t o rema in HIPAA c omp liant

-Op t -in at c linic level by pa t ient s for ma nufac t urer provided ed uca t ion, t hird pa rt y ma rket ing and pre-popula t ed benefit s forms for benefits.

-Dec ision Day t o Prior A ut horizat ion goes from a n end less loop t o 20 minut es rat her t ha n 1-2 mont hs.

-Aut omated Prior Aut horiza tion & Benefit Verifica t ion p rocess reduc ing Dec line t o PA Sub mission t o Approva l30-60 da ys t o 72 hours.

-Increased c linic and pa t ient a dherence.

Physician Recommendation

Decision

Day Patient

PriorAuthorization Insuran ce

Denial

BenefitVerification App rov al

Delivery Adherence

4-6 Day Cyc le


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Lesson:

You do nt know what you don t know

Prop er strategic planning and alloc ating eno ugh time for

a full p ilot is c ritic a l

Myth #8 Piloting is a formality-Plug & Play

Tem porary system s Volume c onsiderations Data share w ith trading partners Exc ep tion ha ndling

Line jam s Lab el c hange s Interna l data integ rity Integration o f third parties Rec eipt and Sending of serialized data


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Traceability is new in pharma (even to the p roviders)

-You don t know w hat you d on t know. Use our learning curve

Technology interoperab ility a nd Data share

Ma gnitude of work

-GS1 St and ardiza t ion (GTINs, GLNs) -Workflow p rocess cha ng es

-Business Rules -Commerc ial Rela t ionships

-Imp act : Cost , Process, Fac ilities -Pilot t est ing

-Trad ing pa rt ner int eg ra t ion -Excep t ion rep orting

Regulatory deadline

-36 months

Availab ility of ta lent

-Limit ed # of resources w it h experienc e

Identify business value/ ROI in ad vance to capture It

Why Start Today


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Next Steps


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Questions? Need More Information?

Mic hael Stewart

Cell (815) 403-8425

Offic e (847) 281-8924

m stew art@pharm tec hinc .com

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8 Myths That Can Derail Your e-Pedigree Traceability Project

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