8 Myths That Can Derail Your e-Pedigree Traceability Project
Transcript of 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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9
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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