Establishing the Supply Chain A Small Company Perspective Biomedical Technology Club March 7, 2006.

Establishing the Supply Establishing the Supply ChainChain

A Small Company PerspectiveA Small Company Perspective

Biomedical Technology ClubBiomedical Technology Club

March 7, 2006March 7, 2006

S. PondellMar 7, 2006

TopicsTopics

Encysive BackgroundEncysive Background Small Company ChallengesSmall Company Challenges Supplier SelectionSupplier Selection Technical TransferTechnical Transfer Contracts and Quality AgreementsContracts and Quality Agreements Relationship ManagementRelationship Management


Encysive SettingEncysive Setting

Small company (200 people)Small company (200 people) In-house compoundIn-house compound

Orphan drug, small volume, small Orphan drug, small volume, small moleculemolecule

Commercialization planned and Commercialization planned and underwayunderway


PerspectivePerspective

Company survival goes with product Company survival goes with product successsuccess

Risk-taking is minimized, if possibleRisk-taking is minimized, if possible Agency requestsAgency requests Information for filingsInformation for filings

Small fish conceptSmall fish concept Effort needed to stay visible to suppliersEffort needed to stay visible to suppliers


The TeamThe Team Process ExpertsProcess Experts

APIAPI FormulationFormulation

Analytical ExpertAnalytical Expert Quality AssuranceQuality Assurance Project ManagementProject Management RegulatoryRegulatory


Challenges for Small Challenges for Small CompaniesCompanies

PrioritiesPriorities MoneyMoney Company success and survival!Company success and survival! Time to marketTime to market Clinical resultsClinical results Big tasks can paralyze multi-taskingBig tasks can paralyze multi-tasking



FinancialFinancial

Feast or famineFeast or famine Manufacturing costs probably not Manufacturing costs probably not

major piecemajor piece Cash flow will direct timing of Cash flow will direct timing of

decisionsdecisions



Technical ExpertiseTechnical Expertise

Experts may be limited in breadth of Experts may be limited in breadth of experienceexperience

Heavier use of consultants and Heavier use of consultants and reliance on themreliance on them

No backup for key peopleNo backup for key people


Challenges for Small Challenges for Small CompaniesCompaniesDecision MakingDecision Making

Fewer decision makers – quicker Fewer decision makers – quicker turnaroundturnaround

BUTBUT Analyses of decision may not be as Analyses of decision may not be as

thoroughthorough Relationships vitalRelationships vital First proposals may be only chanceFirst proposals may be only chance First impressions criticalFirst impressions critical

May be short-term focusedMay be short-term focused


Supplier SelectionSupplier Selection

Dependent on stage and size of drugDependent on stage and size of drug More control necessary in earlier More control necessary in earlier

phasesphases Find suppliers who specialize in that Find suppliers who specialize in that

stagestage Few people – time to travel and time Few people – time to travel and time

out of office are important factorsout of office are important factors


Supplier SelectionSupplier Selection

Local representation for offshore Local representation for offshore suppliersupplier

Very dependent on background of Very dependent on background of sponsor’s technical expertsponsor’s technical expert Past relationshipsPast relationships Out-reach by suppliersOut-reach by suppliers

Language can be an issueLanguage can be an issue


Tech TransferTech Transfer

Pre-clinical to clinical to commercialPre-clinical to clinical to commercial Development expertise to Development expertise to

commercial expertisecommercial expertise Find suppliers with core competenciesFind suppliers with core competencies

Firms may be competitorsFirms may be competitors AwarenessAwareness Facilitate issuesFacilitate issues



Takes longer than you thinkTakes longer than you think More expensive than you thinkMore expensive than you think Costs at both endsCosts at both ends



Formal technical transfer protocolsFormal technical transfer protocols Who initiatesWho initiates Who signsWho signs Who has the expertiseWho has the expertise


ContractsContracts

Points to ConsiderPoints to Consider Set key points before work begunSet key points before work begun Finalize contracts while there were Finalize contracts while there were

optionsoptions Leverage continued to diminish as time Leverage continued to diminish as time

went onwent on Make it a priority, or it won’t happen. Make it a priority, or it won’t happen. Supplier wins when negotiations drag.Supplier wins when negotiations drag.


Quality AgreementsQuality Agreements

Very necessary Very necessary Tied into ContractsTied into Contracts Up-front audit makes for less surprisesUp-front audit makes for less surprises

Reputable suppliers are a keyReputable suppliers are a key Checklist or contract formatChecklist or contract format Typical issuesTypical issues

Regulatory auditsRegulatory audits Degree of controlDegree of control Product releaseProduct release


Relationship Relationship ManagementManagement

Key point person – each wayKey point person – each way Involved in every interactionInvolved in every interaction YOU may be continuityYOU may be continuity


Relationship Relationship ManagementManagement

Project manager takes many rolesProject manager takes many roles Keep emotions in checkKeep emotions in check

FacilitatorFacilitator ScheduleSchedule ScopeScope

EnforcerEnforcer Contract negotiationsContract negotiations Schedule slippageSchedule slippage


Points to ConsiderPoints to Consider

Flexibility in expectationsFlexibility in expectations Visibility to suppliersVisibility to suppliers Choose suppliers wiselyChoose suppliers wisely Get the contracts in placeGet the contracts in place


Points to ConsiderPoints to Consider

Know who the Project Managers will beKnow who the Project Managers will be Use all the skills in your organizationUse all the skills in your organization Get the commercial support Get the commercial support

organization in place as soon as possibleorganization in place as soon as possible


SummarySummary

Know what you want and needKnow what you want and need Reach for help - consultantsReach for help - consultants Select companies that “do this Select companies that “do this

for a living”for a living” Assure that both you and your Assure that both you and your

supplier can prospersupplier can prosper


QuestionsQuestions

Contact Information:Contact Information:

Steve PondellSteve Pondell

[email protected]@encysive.com

(713) 578-6549(713) 578-6549

Establishing the Supply Chain A Small Company Perspective Biomedical Technology Club March 7, 2006.

Documents

Transcript of Establishing the Supply Chain A Small Company Perspective Biomedical Technology Club March 7, 2006.