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Commercialization Planning: The Project Manager's Role in a Successful Product Launch
Anna Crivici, Ph.D.Vice President, Project Management & Business Process DevelopmentAmylin Pharmaceuticals, Inc.
June 11th, 2008 presentation to:
Objectives
How can / do biopharm companies leverage PM during commercialization planning?
How can PMs from R&D prepare themselves to p ptransition with project to commercial world?
How do project managers partner with productHow do project managers partner with productmanagers / directors?
A. Crivici / PM in Pharmaceuticals – 11 June 2008 2
Conclusions
• PM adds tremendous value to commercial projectsp j> Acceptance still a challenge> Value added in many, many ways – especial planning
• PM skills, practices, standards are transferrable> Technical PM skills critical> Soft / interpersonal skills more critical
• Moderate subject matter / domain knowledge needed> Mostly marketing, medical affairs> Can be developed
A. Crivici / PM in Pharmaceuticals – 11 June 2008 3
Outline
• Background: Amylin, Amylin PM, projects & teamsg y , y , p j
• Commercial teams, team members, team lead, PM
Addi l K l t f i l• Adding value: Key elements of commercial planning
f f• Where to go for more information
A. Crivici / PM in Pharmaceuticals – 11 June 2008 4
Amylin Pharmaceuticals, Inc.Challenging Science Changing Lives
Mission:
Challenging Science. Changing Lives.
Amylin is a biopharmaceutical company dedicated to improving lives of patients through the discovery, g g ydevelopment and commercialization of innovative medicines.
Founded in 1987IPO in 1992 (NASDAQ: AMLN)~2100 employeesHeadquartered in San Diego
f f O
A. Crivici / PM in Pharmaceuticals – 11 June 2008 5
Manufacturing facility in Ohio
Amylin’s Commercial Products for Diabetes
SYMLIN® (pramlintide acetate) APPROVED in US - March 2005
> For insulin-using type 2 and type 1 diabetes not properly controlled with optimal mealtime insulin therapy
BYETTA® (exenatide) APPROVED in the US - April 2005BYETTA (exenatide) APPROVED in the US April 2005
> For type 2 diabetes as adjunct to oral anti-diabetic agents > Partnership with Eli Lilly & Company
A. Crivici / PM in Pharmaceuticals – 11 June 2008 6
The Building Blocks of our Product Strategy
ChronicTherapies
Peptide &Protein
HormonesDrug Delivery
A. Crivici / PM in Pharmaceuticals – 11 June 2008 7
Major Stages in Bringing New Medicines to Market
IDEA PATIENT
PostLaunch
Submission& ApprovalPhase 3Phase
2bPhase
2aPhase
1INDPrepDiscovery
Discovery Early DevelopmentProof-of-Concept
Full DevelopmentRegistration Track
Marketed ProductsLine Expansions,
Product Enhancements
Research Product Supply
A. Crivici / PM in Pharmaceuticals – 11 June 2008 8
Definition of a Project & Product at Amylin
molecular entitymolecular entity
Type 2 Diabetes+
target disease+
d t t tiproduct presentation
A. Crivici / PM in Pharmaceuticals – 11 June 2008 9
The Path from Idea to Patient
IDEA PATIENT
PostLaunch
Submission& ApprovalPhase 3Phase
2bPhase
2aPhase
1INDPrepDiscovery
A. Crivici / PM in Pharmaceuticals – 11 June 2008 10
Our Business Decision Points
IDEA PATIENT
PostLaunch
Submission& ApprovalPhase 3Phase
2bPhase
2aPhase
1INDPrepDiscovery
CharterNew Project
Go to FullDevelopment
Go toPhase 3
Go to Regulatory
Go toLaunch
(Go to IND) Submission
A. Crivici / PM in Pharmaceuticals – 11 June 2008 11
Scope of PM at Amylin
IDEA POC LAUNCH LOEIND
Research Early Development
Commercial& Lifecycle
Full Development
IDEA POC LAUNCH LOEIND
cross-functional
teams
major subteams
A. Crivici / PM in Pharmaceuticals – 11 June 2008 12
Amylin’s Project Management & Business Process Development Organizationp g
Reports to SVP, Corporate Development(part of executive team)
VP
Project Management • Systems, tools, standards, processes, training
VPPM-BPD
R&D Project Management
CMC Project Management
Project Management Office
y , , , p , g• Corporate initiative PM
Commercial Project ManagementManagement Management
• Research Team PM• Drug Development
Team PM
• CMC-Dev’t Subteam PM• Commercial Supply
Team PM
• Brand Team PM• Subteam PM
Management
Business Process Development
• Subteam PM
• Leadership, project management, process engineering for new & improved business processes company-wide
• Subteam PM
A. Crivici / PM in Pharmaceuticals – 11 June 2008 13
Development new & improved business processes, company-wide
Team Evolution
IDEA PATIENT
PostLaunch
Submission& ApprovalPhase 3Phase
2bPhase
2aPhase
1INDPrepDiscovery
S l
Early Full
Supply Team
Research Early Development
Core Team
Full Development
Core TeamBrand Team
Research Team
A. Crivici / PM in Pharmaceuticals – 11 June 2008 14
Team
Full Development CommercializationBrand & Supply Teams form during phase 3Brand & Supply Teams form during phase 3
PostLaunch
Submissionand ApprovalPhase 3Phase 2b Launchand Approval
Full Dev’t Core Team
Brand Team
Full Dev’t Core Team
Functional area subteams
e g Commercial
R&D Core Team
Brand Team
Supply Team Supply
Team
e.g., Commercial CMCClinical
A. Crivici / PM in Pharmaceuticals – 11 June 2008 15
Projects / Products, Teams
PostLaunch
Submissionand ApprovalPhase 3Phase 2bPhase 2aPhase 1IND PrepDiscovery
IDEA PATIENT
Launchand Approval
Discovery Early Developmentproof-of-concept
Full Developmentregistration track
Marketed Productslabel expansion, new
indications
P j t / P d t
Type 2 Diabetes
Exendin-4
+ +
Project / Product
e.g.
Cross-Functional TeamsBrand T
Early Full Matrix
Team
Supply Chain
A. Crivici / PM in Pharmaceuticals – 11 June 2008 16
yDevelopment
Core TeamDevelopment
Core TeamTeam Chain
Team
Teams, Team MembersTeams, Team Members
A. Crivici / PM in Pharmaceuticals – 11 June 2008 17
Key Roles & Responsibilities
Team Leader
• Leads the team and drives the overall project• On behalf of the team “owns” the project plans &Leader • On behalf of the team, owns the project plans &
deliverables• Represents senior management perspective on the
team; i.e., aligns project work with corporate objectives)team; i.e., aligns project work with corporate objectives)• Represents & reinforces overall project perspective• Leads project-level trade-off decisions• Escalates decisions and / or issues appropriately
Team Member
• Plans and directs functional activities for the project• Negotiates resource needs and assignmentsMember • Negotiates resource needs and assignments• Acts as a project communication focal point and
facilitates information exchange; represents their line on the project & project to their line
A. Crivici / PM in Pharmaceuticals – 11 June 2008 18
on the project & project to their line
Key Roles & Responsibilities…
Project Manager
• Manages time, cost, scope & quality of project• Drives preparation of an integrated plan and manages itManager p p g p g• Focuses the team on successful planning, execution &
follow-up• Facilitates team & team-line interactions• Facilitates team effectiveness & team performance• Champions our business processes and mentors the team
in their application
Line Manager / Line
• Defines functional strategies• Establishes functional processes, standards, and tools• Delivers on project commitmentsLine p j• Represents & reinforces overall line perspectives• Ensures the quality of deliverables; conducts appropriate
subject-matter content reviews
A. Crivici / PM in Pharmaceuticals – 11 June 2008 19
• Recruits, trains, and mentors staff• Assigns staff to projects and to specific tasks
Alignment of Roles & Responsibilities
Each member of the Project Team or Subteam…
Represents their f ti l t th
Team or Subteam
Project(Team /
functional area to the project & team / subteam
Subteam Member
Subteam)
Functionaland…
R t th j tFunctional Area
(Dept / Group)
Represents the project to their functional area or department
A. Crivici / PM in Pharmaceuticals – 11 June 2008 20
p
Structure & Role of Core Project TeamsIND preparation through NDA approval and launch
Regulatory/Quality
CMC
Pre-Clinical Project
Team LeaderCMC
ClinicalProject
Manager
Commercial
A. Crivici / PM in Pharmaceuticals – 11 June 2008 21
Typical Brand Team – for illustration
FinancePricing &
Reimburse-Managed
CareSales
a ce
Clinical
Reimburse-ment
Brand Team Lead
MarketingMedical Affairs
Lead
Brand PM
Supply Regulatory
Health Outcomes
Market Research
pp y
Customer Pharmaco-vigilenceBusiness
A. Crivici / PM in Pharmaceuticals – 11 June 2008 22
LegalService vigilenceBusiness Analytics
Typical Brand Subteams – for illustration
Regulatory
Marketing Subteam
Label Subteam
g ySubteam
Brand Team Core
Publications Subteam
Medical Affairs
SubteamSupply Team
Core
ExtendedClinical
SubteamNew Device
Subteam CMC Clinical Study Teams
R&D TeamSubteam
A. Crivici / PM in Pharmaceuticals – 11 June 2008 23
Roles & responsibilities of the Commercial PMRoles & responsibilities of the Commercial PM
A. Crivici / PM in Pharmaceuticals – 11 June 2008 24
Role of Commercial PM
facilitate ~ integrate ~ drive ~ communicate ~ be accountable
• Work directly with Brand Team on cross-functional projects / programs in Sales, Marketing, Medical
P t ith B d T L d P d t M / Di t• Partner with Brand Team Lead = Product Manager / Director
• Develop / drive high performance of Brand Team & subteams
• Manage scope schedule costs quality risks of projects• Manage scope, schedule, costs, quality, risks of projects
• Manage stakeholder expectations & communications
• Manage project planning execution monitoring control close-outManage project planning, execution, monitoring, control, close out
• Interface with R&D & Supply Team PMs on relevant projects to drive continuity & integration in planning & execution
A. Crivici / PM in Pharmaceuticals – 11 June 2008 25
Role of Commercial PM…
Scope Define / manage brand planning processDefine roles & responsibilitiesProject kick-off(s)Framing decisionsDeveloping strategy & tactics
Schedule Develop & manage individual & integrated timelines (program, project, sub-project)Monitor & report progress / statusManage change control
Cost Develop budget(s)Monitor & report statusManage change control processPrimary liaison with Finance
A. Crivici / PM in Pharmaceuticals – 11 June 2008 26
Role of Commercial PM…
Stakeholders Partner with Brand Lead (“COO” / “CEO”)Develop / manage chartersFacilitate / manage meetings (pre / during / post)Develop / manage / troubleshoot team performanceTroubleshoot team interface challengesManage & communicate team / subteam structureFacilitate decision making (team, governance, line)Manage / facilitate stakeholder communications (reports, presentations)
Risk / Issues Develop, manage, report risks & issues maps, plansDevelop, manage contingency & mitigation plansMonitor risks, issues
Quality Identify customer / stakeholder requirementsDefine critical success factors, metrics
A. Crivici / PM in Pharmaceuticals – 11 June 2008 27
Monitor quality of process, project, deliverablesManage exception / escalation plan
Job Description – Brand Team PMFor illustration onlyFor illustration only
JOB REQUIREMENTS:• BS or MS degree in biological, life sciences, or marketing (MBA a plus).
• At least 5 years of experience in project management, pharmaceutical drug development, new product commercialization, brand management or marketing in the pharmaceutical or biotech industries.
• Knowledge of project management principles. Must have experience with project management activities either in a formal project management position or through matrix project management responsibility Ability to organize technical projectsmatrix project management responsibility. Ability to organize technical projects and manage multiple sub-projects simultaneously.
• Excellent interpersonal, organizational, negotiation and communication skills. Ability to exert influence diplomatically and have an impact across multiple levels
d li i d t id f th i ti ith t di t th itand lines in and outside of the organization without direct authority.
• Expert skills in Excel, MS Project and similar software programs. Experience working with external alliance partners a plus.
A. Crivici / PM in Pharmaceuticals – 11 June 2008 28
Job Description – Brand Team PM…For illustration onlyFor illustration only
SUMMARY OF POSITION:• The Brand Team Project Manager partners with the Brand Team Leader and
Marketing Directors to manage cross-functional activities of the Brand Team to meet the objectives, milestones, timelines and budget for one or more
d i l t t d l t i li b dcompounds in late stage development or an in-line brand.
• Works with all levels of the organization, including corporate partners, to provide cross-functional project management for assigned project teams or major subteamssubteams.
• Prepares and maintain integrated cross-functional project plans, monitors execution and reports status.
• Prepares and maintains major team documents.
• Collaborates in portfolio and life-cycle planning efforts.
A. Crivici / PM in Pharmaceuticals – 11 June 2008 29
Job Description – Brand Team PM…For illustration onlyFor illustration only
TASKS AND RESPONSIBILITIES:• Manage selected projects or major subteams.
• Partner with the Brand Team to develop the overall strategy and plans. The Project Manager will develop, track / control and report progress against plan (timeline, budgets, planning documents, risk management plans, etc.) for assigned projects.planning documents, risk management plans, etc.) for assigned projects.
• Ensure coordination and integration of brand plans with development plans and timelines.
• Meeting management (meeting organization, facilitation, logistics, agendas, minutes, pre-meeting materials) as necessary, including Brand Team meetings and joint meetings with corporate partners.
• Proactively follow up with team members regarding progress on action items. Evaluate interim progress and identify areas that may need extra attention to ensure timely completion.
• Coordinate production of major team documents and project plans. Manage team documents in the electronic document management system.
• Interfaces with the project managers on the Core Drug Development Team, Launch Supply Team and other sub-team project managers on the assigned project Represents project
A. Crivici / PM in Pharmaceuticals – 11 June 2008 30
Team, and other sub team project managers on the assigned project. Represents project management for Commercial and Marketing on the project.
Job Description – Brand Team PM…
SKILLS AND QUALIFICATIONS:• Strong knowledge of project management principles and practices.
• Strong knowledge of drug development, product commercialization and/or commercialization planning.
• Strong interpersonal skills: communications, negotiations, conflict resolution, influence, and impact without direct authority.
• Expert skills in Microsoft Excel, MS Project and similar computer programs.p j p p g
A. Crivici / PM in Pharmaceuticals – 11 June 2008 31
Where can PM add good value?Planning, planning, planning
A. Crivici / PM in Pharmaceuticals – 11 June 2008 32
Decisions & Business Planning
SET
Portfolio Plan
Strategic Plan
SET STRATEGY
Forecasting
Plan
Brand & Project Plans
Adjustment
Functional Plans
Budget Management
Reporting
Review & Analysis
udgetPlan
Operational Reporting
Reporting
EXECUTE
A. Crivici / PM in Pharmaceuticals – 11 June 2008 33
Critical Commercial Plans
• Label
• New Product Plan
• Launch Readiness Plan
• Lifecycle Plan
A. Crivici / PM in Pharmaceuticals – 11 June 2008 34
Evolution from product profile to labelEvolution from product profile to label
A. Crivici / PM in Pharmaceuticals – 11 June 2008 35
Typical Target Product Profile
Key Attributes of Product Candidate
Compound class
Mechanism of actionMechanism of action
Efficacy & product benefit
Safety & tolerabilitySafety & tolerability
Dosing / administration / regimen
Delivery system / productDelivery system / product presentation / market configuration
Pricing / cost of goods (COGs)
A. Crivici / PM in Pharmaceuticals – 11 June 2008 36
g g ( )
Evolution of Target Profile → Product Label
PostSubmission
IDEA PATIENTPost
LaunchSubmission
and ApprovalPhase 3Phase 2bPhase 2aPhase 1IND PrepDiscovery
Target Candidate
Profile
Target Product Profile
Target Product Profile
Approved Label /
Package InsertProfile Profile Insert
Target
Draft Label /
Package InsertCore Core
DTarget Tx Area Profile
InsertData
SheetCore Data
Sheet
Data Sheet
A. Crivici / PM in Pharmaceuticals – 11 June 2008 37
Sheet
Development of the commercial planDevelopment of the commercial plan
A. Crivici / PM in Pharmaceuticals – 11 June 2008 38
Elements of Brand Management
St t i P f i l C M k t
Brand Strategy
Positioning & messaging
StrategicDecisions
Sales force strategyM di l ff i / d
Professional Segment
Consumer strategy
Consumer Segment
• Positioning & messaging
MarketShaping
messagingPricing decisionsLifecycle management decisions
Medical affairs / med education strategyReimbursement strategyHealth outcomes
messaging
Health outcomes strategy
Prod ct strateg e ec tion Field force e ec tion Prod ct in entor management
Execution
A. Crivici / PM in Pharmaceuticals – 11 June 2008 39
▪ Product strategy execution ▪ Field force execution ▪ Product inventory management
Source: Deloitte Consulting LLP analysis and interviews
Major Elements of Commercial Program
• Message / value proposition
• Product positioning
• Market dynamics & shaping
• Consumer marketing
• Professional education (peer-to-peer)
• Price, access & reimbursement
• Sample strategy & execution
• Sales force allocation & execution
• Product supply
A. Crivici / PM in Pharmaceuticals – 11 June 2008 40
Major Elements of a New Product Plan
• Background• Target Product Profile• Commercialization Strategy• Regulatory Strategy• Marketing Plan• Sales PlanSales Plan• Publications & Communications Plan• Medical Education Plan• Project Schedule & Costs• Risks & Issues
A. Crivici / PM in Pharmaceuticals – 11 June 2008 41
Elements of a New Product Plan - example
Background Medical, commercial environmentTherapeutic usePlanned patient population & sizeValue proposition (e.g., unmet / medical need)
Target Product Profile Mechanism of actionTarget Product Profile Mechanism of actionEfficacy & product benefitSafety & tolerabilityDosing / administration / regimenDosing / administration / regimenDelivery system / product presentation / market configurationPricing / cost of goods (COGs)
N P d t Pl Sit ti l iNew Product Plan Situation analysisSWOT analysisGoals & objectivesS &
A. Crivici / PM in Pharmaceuticals – 11 June 2008 42
Strategy & tactics
Elements of a New Product Plan - example …
Commercialization Strategy Portfolio fitCompetitive landscapeCommercial assessment / valuationStrategic decisions needed
Regulatory Strategy Regulatory landscapeegu ato y St ategy g y p
Label strategy / plansRegulatory submission strategy / plans
Marketing Plan Product description offering benefitsMarketing Plan Product description, offering, benefitsPositioning, messaging, brandingPlace (distribution channels)Price reimbursement access assistancePrice, reimbursement, access, assistance
PromotionPackaging / market configuration
A. Crivici / PM in Pharmaceuticals – 11 June 2008 43
Partnerships (if relevant)Key milestones, deliverables
Elements of a New Product Plan - example …
Sales Plan Strategy & sales force modelRecruitment, traininggCustomer supportSales operations plan
Key milestones deliverablesKey milestones, deliverables
Publication / Communication Plan
Strategy, tactics, ownershipAdvocacy developmentMessage → publications / communications mapMessage → publications / communications mapPR plansWorkshops, seminars, symposia plans & resource kits
F l kitFormulary kitSales aidsProduct monographC ’ /
A. Crivici / PM in Pharmaceuticals – 11 June 2008 44
Competition’s literature / publications
Elements of a New Product Plan - example …
Medical Education Plan Key medical / scientific messagesHealth outcomes strategy & tacticsgyHealthcare service providers strategyKOL strategyPatient advocacy messagesy g
Product Schedule & Resources
Timeline of key milestones, deliverables, events
Budget (internal, external expenses, capital)
Risk / Issues Plan Risks issues mapRisk / Issues Plan Risks, issues mapMitigation & contingency plans
A. Crivici / PM in Pharmaceuticals – 11 June 2008 45
Elements of a launch readiness planElements of a launch readiness plan
A. Crivici / PM in Pharmaceuticals – 11 June 2008 46
Major Elements of a Launch Readiness Plan
• Quality Systems• Packaging & Labeling• Manufacturing• Supply Chain• Commercial Readiness• Customer Support ServicesCustomer Support Services• Clinical & Regulatory• Finance & Legal
A. Crivici / PM in Pharmaceuticals – 11 June 2008 47
Launch Readiness Checklist - example
Quality Systems PAI readiness, executionSOPsResources, trainingRecall plan
Packaging & Labeling Container labelg g gPackage insertPatient instruction sheetCartonCarton ShipperPackage & label for not-for-sale samples
Manufacturing Vendor contracts readinessManufacturing Vendor contracts, readinessPre-launch inventoryTesting & release proceduresSamples
A. Crivici / PM in Pharmaceuticals – 11 June 2008 48
SamplesVolume forecasts
Launch Readiness Checklist - example …
Supply Chain Vendors contracts, readinessRaw materialsFinished product inventoryDistribution network
Sample distribution trackingSample distribution, tracking
Reverse chain
Commercial Readiness Sales demand modelN d t lNew product planMarketing planSales force readyDisaster recovery plan
Customer Support Services
Medical informationCustomer support center
A. Crivici / PM in Pharmaceuticals – 11 June 2008 49
Patient assistance programRecall management plan
Launch Readiness Checklist – for illustration…
Clinical & Regulatory Professional educationLabelTrade nameMarket licence(s)Safety surveillance / pharmacovigilencey p gPromotional materials review processMedical informationLaunch materials regulatory reviewLaunch materials regulatory review
Finance Reporting & accounting systemsBudgetControl systemsControl systemsLiabilities plan
Legal LicensesTrademarks
A. Crivici / PM in Pharmaceuticals – 11 June 2008 50
TrademarksLiabilitiesContracts
Elements of a lifecycle planElements of a lifecycle plan
A. Crivici / PM in Pharmaceuticals – 11 June 2008 51
Major Elements of a Lifecycle Plan
• Background• Lifecycle Roadmap• Opportunities & Investments• Decisions & Assumptions• Risks & Issues
A. Crivici / PM in Pharmaceuticals – 11 June 2008 52
Elements of a Lifecycle Plan - example
Background Molecule / product summary, historyIP estate & landscapePotential label, line, Tx area expansions / extensionsCompetitive landscape
Lifecycle Roadmap Label expansionsLifecycle Roadmap Label expansionsLine extensionsNew indicationsTimingTiming
Opportunity / Investment Table
Expected revenuesExpected investmentsNPVs / eNPVs of optionsNPVs / eNPVs of optionsTiming of investment & revenues
A. Crivici / PM in Pharmaceuticals – 11 June 2008 53
Elements of a Lifecycle Plan - example…
Decisions & Assumptions
Decision → outcome / rationale mapsPrioritization of opportunitiesSWOT of high priority opportunitiesMajor assumptions used in plan
Risk / Issues Plan Risks issues mapRisk / Issues Plan Risks, issues mapMitigation & contingency plans
A. Crivici / PM in Pharmaceuticals – 11 June 2008 54
Where to go to ready yourselfWhere to go to ready yourself
A. Crivici / PM in Pharmaceuticals – 11 June 2008 55
Other Resources
• Web sites:> www.fda.govwww.fda.gov> www.pharma.org> www.pdma.org > www.diahome.org
• Books: > Brand Planning for the Pharmaceutical Industry (2004), Janice Maclennan> Marketing Planning for the Pharmaceutical Industry (1999), John Lidstone &
Janice MaclennanJanice Maclennan
• Industry publications:> Pharmaceutical Executive> PharmaVoice> PharmaVoice> In Vivo
• Professional organization meetings, workshops, training courses
A. Crivici / PM in Pharmaceuticals – 11 June 2008 56
• University extension programs
Summary & conclusionsSummary & conclusions
A. Crivici / PM in Pharmaceuticals – 11 June 2008 57
Objectives
How can / do biopharm companies leverage PM during commercialization planning?
How can PMs from R&D prepare themselves to p ptransition with project to commercial world?
How do project managers partner with productHow do project managers partner with productmanagers / directors?
A. Crivici / PM in Pharmaceuticals – 11 June 2008 58
Conclusions
• PM adds tremendous value to commercial projectsp j> Acceptance still a challenge> Value added in many, many ways – especial planning
• PM skills, practices, standards are transferrable> Technical PM skills critical> Soft / interpersonal skills more critical
• Moderate subject matter / domain knowledge needed> Mostly marketing, medical affairs> Can be developed
A. Crivici / PM in Pharmaceuticals – 11 June 2008 59
Questions?
A. Crivici / PM in Pharmaceuticals – 11 June 2008 60