080611imp Prdct Presentation

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


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


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


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


The Building Blocks of our Product Strategy

ChronicTherapies

Peptide &Protein

HormonesDrug Delivery


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


Definition of a Project & Product at Amylin

molecular entitymolecular entity

Type 2 Diabetes+

target disease+

d t t tiproduct presentation


The Path from Idea to Patient

IDEA PATIENT

PostLaunch


2bPhase

2aPhase

1INDPrepDiscovery


Our Business Decision Points

IDEA PATIENT

PostLaunch


2bPhase

2aPhase

1INDPrepDiscovery

CharterNew Project

Go to FullDevelopment

Go toPhase 3

Go to Regulatory

Go toLaunch

(Go to IND) Submission


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


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


Development new & improved business processes, company-wide

Team Evolution

IDEA PATIENT

PostLaunch


2bPhase

2aPhase

1INDPrepDiscovery

S l

Early Full

Supply Team

Research Early Development

Core Team

Full Development

Core TeamBrand Team

Research Team


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


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


yDevelopment

Core TeamDevelopment

Core TeamTeam Chain

Team

Teams, Team MembersTeams, Team Members


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


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


• 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


p

Structure & Role of Core Project TeamsIND preparation through NDA approval and launch

Regulatory/Quality

CMC

Pre-Clinical Project

Team LeaderCMC

ClinicalProject

Manager

Commercial


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


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


Roles & responsibilities of the Commercial PMRoles & responsibilities of the Commercial PM


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


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


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


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.


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.


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


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


Where can PM add good value?Planning, planning, planning


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


Critical Commercial Plans

• Label

• New Product Plan

• Launch Readiness Plan

• Lifecycle Plan


Evolution from product profile to labelEvolution from product profile to label


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)


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


Sheet

Development of the commercial planDevelopment of the commercial plan


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


▪ 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


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


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 &


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


Partnerships (if relevant)Key milestones, deliverables


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 ’ /


Competition’s literature / publications


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


Elements of a launch readiness planElements of a launch readiness plan


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


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


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


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


TrademarksLiabilitiesContracts

Elements of a lifecycle planElements of a lifecycle plan


Major Elements of a Lifecycle Plan

• Background• Lifecycle Roadmap• Opportunities & Investments• Decisions & Assumptions• Risks & Issues


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


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


Where to go to ready yourselfWhere to go to ready yourself


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


• University extension programs

Summary & conclusionsSummary & conclusions


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?


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


Questions?


Documents

080611imp Prdct Presentation