Managing the Safety Lifecycle of Your Product

Considerations for Stages of Development

Product Safety – A Necessary Evil

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“Of course the death was

study-related, he was reading

the product information sheet

when the bus hit him.”

Evaluation of Safety Needs

Obligation to actively monitor safety throughout clinical

development and marketing of a product

Corporate considerations

Product pipeline

Internal resources

Capital

Goals

Requirements may be product specific

Regulatory Filing Strategy

Country- or region-specific

Global registration plan

Compliance drives pharmacovigilance strategy

3

Product Safety Roadmap

4

Pre-clinical data

Toxicology Clinical trial

data

Post marketing

safety

Risk management

Safety profile develops over time

Start with the end in mind: Product Label

Safety Management Considerations

Corporate & Regulatory needs No. of products

Regulatory requirements

Safety Data Exchange requirements

Resource expertise & availability IT staff

Safety/Pharmacovigilance staff

Cost IT infrastructure

Software costs & licensing

Security, back up, maintenance, patches & upgrades

Flexibility Safety case processing customization

Reporting

Scalability

5

Safety Team

CMO / Safety Physician

Reg. Affairs

PV / Drug Safety

IT

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Clinical Development

Legal

Medical Writing

Safety Database Considerations

Initial Safety “Database” = Excel spreadsheet

Manual tracking of events

SAE narratives as Word documents

Expedited Safety reports completed manually

Large commercial system

Oracle® Argus, Arisg™, etc.

Other drug safety management software

PcVmanager, PRIMO, etc.

Internally developed safety database

Access to business partner solution

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Safety Database Considerations

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Manual

- Inexpensive

- Min. technology

- Low volume

- Time consuming

- Lacks reporting

- Limited scalability

COTS

- Functionality

- Tracking & Reporting

- Data mining

- Module add-ons

- Product options

- Cost

- IT expertise needed

- Maintenance

- Committed

Proprietary

- Highly customized

- Internal expertise

- Lower capital expense

- Software dev. expertise

- Maintenance

- Regulatory intelligence for required updates

Business Partner

- Easily accessible

- Cost sharing

- Flexibility

- Established platform

Safety Database Implementation: In-house or Hosted Solution

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• Purchase

• Install / Configure / Validate / Maintain

• Sponsor case processing

In-house

• Vendor hosts safety database

• Configure / Validate / Maintain

• Sponsor case processing

Software-as-a-service (SaaS)

• Hosts safety database

• Configure / Validate / Maintain

• Vendor case processing

Vendor

Safety Implementation Considerations

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In-house

- Control

- Customized

- Sponsor processes

- Cost

- Maintenance

- Resources needed

SaaS

- Limited capital investment

- Minimal Sponsor IT expertise

- Configuration limitations

- Mixed tenant environ.

- Security (Cloud)

- Safety resources

Vendor

- Limited capital investment

- Minimal Sponsor IT expertise

- Limited Sponsor resources needed

- Vendor management

Considerations for Successful Outsourcing

Regulatory compliance Electronic systems

Database installation, validation, change control

SOPs for outsourced tasks

Expertise of staff Significant experience

Ongoing training

Sufficient resources to handle work load

Detailed scope of work Clearly defined responsibilities, tasks & deliverables

Desired level of service

Level of Sponsor involvement

Flexibility

Communication

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Safety Management Evolution: Case Study

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Phase I

• Single product in development

• Tracking of SAEs in Excel, manual processing

• Low volume of SAEs (< 20 cases)

Phase II

• Vendor hosted safety database

• Case processing & reporting by vendor

• Sponsor provided oversight

Phase III

• Sponsor added PV staff, shared case processing

• Acquired product(s)

• Vendor migration of safety data

Market Approval

• Sponsor expanded staff & PV activities

• Vendor hosted database & provided safety support services

• Electronic exchange of ICSRs between parties

Safety Monitoring – Beyond ICSRs

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Ongoing Safety Data Monitoring

Aggregate Analysis

Benefit-risk Assessment

DSUR (Development Safety

Update Report)

Business Partner Safety Data Exchange

Documentation

• SOPs

• Activities

• Outcomes

Clinical Safety to Post Marketing Pharmacovigilance Transition

ICSR case processing continues

Increase in case volume

Decrease in case detail

Reports directly from patient, HCPs, sales staff, etc.

Additional case types: Product complaints, Med errors

Regulatory reporting obligations change

Medical Information needs

Extensive training of staff on Safety reporting

DSUR PSUR/PBRER

RMP requirements

Safety profile continues to develop

Labeling changes

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Safety Lifecycle Management

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Tips for Success

Safety Management

Roadmap

Flexibility / Scalability

Resource Appropriately

Outsource

Document

Compliance

Maureen Duff, PharmD

Senior Director Medical Operations