Week 1 Video Discussion: Process Mapping for

Supply Chain Management

Process Map: Drug Development Lifecycle

Rafay Baig

September 8th, 2023

MGMT-757: Operations and Supply Chain Management

Overview: Process Mapping for Supply Chain
Management
 Drug Development Lifecycle
Drug development is a complex and highly regulated process in the
pharmaceutical industry. This presentation provides a simplified process map for
drug development.
Research and Discovery

01 Conduct preliminary research and identify potential drug

targets.

02 Identification of a potential drug target.

Preclinical Testing
● Promising drug candidates from research undergo in vitro and in vivo testing for safety
and efficacy.
Investigational New Drug
(IND) Application
● Positive preclinical results lead to the
preparation and submission of an IND
application to regulatory authorities for
approval.
Clinical Development

Phase I: Safety and dosage testing on Phase II: Efficacy and side effects Phase III: Large-scale clinical trials
a small group of healthy volunteers. testing on a larger group of patients. for further efficacy and safety
assessment.
New Drug Application (NDA) Submission
● Positive Phase III results lead to the preparation and submission of an NDA to
regulatory authorities for marketing approval.
Regulatory Review
● Regulatory authorities review the NDA for safety, efficacy, and quality standards.
Drug Approval

● Positive regulatory review results in the

grant of marketing approval for the drug.
Manufacturing Scale-Up
● After drug approval, the manufacturing team scales up production for commercial
manufacturing.
Market Launch
● Successful scaleup leads to the launch of the drug in the market, including distribution
and marketing campaigns.
Post-Market Surveillance
● After market launch, the pharmacovigilance team monitors drug safety, adverse events,
and efficacy in the market.
Lifecycle Management
● Based on postmarket surveillance findings, the
drug development team implements necessary
changes, conducts additional studies, and seeks
label extensions.
Patent Expiry and Generic Competition
● Upon patent expiration, the legal and business development team manages the entry of
generic competitors and explores new markets.
Product Sunsetting
● End of the product lifecycle triggers the strategic planning team to determine the
discontinuation of the product.
 Key Benefits

Ensures compliance with Tracks the drug's progress and

regulatory requirements. 02 lifecycle management.

01 03
Facilitates collaboration Promotes continuous
among cross-functional improvement and safety
teams. monitoring.
04
Downstream Movements
Fast-Tracking: In critical situations,
regulatory authorities may grant
special permissions to accelerate the
drug development process.
Conditional Approvals: A drug may
receive conditional approval based
on promising early-stage results,
allowing it to enter the market
earlier.
Lifecycle Extensions: New data or
additional trials may lead to a drug's
label being extended to cover new
indications or patient populations.
Upstream Movements
● Pipeline Reevaluation: The drug development
pipeline may need reevaluation based on
scientific discoveries, market demands, or
changing priorities.
● Early Engagement with Regulatory
Authorities: Engaging with regulatory agencies
at an earlier stage can help align expectations
and streamline the later regulatory review
process.
● Parallel Processing: Initiating concurrent
activities instead of the traditional sequential
approach can expedite the drug development
process.
● Collaborative Research: Collaborations with
academic institutions or research organizations
 Considerations
Patient Safety: Patient safety must
always be a priority throughout the
drug development process.
05
Data Integrity: Maintaining data
integrity is crucial to ensure reliable
and accurate results.
Careful Consideration: Any
downstream or upstream movement
01
should be carefully considered and
aligned with the overall drug
development strategy.
02
Regulatory Compliance: Regulatory
compliance should always be
prioritized, ensuring adherence to
necessary regulations.
04
03
Prioritizing Quality: Regardless of
the movements introduced,
prioritizing quality is essential in
drug development.
Thank you for your time and attention 🙂