Creating a Comprehensive Drug Development Strategy | Page 5

Figure 4.

Basic Timeline for FDA Involvement

Manufacturing/Quality
The manufacturing and quality aspects of strategic drug development

Meeting with Regulatory Authorities
End of
Phase II
Meeting

Pre-IND
Meeting

include all activities related to the production of the final dosage

Pre-NDA/
BLA
Meeting

form, including sourcing the active pharmaceutical ingredient (API),
creating a viable formulation, assessing and maintaining quality,
packaging, and shipping. Robust answers for the three foundational
questions are particularly important in this area, but the potential time

Compound
Section

Preclinical
Development

Phase I

Phase II

Phase III

Approval

and cost savings associated with advanced planning are also easy to
see. A failure to integrate all of the disciplines in drug development
from the beginning can very quickly leave the manufacturing/quality

IND
Submission

IND
Maintenance

NDA/BLA
Submission

Regulatory Submissions
LEGEND: BLA = biologics license application; IND = investigational new drug application; NDA = new drug application.

group making guesses and ill-informed decisions that can have costly
implications.
When creating a strategic plan for manufacturing/quality, consider the
following questions:

The regulatory strategy document, and the timelines in particular,
often serve as a tracking tool for overall project status and can help
identify risks to the program (e.g., cost overruns, delays, and competitor
activities). However, it’s important to view the strategy as living
document that must be periodically reassessed and updated to retain
its usefulness. This proactive approach is vital when the end goal is
to get the product to market, but it can also be valuable to companies
looking to license or sell their asset. A strong strategy, particularly when
validated by external experts and/or regulatory authorities, can help
attract potential buyers or partners.
A number of contract research organizations (CROs), including
Clinipace, have consulting teams that can be engaged for regulatory
strategy activities ranging from a quick, 90-minute “reality check” on
the table of contents for an IND to a longer-term partnership to help a
company to develop its strategic plan.

• WHO is going to make the active drug ingredient (API)? Who is going
to make the drug product? How much can they produce? Do they have
the engineering and quality expertise to scale up production for clinical
trials and/or commercial use? Is the cost per unit of drug feasible? Based
on your end goal, are you looking for a manufacturer to get you through
Phase II or all the way to the commercial product? Will you need to
import API before your IND is in effect? How will you evaluate and
qualify your cont Ʌ