Creating a Comprehensive Drug Development Strategy | Page 6

• WHERE will the product be used? Do the planned manufacturing

for your product if it demonstrates low toxicity in animals even if

processes meet standards for all target markets (see foundational

the drug has higher-than-normal levels of impurities? Or would it be

question #3)? Good Manufacturing Practices (GMPs) for early stage

better to order a single, fully GMP-compliant batch to cover preclinical,

clinical materials are more stringent in the EU than in the US,

nonclinical, and clinical research? If so, how much time will elapse

particularly regarding facility requirements and quality control.

before the product is used? What kind of stability data will be needed?

If there is any possibility of running clinical trials or seeking marketing
approval in the EU, it is almost always better to start with a EU-certified

• HOW are you going to measure quality? Around the world, there

GMP manufacturer.

are a myriad of standards governing the quality and control of

5 Key Questions to Creating a Strategic
Plan for Manufacturing/Quality

When will the product be needed ?

Practices (GTPs), International Conference on Harmonisation (ICH)
Guidance, EU Directives, regional and dosage form specific guidance,
and the International Organization for Standardization (ISO). How
are you planning to implement these standards? Which standards

OTH
ER

CLINIC
AL DE
VELO
PMEN
T

How are you going
to measure quality ?

PRECLINICAL/NONCLINICAL DEVELOPMENT

What are the properties
of the final dosage form ?

biopharmaceutical products, including regional GMPs, Good Tissue

and recommendations from the World Health Organization (WHO)

PRESCRIBING INFORMATION

Q
RING/
FACTU
MANU

Who is going to make
the API/drug product ?

LITY
QUA
G/RY
N
URI ATO
ACT GUL
E
NUF R
Y
MA
UALIT

Figure 5.

even apply to you? How will quality be ensured, and by whom?
There are a lot of questions here, and companies new to drug
development may wish to consider partnering with a CRO that has
DRUG
DEVELOPMENT

FOUNDATIONAL
QUESTIONS

experience in the broader aspects of drug development, quality
control, and supply chain management. Like regulatory strategy,
manufacturing/quality strategy is fluid and needs to be updated
frequently, particularly when new preclinical/nonclinical data
become available.

Where will the product be used ?

Preclinical/Nonclinical Development
DRUG OR
BIOLOGIC

Both preclinical and nonclinical development refer to studies not
performed in humans: the only difference is when they are performed.

• WHEN will the product be needed? Does is make sense to order a

Preclinical studies occur before Phase I trials (to establish safety

“dirty” (not fully purified) batch to cover preclinical research needs?

before the drug is given to humans) and nonclinical studies occur

This option is available because GMPs are a sliding scale based not only

after Phase I trials begin (to gather additional information, usually

on the stage of development, but also on the dosage form, indication

on safety or pharmacokinetics, and to identify potential biomarkers

and critical quality attributes of the drug itself. Are there advantages

for the development of a companion diagnostic test).

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