STC Quality SIG Article:
Drug Development Framework
A drug development framework is a methodology used by pharmaceutical and medical device workgroups. The methodology adapts the critical path method and project management, and lists all the deliverables due at specified points in time. It is also called the stage-gate method.
The framework calls for programs that produce the deliverables for each phase of drug product development. One of the programs is the marketing of the drug product. Projects address development of the different drug products. A program may control several drug product projects. For instance, a workgroup may market several drug products under the guidance of an established marketing program (plan, execute the plan, report, and audit the process).
A program is developed and documented as follows. We start with a process workflow and a concept graphic that includes all the pieces of the program (plans, studies, information inputs, FDA labeling requirements, approvals, reports, the inputs and outputs), and workgroups associated with the program. All information needs to be backed-up with approved evidence.
After codifying the program workflow and all the
pieces, we write the SOPs that cover each and every
procedure of the program. Hopefully, the program addresses
the needs of all projects (the drug products in the
pipeline) and produces the specific and required deliverables in the development framework on time.
Suggestions for the parts of a marketing program follow:
- Identify the number of patients needing the drug, their location and country, age, sex, race, financial resources
- Identify who pays for the drug (patient, private and federal insurance, US Veterans Administration, private companies)
- Identify the audience(s)
- Establish the delivery workflow and timing
- Estimate lead times
- Document the risks and advantages of the drug
- Estimate advertising costs (presentations, one-on-one, journal articles, esteemed doctors and university support)
- Benchmark similar products and spin-offs from other similar successful products
- Design thematic labels, brochures, advertisements
Collecting this information together under the control of
the marketing program reduces risks of failure for the
program.
One important audience is the US Food and Drug Administration (FDA), who considers any information presented to the user as "labeling." Any
marketing program needs to consider the marketing
documentation (what the seller says or writes to the
potential customer).
This documentation needs to start with
general information on the goals of the drug to patients and
state that this drug product is under investigation. As the
product specifications and results of studies (toxicology,
stability, clinical trials) develop, the marketing folks can
start to ask the potential customers about demand, cost, and
feasibility. Only after the FDA approves the drug product
for commercial release (distribution to the doctors and
patients) can the salesperson state the product claims,
indications for use, dosages, risks, and so on, all of which are
stated in the approved labeling documentation.
Information collected during the development process accumulates into a marketing effort under the control of the marketing plan that produces demand for the drug product. As we all know, getting to market quickly increases profit, but in every case I know, when marketing outruns the ability to deliver a product, everyone suffers.
About the author
Cliff Evans is a Compliance Consultant with CSI, Inc. and a member of the Quality and Process Improvement SIG of STC.