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A Project can best be described as any corporate initiative that displays one or more of the following characteristics:

• It will have a clearly defined bus

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

iness objective, more usually related to introducing change within the business or corporation, and will be a “one off” activity with a definitive Start and Fini

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

h;

• It is likely to involve numerous inter-related tasks and, as an activity, it would benefit from formalised procedures, processes and controls to ensure

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

successful delivery and implementation;

• It may well involve cross-functional working and the use of shared resources including but not limited to departme

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ts or divisions such as Information Technology (IT), Human Resources (HR) and Finance;

Project Lifecycle

There are essentially four (4) stages or ph

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ses in any Project Lifecycle:
1. Initiation;
2. Feasibility Study;
3. Delivery;
4. Closure or Finalisation;

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

b>Principal Purpose of Each Project Lifecycle Phase:

• Initiation – the initiation phase is the undertaking of a high-level investigation into the pr

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

posed project to enable an informed decision to be made on the commitment of funds and the required resources for a more detailed investigation.

The purpose her

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

is to Identify, Scope and Gain Initial Approval for a Project or Projects that will deliver tangible benefit to the business.

• Feasibility Study Phase

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

the study phase is intended to produce a high-level specification of the requirements and to formulate a recommended approach on how to address them, thus allow

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ng a decision to be made on the soundness of the Project and the commitment of corporate funds and resources to the commencement and delivery of the Project – ei

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ther in full or in part.

The purpose of the study phase is to Confirm and Reiterate the business requirements and benefits of the proposed Project (s), Identify

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

and Select the Preferred Solution and to Prepare an Outline Schedule for the Delivery Phase.

• Delivery Phase – to define, plan and schedule the Project’

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

delivery in the required detail, and to proceed to implementation in accordance with the terms of the resulting Scope, Budget and Timescales.

The purpose of th

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

delivery phase is to Design, Develop, Test, Implement and Hand Over the Solution identified in the Feasibility Study Phase. Management of the Project Deliverabl

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

s at a detailed, and if necessary a nitty gritty level, should then be bestowed on the parties involved in delivery during this phase.

• Closure or Finalisat

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

on Phase – the purpose here is to review the effectiveness of the delivery of the Project, to Close the Budget and to Release any remaining financial or othe

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

resources.

The purpose of the Closure or Finalisation phase is to ensure that all agreed deliverables have been accepted by the Users, all costs have been prop

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

rly accounted for and allocated, and the mechanisms for monitoring the delivery of the project benefits are put in place.

Key Project Player
The Key Play

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

r in any Project should be the Business Sponsor who is responsible for sponsoring and championing the proposed project initiative and for monitoring its progress

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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