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The Operation/Branch plans must define the objectives, timeline and resources required to meet the growth objectives of the business unit, department or bra

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

nch.

Analysis of opportunities is useless if it doesn’t degenerate into work. Operational planning, by definition, results in action plans for day-to-day w

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

Examples of combination products may in

rk.

Branch/Operation Planning

The Five Key Elements:

1. A definition of services to be provided

2. Initiatives that support the End Game Vision--- What

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

re the Branch Goals?

3. An examination of available synergy

4. A commitment to timing and sequence of major steps

5. An agreement to measurement criteria

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

and targets

The Five Key Steps

Step 1 – A Definition of Services to be Provided

Criteria:

• It must be future oriented

• It must focus on the external

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

Combination pro

nvironment

• It must consider local competition, customers and products

• It must consider branch weaknesses as well as strengths

• It must match strengt

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

s to local market needs

Typical Questions:

• What is the purpose of your business?

• What business are you in now?

• What business should you be in?

•

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

What are you good at?

• What have you failed at?

• What differential advantage do you have over your competitors?

• What differential advantage do they h

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

ve over you?

• What markets do you serve?

Step #2 – What are the branch goals?

Individual branch initiatives that support the end game must be identified

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

These initiatives not only include budgetary financial goals but they must also include support for all the non financial objectives identified in the end

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

ame that have not been deferred.

Step #3 -- An Examination of Available Synergy

Synergy arises when two actions performed jointly produce a greater result

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

Following aspects would a

than they would if performed independently. When 2 + 2 = 5.

Influencing Factors

• Optimum scale of operations

• Expansion methods

• Negative effects – 2

dd to the challenges in developing combination products:

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

+ 2 =3

• Knowledge/expertise transference

Step 4 – A Commitment to Timing and Sequence of Major Steps

Since resources are always limited, a branch manage

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

must decide what to do first and what to defer. An action planning process must occur for each initiative that supports the end game. Assigned accountabili

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

ty, expected results for each step in the plan and a completion date for each step of the action plan is essential.

Criteria:

1. Implementation is serial

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

n nature

2. Parallel opportunities should be exploited

3. Determine foregone opportunities

Step 5 – An Agreement to Measurement Criteria and Targets

Typ

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

Professional from academic institutions, pharmaceutical industries, health care indust

cal Criteria:

1. Return on investment

2. Risk of losing investment

3. Company growth

4. Contribution to social welfare

5. Stability and security of emp

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

oyment

6. Prestige of the company

7. Future controls

8. Inventory turns

9. Fill rates

10. DSO (Days Sales Outstanding)

11. Cash to cash cycle

Remembe

.

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

:

• Work = Task Description + Tangible Output + Person Responsible +Due Date

• The Action Item is a piece of “bite sized” work that is scheduled to be com

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

Companies that provide selfless information through particip

lete prior to a review event.

• Effective creation requires major attention to available resources, e.g. time.

• Accountability = Authority +Responsibilit

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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