Subjects - Business

During the course of day-to-day business, only one thing can be expected. That is that problems how will arise. Some businesses hold individual managers responsible to resolve problems. Others address problems through teams of managers aligned either organizationally or functionally with the problem. And yet other businesses intentionally or unintentionally ignore problems until they are so impactful on business outcomes th

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

at they must be addressed in some manner. The latter usually requires additional resource due to the crisis nature of the problem. In that business problems are a given, there should be a consistent methodology for addressing problems as they arise. The purpose of this document is to summarize one of the most effective was to identify, address and resolve business problems.

Identifying business problems.

One of the greate

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

Examples of combination products may in

t challenges in business is separating problems from the numerous daily issues, challenges, competitive pressures and change. Many if not most of these are part of the day-to-day and must be addressed by the individual managers with functional or organizational accountability in the area where they arise. This is not to minimize the importance of these. It is just that they must be acted upon by the individuals who have acc

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

untability and responsibility where they arise. There are other business problems that go beyond the accountability of the individual manager. Some of their characteristics are:
- They impact the revenue top line against the business plan
- They impact the cost and/or expense against the business plan
- They impact market share against what was targeted in the business plan
- They impact customer satisfa

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

tion against the measure in place
- They impact employee retention and/or satisfaction against the measure in place

While there may be business problems beyond these that need to be addressed by a team and the process outlined below, these are the key indicators externally and internally for the success of any business. Any deviation in any of these measures against the business plan or other internal metric is a cand

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

Combination pro

date for action by a cross functional and/or cross organizational action team.

Step 1: IDENTIFY THE PROBLEM IN CLEAR, CONCISE LANGUAGE

Team to resolve the problem

Now that the problem has been identified and documented in clear, concise language, the next step is who can address the problem. Short of the Chairman or the CEO, who is the business owner for the outcome or achieving the committed business result? This needs

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

o be defined clearly within the organization at the functional and organizational level. Once that individual has been identified, she must be empowered by a senior leader (CEO ideally) to own and resolve the problem. Along with this goes the charter to establish an action team to work the problem to resolution. The CEO (or other senior executive) needs to be clear about the time frame for action. The problem owner must nex

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

t reach within and outside their organization to assemble a team to address and resolve the problem. While this team may include members of organizations such as Finance, Marketing, Sales, Operations, Research and Development and Human Resources, the composition should be specific to the problem and not include more than one participant per organization or functional area. The members of the action team need to be committed

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

to the project through their leadership and committed to a pre-agreed amount of their work time and project duration. While these may change at points during the project, they should be communicated up front.

Step 2: ASSEMBLE AN EMPOWERED TEAM TO RESOLVE THE PROBLEM

Initial Meeting

The action team must have an initial meeting for several purposes. First it should serve to communicate the problem to all participants. Seco

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

dly it should serve as an occasion for all the action team members to get to know one another. Thirdly, the timeline, expectations, and roles must be clearly outlined at the initial meeting. Finally, specific fact-finding assignments must be made during the initial meeting along with time frames for reporting out information from the fact-finding. More information is better. While business instincts are important, facts ser

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

e to take emotion out of the exercise. Whether individual or small teams, clear assignments must be made with the expectation of how the information should be summarized or presented to the action team and when. Ideally, they should be in the form of a presentation with back-up details in advance of the next action team meeting to allow for detailed review prior to the next meeting.

Step 3: DO YOUR HOMEWORK

The Second Act

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

Following aspects would a

on Team Meeting

Action teams must work in compressed time frames to be most effective. Within a short period following the initial action team meeting and the completion of the assigned research, the team should reconvene, in an environment where they cannot be interrupted by any normal day-to-day issues. These should be either delegated or temporarily reassigned during the action team meeting to allow complete focus on th

dd to the challenges in developing combination products:

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

task at hand. The action team meeting should be structured as follows:
- Restatement of the business problem
- Review of the direction from the CEO including the time frame for resolution
- Crisp presentations by each of the individuals or teams on their research topic
- Boarding (Post Its or large flip charts) the causes of the issue, actions to address the problem, other effects of those actions and g

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

od ideas and issues but unrelated to the problem at hand should be posted on a “parking lot”
- Vote on the issues and actions to identify the top three of each
- Assign a team to present each of the issues and a team to present each of the actions

Step 4: CLARIFY THE TOP THREE ISSUES AND RELATED TOP THREE ACTIONS

The Third Action Team Meeting

The action team should reconvene to present the top three issues and

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

related top three actions. This could be the next day or the next week. It should not be more than two weeks after the Second Action Team meeting. The third action team meeting should be structured as follows:
- Review of the business problem and time frame for resolution
- A crisp presentation by each of the sub team of their top (one of three) issues and related action (one of three)
- At the end of each th

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

re should be a rigorous question and answer period. The points should be boarded on a flip chart
- When the discussion of all three issues and actions have been completed and documented, their should be a vote among all participants of the dominant issue and action
- The dominant issue and action should be documented to insure clarity among all participants
- Each participant should speak to their role in add

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

Professional from academic institutions, pharmaceutical industries, health care indust

essing the issue; this should not be constrained by resource, budget or organizational contention
- The agreed upon issue and action including first step organizational and functional roles should be documented and reviewed with the entire action team
- A target for presenting the action team issue, action and accountabilities to the CEO or senior business leader should then be scheduled

Step 5: ALIGN ON A SINGLE

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

ISSUE, SINGLE ACTION, FUNCTIONAL OWNERS

Present, Close and Act

The agreed upon issue, action and owners with accountabilities and time frames must next be presented to the CEO or senior business leader. If the senior business leader agrees with the action team’s recommendations, the next step is to implement the action plan with specific objectives, owners and time frames (metrics). If the senior business leader does not

.

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

gree with the action team’s recommendations, the action team must either go back and do additional research and follow the subsequent steps or if additional research is not needed then the team should go back to step 3.

Step 6: ACT, MEASURE, CORRECT, ACT, MEASURE, CORRECT

During the execution of the action plan, the individual functions and organizations must perform the roles, actions and within the time frames presented

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

Companies that provide selfless information through particip

by the action team to and as approved by the CEO or the senior business leader. The action team does not own this, they must be owned by the functions and the organizations as part of day-to-day business. Otherwise it will be viewed as an action team issue and not a business issue. The time frames, metrics and readouts to the CEO or senior executive by the overall business owner are essential to resolve the business problem

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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