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Having a good team is fundamental in accomplishing your dreams. In this complex corporate world, no single person can have all the answers. The world is changing so rapidly that ev

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

en a team comprising internal experts is overwhelmed in trying to follow and monitor the changes. The internal team should also include the use of external consultants and experts

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

Examples of combination products may in

to bring in knowledge and skills that are currently not available in the company.

Similar to a surgical operation, a company needs a team to successfully perform a turnaround. Tur

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

naround is seldom a one-person show. Most well-orchestrated corporate comeback teams are fielded with the best talents from within or outside the company including skilled professi

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

onals such as insolvency lawyers, auditors and turnaround consultants.

The first step, especially during the surgical stage is to assemble the turnaround team by getting everyone

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

Combination pro

n board. Change is crucial and is characteristic of a turnaround process. Preferably, the team should comprise the turnaround manager, whether appointed from outside the organisati

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

on or seconded internally, the financial controller and other key internal staff. The team must work closely with the other stakeholders such as the shareholders, creditors and uni

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

on.

Whatever the composition, the team must move swiftly like the SWAT unit. Members need to regularly update each other on the status as well as progress of the specific duties o

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

f each member. There must be a clear and unchallenged team leader who has the final say in case of dissenting views.

Flexibility is the key and the team may be changed periodically

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

as the situation warrants. For instance, once the company turns around and the financial crisis blows over, the company may need to transform its corporate culture. The team needed

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

at this stage is a change agent. It calls for a more democratic and participative team as opposed to the “surgical” team, which calls for a more autocratic one.

Thus increasingly,

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

Following aspects would a

human resource management has recognised the importance of good teamwork as an ingredient to the success of the company. Staff appraisal system has recognised one’s ability to wor

dd to the challenges in developing combination products:

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

k as a team and not just individual performance as a key measurement of the staff’s performance. Nicor Steel put great emphasis on teamwork.

There are cases whereby staff voluntaril

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

y chase out their own colleagues who are poor performers. The staff of Nicor Steel are one of the highest paid employees in the industry.

Companies too need to work in teams. No com

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

pany is an island. Companies also need to team up share expertise, financial resources and technology. Companies at times too need to consider teaming up with their competitors in

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

trategic alliances when venturing overseas. In today’s corporate world, things are no longer cut dried and clean. For instance, there are mega infra-structural projects that requir

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

Professional from academic institutions, pharmaceutical industries, health care indust

e the competitors to pool their financial resources together to clinch mega-projects, which are too big for any single player to handle. In the pharmaceutical industry, R&D develop

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

ment costs for new drug development may be too prohibitive and requiring a few pharmaceutical companies to pool together their resources towards its development. As a matter of fac

.

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

t, pharmaceutical companies are merging and teaming up because of the phenomenal development costs. Some studies indicate that in the years to come, there may only be five major

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

Companies that provide selfless information through particip

pharmaceutical companies left worldwide as compared to the current few dozens.

Therefore no man or company can be an isolated island. A good team is vital to fulfilling your dream

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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