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"We just don't work as a team!" Janet, a group manager for a large insurance company, was complaining to Larry, her human resources consultant. "Everyone just seems to do their own thing, they don't share information, don't try to help each other, and don't seem to care about anyone else

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

's problems. What we need is a team building offsite!" Janet and Larry decided to put together a two-day offsite for the team at a resort about two hours away from work. Janet wanted immediate focus on the problem so Larry worked double-time to put together the event to be held later in

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

Examples of combination products may in

he month. Larry put together an agenda full of trust-building exercises, ice-breakers, and brainstorming sessions on how the team could work better together.

On the first day of the offsite only about half of Janet's team had shown up; the other half were working on a hot project that n

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

eeded to be completed later in the week. The remaining team members politely participated in the team building exercises, but didn't seem very interested in the activities as they felt too "squishy." Because Janet wanted to focus the offsite on team building, there was no clearly stated

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

usiness purpose for the event. The brainstorming sessions were good, but no tangible actions were taken down for the team to follow up on. In short, the offsite was met with a resounding thud from the team and was a dismal failure.

To some, this may be a gross exaggeration; but to other

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

Combination pro

, this closely resembles an offsite they attended or were responsible for planning. Offsites are a very effective means to getting the team focused on solving a business problem, defining a strategy, or creating a revolutionary way of doing things. A very key by-product of offsites, thou

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

gh, is the team-building that occurs while addressing business issue at hand. Done well, an offsite not only puts great minds together to address a business issue but it also builds better teams that work more effectively together and get more things done. Done poorly, an offsite will be

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

viewed as a huge waste of time and will poorly reflect on you as a leader.

How can you ensure your offsites are successful at building teams and getting things done at the same time? Consider the following simple tips:

Have a clear purpose for the offsite - Define some clear business r

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

ason for having the offsite. Consider things such as developing strategic goals for the upcoming fiscal year, account planning for strategic customers, or generating solution alternatives for a key business problem. If you make the goal of the offsite "Team Building" then your team is li

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

kely to look at the offsite as a waste of time that will have no real business benefit. Do your team building under the guise of solving a problem or defining the future.

Balance work with play - All work and the offsite becomes too fatiguing. All play and it becomes a boondoggle. Balan

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

e your agenda with a combination of work sessions with some fun team-building events sprinkled in. Make sure the "play" events you define are something everyone can participate in and go beyond the overused catch-me-as-I-fall-backwards event. Better still, ask the team what types of thin

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

Following aspects would a

s they'd like to do during playtime.

Provide plenty of time for networking - Give ample time during the day and evening for the team to have snacks, enjoy beverages, and just talk about whatever strikes them. Team building starts with building relationships, and building relationships s

dd to the challenges in developing combination products:

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

tarts with getting to know each other. Allow for networking time to be free and unscripted and let the team enjoy some casual conversation with each other.

Don't hold the offsite during a crunch period - When you do hold your offsite, you don't want your team members to be checking emai

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

every five minutes or constantly leaving to make important calls. Do your best to hold an offsite during a "slow" time in your business. As with most businesses, there will probably never be an optimal time to hold an offsite but do your best to avoid times when team members are already

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

burning the midnight oil.

Make it an overnight event - Some of the best offsites I've held were those where the team ate dinner together, enjoyed a couple of drinks, and stayed up late discussing major business problems or brainstorming on a radically new strategy. These late night sess

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

ions were valuable in that team members put their heads together to address some problem or opportunity. More importantly, team members built relationships which provided an outstanding foundation for strong teams.

Don't make the team work overtime to "make up" the time spent at the off

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

Professional from academic institutions, pharmaceutical industries, health care indust

ite - If you're going to have an offsite, allow the team to move some of their other commitments out a few days so they don't feel the pressure of needing to get their work done while at the offsite. The last thing you want is your team thinking about working late because of wasted time

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

t a dumb offsite. Relax some of the deliverables and let the team focus on the offsite, not on what work isn't getting done.

Put together a follow-up plan to continue the work from the offsite - One of the most frustrating things I've experienced with offsites was the lack of a follow-u

.

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

p plan to implement some of the great ideas which came out of the offsite. Put together an actionable follow-up plan with tasks, dates, and owners and you'll keep the excitement going out of the offsite and will get some of the great ideas implemented. Neglect putting together a follow-u

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

Companies that provide selfless information through particip

plan and you'll have an offsite that the team sees as a waste of time.

Offsites can be a very effective means of getting things done and building outstanding teams at the same time. Just make sure to follow these simple steps and you'll better ensure your next offsite is a huge success

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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You want to meet the Rich Jerk! Ha – don’t make me laugh. What do you think the chances are of ever getting to meet this 26-year old brat who has more money than you’ve had hot dinners?

Many of the car washes in Louisiana do hire illegal immigrants and illegal aliens. It is unfortunate if you consider the huge 200-Billion Dollar spending bill after Hurricane Katrina to see the business owners and their lack of caring for the rest of the citizens of the United States of America.

Wondering about how to generate buy-in to performance measurement so you can reduce your fussing and forcing of people to get involved? Here are some tips to help you out.

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