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So you think you know how to play spades. You've learned the rules, played some games, and finally you have won some and are feeling pretty good about your play. Okay, let's talk about the end game, or "BID TO WIN!". More tight games are lost a

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

t the end due to poor bidding.

You simply MUST look at all your options and pick the one that will give you the best chance of winning, even if the odds are stacked against you. Let us look at a few situations to see exactly what I am talkin

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

Examples of combination products may in

about.

Whenever we talk about hands, it is just assumed that we are in the SOUTH seat and our partner is in the NORTH seat.

We will examine these situations without ever looking at cards because you need to know what your options are even be

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

fore you look at your cards.

Let's assume that the score is 360 to 450 (we are listed first). We are bidding last just for the sake of arguement.

West bids 3, your partner bids 3, and East bids 2. What are your options? Was your partner's bid

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

a good one or not?

Your partner's bid actually is very poor. He should have bid at least 4 even if it didn't look like he had it. The reason is simple, it puts the pressure on your opponenets (if they can do math). With a 4 bid, if you NIL and

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

Combination pro

make your bid, then you have 500pts. If they bid team 5, then it comes down to bags. Not the way you want to play a game for the win.

So if your partner bids 4 this forces them to look at bidding team 6, which they may not have. This of cours

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

then puts the situation right smack in your lap.

Now in the case given, you have only 2 choices for a bid. You must bid 6 or blindnil. The logic is simple for the 6 bid. You either set them or lose. If you set them, you may as well get the po

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

ints for it and not just bags. You are telling your partner (and opponents) you are going for the set.

Change this a little bit. IF your partner actually bids 4 or more, they may not bid the 5 necessary to go over 500 for fear of pushing you i

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

to a nil bid. In that case, there will be at least 1 more hand unless you do bid nil and make it.

This is what I am talking about with "BID TO WIN". Analyze ALL of your options and decide what will put you in the best position to win. Even if

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 win is unlikely. Do it whether you are bidding first or last. Do the math.

I've seen people bid blindnil when it would do absolutely no good at all and it turned out they had the cards to set the opponents and add a hand to the game.

This

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

isn't just if you are behind either. I've seen people blow it totally by trying to stretch for the finish. Don't overbid your hand unless you have no choice.

I one time played a game that looked hopeless. Nothing was going right. My pard and I

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

Following aspects would a

couldn't make the Ace of Spades fly, that's how bad it was. Game looked over. It was for the top spot and the opponents had made a lot of tough talk about how they were the best of the best and they would crush us.

So here it was, the game was

dd to the challenges in developing combination products:

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

at -150 to 479. Seemed pretty bleak. Of course on the next hand, the opps were saying things like "cream rises to the top, we the bomb" blah blah blah. They were patting each other on the back and figuring it was over. Little did they know.

O

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

course in this situation, they figured we would go for the bag set. So they overbid their hand and we set them 70 pts. while going up 70 pts. Yes, we had followed our "bid to win" strategy and my pard had bid last and took it to a 14 bid total

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

.

Score was now -80 to 419. "Oh well, just delaying the inevetible". So they thought. Now one of them got antsy and decided to get this game over with or at least get rid of the bags while going up in score. So he bid nil. As it turned out, it

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

was a very weak nil. But he thought he could get away with a piggy back nil. I had bid nil. One that I could have slept through. 1 very low spade and nothing over a 9. So we bid nil/5 and they bid nil/5. My partner knew she had to set some part

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

Professional from academic institutions, pharmaceutical industries, health care indust

of their bid. The obvious choice was to give them a bag. But if they pulled off the nil, it still put them going up 50 pts.

Instead she went for the set on the nil. She knew I wouldn't have gone nil in this situation unless it was in the bag.

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

So she went after their nil with a vengence and sure enough, nailed it. As a bonus here, their 5 bid was set also. Between the 2 of them, they pulled 4 tricks.

Score now 70 to 269. They still had 9 bags.

Next hand they had a weak bid of team

.

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

3 and we bagged them out. We ended up winning the game in a blowout as they tried desperation nils to get back in control. They had been so focused on those 9 bags, that we were able to set them.

Bid to win. They should have just bid their han

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

Companies that provide selfless information through particip

s and eaten the bags right off the bat. Don't push nils unless you have to.

Always look at all your options on every bid before you even look at your cards.

Of course being the good sportspeople we were, we only rubbed in the victory a little

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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