Advice You - Business

Well, we finally did it to ourselves. Our profession refused to police itself, much less exercise prudent lending practices; now the government (state and soon federal) will do it for us

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

… plus …

FBI Suspicious Activities Reports have tripled in the last couple of years, from 10,000 to 35,000. That is an indication that fraud is blooming in the business. One statistic

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

Examples of combination products may in

from the FBI is that 80% of all known fraud cases involve somebody internal in the industry. Frequently people see the other guy, cutting corners and the like, all in the name of commiss

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

ions commissions commission! I don't think it's strictly "I want to maintain these good times for my own income." There is a little element of "I'm making the American dream come true fo

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

somebody. I've got this person who has a perfect house and if I can just inch their income up by just $10K …" These aren't industry experts, they're loan officers (industry entry-level

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

Combination pro

personnel), so they don't necessarily understand that the raging good times always have resulted in a significant downturn, as the cycle swings in reverse for a similar length of time.

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

It's also a large problem from the origination base to when they go into loan pools and are bought and sold on Wall St. as bonds, these bonds are underperforming as well, it's becoming a

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

major problem in the past couple months. These loan pools are getting downgraded every day. Usually this was due to prepayments ('churning' by originators also hurt a great deal here). N

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

ow you have to look into the escalating Early Payment Defaults (EPDs) as well, because it was normally factored in as a fixed, half-percent, but now we're seeing a lot of times it's risi

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

ng into a whopping 6% and 7% factor! When these bonds are bought and sold to investors that try to sell them for fixed-income and aren't getting results, their reputations are getting ha

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

mered in a big way.

The reason it took several years to finally explode, is that underwriting used to be what we call the three C's: Character (credit history), Capacity, and Collateral

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

Following aspects would a

- somehow credit and capacity fell by the wayside for the most part and everybody seemed to start focusing on the Collateral part. If a lender had a decent AVM along with the added plus

dd to the challenges in developing combination products:

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

of warp-speed appreciation of 15%-25% per market, you could not do a bad loan.

As rates have finally stopped falling like a stone, and property values nationally are sinking back onto

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

a more realistic plateau (from values soaring up and up year after year), everybody needs to re-assess their new role as career industry professionals (those who don’t see this as a care

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

r or as professionals need to exit the industry immediately for everybody's good) since they are not a positive force for those of you who love the biz – and I know there are many of you

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

out there that feel that same way as I still do.

I myself learned this ‘brother’s keeper’ lesson early in my career; it has done me well ever since I was a 'twenty-something' newbie. E

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

Professional from academic institutions, pharmaceutical industries, health care indust

veryone needs to look-out for the other guy. When you see things being done that are inappropriate, it is your duty as a good industry citizen to speak up and help all of us out. Lately

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

ou have all seen where when one sector is injured, it goes around full circle and bites YOU and me on the butt … every time … so I guess you could say in addition to being Ethical, you a

.

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

re protecting yourself by doing your best to influence others to stand up and do the right thing. With the right set of values, the career minded ones of you have a responsibility to ‘he

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

Companies that provide selfless information through particip

lp them’ … and when they don’t, there’s another answer right HERE for you to consider

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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Do you think of your business as a brand? Because it is one, whether you view it that way or not. Even if it's just you, a solo-professional, working out of your home. Here are some tips for making a small company a big brand.

Over Forty? Give yourself permission now to follow your heart; it may save your life By Craig Nathanson The Vocational Coach

Is it possible to fix service problems from just one vantage point, say just by training your employees in customer service skills? Or does it require a more holistic approach that looks at all the points of entry into your organization such as hiring, vendor relationships and more?

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Advice You - Not my Brother's Keeper? You Should Be!

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