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Advice You - Don't Skip The Details
Don’t Skip The Details - I’m sitting in a room on the 10th floor of Paramount Plaza, NYC. I have a bag of cash on the floor in front of me. Four hundred thousand dollars at last count. There are eight other people in the room. At great cost, their sponsors have flown them in from three different states. They’re all here prim
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
ed and pumped to wrestle the cash from me. This isn’t going to be pretty. In this match, anything goes. Soon, a mature prominent man walks in and with the wave of his hand the spectacle begins. The contestants circle the bag, each from time to time diving for a snatch of cash, only to be fended off. After days of testing my s
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
rength we are all tired and bruised but nothing has left the bag. We decide that continuing the ordeal would be fruitless. The practical course is to offer a nominal amount in return for an end to the contest. The sponsors are dissatisfied with the result but relieved to be free of the high cost of hosting the match. I’m a pr
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
fessional cash wrestler. I’m an attorney.
My client was a large media sales organization and it didn’t have to be this way. This arbitration could have easily been avoided had the parties paid more attention to the details of their business. Let me explain. On its face, this was a simple case of breach of contract. The claim
My client was a large media sales organization and it didn’t have to be this way. This arbitration could have easily been avoided had the parties paid more attention to the details of their business. Let me explain. On its face, this was a simple case of breach of contract. The claim
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nt, a supplier, contended it had delivered pursuant to written agreement. My client, a media sales agency, contended that it ordered wine but received grape juice, and refused to pay.
Now here is where this could have all been avoided. The "written agreement" was really a mishmash IO’s, PO’s, and email, each using contrary a
Now here is where this could have all been avoided. The "written agreement" was really a mishmash IO’s, PO’s, and email, each using contrary a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
d vague terms, definitions and conditions. All subject to wide and wild interpretation. Each signed by a parade of sales, management and production staff of varying authority and expertise. Add to the mix a gaggle of alleged telephone conversations and vanishing Instant Messages, and by the time this came to trial it was down
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
to a "he said - she said" free for all. Of course, being in arbitration was itself a litigated issue, there being competing documents each requiring a different forum. In other words, the parties were so anxious to do business that they failed to nail down the details. So when things went wrong, they had no road map to resolu
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
ion.
Having run a sales organization myself, I know that paperwork is its Achilles heel. Sales people try to avoid it at all costs. Easily deleted Email and vanishing Instant Messages have become the preferred way of doing business. But management cannot throw up its hands; it must implement policies to ensure that deals are
Having run a sales organization myself, I know that paperwork is its Achilles heel. Sales people try to avoid it at all costs. Easily deleted Email and vanishing Instant Messages have become the preferred way of doing business. But management cannot throw up its hands; it must implement policies to ensure that deals are
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
accurately documented and that proper "paper" trails exist. Here are a few observations:
*Battle of the forms – From the salesperson’s perspective, when confronted with legal documents - "we sign their PO and they sign our IO" - seems like a fair solution. Unfortunately, nothing could be further from the truth. Inconsistency
*Battle of the forms – From the salesperson’s perspective, when confronted with legal documents - "we sign their PO and they sign our IO" - seems like a fair solution. Unfortunately, nothing could be further from the truth. Inconsistency
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
and poor documentation sends deals to court. The solution is to hash out your differences upfront using your form or their form with a Rider. Using both is an invitation to the quicksand of litigation.
*Old forms – Speaking of forms, at minimum, you should annually check your sales documents to ensure they are current and th
*Old forms – Speaking of forms, at minimum, you should annually check your sales documents to ensure they are current and th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t operative terms are defined and consistently used. For instance, definitions for Internet media change faster then the seasons, i.e., is your definition of "opt-in" up to date? Your sales documents must be sufficiently elastic to encompass dynamic changes. And it’s not enough to just revise a form. Fear of technology has ma
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
y sales people with photocopies in their desk for easy use. Revisions never make into the draw. If you don’t search out and destroy the old forms, they will circulate forever.
*Documentation is ongoing – Doing business with a buddy list is fast and economical but no substitute for maintaining deal notes or confirming deal po
*Documentation is ongoing – Doing business with a buddy list is fast and economical but no substitute for maintaining deal notes or confirming deal po
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
nts in writing. Management must regularly check contact notes and email logs against sales performance. Any incongruity requires further inspection. Big producers should have substantial contact notes or email logs. If not, too much information is being exchanged via telephone or IM. Remember, your institutional memory is onl
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
as good as your documentation.
*Understandings – We’ve all heard this a thousand times: "don’t worry, we have an understanding". I always respond with this question: are you dealing with the same person today you were dealing with a year ago? Two years ago? New management means a new interpretation of old deals. What you th
*Understandings – We’ve all heard this a thousand times: "don’t worry, we have an understanding". I always respond with this question: are you dealing with the same person today you were dealing with a year ago? Two years ago? New management means a new interpretation of old deals. What you th
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ught was "understood" now becomes an issue. And what exactly is understood? For instance, in my case both parties had a different understanding of the term "unlimited". My adversaries relied on the paperwork and took it literally, while my client relied on previous custom and practice, so understood it "contextually". Of cour
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
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
e, it became a central issue. If you have an "understanding" with regard to specific terms, confirm it in writing.
*Don’t rely on your backup system – Many managers assume that whatever is not in the files can be found in the company’s backup tapes. Guess again. Employees have learned to use the delete button on a daily bas
*Don’t rely on your backup system – Many managers assume that whatever is not in the files can be found in the company’s backup tapes. Guess again. Employees have learned to use the delete button on a daily bas
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
s so as to avoid being included in the end of day backup. And even your best employees can’t be relied upon to retain info that will negatively reflect on them. Worse, retrieving selective information from a system backup can be an extremely expensive and time-consuming project.
*Document ignorance –Too many sales teams, are
*Document ignorance –Too many sales teams, are
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
poorly trained in deal making from a legal perspective. Most haven’t read their own sales documents and can’t explain the majority of its terms, let alone that of another company. A seminar explaining the legal nuances of the sales process and the attendant forms is a qualitative step in developing true sales professionals. M
.
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
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
ke sure that the seminar is not given in lawyer-speak, so that the sales force understands and appreciates the information. And since sales people have a low threshold for retaining legal concepts (a/k/a boredom), it’s of paramount importance that scripts are prepared and handed out for overcoming objections to contract terms
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
If management doesn’t take its paperwork seriously, neither will its sales force. This becomes increasingly important with today’s ephemeral communications. You can enforce good business habits by conducting random paper audits of current deals. Business is complex. Being proactive will save you time and money down the road
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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