Advice You - Business

How much should I charge for my expert witness services? It’s an important question that will determine the success

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

of your consulting practice.

You can establish competitive pricing levels in several ways. One way is to discrete

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

Examples of combination products may in

ly conduct some research to find out what other experts are charging. Another way is to review pertinent court reco

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

ds, since experts have to disclose their rates as part of their Rule 26 or equivalent reports.

SEAK publishes a ref

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

erence book that you might find useful in creating your rate structure. Ask for the “National Guide to Expert Witne

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

Combination pro

ss Fees and Billing Procedures,” written by Alex Babitsky, MBA, Steven Babitsky, Esq., and James J. Mangraviti, Jr.,

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

Esq.

Now that you have a better sense of how to set your hourly rates, here are five tips to help you prepare a com

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

petitive rate card:

1. Get it in writing! Always start with a letter of engagement that clearly identifies your rat

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

es and business terms. You want to be entirely clear on how and when you will get paid.

2. Establish a minimum. Re

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

ardless of the job size, you have to set all your other work aside in order to concentrate on every new case. Consi

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

der setting a 5 or 10 hour minimum for smaller jobs. This policy will reimburse you for the value you provide to you

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

Following aspects would a

r client.

3. Ask for a retainer. You can insure payment by asking for a retainer that gets replenished as funds are

dd to the challenges in developing combination products:

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

drawn down over the course of your assignment.

4. Implement a cancellation fee. The vast majority of cases settle o

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

ut of court, so you could easily find yourself with holes in your calendar where you once had billable hour commitme

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

nts for depositions or court testimony. Your cancellation fee may vary with the degree of notice you receive. For e

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

ample, perhaps there is no penalty for cancellation 10 days prior to an engagement, but a 50% fee for cancellation 4

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

Professional from academic institutions, pharmaceutical industries, health care indust

8 hours in advance.

5. Review your rates. An annual rate increase is a fairly common business practice. Take a lo

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

ok at your rates every December and update your rate card as of January 1st of every year. As a rule of thumb, you g

.

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

nerally have some room to increase your rates if none of your clients complains about them. Test higher rates on you

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

Companies that provide selfless information through particip

r new clients.

Always remember, you are paid for your knowledge and not your testimony. Price and bill accordingly

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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