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I recently had lunch with a young attorney with a local IP firm to discuss her career goals. We were paired through a mentor progr

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

am. I find it a pleasure to chat with attorneys at the start of their careers, when everything is possible.

During our lunch, she

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

Examples of combination products may in

asked for my thoughts on the three things every young attorney needs to know to be a success in private practice.

The three keys

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

to success? A provocative question. I've been a lawyer for over twenty-five years, and to repeat an old joke, I still don't have

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

it right, that's why I'm still practicing.

I knew that wasn't what she wanted to hear, so after some thought I came up with my li

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

Combination pro

st of three. This advice applies to all fields of law or other professions. The steps are simple but not easy. But they can be

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

fun. Good luck.

1. Become a good lawyer. This is your first job. Learn all you can about your area of practice. Get all the expe

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

rience you can handling matters of clients. Treat the partners you work for as if they are your clients. Communicate. Be responsiv

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

e. Provide good work product. Know the latest case developments. Anticipate needs. When reporting on a problem, propose a solution

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

. In short, learn to be a great lawyer. You have to have the knowledge and skills necessary for the job.

2. Network. Practicing l

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

aw is a relationship business. It's not enough to have knowledge and skills. You need to know people. And people need to know you.

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

Following aspects would a

Keep in touch with classmates. Meet other young lawyers. One may end up general counsel for GE. Treat opposing lawyers with court

dd to the challenges in developing combination products:

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

esy and respect. Conflicts happen and result in referrals to good lawyers who keep in touch. Get involved in a civic groups: commu

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

nity, school, church, whatever. Get involved in professional associations: ABA, local bar, state bar, etc. Participate, don't just

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

join. Keep in touch with the people you meet. Excellent lawyers are overlooked everyday because no one knows them.

3. Build cred

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

entials. What you know and who you know is important, but it's not enough. You also need to establish a reputation as an expert. I

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

Professional from academic institutions, pharmaceutical industries, health care indust

t's a given that you're a good lawyer, that's the starting point. You need to establish credentials so that your network of potent

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

ial contacts can justify recommending you to their companies and others. Write, teach, speak, chair committees, win cases, whateve

.

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

r is the best fit.

If you can make it a habit to do each of these things in the early years of your career, you'll be well 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 way to a successful career, as a partner, leading your own practice, or running an inhouse legal department, whatever your goal.

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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