E-Articles - Reference and Education

During a recent teleseminar, I was asked to rank test score, GPA, experience, etc. by order of importanc

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

e in admissions decisions. I ranked them, but after the seminar ended I kept thinking of situations in w

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

Examples of combination products may in

ich the order I gave would have been wrong.

I realized that any attempt to rank elements of an applicat

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

ion for all applicants is flawed, even for law and medical school, which are the most numbers-driven of

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

he major admissions categories. Why? No element always outweighs all others. No score, essay, GPA, or ex

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

Combination pro

perience will guarantee your admission at top schools. On the other hand, many scores, GPAs, experiences

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

and essays virtually guarantee rejection, certainly at top schools.

But there is at least a partial an

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

swer to the question I was posed: The most important element of your application is the weakest one. It

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

an cause your rejection. It can keep you out. It is the factor that the rest of your application must ov

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

ercome.

For example, when we moved into our current home, Laurie, the daughter of a new neighbor had ju

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

t applied to medical school. Her mother confided one winter day that Laurie -- with a mid-30's MCAT, a s

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

Following aspects would a

imilarly dazzling GPA at an Ivy League college, and truckloads of research experience -- had only been w

dd to the challenges in developing combination products:

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

itlisted at several schools. Her impressive stats had not earned her an acceptance at even one of the to

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

p medical schools to which she had applied. I asked about clinical or volunteer experience, and her moth

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

r said that Laurie hadn't had the time.

Lack of clinical exposure was the Achilles heel of her applicat

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

ion. I encouraged Laurie to volunteer in a clinical setting or shadow a physician and then inform the sc

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

Professional from academic institutions, pharmaceutical industries, health care indust

ools that had wait-listed her of this new element in her experience. She did, and when I ran into her mo

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

ther again on a beautiful spring morning walk, Laurie had been accepted at a leading medical school.

Im

.

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

lication for you: Put your best foot forward. Trumpet loudly and articulately your achievements and qual

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

Companies that provide selfless information through particip

ifications for your program. But also take the time to eliminate or reduce the impact of your weaknesses

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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One of the major challenges facing entrepreneurs and business leaders is finding the right business partners. Great care should be exercised when selecting associates because the right choice can bridge gaps and assist in the execution of your business plan. The wrong choice can harm the reputation and earnings of your company. One should consider the following when forming strategic alliances:

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