Advice Pool - Health and Fitness

Cochlear Celebration 2007 was held this past February in San Antonio. It was an event to celebrate 25 years of miracles, and we were glad to be part of the event. We will try to briefly recapture some of t

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

he memories of this spectacular event.

Cochlear Corporation, the manufacturer of the Nucleus® cochlear implant, organized the 3 day convention, held in the luxurious Westin La Cantera resort on the ou

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

Examples of combination products may in

tskirts of San Antonio. There were over 1,000 attendees at the event, all were either Nucleus® cochlear implant users and their family members.

As with most conferences, this provided a wonderful oppo

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

tunity for cochlear implant users and their families to meet with others like them and share their stories. Children were able to spend time with other children, and parents met with others who shared guid

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

ance and inspiration with each other.

Dr. Graeme Clark, an Australian physician, believed that a "bionic ear", as he called it, could be developed that would be able to produce hearing sensation

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

Combination pro

for the brain that would be able to recognize distinct sounds. His hope was to produce an implant for the deaf that would enable them to be able to understand speech and other finely tuned sounds. Present

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

ations were given by Dr. Clark himself, and Rod Saunders, the first person to undergo the cochlear implant surgery back in 1978. This required tremendous sacrifice and bravery of them.

Jim Patrick, chief

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

cientist at Cochlear Corporation, was one of the first to join Dr. Clark in his efforts. His presentation traced the development of the original cochlear implant into what we have today. There were photos

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

of the implant's first appearances, such as the over-the-head coil, the pocketbook processor, and the other oddities that today we take for granted.

Many sessions were held that covered a variety of topic

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

. Dr. Don Goldberg, Director of the Cleveland Clinic's Speech & Hearing Center, presented the topic "Charting the Course for CI Success," which described the different ways parents can ensure

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

their child is doing their best they can. "A parent is worth more than 10,000 schoolmasters."

Another hot session was titled: "Bilateral Cochlear Implants: How Two Ears are Better than One

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

Following aspects would a

." Dr. Bob Peters, Medical Director of the Dallas Otolaryngology Cochlear Implant Program introduced the medical and clinical research demonstrating the advantages of bilateral implants. His remarks w

dd to the challenges in developing combination products:

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

re followed by an emotional recount by Mark Doshier, an employee of Cochlear, who received a second implant from Dr. Peters. His first person account gave a real glimpse into the advantages of bilateral im

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

plants.

Sea World® San Antonio

Clearly, for many of the attendees, the big highlight of the event was the outing to Sea World, which was then closed

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

to the public. The kids (and many of the adults, including many of the Cochlear staff) ran off to ride the 2 roller coasters that were operating. There was a large dinner party and a live show with dolphin

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

s, and of course, the Shamu® Show. Mixed into the show was a wonderful performance by a young pretty girl with bilateral implants, who bravely stood on stage and told the audience of her dreams.

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

Professional from academic institutions, pharmaceutical industries, health care indust

g>Dr. Graeme Clark Scholarship Awards

At the closing session on Sunday morning, the scholarship awards named in honor of Dr. Graeme Clark were presented to 5 college bound young adults, all profo

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

undly deaf and cochlear implant users. Dr. Clark and Heather Whitestone, Miss America 1995 and a cochlear implant user, presented the awards to the winners. Dr. Clark noted how these children are an inspir

.

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

tion to him, and he is certain that they will accomplish great things with their lives.

From tiny infants to elderly grandparents, the cochlear implant has dramatically improved the quality of life for it

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

Companies that provide selfless information through particip

s users and those around them. Cochlear Celebration provided a much needed opportunity for those who benefit from the implant to meet each other, share in their experiences, and learn how to do even better

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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