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In the late Seventies, it felt safe to roam around London streets late at night. Visiting American celebrities weren’t so regimentally guarded as they are now. They weren’t always flanked by burly bodyguards, or a retinue of

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

anxious PR people forbidding journalists to ask them an impromptu question. When I used to be a freelance film journalist, it was easy to get interviews with celebrities. Nowadays, showbusiness is completely PR driven. If y

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

Examples of combination products may in

u are lucky to get more than ten minutes with a celebrity, their subservient publicist will be glued to their famous clients' side, making sure you stick to asking innnocuous questions. In those days, stars were more accessi

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

ble. I once asked the actor Robin Williams for an interview in Tramp, the Jermyn Street nightclub and he granted me a breakfast session at the Savoy hotel, the following morning. In those days, journalists were allowed to e

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

ter the five star hotels by the main entrance and sit in the lobby with their camera crew, if they had one in tow. Nowadays, journalists are usually requested to use the tradesmen’s entrance.

When Raquel Welch was promoting

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

Combination pro

her yoga book, ‘The Raquel Welch Total Beauty Book’ at the Hippodrome in the early Eighties, a gang of enthusiastic journalists, myself included, had no problem plonking ourselves down uninvited at her table. We consequently

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

spent the entire evening with her, blatantly holding our tape recorders underneath her nose. Her personal publicist hovered discreetly at a distance, forbidding anyone else to join our table for the entire evening.

I had k

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

own most of the showbiz publicists since my days as a press officer for Warner Bros. After I became a journalist, they always made sure I was at the top of their scheduled interview list, even if I was writing the article fo

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

a small circulation periodical. When I once interviewed the late Robert Altman at the Athenaeum, his PR left me alone with him for the entire day. I was one of the few journalists who interviewed Frank Zappa when he was onc

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

e in town for a couple of days, because his PR lady who got me the gig was one of my tennis partners. But, if you ever let the publicists down, like not turning up for an interview, you were out. Once, I inadvertently upset

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

well-connected socialite after writing about her wedding reception at Mr Chow. Her powerful PR friends blacklisted me for a week, until they realised they needed me to write 'puff' pieces about their ‘A’ list clients.

I wa

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

Following aspects would a

friendly with the PR lady, who was looking after Cary Grant when he worked for Faberge, and consequently I was one of the chosen few who was granted a 'one to one' interview with the legendary actor. I used to smoke in thos

dd to the challenges in developing combination products:

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

e days, and before my interview, the PR lady told me I was not allowed to smoke in Mr Grant's presence. I got an even bigger shock after the PR left me alone with the silver haired ex-film star in the lobby of the Royal Lanc

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

ster hotel. Mr Grant informed me he wouldn't permit me to use my tape recorder. His reasoning was he could tape himself. Nowadays, the publicist would definitely have sat in on the interview, and under similar circumstances,

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

I would have been grateful for her recollection afterwards.

Because I had been given a freebie tape recorder some time before, I had woefully neglected my shorthand and my speed had been reduced to about 25 words per minute

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

, which would have been perfect if I had been recording a laid back parrot! I prayed the interview would be brief, but unfortunately we got on so well, that Cary refused to answer all his incoming phone calls, saying he was

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

Professional from academic institutions, pharmaceutical industries, health care indust

ied up. So, there we were, Cary Grant and I lolling around on the sofa together, while I tried to dredge up some original questions to ask him. I was unable to appreciate his nuggets of wisdom though, as I was on constant re

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

alert, frantically hoping I was going to remember everything he uttered. I would have been with him for a week if his wife hadn’t come up to interrupt us after several hours, saying they had an important appointment to keep

.

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

. I could have kissed her. I ran out of the hotel, sprinted all the way home and threw myself over my typewriter where I bashed out my interview purely from memory (my random notes were illegible). I must have done something

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

Companies that provide selfless information through particip

right, because when the Cary Grants visited London next time, Mrs Grant rang me up to say how much her husband had enjoyed the interview. Nowdays, the PR would have passed on her comments to me.

Copyright: Frances Lynn, 200

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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