Advice You - Business

Elizabeth is the executive director of a large non-profit organization that provides wide-ranging services to people in need. She and her staff work long hours to help their clients as effectively as po

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

ssible, always trying to make the best use of limited resources. While she acknowledges that hard work and scarce resources are the way of the non-profit world Elizabeth admits that she feels increasing

; 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 overwhelmed. She accepts as fact that she will work herself to burnout then leave the organization.

Frank, a successful surgeon, is a popular, sought-after speaker at medical conferences around the

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

world. He struggles to balance the challenges of his work with the demands of his family while trying to squeeze a little time for himself out of his tight schedule. Like Elizabeth, Frank has resigned h

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

mself to what he sees as the inevitable cost of his career. Living with exhaustion and fatigue is the price he has to pay for his success.

Kate is the mother of three small children. She works a part-t

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

Combination pro

ime job, struggling to maintain her home, care for her kids, spend time with her husband, get enough exercise, and tend to her aging parents' needs. Like Frank and Elizabeth, Kate resignedly accepts her

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

situation the way it is. She feels powerless to change things.

Kate, Frank and Elizabeth find themselves in demanding situations. They sought coaching because they were tired. They want to make change

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

s in their lives and their livelihoods but because they see so many others experiencing similar fatigue, exhaustion and burnout, they assumed they had to accept the status quo. They felt resigned that t

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

is is just the way things are.

A strong desire to serve the people around them drives Kate, Frank and Elizabeth. They are committed to doing their best and giving their all. Their intentions are good a

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

nd their dedication is admirable. Their behavior, though, is incompatible with their goals; in fact, it is counterproductive. Each fails to see that a frantic lifestyle is not good for anyone.

Elizabe

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

th's staff, for example, looks to her as a role model. She sets the standard for their work methods. She stressed the importance of seeking balance in life and work, but her own life demonstrated a lack

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

Following aspects would a

of balance. She talked the talk, but she did not walk the walk. As her staff modeled her behavior, they wore out quickly and failed to produce the desired high quality of their vitally needed services.

dd to the challenges in developing combination products:

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

With coaching Kate, Elizabeth, and Frank were able to stop long enough to reflect on the consequences of their actions. Frank was able to re-connect to his goal to treat and help many patients over a l

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

ong career. He sees now that he will not be able to achieve his goal if he continues to work at his current pace. He simply will not have the stamina. Kate was able to admit to how irritable she is with

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

her family because of her pressured schedule, and to recognize the undesirable impact it has on her children. Elizabeth is learning to practice what she preaches.

Armed with their new awareness, all t

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

hree are finding creative ways to live and work differently than before yet still make true, sustainable differences in people's lives. Frank, Elizabeth and Kate each started small, but with every small

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

Professional from academic institutions, pharmaceutical industries, health care indust

success, they find the energy and the incentive to continue to change their lives for the better. They feel healthy and motivated, thus they can give more to the people and the organizations they lead.

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

• Are you trying to give of yourself in spite of exhaustion and fatigue?
• Are you exhausted to the point of questioning your ability to meet your goals?
• Do the people around you sense yo

.

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

ur exhaustion?
• How has your exhaustion affected the people you lead?

I challenge you to stop. Step back. Look for some small immediate change you can make to energize and to care for yourself.

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

Companies that provide selfless information through particip

Now do it. Continue with other small, manageable changes. As you feel more energy you will find the motivation to look for new ways to overcome your resignation to situations you thought were inevitable

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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