Answers - Real Estate

Besides providing your home with more living space, a home addition can be a terrific investment. However, before embarking on such a project the homeowner should first consider several important items. These items include: home m

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

arket values in the neighborhood, financing, size and scale of project, architecture, timetable for completion, personal disruption/inconvenience threshold and the sweat equity commitment level.

Size of Addition and Market Val

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

Examples of combination products may in

e

Prior to actually breaking ground on a home addition, it is best to first determine what you are looking for in terms of additional living space. For example: How many square feet? What types of rooms? Once this is underst

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

od, it is then important to find out the market value of homes in the local area with similar size and features to the new and improved home. With this information the homeowner can then calculate the difference between their curr

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

ent home market value and the new and improved home market value. This difference should represent the maximum budget for the new addition if a positive investment is desired. For example, a homeowner would not want to spend $50,0

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

Combination pro

0 on a new home addition that provides only $25,000 in increased market value to the improved home.

Financing

The next important question involves how to fund the home addition. Unless the project is being funded via cash

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

savings then financing will be required. If current mortgage rates are higher than the existing mortgage, then a home equity loan will probably make the most sense. If current mortgage rates are lower than the existing mortgage, t

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

hen refinancing the entire home, including the cost of the home addition project, may make the most sense.

Architectural Considerations

Once the financial items have been addressed it is then time to focus on the size and

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

scale of the project, as well as the architectural and aesthetics of the new addition. The addition should be of size and scale such that it aesthetically melds into the original house. It should not be too small or too big. Freq

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

ently, homeowners get carried away and add large amounts of new living space without sufficient thought on the outside appearance. From a market value, there is more to a home than just pure living space. A home needs to maintai

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

its exterior aesthetics as well. It is important to consider such items as siding, doors, windows, rooflines, and elevations. All should meld into the existing home exterior seamlessly and aesthetically.

If an architect is not p

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

Following aspects would a

lanned for the project, then the homeowner should at least make some sketches of the home exterior with the new addition. The building inspector will probably require them anyways during the permit process. Also, there are many Ho

dd to the challenges in developing combination products:

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

e Design software packages on the market today that can help create such drawings.

Schedule and Sweat Equity Commitment

The next two items that should be considered include the timetable for completing the project and the

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

homeowner sweaty equity commitment level. Many homeowners assume they can do a lot more than they are either skilled to do or have the time to do. From personal experience, I would suggest contracting out the site/ground work, rou

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

gh framing, roofing, siding, heating/cooling, and the drywall. All of these tasks require skill, time and brawn. If local laws permit, electric and plumbing may be tackled by the homeowner. However, both require skill and can be

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

life threatening if not performed properly. Other tasks that a homeowner could tackle include installing interior doors, finish trim, painting, cabinet installation, tiling and hardwood flooring. Prior to a homeowner signing up t

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

Professional from academic institutions, pharmaceutical industries, health care indust

any specific task however, they should first honestly assess their skill and available time, and compare them to their project schedule. If they don’t match, hire the contractor.

Threshold of Inconvenience and Disruption

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

Finally, a homeowner should consider their threshold for inconvenience and disruption. A home addition, particularly if it involves the kitchen, is very disruptive to today’s busy lifestyles. It is also a dusty, dirty and noisy

.

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

ndeavor. In addition, dealing with subcontractors can be challenging at times. For a typical addition anticipate several months of effort and inconvenience.

If after assessing all these issues you are still willing to move forwar

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

Companies that provide selfless information through particip

with the project, contact your subcontractors, pull your permits and get ready for an exciting time. For most homeowners tackling a home addition is a positive experience that provides both new living space and a great investment

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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