NOVARTIS“NEW PRODUCT DEVELOPMENT”

ASSIGNMENT # 1Submitted By:

Hamza Ejaz (070720)Mohsin Nazir (070731)Hassam Wali (070722)

Submitted To:Madam Fazaila Qazi

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ACKNOWLEDGEMENT

We are heartily thankful to Mr. Hassan Ejaz (Assistant Brand Manager – OTC Novartis Consumer Health) for his help and cooperation in the conduct of this assignment.

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ContentsACKNOWLEDGEMENT...............................................................................................................2

Company History.............................................................................................................................4

Mission............................................................................................................................................4

Healthcare Portfolio.........................................................................................................................4

RESEARCH AND DEVELOPMENT AT NOVARTIS.................................................................5

Drug discovery and development process...................................................................................5

Novartis Institutes for BioMedical Research (NIBR).................................................................5

Pharmaceutical Development......................................................................................................5

Animals & Research at Novartis.................................................................................................5

New Product Development Process – OTC “Benefiber”................................................................6

Over-the-Counter.........................................................................................................................6

Benefiber..........................................................................................................................................6

Research & Market Need Analysis..........................................................................................7

Standardization of Ingredients.................................................................................................7

Development of Prototype and Testing...................................................................................7

Volume Scale-Up.....................................................................................................................7

Packaging/Distribution Considerations...................................................................................8

Manufacturing Plant Trials......................................................................................................8

Shelf Life Testing....................................................................................................................9

Product Marketing Considerations..........................................................................................9

Final Product Rollout...............................................................................................................9

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Company HistoryNovartis was created in 1996 through the merger of Ciba-Geigy and Sandoz, two companies

with a rich and diverse corporate history. Throughout the years, Novartis and its predecessor

companies have discovered and developed many innovative products for patients and consumers

worldwide.

MissionWe want to discover, develop and successfully market innovative products to prevent and cure

diseases, to ease suffering and to enhance the quality of life.

We also want to provide a shareholder return that reflects outstanding performance and to

adequately reward those who invest ideas and work in our company.

Healthcare PortfolioNovartis portfolio best meets the varied and often complex needs of patients and societies.

Novartis is positioned to lead in innovation, partner with others and offer solutions to patients

across a broad healthcare spectrum. In addition, a diverse portfolio of Novartis reduces financial

risk, bringing greater value to those who invest in our company.

Their portfolio, is focused on broad areas of healthcare & aims to best meet the evolving needs

of patients and societies worldwide.

Novartis is the only company with leading positions in four key areas:

Pharmaceuticals : Innovative patent-protected medicines Vaccines and Diagnostics : Vaccines and diagnostic tools to protect against life-

threatening diseases Sandoz : Affordable, high-quality generic medicines and bio-similars Consumer Health : Strong, trustworthy brands for increasingly knowledgeable

consumers: OTC (Over-the-Counter), Animal Health and CIBA Vision

Since Novartis was created in 1996 - when only 45% of net sales came from healthcare – the

company has shifted focus to fast-growing areas of healthcare. Their strategy is to provide

healthcare solutions that address the evolving needs of patients and societies worldwide.

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RESEARCH AND DEVELOPMENT AT NOVARTIS

Drug discovery and development processNovartis drug discovery and development efforts begin and end with the patient. Our R&D

efforts are guided by two principles:

Do we understand the underlying mechanism or cause of the disease?

Does this disease represent a significant unmet medical need in patients?

If the answer to both questions is "yes," then a research program is developed that is aimed at

better understanding the disease and finding an effective chemical or biologic based medicine.

Novartis Institutes for BioMedical Research (NIBR)The Novartis Institutes for BioMedical Research (NIBR) is a global pharmaceutical

research organization of Novartis. With approximately 5 000 scientists and physicians around

the world, their research is focused on discovering innovative new drugs that will change the

practice of medicine. They have an open and entrepreneurial culture, encouraging collaboration

to make effective therapies.

Pharmaceutical DevelopmentThe Novartis Pharmaceutical Development organization is responsible for developing drug

candidates from the Novartis Institutes for BioMedical Research, Novartis Biologics or licensing

partners. There are 143 projects in the pharmaceutical product pipeline.

Novartis aspires to transform drug development by applying innovative approaches to enhance

quality and productivity of clinical development and significantly decrease development time.

Animals & Research at NovartisAdvances in medicine are responsible for saving and improving the lives of millions of people,

as well as those of farm and domestic animals. Animal research is key to many of the great

medical advances that we take for granted today, including: vaccines for diseases like polio; cancer drugs;

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drugs to treat neurological diseases like epilepsy and schizophrenia; medicines for global killers like high blood pressure, diabetes, malaria and much

more

Novartis needs animal research to find innovative, safe and life-saving medicines for

patients. Novartis would rather see the end of medical research involving animals.

Unfortunately this is not completely possible today. There are two reasons for this: Although much research and development can be done in a "test tube" (in vitro) or

using computers, complex disease mechanisms can often only be better understood

through the use of animal studies. Governments and regulatory authorities require that medicines be tested in animals

before they are tested in humans.

Novartis is committed to refining, reducing and replacing animals in research and to upholding

the highest standards in animal welfare. They have a Global Animal Welfare Organization that is

dedicated to ensuring the animal’s well-being. Their Animal Welfare Policy meets or exceeds

governmental regulations in the countries where they have operations.

New Product Development Process – OTC “Benefiber”

Over-the-CounterNovartis OTC (Over-the-Counter) is a world leader in the research, development, production and

marketing of self-medication products that do not require prescriptions. These products are

designed for in-home treatment and prevention of medical conditions and ailments, as well as the

enhancement of overall health and well-being.

The main Novartis OTC product categories are analgesics, cough, cold, allergy, gastrointestinal,

skin care and smoking-cessation treatments, as well as mineral supplements.

BenefiberBenefiber Powder gives you the freedom to add fiber to your diet any way you choose. Benefiber

Powder dissolves completely in water and is easily added to the things you normally eat and

drink.

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Research & Market Need Analysis Novartis utilizes its in house research facilities that are in contact with leading health experts and

medical practitioners who keep them apprised with rising needs in patient healthcare. They also

keep in touch with government research on patient care/healthcare. In the development of

Benefiber the need for a product delivering fiber intake was realized through the research of

American Diabetic Association. The American Dietetic Association recommends that a healthy

diet include 20–35 grams of dietary fiber daily from plant foods. Yet, Americans only consume

about half of the recommended daily amount. After, realizing a need in the market the Novartis

Institute for Bio-Medical Research was tasked with the development of a product that would

make fiber intake easy as well as enjoyable. The research for a new product in Novartis is a

sequential process.

Standardization of Ingredients Product development work in the laboratory ensures through rigorous testing that the ingredients

used in the product are performing the intended job and are complying with important medical

regulations around the globe. Unlike most other bulk fiber powders, Benefiber Powder is grit-

free and non-thickening. Benefiber Powder is taste-free, so you can add it to your beverages or

meals without altering the taste. Benefiber Powder can be added to beverages (hot or cold) or

soft foods that you normally eat. With Benefiber Powder, you have the freedom to take your

fiber any way you choose.

Development of Prototype and Testing Once a formulation has been developed, a prototype of the product is made, which is then

evaluated for potentially problematic considerations. Difficulties may arise from the ingredients

or the preparation method once the process is reproduced in the laboratory and the ingredients

have been standardized to weight measurements.

The problems are then worked on by modifying/alter the ingredient type, quality, quantity or the

preparation method in order to correct any problems.

Volume Scale-Up Determining the readiness of the product for scale-up to pilot production of high volumes is

next. The goal is to duplicate the taste, color, texture, appearance and other physical and sensory

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properties of the product on a large scale, while maintaining economic viability of manufacturing

the product. 

Packaging/Distribution Considerations Packaging materials for the end product are chosen in consultation with the marketing

department. The marketing as well as production department are responsible for cost

considerations, including marketability and image of the packaged product. The NIBR along

with the marketing department responsible for evaluating practical parameters, such as safety,

functionality, interaction between food and packaging material and stability of the packaged

product.

In choosing appropriate and desirable packaging, decisions must be made about the following

parameters:

Glass or plastic jars or bottles

Metal or plastic lids

Pressure- or heat-sensitive seals in lids

Tamper-proof strips over or around lids

Light and moisture barrier

Cellophane, foil or paper packaging

Consumer convenience 

Manufacturing Plant Trials Once a prototype has been prepared, pilot scale trials are conducted for test marketing. 

Equipment selection occurs and processing parameters are established. Processing effects are

determined and calibrated for in maintaining quality control of the product and process

development. Effects on the raw materials of the processing time, temperature, agitation,

pumping and other preparation are considered in ensuring process reproducibility and

maintaining the product quality once scaled up to commercial quantities. Troubleshooting

occurs, including adjustment of the product formula, processing conditions or equipment used as

required.

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Shelf Life Testing Shelf life testing is conducted to determine the length of time that the product will maintain its

safety and quality. Shelf life varies according to packaging type and method, as well as storage

conditions.  Temperature, humidity and exposure to light must be controlled. The components of

shelf life testing include assessing the physical, chemical, microbiological and sensory attributes

of the product.  

Product Marketing ConsiderationsBranding and Labelling requirements must be considered by the marketing department in

creating a product for commercial distribution. Requirements vary between countries. Basic label

requirements in Pakistan include:

Common name of the product \

Net quantity

Name and address of the producer

List of ingredients

Durable life date

Nutrition facts table 

Final Product Rollout  When the work has been completed, a final report is created. The written report includes a

detailed description of the research and development conducted. The product formulation is

documented as well as the processing conditions. Ingredient suppliers are noted and equipment

recommendations are made. The results of the shelf life studies are included as well. 

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