Biobusiness Coursework on
development of a novel therapeutic product to combat arthritis
development of a novel therapeutic product to combat arthritis
Introduction
With the emergence of complexity of diseases, innovative drugs play an important role in everyone’s life by acting as a lifesaver or enhancing the better sustainability of an individual. It is important that drugs are launched in the market by proper research and development and also by understanding the market trends. Due to high competition and with aim of acquiring the best quality at lower price, the importance of developing an effective new product comes into focus which enhances the quality of life.
Arthritis is a chronic inflammatory disease affecting nearly millions of people worldwide and causes joint destruction and severe impairment on the quality of life (Firestein GS, 2005). Depending upon the aetiology and site affected the disease arthritis may be categorized into rheumatoid arthritis, osteoarthritis, infectious arthritis and ankylosing spondylitis. Out of them, rheumatoid arthritis (RA) is the most commonly occurring form of arthritis which involves the multiple joints in symmetrical pattern. Main symptoms of RA include the pain, stiffness and swelling of the peripheral joints. Joints affected in the initial stage of the disease are those of knee, hands and feet; however almost all peripheral joints may be affected in the chronic stage of the disease (Yelin E, Wanke LA, 1999).
Currently there is no primitive treatment for RA other than reducing the inflammation. There are certain drugs like Anakinra, Leflunomide, Etanercept, Infliximab, Aspirin, which has got side effects like stomach pain, bleeding, ulcers etc.
Similarly another group of drugs called Cox-2 inhibitors have tendency to cause heart attack. On the light of a recent research conducted by a pharmaceutical company, a warning has been declared that some of the anti-inflammatory drugs for arthritis may leave users more susceptible to congestive heart failure, tuberculosis, and other fatal infections. Most of the arthritis drugs produced by different pharmaceutical companies contain the formulation of drugs including the gold compounds which eventually produce toxic side effects to the body. Hence, most of the sufferers of arthritis do not have safe and effective treatment options. (Quan L. et al, 2009). Moreover these drugs are too costly. So it’s necessary to develop a new drug which can cure Arthritis completely.
‘Arthricure’: A Revolutionary Panacea against Arthritis
Addressing the demand of dire need of an alternative medicine to combat arthritis, Himalayan Pharmaceuticals, based in south East Asia, have endeavored to launch a novel therapeutic agent for the treatment of arthritis. ‘Arthricure’ is a recently innovated herbal product consisting of traditional Ayurvedic formula and having potency to relieve inflammation. It consists of eight herbs of Himalayan forest that attack against the agents causing inflammation, pain, and stops the destruction of joint tissue.
Methodology of Product Development
1. Idea generation
Ayurveda is an indigenous and traditional medical system practised in Asian countries for thousands of years. It involves the use of natural herbal ingredients as therapy for different diseases especially the chronic ones. Arthritis, being a chronic inflammatory disease, was considered as the most fertile landmark for the experimentation of an Ayurvedic medicine. The merits of Ayurvedic medicine over the contemporary allopathic medicine led the ‘think tanks’ of Himalayan Pharmaceuticals to quest innovative ideas for the treatment of arthritis. The main motive behind the formulation of an Ayurvedic product was its efficacy to treat disease with almost no side effects. As an initiative step towards the innovation of new drug, different ideas generated from different pharmaceutical experts were assembled in the form of proposals. These proposals involved different pharmaceutical designs produced by different experts.
2. Screening of the concept and basic Research
On the basis of feasibility, potential efficacy and scope, different expert opinions can be analyzed. On consensus, a formula that appeared to be more effective than other contemporary medicines on easing pain and preventing tissue damage in people suffering from arthritis was selected for synthesis. The new formula derived after assembling different concepts involved following eight herbs as its active ingredients of the prospective novel drug: 1) Guggul 2) Boswellia 3) Madder 4) Horse radish tree 5) Gokshura 6) Musk mallow 7) Guduchi and 8) Liquorices. Guggul acts as an anti inflammatory. Boswellia fights inflammation and supports healthy joints. Madder has the role on immune regulation. Similarly, Horse radish tree is a stimulant, and Gokshura is an anti inflammatory natural steroid. Musk mallow has role on supporting healthy joints. Guduchi acts against bacteria and supports immune system. Similarly, Liquorice also acts as a stimulator of immune system. The Research and Development Committee adopted a prediction that the combined effects of all these ingredients will be proved to be the most effective therapeutic tool for arthritis.
3. Preclinical Testing
The first step in the laboratory begins with testing of the product.By approval of the governing body the products can be tested on animal which can show the biological activity of compound against Arthritis. This is done for testing the toxicity and carcinogenicity of the drug. After pre clinical testing if the product proves that it does not have any toxic effect, the pharmaceutical company can file Investigational New Drug Application (IND) to FDA in testing in humans and becomes effective if FDA doesn’t approve within 30 days. These will review the test and conduct the test once again by Institutional Review Board (Kotelnikov, 2001).
4. Clinical Trials
After being approved by IND the next procedure is to clinical trial the drug which undergoes 3 phase: phase 1, phase 2 and phase 3. In the first phase which takes approximately a year involves testing about 80 volunteers which gives drugs safety profile, dosage range etc. In the second phase about 300 volunteers are tested for drug’s effectiveness. The last phase involves 1000 to 3000 volunteers from hospitals under the supervision of physicians for checking the efficiency and the drugs adverse reactions. For certain medicines it includes one more phase which determines the long term use of drugs and its beneficiary effects at a global basis. All together clinical trial takes more than 5 years. The next step involved in the process is the submission of details of the clinical trials to NDA along with FDA demonstrating the effectiveness and safety. It includes submission of more than 100,000 pages of scientific information’s about the drug and FDA approves the drug after reviewing it within a time period of 6 months. After approval by FDA physicians can prescribe this drug but won’t be available in the market for the customers. It needs further more research and approvals from FDA.[ Drug Manufacturing Process, 2002]
5. Marketing strategy and development of the product
It is essential that the company must have appropriate marketing plan which includes major goals, policies and actions from board of planning including the financial expenditure which gives 100% satisfaction to the customers’ needs. Mainly marketing is based on price strategies, product strategies, promotional strategies and placement strategies. It mainly targets on the customer needs by calculating the objectives to be achieved by targeting the sales and profit.
6. Business Analysis
Business analysis is necessary to identify the business needs and solutions to the business problems. It is important to know the fate of the financial status of the company within the long term run. This mainly focuses insight on the market share of the product, cash flow which the product can generate and the expected life of the product. There are various techniques and attributes adopted by analysts for the success of the company. Some of them are PESTLE (Political, Economic, Sociological, Technological, Legal, and Environmental) MOST (Mission, Objective, strategies and tactics) and SWOT (Strengths, Weakness, Opportunities, and Threats). Among this SWOT analysis is commonly used as a strategy for business analysis. This helps to focus on the opportunities and the strengths in the current market which determines the advantages, what can be made to improve the product, and also the obstacles the company going to face.[ Product development, 2010]
7. Product Development
It is the stage at which the product is produced enormously by the approval of FDA and with all the tests targeted to the customer. It is essential to analyze the funding and production cost for the purpose of pricing the product. It also determines the overall number of products launched in the market for a successful trade. There should be a Good Manufacturing practice in every stage of production of the product. There should be updated engineering, controlled environment and facilities and also complete personal safety along with full documentation. At this stage the drugs life cycle is monitored [Kim et al, 2005].
8. Test marketing
Before launching a product to the National or International market it is necessary to test market of the product. This is the stage at which the product is tested in the market other than in volunteers, within a specific area. This can also be under commercialization or advertisements rather than media. By test marketing the demand of the product can be understood. It will also give an idea about the demand and overall performance of the drug.
9. Commercialization
After the successful completion of the product in the test market , the product can go for National launch. Here comes the importance of commercialization of the product which determines how the product going to be sold out. The commercialization of the product takes place only when the following questions meet the answer. When the company is going to launch the product? Will the new product affect the sales of other products of the company? What is the best time for introduction of the product? And must analyze the current economic status and if it is down, the launching should be delayed. All these things depend upon the company’s capital, confidence and operational capacities. Above all the main thing is that where company is going to launch the product (National or International).
10. Monitoring and Evaluation
After launching the product, there should be a better monitoring and evaluation of the product because there should be enough ideas and renovations for the product which will sustain it in the market. It is necessary that the cost of production meets the selling out of the drug.
Discussion
Effective coordination and communication among the members of the organization, planning and control about innovative ideas, perfect research and development strategies led to the process of obtaining innovative ideas for distinct reliable product development. The financial support was available from the government, large companies as well as other private investors. After this long scenario, as continuation of the project, the product passed the clinical trials with good results followed by analysis, marketing and product testing. The idea was exciting; and the next step was to bring it in the market to meet the target. The market testing of the product showed customer satisfaction and their positive responses towards the product and high intention of the public to buy the product from the clinics where the products were launched for trials. Different institutions of health sectors of Japan, America, United Kingdom, China, and Germany were contacted for collaboration so that the product can be available in the global market (including new markets) and compete easily with other drugs found in the markets. After launching the product, efficient monitoring was set up which made the product compete the products of other companies and stood on first line due to its efficacy, abundance and less side effects. Customer satisfaction was one of the focuses of this innovative product that ultimately led to the successful consumption of the product by the customer since they were ensured that the product was new (ayurvedic) and effective against arthritis. Thus, ‘Arthricure’ led to efficient turnover of the business since the people of first world countries were effectively attracted due to its innovative nature that also enhanced the value of share in the market and many proposals of investment for the company in the future. (Williamson, D. et. al. 2004)
Conclusion
Planning of strategy for drug development with reliable forecasting ability with sufficient financial support is the inevitable element for the success of the project. However, innovative ideas accumulated from various research activities are also the most essential credentials for product innovation and critical analysis of the future aspects and impression of the innovation (quality) have to be taken into consideration. Management of the technological innovation is the challenge that should be faced properly through effective market testing, monitoring and evaluation of the commercialized product which is in large quantity globally through different regional institutions. Finally, these all activities ultimately led to the customer satisfaction which was the key to the success of the innovative product ‘Arthricure’.
REFERENCES
1. Dibb, S. et al., 2001. Marketing – Concepts and Strategies; Fourth European Edition Boston : Houghton Mifflin
2. Drug Manufacturing Process, 2002. MSD [Online] Available from: http://www.msd.com.hk/health_info/drug_education/e_dmp_what_is_gmp1.html
[Accessed on 1st April 2010]
3. Firestein GS, 2005. Etiology and pathogenesis of Rheumatoid Arthritis. Philaldelphia: Elsevier Saunders. Pp. 996-1042.
4. Gabriel SE, 2001. The epidemiology of rheumatoid arthritis. Rheum Dis Clin North Am.27 (2): 269-81.
5. Jobber, D., 2001. Principles & Practice of Marketing; Third Edition McGraw-Hill; London
6. Kim T. Gordon,2005. Marketing Tips for Launching a New Product. Entrepreneur [Online] Available from: http://www.entrepreneur.com/marketing/marketingcolumnistkimtgordon/article76364.html [Accessed on 30 March 2010]
7. Kotler, P. et al. ,1996: Principles of Marketing; Fourth European Edition Prentice Hall; Harlow (UK)
8. Lancaster, G. and Massingham, L.,1999. Essentials of Marketing; Third Edition McGraw-Hill; London
9. Wikipedia, 2010. [Online] Available at http://en.wikipedia.org/wiki/Product_development [Accessed on 30th march 2010].
10. Quan L. et al, 2009. The Development of Novel Therapies for Rheumatoid Arthritis. Expert Opin Ther Pat.18 (7): 723-738.
11. Vadim Kotelnikov ,2001. Marketing Strategy. Business e-Coaching. [Online] Available from: http://www.1000ventures.com/business_guide/marketing_strategy.html [Accessed on 30th March 2010]
12. Williamson, D. et. al. 2004. Strategic management and business analysis. Oxford. Elsevier Butterworth Heinemann.
13. Yelin E, Wanke LA, 1999. An assessment of the annual and long-term direct costs of rheumatoid arthritis: the impact of poor function and functional decline. Arthritis Rheum. 42(6):1209-18
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