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Running head: HEALTHCARE PHARMACEUTICAL BUSINESS PROPOSAL Name of the Student Name of the University Author Note 1 HEALTHCARE Table of Contents Backgr ...
Running head: HEALTHCARE PHARMACEUTICAL BUSINESS PROPOSAL Name of the Student Name of the University Author Note 1 HEALTHCARE Table of Contents Background ................................................................................................................................ 2 Product Description and Development ...................................................................................... 3 Market Awareness ...................................................................................................................... 7 Scientific testing ......................................................................................................................... 8 Ethical, Health and Safety Considerations ............................................................................... 11 References ................................................................................................................................ 12 2 HEALTHCARE Background Special preparations used in modern and conventional medicine are pharmaceutical products -also known as medicines or drugs. They are critical for disease prevention and recovery and the safety of public health. Therapeutic failure, exacerbation of the disease, resistance to medicines and often death will result from the use of ineffective, low quality, harmful medicines (Chen et al. 2018 ). It also undermines confidence in health systems, health practitioners, producers of pharmaceuticals and distributors. For many nations, maintaining daily access to high quality, secure and affordable medicines is still a problem. The WHO Eastern Mediterranean Regional Office shall provide the Member States in the Region with sufficient expertise and technical assistance in the areas of quality assurance, regulation and legislation, protection and efficacy of medicines (Dave et al. 2017 ). Pharmaceutical products shall mean any product, compound, medicinal product or therapeutic product which, as a medication, medicinal product or controlled substance, is subject to regulations. Adalimumab is a drug used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, uveitis and juvenile idiopathic arthritis, sold under the brand name Humira, among others. Adalimumab is used to treat some forms of arthritis to alleviate discomfort and swelling (such as rheumatoid, psoriatic, juvenile idiopathic, ankylosing spondylitis). This medicine is also used to treat many skin conditions (such as plaque-type psoriasis, hidradenitis suppurativa) (Doty et al. 2018 ). It works by blocking aprotein located in the body's immune system (tumour necrosis factor or TNF) that causes joint swelling and damage in arthritis as well as red scaly patches in psoriasis. Adalimumab belongs to aclass of medicines known as blockers of TNF 3 HEALTHCARE (Gellad and Good 2019 ). This treatment helps to decrease further joint damage and maintain joint function by reducing joint swelling. Adalimumab is a drug used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, uveitis and juvenile idiopathic arthritis, sold under the brand name Humira, among others. In general, use is only recommended for individuals who have not responded to other treatments. It is administered under the skin by injection (Gellad and Good 2019 ). Common side effects include inflammation of the upper respiratory tract, pain at the injection site, rash, and headache. Extreme diseases, cancer, anaphylaxis, hepatitis B reactivation, multiple sclerosis, heart disease, liver failure, and aplastic anaemia can also have other side effects (Haffajee and Mello 2017 ). It is not approved for use during pregnancy, although some reports demonstrate that use during breastfeeding may be healthy. Adalimumab is an antirheumatic disease- modifying drug and a monoclonal antibody that acts by inactivating the alpha-factor of tumour necrosis. Since this drug is one of the topmost sold drugs in the field of pharmacy, it is proposed to carry out the manufacture and selling business of this medication – Adalimumab + (the hypothetical name for the chosen product) in the current organisation. This paper will talk of abusiness proposal for the manufacture and selling of Adalimumab +(with fewer side effects) including atesting experiment for the efficacy of the proposed product. Product Description and Development The pharmaceutical product chosen for this business proposal is HUMIRA and after modification, it will be named HUMIRA+. This product has been selected for the business proposal because it is the top drug that is sold in today's market (Kesselheim et al. 2017 ). 4 HEALTHCARE However, this drug has been found to have astructural configuration which has relation with the side effects occurring in people who are administered with this drug. In adult patients with moderately to severely active rheumatoid arthritis, HUMIRA is indicated to minimize signs and symptoms, elicit asignificant clinical response, prevent the development of structural damage, and enhance physical function. HUMIRA can be used alone or in combination with methotrexate or other anti-rheumatic drugs which change non- biological diseases (DMARDs) (Kleinebudde, Khinast and Rantanen 2017 ). In patients, 2 years and older, HUMIRA is suggested to reduce the signs and symptoms of moderately to seriously active polyarticular juvenile idiopathic arthritis. HUMIRA can be used with methotrexate alone or in combination (Hearne et al. 2017 ). HUMIRA is indicated in adult patients with active psoriatic arthritis for the reduction of signs and symptoms, inhibition of structural damage development, and enhancement of physical function. HUMIRA may be used alone or with non-biologic DMARDs in combination (Moffatt et al. 2017 ). In adult patients with active ankylosing spondylitis, HUMIRA is recommended for the reduction of signs and symptoms. In adult patients with moderately to seriously active Crohn's disease who have had an ineffective response to traditional therapy, HUMIRA is indicated for the reduction of signs and symptoms and for inducing and sustaining clinical remission. HUMIRA is indicated in these patients for the reduction of signs and symptoms and for the induction of clinical remission if they either have lost reaction to or are intolerant to infliximab (Hsiao et al. 2018 ). In pediatric patients 6 years of age and older with moderately to seriously active Crohn's disease who have had an ineffective response to corticosteroids or immunomodulators, HUMIRA is suggested to minimize signs and symptoms and induce and sustain clinical remission. In adult patients with moderately to seriously active ulcerative colitis who have had an ineffective response to immunosuppressants such as corticosteroids, azathioprine or 6- 5 HEALTHCARE mercaptopurine (6-MP), such as azathioprine or 6-mercaptopurine, HUMIRA is indicated to induce and maintain clinical remission. About methotrexate. Adalimumab (trade name Humira) is a monoclonal antibody in the treatment of arthritis, ankylosing spondylitis and Crohn's disease. It is atypical IgG1 antibody that inhibits tumour necrosis factor-alpha (TNF α), similar to Enbrel, Simponi and Remicade (Pritchard et al. 2018 ). TNF α plays an important role in inflammatory/autoimmune diseases including arthritis, plaque psoriasis and ankylosing spondylitis and is central to the inflammatory reaction. Via this capacity to suppress TNF α,adalimumab is therefore used to treat certain inflammatory diseases (Prasad and Mailankody 2017 ). Adalimumab is afully human IgG1 monoclonal antibody that specially binds to TNF/alpha and is provided by subcutaneous injection. The action mechanism is based on the neutralization of the bioactivity of the TNF- alpha and on the induction of apoptosis of mononuclear TNF expressing cells. High TNF levels are found with rheumatoid arthritis (RA) patients in the synod fluid and lead to the pathologic inflammation or articular destruction characterized by psycho-diagonal arthritis (JIA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) (Povero and Pradelli 2020 ). HUMIRA assists in disease-based regulation of inflammation in infected areas. It is a fully human monoclonal antibody that is specifically formed to bind with TNF- α.The structure and function of HUMIRA are indistinguishable from the natural IgG1 of humans (Sands et al. 2019 ). For the reduction of signs and symptoms, significant clinical response, inhibition of development of structural damage and improvement of physical activity in moderate to extreme rheumatoid arthritis in adult patients, HUMIRA is indicated, either alone or in combination with methotrexate or other non-biological DMARDs. The risk of severe infections leading to hospitalization or death in patients treated with HUMIRA is increased. Concomitant immunosuppressants such as methotrexate or 6 HEALTHCARE corticosteroids have been used in patients who acquired these infections. When a patient develops asevere infection or sepsis, discontinue HUMIRA (Sands et al. 2019 ). Active TB, including latent TB reactivation. The disseminated or extrapulmonary disease has also occurred in TB patients. Test latent TB patients prior to and during therapy with HUMIRA. Initiate latent TB therapy before the use of HUMIRA. Fungal invasions such as histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis are invasive (Taylor et al. 2017 ). Disseminated disease may occur in patients with histologic or any other invasive fungal infections rather than locally. In certain patients with successful infection, antigen and antibody tests for histoplasmosis may be negative. In children and adolescent patients treated with TNF blockers, including HUMIRA, lymphoma and other fatal illnesses have been identified. In TNF-blocking patients including HUMIRA, post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), which is arare form of Tcell lymphoma were identified. These cases were very violent and lethal in nature. In Crohn's disease or ulcerative colitis, the majority of recorded TNF blockers occurred, and in young adult males, the majority of them occurred (Sarpatwari et al. 2018 ). Nearly all these patients were treated with azathioprine or 6-mercaptopurine at or before diagnosis along with a TNF blocker. It is unclear whether HSTCL occurs in conjunction with certain other immune-suppressants due to the use of aTNF blocker or aTNF blocker. Thus, to reduce these complications, structural changes will be introduced in the compound drug. These changes are expected to reduce the complications and increase the market presence of this drug. The product will be developed in the laboratory department of the organisation by using structural chemistry types of equipment. After changing the structure of several functional groups of the drug – it will be tested for efficacy after injecting them in mouse models and finally performing human trials. This process is primarily effective in developing or modifying drugs as stated in many other research papers. The product will be 7 HEALTHCARE developed in 7 months and human trials are expected to be started in 12 months. Financial support will be provided from the stakeholders of this organisation and will totally be performed in the non-governmental support-oriented way. After passing the animal trial stage, governmental support will be requested while performing the human trials. In this way, the whole developmental process is planned. Market Awareness The size of the Adalimumab market is expected to hit $4.3 billion by 2025, which will increase in the projected 2020-2025 CAGR of 4.98%. Adalimumab, Humira and Exemptia brand name, an anti-TNF medicine to treat rheumatoid arthritis, psoriatic arthritis, Crohn's disease, psoriasis and ulcers (Yoneda, Torisu and Uchiyama 2020 ). Tumour-necrosis factor- alpha (TNF α)is generally related. When TNF α binds to the TBF α receptor, it induces an autoimmune inflammatory response. The medication decreases the chances of an allergic reaction by binding to TNF α (Schwartz and Woloshin 2019 ). Acute arthritis and ulcerative colitis are increasingly affecting the adalimumab market. Difficulties in the immune system are estimated to stimulate the growth of the adalimumab market because of unhealthy lifestyle adaptation, rising stress in daily life and. The global market for Adalimumab based on the modes of dysfunction may further segment into Crohn's, Psoriatic, Rheumatoid, Ulcerative, and other diseases (Pritchard et al. 2018 ). The most costly rheumatoid arthritis segment in 2019 is expected to rise to the highest CAGR over the 2020-2025 forecast years (Taylor et al. 2017 ). This is because rheumatoid arthritis has ahigh prevalence in the world. New medicinal agents are the key drivers for rheumatoid arthritis and government funding for drugs that are high-cost. The worldwide geography-based Adalimumab market is also divided into North America, Asia-Pacific, Europe and the rest of the world. Due to advanced medical facilities, reimbursement coverage and awell-regulated regulatory system within the region, North America reported the most important revenues to share of 37.1 per cent in 2019 8 HEALTHCARE (Pritchard et al. 2018 ). Therefore, the market of the new product – an innovative product – Adalimumab + can be stated to be similar to Adalimumab. However, the selling price of this product may be higher than the original because itwill have ahigher cost of manufacture due to the structural modifications that will be induced in it. Thus, at first, before the medicine is trusted by all the sections of the population, it can be stated to be less bought by people. However, as soon as the trial results are submitted and efficacy tests are performed, the drug may get NOD for use as well as trust from the patient community also. This business will be promoted in the pharmaceutical category of advertisements – both television broadcast as well as internet website advertisements. The most significant target customer section for this product will be the patient population and the medical professionals associated with the use of this drug (Yoneda, Torisu and Uchiyama 2020 ). The qualitative market will be used to analyze whether the product market will be positive or not. Social media market research based on interviewing afocus group or the target audience as stated above will be performed (Povero, and Pradelli 2020 ). Competitors will not be apresence for this product since it is a completely innovative solution for the modification of the original Adalimumab and no one has still researched on it yet. This process of the market research will help the business process to become more profitable – medicine manufacture and buying. So making aprofit will be somewhat easier for this product. Scientific testing Scientific testing of this product will be done by designing an experiment to test both the efficacy and the nature of the product. In clinical trials, also known as clinical trials, human voluntary possible therapies are tested to see whether it is tolerated in the general public for further use (Sarpatwari et al. 2018 ). A medicine or amedical device, such as avaccine, a blood product or gene therapy may be used for treatment. However, possible therapies should first be examined in laboratory animals, before they can be tested in humans. Therapies with 9 HEALTHCARE appropriate safety profiles that show the most promise are then shifted to clinical trials. The FDA is committed to providing accurate information to the participants in clinical trials as well as to protecting them. Some researchers recently showed alack of ethics that had rattled public faith and encouraged the federal government to develop clinical research rules and guidelines to protect participants from unnecessary risks (Chen et al. 2018 ). Each clinical trial is planned carefully to address certain research questions. A trial plan called aprocedure map out how and when to perform the analysis. Items are also checked to see if they compare or do not undergo standard treatments. The FDA offers comprehensive technical support for clinical researchers, allowing them to design better studies that can more accurately characterize the impacts of anew product, while also reducing the risk of participants. The team comprises physicians, nurses and other experts in the clinical trial. Step 2studies require more participants (around 100-300) suffering from a disease or disorder theoretically treatable by the medication (Jaffe et al. 2016 ). If phase 2 experiments demonstrate that the treatment can be successful — and risk is appropriate given the effectiveness and seriousness of the disease detected — the medicinal product moves into phase 3. In Step 3, abroader variety of people with the disease will study the medication (approximately 1,000-3,000) (Prasad and Mailankody 2017 ). Phase 4 trials are often done after amedication has already been accepted and available on the market to find out about long-term complications, advantages and best use of the treatment or to test this product for various populations, including infants. While attempts are made to monitor the risks to patients in clinical trials, acertain amount of risk may be inevitable due to the uncertainty that new medical products bring in clinical research. It is also crucial that people decide only when they completely understand the whole process and the risks involved to participate in aclinical trial. 10 HEALTHCARE The materials needed for this experiment will be the target organ tissue sample from ten individuals followed by preparing aliquots of the product solution –starting from the lowest to highest (example –10, 20, 30, 40 and 50 microgram/litre). Secondly, in all the test samples, the drug – 10, 20, 30, 40 and 50 microgram/litre aliquots will be added. Efficacy will be tested by observing for positive signs of improvement (Povero and Pradelli 2020 ). The same will be compared with normal Adalimumab and tested whether Adalimumab + has higher efficacy at lower concentrations or dosage range than the original Adalimumab. To test that nature of this drug –whether there are any side effects of this drug or not. This experiment will be performed by administering lower doses of the drug in human subjects and checking for the presence of any side effect such as nausea, fever, tiredness or loss of appetite. The visual results will be noted down and compared with the side effect results of normal Adalimumab. If there are fewer side effects of the drug, then itcan be used in place of Adalimumab in the human community. Fig 1: Drug efficacy curve –DRUG B is the new drug Source: Created by the author 11 HEALTHCARE Ethical, Health and Safety Considerations Drug liabilities are growing, more publicly accessible and more expensive. They affect patient experience, clinical study and medical communication by physicians. Comprehensive evaluations reveal a generally negative view of ethical questions in the pharmaceutical industry and highlight the scrutiny of pharmaceutical firms. The main concerns raised are the safety of drugs, pricing, disclosure of data, importation, the nature of the clinical trials, marketing limitations, DTC ads, animal testing, foreign markets, developing countries, issues concerning vaccine, growth in the counterfeiting of medicinal products, the cost-effectiveness of treatments, and pharmaceutical fraud in the last 10 years. 12 HEALTHCARE References Chen, J., Luo, X., Qiu, H., Mackey, V., Sun, L. and Ouyang, X., 2018. Drug discovery and drug marketing with the critical roles of modern administration. American Journal of Translational Research ,10 (12), p.4302. Dave, C.V., Kesselheim, A.S., Fox, E.R., Qiu, P. and Hartzema, A., 2017. High generic drug prices and market competition: a retrospective cohort study. Annals of internal medicine ,167 (3), pp.145-151. Doty, A., Schroeder, J., Vang, K., Sommerville, M., Taylor, M., Flynn, B., Lechuga- Ballesteros, D. and Mack, P., 2018. Drug delivery from an innovative LAMA/LABA co- suspension delivery technology fixed-dose combination MDI: evidence of consistency, robustness, and reliability. AAPS PharmSciTech ,19 (2), pp.837-844. Gellad, W.F. and Good, C.B., 2019. Adalimumab and the Challenges for Biosimilars. Jama ,322 (22), pp.2171-2172.\ Ghaffar, S.H., Corker, J. and Fan, M., 2018. Additive manufacturing technology and its implementation in construction as an eco-innovative solution. Automation in Construction ,93 , pp.1-11. Haffajee, R.L. and Mello, M.M., 2017. Drug companies ’ liability for the opioid epidemic. New England Journal of Medicine ,377 (24), pp.2301-2305. Hearne, E., Alves, E.A., Van Hout, M.C. and Grund, J.P.C., 2017. Home Manufacture of Drugs: An Online Investigation and aToxicological Reality Check of Online Discussions on Drug Chemistry. Journal of Psychoactive Drugs ,49 (4), pp.279-288. Hsiao, W.K., Lorber, B., Reitsamer, H. and Khinast, J., 2018. 3D printing of oral drugs: a new reality or hype?. 13 HEALTHCARE Jaffe, G.J., Dick, A.D., Br ézin, A.P., Nguyen, Q.D., Thorne, J.E., Kestelyn, P., Barisani- Asenbauer, T., Franco, P., Heiligenhaus, A., Scales, D. and Chu, D.S., 2016. Adalimumab in patients with active noninfectious uveitis. New England Journal of Medicine ,375 (10), pp.932-943. Kesselheim, A.S., ORIGINS OF AND SOLUTIONS TO HIGH DRUG PRICES IN THE US. Kesselheim, A.S., Rome, B.N., Sarpatwari, A. and Avorn, J., 2017. Six-month market exclusivity extensions to promote research offer substantial returns for many drugmakers. Health Affairs ,36 (2), pp.362-370. Kleinebudde, P., Khinast, J. and Rantanen, J. eds., 2017. Continuous manufacturing of pharmaceuticals .John Wiley & Sons. Moffatt, K., Wang, Y., Singh, T.R.R. and Donnelly, R.F., 2017. Microneedles for enhanced transdermal and intraocular drug delivery. Current Opinion in Pharmacology ,36 ,pp.14-21. Povero, M. and Pradelli, L., 2020. Funding Innovation Thanks to Anti-TNF- α Biosimilars Uptake: The Economic Impact in Italy. Farmeconomia. Health economics and therapeutic pathways ,21 (1). Prasad, V. and Mailankody, S., 2017. Research and development spending to bring asingle cancer drug to market and revenues after approval. JAMA internal medicine ,177 (11), pp.1569-1575. Pritchard, J.N., Hatley, R.H., Denyer, J. and Hollen, D.V., 2018. Mesh nebulizers have become the first choice for new nebulized pharmaceutical drug developments. Therapeutic Delivery ,9(2), pp.121-136. Sands, B.E., Peyrin-Biroulet, L., Loftus Jr, E.V., Danese, S., Colombel, J.F., Törüner, M., Jonaitis, L., Abhyankar, B., Chen, J., Rogers, R. and Lirio, R.A., 2019. Vedolizumab versus 14 HEALTHCARE adalimumab for moderate-to-severe ulcerative colitis. New England Journal of Medicine ,381 (13), pp.1215-1226. Sarpatwari, A., Beall, R.F., Abdurrob, A., He, M. and Kesselheim, A.S., 2018. Evaluating the impact of the Orphan Drug Act ’sseven-year market exclusivity period. Health Affairs ,37 (5), pp.732-737. Schwartz, L.M. and Woloshin, S., 2019. Medical marketing in the United States, 1997- 2016. Jama ,321 (1), pp.80-96. Taylor, P.C., Keystone, E.C., van der Heijde, D., Weinblatt, M.E., del Carmen Morales, L., Reyes Gonzaga, J., Yakushin, S., Ishii, T., Emoto, K., Beattie, S. and Arora, V., 2017. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. New England Journal of Medicine ,376 (7), pp.652-662. Yoneda, S., Torisu, T. and Uchiyama, S., 2020. Development of syringes and vials for delivery of biologics: current challenges and innovative solutions. Expert Opinion on Drug Delivery .
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