The Potential Growth Of Companies

This paper hopes to share insight into the steps that are taken by companies, and the strenuous process behind developing an effective new drug.

The barrier to enter Biotechnology industry is high. The first barrier is the extensive requirements in funding coming from heavy expenditures in R&D, along with the risk of little to no returns or even heavy losses if the drug fails to reach the market. Regulatory environment partly contributes to the barrier as the new drug approval process can be time-consuming with relatively 89% of failure to pass through. The second barrier is specialization. Companies with knowledge in obscure diseases will enjoy low threat of new entrant for there are few experts in the field.

Extremely risky drug discovery and development, lengthening development times which increase development cost, return on investments, and generic competitors.

With the huge diversity and changeability of human biology, it is impossible to imagine a reality without some mutations, changes, or issues in the organs and tissues of humans. Thus, it rightly follows that medications and pharmaceuticals have been created in an effort to counteract the various ailments and illnesses that people can experience. However, as time has gone on and these pharmaceuticals have become more and more high-tech, regulated, and trusted, they have also become incredibly commercialized. Worse still, medications have become incredibly expensive and can be unattainable for some people.

Many scientist have tried, but it’s hard to replace what’s never been there. There have been many treatments that have been tried. A recent drug called Vimizim, which is made by BioMarin Pharmaceutical Inc., is very helpful for patients with morquio type A.(Reuters, 19) It had an improvement in energy and endurance, allowing the patients to better socialize, learn and function independently.(Reuters, 19) After 24 weeks of treatment with the drug, Vimizim increased patients' six-minute walk distance by 22.5 meters.(Reuters, 15) Vimizim has been given "orphan drug" status by the FDA, which means it will receive seven years of market exclusivity if approved.(Reuters, 19) An orphan drug treats diseases that affect fewer than 200,000 patients.(Reuters, 19) The main safety concerns of the drug relate to anaphylaxis and allergic reactions.(Reuters, 19) The panel said such side effects are consistent with other enzyme replacement therapies and that the benefits outweigh the risks.(Reuters,

Pills & Co is a pharmaceutical company that has over 100 years of history, over 57,000 employees and annual sales of $28 billion in 2010. Pills & Co concentration has been broad, researching a wide array of diseases. They have recently realigned their focus to the top 10 “priority diseases”. Star Genomics is a biotech company with less than 10 years of history. They have less than 50 employees, require public support and grants

There are several rewards to consider with expansion of Biocon. Currently in India, there is a growing market for contract research organization and the growth of Biocon falls right within this opportunity. The growth is expected to last for more than few years with a rate that looks promising. Clinigene is expected to reap revenues much higher than the current Biocon and Syngene combined (Kalegaonkar A., Nov 4, 2008). It will take clinical studies to a higher level with better options in terms of drug manufacturing. With other countries ready to outsource the service of clinical studies, Clinigene’s future looks bright.

Nucleon is a small biotechnology start-up company focused on developing biotechnological pharmaceutical products based on a class of proteins known as cell regulating factors. The company has been in the market for five years, and currently, they are in the process of human trials for their first potential product, “cell regulating protein-1” (CRP-1). Overcoming these phases, Nucleon has to decide among several alternatives on producing CRP-1. Knowing that the process involved a tremendous amount of time and money, Nucleon has to choose the right decision for their long-term survival in the intensively competitive and high-stakes drug industry.

EXECUTIVE SUMMARYSilicon Valley Medical Technologies (SIVMED) was founded as a research and development firm. In the beginning, SIVMED performed its own basic research, obtained patents on promising technologies, and then either sold or licensed the technologies to other firms which marketed the products. The firm has since then grown and is now contracted to perform research and testing for larger genetic engineering firms, biotechnology firms, the US government, and is now widely recognized as the leader in an emerging growth industry. SIVMED's founders were relatively wealthy individuals when they started company, and they committed a great deal of their own funds to the venture. Their personal funds, however, were soon exhausted by the

Alexion Pharmaceuticals is a biopharmaceutical company that creates drugs to treat ultra rare and life threatening diseases. Ultra rare diseases are categorized as a percent and to be considered an ultra rare disease, the disease must affect less than twenty people in a population of one million.One of Alexion’s popular drugs on the market right now is Soliris, which treats Paroxysmal nocturnal hemoglubinaria (PNH), which is a life threatening disease of the blood. On March 31st, 2016 we were able to go on a site visit to Alexion in Smithfield that started with a demonstration using macaroni on the upstream and downstream processes. During the visit I met Kristie who worked in wet chemistry, Kerrie who worked in raw materials, Betsy who worked in microbiology and Cassie, who worked in immunochemistry.

- The biotech industry is a very uncertain environment top operate in. Giving a quantative planning can create a false sense of accuracy. That way a planning can lose much of it’s added value and confidence in planning might even disappear altogether. Strong points in Amgen’s planning is that the company focuses mainly on qualitative aspects. It should be remarked however that Amgen is in the luxurious situation that because of two very successful products she is not (totally) dependent on external investments.

In order to decide on the R&D portfolio, an objective quantitative analysis might not be suitable considering the high levels of uncertainities and consequently the risks involved in pharmaceutical research projects. It is important to have a qualitative analysis of the situation as a whole that includes Vertex’s own financial position, strategic implications, a quantitative analysis of its Portfolios with realistic estimations and a risk analysis of the portfolios.

Achieve a median composite eight-year product development cycle by 2010. Deliver two new molecular entity (NME) launches on average per year from 2010. In order to achieve the above objective, ensure that we have 10 or more NMEs in Phase III development by 2010. Development cycle times and quality for small molecules and biologics. Number of NME launches per year. Attrition rates. Number of development projects by phase. Number of in-licensing deals, alliances and acquisitions. R&D investment levels. Improving R&D quality and speed through leading-edge science, effective risk management and decision-making and overall business efficiency. Maximising the value of our biologics business and continuing to build a major presence in this fast-growing sector. Investing in external opportunities to enhance our internal innovation through in-licensing, alliances and acquisitions. 2008 target exceeded for small molecule development cycle times. NME and life-cycle management progressions

Bayer AG is fully committed to expanding its business operations through pharmaceuticals, consumer health, and crop science. Bayer AG understands that in order for the company to successfully expand its Pharmaceuticals department they must properly invest in research, development, and marketing of innovative medicinal products. In addition, Bayer AG is developing clinical programs, which will enable the company to provide various of its products to a greater number of people. Bayer AG ability to identify areas in medicine that remain untapped is crucial to the firm’s long term sustainability. For example, Bayer AG has identified the fields of cardiology, oncology, gynecology, and

The research and development of the pharmaceutical industry is very important as the industry relies on it to develop new products to maintain and sustain the growth of the industry (ALRC 2014). According to the Australian Government Law Reform Commission, every year, the total spending in research and development in pharmaceutical industry, which includes drug discovery, pre-clinical testing and clinical trials on drugs is around $300 million (ALRC 2014). Mergers and acquisitions are intensifying in the global pharmaceutical industry, especially over the last 10 years. With factors like exorbitant research and development costs, the relatively shorter product life cycles, and the rarity of discovering a new life-changing drug acting as catalysts, leading pharmaceutical companies now have more cause to step out and look for external collaboration. This results in an increasing number of smaller biotechnology companies merging with bigger pharmaceutical companies (The