Translating Biomedical Innovation / Mental Term Paper

Pages: 14 (4501 words)  ·  Bibliography Sources: 1  ·  File: .docx  ·  Level: Master's  ·  Topic: Medicine

SAMPLE EXCERPT . . .

With the ethical compliance requirements not so transparent in the private sector and their primarily commercial interest in biomedical research leads to several problems. In a collaborative setting, conflicts of interest arise out of such a situation. For instance, as the authors state, a federal research employee "would have official responsibilities with an outside organization with which that employee has a financial interest or affiliation." This automatically puts them "in the position of having an official responsibility or action which could directly influence his or her own financial interests, or those interests which are imputed to him or her." [Raymond S. Fresko, Pg 106] In general, the ethical liability involved in privately funded embryonic research is all the more reason for the federal government to actively sponsor the research. This would also ensure commercialization of stem cell research without ethical compromise, as research would be subject to stringent review requirements.Download full Download Microsoft Word File
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TOPIC: Term Paper on Translating Biomedical Innovation / Mental Assignment

Academic research is in general perceived as a purely scientific endeavor not marred by commercial interests. However, as the authors discuss conflicts of interest could even affect institutional research. This is more likely if the institution has a financial link to the organization in the form of equity, ownership or sponsorship. As a case in point is the association between Scripps research institute, a scientific institute in California and Sandoz the Swiss pharmaceutical company. It was publicly disclosed that Sandoz struck a deal with Scripps institute to contribute $30 million every year for 10 years in exchange for the commercial license and rights to all the new discoveries by the institute. Invariably, collaboration with financial strings attached lead to what is known as "publication bias" where "commercial stake" affects the outcome of the study. This could also come in the form of attempts to suppress the publication of research results that could affect the commercial interests of the funding firm. Furthermore, academic researchers who have signed a non-disclosure agreement with corporations would not share their research results with peer researchers, which undermines the fundamental values of educational research. Commercial research is largely profit centric while public health interests take second place. Commercial research on stem cells has also failed to deliver the miracle cures that were promised for many chronic and fatal conditions. This could be evidenced from the field of cancer stem cell research. Pharmaceutical companies have largely stuck to the tumor regression treatment while prophylactic treatment for metastasis has remained largely neglected. The reason being the difficult regulatory process involved in the later case. This trend wherein pharmaceuticals are contended in making what the author calls the 'Billion dollar blockbuster' drugs does not serve the public health interest in the best way possible.

In conclusion, the authors call for 'increased moral accountability' from the different partners in new biomedical drug research as an essential prerequisite for the effective translation of technology into clinically promising therapy that improves the outcome for patients suffering from chronic and currently incurable conditions. The trend to overstate the promises of such novel therapies as stem cell therapy or to manipulate research findings, guided by commercial organizational interests, should be avoided. The authors conclude by stating that biomedical research should adhere to strict ethical standards and public should be informed of the factual report of the research findings as they have the right to know the truth.

Bibliography

1) Raymond S. Fresko & Hind Merabet, 'Sponsored research and the Public's Right to Know', Drug Development Research 63:103 -- 111(2005)

TASK 1

A new drug development is a prolonged, knowledge intensive and costly process, which every pharmaceutical company has to go through before it could successfully bring out a drug from the laboratory to the market. The drug development process involves a collaborative effort from researchers with different backgrounds including organic chemists, physiologists, toxicologists, pharmacologists, statisticians and even computer experts. Several stages are involved in the new drug development process. These include the 'preliminary assessment' ' detailed business case preparation', 'product development', 'preclinical and clinical testing' and the application for the investigational new drug status with the FDA after which the drug becomes available for the physicians to prescribe to patients. So essentially the NPD process includes all the stages from idea generation to idea screening to concept development and testing, business and market analysis, product development and commercialization. Understanding the NPD cycle is important for firms to carefully plan the resources necessary for the product development and the release of new products into the market. Also understanding the NPD cycle and the cost of the different stages of drug development are crucial for a firm to make strategic business decisions. For instance most new, small to medium level research firms would be heavily burdened by the cost of clinical trials as clinical trials are known to constitute almost 45% of the functional cost of new drug development. [Venkatesh Gopal] Therefore understanding the NPD cycle along with the costs of different stages enables them to enter into production and marketing contracts with well-established companies that can fund these expensive phases of the product development cycle.

I learnt about funding organizations from organizational websites. Particularly the website of the American Association for the Advancement of science (AAAS) provides a detailed listing of the association of the various federal and HHS grants. Other websites such as the Illinois researcher information service (IRIS) and the government website Grants.gov carry a listing of many funding programs that are available for medical researchers.

1C ) One of the important business strategies for an organization involved in new drug development is the decision on whether to outsource product development or to develop it in their own organization. This choice is crucial and requires a careful appreciation of the cost factors and other market dynamics. There are risks involved in outsourcing product development. Particularly if there is weak intellectual property protection the innovator is at risk of having their hard work duplicated by the collaborator or even other competing organizations. However, if there is strong IP protection and significant technological complexity and costs are involved in setting up a production center, then it is a strategically wise choice to enter into a contract with an established pharmaceutical production company and outsource the production and commercialization part of the new product development cycle. If there is weak IP protection and high technological complexity and costs, then the developer should invest in the entire value chain. If there is low IP protection and low technological complexity and cost, then the innovator should only outsource selective components of the production and keep the main aspects such as product assembly and testing within the organization. The following diagram depicts this combination of factors and the recommended business model choice for the pharmaceutical or biotech firm engaged in research and development of new drugs. As we discussed above, a careful assessment of the degree of appropriability and the costs of developing an entire value chain from the scratch have to be performed to make the most beneficial business decisions.

Bibliography

1) Venkatesh Gopal, 'Ph.D, 'Translating Biomedical Innovation from the lab to Marketplace'.

Task 2

The regulatory paths to market for medical devices implies a series of tests, classifications and approvals which a new medical device has to clear in order for it to be permissible as an approved medical device in the market. These include 'quality system regulations', 'Non significant risk study' and review by the Institutional review board. It is important to know how to market the medical device as marketing clearance from the FDA is necessary to release the product into the market. It is important to submit the appropriate marketing application to the FDA in order to facilitate quick approval. First and foremost it is necessary to make sure that the device falls under the 201(h) of the FD&C Act. For instance if it is a radiation emitting electronic device it might come under the purview of other regulations which also have to be met with. Furthermore it is also essential to know under which FDA category the device will be classified (class 1, 2, 3 ) as it determines the marketing process that is applicable (premarket approval (PMA) or premarket notification [510(k)]) [FDA]

The IND review or Investigational new drug application review by the FDA is to ensure that the new drug does not cause any serious danger to the human subjects. Also since federal laws require that a drug has an approved marketing application before it can be transported across state borders, the IND Provides this authorization for Pharmaceutical companies to ship their drugs to different states for respective regulatory and safety tests. After the animal tests are concluded showing significant positive effects, the drug manufacturing company applies to the FDA seeking permission to test the drug for its therapeutic value in human subjects. At this point the drug is classified as investigational new drug (IND). The drug company should provide manufacturing information, results from the pharmacology and toxicology studies of the new drug conducted on animals and a detailed clinical… [END OF PREVIEW] . . . READ MORE

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