War may be hell, but it has a way of accelerating medical research.

(Anne Underwood, 2010) World War I brought methods for collecting and preserving blood for transfusions. World War II saw the introduction of penicillin into medical practice. One day, medical historians may remember Iraq and Afghanistan for spurring regenerative medicine. The article published in the Newsweek magazine by Anne Underwood titled War on Wounds, tells the story of the men and women who have been seriously injured while serving on behalf of our country. With many soldiers surviving injuries, thanks to our past medical advances, they come home with multiple traumatic injuries to the face, head and limbs that will take years to treat and will result in lifelong impairment. (Atala, 2011) Scientists believe they have found the solution to this, and perhaps they have. They say that we can repair ourselves from one embryonic stem cell. These are the first cells that can generate every cell in the body. In the womb, it can become every part of the body for the initial 6 days. Scientists can now divide these cells while making them capable of creating cells to repair tissue. Cells such as these will completely revolutionize medicine. For soldiers and others, this is just the beginning of a sense of hope. In addition to we live in a time where social expectations are high. We want to live longer, cure diseases and heal injuries that potentially cause permanent tissue damage. There are a high number of unmet needs within our healthcare system and in response to this the emergence of an industry has flourished. Regenerative Medicine is a new kind of cell based medicine that is regenerative in nature. (Dodgson, 2011) By addressing the underlying causes of diseases, we will be better equipped to treat patients at the cellular or molecular level. The emerging regenerative medicine industry is a new kind of manufacturing industry. (Science, 2013) It will use many biological materials as input and its products will frequently be living materials. Like the medical device and pharmaceutical industries, it has different customers to those encountered in conservative manufacturing. These include the regulator, the payer, and the healthcare delivery process and these create a different value system. (Underwood, 2013) The new product introduction process and the cost to the market; the payer and the healthcare delivery process define the value in the market. However, unlike the pharmaceutical and the medical device industries, the manufacturing process and the manufacturing and distribution system are complex and cost of goods may be significant. When these

products reach the market, they will hopefully deliver cures instead of just managing symptoms. The benefit of these cures may go beyond the traditional boundaries of heightened primary and social care. Since Regenerative Medicine is an emerging field and the vision of creating new tissue must be balanced with the realities of bringing those therapies to patients in a model that encourages investment at every step in the value chain. Regenerative medicine has been called the next evolution of medical treatments by the US department of health and safety that is projected to revolutionize healthcare. The delivery of living cells to restore normal tissue includes cell therapy (Dodgson, 2011) tissue engineering repair and regeneration of stem cells. In this paper I present Regenerative Medicine as an emerging industry and I will address how technology, markets, business models, industry dynamics, government, investment, production, and supply networks work together to affect its emergence. Technologies Regenerative medicine is important from a national healthcare perspective, as these technologies have the potential to create less costly and more effective therapies for some of the most expensive and devastating conditions plaguing our society. (Dodgson, 2011) There are three major stages in the developmental phase for cell based products. Stage I is usually an academic phase, where basic hands on by students and initial animal studies are performed. In stage II, the more capable technologies are transitioned from on campus projects to early clinical use. Then, in stage III, the technology is transitioned to a low cost sustainable business. Business Models, Production, and Supply Networks The emergence of an industry encounters many changes and developments while it strives to create its own business model that works. Research suggests that business models associated with cell therapy have struggled due to limitations on the technologies associated with it. However limited it has been or will continue to be, there is still a need to develop a strategic plan or business model to ensure the focus of any emerging industry. In response to this was the research of one individual who stated that the Regenerative Medicine Industry can identify four business models in cell-based therapies and indicate the possible evolution pathways between them. DSpace identifies these four business models to include the on site model, the host base model, the donor based model and the

cell modifier model. Cell modifiers are manufactured as biologicals , and are transported to the healthcare facility. They are not affiliated with pharmacies in any way. Cell modifiers are produced and transported to the healthcare facility, and are ready for onsite administration whenever required. After its administration to the patient, cell selfrenewal and separation will happen on site inside the patient. In the donor business model, the sample is collected from a donor and naturally stored in tissue. The sample is then transported off site to the company for manufacturing. The processed cells are then stored and transported to the healthcare facility to be administered to the recipient. The host business model follows the same path as the donor, but the patient is both the source and the recipient. (Green, 2000) This in turn eliminates the need for the stem cell bank. In the on-site business model, the patient is both the source and the recipient, but the sample of cells taken from the patient are stored for six days in attempt to re grow the therapy needed to be administered to the patient.

Successful Models 1 Markets According to Dodgson as an industry reemerges, it encounters a conceptual stage to market acceptance. An example of this is described by Chris Mason when hes described the Regenerative Medicine industry leaving the developmental phase into a successful and sustainable healthcare system. Mason notes that the 20 year history of Regenerative Medicine, as it was pioneered in laboratories with high media frenzy around the technology of growing human organs, companies were able to keep the much needed financial contributions but found it challenging to keep up with expectations. At the firm level much of regenerative medicines focus was on Research and development and little about translation into a genuine product. The development phase fell short on seeing the light at

the end of the tunnel where patients and shareholders would be informed of the benefits Stem cell research would actually convey. Government On March 9, 2009, President Barack Obama lifted, by Executive Order, the Bush administration's eight-year ban on federal funding of embryonic stem research. (Science, 2013) His speech stated that today... we will bring the change that so many scientists and researchers, doctors and innovators, patients and loved ones have hoped for, and fought for, these past eight years." Within the past eight years, Regenerative Medicine has made some enormous breakthroughs, California passed Proposition 71, allowing funding for research and development of stem cell research. In addition, we witnessed the first cloning of the Dolly, and Jamie Thomsons derivation of embryonic stem cells, and this is living proof that this new industry is emerging with the collaboration of science and technology. Like technology, evolution of new market is dependable on its features and benefits. Regenerative Medicine was exciting and was said to be the end all be all to chronic illness and tissue injury. Although this excitement was short term, the long term financial commitment could only be sustained by successfully translating the science into social benefit that preformed better than its prior equivalent. In doing so would require a business model that would perform elastically and could grow and shape itself to adapt to a wide range of forms. Innovation science and technology are still the key components of our nations Gross Domestic Product and science and innovation investments are key drivers to a high quality of life. The uncertainties about future production scale and unsynchronized regulatory systems have left Regenerative medicine with many challenges giving its unique nature of a first mover disadvantage. In early technology markets such as Regenerative medicine, success depends on co-evolving business models in cell based therapies. Ethics As a treatment to illness, disability and injury, advances in regenerative medicine raise ethical, legal, and social questions that need answers. Regenerative medicine is a new field of medicine in which different techniques are used to repair damaged organs and

tissues. Stem cell therapy is one possibility of regenerative medicine. Stem cell therapy has enormous potential for good. The ethical issue is not whether to use stem cells or not but where we get the stem cells from. The destruction of embryos for stem cells for stem cell research is ethically unacceptable to many. I recommend a course of action that would allow the use of spare embryos for Research and Development, even more so if they are donated. Pains Ethical framework can be applied to this ethical solution. One part of Pains Ethical Framework follows from one of the most powerful duties that we share amongst each other, the duty not to harm others. Where our actions will, or may probably prevent serious harm then if we can, reasonably we clearly should, act because failing to do so is to accept responsibility for the harm that would have been prevented or cured. We have a basic moral obligation to help other people in need. A person less fortunate than yourself deserves the best you can give. Because of duty, and honor, and service. You understand those words? You should do your job right, and you should do it well, simply because you can, without looking for notice or reward. (Quote) Most, if not all diseases create hardships and specific needs and physical accidents affect relatives, friends and careers and indeed our society. Since medical research allows individuals to exercise their right to that need in many circumstances, furthering medical research becomes a moral obligation. This obligation is not limited to actual physical participation in research projects, but also involves supporting research in other ways. Our duty, for example, as a power nation is to make sure other nations do not threat and try to take control. Individuals should not make decisions for a womans choice to have an abortion or to donate her embryos. It is an individual choice and we have a duty to respect that. Pains second part of his framework is focused on how do the decisions I make today affect others or the future of others. Without Stem Cells Research, we may never find the cure. If someone has a chance to walk again after losing this leg in a accident, we should have respect for the individual and their ability to make decisions with regard to their own health and future. Actions that enhance autonomy are thought of as desirable and actions that 'dwarf' an individual and their autonomy are undesirable. If a donator of embryos decides to donate for whatever reason, that decision does not truly harm anyone.

For best practices, the third part, going above and beyond required is always ideal. When we consider values and beliefs of individuals, the belief of destroyed embryos for stem cell research is always different. We always have respect for peoples thoughts and feelings and really it is always a end instead of a means to an end. The fourth part, commitments among regenerative medicine is supported by the use of embryos donated for either research or development. We have a commitment to health and preparing for the next generation. Their health and happiness is just as important, if not more as our feelings about regenerative medicine. Stakeholders The stakeholders in biosciences include virtually every individual and organization, worldwide. What happens in life sciences will affect everyone, everywhere. Jamie Lees interview states that the science of Regenerative Medicine is exciting and progress is being made, but regenerative healthcare is still in its infancy. This is a perfect example of hurry up and wait. Stem cell therapies, for example, have been the next big thing for well over a decade. Bioprinting is the hottest new technology, but the hype still far exceeds reality. Put together your watch lists and get familiar with the key players in the industry. (Danforth J. , 2013) Of the 30 publicly-traded stocks in the ARM Regenerative Medicine Index, only Mesoblast has a market cap over one-billion dollars. So, Lee states that the industry is looking at a collection of development-stage companies that are flowing cash with years to go before they have revenues (much less profitability). This usually ends in dilution when additional shares are issued to raise much-needed funding. Nonetheless, companies like Osiris Therapeutics are finally getting treatments approved and on the market. From his perspective, many of these stocks are more speculation than investment. Biotech stocks have the highest volatility of any market sector; they can be endlessly exciting and frustrating. In recognizing the military medical challenges regarding the hopes to return dedicated service members to fully or near pre-injured state, the U.S. Congress recently issued a legislative request to the Surgeon General of the Army to fund studies on new

methods for wound healing and scar reduction following battlefield injuries with the goal to develop new, innovative treatments. In addition we live in a time where social expectations are high. We want to live longer, cure diseases and heal injuries that potentially cause permanent tissue damage. There are a high number of unmet needs within our healthcare system and in response to this the emergence of an industry has flourished. Regenerative Medicine holds the fate that one day we restore out broken healthcare system and find permanent cures for those suffering from illness or injury.

Works Cited
Atala. (2011). Life Science Intelligence. Congress Testimony. Danforth, J. (2013, July 7). Director of Education. (J. Galvez, Interviewer) Upland, CA. Danforth, K. (2013, August 1). Simple Green. (J. Galvez, Interviewer) Dodgson. (2011). How Stem Cells are Used in Reserach. New York. Green, H. (2000). Cultured Cells for Treatment of Disease. Science, E. a. (2013). Project. Underwood, A. (2013). News. Executive editor, Harvard special health reports .