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International Agency for Research on Cancer and 3 mood disorder lecture notes buy eskalith american express, and adenocarcinoma in situ: a combined analysis of four randomised World Health Organization; 2012 depression disability eskalith 300 mg mastercard. Screening and adenocarcinoma of vaccination against human papillomavirus infection and disease in women: the cervix depression symptoms boyfriend eskalith 300 mg fast delivery. Comparison of risk factors for invasive squamous cell carcinoma and human papillomavirus and risk of cervical adenocarcinoma mood disorder child order eskalith 300mg without a prescription. Available at: on 8,097 women with squamous cell carcinoma and 1,374 women with. A randomized trial of pelvic and squamous cell carcinoma incidence trends among white women and radiation therapy versus no further therapy in selected patients with stage black women in the United States for 1976-2000. Gynecol Oncol cancer patients receiving surgical resection followed by radiotherapy: a 1994;53:109-113. Int J Gynecol Cancer carcinoma or carcinoma-in-situ at hysterectomy following cervical 2012;22:291-295. Microinvasive carcinoma of the classification of invasive endocervical adenocarcinoma, depth of invasion cervix. Available at: measurement and distinction from adenocarcinoma in situ: interobserver. Interpretability of excisional biopsies of the cervix: cone biopsy and loop excision. Available at: neuroendocrine carcinoma of the cervix: outcome and patterns of. Gynecol Oncol 2014;132:624 abdominal radical trachelectomy for early-stage cervical cancer: 627. Radical trachelectomy: the first as a method of fertility preservation for cervical cancer. Establishing a sentinel lymph node early-stage cervical cancer: utility of intraoperative versus postoperative mapping algorithm for the treatment of early cervical cancer. Bilateral negative sentinel biopsy on staging of early cervical cancer: Results of a prospective, nodes accurately predict absence of lymph node metastasis in early multicenter study [abstract]. The sentinel node technique conization and sentinel lymph node mapping in the treatment of stage I detects unexpected drainage pathways and allows nodal ultrastaging in cervical cancer: is less enough? Available at: for lymph nodal staging of uterine cervix cancer: a systematic review and. Surgical versus radiographic determination of para-aortic lymph node metastases before 93. Sentinel Node Mapping in chemoradiation for locally advanced cervical carcinoma: a Gynecologic Cervical and Endometrial Cancer: Indocyanine Green Versus Other Oncology Group Study. Survival rate comparisons amongst cervical cancer patients treated with an open, 116. A multi-institutional robotic-assisted or laparoscopic radical hysterectomy: A five year experience with robotic-assisted radical hysterectomy for early stage experience. Primary surgery chemotherapy compared with pelvic and para-aortic radiation for high-risk versus primary radiation therapy with or without chemotherapy for early cervical cancer. Available at: lymph nodes: a Gynecologic Oncology Group and Southwest Oncology. Ovarian transposition for patients with cervical carcinoma treated by radiosurgical combination. Lancet randomized trial comparing concurrent single agent cisplatin, cisplatin 1997;350:535-540. Available at: based combination chemotherapy, or hydroxyurea during pelvic irradiation. Concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk chemoradiation with carboplatin for elderly, diabetic and hypertensive cervical cancer: an update of radiation therapy oncology group trial patients with locally advanced cervical cancer. Concurrent carboplatin uncertainties about the effects of chemoradiotherapy for cervical cancer: a with pelvic radiation therapy in the primary treatment of cervix cancer. Impact of adoption of mitomycin C, 5-fluorouracil, and radiotherapy in the treatment of locally chemoradiotherapy on the outcome of cervical cancer in Ontario: results of advanced carcinoma of the cervix: a randomized trial. Chemoradiation and adjuvant concurrent weekly cisplatin and radiotherapy for cervical carcinoma with chemotherapy in cervical cancer. Vaginal radical trachelectomy: a valuable fertility-preserving option in the management of 164. A review of of upstaging after laparoscopic staging for patients with locally advanced hypofractionated palliative radiotherapy. Available randomised controlled trial of neoadjuvant chemotherapy plus radical at. Available at: of lymph vascular space invasion on time to recurrence in women with. Eur J Surg Oncol 2013;39:115 lympho vascular space involvement and lymph node micrometastases in 124. Available at: chemotherapy followed by radical surgery in the management of stage. An update on post-treatment surveillance and diagnosis of recurrence in women with gynecologic 185. Available at: cisplatin prior to radical hysterectomy and pelvic/para-aortic. Complementary Prognostic Value posttherapy positron emission tomography with tumor response and of Pelvic Magnetic Resonance Imaging and Whole-Body survival in cervical carcinoma. Available at: Fluorodeoxyglucose Positron Emission Tomography/Computed. J Natl exenteration: the Albert Einstein College of Medicine/Montefiore Medical Cancer Inst 2007;99:1634-1643. Available at: survival after interdisciplinary salvage surgery for advanced or recurrent. Hyperfractionated radiotherapy with concurrent chemotherapy for para-aortic lymph node recurrence in 220. Available at: squamous cell carcinoma of the cervix: a gynecologic oncology group. Bevacizumab for advanced cervical cancer: patient-reported outcomes of a randomised, phase 3 trial 230. J Clin squamous cell carcinoma of the uterine cervix: a Gynecologic Oncology Oncol 2017;35:4035-4041. A randomized the treatment of persistent or recurrent squamous cell carcinoma of the comparative trial of carboplatin and iproplatin in advanced squamous cervix: a gynecologic oncology group study. Evaluation of gemcitabine in previously treated patients with non-squamous cell carcinoma of the 263. Gynecol study of topotecan in patients with squamous cell carcinoma of the cervix: Oncol 2005;96:103-107. Evaluation of vinorelbine in ifosfamide in advanced and relapsed carcinoma of the cervix. Cancer persistent or recurrent squamous cell carcinoma of the cervix: a Chemother Pharmacol 1986;18:280-283. Available National Institute of Allergy and Infectious Disease and Food Allergy and at. Improving target volume delineation in intact cervical carcinoma: Literature review 268. Rapid inpatient/outpatient desensitization for chemotherapy hypersensitivity: standard protocol 277. Assessment of Parametrial Response by Growth Pattern in Patients With International Federation of 273. Philadelphia: radiotherapy in postoperative treatment of endometrial and cervical Lippincott Williams & Wilkins; 2009:325-380. Consensus guidelines for delineation of clinical target volume for intensity-modulated pelvic 289. Comparison of hematologic radiotherapy for the definitive treatment of cervix cancer. The effect of treatment Cisplatin and intensity-modulated pelvic radiotherapy: comparison with duration in the local control of cervix cancer.


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Results: Between October 2015 and April 2018 depression definition economic purchase eskalith 300mg free shipping, 28 patients received radiotherapy to angle of depression definition geometry discount eskalith amex a median dose of 30 Gy (range 15–66 depression cherry stream cheap eskalith 300mg. Radiotherapy volume was limited to depression symptoms fever generic eskalith 300mg without a prescription gross tumor plus margin in 258 most cases (n = 22), but regional nodes were included in patients treated with definitive intent (n = 6). Six patients (21%) experienced recurrent bleeding at a median interval of 15 months. Factors not predictive of recurrent bleeding were total radiation dose, dose per fraction, and radiation technique (P > 0. Two (7%) grade 3+ toxicities were observed (vaginal fistula and small bowel obstruction). Conclusion: Conformal palliative radiotherapy is highly effective at controlling vaginal bleeding secondary to gynecologic malignancies. Patients who live longer are at higher risk of recurrent bleeding, warranting additional study to find a durable treatment regimen in selected patients with favorable prognoses. Patients rated symptom severity and interference at its worst over 24 hours from 0 = “not present” to 10 = “as bad as you can imagine. Linear mixed effect models examined longitudinal changes in symptom burden based on whether patients were alive or died within 12 months of most recent recurrence. Median age was 63 years; 71 patients (82%) had stage lll/lV disease; 71 (82%) had serous histology; and 41 (47%) were receiving platinum-based treatment at enrollment. The most severe symptoms were fatigue, numbness, pain, sleep disturbance, and drowsiness. Patients who died reported worse symptom interference compared to patients who were alive at 12 months (3. While patients who died had consistently higher pain levels, this was in the mild range and remained stable even near the end of life. The distinctly different symptom burden trajectories trend over months and provide insight into the utility of utilizing symptom burden trends to alert patients and clinicians to symptoms on which to focus supportive care efforts. Participants were asked to rate reasons to refer patients to hospice as well as barriers to hospice referral. The highest rated reason for hospice referral was “pain or symptom control” (median 3 on 1–4 scale), followed by “assistance through the dying process” (median 4). Attendings were more likely than fellows to place importance on hospice referral for “nursing support” (P = 0. The highest rated barriers to hospice referral were “difficulty predicting patient death within 6 months” (median 2 on 1–4 scale) and “physician desire to pursue additional lines of chemotherapy” (median 2), which were both more likely to be rated higher by fellows than attending physicians (P = 0. Fellows were also more likely than staff physicians to agree that they had a “lack of time” to discuss issues of dying and hospice care (P = <0. Respondents were also asked to describe the primary role of palliative care at their institution, choosing from pain management (31%), goals of care (18%), transition to hospice (22%), and other symptom management (29%). Respondents were more likely to associate palliative care with pain and symptom management if they were fellow physicians (P = 0. Likert scale data also differed by the fellow–attending divide, as fellows were more likely to agree that palliative care physicians were better communicators than gynecologic oncology physicians (P = 0. Forty percent of respondents thought the primary role of palliative care to be goals of care and hospice transition, highlighting a potential trend in the respondent population to late involvement of palliative care services. The American Society of Clinical Oncology defines value in cancer care as clinical benefit in the context of morbidity and costs. Our objective was to elucidate patient preferences in ovarian cancer and to ascertain what they value the most. Method: From January 2017 to May 2017, 50 patients with ovarian cancer were enrolled in this prospective study. Patients rated each attribute using a Likert scale from 1 (not important) to 5 (deeply important) and ranked them from the most important (1) to the least important (11). This was followed by progression-free survival, physical/mental well-being, permanent complications/sequelae. Chemotherapy schedule/type, assistance with care, cost of care, and logistical issues were the least important attributes. There were no differences in preferences between patients who recurred versus those who did not. Method: this study was approved by the University of Pittsburgh Institutional Review Board. Results: Fifteen women undergoing surgery for presumed gynecologic malignancy had concordant harvesting of ovarian cortical tissue for cryopreservation; five additional women were consented but did not require oophorectomy. Fourteen women did not qualify for standard-of-care oocyte cryopreservation; three women were pregnant at the time of surgery. Normal ovarian tissue appropriate for cryopreservation was recovered from 13 of 15 patients (86. The procedure is performed in conjunction with surgical staging and typically does not add complexity to the case. We advocate for discussion and consideration of this procedure in appropriately counseled, premenopausal gynecologic oncology patients. This approach is an option for patients who do not qualify for oocyte or embryo cryopreservation because of suspected ovarian malignancy or because of need to proceed with surgery expeditiously. Patients should be counseled about the possible need for experimental in vitro maturation because ovarian tissue transplantation may not be appropriate in the setting of prior malignancy. Overall, among patients for whom symptom improvement was available to date, 17/20 (85%) noted improvement. Four (12%) patients reported unwanted side effects, which were euphoria, dizziness, fatigue, and paranoia. Only one (3%) patient ceased medical marijuana use because of untoward adverse effects. Results: Gynecologic cancers had higher hospitalization rates in the last 30 days of life compared to nongynecologic cancers (52. Gynecologic cancers had lower rates of hospice utilization compared to nongynecologic cancers (14. More gynecologic cancer patients received chemotherapy within 14 days of death compared to patients with nongynecologic cancers (1. This difference was likely driven by ovarian cancer patients with rates double that of other malignancies (1. Conclusion: Patients with gynecologic cancers may have barriers in their care that delay or impede hospice enrollment and allow for continued medical treatments such as chemotherapy, even at the end of life. Further research in this area is necessary to identify explanations for this discrepancy for patients with gynecologic cancers. End-of-life care by cancer type 1613 Poster Session Outcomes after gastrostomy tubes for malignant bowel obstruction C. Future research, however, should focus on patient-reported outcomes and quality of life to assist in shared decision making. Results: A total of 43 women were treated with a bev-containing chemotherapy regimen; among them, 34 (79. Secondary endpoints included evaluation of postoperative patient-reported symptoms after surgery and patient satisfaction. An 8-item symptom inventory of pain, nausea, vomiting, shortness of breath, fever, swelling, discharge, and redness was developed. If responses exceeded defined thresholds of severity, alerts to health care providers were triggered. The symptom assessment method was deemed successful if 64 of 100 patients responded. Phone calls with review or adjustment of supportive medications were sufficient to address most symptoms. Most patients agreed or strongly agreed that electronic symptom tracking was helpful and easy to use and that they would recommend it to other patients. Conclusion: Electronic postoperative electronic symptom tracking is feasible for patients undergoing ambulatory gynecologic cancer surgery. Assessment points were at baseline (T1), 4–6 weeks (T2), 12–14 weeks (T3), and 22–24 weeks (T4) after starting study treatment.

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Assessment example depression internet test buy discount eskalith 300mg on line, a diagnosis of dyslexia depression definition in sport order eskalith no prescription, blindness mood disorder pathophysiology order eskalith 300 mg otc, or and evaluation systems are ofen focused on deafness can facilitate access to depression zombie discount eskalith 300 mg without a prescription technological academic performance rather than individual and communication support and specialized progress and therefore can also be restrictive teaching (75). A study in two states of the types of disabilities they perceived to be easier United States examined the responses of 155 to work with in mainstream settings (36). Two distinct versions of dents with disabilities, expectations might be a questionnaire were created, including short low, with the result that little attention is paid sketches describing children with disabilities. Teachers, parents, One included a “labelling” version that used and other students may well be caring but at terms such as cerebral palsy. The other did not the same time not believe in the capacity of use labels, but simply described the children. Some families the teachers who completed the non-labelling with disabled students may believe that special version were more positive about including schools are the best places for their children’s disabled children than those who completed education (76). This suggested that a label can lead to more negative attitudes and Violence, bullying, and abuse that adults’ attitudes were critical in develop Violence against students with disabilities – by ing policies on the education of children with teachers, other staf, and fellow students – is disabilities. Students with disabilities ofen become the targets of Attitudinal barriers violent acts including physical threats and Negative attitudes are a major obstacle to the abuse, verbal abuse, and social isolation. In some fear of bullying can be as great an issue for cultures people with disabilities are seen as a children with disabilities as actual bullying form of divine punishment or as carriers of (88). As a result, children with attend special schools, because of the fear of disabilities who could be in school are some stigma or bullying in mainstream schools (88). A community Deaf children are particularly vulnerable to based study in Rwanda found that perceptions abuse because of their difculties with spoken of impairments afected whether a child with communication. Negative commu nity attitudes were also refected in the language used to refer to people with disabilities (82, 83). Addressing barriers The attitudes of teachers, school admin to education istrators, other children, and even family members afect the inclusion of children with Ensuring the inclusion of children with disabilities in mainstream schools (74, 84). As with ers, believe they are not obliged to teach chil other complex change, it requires vision, dren with disabilities (84). In South Africa it is skills, incentives, resources, and an action thought that school attendance and completion plan (90). One of the most important ele are infuenced by the belief of school admin ments in an inclusive educational system istrators that disabled students do not have a is strong and continuous leadership at the future in higher education (85). A study com national and school levels – something that paring Haiti with the United States found that is cost-neutral. A 1993 study carried out in Legislation a quarter of the country’s primary schools, The success of inclusive systems of education involving interviews with more than 2649 depends largely on a country’s commitment to teachers, found that 17% of children in Lesotho adopt appropriate legislation, develop policies had disabilities and special educational needs and provide adequate funding for implementa (95). Since the mid-1970s Italy has had legisla education was launched in 10 pilot schools, tion in place to support inclusive education for one in each district of the country. Training all children with disabilities resulting in high in inclusive teaching was developed for teach inclusion rates and positive educational out ers in these schools, and for student teachers, comes (33, 91, 92). A recent study on inclusive istries can promote an understanding of the education in Lesotho found variability in the right to education of disabled students by: way that teachers addressed the needs of their publicizing support available for disabled children (96). Tere was a positive efect on children the attitudes of teachers, and without a formal reminding school boards of their legal policy it is unlikely that improvements would responsibilities have occurred. National plans Creating or amending a national plan of action A survey of low-income and middle-income and establishing infrastructure and capacity to countries found that if political will is lacking, implement the plan are key to including children legislation will have only a limited impact (31). Ministry of Education (97), with coordination, as appropriate, with other relevant ministries. Policy National plans for Education For All should: Clear national policies on the education of chil refect international commitments to the dren with disabilities are essential for the devel right of disabled children to be educated; opment of more equitable education systems. By 1991 it provision and training programmes; had established a Special Education Unit and make available sufcient funds; 217 World report on disability Box 7. Inclusion is possible in Viet Nam – but more can be done In the early 1990s Viet Nam launched a major programme of reform to improve the inclusion of students with disabilities in education. The Centre for Special Education worked with an international nongovernmental organi zation to set up two pilot projects, one rural and one urban. Local steering committees for each project were active in raising awareness in the community and conducting house-to-house searches for children who were missing from official school lists. The pilot projects identified 1078 children with a wide range of impairments who were excluded. Training was provided to administrators, teachers, and parents on: the benefits of inclusive education special education services individualized educational programmes carrying out accommodation and environmental modifications assessment family services. In addition, technical assistance was given in such areas as mobility training for blind students and training for parents on exercises to improve mobility for children with cerebral palsy. Four years later, an evaluation found that 1000 of the 1078 children with disabilities had been successfully included in general education classes in local schools – an achievement welcomed by both teachers and parents. With international donor support a similar programme was conducted in three other provinces. Within three years attendance rates in regular classes of children with disabilities increased from 30% to 86%, and eventually 4000 new students were enrolled in neighbourhood schools. Follow-up evaluations found that teachers were more open to including students with disabilities than previously – and were better equipped and more knowledgeable about inclusive practices. Teachers and parents had also raised their expectations of children with disabilities. This sum did not cover specialized equipment – such as hearing aids, wheelchairs, and Braille printers, which many students with disabilities required and whose cost was prohibitive for most families. Despite the progress, only around 2% of preschool and primary schools in Viet Nam are inclusive, and 95% of children with disabilities still do not have access to school (90). But the success of the pilot projects has helped change attitudes and policies on disability and has led to greater efforts on inclusion. The Ministry of Education and Training has committed itself to increase the percentage of children with disabilities being educated in regular classes. The criteria for eligibility of age groups, and drop of sharply by secondary funding can be complex. The decline in resources for these model is used, it should: categories may refect higher drop-out rates for be easy to understand these groups, especially in the later stages of be fexible and predictable secondary school, implying that the system is provide sufcient funds not meeting their educational needs. It is clear that the Central and South American One system for comparing data on resources countries are providing resources for students between countries categorizes students accord with disabilities in the pre-primary and pri ing to whether their needs arise from medical mary years. But there is a rapid fall-of of pro conditions, behavioural, or emotional condi vision in the early secondary school period and tions, or socioeconomic or cultural disadvan no provision at all in the later secondary period. Tose allocated to children across the full age range, even though the pro with socioeconomic or cultural disadvantages vision is reduced at older ages. Percentage of students with disabilities receiving educational resources by country and by level of education Country Compulsory Pre-primary Primary Lower Upper education (%) (%) (%) secondary (%) secondary (%) Belize 0. Low-income countries will require long European Agency for Development in Special term predictable fnancing to achieve this. In Needs Education studied forms of assessment the Lao People’s Democratic Republic, Save that support inclusion in mainstream settings the Children and the Swedish International (105). Involving 50 assessment experts in 23 Development Cooperation Agency provided countries, the study addressed how to move from long-term funding and technical support for an a defcit – mainly medically-based – approach to Inclusive Education Project from 1993–2009. The fol The project resulted in a centralized, national lowing principles were proposed: approach to the development of policy and Assessment procedures should promote practice in inclusive education. Inclusion has the best chance The assessment procedures should aim to of success when school funding is decentral promote diversity by identifying and valu ized, budgets are delegated to the local level, and ing the progress and achievements of each funds are based on total enrolment and other student. Access to small amounts of fexible Inclusive assessment procedures should funds can promote new approaches (103). Instead, assessments should focus on learning and teaching practices that lead to Recognizing and addressing more inclusion in a mainstream setting. The curricula, multidisciplinary process, they identify needs, teaching methods and materials, assessment learning goals and objectives, appropriate and examination systems, and the manage teaching strategies, and required accommo ment of classes all need to be accessible and dations and supports. Many countries such as fexible to support diferences in learning pat Australia, Canada, New Zealand, the United terns (19, 69). Kingdom and the United States have policies Assessment practices can facilitate or and documented processes for such plans (106). The need to attain aca Creating an optimum learning environ demic excellence ofen pervades school cultures, ment will assist children in learning and so policies on inclusion need to ensure that all achieving their potential (107). Streaming and communication technologies, including 220 Chapter 7 Education assistive technologies, should be used when children with disabilities to participate in ever possible (69, 108).

Technical support For more information or technical assistance postpartum depression definition who buy discount eskalith, call depression definition lexikon discount eskalith 300 mg on-line, write depression test calm clinic generic eskalith 300 mg online, fax anxiety from alcohol order eskalith 300 mg online, or email our award-winning Technical Support. Limited product warranty Thermo Fisher Scientific Corporation and/or its affiliate(s) warrant their products as set forth in the Thermo Fisher Scientific’ General Terms and Conditions of Sale found at thermofisher. A review of retroviral pathogenesis and its relevance to retroviral vector-mediated gene delivery. All trademarks are the property of Thermo Fisher Scientifc and its subsidiaries unless otherwise specifed. It much they are willing to spend for patients to be healed promises novel therapeutic approaches to replace or re of deadly diseases. The feld also includes stem Pharmaceutical companies, for their part, must prepare cell and gene therapies, tissue engineering and materials themselves for the coming revolution, ensuring that science. Indications range from wound healing and tis they are able to integrate and launch the new therapies sue transplantation to curing damaged organs and even as and when they emerge. This will involve strengthen entire diseases, such as cancers, genetic disorders and ing their "innovation radar" and scouting capabilities, autoimmune diseases. They also represent a revolution for use of the new products and generate real-life data, and patients, shifing the focus from treatment to healing. Clearly desirable from a human perspective, generative medicine is on course to these new approaches are also highly attractive from transform the pharmaceutical both a scientifc and a commercial perspective. By following our practical But this revolution in medicine raises many questions recommendations, Big Pharma can and hurdles. Big Pharma is currently less active in the feld of stem-cell and gene therapies than other players, ensure that it is not left behind in and a real risk exists of them missing out on this oppor the process. Alongside biotechnology ("biotech") companies and university hospital research centers, a new type of player has emerged in the feld: medical technology ("medtech") companies. Once regenerative medicine has become mainstream, the entire healthcare ecosystem will have to adapt. Re generative medicine requires special patient settings for application and new forms of reimbursement. Regenerative medicine –Roland Berger Focus 5 Regenerative medicine is currently limited to very few What is striking, however, is the current lack of involve specialist clinics and trial situations. Only clinicians today know little about regenerative medi around 50 of the 300 or so stem-cell and gene therapies cine and its potential. But regenerative medicine is set currently on the way – less than 20 percent – are being to transform the future of healthcare. This approach is driven by precaution Stem-cell and gene therapies are on the rise, and their and the desire to bet only on sound, proven concepts. The reason these new treatments While this makes sense from a risk perspective, the are so important is that they ofer a potential cure for danger is that Big Pharma will miss out on major op diseases rather than long-term treatment, shifing the portunities and potential "hidden stars. The current industrial maceutical companies need to decide whether to play pipeline is packed, with around 300 stem-cell and gene an active role in the emerging business of regenerative therapies in development registered in public databas medicine or to stand on the sidelines. We estimate that a further 10 to 30 percent of stem time, they must be aware that new developments in re cell and gene therapies are currently in development generative medicine may cannibalize drug innovations outside the industry at academic institutions such as that have a more traditional mode of action. Regenerative medicine –Roland Berger Focus 7 We believe that both Big Pharma and biotechs will have to evolve from drug-product manufacturers to provid ers of therapeutic interventions. Stem-cell and gene Production of stem-cell therapies are much more difcult to integrate into the pharmaceutical value chain than previous innovations and gene products not as they require a controlled process, from intervention only requires completely by doctors to application in patients. By comparison, when biopharmaceuticals, or "biolog diferent skills and ics" – drugs manufactured from biological sources – appeared on the scene some decades ago, only the ear technology, it needs to be ly development steps had to be changed, from screening compound libraries to engineering the molecules need located closer to ed. Nevertheless, it took about two decades for Big Pharma to incorporate biologics into their product physicians and patients. Even today, many pharmaceutical companies prefer to partner with a biotech to in-license products in early clinical development stages rather than con duct early development on their own. Other specialists such as clinical chemists or diferent from chemicals and biologics as the interac geneticists will then apply a procedure to the material tions of numerous parameters need to be optimized, obtained to give it the desired efects, or process the in such as gene expression, cell viability and matrix. Not formation obtained, and turn it into a pharmaceutical only that, clinical development and the relevant regu therapy before it can be readministered to the patient. Another key issue concerns protecting intellectual prop Even when a stem-cell or gene therapy product is ap erty. It will not be enough for companies to simply ceutical company can add to such a form of therapy lies: establish a production site somewhere in the world to it can simplify and standardize the use of highly com serve global demand. Stem-cell and gene therapies are plex procedures along the processing chain for stem mostly patient-specifc with a batch size of one unit. B While hospitals and healthcare professionals unable integrate stem-cell and gene therapeutics into are responsible for delivering treatments, regulatory au its current operations. Maybe a diferent mindset is thorities and insurance companies are responsible for needed to cope with products of such high complexity. Pharmaceutical, bio Or maybe new business models are required to gener tech and medtech companies supply the system and ate proft with such products. Now all par A new competitor has emerged on the scene: medtech ties will need to join forces to ensure broad, high-quality companies. Some medtech companies are already one patient access using diferent means of integration, step ahead of Big Pharma. Indeed, the medtech industry such as digital platforms and new reimbursement seems to be better positioned to proft from regenerative schemes. Medtech companies do not depend on single be more important than ever, as healthcare systems will blockbuster products but generate profts with a large only pay for performance. These players are also used to design Substantial changes are likely on the operations side. Re ing customer-specifc solutions and adapting them to in generative medicine, unlike current of-the-shelf phar dividual needs, as is the case with surgical instruments. For many therapies, tive medicine, where combination products such as cellular material must frst be sourced from blood, bone engineered tissues are produced. This is unlikely to take place at the manufac Future therapies involving regenerative medicine will turing sites of pharmaceutical companies. Instead, ini require tools, techniques and agents that can be used tial processing will probably occur at the bedside in the in-house to ensure their broad availability and use. The procedure involved involving instruments and agents will be needed, and will require special training and investment in the nec will be provided by the medtech industry. Or will peer-to-peer collaboration models investment both in infrastructure and in the education with Big Pharma succeed? Today, the race seems open and training of qualifed personnel is therefore re – and it also involves competing biotech companies and quired if patients are to be treated with regenerative leading research-driven healthcare providers. Regenerative medicine is a new and valuable treatment op consortium HemAcure addresses a far more frequent disease, tion for more and more acute and chronic clinical conditions. HemAcure consists of aca to signifcantly improve such chronic conditions as cartilage demic groups from Germany, Italy and the United Kingdom, defects or malignant melanomas. It is even possible to cure and uses a medical device supplied by a Canadian medtech certain diseases, such as some types of leukemia and a rare company. In terms of transplants, scientists have managed to tissue engineer the One European biotech company is even further along the frst autologous organ parts when donors were lacking. They road, with an allogenic stem-cell injection currently in the ap have successfully constructed bladders, blood vessels, skin proval process. In fact, it is not impossible that we will see dis An ex-vivo gene therapy approach has also been chosen by eases become extinct for which patients used to take daily another partnership between academia and industry. B: Regenerative medicine is set to transform the healthcare ecosystem Patient Payer Promises a cure Healthcare provider vs. The question must be answered separately for each treatment, based on the W e foresee far more target population size and the severity of the disease. However, the problems it raises and the need for nego complex and integrated tiation between payers and providers of such therapies will be the same in each case. Unfortunately, this is not the way pharmaceu tives will also be needed for the clinical laboratories tical remuneration works. Healthcare systems will sim and hospital pharmacies involved in the event that ply not be capable of paying such linear extrapolations therapies need to be partially delivered on site. At some point, the fnan Designing commercial models for these complex, cost cial value will grow more slowly than the value the ther ly therapies is likely to determine whether or not they apy provides to the patient.

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