ISBN 10: 1907568093 / ISBN 13: 9781907568091
Gebraucht / Anzahl: 0
Bei weiteren Verkäufern erhältlich
Alle  Exemplare dieses Buches anzeigen

Über dieses Buch

Leider ist dieses Exemplar nicht mehr verfügbar. Wir haben Ihnen weitere Exemplare dieses Titels unten aufgelistet.

Beschreibung:

Buchnummer des Verkäufers

Über diesen Titel:

Bewertung (bereitgestellt von GoodReads):
4 durchschnittlich
(2 Bewertungen)

Inhaltsangabe: Summary: This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. Before the orphan drug legislation enacted in the US in 1983, there was a limited interest from industry to develop treatment for very small patient groups. One of the difficulties is, of course, that similar levels of investment are needed from a pharmaceutical company to bring a drug to the market for both small and large patient groups. The journey from application of an orphan drug designation to a reimbursed market- approved drug is long and many obstacles occur during the journey. After reading the book, readers will: Understand who the players/stakeholders are in the rare orphan disease field and their specific needs and concerns: patients and patient organizations, researchers and treating physicians within the field, industry, regulatory and reimbursement bodies* Understand the strong partnership between the different players and the various initiatives to improve and increase access to treatment for patients; minimizing the gap between numbers of known diseases, orphan designations, approved drugs and paid drugs. The book also provides short practical case stories from patients and researchers, as well as representatives from industry and authorities on the challenges they came across in developing orphan drugs or getting access to orphan drugs. About the authors: Elizabeth Hernberg-Stahl, M.Sc, is founder of Late Phase Solutions Europe AB, based in Sweden; it is an independent consultancy focusing on providing strategic and operational guidance on late phase drug development as well as guidance on processes and activities related to orphan drug development and market access. The author has more than thirty years experience from the international biotech and pharmaceutical industry (20 of which were in the orphan drugs area). During her 10 years at TKT/Shire HGT Elizabeth was responsible for developing and establishing the Global Outcome Survey Department, which manages global patient registries. Elizabeth was also member of the Shire HGT European Management Team and the Global Medical Affairs Leadership Team. Elizabeth has published numerous papers and is a frequent speaker at several congresses on topics related to orphan rare diseases. Miroslav Reljanovic, MD, MSc, is a board-certified neurologist. Whilst practising as a physician in a large WHO Collaborating Centre in Zagreb, he was the clinical investigator in numerous Phase II and III studies in the field of neurology and a consultant to various pharmaceutical companies. In 1997, Miro founded Ergomed contract research organization (CRO) and he introduced the novel Study Site Coordination model as an intrinsic part of the conduct of clinical studies. This model became a landmark of the Ergomed approach to clinical research which is paramount to provide high quality trial data in very demanding areas like oncology, neurology, and orphan diseases including rare cancers. Contents: Introduction; Orphan drugs and orphan drug legislation; Characteristics of rare diseases; Patient network and advocacy groups; Organisations and networks dedicated to rare diseases and orphan drugs; Policies and research funding; Designing robust clinical trials for orphan drugs; Market access procedures for orphan drugs

Über den Autor: Elizabeth Hernberg-Stahl, M.Sc, is founder of Late Phase Solutions Europe AB, based in Sweden; it is an independent consultancy focusing on providing strategic and operational guidance on late phase drug development as well as guidance on processes and activities related to orphan drug development and market access. The author has more than thirty years experience from the international biotech and pharmaceutical industry (20 of which were in the orphan drugs area). During her 10 years at TKT/Shire HGT Elizabeth was responsible for developing and establishing the Global Outcome Survey Department, which manages global patient registries. Elizabeth was also member of the Shire HGT European Management Team and the Global Medical Affairs Leadership Team. Before joining Shire HGT/TKT Europe-5S, Elizabeth held a similar position for 8 years at Pharmacia/Pfizer where she established and managed a global patient registry KIMS on the rare condition adult GHD and the outcome of growth hormone treatment. Elizabeth has published numerous papers and is a frequent speaker at several congresses on topics related to orphan rare diseases. Miroslav Reljanovic, MD, MSc, is a board-certified neurologist. Whilst practising as a physician in a large WHO Collaborating Centre in Zagreb, he was the clinical investigator in numerous Phase II and III studies in the field of neurology and a consultant to various pharmaceutical companies. In 1997, Miro founded Ergomed contract research organization (CRO) and he introduced the novel Study Site Coordination model as an intrinsic part of the conduct of clinical studies. This model became a landmark of the Ergomed approach to clinical research which is paramount to provide high quality trial data in very demanding areas like oncology, neurology, and orphan diseases including rare cancers. Miro has also successfully introduced the first European innovative co-development business model and he has completed several transactions with European and North American listed biopharmaceutical companies. Together with co-founder Elliot Brown, MB, MRCGP, FFPM, a well known international expert in drug safety, Miro started PrimeVigilance in 2008, which soon became a leading specialist vendor of contracted pharmacovigilance services to the pharmaceutical industry. Through a strategic partnership with Elizabeth Hernberg-St hl, Miro established a specific division at Ergomed, focusing on providing assistance and support to biotechnology and drug industries, clinicians, and researchers, to facilitate the development of candidate drugs for rare diseases in this challenging field.

„Über diesen Titel“ kann sich auf eine andere Ausgabe dieses Titels beziehen.

Bibliografische Details




Zustand: New

Beste Suchergebnisse beim ZVAB

1.

Elizabeth Hernberg-Stahl
Verlag: Elsevier Science & Technology Okt 2013 (2013)
ISBN 10: 1907568093 ISBN 13: 9781907568091
Neu Anzahl: 1
Anbieter
AHA-BUCH GmbH
(Einbeck, Deutschland)
Bewertung
[?]

Buchbeschreibung Elsevier Science & Technology Okt 2013, 2013. Buch. Buchzustand: Neu. 242x165x24 mm. Neuware - This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. 334 pp. Deutsch. Artikel-Nr. 9781907568091

Weitere Informationen zu diesem Verkäufer | Frage an den Anbieter

Neu kaufen
EUR 201,55
Währung umrechnen

In den Warenkorb

Versand: EUR 29,50
Von Deutschland nach USA
Versandziele, Kosten & Dauer