Founder and Managing Director of klausrose Consulting, Riehen, Switzerland
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1 Curriculum Vitae Dr. med. Klaus Rose (MD, MS) Current Address klausrose Consulting Pediatric Drug Development & More Aeussere Baselstrasse Riehen Switzerland Phone Mobile Personal Data Born 2 nd November 1953 in Heidelberg, Germany Nationality: German Married, two daughters Current Position Founder and Managing Director of klausrose Consulting, Riehen, Switzerland Education and Qualifications 2004 Master s Certificate in Project Management, The George Washington University School of Business, Washington D.C., USA 2000 Equivalence Certificate to Swiss Postgraduate Degree (FMH) in Pharmaceutical Medicine 1999 Diploma European Course Pharmaceutical Medicine (ECPM) 1992 German Postgraduate Degree in General Medicine Postgraduate clinical training in General Medicine in Germany and England (pediatrics, psychosomatic medicine, internal medicine, surgery, geriatrics) Study of Medicine in Berlin, Thesis in Medicine Study of Latin Languages & Psychology in Heidelberg and Berlin, MS in Psychology Employment History March 2011 today Managing Director, klausrose Consulting, Riehen, Switzerland March 2011 Principal Consultant at Granzer Regulatory Consulting, Munich, Germany Global Head Pediatrics, F.Hoffmann-La Roche Pharmaceuticals, Basel, Switzerland Novartis Pharmaceuticals, Switzerland Global Head Pediatrics - 1 -
2 Head, Special Projects, Clin Dev & Medical Affairs Senior International Medical Advisor, Basel (HQ) Medical Advisor in Bern (Swiss affiliate) 1996 Medical Director Lohman Medical, Neuwied, Germany Clinical Research Associate, Byk Gulden Pharmaceuticals, Germany (today: Takeda); in parallel: Medical Director, Byk AG, Switzerland Postgraduate clinical training in General Medicine in Germany and England (pediatrics, psychosomatic medicine, internal medicine, surgery, medicine for the elderly) Other Professional Activities: Regular speaker on international confererences on pediatric drug development; member of EFGCP, DIA, AAAS, ESDP, facultuy member of several institutions that train in drug development and clinical research (ECPM, FORUM, ECCRT, others) Leadership in International Institutions 1/2005 to 12/2014 Chairman, EFGCP Children s Medicines Working Party Chairman, DIA Pediatric SIAC 8/ /2009 Chairman, IFPMA ( Pediatric Task Force Professional Experience After clinical training started in Byk Gulden, Konstanz, Germany (today: Takeda) as a clinical trial physician. Run two phase 1 trials and several large international pantoprazole phase 3 trials in Europe and Latin America. Worked in parallel at Byk Gulden Switzerland as Medical Director. Trained the sales representatives in gastroeneterology (pantoprazole), pneumology (theophyllin), cardiovascular diseases (omega-3-oil capsules), and other areas. Worked ½ year in Lohman Medical Devices in Germany, buildung up the fundaments of a medical affairs team. Worked in Bern, Switzerland with Novartis Switzerland as a clinical trial physician in the areas of oncology, dermatology, pneumology, gastroenterology and central nervous system. When promoted to Novartis Headquarter in Basel, Switzerland, as Senior International Medical Advisor, built up the international Medical Communication function which eventually became an own department. Furthermore, established the cross-functional Pediatric Advisory Group (PAG) in 2000 to improve the company s capabilities in handling the US American pediatric legislation, including 6 months Pediatric Exclusivity (patent prolongation). Advised teams in building pediatric development plans across all development functions (preclinical toxicology & safety; galenic formulations; modelling & simulation (M&S) / Clinical Pharmacology; Clinical Development; Post-Marketing Commitments) and across all indication areas (oncology, cardiovascular diseases, dermatology, respiratory diseases, Central Nervous System, others). Was involved with the Xolair team in the preparation of the pediatric strategy. Established a network within the top twenty pharmaceutical companies to drive cooperation in pediatric drug development and established the annual EFGCP pediatric conference together with colleagues from other companies, academia, and from regulatory authorities from EU national countries and the European Medicines Agency. This conferences was later merged with the DIA pediatric conference and is continuing until today
3 With the move to Roche in 2005 established the Roche Pediatric Group as cross-functional pediatric drug development structure and worked with teams across all development functions and indication areas (inflammatory diseases, nephrology, oncology, others). Started to advise teams and work with them on EMA / PDCO (pediatric committee) pediatric investigation plans (PIPs) when the EU pediatric regulation came into force in Established together with a colleague from GlaxoSmith Cline the pediatric taskforce of the IFPMA (International Federation of Pharmaceutical Industries and Associations), serving as chairman. Co-chairman was a colleague from Pfizer. With the move to Granzer Regulatory Consulting in 2010 responsible for hands-on preparation, writing, submission & negotiation of PIPs with the EMA / PDCO. Sucessfully concluded 8 PIPs from scratch to final acceptance by EMA. With establishing an own company, started to advise US & EU based companies on strategies in handling FDA & EU regulatory pediatric requirements. Continued to chair the EFGCP Children s Medicines Working Party and as such member in the organizing committee of the EFGCP/DIA/EMA annual conference on Pediatric Drug Development which in 2012 was held September 26/27 in London, UK. Also continued international network in pediatric drug development resulting in numerous presentations on international conferences. Leadership Skills Most responsabilities were performed in a matrix structure coordinating with up to 25 people in general issues of pediatric drug development both in Novartis and Roche. Pediatrics was usually 10 20% of coordinated persons KPI s which had to be evaluated annually. Maximum number of direct reports was 5 in a Roche taskforce. Publications Rose K & Kummer H: A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials. Children 2015, 2, Rose K & Spigarelli MG: Cystic Fibrosis Treatment: A Paradigm for New Pediatric Medicines, Globalization of Drug Development and the Role of the European Medicines Agency. Children 2015, 2, ; Rose K & Senn S: Drug development: EU paediatric legislation, the European Medicines Agency and its Paediatric Committee adolescents melanoma as a paradigm. Pharmaceutical Statistics 2014; 13(4): Rose K: The Vision of Better Medicines for Children and the Role of Regulatory Authorities. Pharmaceutical Regulatory Affairs 2014; 3:2 better-medicines-for-children-and-the-role-of-regulatory-authorities e127.pdf Rose K: European Union Pediatric Legislation Jeopardizes Worldwide, Timely Future Advances in the Care of Children With Cancer. Clinical Therapeutics 2014, 36 (2),
4 Bar-Shalom D & Rose K: Pediatric Formulations A Roadmap (Textbook). AAPS & Springer, ISBN: Bar-Shalom D & Rose K: Pediatric Formulations A Roadmap (Textbook), preface: free Rose K: Clinical Testing in Children. In: Bar-Shalom D & Rose K: Pediatric Formulations A Roadmap, AAPS & Springer, 2014: chapter 25, pp Rose K: Pediatric Pharmaceutical Legislation in the USA and EU and Their Impact on Adult and Pediatric Drug Development. In: Bar-Shalom D & Rose K: Pediatric Formulations A Roadmap, AAPS & Springer, 2014: chapter 28, pp Klaus Rose: A Paediatric Investigation Plan Case Study. Pharm Med 2012; 26 (5): Klaus Rose: Pediatric Drug Development. A Closing Thought. Applied Clinical Trials 2012; 21 (11), 50 Klaus Rose: Impact of EU & US Pediatric Legislation on Industry, Authorities & Academia. American Pharmaceutical Review, online, December 2011 Klaus Rose & Oscar della Pasqua: Development of Paediatric Medicines: Concepts and Principles. in Seyberth, HW. Rane A, Schwab M (Eds.): Pediatric Clinical Pharmacology (Handbook of Experimental Pharmacology Vol. 205), Springer, September 2011 Rose, K. (2011): The value of juvenile animal studies: a pediatric clinical perspective. Birth Defects Research Part B: Developmental and Reproductive Toxicology 2011; 92 (4), Klaus Rose & John van den Anker (Editors): Guide to Paediatric Drug Development and Clinical Research. Karger, May 2010, ISBN-10: , ISBN-13: Irina Staatz & Klaus Rose: Paediatric Legislation A Potential Roadblock to New Drugs in Europe. Business Development & Licensing Journal ( issue 11, January 2010 Klaus Rose: Grosse Anstrengungen für die Kleinen. VSAO Journal 6 / 2009, Klaus Rose: Challenges in Pediatric Drug Development. A Pharmaceutical Industry Perspective. Pediatr Drugs 2009; 11 (1): Klaus Rose: Ethical Principles of Pediatric Research and Drug Development. Chapter 11 in: Pediatric Drug Development Concepts and Applications. Mulberg AE, Silber SA & van den Anker, JN (Editors), Wiley-Blackwell, 2009 Klaus Rose: European Perspectives. Chapter 13 in: Pediatric Drug Development Concepts and Applications. Mulberg AE, Silber SA & van den Anker, JN (Editors), Wiley-Blackwell, 2009 Klaus Rose: Ethical, Regulatory and Scientific Challenges in Paediatric Drug Development. Pharm Med 2008; 22 (4): Sergio G. Golombek, John van den Anker, & Klaus Rose: Clinical Trials in Children. Ethical and Practical Issues. Int J Pharm Med 2007; 21 (2): Klaus Rose & John van den Anker (Editors): Guide to Paediatric Clinical Research. Karger 2007; ISBN-10: / ISBN-13:
5 Klaus Rose: Integration of pediatric aspects into the general drug development process Ernst Schering Res Found Workshop. 2007;(59): Klaus Rose : Which industry-sponsored pediatric research programs can be expected to be triggered by the EU pediatric regulation? Standardy Medyczne 2005; 5: Klaus Rose: European Draft Pediatric Regulation and Challenges in Pediatric Drug Development: Jap J Clin Pharmacol & Ther 2005;18 (1) 9-14 Klaus Rose: Better medicines for children where are we now, and where do we want to be? Br J Clin Pharmacol. 2005; 59(6): Languages Fluent in German, English, Spanish, Italian, French. Basics in Portuguese, Greek and Hungarian. Private interests Family, Classical Guitar, Latin Culture, Cooking, Gardening Riehen, October 2015 Klaus Rose - 5 -
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