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CTU LectureWeiterbildungsmöglichkeiten in der klinischen Forschung in Bern
Mittwoch, 13. Dezember 2017Hörsaal 2 Chirurgie, OPO
CTU Bern, Finkenhubelweg 11, 3012 Bern, www.ctu.unibe.ch
Weiterbildungsmöglichkeiten in der klinischen Forschung
(mit) organisiert durch das ISPM der Universität Bern
Marcel ZwahlenInstitute of Social and Preventive Medicine
University of [email protected]
http://www.ispm.unibe.ch/about_us/staff/zwahlen_marcel
ISPM staff involved in teaching epidemiology and biostatistics
to– Participants of the Swiss German MPH Programme
(https://www.public-health-edu.ch)• CAS in Epidemiologie und Biostatistik (CHF 13’800)• CAS in Gesundheitsökonomie und
gesundheitsökonomischer Evaluation (CHF 11’800)– PhD candidates at 2-3 Graduate Schools– Students in Biomedical Sciences– Medical students
CAS Epi & Biostatitics
CAS in Gesundheitsökonomie
Both not really tailored the clinical researchers
Swiss Epidemiology Winter School (since 2012)
http
s://w
ww
.epi
-win
ters
choo
l.org
/
Academic fee per course: ~ 1’000Industry fee per course: ~ 2’000
CAS in Clinical Epidemiology / Clinical Research
www.ispm.unibe.ch/continuing_education/cas_in_clinical_epidemiology/
Structure
Costs for PhD students in clinical science : 4 000
The CAS will be part of a larger MAS on «Leading Learning Health Care Organisations”
• CAS in Clinical Research in Health Care Organisations
• CAS in Leadership in Health Care Organisations• CAS in Managing Medicine in Health Care
Organisations
“Reglement” should be approved in Dec by the faculty
Content of CAS Clinical Epi / ResearchRed modules exist or need adaptation
• Introdcution to epidemiology and study designs• Introduction to biostatistics• Software for statistical analysis and data bases• Regressionmodels in clinical epidemiology: linear,
logistic, Cox- and Poisson-Regression• Studying diagnostic tests and screening interventions• Prognostic studies and prognostic modelling• Randomised clincial trials• Systematic reviews und meta-analyses• Advanced course modules from the Swiss
Epidemiology Winter School in Wengen
Planned schedule of courses 2018 and 2019Contact: send an email to [email protected]
sitem-insel School for Translation & Entrepreneurship
in Medicine
Prof. Dr. med. Uyen Huynh-Do, MD MMEDivision of Nephrology and Hypertension
Inselspital Bern, Switzerland13.12.17
CAS/DAS/MAS (Certificate, Diploma and Master of Advanced Studies) in Translation
and Entrepreneurship in Medicine
Prof. Dr. med. Uyen Huynh-Do, MD MMEDivision of Nephrology and Hypertension
Inselspital Bern, Switzerland13.12.17
A spectacular drop in worldwide R&D productivity
Paul, Nature 2010; Tufts CSDD 2007
The problem with translational medicine in Switzerland
Swiss Clin. Trials OrganisationClin. Trial Units (SNF)
The problem with translational medicine in Switzerland
Good ideas, good researchersBUT …
Many obstacles !!Complexes and long ethical revision processesQuality Control, Regulatory affairsScientists have very few/no knowledge in
management and entrepreneurship
One solution for our problem with translational medicine ...
To bring under one rooftop:
- Researchers- Agencies, which to date have slowed the process Direct contact
facilitates communication: «Promoting agencies»- Core facilities: «Enabling agencies»- Postgraduate educational program: sitem-insel School
Public private:- University of Bern- University Hospital Inselspital- Canton of Bern- Industry: PET Diagnostik AG, SWANTEC AGCSL Behring, Straumann AG, Bichsel , Ypsomed ...
sitem-insel AG: Swiss International Center for Translational and Entrepreneurial Medicine(non profit) Aktiengesellschaft
sitem-inselSwiss Institute für Translational and Entrepreneurial Medicine
www.sitem-insel.ch
Promoting agencies
Promoting agencies
Enabling facilities:- Biobank, Bio-informatics- «At the edge» technologies, for ex. 3D printing- «Clinical anatomy» and hybrid operation rooms - Brain interface lab- Imaging (for ex. 7 Tesla MRI, etc)- Clinical trials units- ...
sitem-insel AG: Swiss International Center for Translational and Entrepreneurial Medicine
I ) Analysis of educational programs in translational medicineand Bio-entrepreneurship in CH and surroundings countries
II ) Interviews of representants from universities and universityhospitals (30%), and industries (70%)
I – Needs Assessment( Sommer – Fall 2014)
III ) Meetings with SIBER (Society for International Bioentrepreneurship Education and Research)
II – Conclusion«Educational landscape» in Oct. 2014
- Postgraduate programs in translational medicine are beingset up at numerous placesbut
(in Europe) only few combined with bioentrepreneurshipmost of them teacher-centered
«one size fits all»most of them drugs oriented
still few on medical devices
III – sitem-insel School conceptAdressing unmet needs
(in Europe) only few combined with bioentrepreneurshipmost of them teacher-centered
«one size fits all»most of them drugs oriented
still few on medical devices
Postgraduate program in Translational Medicine and Bio-Entrepreneurship
Personalized education program«project based – learning by doing»
Diagnostics – Drugs – Medical Devices
sitem-insel SchoolGeneral Principles of Curriculum
Master of Advanced Studies in Translation andEntrepreneurship in Medicine, over 4 semesters
or
Separate modules, which can be added up to obtain a CAS (Certificate of Advanced Studies), orDAS (Diploma of Advanced Studies) in TranslationalMedicine and Entrepreneurship
MAS in Translation and Entrepreneurship in MedicineConditions for admission
Graduates from a Swiss or foreign University or University ofApplied Sciences (MD, PhD, DMD = Dr. med. dent., DVM= Dr. med. vet., PharmD, Dipl. Ing. etc)
- at least 2 years research experience- english knowledge TOEFL level
Project in translational medicine (Master thesis, refereefrom university, co-referee from business; or vice-versa)
Career plan and letter of recommendation from institutiondirector, or industry project head
General biomedical product development chain
R & D
Quality management and GMP (Good manufacturing practice)
Intellectual Property (IP)
Regulatory affairs
Biomedical entrepreneurship and management
Preclinical phase
Clinicalphase Registration Production/
MarketingPost-market
phase
Clinical trials
Mod.1
Mod.2
Mod.3
Mod.4
Mod.5
Mod.6
Module 1: “Research and development” 3 ECTS
Module 2: “Good Manufacturing Practice, QM” 5 ECTS
Module 3: “Intellectual property” 3 ECTS
Module 4: “Regulatory affairs” 5 ECTS
Module 5: “Clinical trial design & performance” 5 ECTS
Module 6: “Med. Entrepreneurship & Management” 15 ECTS
Master thesis: “Med. Entrepreneurship & Management” 30 ECTS
CAS(Certificate)
DAS(Diploma)
15 ECTS 30 ECTS
Masterof adv studies
60 ECTS
CAS in Transl. Medicine( 3 out of 5 modules,
PlusZertifikatsarbeit 2 ECTS)
CAS in Med. Entrepreneurship& Management
(incl. Case studies &Zertifikatsarbeit )
CAS Trl. Med Plus
CAS Med.Entrepr. & Mgt
sitem-insel School:Modules
Module 5Clinical trialsdesign & performance5 ECTS
Module 3 Intellectual
property
3 ECTS
Module 4RegulatoryAffairs
5 ECTS
Year 1 Year 2
Module 6: Biomedical Entrepreneurship & Management
15 ECTS
Master Thesis24 ECTS
Master Thesis = Project presentation
sitem-insel SchoolMaster of Advanced Studies in Translation and Entrepreneurship in Medicine
Module 1Introductionto Transl.Med,R&D3 ECTS
Module 2Quality Management GMP5 ECTS
(for diagnostics, drugs and biomedical devices)
Translational project
sitem-insel SchoolBiomedical Entrepreneurship – Module leaders
- Module 1: Introduction to Translational MedicineU. Huynh-Do (UniBE), A. Wallnöfer (former Head Clinical DevelopmentMetabolism & Neurosciences Roche)
- Module 2: GMP and Quality ManagementM. Corbett (UCB), S. Soniec (Meditec Consulting)
- Module 3: Intellectual PropertyH. Müller (Fed Institute for Intellectual Property)
- Module 4: Regulatory affairsS. Soniec (Meditec Consulting ), B. Jentges (Phact Consulting)
- Module 5: Clinical trials and performanceS. Trelle (Clinical Trials Unit UniBE)
- Module 6: Bio entrepreneurship and ManagementA. Baldauf (Institute for Entrepreneurship, UniBE)
sitem-insel SchoolCore curriculum – Teaching form
Frontal lectures 10-20 %Case-based workshops and seminars 80-90 %
Tool: «Blended learning» = Face-to-face sessions (discussion of own project, andpeer teaching)
& E-Learning platform (Hset= Health science e-training)
sitem-insel SchoolBiomedical Entrepreneurship – Topics
1) Idea generation Innovation and Entrepreneurship
2) Opportunity evaluationNew venture creation
3) Executing ideas and plan into realityBusiness modelling & planning
4) Team buildingLeadership
sitem-insel School1. Kohorte (April 2017 - 2019)
- 9 MAS Absolventen, 1 CAS in Translational Medicine- Die meisten mit > 5 Jahre Erfahrung in Forschung & Entw.- Inselspital, DBMR, NCCR Transcure
Merkle Institute Fribourg, Industrie (Start up)
- Diagnostik, Moleküle, Devices- Patente: 2 in 2017, wahrscheinlich noch 1 in 2018- Start up: 1 Ende 2017 - 2018
VITA 4/17
sitem-insel School for Translation & Entrepreneurship
in Medicine - Kohorte 2
E-mail: [email protected]
Kick Off Minisymposium: 19.04.2018, 16.00- 18.00, Inselspital Hörsaal Chirurgie Start Modul 1: 20.04.2018
Anmeldung bis Ende März 2018Es gibt eine begrenzte Anzahl von «Fellowships» für MAS ( 31’500.- Sfr)
PhD in Health Sciences (Clinical Sciences)
CTU Lecture 13.12.2017
Urs FischerCTU BernUniversität Bern
43
> …Developing attractive employment conditions and career opportunities for young clinical researchers…
> …Bottom-up process that starts in clinical departments with the identification of potential candidates, continues with the establishment of a dual path allowing clinical specialisation in parallel with academic activities…
> Das universitäre Netzwerk Klinische Neurowissenschaften Bern (CNB) hat auf Grund dieser Empfehlungen die Initiierung des PhD in Health Sciences (Clinical Sciences) gefördert.
44
PhD in Health Sciences (Clinical Sciences)
> Neues Programm der Graduate School for Health Sciences (GHS)
45
Graduate School for Health Sciences
46
PhD in Health Sciences (Clinical Sciences)
> Neues Programm der Graduate School for Health Sciences (GHS)
> ZIEL: Duale Karrieren fördern – klinische Tätigkeit im 50% Pensum / klinische Forschung im 50% Pensum
> ANFORDERUNGEN: Staatsexamen oder Master in Medizin, Psychologie oder einem verwandten klinischen Gebiet
> DAUER: 4 – 5 Jahre
47
PhD in Health Sciences (Clinical Sciences)
> FINANZIERUNG: 50% über die Klinik (Ansätze der jeweiligenKlinik), 50% über die/den Dissertationsleitende/n (Ansätze SNF)
> ANFORDERUNGEN FÜR DEN ABSCHLUSS:
• Erfüllung der Leistungskontrollen
• Dissertation und Dissertationsprüfung
• Min. drei wissenschaftliche Arbeiten
• 18 ECTS aus Kursen (siehe nächste Slide)
48
Lectures and Courses GHS
49
CAS in Clinical Research
> Kosten für Teilnehmende des PhD Programms: CHF 4000.-> Möglicher Beitrag von Seiten der GHS wird momentan geprüft
50
Graduate School for Health Sciences
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Kontakt
> Erstkontakt :
PD Dr. Marlene WolfGraduate School for Health Sciences (GHS)[email protected]
> Fachspezifische Fragen:
Prof. Dr. Tobias Nef Prof. Dr. med .Urs FischerARTORG Center Department of [email protected] [email protected]
