Mini-MBA-Course „Translation of Science into Business”

Professor John Findlay is the co-ordinator of a Marie Curie EST Project BIOMEM and would like to advertise a Mini-MBA course to students outside this project.

Further information on the mini MBA course can be found on http://www.donau-uni.ac.at/de/studium/minimba/index.php
or obtained from:

Susan Wright

Secretary to Professor John B C Findlay
Institute of Membrane and Systems Biology
University of Leeds
Tel: 0113 343 3029
Fax: 0113 343 6603

The total cost of the course is EUR1500 to include accommodation.

Program Topics and Areas

1.    Chairman’s Introduction to Bio-business Management Concept 

2.    Project Management (Uwe Schlokat)
•    Strategy – Portfolio Management – Project Management
•    Traditional vs. modern Project Management, introducing PMI – the international “golden standard” in project management
•    The skill set required by successful project managers
•    Major methodologies in Project Management, e.g. Work Breakdown Structure, Network Diagram, Critical Path Analysis, etc.
•    Project milestones and their definitions in drug development
•    Developmental, preclinical, clinical and regulatory activities within drug development
•    Licensing processes in the major target markets i.e. USA (FDA), Europe

3.    Marketing and Sales (Fred Harms)
(6-7 bullet points provided by a marketing and sales expert including strategic marketing, competing in the pharmaceutical marketplace, sales and marketing roles, supply chain management, sales force management…)

4.    Process Development (Karl Wagner)

5.    Quality Assurance (Marion Pfahl)

6.    Manufacturing (Karsten Sauer)
(GMP, ISO, SOPs, facility requirements, QA, Product stability, cleanroom classes, key specifications and key tests , FDA CFR, Pharmacopeia, batch records ...)

6.    Non-clinical Development (Bertram Ober)
(pharmacokinetics studies, challenges of long term studies (chronic tox), major differences in pre-clinical program of biologics vs.  small chemicals, reproduction studies, oncogenicity, mutagenicity, Pharmacodynamics, 2 species rule, acute-,  subacute-, subchronic- and chronic toxicity, safety pharmacology, ADME, NOAEL)

7.    Clinical Development (Salma Michor)
(clinical Phases (I-IV), study designs (open label, blinded, double blinded, crossover,...), Regulatory requirements to enter clinical trials (agencies/FDA & EMEA; IND/IMPD, Investigator‘s brochure, Protocol,...), GCP/Quality requirements, How is a clinical trial really conducted (study sites, documents during the trial,..), issues of contracting CROs

8.    Regulatory Affairs (Salmar Michor)
(Europe EMEA – Centralized Procedure, Decentralized Procedure, Variations (I & II), Line extensions; CHMP & COMP; Orphan drugs; scientific advice and pre-submission meetings; national filing processes; Mutual Recognition Process; timelines & costs for these processes; MAA); In US/FDA (BLA, NDA, FDA structure & different offices eg cder & cber; combination products, Prior Approval Supplement, CBE30, timelines & costs; meetings with FDA (pre-IND, end of phase I), Medical Devices (notified body), ICH, CTD and its structure, Electronic submissions, Registration Processes in Japan and Intercontinental countries)

9.    Corporate Strategy and Business Development (Katherine Cohen)
•    Funding a biotech company
•    Venture Capital Finance
•    Strategic planning and growth
•    M&A and Licensing strategies
•    Due diligence process
•    Making business deals

10.    Intellectual Property  and Technology Transfer (Katherine Cohen)
•    Why are patents needed?
•    What can be patented?
•    How to harvest inventions?
•    Case studies for biotech and pharmaceutical inventions and patents
•    Patent portfolio management
•    What means freedom to operate, infringement and litigation?
•    Technology Transfer and Licensing