Michael Borek Email & Phone Number

Itter, Tyrol, Austria

As certified sound engineer I offer mobile recording services for classical music (e.g. orchestra, choir, chamber music), including mixing and mastering for CD production. You can listen to some references on my MVB Records SoundCloud channel https://soundcloud.com/mvb-records-569256599/albums

Kundl, Austria

Leading a TA team of 4 Global Medical Managers responsible for a portfolio of 250 generic molecules covering the ATCs of Anti-Infectives, Dermatology and Oncology, providing medical input to stakeholders throughout the whole generic product life cycle:- Medical Evaluations for Global/ Regional Portfolio (PK/PD, clinical trials on efficacy/safety of molecule, guidelines, competitive landscape and Standard of Care, and place in current (and estimated future) therapeutic strategy in respective TA/Disease)- Medical contribution to Due Diligence and M&A assessments- Medical expertise inputs to in-house product development teams (medical intelligence on originator, medical risk assessments of formulation specifics, input to patents/IP topics)- Medical inputs for Scientific Advice (EU, FDA) and preparation of medically relevant documentation (incl. EU PIP/PIP waiver/FDA iPSP)- Medical contribution for complex projects to Clinical Development Plan and study design of patient studies (e.g. oncology Gx studies)- Medical ownership of CTD modules for EU Regulatory filing and FDA 505b2 submission- Medical ownership of Regulatory Maintenance for Safety Label Changes and Renewals - Support of Patient Safety for RMP and Pregnancy Prevention Programs- Medical representative for Key External Expert interactions (e.g. Research Collaborations); collaboration with Global Medical Affairs in conducting Advisory Boards - Medical review of Post Marketing Studies IIT protocols- Medical education materials & medical training for Country Organizations medical teams- Answering Medical Queries - Medical Risk Assessments for QA/TechOps (e.g.OOS deviations, deficiency letters), including cooperation with IVIVC team (e.g. PKPD modelling)

Kundl, Tyrol, Austria

Head Medical Affairs / Sandoz Development Center (SDC) Kundl / Sandoz GmbHClinical Development function was consolidated in different location. Medical Affairs team and tasks remained unchanged as described below.Further contribution to the strategic reorganization initiative leading to the creation of Medical Office in 2014 (see above).

Kundl, Austria

Leading a team of Clinical Development (2 associates) and Medical Affairs (3 associates):- Clinical Development team responsible for planning, designing and oversight of BE studies (conducted with external CROs): performance of in average 7 to 8 studies per year for High Regulated scopes (EU, FDA, BR)- Medical Affairs team responsible for: Regulatory Affairs (EU MRP/DCP Procedures): Support in registration strategy, medical writing, EU labeling (SmPC/PIL) for new submissions and maintenance (variations), ROW labeling, answering deficiency letters, medical input in Scientific Advice requests to Health Authorities, regulatory intelligence Medical support of Country Organizations for Post Marketing Studies (Study Protocol, CRF, study report), including planning, designing and oversight of a multicenter Phase 4 trial for TB 4-FDC (see publication list)April 2009- November 2012: Functional Head Medical Departments of SDC Kundl, SDC Holzkirchen (Hexal) and SDC Ljubljana (Lek).In this function, leading role in several strategic initiatives aiming at harmonizing and streamlining regulatory maintenance processes by a molecule owner concept, with redistribution of molecule responsibilities between Medical Departments (2010-2011).Presentation in November 2012 to R&D Management of a Therapy Area organizational concept which was implemented as the future structure of Medical Office in 2013-2014

Kundl, Autria

- Planning, designing (incl. protocol & CRF writing) and management of a PKPD study and 3 multicenter Phase IIIb studies (incl. supervision of external monitor) supporting twice daily (bid) dosing concept for Amoxicillin and Penicillin V: Double-blind randomized study in acute exacerbations of chronic bronchitis in adults (395 patients, 14 centers in Austria, FPFV/LPLV 1997-1998) (see JAC publication) Double-blind randomized study in acute otitis media in children (516 patients, 26 centers in Austria and Germany, FPFV/LPLV 1998-1999) (see 40th ICAAC Oral Presentation) Open randomized study in acute group A ß-hemolytic streptococcal tonsillopharyngitis in children (492 patients, 20 centers in Germany) (FPFV/LPLV 1999-2001; study failed to show non-inferiority of bid regimen, results were not published) Designing of a PKPD study, investigating the Time > MIC of different penicillin V doses after single dose oral application in 12 healthy volunteers (performed at external CRO in 1999)- Responsible for medical parts of dossier for EU regulatory procedures (MRPs): Support in registration strategy (SmPC comparisons for selection of RMS and identification of common denominators in RMS/CMS SmPCs) Medical writing of Clinical and Non-Clinical Overviews (i.e. oversight of CRO) including specific requirements for antibiotics (antibiotic resistance sections) Preparation and updates of EU Product Information (SmPC/PIL) according to current EU Regulatory Guidelines Answering deficiency letters during MRP procedures, including discussions with assessorsBetween 1997 and 2001: Completion of 4 MRPs for 3 antibiotics (amoxiclav, cefazolin, amoxicillin), preparation of 2 MRPs completed in June 2002.- Medical Marketing: Medical Support of Product Management: medical input and review of Promotional Concepts & Materials Providing Medical Training on new TAs (diseases, therapies) for Field Force/Country Organizations

Medical Manager / Medical Department, Dermatology / Roche (Paris, France)- Responsible for Retinoids portfolio in France (incl. Roaccutane):  Answering medical queries from Dermatologists Medical training/education of Field Force - Medical Affairs activities for the launch in France of topical Isotretinoin Gel: Presentation of Clinical Trial results at investigator meetings, scientific meetings/local congresses and press conferences Medical input and review of marketing promotional materials and communication