Tressl_Klaus_CV_EN

Klaus P. Tressl(Licensed Pharmacist)

Schulangerweg 282152 PlaneggGermanyTel. +49 89 85662145Mobile +49 176 [email protected]

CURRICULUM VITAE

Profile

I am a scientist who is highly oriented towards results and thinks strategically, analyzing interconnections, opportunities, risks, and markets in depth, and subsequently defining the most

appropriate processes and practices required.

With my structured approach, my powers of persuasion, and my perseverance I implement these projects rapidly and achieve targets that always benefit the company.

CV Klaus P. Tressl - page 2

Personal Data

7 July 1963 Born in Bad GriesbachPartnered, 2 children (15 and 9 years old)

Languages: German - native language English - fluent French - good basic knowledge

IT skills: - All MS Office programs, -MS Project Windows, -SAP

Professional Experience

SEP 2015 - present Baxalta Germany (Dtld.) GmbH, Unterschleissheim, GermanyDirector RA/QA Central and Eastern Europe (CEE); QP/RP in Germany

2015 – JAN to JUL Cinfa Biotech GmbH, Munich, Germany Director RA/QA, QP Biosimilars

2011 - 2014 Linde Gas, GBU Healthcare, Pullach, Germany(Manufacture and sales of pharmaceuticals [medical gases] and devices, international company)

Global Head Regulatory Affairs (RA)

• Develop and gain FDA/CDRH approval for first-time medical device (Sedara®) for marketing in USA

• Achieved new quality management system (QMS) for medical devices and certification through TÜV Süd according to ISO 13485

• Define regulatory strategy, including operational implementation of expansion of medical gases as pharmaceuticals (Livopan®, INOmax®, Conoxia®) in eastern European and emerging markets, and FDA approval of manufacturing facilities in USA

• Ensure pharmaceutical legislation conformity in manufacturing and quality according to international GMP/GDP standards in EU/EEA through timely life-cycle management of 409 licenses in Europe (centralized procedures EMA, MRP/DCP and national approval procedures)

• Built up and implemented new pharmacovigilance system (PV) to monitor risks associated with pharmaceuticals in EU markets (16 new good vigilance practices - GVP module), successfully inspected by authorities (MHRA/UK, MPA/SWE)

• Developed completely new working procedures in order to integrate small acquired companies (M&A) with matching technology platforms (e.g. asthma or COPD), and achieve market and financial synergies within framework of mini MBA program in Oxford, UK (Said Business School)

2005 - 2011 Bavarian Nordic GmbH, Martinsried(Manufacture and sales of prophylactic and therapeutic vaccines, medium-sized biotech company)

Director Regulatory Affairs (RA)

• Responsible for approval strategy of overall development of all vaccines (attenuated and recombinant DNA vaccines) in Europe und USA: MVA-BN®/IMVAMUNE®, Prostvac®, RSV

• Prepared complete development plan as company concept (RFP) in response to tenders from US government and NIH/NIAIDs, thus financially and technically ensuring biological vaccine manufacturing during up-scaling from preclinical to regulatory and quality approval in USA with FDA GMP inspections, Canada and EU

• Won biggest ever awarded biological development program bid from US government worth $600m within framework of bioshield project


• Built up regulatory affairs unit (RA) from scratch with high-level chemistry, manufacturing and control (CMC) knowledge in line with cGMP conditions in Germany, Denmark and USA, integrated into QMS

• Implemented and approved first electronic (eCTD, Extedo) approval dossier submission for 3rd generation smallpox emergency vaccine (MVA-BN®/IMVAMNUE®) for Health Canada (new drug submission; NDS) as basis for improved marketing in other regions

• Worked closely together with FDA/CBER; convincingly explained entire clinical and technical (CMC) Idevelopment concept within framework of eIND submission up to market maturity in new development strategies

• Ensured successful inspection of manufacturing facilities by FDA/CBER cGMP as approbation precondition of emergency approval for IMVAMNUE® and basis of commercial marketing

2004 - 2005 Novartis Pharma AG, BU Oncology, Basel (Switzerland)(Global leading pharmaceutical company)

Manager Drug Regulatory Affairs (DRA)

• Global responsibility (USA/EU/Japan) for thirteen development programs in I/II to IV phases to expand indications (scientific advice processes) of oncology blockbuster Glivec® (life-saving leukemia therapy capsule; CML)

• Achieved paediatric market approval in EU, USA and Japan within shortening of approval times to just under three months, thus opened new market and generated significant revenue by consolidating market leadership

• Successfully created and achieved official authorization for three new indications as orphan drugs within one year (e.g. acute lymphatic leukemia - ALL)

• Significantly improved overall commercial attractiveness of Glivec® doubling the blockbuster’s revenue (approx. $1.9bn)

2003 - 2004 Organon GmbH, Oberschleissheim, Germany(Subsidiary of Akzo Nobel - international company)

Head of Regulatory Affairs Unit (RA) / Quality Assurance (QA)

• Submitted marketing authorization applications (MAA) to Federal Institute for Drugs and Medical Devices (BfArM) to reduce administrative requirements in national graduated paln procedure in hormone replacement therapy (HRT)

• Updated core medical information product labeling for following indications: central nerve system, contraception, hormone replacement therapy, in-vitro fertilization and anesthesia

• Represented company at higher federal authorities and local supervisory authorities in lack of quality compliance (Nuvaring®)


2001 - 2003 MediGene AG, Martinsried, Germany (Medium-sized German biotech company)

Manager / Associate Director Regulatory Affairs (RA) and Qualified Person (QP) for quality in Europe

• Developed and implemented global approval strategy for dermatological virustatic: PolyphenonE (Veregen®) while obtaining globally accepted phase III program by FDA (USA) and European authorities (BfArM/MRP)

• Represented all approval issues in interdisciplinary project teams, implemented accelerated, electronic (eCTD) submission system (Docubridge®)

• Obtained first regulatory approval (MA; Veregen®) for German biotech company from FDA in USA

• Developed and authorized QC laboratory with QA/QMS system for Leuprogel® for approval in EU/EEA - registered as qualified person (QP) by local supervisory authorities (Reg. v. OB)

1999 - 2001 Genetics Institute GmbH, Martinsried, Germany(Biotechnology company - 100% subsidiary of Wyeth-Biopharma)

Regulatory Affairs Compliance Officer (CMC/Quality)

• Responsible for developing and re-certification of recombinant proteins (pharmaceuticals) in Europe focusing on quality and manufactured in compliance with TSE/BSE risk assessment

• Submitted timely variations to EMA in central approval procedure for recombinant blood coagulation factors VIII and IX (ReFacto® and BeneFIX®)

• Avoided threatened withdrawal of market approval for BeneFIX® with successful oral hearing at EMA in London

• Obtained first market approval for bone growth protein in combination with medical device (rhBMP-2/ACS; Inductos®) in both USA and EU in spite of TSE/BSE challenges

• Transferred technology of existing manufacturing and monitoring processes to new manufacturing facilities with timely approval from FDA/EMA

1996 - 1999 PlasmaSelect GmbH; Teterow, (Eastern) Germany (Manufacture of polyclonal antibodies for extracorporeal immune apheresis column therapy in humas - spun off and transferred from Baxter Dtld. GmbH)

Head of Manufacturing - registered qualified person (QP) according to § 15 AMG

• Designed and built up new GMP manufacturing site in Mecklenburg-Vorpommern (sterile filling, aseptic manufacturing)

• Responsible as head of manufacturing according to § 15 AMG - qualified person (QP) – managed 3 GMP teams with forecast and budget monitoring (clean room and isolator-sterile technologies)

• Optimized and up-scaled bio affinity chromatographic anti-human LDL and / -IgG antibody purification processes with biopilot (BPL) system from Pharmacia

• Implemented new bioprocess chromatography and tangential-ultra-filtration plant, optimizing yield and manufacturing costs


1991 - 1996 Baxter Dtld. GmbH - Therasorb Medizinische Systeme GmbH, Unter-schleissheim, Germany(Leading pharmaceutical company)

1994 Group Leader of Immune Therapy Manufacturing - acquired expertise as head of manufacturing (QP) according to § 15 (1) and (3) AMG for biological pharmaceuticals

• Responsible for GMP-compliant planning and implementation of polyclonal and monoclonal antibody manufacturing with manufacturing method optimization and QA/QC (final approval)

• Implemented and integrated CHO fermentation and five new monoclonal antibody (MAK) manufacturing lines while expanding GMP manufacturing permission to clinical trials

• Conducted supplier QA audits and successfully passed national and international authority inspections including FDA, TÜV, PEI etc.

1991 Research Assistant to Head of Quality Assurance and Quality Control (QA/QC)

• Conducted QC approval tests and GMP monitoring with method optimization (sterility/ chromogene LAL test)

• Built up quality assurance systems (QMS) according to DIN ISO 9001 for in-vitro diagnostics (IVD) and GMP manufacturing

• Stood in for head of quality control in line with AMG to batch release parenteral infusion solutions (TPN) in homecare oncology business

• QA product complaint coordinator for pharmaceuticals and medicinal products

Education

1991 Licensed as practicing pharmacist (cum laude)

1990 - 1991 One year practical studies in St. Ulrich Pharmacy, Pocking, Germany

1985 - 1990 Major in pharmacy at Friedrich Alexander University, Nuremberg-Erlangen – research assistant at institute for pharmaceutical chemistry

1983 - 1984 National service, tank platoon

1970 - 1983 School education in Ruhstorf an der Rott and PockingAdvanced courses in chemistry and EnglishLeaving certificate: university entrance qualification (magna cum laude; 1,9 “Abitur”, German high school degree)

In Addition

• Qualified as head of manufacturing (Qualified Person, QP) according to § 15 German Medicines Act (AMG) including biological medicincal products, thus allowing possible takeover of responsibility as qualified person (QP) for quality and QMS

• Baxter Inc., Science and Technology award for purification of five new monoclonal antibodies (MAK) for therapy of non-Hodgkin lymphoma (NHL)

Continuing Education

• Regularly continue education in GMP/quality and clinical developments in pharmaceuticals and medicinal products and medical devices

• Linde: Said Business School, Oxford, UK - global leadership development circle (MBA program)


1991 - 1996 Baxter Dtld. GmbH - Therasorb Medizinische Systeme GmbH, Unter-schleissheim, Germany(Leading pharmaceutical company)

1994 Group Leader of Immune Therapy Manufacturing - acquired expertise as head of manufacturing (QP) according to § 15 (1) and (3) AMG for biological pharmaceuticals

• Responsible for GMP-compliant planning and implementation of polyclonal and monoclonal antibody manufacturing with manufacturing method optimization and QA/QC (final approval)

• Implemented and integrated CHO fermentation and five new monoclonal antibody (MAK) manufacturing lines while expanding GMP manufacturing permission to clinical trials

• Conducted supplier QA audits and successfully passed national and international authority inspections including FDA, TÜV, PEI etc.

1991 Research Assistant to Head of Quality Assurance and Quality Control (QA/QC)

• Conducted QC approval tests and GMP monitoring with method optimization (sterility/ chromogene LAL test)

• Built up quality assurance systems (QMS) according to DIN ISO 9001 for in-vitro diagnostics (IVD) and GMP manufacturing

• Stood in for head of quality control in line with AMG to batch release parenteral infusion solutions (TPN) in homecare oncology business

• QA product complaint coordinator for pharmaceuticals and medicinal products

Education

1991 Licensed as practicing pharmacist (cum laude)

1990 - 1991 One year practical studies in St. Ulrich Pharmacy, Pocking, Germany

1985 - 1990 Major in pharmacy at Friedrich Alexander University, Nuremberg-Erlangen – research assistant at institute for pharmaceutical chemistry

1983 - 1984 National service, tank platoon

1970 - 1983 School education in Ruhstorf an der Rott and PockingAdvanced courses in chemistry and EnglishLeaving certificate: university entrance qualification (magna cum laude; 1,9 “Abitur”, German high school degree)

In Addition

• Qualified as head of manufacturing (Qualified Person, QP) according to § 15 German Medicines Act (AMG) including biological medicincal products, thus allowing possible takeover of responsibility as qualified person (QP) for quality and QMS

• Baxter Inc., Science and Technology award for purification of five new monoclonal antibodies (MAK) for therapy of non-Hodgkin lymphoma (NHL)

Continuing Education

• Regularly continue education in GMP/quality and clinical developments in pharmaceuticals and medicinal products and medical devices

• Linde: Said Business School, Oxford, UK - global leadership development circle (MBA program)

Documents

Tressl_Klaus_CV_EN