Dr. Nina Hasiwa - Chief Scientific Officer

Since 07/2016

CEO and Managing Director 

Imperia – Drug Safety Services  

07/2014– 09/2016     

Compliance & Training Specialist Mallinckrodt, Germany

Drug Safety, Pharmacovigilance, Compliance, Reconciliation with world-wide partners, PV Training, Late Case Handling, Exception and CAPA Management, Set up and monthly evaluation of Key Performance Indicators: Timely Processing of ICSRs, Signal Detection, CCSI Update, PSUR Submission

12/2012– 06/2104     

Scientific Freelancer for syneed medidata GmbH, Konstanz

Drug Safety, Pharmacovigilance, Medical Translation, Medical Communication, Case Handling and Query Management           

Since 03/2011       

CEO and Managing Director 

AtaX-Advice - Alternatives to Animal Xperiments

Scientific Services: Workshop Organization, Scientific Publications

01/2011– 03/2016     

Scientific Officer CAAT-Europe, University of Konstanz

Meeting Organization, Scientific Publications, Workshops, Reports, Project Management       

01/2010– 12/2010   

Scientific Consultant for Alternatives to Animal Experiments

12/2006– 11/2009     

Scientific Offficer for the European Commission (EC), Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP), In-vitro Methods, Reproductive Toxicity

Development of ‘in vitro’ methods used for toxicological substance testing of drugs based on human embryonic stem cells and the ethical background embryonic stem cells

Participation and responsibility in various European projects, including meetings and workshops preparation and participation, reporting, advisory role

12/2003– 11/2006               

Scientific Officer for the European Commission (EC), JRC, IHCP, ECVAM (European Centre for the Validation of Alternative Methods), in cooperation with the group “Nanobiotechnology”

10/2006 Dissertation

Development of ”in vitro” methods in cooperation with the physical-chemical unit (acquirement of inter-disciplinary knowledge)

Advisory role to apply physical-chemical methods and nanotechnology to biological and medical applications

10/2002– 11/2003    

PhD student at the University of Konstanz at the Chair of Biochemical Pharmacology

10/1995– 9/2002    

Biology studies at the University of Konstanz

10/1992– 9/1995     

Maternity leave

10/1991– 9/1992  

Law studies at the University of Konstanz

06/1991             

Abitur/graduation at the Tagesheimgymnasium Kerpen, Germany

German
English
Italian
French

mother tongue
business fluent (level C2)
fluent (level C1)
basics (on course)   

• Microsoft Offfice (Word, Excel, Power Point) and Microsoft Project
• Adobe Acrobat, Photoshop
• Softmax Pro and GraphPad Prism (data and statistical analysis)
• Endnote (literature database)
• ARGUS database, Trackwise, PVQ

• Project initiation, planning and the implementation in cooperation-based networks as focal point in between biology, chemistry and physics in the frame of European projects
• Organization of workshops und meetings including chairmanship, minutes and final report
• Pharmacovigilance: drug safety, case processing, query management, reconciliation with world-wide partners, medical coding, medical translation, late case processing, exception and CAPA management, all in regard to clinical trials, post-marketing studies and spontaneous reports. ARGUS database, Training of National Responsible persons
• Inter-disciplinary knowledge in the drug developmental process, pre-clinical toxicology of drugs, REACH, Cosmetics and the related guidelines, biology, immunology, plasma physics, surface chemistry plus characterization and human embryonic stem cells
• Expertise in the validation and development of toxicity testing methods including the requirements and guidelines (e.g. ICH, OECD, REACH)
• Various cell lines, maintenance and the set up of experiments used for substance testing in toxicology

• Risk and Hazard Assessment
• Principles of Good Laboratory Practices (GLP)
• Communication Skills and Conflict Management
• Training of Public Speaking
• Basics of Project Management and Microsoft Project
•  Chairing and Conducting Meetings

• Since 2013: Dog trainer for advanced target search in devastation scenes, package rows and flat areas, including object differentiation at the local dog training facility “SWHV”
• 3 years as representative in the ”Women in Science Network” for the Institute for Health and Consumer Protection, JRC, Ispra, Italy
• 3 years as a member in the executive board Contrast e.V., youth work
• 2 years as a member in the executive board ESG e.V., self-governed tenant project 
• 6 years: Organization and implementation of the annual district festival
• Member of the executive board in various educational facilities

• Gordon S, Hasiwa N et al. Non-Animal Models of Epithelial Barriers (Skin, Intestine and Lung) in Research, Industrial Applications and Regulatory Toxicology, ALTEX 2015, 32
• Leist M, Hasiwa N, Rovida C, Daneshian M, Basketter D, Hartung T. Consensus report on the future of animal-free toxicity testing, ALTEX 2014, 31.
• Hasiwa N, Daneshian M, Bruegger P, Fennrich S, Fleck R, Hochadel A, Hoffmann S, Rivera-Mariani FE, Rockel C, Schindler S, Spreitzer I, Stoppelkamp S, Vysyaraju K and Hartung T. Evidence for the detection of non-endotoxin pyrogens (NEPs) by the whole blood monocyte activation test. ALTEX 2013, 30.
• Hartung T, Hasiwa N, Daneshian M, Holtkamp B, Schmitz G and Hossfeld A. Eine wirklich humane Bestimmung von Endotoxinen und Nicht-Endotoxin-Pyrogenen. [A truly human(e) determination of endotoxin and non-endotoxin pyrogens]. PharmInd 2013.
• Leist M, Hasiwa N, Daneshian M (2013) Summary and validation of new animal-free toxicity tests. ALTEX Proceedings 2, 27-37
• Leist M, Lidbury BA, Yang C, Hayden PJ, Kelm JM, Ringeissen S, Detroyer A, Meunier JR, Rathman JF, Jackson GR, Stolper G, Hasiwa N (2012) Novel technologies and an overall strategy to allow hazard assessment and risk prediction of chemicals, cosmetics and drugs with animal-free methods. ALTEX 29, 373-388.
• Leist M, Hasiwa N, Daneshian M and Hartung T. Validation and quality control of replacement alternatives – current status and future challenges. (2012) Toxicological Research 1: 8, DOI: 10.1039/C2TX20011B.
• Basketter DA, Clewell H, Kimber I, Rossi A, Blaauboer B, Burrier R, Daneshian M, Eskes C, Goldberg A, Hasiwa N, Hoffmann S, Jaworska J, Knudsen TB, Landsiedel R, Leist M, Locke P, Maxwell G, McKim J, McVey EA, Ouédraogo G, Patlewicz G, Pelkonen O, Roggen E, Rovida C, Ruhdel I, Schwarz M, Schepky A, Schoeters G, Skinner N, Trentz K, Turner M, Vanparys P, Yager J, Zurlo J and Hartung T. A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing. ALTEX 2012, 29:3-89.
• Hasiwa N, Bailey J, Clausing P, Daneshian M, Eileraas M, Farkas S, Gyertyán I, Hubrecht R,  Kobel W, Krummenacher G, Leist L, Lohi H, Miklósi A, Ohl F, Olejniczak K, Schmitt G, Sinnett-Smith P, Smith D, Wagner K, Yager JD, Zurlo J and Hartung T. Critical evaluation of the use of dogs in biomedical research and testing in Europe. ALTEX 2011, 28:326-340.
• Hasiwa M, Kylián O, Hartung T and Rossi F. Removal of Immune-stimulatory Components from Surfaces by Plasma Discharges, Innate Immunity, 2008, 14: 89-97.
• Stummann TC, Beilmann M, Duker G, Dumotier B, Fredriksson JM, Jones RL, Hasiwa M, Kang YJ, Mandenius CF, Meyer T, Minotti G, Valentin YJ, Zünkler BJ,Bremer S. Report and recommendations of the workshop of the European Centre for the Validation of Alternative Methods for Drug-Induced Cardiotoxicity. Cardiovasc Toxicol. 2009 Sep;9(3):107-25. Epub 2009 Jul 2.
• Brétagnol F, Rauscher H, Hasiwa M, Kylián O, Ceccone G, Hazell L, Paul AJ, Lefranc O, Rossi F. The effect of sterilization processes on the bioadhesive properties and surface chemistry of a plasma-polymerized polyethylene glycol film: XPS characterization and L929 cell proliferation tests. Acta Biomater. 2008 Nov;4(6):1745-51. j.actbio.2008.06.013. Epub 2008 Jul 2.                             
• Benedikt J, Raballand V, Halfmann H, Awakowicz P, von Keudell A, Kylian O, Hasiwa M, Rossi F, Muranyi P, Wunderlich J, Comoy E, Schell J, Deslys JP. BIODECON - European project on plasma inactivation of bacteria and biomolecules. GMS Krankenhhyg Interdiszip. 2008 Mar 11;3(1):Doc04.