Isabella Andreini

PRECLINICAL EXPERT, PRECLINICAL DEVELOPMENT.

Personal Information

Address Via Poggio di Venaco, 30 – 00122 Rome Italy
Telephone(s) +39 06 91 601 203
Mobile +39 348 86 24 267
E-mail i.andreini@akrosbioscience.eu
Nationality Italian
Date of birth 05/03/1962
Gender Female

Education and training

October 1995 Ph.D. in “Veterinary Environmental Toxicology” University of Pisa – Veterinary Medicine – Italy
October 1990 Post-Master Specialization in “Animal Health, Hygiene of Animal Breeding Centers and Productions” University of Pisa – Veterinary Medicine – Italy
December 1988 Qualification to practice Veterinary Medicine (Esame di Stato) University of Pisa – Veterinary Medicine – Italy
November 1988 Degree cum laude in Veterinary Medicine – University of Pisa – Italy
July 1981 High School Diploma (leaving qualification in classical studies) Liceo Classico Statale “Anco Marzio” Lido di Roma – Italy

Personal skills

Languages

Italian Mother tongue
LanguagesUnderstandingSpeakingWriting
English Listening C2; Reading C2 Spoken interaction C2; Spoken production C2 C2
Français Listening A2; Reading B2 Spoken interaction A2; Spoken production A2 A2
Levels: A1/2: Basic user – B1/2: Independent user – C1/2 Proficient user Common European Framework of Reference for Languages

Additional title:

ERT – European Registered Toxicologist
Certified since 2016

Training

Participated to >15 training courses
Attended >50 National and International congress

Work experience

November 2019 – Partner & Associate

AKROS Bioscience Srl, piazza Aldo Moro 20/D 00071 Pomezia (RM) Italy.

– Director, Preclinical Expert 2019 – present

April 1997- October 2019 – Different roles, see below at RTC Srl, via Tito Speri 12 00071 Pomezia (RM) Italy.

– Study Director 1997-1999

– Scientific Business Manager 1999-2002

– Pathologist and Head of Necropsy and Histology lab. 2002-2006

– Head of Immunology Unit 2006-2009

– Senior Scientist, Expert in Immunotox and Biomarkers 2010-2019

– Project manager 2015-2019

November 1996 – March 1997 Post-doc Fellow.

University of Pisa. Scuola di Studi Superiori e Perfezionamento S. Anna Pisa, Italy

April 1995 – November 1996 Post-doc Fellow

Institute fur Zoophysiolgie. Stuttgart, Germany.

March 1992 – December 1994 Visiting Scientist.

Monell Chemical Senses Centre. Philadelphia, USA

January 1989 – February 1992 Post-graduate Fellow

Istituto di Mutagenesi e Differenziamento National Council of Research ( C.N.R.) – Pisa, Italy 2

November 1996 – March 1997 Post-doc Fellow.

University of Pisa. Scuola di Studi Superiori e Perfezionamento S. Anna Pisa, Italy.

March 1980 June 2000 CEO and Scientific director
Research Toxicology Centre Spa, via Tito Speri 14 Pomezia, Rome, Italy

Main activities and responsibilities Scientific Management in the preclinical CRO RTC; toxicology laboratory; animal and in vitro experimentation on safety evaluation on drug, chemicals, agrochemicals; biotechnology products, medical devices, food supplements.

July 1999 – March 1980: Scientific officer

Farmindustria, Pharmaceutical association in Italy Rome Industrial association

Scientific advisor in the Italian Association of Pharmaceutical Companies, acting in the field of interaction with EC and national authorities for implementation of scientific guidelines for drug safety evaluation.

Additional information

Academic Activity

2009-2019 – Lecturer at University Cattolica Sacro Cuore – Roma Advanced Level Master on Pharmaceutical Product Preclinical and Clinical Development Module I ”Pre-clinical development”

2009-2015, Lecturer at the Master Degree (Laurea Magistralis) in Health Biology – Alma Mater Studiorum, Università di Bologna Teacher of Lesson entitled ”Pre-clinical development of a biotechnological drug”

2009-2021 – Lecturer at University Cattolica Sacro Cuore – Roma Advanced Level Master on Pharmaceutical Product Preclinical and Clinical Development Modules 1 and 6 ”Pre-clinical development”

Tutor for the preparation of final thesis and presentation of candidates of above mentioned Master

2021 – Lecturer at Course of Pharmacology – School of Medicine, Faculty of Medicine, University of Foggia – Lessons on “Sviluppo preclinico dei farmaci”; 11 and 18 May 2021

2020 – Lecturer at University La Sapienza – Roma Advanced Level Master on “Key managers in the nutraceutical and cosmeceutical company” – Department of Chemistry and Pharmaceutical Technologies

Scientific Production

Author of 17 full articles/book chapters
Author of > 60 Posters and Oral Presentation

Representative production of the last 5-10 years is reported below

Scientific Association Membership

SITOX – Società Italiana di Tossicologia

Member since 2010

Member of the Directive Council 2012-2018

SIF – Società Italiana di Farmacologia

Member since 2015

SIMeF – Italian Society of Pharmaceutical Medicine (before known as SSFA – Società di Scienze Farmacologiche Applicate)

Member since 2010

SINUT – Società Italiana di Nutraceutica

Member since 2019

Publications and posters (from 2005 on)

  1. Andreini I., Cinelli S., Oberto G. “Stem cell therapy: the point of view of a pre-clinical CRO on the safety evaluation process” 8th ILSI Biomed meeting (National Life Science & Technology Week ) June 15-17 2009 – Tel-Aviv Israel- Poster
  2. Andreini I., Cinelli S, Venturella S. Oberto, G. “Pre-clinical safety evaluation of a cell based medicinal product (stem cell therapy)” XII IUTOX (International Congress of Toxicology) – Barcelona July 2010 – Poster
  3. Andreini I., Rees D., D. Oberto, G., Orsi A. “The marmoset as a model for the evaluation of novel pharmaceuticals and biotechnology-derived products” XII IUTOX (International Congress of Toxicology) – Barcelona July 2010 Poster
  4. Andreini I., Cinelli S, Bisini L. Oberto, G. “Immunogenicity assessment and lack of dilution linearity: special case and possible solution” – EBF (European Bioanalytical Forum) – Barcelona November 2010 – Poster
  5. Orsi A., Rees D., Andreini I., Venturella S., Cinelli S., Oberto G. “Overview of the marmoset as a model in nonclinical development of pharmaceutical products” Regulatory Toxicology and Pharmacology 2011 Feb;59(1):19-27
  6. Andreini I. Translator for the Italian Edition of Casarett & Doull’s “Essentials of Toxicology” Second Edition 2013 – Chapter 12 “Toxic responses of the Immune System” Pg 161-176
  7. Rosado M., Getuli C., Andreini I. “Phenotypic characterization and intra cellular staining of minipig lymphocytes” – Minipig Research Forum – Barcelona May 2018 – Poster
  8. C. Getuli, Andreini I, M.M. Rosado and S. Cinelli “GLP Validation and application of the flow cytometric method to evaluate lymphocyte subset in rat splenocytes in EOGRT studies (OECD443)” 12th European Bioanalysis Forum -November Barcelona- 2019 Poster
  9. A. Nunziata, S. Bianco, I. Andreini “PRECLINICAL EVALUATION IN THE LIGHT OF NEW REGULATIONS (EUROPEAN REGULATION MDR 2017/745 AND ISO 10993-1/2018)” SITOX Bologna February 2020 Poster

Oral presentations (from 2009 on)

  1. Andreini I. “Aspetti salienti dello sviluppo preclinico dei biosimilari” XVI Congresso Nazionale SITOX – 21 March 2012 – Catania – Italia, Oral presentation
  2. Andreini I.,” Design And Data Interpretation During The Toxicological Development Of Biotech Products And Advanced Therapies ” SOT San Francisco March 2012, Oral presentation (Symposium)
  3. Andreini I.” Kinetic and immunogenicity measurements using immunology-based methods “– Round Table – Barcelona – June 2012; Paris – October 2012; Rome – December 2012 Oral presentation
  4. Andreini. I “Metodi immunologici Implementazione delle linee guida su cinetica e immunogenicità” RTC Round Table Milano February 2013; Rome – March 2013 Oral presentation
  5. De Siena R., Andreini I “Case study: the pig as a preclinical model for heart regenerative therapy “ MiniPig Research Forum – Rome November 2013 Oral presentation
  6. Andreini I. “Challenges of the preclinical safety assessment of a DNA vaccine” Gene Vaccination in Cancer Meeting – Ascoli Piceno October 2013 Oral presentation
  7. Andreini I. ” Nuove frontiere nella bioanalitica e laboratorio clinico” Chairperson and organizer – February 2015 – Round table held in RTC-Pomezia, Roma Oral presentation
  8. Andreini I. “Tossicologia preclinica di prodotti biotecnologici e terapie avanzate” Chairperson and speaker – Symposium in XVII Congresso Nazionale SITOX – 17-20 March 2015 – Milano – Italia, Oral presentation
  9. Andreini I. ” Nuovi biomarcatori in tossicologia” Chairperson – Symposium in XVII Congresso Nazionale SITOX – 17-20 March 2015 – Milano – Italia, Oral presentation
  10. Andreini I.,” Doxorubin – Case Study Supporting the Relevance of the Minipig as Animal Model for Long-Term Treatment with Anticancer Products ” SOT San Diego USA, 23 March 2015 Oral presentation (Symposium)
  11. Andreini I., Grassetti A., Oberto G. ” Doxorubin – Case Study Supporting the Relevance of the Minipig as Animal Model for Long-Term Treatment with Anticancer Products ” Minipig Research Forum – Rome – Italy 21 May 2015 Oral presentation
  12. Andreini I., Venturella S. ” Non-clinical development of anticancer products, real cases in conventional and non-conventional non-rodent species” Innoqua Scientific Seminar – Barcelona – Spain 2 June 2015 Oral presentation
  13. Andreini I. Trial preclinici e il giusto “bridging” verso gli studi clinici” XVI Congresso Nazionale Di Ipovisione Low Vision Academy –5 October 2015 – Roma Oral presentation
  14. Andreini I., Cinelli S., Monetini L., Oberto G. ” Preclinical safety assessment of cytotoxic and biotechnology anticancer drugs complying with the Regulatory, Scientific and Ethical aspects… what a challenge!” SIF – XXXVII Congresso Nazionale della Socieltà Italiana di Farmacologia –30 October 2015 – Napoli Oral presentation
  15. Andreini I., Cinelli S., Monetini L., Oberto G. ” CRO case Study Report: how we addressed the concerns on Endocrine Disruption ” SFT Congrès Annuel de la Société Française de Toxicologie –25 November 2015 – Paris Oral presentation
  16. Andreini I., Cicalese R. ” Intratracheal administration in juvenile minipigs- a technical approach” Juvenile Toxicity Symposium – Beerse – Belgium 7-8 April 2016 Oral presentation
  17. Andreini I. ” The Göttingen minipig in non clinical toxicology: a leading non-rodent species accepted by all regulatory authorities” – Round table organized by RTC-3 June 2016 – Barcelona – Spain Oral presentation
  18. Andreini I.,” Modern challenges of preclinical regulatory safety assessment ” XV Meeting of the Italian Hungarian Spectrometry Society – Pisa – Italy 13 June 2016 Oral presentation
  19. Andreini I. “Aspetti Farmaco-Tossicologici dello Switch” Conferenza Nazionale sullo Switch Farmacologico – 5 Ottobre 2016 – Milano Oral presentation
  20. Andreini I. “Species selection for the non-clinical testing of Biologicals – BelTox (Belgian Society of Toxicology) – 11 May 2017 – Beerse – Belgium Oral presentation
  21. Andreini I. “Phenotypic characterization and intra cellular staining of minipig lymphocytes – Minipig Research Forum – 17-19 May 2017 – Cambridge – UK Oral presentation
  22. Andreini I. ” The Göttingen Minipig in Regulatory Toxicology” – Round table organized by RTC-6 June 2017 – Frankfurt – Germany Oral presentation
  23. Andreini I. “Sviluppo di un farmaco biologico e biosimilare: cosa chiede l’industria” SITOX Event on Immunogenicità e Reazioni Avverse a Farmaci Biologici e Biosimilari – 15 November 2017 – Milano – Italia Oral presentation
  24. Andreini I. “Trial preclinici di prodotti biotecnologici e il giusto “bridging” verso gli studi clinici” Symposium in XVIII Congresso Nazionale SITOX – 10-13 April 2018 – Bologna – Italia Oral presentation
  25. Andreini I. “Minipig and biologics” RTC Round Table, Frankfurt October 2018 Oral presentation
  26. Andreini I. ” Preclinical safety of vaccines the point of view of the CRO” 1st Vitares Annual Meeting – Rome – February 2019 Oral presentation
  27. Andreini I., Longobardi C. ” Preclinical toxicology for wound healing therapies: animal models and analysis” DDD Summit Frankfurt May 2019 Oral presentation
  28. Andreini I., ” Infusion study in NHP” Eurotox Helsinki, September May 2019 Oral presentation
  29. Andreini I. ” Strategies of Preclinical Safety Assessment of Monoclonal Antibodies” 1st Therapeutic Antibody Workshop, Rome November 2019 Oral presentation
  30. Andreini I. “Preclinical Safety Testing on Drug-Dependent Combination Products (DDC) with Biological Drugs” SITOX Bologna February 2020 Oral presentation
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