Dr Jenny Sims
Jenny has a degree in Biochemistry and a PhD in Pharmacokinetics and Toxicology.
Jenny has more than 30 years of experience in non-clinical drug development, with a focus on biotechnology products (monoclonal antibodies, antibody drug conjugates, protein drug conjugates, therapeutic proteins, novel scaffolds, DNA vaccines and cell & gene therapies). Jenny worked for 12 years as an Expert Preclinical Assessor in the Clinical Trials Unit and Biotechnology Group at the MHRA and was a member of many CHMP Rapporteur/Co-Rapporteur assessment teams for biopharmaceuticals and scientific advice. She then became Head of Project Safety Assessment Group, Preclinical Safety at Novartis Pharma AG in Basel, Switzerland. Jenny then Headed up the BioPharma Safety Assessment Group at MedImmune before returning to Novartis to take on the role of Head of Translational Sciences and Safety, in the Novartis Biologics group. In 2012, Jenny established Integrated Biologix GmbH, to provide independent non-clinical development consultancy for biopharmaceuticals and advanced therapy products, working with early start-ups and small/large companies at all stages of the drug-development cycle. Jenny has been involved in many successful clinical trial and BLA/CTD approvals and has experience of supporting projects at Health Authority Scientific Advice meetings, FDA advisory committees and CHMP oral hearings. She is a regular member of company Scientific Advisory Board meetings.
Jenny was the MHRA/UK delegate to the CHMP Safety Working Party and MHRA observer on the UK Gene Therapy Advisory Committee (GTAC). She was a member of the Expert Working Groups for ICHS6/ICHS6R(1), ICHS8, ICHM4(S) and was part of the UK industry review team post-Tegenero which recommended greater consideration of the pharmacological active dose (PAD) and MABEL approach for First in Human trials.
+41 (0) 79 128 06 09
Dr Sarah Taplin
BSc PhD BVMS FRCPath
Sarah has an Intercalated degree in Veterinary Medicine and Molecular Biology and a PhD in Molecular Biology and Gene Therapy. Sarah is also a board certified pathologist as a Fellow of the Royal College of Pathologists by examination in Toxicological Pathology.
Sarah has more than 16 years experience in non-clinical drug development, with a focus on biotechnology products (monoclonal antibodies, antibody drug conjugates, protein drug conjugates, therapeutic proteins, novel scaffolds, DNA vaccines and cell & gene therapies). Sarah has worked as a Senior Toxicological Pathologist and Safety Assessment Expert in large pharmaceutical companies including GlaxoSmithKline and AstraZeneca and was Head of Pathology in the Biologics Group at Novartis Institute of BioMedical Research where she also established a Molecular Pathology/Immunology laboratory delivering immunohistochemistry, in situ hybridisation, cellular proliferation assays, ADCC, CDC and cytokine release assays in support of biopharma programs. In 2009, Sarah became an independent toxicological pathologist providing preclinical safety assessment expert advice on biopharmaceutical product development specializing in toxicological pathology histopathology peer review and integrated interpretation of data. In 2018, Sarah joined Integrated Biologix GmbH.
Sarah is the Chair of examiners for FRCPath (subspecialty Toxciology) and an active member of the BTSP.
+44 (0) 7225 127 311
Dr Simon Chivers
Simon has a degree in Pharmacology and PhD in Applied Pharmacology.
Simon has more than 20 years experience in non-clinical drug development, with a focus on biotechnology products (monoclonal antibodies, antibody drug conjugates, protein drug conjugates, therapeutic proteins, novel scaffolds and cell & gene therapies). Simon has worked in leadership roles in both large pharmaceutical companies (Global Head of Biologics Safety Assessment at the Novartis Institute of BioMedical Research and Senior Safety Assessment Expert at AstraZeneca / MedImmune) and small biotech companies (Head of Toxicology at ADC Therapeutics and Senior Toxicologist at Syngenta Biopharma). Simon has developed excellent relationships with both small and large CRO’s globally, selecting appropriate CRO’s to address the question of interest. In 2019, Simon joined Integrated Biologix GmbH.
Simon was the Novartis representative on the EFPIA pre-clinical development committee, is an active member of the British Toxicology Society and British Pharmacological society, performs article reviews for the Journal of Applied Toxicology and actively supports relevant BioSafe committees (currently supporting Antibody Drug Conjugate group).
+44 (0) 7908 055 735
Dr Sebastian Spindeldreher
Dipl. Biol. PhD
Sebastian has a diploma in Biology and a Doctor rerum naturalium (PhD in natural sciences).
Sebastian has more than 18 years of experience in non-clinical drug development, with a focus on biotechnology products (monoclonal antibodies, antibody drug conjugates, protein drug conjugates, therapeutic proteins, novel scaffolds and cell & gene therapies). At F. Hoffmann-La Roche, Sebastian was heading a lab in immunosafety, and at the Novartis Institutes for BioMedical Research, he was a section head from 2009 to 2014 and then the Global Head of Biologics Bioanalytics between 2014 and 2019. At Novartis, he also established a cross-functional team for the integrated assessment of immunogenicity risk that developed and applied assays to understand immunogenicity liability of new biotherapeutics prior to entering human clinical trials. Sebastian is experienced in developing integrated strategies for pharmacokinetic, pharmacodynamic (target engagement) and immunogenicity analysis including immunogenicity risk assessment. His experience ranges from early discovery through non-clinical and clinical development to post-launch and covers GLP, GCP as well as outsourcing of activities. In 2019, Sebastian joined Integrated Biologix GmbH.
Between 2012 and 2018 Sebastian was co-leader of the immunogenicity prediction work package of the Innovative Medicines Initiative (IMI) project ABIRISK that ended in February 2018. Between 2016 and 2018 he was the EFPIA coordinator of ABIRISK. Since 2010, Sebastian is member of the board of directors of the European Immunogenicity Platform (EIP).
+41 (0)79 559 01 57