Torsten Reinheimer

I have been employed in the pharmaceutical industry in Germany and Denmark for 22 years, with a focus on non-clinical research and development of peptides, and biologics, including pharmacology,

safety pharmacology, pharmacokinetics, and toxicology. I have been engaged in several therapeutic areas including intensive care, cardiovascular and inflammatory diseases, reproductive science, gastroenterology together with liver diseases, immunology, and microbiome. I have contributed to and led international project teams successfully transitioning numerous drug candidates from preclinical or clinical phases to regulatory submissions in Europe and US.

Please consider me as Pharmacologist/Toxicologist ERT. I am an experienced drug developer with strong scientific background/network, familiar with non-clinical strategy design, safety assessments and influencing global multidisciplinary collaborations. Importantly, I have broad understanding monitoring multisite GLP studies, implementing disease models, translational PK/PD, CRO engagement, documentation filing/reviews (eCTD, IB), regulatory interaction (FDA, PEI), support management, manage stakeholders/external partners, build scientific evidence, and due diligences of external opportunities.

since 2020: Owner of reinheimer.expert ApS, Copenhagen, Denmark

Pharmacology, toxicology, pharmaceutical R&D consultancy

Advising a Danish biotech on toxicology strategy for an anti-CMV protein

Lecturer for pharmacology and toxicology at Döpfer University Germany

Advising a Swiss start-up on pharmacology and PK of a tocolytic drug

Advising an US start-up on their tox package for an antihypertensive

Advising a Chinese company on their tox strategy for an antiviral drug

Director/Principal Scientist Experimental Medicine/Non-Clinical Dev.

2002 - 2020 FERRING Pharmaceuticals A/S, Copenhagen, Denmark a privately-owned, global, mid-sized pharmaceutical enterprise

2 billion € yearly turnover, ca. 7,000 employees worldwide

TAs reproductive medicine/maternal health, gastroenterology, urology

Responsibilities

• Design non-clinical strategies, safety pharmacology, PK/PD
• Principal pharmacologist/toxicologist, overall NC safety assessment
• Inspire, lead project teams/management; prepare development plans
• Leading role in health authority meetings
• Search new in-vitro, ex-vivo or animal models, manage CROs
• Build-up network of scientific advisors and academic centres
• Initiate/facilitate early-stage feasibility activities, experimental support
• Scientific support to Ferring research, endorse testing strategies
• Lead due diligences, provide scientific insight and final evaluations
• Innovation leadership, use patents and drug candidate profiling
• Coach pharmacologists and toxicologists, present lectures

Achievements

• Characterised terlipressin as a prodrug & its PK/PD characteristics
• Developed V1A antagonist in preeclampsia, improved foetal outcome
• Characterised quinagolide for non-hormonal endometriosis treatment
• Developed vasopressors to lower portal pressure in liver cirrhosis
• Characterised selepressin as anti-leakage, V1A-selective sepsis drug
• Microbiome replacement therapy to cure refractory C. diff. infection
• Developed olamkizept to treat chronic inflammatory bowel disease
• Characterised DNAase as treatment for male fertility or DNA damage
• Developed barusiban as OT-selective tocolytic in primates
• Life-cycle management of atosiban, a globally registered tocolytic
• Developed carbetocin for prevention of post-partal haemorrhage

Since 2013 Registration as British/European toxicologist BRT/ERT

2008 - 2013 Master of applied toxicology with distinction, Postgraduate studies, University Surrey UK

2007 - 2023 Honorary professorship, Warwick Medical School, UK, Biomedical Research since 1996 Qualification as pharmacologist approved by DGPT since 1995 PhD-degree in neuropharmacology with magna cum laude

1990 - 1997 Institute of Pharmacology, PhD student, Joh. Gutenberg-University Mainz

1984 - 1989 Qualification as pharmacist, Johannes Gutenberg-University Mainz

1970 - 1983 Matriculation standard, secondary school Groß-Gerau, Germany