TranScrip Internal Medicine

TranScrip expertise and experience extends to a wide range of Internal Medicine areas including nephrology, haematology, gastroenterology, rheumatology, immunology, endocrinology and cardiovascular diseases.

Additional therapeutic areas

Infectious Diseases, Oncology, RespiratoryCNS/Pain

Expertise
Experience

TranScrip Internal Medicine Experts

TranScrip’s Internal Medicine team has worked on all phases of clinical development ranging from proof of concept / mechanism, submission of orphan designations including negotiations on the development plan, translational programmes to registrational work involving submissions and post-registration programs for big pharma and small biotech companies. TranScrip´s experience extends to a wide range of Internal Medicine areas including nephrology, haematology, neurology, gastroenterology, rheumatology, immunology, endocrinology and cardio-metabolic diseases. TranScrip has extensive experience working with regulatory authorities worldwide, including EMA, FDA and PMDA. TranScrip´s services range from ad-hoc advice to deployment of fully operational project teams.

Tim Joslin
Head of Internal Medicine

Tim leads TranScrip's clients' programmes in internal medicine product development, registration, and post-licensing.

He has over 30 years of industry experience covering the complete product  life-cycle from "Target Product Profile" and national/global launches to post-patent strategies for cardiometabolic, immunology and other areas within the internal medicine therapeutic area.

Gilbert Wagener
Deputy Head of Internal Medicine

Gilbert is a key TranScrip expert in cardiovascular, immune-mediated CNS and non-oncology orphan diseases including due diligence.

He has 20 years’ experience in global drug development in cardiovascular, immune-mediated and CNS indications, including biopharmaceuticals, stem cells, gene therapy, MABs and antisense oligonucleotides in collaboration with external partners and academic institutions.

Gilbert studied human medicine in Marburg, Germany, completed his MD thesis in pharmacology and gained experience in Neurophysiology and clinical Neurology at the University Hospitals in Marburg. He joined Bayer Healthcare in 1993 covering positions of increasing responsibilities in late stage development, life cycle management as well as phase 1 and proof-of-concept studies of drug candidates in cardiovascular indications. Having supervised the conduct of two large randomized controlled clinical trials, his particular interest is clinical trial design and the adoption of results of large clinical trials into medical practice. In 2004 Gilbert joined Genzyme Europe as Vice President for clinical research cardiovascular in The Netherlands. He was responsible for proof-of-concept trials with stem cells and gene therapy in cardiovascular indications, the coordination and conduct of medical due diligence in Europe: He supervised phase 3 studies with a MAB in CNS indications and the global phase 2 and 3 program of an antisense oligonucleotide, including submission of the MAA to the EMA. Gilbert worked as a strategic consultant on PCSK9 inhibition in hyperlipidaemia. In addition, Gilbert has developed the design of proof of concept studies with dual biologic therapy in rheumatoid arthritis and with a small molecule in primary Sjogren´s syndrome. Since 2014 Gilbert is, in his role as Senior Partner at TranScrip, acting as an interim CMO at Cell2B.

Gilbert is a fellow of the European Society of Hypertension, a member of the European Society of Cardiology and a member of the working group on cardiovascular pharmacology and drug therapy and a Member of the BIA Cell Therapy and Regenerative Medicine Advisory Committee. He is also a member of the German Society of Pharmacology and Toxicology and the German Society of Physiology. Gilbert earned a MBA from the University of Basel, Switzerland, in Pharmaceutical Medicine. Gilbert completed his PhD thesis in Epidemiology / Public Health at the Erasmus University, Rotterdam, The Netherlands, in 2007.

Latest Internal Medicine News

14 June
2018

'Towards a cure for Haemophilia'

A report by Senior Partner, Mark Watling.

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Company Product Phase Indication and Service
Top 50 Synthetic Analogue of Calcitriol Translational Hyperparathyroidism: Advisory Board support.
Top 50 EPO Glycoprotein Launch Anaemia: Participate as speaker and chairperson at the Nephrology Educational Winter Symposium.
Top 50 HIF-PH Inhibitor Translational Anaemia: Translational medicine, ad board and regulatory support (including for PIP) and support for various clinical research and clinical development documents.
Top 50 Lipoglycopeptide Translational Antibiotic and renal toxicity: Medical writing in renal impairment study.
Top 50 Phosphate Lowering Therapies CKD Launch Hyperphosphataemia: Chairing and support for symposium.
Medium Phosphate Binder Phase III Hyperphosphataemia: Medical Director and department responsbilities for clinical development, regulatory affairs, drug safety and commercial discussions for phase II through to phase III.
SME Various Translational Anaemia: Medical input to treatment and drug development of a product for iron deficiency anaemia in CKD.
Top 50 Phosphate Binder Phase III Hyperphosphataemia: Involvement in preparation of MAA and NDA submission clinical materials including CSRs, clinical summaries, defence of agency questions, support for scientific advice meetings.
Top 50 Iron Product Phase III Anaemia: Support for drug safety and clincal study reports for the submission.
Top 50 NA Mature Hyperphosphataemia: Advisory Board and symposia support.
Top 50 Thrombopoietin-Receptor Agonists Phase III Thrombocytopaenia: Review of clinical protocols, clinical development and writing of a PIP.