TranScrip Respiratory

TranScrip has conducted an extensive number of respiratory projects since 2008. It has covered projects ranging from translational medicine, working with mature products and managing the challenges of inhaled generics.  The contracts include supporting major successful MAAs and NDAs, variations and a wide range of expert services in translational medicine and drug development.

Additional therapeutic areas

Infectious Diseases, Oncology, Internal Medicine, CNS/Pain

Expertise
Experience

TranScrip Respiratory Experts

TranScrip’s Respiratory team has worked on all phases of projects ranging from translational programmes involving provision of a complete, virtual biotech team to peri-registration work involving submissions for big pharma. Project size has ranged from provision of therapeutic, operational and / or strategic expertise by individuals through to provision of multifunctional strategic and operational teams of up to 10 people.

Tim Joslin
Head of Respiratory

Tim leads TranScrip's clients' programmes in respiratory 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 respiratory and other therapeutic areas.

Gilbert Wagener
Deputy Head of Respiratory

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 saupervised 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 Respiratory News

17 October
2017

ERS 2017 Asthma Back in Focus

At the European Respiratory Society (ERS) Congress September 9 – 12, Milan, there was a renewed interest in asthma, with several new approaches to the treatment of severe asthma being presented. This interest was sparked by new data and events in the asthma space.

Forthcoming Events

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Company Product Phase Indication and Service
SME Complement Inhibitors Translational Asthma: Identification and coordination of centres to run phase 1a/1b studies. Developing clinical programme design, managing translational clinical programme and decisions relating to next steps. Regulatory strategy input to support European development in asthma. Providing legal representation and 'responsible' person.
Medium Inhaled LABA & LAMA Phase III Asthma: Support for regulatory and development programmes and the submission dossier and answering specific regulatory questions.
Top 50 CRTH2 Antagonist Phase III Asthma: Support of study feasibility & investigator suitability, study investigator training plan, additional appropriate study sites and creation of contingency plans for patient recruitment and retention.
SME PDE-4 Inhibitor Translational Asthma and COPD: Due diligence on in-license of respiratory portfolio and specific due diligence on a PDE-4 inhibitor.
SME Inhaled IFN Translational Asthma and COPD: Medical director and drug safety management, clinical development operations. Regulatory support for strategic, operational and clinical development activities.
Top 50 Various Translational - Phase III Asthma and IPF: Clinically responsible for development programs, including development of clinical plans, authority contacts etc.
SME CRTH2 Antagonist Translational Asthma and Allergy: Outline regulatory plan for paediatric development, GAP analysis to support paediatric regulatory plan, discussion of GAP analysis and/or clinical development plan with client and preliminary planning of clinical development plan.
Not Pharma Various Translational Asthma and COPD: Due diligence advice in relation to potential investment in drug projects already in clinical development.
Medium Inhaled Device Translational Asthma and/or COPD: Provision of expert support to design a PoC study for potential development of a combination product in an API-activating device.
Medium Inhaled Anticholinergic Phase III COPD: Regulatory support for clinical summary and clinical expert report (2.5).
SME IL8 Antagonist Translational COPD: Oversight of first in man study, creation of IB and clinical trial applications.
Top 50 Inhaled Immunological Mature Pulmonary Arterial Hypertension: Scientific advice for early research and development projects plus mechanism and regulatory, positioning support.
SME Inhaled Product Translational Pulmonary Arterial Hypertension: regulatory project, successfully obtaining orphan drug designation. Managing the regulatory approval to run trials in US and UK, managing the clinical trials and the drug safety database, responsible person and annual reporting.
Medium Surfactant Mature Respiratory Distress Syndrome in Newborns: Risk Management Plan update for an orphan drug in the new regulatory approved format.
Medium Inhaled ICS LABA Translational Acute Respiratory Distress: QC of Common Technical Document Sections (2.7.2, 2.7.3, 2.7.4 and 2.5) and due diligence.
Top 50 Surfactant Translational Acute Respiratory Distress in Neonates: Consultation on clinical development.
Medium Various Mature Respiratory: Assessing and facilitating access to respiratory portfolio for the Japanese and Asian market.
Medium Various Inhaled Phase III Respiratory: support for new inhaled devices.
Top 50 Various Translational Allergy: Evaluation and development plan for approval of a new therapy for allergy.
SME Inhalation Devices Phase III Cystic Fibrosis: Provision of advice on inhaled therapies and inhalation devices.
SME Peptide Translational Cystic Fibrosis: Preparation of a grant submission to the Cystic Fibrosis Foundation.