Thomas Wiese
Binningen
Summary
Personal Profile___________________________________________ Board-Certified Paediatric Psychiatrist with a robust 15-year tenure in drug development, clinical research, and clinical care. Proven track record in translational medicine and escalating roles in clinical development. Expertise in designing, planning, and executing studies throughout the development cycle, from Phase 1 to Phase 3. Comprehensive understanding of global drug development strategies for both small and large molecules. Experience across diverse neuroscience indications including Autism, Angelman Syndrome, Social Anxiety Disorder, Sleep Disorders, Acute Ischaemic Stroke, Spinal Muscular Atrophy, and Huntington Disease. Demonstrated success in matrix team leadership, line management, and spearheading cross-organizational initiatives. Specialized expertise in the development of innovative outcome measures and rare disease endpoint strategies, including decentralized trial and placebo mitigation strategies. Collaborative leadership style fostering synergies towards common objectives and fruitful collaborations with biotech partners. Established network of Key Opinion Leaders (KOLs) and Principal Investigators (PIs) in the field of autism, neurodevelopmental disorders, and other indications (HD, SMA) across Europe and the US.
Overview
34
34
years of professional experience
Work History
Translational Medicine Leader
F. Hoffmann la
11.2021
- Of translational medicine teams focusing on Autism, Angelman Syndrome, Sleep Disorders, and Rare genetic epilepsy
- Line manager for a team of four clinical scientists
- Responsible for the design of early clinical development plans; including biomarker strategies, proof of concept (PoC) and proof of mechanism designs (POM)
- Led the design, planning, and execution of phase 2 and phase 1 studies in autism (BP41316), Angelman Syndrome (BP41315, BP41764), and healthy volunteers (BP41695)
- Successfully led various project-related regulatory milestones, including Pre-IND consultation and IND submissions
- Acted as Roche representative for collaboration with global autism and Angelman patient consortia (e.g., EU AIMS)
- Served as PRED neuroscience lead for decentralized elements in clinical trial initiative, involving cross-organizational and cross-functional work streams and collaboration with external stakeholders including regulatory health authorities
- Participated in advisory boards and scientific collaborations with academic disease experts on different projects
- Functionally led the development of novel clinical outcome measures
- Collaborated with clinical pharmacology and biomarker function for the development of disease biomarker strategies, including genetic, electrophysiological, and digital biomarkers
- Contributed to alignment on strategy between pharma development and discovery, supported target and clinical candidate selection, and provided medical guidance
- Oversaw the selection and conduct of Contract Research Organizations (CROs), including review of contracts/agreements.
Scientist
Adolescent Psychiatry
01.2016
- Oleos study
- Involvement in clinical development planning and study design (phase 2, SMA)
- Protocol amendment, ICF development and writing
- Lead for building a SMA information and recruitment webpage in collaboration with PRED informatics, Medical Information
- Patient Partnership (Huntington Disease)
- Patient Partnership functional representative on global development and lifecycle team
- Planning and execution of a global patient strategy and tactics
- Building ongoing collaborations with the key regional patient groups and HCPs
- Building open and trustful relationships with the HD community (e.g
- EHA, HDSA, CHDI) and ongoing collaboration (HD-Cope)
- Partnering in the clinical development through
- Leveraging patient insights on the disease and its impact on daily living
- Seeking continuous advice and feedback on various clinical development activities
Principal Medical Director and Clinical Expert Team Leader
11.2021 - Current
Associate Medical Director
Autism, PDN, F. Hoffmann la Roche
02.2018 - 10.2020
- Late stage drug development), Specific tasks included:
- Led the design of clinical development plans in autism and other psychiatric indications, such as Social Anxiety Disorder
- Developed study design and protocols for two studies in Phase 2 and Phase 1b
- Served as the science lead for indication extension workstream
- Acted as the medical director and monitor for Phase Ib and Phase 3 autism studies
- Medical monitor for a Phase 3 study in acute ischemic stroke (AIS)
- Supported various regulatory interactions, including Type B and C meetings with the FDA
- Responsible for protocol amendments and Informed Consent Form (ICF) writing
- Oversaw study setup and execution, including investigator meeting presentations and trainings
- Developed outcome measure strategies (VABS, BOSCC)
- Led the balovaptan autism Phase 3 Scientific Steering Committee
- Led the Nerve Conduction Velocity substudy for balovaptan, focusing on safety
- Collaborated with the commercial team on various topics and work streams, such as patient population segmentation
- Supported Health Authority interactions, including the NCV substudy and Phase 1b study (WP40877).
Clinical Science Specialist and Patient Partnership Director
F. Hoffmann la Roche
11.2016 - 02.2018
- PRED, Rare Diseases) at, Specific tasks included:
- Clinical Science (Spinal Muscular Atrophy (SMA))
Study Doctor
09.2013 - 02.2016
- For the ADDUCE Study (Switzerland)
- EU sponsored multi-centre observational study investigating the long-term adverse effects of treatment with methylphenidate in children with ADHD, Switzerland)
- EU sponsored Multi-Center study investigating the long-term adverse effects of treatment with methylphenidate in children with ADHD
clinical researcher
University Hospital
11.2010 - 08.2015
- In the area of Child an Adolescent Psychiatry at the, Zürich (KJPD)
- Additional
03.2012 - 06.2015
- Post graduate psychotherapy degree in cognitive behavioural, system and family therapy; Institute for Psychotherapy of Childhood and Adolescence of the Universities Basel, Bern, Zurich (IPKJ)
01.2012 - 01.2014
Representative
01.2011 - 01.2014
- Elected speaker for the Assistant doctors
Medical consultant
02.2009 - 10.2010
- Controlling) for the Franziskus-Hospital in Ahlen and St
- Elisabeth-Hospital in Beckum
Doctoral research, Prof
University Hospital Münster
01.2004 - 01.2010
- Dr
- Med
- S
- Fuchs-Winkelman)
- Topic: Expression of the v5 CD44-receptor in the synovial membrane in the development of an artificially induced arthrosis
- Other skills________________________________________________
Medical, Private University of Witten
07.2008 - 02.2009
- Of the research staff at
Research Doctor
12.2006 - 04.2008
- In Anxiety and Depression disorders lead by Prof Peter Zwanzger
Treating physician and clinical research at the
University Hospital
11.2006 - 04.2008
- Münster in the Department of Adult Psychiatry and Child and Adolescent Psychiatry
Universität
04.2000 - 06.2006
Mauritius-Gymnasium Büren
01.1990 - 01.1999
- Degree Class: 1.4 (best 1.0, worst 6.0)
- Academic Research_________________________________________
Skills
- Computer Skills
- Spotfire, Rave, SPSS, MS Office: Excel, Word, Powerpoint
Timeline
Translational Medicine Leader
F. Hoffmann la
11.2021
Principal Medical Director and Clinical Expert Team Leader
11.2021 - Current
Associate Medical Director
Autism, PDN, F. Hoffmann la Roche
02.2018 - 10.2020
Clinical Science Specialist and Patient Partnership Director
F. Hoffmann la Roche
11.2016 - 02.2018
Scientist
Adolescent Psychiatry
01.2016
Study Doctor
09.2013 - 02.2016
03.2012 - 06.2015
01.2012 - 01.2014
Representative
01.2011 - 01.2014
clinical researcher
University Hospital
11.2010 - 08.2015
Medical consultant
02.2009 - 10.2010
Medical, Private University of Witten
07.2008 - 02.2009
Research Doctor
12.2006 - 04.2008
Treating physician and clinical research at the
University Hospital
11.2006 - 04.2008
Doctoral research, Prof
University Hospital Münster
01.2004 - 01.2010
Universität
04.2000 - 06.2006
Mauritius-Gymnasium Büren
01.1990 - 01.1999
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