Dr. Erik Buntinx is a qualified psychiatrist and psycho-pharmacologist, and previously founded the Anima Center, an outpatients psychiatric clinic and integrated clinical and pharmacological research unit. For more than 25 years, Dr. Erik Buntinx has been Principal Investigator for various Phase IIa-III Clinical Trials for which he observed several hundreds of patients. He was involved in programs on
- risperidone in schizophrenia (1987-1988),
- mianserine in major depression (1989-1990),
- cycloserine in cognitive impairment (1991-1992),
- sertraline in obsessive-compulsive disorder (1993-1994),
- agomelatine in major depression (2000-2001),
- escitalopram in major depression (2001-2002), for which he also acted as the Coordinating Investigator,
- post-menopausal osteoporosis (2002-2003)
- several NK1-Antagonists in major depression (2003-2005)
- aripiprazole in schizophrenia (2004)
- gaboxadol in primary insomnia (2004-2005),
- asenapine in schizophrenia (2006-2007), for which he also acted as the Coordinating Investigator towards the Central Ethical Committee.
Dr. Erik Buntinx also has been developer of Investigator Initiated Trials in Delirium / Alzheimer (1990-1992) and advised the WHO on psychiatric diagnostic expert systems (1991-1993). Based on Dr. Buntinx’ inventions in the field of new CNS drug treatments, he achieved 9 granted patents worldwide in psychotic and mood disorders and Parkinson disease.
Dr. Erik Buntinx developed and implemented the PNB01 Phase IIa/b (2006-2009) and Phase III (2010-2013) study programs in major depression and the PNB02 Phase IIa-Biomarker (fMRI) (2010-2013) study program in treatment resistant schizophrenia. For each of these clinical study programs, Dr. Erik Buntinx interacted as sponsor and medical director with both Regulatory Agencies (A) and Ethical Committee’s (B) in different Western countries i.e.:
(A) Regulatory Agencies
- The Federal Drug and Food Agency (FDA) in the US (at pre-IND, IND, End of Phase II and Phase III Special Protocol Assistance (SPA) stage)
- The Committee for Medicinal Products for Human use (CHMP) at the European Medicines Agency (EMA) with EMA/HTA parallel advice (at Phase III stage)
- The Regulatory Agency Health Canada (HC) in Canada (at Phase III stage),
- The Regulatory Agency ‘Bundesinstitut für Arzneimittel und Medizinprodukte’ (Bfarm) in Germany (at Phase III stage)
- The Medicines and Healthcare products Regulatory Agency (MHRA) in England (at Phase II stage)
(B) Ethical Committee’s
- The Medical Ethical Committee UZ/KU Leuven (Belgium) (at Phase II stage)
- The Multi-centre Research Ethics Committee (MREC) of Scotland (at Phase II stage),
- The Swedish Medical Products Agency (SE- MPA) in Sweden (at Phase III stage)
- The Dutch Medicines Evaluation Board (MEB) in The Netherlands (at Phase III stage)
- The Ethik-Kommission bei der Landesärztekammer Hessen in Germany (at stage III stage)
- Multiple institutional review board (IRB) / independent ethics committees (IECs) in the US (at Phase III stage)
In 2011, Dr. Erik Buntinx was the first clinician in the world to get support from the FDA for a pivotal phase III trial that used a new endpoint demonstrating superior efficacy over standard of care in major depression: ESR (Early and Sustained Response Rate). This was achieved during a FDA granted Special Protocol Assistance procedure.
Since 2014 and to date, Dr. Erik Buntinx is involved in the esketamine treatment resistant depression study program as independent investigational expert.
As a serial biotech entrepreneur, after PharmaNeuroBoost in 2006, in 2017 Dr. Erik Buntinx created the emerging new CNS venture ANeuroTech (ANT) based on his innovative vision of reaching real patients value using the unique combination of in-depth clinical developments experience and global CNS partnering.
Dr. Erik Buntinx, driven by the belief of his mentor, the late Dr. Paul Janssen, in his clinical innovative capacities, is a frequent speaker and moderator in relation to his CNS and clinical development expertise. He has been invited to present at numerous top level international CNS scientific meeting such as the CNS Summit, the annual meeting of the International Society for CNS Clinical Trials and Methodology (ISCTM) and the American Society of Clinical Psychopharmacology (ASCP-former NCDEU), a global scientific society that includes representatives from academia, the National Institutes of Health (NIH), Food and Drug Administration (FDA), European regulatory agencies and industry.