Business Development, Clinical Development, Medical Affairs, R&D Strategies, Strategic Marketing
Wittnau (close to Freiburg, Germany)
Services offered worldwide
Consultancy and hand-on support in the full range of CNS-active compound development (neurospychiatric and related disorders) on a world-wide basis.
- Preclinical development (profiling clinical candidate, gaps)
- Clinical development (POC, I-III)
- Regulatory support (clinical, EMA, FDA)
- Medical Affairs support (IIIb/IV, perilaunch, market access)
- Business development activities (licensing, due diligence)
- Portfolio review
- Repurposing approaches
- Interim management
Dr. Dr. Bernd Schmidt does focus his consultancy on the development of compounds and therapeutic strategies for CNS indications (neurologic and psychiatric) as well as related disorders.
He trained in neurobiology (Ph.D), is a board certified neurologist and psychiatrist (M.D.), held university positions, and was Head of International CR&D, CNS, within a major global pharmaceutical company. Now since 24 years he advises and supports hands-on big pharma, middle-size and small companies world-wide, balancing theoretical consultancy with seeing private patients in his clinic.
His activities reach from early preclinical through full clinical development bridging into regulatory aspects, market access and competitive positioning.
Dr. Dr. Schmidt´s support includes evaluation of preclinical development candidates in respect to an intended target product profile, gap analyses, strategies for early proof-of-concept, input into global clinical development plans suitable for worldwide dossiers, medical “firebrigade” activities during conduct of clinical programs, interaction with sponsors and CRO´s, set up, running and moderation of KOL Ad.-Boards, gap analyses of regulatory documents for FDA and EMA, preparation and on-site support for sponsors at FDA and EMA meetings, advice on market access and competitive positioning, presentations, perilaunch and Medical Affairs support worldwide, due diligence, repurposing and business development activities, as well as portfolio reviews.
In his neuropsychiatric area of expertise he also provides high level interim management.
More recent Dr. Dr. Schmidt was involved in projects covering epilepsy, migraine, multiple sclerosis, neuropathic and chronic pain, spasticity, fibromyalgia, Parkinson´s disease, MSA, Alzheimer´s disease, stroke, TBI, bipolar disorder, depression, anxiety, schizophrenia, tinnitus, sleep disorders and CNS-related orphan diseases.
Broad and deep clinical and drug development background in the field of CNS-active compounds and related disorders, since 1983.
Member American Academy of Neurology
Member British Faculty of Pharmaceutical Medicine
Board certified Neurologist and Psychiatrist
Areas of Expertise:
Business Development, Clinical Development, Due Diligence, Interim Management, Medical Affairs, Preclinical Development, R&D Strategies, Strategic Marketing