13.07.2015 Views

Alain Stricker-Krongrad, PhD

Alain Stricker-Krongrad, PhD

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3/14• Preclinical Function: Participated in global cross-site initiatives related to scientific initiatives,harmonization of procedures, and standardization of templates for protocols and reports. Providedscientific and regulatory advice.• Regulatory: Participated in regulatory consulting by responding to Sponsor requests, such as thedevelopment of drug development strategies, placement of non-clinical studies, and compilation ofregulatory submissions (INDs and NDAs).• Business Development: Identified and evaluated new capabilities to expand the scientific base ofthe company. Provided a focal point for assessing client-related program needs and proposals forimprovement and effect their implementation at different sites within Preclinical Services.2006 (Jan)-2008 (Feb) Senior Director and Head of Preclinical Safety and Pharmacology andMetabolism and Pharmacokinetic Services• In charge of Pharmaceutical and Experimental Medicine (P.E.M.) for the non-clinical evaluation(efficacy and safety) of synthetics, biologics, cell-based, devices and surgical products• In charge of Metabolism and Pharmacokinetics (M.A.P.) for the non-clinical and clinicalpharmacological evaluations (metabolism and PK) of synthetics and biologics.• Directed the execution of pharmacology models (designed to evaluate efficacy) as well as nonclinicalsafety assessment (toxicology and safety pharmacology) of therapeutic candidates.• Directed the planning, execution, modeling and reporting of non-clinical (GLP) and clinicalpharmacokinetics studies (bio-availability, distribution and metabolism).• Development of short- and long-term strategic plans regarding capital investment, newtechnologies and services, and scientific staffing and facilities as they relate to the globaldepartment and the different locations.• Developed and maintained client/sponsor relationships and serve as primary sponsor contact forpharmacology as well as non-clinical safety assessment studies.• Responsible for overall coordination of study bids, study design/conduct, protocol review,consultant interactions, staffing needs, and analysis/reporting of pharmacokinetics as well as nonclinicalsafety assessment studies. Served as study director.• In collaboration with other scientific staff, provided senior-level review of protocols, reports andrelated documents for appropriate scientific content and interpretation.• Directed and supervised the following functional area: Pharmacology and Experimental Medicine,Metabolism and Pharmacokinetics, Safety Pharmacology and Preclinical Safety.• Supervised a group of more than 150 employees, including 12 <strong>PhD</strong>s and DVMs.Athersys, Cleveland, OH, USA2004(Dec)-2006(Jan) Senior Director, Head of Pharmacology2003(May)-2004(Dec) Director, Head of Pharmacology• Directed Pharmaceutical R&D for Metabolic Diseases, Oncology, CNS and Inflammation:• Identified hit series and developped leads for the three targets (sub-nanomolar potencies)• Optimized leads for pharmaceutical properties (DMPK, rodent, dog and primate)• Evaluated leads for Efficacy and Safety (acute and chronic, rodent and dog)• Moved two compounds in late stage preclinical evaluation (Safety and TOX, rodent, dog andprimate)• D.D.C. (Drug Development Candidate) status reached in May 2005 for ATX-105.• Investigational New Drug submitted in 2006 and Phase I succesfully completed in 2007.

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