Services
[ Therapeutic Expertise ] [ Trials Management Services ] [ Early Development Services ] [ Late Phase Services ] [ Drug Safety Management ] [ Electronic Regulatory Submissions ]
Therapeutic Expertise
[ Focus ] [ Therapeutic Specialization ] [ Services ] [ Meet the Experts ]
Meet the Experts
Therapeutic Expertise is led by Kent Thoelke, Vice President and Head, Therapeutic Expertise.
|
Kent Thoelke
Vice President and Head, Therapeutic Expertise Over 15 years of drug development
experience specializing in hematology/oncology,
cardiology, and infectious disease within the
pharmaceutical, biotech and CRO industries.
Extensive global experience in over 30 countries
with regard to clinical standards of care,
healthcare reimbursement and clinical trial design.
Translational medicine expertise in taking drugs
from the bench to market and providing consultative
drug development planning. Experience and global
interaction with regulatory agencies in the United
States, Europe, and China. |
 |
Other team members are:
- Ute Berger, MD, Director, Therapeutic Unit Oncology
- John Constant, PhD, Vice President, Therapeutic Unit Oncology
- Michael Kirchengast, PhD, Vice President, Therapeutic Unit Cardiovascular
- Anthony Risser, PhD, Director, Therapeutic Unit CNS/Neurobehavioral Unit (NBU)
- Jack Wanger, MS, Clinical Research Scientist, Therapeutic Unit Respiratory
|
|
Ute Berger, MD
Director, Therapeutic Unit Oncology
Board-certified in internal medicine, hematology and oncology with 18
years of clinical experience in academia. Extensive experience in
clinical trials, especially in leukemia and lymphoma. Set-up and
scientific coordination of new research structures in Germany and
Europe, Medical Coordinator at the Study Center of the German CML Study
Group, Managing Director of the German Competence Network "Acute and
Chronic Leukemias", Scientific Network Manager of the "European
LeukemiaNet". Member of the American Society of Hematology and the
German Association of Hematology and Oncology. |
 |
|
|
John Constant, PhD
Vice President, Therapeutic Unit Oncology
PhD in Statistics (Random Graph Theory); theoretical
and applied statistical expertise in clinical research. 24 years of
experience in academics (Professor, University of California at
Berkeley), large pharma, and in CRO and consulting industry. Extensive
FDA work for Phase II/III trials, i.e. EOP II, SPA (CBER, CDER, EMEA),
NDA, BLA. Extensive DSMB/DMC participation, i.e. voting and reporting
membership, charters, analysis, management. |
 |
Michael Kirchengast, PhD
Vice President, Therapeutic Unit Cardiovascular
PhD in Biology. Associate professor of experimental
pharmacology (University of Heidelberg). 22 years of experience in
cardiovascular R&D with academia, big pharma, biotech and CRO. Team
member/leader of several cardiovascular development programs, including
antiarrhythmic, antithrombotic, antihypertensive and cardioprotective
drugs. One of the scientific founders of Knoll’s endothelin receptor
antagonist program. Member of several professional associations.
Authored > 80 scientific publications and presented invited
state-of-the-art lectures at international meetings. |
 |
Anthony Risser, PhD
Director, Therapeutic Unit CNS/Neurobehavioral Unit (NBU)
Consulting neuropsychologist, adjunct scientist, Moss Rehabilitation
Research Institute (Philadelphia) with 19 years of experience in
neuropsychology consultation; 10 years of experience providing
internet-based content development & management and online education
services. Co-author of 3 textbooks, including “Assessment of Aphasia”;
recently, Hawn Sr. Fellow in Symptom Research at Univ. of Texas M.D.
Anderson Cancer Center. |
 |
Jack Wanger, MS
Clinical Research Scientist, Therapeutic Unit Respiratory
Over 35 years in respiratory physiology and therapeutics. Recognized
expert in pulmonary function testing and standards development. Member
of ATS Committee on proficiency standards for clinical pulmonary
function laboratories, member of ATS/ERS task force on standardization
of lung function testing. |
 |

Page last updated:
28 July 2008
|