Mission: Conduct research to improve patient care
Our Focus
 

·         Pulmonary Diseases

·         Infectious Diseases

·         Critical Care (Intensive Care)

·         Oncology

·         Immunological Disorders

 
Our Services
 
Licensing and business development opportunity evaluation

     

·    Identification and evaluation of unmet medical need 

·    Science based program inflection point planning

·    Evaluation of clinical pharmacology, toxicology and clinical data

·    Assistance with fund raising
 
 
 Strategic and operational support for clinical development plans
 

·         Interface between diagnostic testing and clinical investigations

·         Transition from pre-clinical to clinical

·         Protocols Phase I, II, III, IV

·         Study reports

·         Coordination with contract research organizations (research talent coordination)

·         Preparation of integrated summaries of safety and efficacy

·         Safety Assessment

·         Clinical Development Plans


 

 Regulatory Meeting Planning

 

·         Meetings with FDA/ CHMP

·         Briefing document preparation
·        Regulatory advisory meeting planning
 

Recent Announcements

  • Our Debt to the Rockefeller University  Zanvil Cohn Ralph Steinman and the Dendritic Cell
    Posted May 30, 2012, 4:22 PM by Luke Solomon
  • FDA Guidance of Development of Combination Therapies FDA Guidance for Codevelopment of Two or More Drugs in Combination Development of Combination Therapies Janet Woodcock, M.D., Joseph P. Griffin, J.D., and Rachel E. Behrman, M.D ...
    Posted Feb 16, 2014, 6:10 AM by Luke Solomon
  • Hepatitis C Guidelines and Intelligence  Food and Drug Adminstration, (USA September 2010)   Centers for Disease Control (USA)   European Association for the Study of Liver 2014 British HIV Association guidelines HIV Infected Patients 2013American Association ...
    Posted Dec 29, 2013, 6:44 PM by Luke Solomon
  • Guidelines for the treatment of Chronic Obstructive Lung Disease (COPD)  American Thoracic Society and European Respiratory Society Guidelines (2004)  Global Initiative for Chronic Obstructive Lung Disease  British Columbia, Canada (2011)   In future revisions of the guidelines, use of roflumilast will ...
    Posted May 30, 2012, 3:40 PM by Luke Solomon
  • Keep up-to-date with FDA’s Public Consultations  Link to FDA Guidance portal Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for TreatmentEditor's note: development of new drugs for hospital-acquired and ventilator ...
    Posted Jun 22, 2014, 11:10 AM by Luke Solomon
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