Welcome to
MIDWEST BIOFLUIDS

We offer expert clinical research and development consulting services in  Phase 1-IV  stages.  Midwest Biofluids was founded by Michael W. Rooney, PhD in 2001 (formally known as Du Page Biofluids Inc).   Dr. Rooney held senior positions with Contract Research Organizations (CROs), Pfizer, Monsanto, Pharmacia, Upjohn and GD Searle. Previous to industry appointments, Dr Rooney served as an Assistant Professor of Medicine with Loyola University School  of Medicine, and Postdoctoral Fellow in Anesthesiology with University of Illinois College of Medicine. Dr. Rooney holds a PhD in Biomedical Engineering from Northwestern University and a Master of Science in Bioengineering from the University of Illinois.

Our experience includes more than 25 years of Phase I-IV clinical research experience in multiple therapeutic areas including Oncology/Vaccines, Arthritis, Pain and Inflammation, Lipidology and Cardiovascular Intervention, Hematology/Immunology, Men/Women’s Health and Urology Metabolism/Endocrinology, Neurology, Anesthesiology/Surgery.

Midwest Biofluids offers complete regulatory services from preIND to initial IND protocol submission to EOP1 and EOP2 meeting requests/briefing packages and finally 505 (b)(1) and (2) NDA and BLA registrations. We are experts in electronic Common Technical Document (eCTD) assembly and submission.   

Midwest Biofluids has worked globally with some of the top 50 best-selling drugs available through its full spectrum of clinical R&D services. Dr. Rooney personally has been integral to obtaining approval of 10+ new drugs (NCE), generics and  biosimilars. A key difference with Midwest Biofluids is the ability to develop successful clinical endpoints in all phases of study and interpret FDA division input throughout those stages. Remember, with the FDA, "Communications are the Keys to the Kingdom!"    

Midwest Biofluids offers complete Clinical and Regulatory consulting services

• Develop ICH clinical protocols
• Develop primary endpoints for FDA approval of indications
• Prepare clinical study reports (CSRs)
• Author Investigator Brochures (IBs)
• Author Product Labels and Summary of Product Characteristics
• Attend FDA meetings (ABC) and develop meeting requests, briefing documents, responses, and minutes
• Develop SPA submissions and briefing packages
• Author regulatory eCTD summaries and overviews
• Author FDA white papers and information requests

Midwest Biofluids offers Pharmacovigilence, Safety Updates, Annual Reporting, and Database Summaries  

• Pre/Post-marketing (DSUR, PSUR)
• Annual Reports
• IND Safety Updates
• FAERS access and summaries
• AERS access and summaries
• CIOMS access and summaries
• MedWarch access and summaries
• MAUDE access and summaries
• IMPD development
• CCDS development
• eCTD clinical modules (2.2, 2.5, 2.7)
• Periodic Safety Updates
• SAE Narratives

Midwest Biofluids offers Intellectual Property Development, Regulatory Registration and Entreprennural Business Development

A division of Midwest Biofluids has assisted with the intellectual property filing and trademark registration of novel biopharmaceutical therapeutics. MBI has provided R&D and commercialization services for the development of a novel blood substitute, POWERBLOOD (generic: hemodine) aimed at satisfying an unmet medical need.  The blood substitute has superoxygenating properties intended for use in clinical and emergency settings as well as for use in the civilian or military environments.  

Midwest Biofluids also provides consulting and management services to early-stage biopharmaceutical companies from discovery through first-in-human clinical trials and beyond.