sarfaraz k. niazi, ph.d., si, frsb, fpams, facb
Founding Executive Chairman and CSO, Sarfaraz is a widely recognized pioneer of biosimilars with track record of taking biosimilars to US and other global markets. Founder and Ex-Executive Chairman, Adello Biologics, LLC. As an entrepreneur, he has raised hundreds of millions of dollars and inducted Entrepreneur Hall of Fame. As the world's most prolific inventor, he has contributed 100+ technologies, as an author, he has contributed scores of books and hundreds of papers. Sarfaraz is also a patent law practitioner, a photographer, a blogger and radio broadcaster; he continues to serve on the faculty of four major universities and works closely with regulatory agencies to create a rational scientific approach to approving biosimilars. More details.
Zafeer Ahmad, Ph.D.
Chief Technology Officer (CTO), Zafeer is a 30-year industry veteran having developed dozens of biological, new and biosimilar drugs; process development with early stage and late stage programs; technology development and transfer; management of outsourced services; regulatory dossier preparation and BLA filings; facility and equipment validation and cGMP audits. Most recently, was the CTO at Adello Biologics, and held other senior positions at Goodwin Biotechnology, GSK and Hoffman-La Roche. Zafeer has taught at the Indiana University and was a Visiting Fellow at the NIH; he has published extensively in the field of protein chemistry.
Machinani J. Rao, Ph.D.
Chief, Analytics and Regulatory Office is an accomplished leader with over 30 years of experience in analytical Sciences/auality Control and Reg-CMC that spans biopharmaceuticals (biosimilars, antibodies, antibody drug conjugates), pharmaceuticals, radiopharmaceuticals (imaging agents and therapeutics), fusion proteins, lentiviral and adeno-associated virus (AAV) vectors-based cell/gene therapy products. I have a successful track record of building new strategies for improving analytical systems, formulations, process development & validation, GMP quality systems and regulatory filing strategies for early and advanced stage biologicals as well as product expansion efforts. He lead the biosimilars analytical team at Adello Biologics.
sigrun hallmayer, md
Chief of Clinical Operations (CCO), Sigrun is a well-recognized oncologist, holding the Chair, Cancer Committee Advocate Lutheran General Hospital, Medical Director, ALGH Survivorship Program and Director, Oncology Specialists Research Institute OSRI in Park Ridge, IL. Sigrun has lead many clinical trials biosimilars prospective, phase I-III studies for monoclonal antibodies, cytokines, and other treatment modalities. She has published widely and is highly recognized for her contributions to clinical trials management. At KBL, Sigrun provides supervision of the clinical programs.
Sunitha lokesh, BE, MS
Director, Development, Sunitha has over 10 years of experience in deeloping biopharmaceutical products, from the cell line to process validation. A biotechnology graduate from Illinois Institute of Technology, Sunitha began her career at Adello Biologics where took several products, both bacterial and mammalian, to final development and regulatory filing. Involved at all stage of R&D and commercial manufacture, Sunitha adds to the lead team of KBL, where she leads identification and technology development of the fast expanding porfolio of bioharmaceutical products.
brittany ristucci, mba
Director, Business Development, Brittany has over 15 years of experience in leadership and business coordination at leading healthcare systems including The Ohio State University, Northshore University Health System and the University of Chicago. She has helped built several startups through her consulting company VisAttain. At KBL, Brittany manages all business development needs including identifying and nurturing technical and business partnerships worldwide. She is also coordinating all financial and corporate compliance activities of KBL.
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