Dr Ann LeFever
Ann LeFever has over 30 years experience in the development of biological products for the treatment of cancer and other diseases She has participated in the development of a number of biotechnology companies focusing on strategic business and product development as well as clinical and regulatory affairs. She has also served as a company liaison for clinical trials for pharmaceutical companies and served as a scientific advisor to early stage companies. Her activities include strategic planning of clinical trials and product development, and providing regulatory support pertaining to clinical biological product evaluation in the United States and Canada. In addition, Dr LeFever has evaluated biotechnology products for venture capital concerns and audited company processes, facilities and staff in preparation for external FDA inspections. She has extensive experience in project and team management, grant writing, grant execution, and grant audit responses
Dr LeFever is currently the Director of the Mathews Center for Cellular Therapy at Northwestern Memorial Hospital, Chicago, IL. This facility provides clinical grade cellular products as well as other biological and combination products that are manufactured under good manufacturing practices (GMP) and good tissue practices (GTP). The MCCT is a Federal Registered HCT/P establishment and has received accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT) and conformed to JCAHO and FDA requirements. The GMP cleanrooms of the facility meet all FDA GMP regulatory requirements.
Dr LeFever is an experienced communicator who has presented over 100 invited seminars and research presentations at both national and international venues and is a widely published author of original research reports. She has served on Institutional Review Boards for over twenty years and currently holds an adjunct faculty appointment through the Feinberg School of Medicine, Northwestern University, Chicago, IL.
She received a BA in Cell Biology from Northwestern University in 1973 and MS in Radiobiology and Immunology from the University of Oklahoma Health Sciences Center in 1975. Dr LeFever earned her PhD in Immunology in 1981 from Marquette University with additional post-doctoral studies in experimental stem cell transplantation and preclinical evaluation of biological products.
Dr Timothy Fawcett
Timothy Fawcett, PhD, has been in the biotechnology business for over 30 years. Trained as a biochemist he has held senior positions in both academics and industry and has been a mentor to many young scientists throughout his career. For the last 13 years Dr Fawcett has been the Director of the BioTechnical Institute of Maryland (BTI) a non-profit institute located in Baltimore, Maryland. He is also the Founder and Director of BioSciConcepts, a social venture of BTI that provides hands-on training for professional scientists in cell culture, baculovirus based expression, as well as topics such as molecular biology, PCR and real-time PCR. BioSciConcepts is an internationally recognized provider of expertise in cell culture and the biological sciences and has provided consultation services to several small and large biotechnology companies.
Bryan Monroe is a process development/manufacturing professional who has been employed in the biotech industry for more than 25 years. During his career, Bryan has worked on a wide array of successful drug candidates including insulin, Factor X, Tretten, NovoSeven, Recothrom, Orencia, Nulojix, and Provenge, as well as diagnos c kits for HIV 1, HIV 2, and HTLV 3. His role in these programs included development, op miza on, scale up and transfer of recombinant protein expression processes in yeast, E.coli, insect cells, and mammalian cells. Bryan also has extensive experience in basal and feed media development and optimization, utlizing a variety of technologies to be er understand cellular metabolism as it relates to protein expression processes in both fed batch and perfusion modes.
As a consultant, Bryan has contributed to the successful scale up and/or transfer of more than 75 unique therapeuticprograms throughout the global market, targeting more effecient processes, reduced time to clinical investigaion, cost of goods improvements, and the development of robust expression platforms.
Bryan held the position of Manufacturing Engineering Development Associate at Genetic Systems for 3 years, Senior Research Scientist at Bristol Myers Squibb for 7 years, Process Development Group Leader at ZymoGenetics/Novo Nordisk for 2.5 years, Process Development/Clinical Manufacturing Manager at Dendreon for 2.5 years, and Senior Process Science Fellow (a customer consultative role) at Life Technologies for 9 years. Bryan founded Primus Consulting, LLC. nearly 4 years ago to share his knowledge and experience with companies large and small.
Bryan holds a BS in Virology and Marine Biology from the University of Puget Sound and a Technology Management Certificate from the University of Washington.