Pecan Biotherapeutics, Inc.
Director, Founder, and Chief Executive Officer
Dr. Craig S. Rosenfeld is a Founder of Pecan Biotherapeutics and currently serves as President and CEO.
Dr. Rosenfeld received his B.A. and M.D. degrees from the University of Missouri in Kansas City, and he completed his internship and residency at the University of Nebraska Medical Center. Dr. Rosenfeld completed fellowships in Hematology and Oncology at the University of Kansas Medical Center. After completing his fellowships, he joined the Faculty of University of Pittsburgh. In 1990, Dr. Rosenfeld was appointed Director of the Bone Marrow Transplant Program at the Western Pennsylvania Cancer Institute. In 1994, Dr. Rosenfeld moved to Dallas to open and run the Bone Marrow Transplant Program at Medical City Dallas Hospital. In 2002, Dr. Rosenfeld was appointed Chief Scientific Officer at SuperGen, Inc. While Chief Scientific Officer, Senior Vice President, and later as Chairman of the Medical Advisory Board and Consultant for Dacogen NDA, Dr. Rosenfeld directed the pivotal trials to completion, leading to submission and FDA approval of Dacogen. In 2005, Dr. Rosenfield co-founded The Vaccine Company, and served as Chief Medical Officer and Executive Vice President raising approximately $26 million in capital.
Dr. Rosenfeld currently serves on the Board of Directors of the Texas Israel Chamber of Commerce. He is a member of the American Society of Clinical Oncology, American Society of Hematology, Dallas County Medical Society, and Texas Medical Association. Dr. Rosenfeld received the 2008 Dallas Humanitarian of the Year Award from B'nai Zion.
During almost 20 years of practice, Dr. Rosenfeld has devised, conducted, and led numerous clinical research protocols from pre-clinical to FDA approval. He has authored or co-authored close to 100 publications in book chapters and peer reviewed journals. Additionally, Dr. Rosenfeld has presented original research and expert review at international symposia including the American Society of Hematology and the American Society of Clinical Oncology.
Senior Operations Consultant
Mr. Bakes attended the University of Tasmania. He earned a degree in Applied Science with Honors.
Mr. Bakes has worked at Hitachi Instruments, Inc., UT Southwestern Medical Center, and CSIRO Australia. He held various management positions at Cumbre Pharmaceuticals, including President from 2006 to 2009. Most recently, he was Vice President - Operations at Affinium Pharmaceuticals. He has managed the preclinical and early clinical development of several drug candidates for the treatment of bacterial infections.
Mr. Bakes is an independent consultant with over fifteen years of experience in research and development of small molecule therapeutics. He currently provides consulting focused on company operations and strategy, business development and drug development.
Senior Regulatory Consultant
Dr. Noel earned a B.S. and Ph.D. in Biophysics from the University of Michigan.
J. Kay Noel & Associates, Inc., established in 1986, is an independent business consultant to biotechnology and healthcare companies. In 2007, Dr. Noel co-founded OncoEthix, an oncology drug development company based in Switzerland. For the last decade, Dr. Noel has focused on oncology and virology drug development. She has obtained approval/clearance for over 30 IND, orphan drug, and NDA filings; brought manufacturing facilities into GMP compliance; and achieved successful FDA pre-approval inspections.
Dr. Noel is a consultant with over thirty years experience in technology assessment, strategic planning, development and implementation of regulatory strategies for expedited commercialization, and strategic partnering. Her previous successful start-up and development experiences include creation and financing of the first healthcare business plan, including managing a $75 million financing, and development and marketing of the first PCR test kits at Cetus Corporation; cofounding a novel distribution system called Oncology Therapeutics Network, subsequently sold to Bristol Myers Squibb; and forming an oncology drug development company that licensed oxaliplatin as its first portfolio product.