Susan is best known in the global cell and gene therapy market as a Business Connectivity Matchmaker, Innovative Commercial Strategist, and is a Networking Powerhouse. Susan has more than twenty years of corporate management and leadership experience in high growth biotech, entering the cell therapy arena in 2010.
Susan brings a unique perspective having served in executive management roles with early stage, emerging, and fortune 500 companies such as Thermo Fisher, Hitachi Chemical, Baebies, and Invetech, a division of Fortive Corporation. At her core Susan is a Builder. Throughout her career, she has successfully built market opportunities, product platforms, high performing teams, and pipelines in excess of one billion dollars collectively. Susan has an impressive track record of “first-ever” leadership often blazing the trail for others to follow. Ms Nichols has managed corporate departments relating to sales, marketing, business development and collaborations between private and public-sector entities, including the FDA and EMA.
Susan grew up in Harrisburg Pennsylvania where she lived before moving to Raleigh NC in 2012. Rare Disease Forum Steering Committee Member 2018-present. Special Olympics Volunteer 2018-present. Chair of Women in Bio RTP, 2013 – 2015. Founder and Chair Women in Bio, Board of Supporters, 2015 – 2017. Board of Supporters Cystic Fibrosis Foundation 2013 – present.
Shawn Hingtgen, PhD
Shawn is the CSO and founder of Falcon, an Associate Professor in the UNC Eshelman School of Pharmacy’s Division of Molecular Pharmaceutics and Pharmacoengineering, and an assistant professor in the Department of Neurosurgery at the UNC School of Medicine. His research is focused on combining advancements in cell engineering, biomedical engineering, and cancer therapy to generate novel engineered cell therapies for cancer. His team was the first to show that skin cells could be directly converted into cells that seek out and kill cancer and has made significant contributions to the generation of scaffolds for cell-based cancer therapy, and new cancer models that more accurately reflect the clinical scenario.
In 2014 he received the Young Investigator Award from the Society for Neuro-Oncology and the UNC Hettleman Prize for Scholarly and Artistic Achievement by Young Faculty in 2018. He is the author of over 30 refereed papers and articles that have been cited more than 700 times, as well as the inventor on multiple patents.
Shawn completed his undergraduate work and earned his Ph.D. in anatomy and cell biology from the University of Iowa. He then completed postdoctoral fellowships with Ralph Weissleder, M.D., Ph.D., and Khalid Shah, Ph.D., at Harvard Medical School and Massachusetts General Hospital in Boston.
Fred Miesowicz, PhD
Fred brings to Falcon Therapeutics his extensive experience in the manufacturing of individualized cellular therapies. In a consultant capacity, he assists management in the development of GMP manufacturing process both at the manual and automated stages.
Prior to Falcon, Fred was the Chief Operating Officer of Argos Therapeutics, a position which he held for 14 years. Argos Therapeutics developed immunotherapies by reprograming dendritic cells to target antigens specific to each person’s disease. Prior to this, Dr. Miesowicz was the Vice President of Operations for Gamida-Cell, a stem cell company. He was Senior Vice President and General Manager of Hybridon Specialty Products which manufactured GMP oligonucleotides for cancer therapeutics and research applications and was acquired by Merck. He served as Vice President and General Manager of Cellcor, a subsidiary of Cytogen, Inc., from 1995 to 1998, where he directed all operations related to Cellcor’s cellular immunotherapy programs. He also served as Senior Vice President of Scientific Affairs at Cellcor from 1992 to 1995.
Fred has an extensive background in cellular therapies and medical devices. Prior to joining Cellcor, he managed the U.S. and European SteriCell Division of the Terumo Medical Corporation after it was acquired from DuPont, and was with E.I. DuPont de Nemours & Company for 14 years managing both immunotherapy and immunodiagnostic R&D groups. He holds a B.S. degree in Chemistry from Siena College and received a Ph.D. in Chemistry from Harvard University.
Joy Cavagnaro, PhD, DABT, RAC
Joy is the former VP Regulatory Affairs and Integrated Compliance at Human Genome Sciences, where she established the Regulatory Affairs Department, which included regulatory affairs and clinical data management data programming functions and assisted in identifying and developing new pre-clinical opportunities.
She served as company spokesperson with the FDA and foreign agencies in all aspects of the regulatory process. Before that she was Senior Pharmacologist & Director of Quality Assurance Office of the Center Director of FDA CBER responsible for policy guidance for the pre-clinical development and safety assessment of biological projects.
She also served as FDA safety topic lead for the International Conference on Harmonization of Technical requirements for Pharmaceuticals (ICH) initiative and as rapporteur for the ICH S6 guidance on pre-clinical safety evaluation of biotechnology-derived pharmaceuticals.
Anika Weber, DPhil (Oxon)
Anika brings Falcon over 10 years of molecular cell biology experience. With 9 years in cancer research in positions ranging from hospital settings to T cell therapy development, Anika has distinguished herself in translational medicine and pre-clinical development of cancer therapeutics.
With several years of experience working for a leading T cell therapy company, her previous focus was the pre-clinical safety and efficacy testing of affinity enhanced T cell therapies for cancer treatment. In her role as Senior Scientist, she was involved in the development of new processes and assay platforms, as well as the troubleshooting of existing processes, for pre-clinical testing of T cell therapies and second generation programs. She also contributed to multiple pipeline projects to improve current and identify future clinical targets.
Anika holds an M.Sc. in Molecular Medicine from the University of Freiburg. She went on to complete her PhD in Radiation Oncology at the University of Oxford, where she worked on the pre-clinical evaluation of novel DNA damage response modulators alone and in combination with chemo- or radiotherapy.
Juliana Blum, PhD
Juliana has spent over 15 years leading the development, management, and execution of novel and innovative regenerative medicine products. Her experience and leadership focuses on a broad range of research and development activities through biologic product commercialization; including strategic operations, business alliances, global regulatory affairs (US, EU, Japan), CMC development, domestic and international product distribution, and manufacturing scale up. She has also spent the last 10 years overseeing tissue based regulatory compliance and industry trends in the donation, recovery, processing, and use of tissue and cells in HCTPs.
Juliana received her doctorate in Molecular Biology from Loyola University Chicago with a focus in cardiovascular gene therapy in 2003, and completed her BS at Carthage College in Wisconsin.
Kevin Sheets, PhD
Kevin comes to Falcon after training nearly 5 years under Shawn Hingtgen as a Postdoctoral Research Associate and Research Associate.
During this time, Kevin worked extensively on the spectrum of the cell therapy platform, from manufacturing and characterization to routes of administration and pre-clinical modeling. To this end, Kevin published work on the use of different cell sources and scaffolding materials to treat glioblastoma in the context of clinically-relevant primary tumor resection and recurrence. Kevin then pioneered efforts in scale-up safety and efficacy studies en route to a first-in-human clinical trial.
His previous research involved using his materials background to develop improvements in the delivery and efficacy of cell therapies for treatment of post-operative cancers. Kevin holds a B.S. and M.S. in Materials Science & Engineering and received his Ph.D. in Biomedical Engineering at Virginia Tech in 2014.
Rhonda is an accomplished financial professional with over a decade of financial leadership experience. She has broad finance and accounting experience including, initial public offerings, mergers and acquisitions, reverse mergers, operations and management for life science and biotechnology organizations.
She previously served as the CFO of Asklepios Biopharmaceutical, Inc. and Bamboo Therapeutics, Inc. a privately held gene therapy company which was sold to Pfizer, Inc. in 2016. In addition, she has served as Chief Accounting Officer, Vice President of Finance, Corporate Controller and Treasurer of several publicly traded and venture-backed biotechnology companies including Nephrogenex, Inc (NASDAQ: NRX), Tranzyme, Inc. (NASDAQ: TZYM), Pozen Inc. (NASDAQ: POZN) and Aldagen, Inc.
Rhonda has a Bachelor of Science degree in accounting from Bradley University, holds an M.B.A, is a Certified Public Accountant and a Registered Nurse. In addition, she served as a Captain in the U.S. Army Finance Corp.