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NewsCBO Admin2025-11-24T20:33:17+00:00
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Providing comprehensive and quality patient care while developing cellular therapies to treat solid tumors.

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    • BioCytics

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Dr. John Powderly
Founder, President, and Oncologist
Dr. John Powderly attended Georgetown Medical School from 1991-95 and was awarded the Lawrence Dean Scholarship. His 4th year of Med School was spent at National Cancer Institute (NCI) as an internship on the Immunotherapy Service. From 1995-1999 he attended the University of Texas, at Houston Health Science Center for a combined Medicine/Pediatrics Residency. In 1999-2000 he was appointed faculty at MD Anderson Cancer Center and performed additional immunotherapy research. His oncology fellowship at University of North Carolina, Chapel Hill from 2000-02 focused on dendritic cell immunotherapy.
MD, CPI
Dr. John Powderly
Dr. John Powderly attended Georgetown Medical School from 1991-95 and was awarded the Lawrence Dean Scholarship. His 4th year of Med School was spent at National Cancer Institute (NCI) as an internship on the Immunotherapy Service. From 1995-1999 he attended the University of Texas, at Houston Health Science Center for a combined Medicine/Pediatrics Residency. In 1999-2000 he was appointed faculty at MD Anderson Cancer Center and performed additional immunotherapy research. His oncology fellowship at University of North Carolina, Chapel Hill from 2000-02 focused on dendritic cell immunotherapy.
Founder, President, Oncologist
MD, CPI
Sherene Banawan
Physician Assistant
Sherene Banawan, PA-C is a board-certified Physician Assistant who specializes in oncology. She earned her Bachelor of Science degree in Biology from the UNC at Charlotte and pursued further education at Wingate University, where she obtained her master’s degree in physician assistant studies (MPAS). Before pursuing her master’s degree, Sherene served as a dedicated Medical Laboratory Scientist (MLS) with expertise in Molecular Biology (MB) at Atrium Health. Sherene's exceptional care and compassion have endeared her to all her patients, who hold her in high regard.
PA-C, MPAS, MB, MLS
Sherene Banawan
Sherene Banawan, PA-C is a board-certified Physician Assistant who specializes in oncology. She earned her Bachelor of Science degree in Biology from the UNC at Charlotte and pursued further education at Wingate University, where she obtained her master’s degree in physician assistant studies (MPAS). Before pursuing her master’s degree, Sherene served as a dedicated Medical Laboratory Scientist (MLS) with expertise in Molecular Biology (MB) at Atrium Health. Sherene's exceptional care and compassion have endeared her to all her patients, who hold her in high regard.
Physician Assistant
PA-C, MPAS, MB, MLS
Dr. Neel Gandhi
Oncologist & Hematologist
Neel Gandhi, MD is a board-certified hematologist and oncologist who joined Carolina Bio-Oncology in May 2023. Dr. Gandhi has an educational background in chemical and biomedical engineering, and this led him to ultimately pursue medical school, graduating from the University of Tennessee in 2006. He then completed an internal medicine residency at Boston Medical Center, followed by a medical hematology and oncology fellowship at Fox Chase Cancer Center in Philadelphia. Prior to his arrival, Dr. Gandhi was in clinical practice for over ten years in New Jersey, where he served as the Director of Neuro-Oncology at Capital Health Medical Center from 2019-2023. Over the last few years he has been very interested in cancer immunotherapy research and drug development, particularly in primary and metastatic brain tumors. This led him to make a career shift toward Phase 1 immunotherapy. He has presented at regional and national meetings and is an active member of ASCO and SITC.
MD
Dr. Neel Gandhi
Neel Gandhi, MD is a board-certified hematologist and oncologist who joined Carolina Bio-Oncology in May 2023. Dr. Gandhi has an educational background in chemical and biomedical engineering, and this led him to ultimately pursue medical school, graduating from the University of Tennessee in 2006. He then completed an internal medicine residency at Boston Medical Center, followed by a medical hematology and oncology fellowship at Fox Chase Cancer Center in Philadelphia. Prior to his arrival, Dr. Gandhi was in clinical practice for over ten years in New Jersey, where he served as the Director of Neuro-Oncology at Capital Health Medical Center from 2019-2023. Over the last few years he has been very interested in cancer immunotherapy research and drug development, particularly in primary and metastatic brain tumors. This led him to make a career shift toward Phase 1 immunotherapy. He has presented at regional and national meetings and is an active member of ASCO and SITC.
Oncologist & Hematologist
MD
BioCytics Successfully Completes a Key Regulatory Milestone with Recent FDA INTERACT Meeting

Huntersville, NC, November 18, 2025—BioCytics is pleased to announce  they successfully reached a regulatory milestone for de-risking clinical development plans with a productive FDA INTERACT meeting during which they discussed manufacturing immune cell therapies at the point of care.

 

This INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) meeting is a first step in getting feedback from the FDA regarding the feasibility of BioCytics’ cell therapy platform development plans.  By accepting this meeting and reviewing the plans, the FDA is indicating that BioCytics’ immuno-oncology tumor treatment protocol efforts, the first of which is called BioCytics Immune Fraction #1 (BCyIF-1), show enough pre-clinical scientific potential to warrant continued research development and upscaling manufacturing efforts. This milestone feedback from the FDA speaks volumes for BioCytics’ work towards a future Investigational New Drug (IND) submission.  It solidifies plans of getting to first-in-human clinical trials in 2027, with the ultimate goal of treating solid tumors.

 

Dr. John Powderly, Oncologist and President of BioCytics said “We are delighted to have received insightful feedback from the FDA regarding development of BioCytics BCyIF-1, a cellular therapy to be manufactured at the point of care.  The FDA’s willingness to review our pre-clinical research data and hold the INTERACT meeting with us results in substantially reduced regulatory risk as we move towards a future IND. It is fantastic to have our early research validated and to be able to enter confidently into our IND-enabling and manufacturing efforts.”

 

About BioCytics, Inc.

BioCytics, founded in 2005, is a privately held health technology company located in Huntersville, North Carolina. BioCytics is researching autologous Adaptive Cell Therapy (AACT) to develop an immuno-oncology platform for treating solid tumors with the patient’s own immune cells. AACT is a revolutionary point-of-care cell manufacturing process designed to generate nongenetically modified effector cell fractions for all stages of all solid tumors.  For more information, please visit Biocytics.com or find us on LinkedIn.

 

About Carolina BioOncology Institute, PLLS

Carolina BioOncology Institute (CBOI), a cancer treatment and clinical trial facility, is co-located with BioCytics, in Huntersville, NC.  CBOI is an independent community-based cancer research clinic that serves the Southeast region as a referral hub for metastatic cancer patients’ access to Phase I clinical research trials.  For more information, please visit Carolinabiooncology.org or LinkedIn.

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Media Contact:

Jennifer Montague

j.montague@biocytics.com

980-441-1150

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