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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

Dr. Powderly’s Episodes on the “TIL Talks” Podcast

·       Link to Episode #12

A discussion of advancements in immunotherapy, particularly focusing on Peripheral Tumor Infiltrating Lymphocytes (TIL) and their potential in cancer treatment.

Dr. Powderly shares insights from his experience as an oncologist and the work being done at the Carolina Bio-Oncology Institute. They explore the logistics of cell therapy, the importance of decentralization in treatment access, and the challenges faced in personalized medicine. The discussion also highlights the significance of patient awareness regarding clinical trials and treatment options available to them.

They emphasize the need for patients to take an active role in their treatment options and the potential for regulatory changes to improve access to innovative therapies. The discussion also highlights the significance of understanding the differences between in vivo and ex vivo therapies and the future of cancer treatment.

 

·       Link to Episode #16

In this conversation, Chris and Dr. John Powderly discuss the intricate relationship between neoantigens, vitiligo, and immunotherapy in cancer treatment. They explore Chris's personal journey as a melanoma survivor, the science behind neoantigens, and the implications of autoimmune responses.

The discussion emphasizes the importance of patient advocacy, effective communication between healthcare providers, and the impact of lifestyle changes on health outcomes. They also touch on the unique challenges of mucosal melanoma and the future of immunotherapy, highlighting the need for patient education and empowerment.

 

·       Link to Episode #18

In this episode of TIL Talks, Chris White welcomes back Dr. John Powderly to discuss the latest advancements in immunotherapy research and the importance of empowering patients to seek out clinical trials. They delve into the critical role of nutrition and gut health in cancer treatment, emphasizing the impact of dietary choices on recovery. The conversation also highlights the dangers of processed foods, synthetic additives, and environmental toxins, urging listeners to adopt healthier lifestyles. Finally, they discuss the significant benefits of regular exercise for cancer patients and the need for awareness regarding microplastics and their potential health risks.

John Powderly MD and Chris also discuss various aspects of cancer survivorship, including the risks associated with imaging, the emotional toll of scan anxiety, and the importance of mental health support for patients and their families. They emphasize the need for community involvement, the significance of finding purpose in survivorship, and the advancements in cancer treatment. The conversation also highlights the critical role of blood donation in supporting cancer patients and the ongoing need for awareness and education in the field.

 

·       Link to Episode #19

In this episode of TIL Talks, Chris White and Dr. John Powderly discuss the evolving landscape of digital health in oncology, focusing on the challenges of electronic health records (EHRs), the Open-EHR movement aimed at standardizing clinical data, and the importance of patient empowerment in accessing their health information.

They explore the future of clinical trials, the role of AI in healthcare, and innovations in early cancer detection, emphasizing the need for collaboration among healthcare professionals to improve patient outcomes.

 

·       Link to Episode #22

In this engaging conversation, Chris White and Dr. John Powderly delve into the intricate relationship between immunotherapy and vitiligo, exploring how the immune response can be harnessed to combat cancer.

They discuss historical insights into cancer treatment, the significance of animal models in research, and the groundbreaking advancements in checkpoint inhibitors that have transformed cancer therapy. The dialogue emphasizes the importance of understanding the immune system's mechanisms and the potential for personalized medicine in future treatments.

 

·       Link to Episode #23

In this episode of TIL Talks, Chris White and Dr. John Powderly continue and pick up from their last recording and discuss the advancements in immunotherapy and cell therapy, focusing on the mechanisms of checkpoint inhibitors, the challenges of immune resistance, and the importance of personalized medicine.

They explore the role of the tumor microenvironment, the significance of patient-centric approaches, and the regulatory challenges faced in the development of cell therapies. The conversation emphasizes the need for innovative solutions in point-of-care manufacturing and the future directions of cancer treatments.

Some Key takeaways include the significance of clinical trials, the complexities of immune resistance, and the future potential of personalized cell therapies. As research continues to evolve, it is essential for patients and families to stay informed and consider participating in clinical trials to access cutting-edge treatments.

Dr. Powderly Keynote Speaker at “Hope is Not a Workflow” Symposium

Dr. Powderly was recently a Keynote Speaker at an event organized by “Hope is Not a Workflow” cell and gene therapy (C&GT) stakeholder collective partnership.  Taking place on March 25, 2026, in Research Triangle Park, the daylong symposium focused on advancing manufacturing for C&GT.  Specifically, the mission for “Hope is Not a Workflow” is to convene developers, manufacturers, clinicians, patients, and regulators to build trust, enable collaboration, and accelerate the delivery of safe, scalable, and accessible therapies.  Dr. Powderly discussed how the two companies he founded in 2005, Carolina BioOncology Institute (CBOI) and BioCytics, are aligned with this mission because of the shared commitment to make immune cells for cancer clinical trials both accessible and affordable.  Achieving these goals will require novel clinical delivery systems, new business models, and governing authorities enabling regulatory frameworks with modular devices for point of care manufacturing similar to the United Kingdom and China.

Truly, hope alone is not enough for metastatic cancer patients in 2026—they need tangible changes to the biopharma and medical industry complex to increase access and affordability to promising C&GT.   

Dr. Powderly went on to discuss how BioCytics’ and CBOI’s original mission from their founding in 2005 was to develop personalized immune cells for patients at the point of care, with research and development towards a novel delivery platform.  This integrated model is based upon a futuristic paradigm shift from “cells as a drug product” to “cells as a professional medical research service, manufactured at the point of care.” In many other countries, immune cells are already being researched, developed and manufactured at affordable costs at the point of care at regional health care facilities, all of which is driving access and enabling iterative research improvements. We need to prepare and train the American physician workforce for the future potential of C&GT as regenerative medicines, while building new patient-centric “direct care” models instead of the current employer-based insurance payor models, with a track record of deny and delay tactics.     

Caroline Mastrosante
Nurse Practitioner
Caroline Mastrosante AGPCNP, OCN is a board-certified Nurse Practitioner who specializes in oncology care. With extensive experience in the diagnosis, treatment, and management of patients with cancer and hematologic disorders, Caroline is dedicated to providing evidence-based, compassionate, patient-centered care across the cancer continuum. Caroline earned her Bachelor of Science in Nursing at Gardner-Webb University in 2008 and worked as an Oncology nurse for ten years before pursuing her master’s degree in nursing- Adult Gerontology Nurse Practitioner program at South University. Throughout her nursing career, she gained valuable clinical experience caring for oncology patients in both inpatient, and outpatient settings including Oncology Research and Infusion Nursing. She completed a Hematology Oncology Advanced Practice Provider Fellowship at Atrium Health 2019-2020. As a sub-investigator in clinical research, Caroline is committed to advancing cancer care through clinical research and expanding patient access to innovative therapies that improve outcomes and quality of life.
AGPCNP, OCN
Caroline Mastrosante
Caroline Mastrosante AGPCNP, OCN is a board-certified Nurse Practitioner who specializes in oncology care. With extensive experience in the diagnosis, treatment, and management of patients with cancer and hematologic disorders, Caroline is dedicated to providing evidence-based, compassionate, patient-centered care across the cancer continuum. Caroline earned her Bachelor of Science in Nursing at Gardner-Webb University in 2008 and worked as an Oncology nurse for ten years before pursuing her master’s degree in nursing- Adult Gerontology Nurse Practitioner program at South University. Throughout her nursing career, she gained valuable clinical experience caring for oncology patients in both inpatient, and outpatient settings including Oncology Research and Infusion Nursing. She completed a Hematology Oncology Advanced Practice Provider Fellowship at Atrium Health 2019-2020. As a sub-investigator in clinical research, Caroline is committed to advancing cancer care through clinical research and expanding patient access to innovative therapies that improve outcomes and quality of life.
Nurse Practitioner
AGPCNP, OCN
Carson Kirby
Physician Assistant
Carson Kirby, PA-C, is a board-certified Physician Assistant specializing in oncology. She earned her Bachelor of Science in Health Sciences from Furman University before completing her Master of Physician Assistant Studies at Wingate University. Carson is committed to providing compassionate, patient-centered care and helping patients navigate their cancer journey with confidence and support. She has a particular interest in addressing the mental and emotional health needs of patients and their families throughout the cancer experience.
PA-C, MPAS
Carson Kirby
Carson Kirby, PA-C, is a board-certified Physician Assistant specializing in oncology. She earned her Bachelor of Science in Health Sciences from Furman University before completing her Master of Physician Assistant Studies at Wingate University. Carson is committed to providing compassionate, patient-centered care and helping patients navigate their cancer journey with confidence and support. She has a particular interest in addressing the mental and emotional health needs of patients and their families throughout the cancer experience.
Physician Assistant
PA-C, MPAS
Sydney Noldin
Physician Assistant
Sydney M. Noldin, PA-C, is a Physician Assistant specializing in Phase I oncology, where she is dedicated to advancing early-stage cancer therapeutics while providing compassionate, evidence-based, and patient-centered care. She earned her Bachelor’s degree in Biomedical Engineering from Rensselaer Polytechnic Institute before choosing to pursue a more direct, patient-facing path in medicine. Her clinical journey began as a clinical research coordinator at the CBOI, where she spent four years building a strong foundation in both research and patient care. She then completed her Physician Assistant training at Elon University and returned to CBOI as a practicing PA, bringing her experience full circle. In her current role, Sydney supports patients participating in early-phase oncology trials, guiding them through complex treatment protocols with attentiveness and empathy. She finds this work deeply meaningful and considers it a privilege to walk alongside patients facing serious illness. She also has a strong interest in nutrition and its role in supporting overall health and well-being.
PA-C, MPAS, BS
Sydney Noldin
Sydney M. Noldin, PA-C, is a Physician Assistant specializing in Phase I oncology, where she is dedicated to advancing early-stage cancer therapeutics while providing compassionate, evidence-based, and patient-centered care. She earned her Bachelor’s degree in Biomedical Engineering from Rensselaer Polytechnic Institute before choosing to pursue a more direct, patient-facing path in medicine. Her clinical journey began as a clinical research coordinator at the CBOI, where she spent four years building a strong foundation in both research and patient care. She then completed her Physician Assistant training at Elon University and returned to CBOI as a practicing PA, bringing her experience full circle. In her current role, Sydney supports patients participating in early-phase oncology trials, guiding them through complex treatment protocols with attentiveness and empathy. She finds this work deeply meaningful and considers it a privilege to walk alongside patients facing serious illness. She also has a strong interest in nutrition and its role in supporting overall health and well-being.
Physician Assistant
PA-C, MPAS, BS
BioCytics and CBOI Publish Novel Solution for Immune Cell Therapy Manufactured at the Point-of-Care

The team at BioCytics and Carolina BioOncology Institute (CBOI) collaborated to produce an article recently published in a special supplemental edition of Transfusion, the official journal of the American Association of Blood and BioTherapeutics. The Transfusion special edition is called “Evolving Biotherapies: Stakeholders, Solutions, and the Science of Tomorrow”. BioCytics-CBOI’s manuscript is titled “Enabling community-based autologous adaptive immune cellular therapy manufactured at the point of care: A narrative review of global regulatory frameworks, affordability, and implementation strategy of a novel integrated facility and digital platform in the United States”.  

 

The article outlines that while there have been great scientific successes in the fields of cell and gene therapy, very little of these advances are being felt by the actual patients.  One of the main reasons for this mismatch is that the current delivery system is outdated.  The existing pharmaceutical-medical network and logistics are built around having one centralized site for drug manufacturing with downstream distribution to medical centers.  This network is excessively expensive and has many systemic challenges.  In contrast, distributed/decentralized manufacturing at the point-of-care (like the BioCytics-CBOI platform), enables manufacturing and treatment at the same site for the patient.  Logistic costs are minimized resulting in lower overall costs and greater efficiency.  The article describes these benefits in greater detail and outlines regulatory hurdles and solutions to enhance cell and gene therapy and point-of-care manufacturing. 

The article also discusses that in addition to the innovative point-of-care treatment and manufacturing model, the companies are also pursuing an innovative approach to treating cancer.  Briefly, this approach involves isolating various fractions of immune cells (such as exhausted-reinvigorated T cells, NK cells, and γδ cells), each uniquely suited to kill tumor cells at different stages of tumor development, thus allowing a sequential approach to cancer treatment.  Other specialized fractions include tumor-infiltrating immune cells and creation of an ex vivo lymph node (ex-cellerator lymph node, or Ex-CLN).

In summary, cell and gene therapies have delivered unprecedented clinical breakthroughs in oncology, yet the centralized commercial drug-product model has proven financially fragile and operationally inefficient. Even where therapies have gained FDA approval, commercial success has been elusive, with companies trading at a fraction of asset value and health systems struggling to reconcile prices with budgetary realities. Adopting point-of-care models has the potential to align innovation with health system affordability, broaden patient access, and ensure the long-term viability of personalized immunotherapy.

In the future, BioCytics’ warm-chain point of care autologous adaptive immune cell therapy (AAICT) platform could potentially be applied to all solid tumors of all grades, all tumor mutational burden status, and all stages including early detection and recurrence by diagnostic leukapheresis with early intervention before patients develop metastatic burden.

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