People: Multi-Phase Leaders
End-to-End In-House Expertise
We have the experts, in-house. From cell biology to first-in-human clinical trials, the deep bench of Roswell Park Comprehensive Cancer Center can be consulted throughout your process.
The GMP leadership and operations team includes individuals with significant accomplishments and experience in clinical manufacturing, immune-analysis, process development, QA, and commercialization of innovative therapies.
At Roswell Park, you benefit from decades of unmatched cell therapy experience, built on the groundbreaking innovations of our physician-scientists. Our extensive network of researchers, clinicians, and veteran shared resources teams are ready to contribute if needed to keep your project moving forward.
Process Development
Our Process Development services stand at the forefront of efficiency and innovation. We recognize that each project is unique, and our approach is meticulously tailored to reflect this. Our expertise encompasses a wide range of processes, from scaling up small batches to optimizing large-scale production to supporting early and late-stage trials. We focus on enhancing product yield, purity, and overall quality while ensuring cost-effectiveness and compliance with regulatory standards. Our team works closely with clients, offering transparent communication and expert guidance through every step, ensuring that your product's journey from lab to clinic is seamless and successful.
Clinical Manufacturing
Roswell Park's GEM clinical manufacturing capability is where science meets scalability. We specialize in bridging the gap between experimental research and clinic-ready products. Our facilities are equipped to handle a variety of manufacturing scales, from small pilot batches to large clinical scale batches, adhering to the highest standards of GMP compliance. Our team's extensive experience in clinical manufacturing ensures not only the quality and integrity of your product but also a streamlined, cost-effective pathway through clinical trials. We provide end-to-end support, from material procurement to final product release, ensuring that your journey through clinical trials is smooth and efficient, paving the way for commercial success.
Meet Our Team
Yeong “Christopher” Choi, PhD, MBA
Expertise in GMP, Process Sciences & Tech Transfer
With over two decades of expertise in cell and gene manufacturing, coupled with extensive experience in the biotech sector, Dr. Choi stands out as an industry leader. Recognizing the advantages of in-house development and testing of cellular therapies at Roswell Park, Dr. Choi is committed to expediting the delivery of groundbreaking treatments to patients. Partner with us to leverage this wealth of experience and accelerate advancements in cell and gene therapies through strategic collaboration.
Peter Maslak, MD
Expertise in Immune Therapy, Analytical Development, QC &QA
Boasting over 25 years of expertise in advancing cell-based treatments for leukemia, Dr. Maslak is a distinguished leader in the field. His seasoned leadership in clinical flow cytometry, immunophenotyping, and immune monitoring has solidified his position as a prominent figure in the realm of cell-based therapies. Instrumental in developing laboratory correlates supporting numerous clinical trials, Dr. Maslak brings a wealth of experience to the forefront of cutting-edge advancements. Collaborate with him to drive innovation and excellence in cell-based therapies.
Operations Team
Over 30 years’ experience in GMP manufacturing and building high performing teams
As Director of Cell Therapy Manufacturing, Rob Keem brings over 30 years’ experience in GMP manufacturing, with expertise in manufacturing, quality, and product development. His experience includes starting aseptic operations and building large, high performing teams to support sterile products and getting approval of new drug products.
Email: Robert.Keem@RoswellPark.org
Certified Quality Auditor, Biomedical Auditor, Certified Six Sigma Green Belt
Roswell Park GEM’s Director of Cell Therapy Quality has 25 years of demonstrated success in pharmaceutical and biological product manufacturing. James has served in roles in QA & QC management, and as an FDA Investigator. He understands quality systems and their impact on creating safe and efficacious cellular products.
Email: James.Bridges@RoswellPark.org
Phone: 716-845-5968
MBA in Corporate Finance and Operations Management
With seven years of experience in business and operations management, Raman has consistently applied strategic planning, process optimization, and team leadership to drive efficiency and achieve organizational goals and customer satisfaction. Leveraging data-driven insights, Raman has implemented scalable solutions that streamline operations, reduce costs, and enhance overall performance. Her expertise lies in fostering cross-functional collaboration and implementing innovative strategies that align with the company's objectives, ensuring sustainable growth and long-term success.
Email: Ramandeep.Kaur@RoswellPark.org
Phone: 716-845-1300 x7547
Research
We specialize in cutting-edge research and have a team of world-class scientists who are experts in tailoring innovative solutions to meet the unique needs of our clients. We use state-of-the-art technology and methodologies to ensure that our client's needs are met for IND enabling studies for their products. Our collaborative approach to research not only accelerates the discovery phase but also aligns perfectly with our clients' strategic objectives, ensuring that their projects are scientifically sound and clinically viable. Partner with us to transform your early-stage ideas into promising therapeutic candidates.
Our deep bench includes these elite researchers at Roswell Park:
