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Candice earned her bachelors of science (BS) in business management from North Carolina State University. She has held various roles with increasing responsibility, including in financial consulting, billing, bank reconciliation, and financial reporting for small, mid-size, and large companies. Candice and her family spend significant time giving back to their community, including with food banks and other mentoring for those less fortunate. Ms. Brett lives in North Carolina with access to numerous CRS clients, including emerging life sciences companies and other existing partnerships.

Dr. Chauhan earned his doctorate from Oxford University in Molecular Virology, where he conducted early studies in the generation of the now established baculovirus expression system employed for viral vaccines and gene therapy vectors. He came to the U.S. where he has spent the last 22 years on ocular and rare disease research yielding more than 20 peer-reviewed papers, numerous national and international presentations at research conferences, and acting as a reviewer of scientific manuscripts and grants.

At the Albert Einstein College of Medicine in New York, his research focused on cataracts, conducting both gene regulation and high-throughput gene expression analyses. While at the nationally leading Cincinnati Children’s Research Foundation, he focused on development of eye tissues important in understanding congenital ocular diseases, where he primarily utilized transgenic mouse models of eye disease with state of the art imaging devices to probe the molecular and cellular biology of anterior ocular diseases. Dr. Chauhan worked at the UPMC Children’s Hospital of Pittsburgh to translate his basic research to the bedside by primarily performing studies on human tissues.

Dr. Fuller earned her doctorate of philosophy in bioengineering from the University of Pittsburgh’s Swanson School of Engineering while conducting extensive research in on-a-chip systems, multi-scale robotics, and precision medicine as a part of the Synthetic Biology and Biomimetics Laboratory of Warren Ruder, PhD.

Haley was a Cardiovascular Bioengineering Training Program T-32 Fellow and collaborated with interdisciplinary research teams at the University of Pittsburgh Vascular Medicine Institute and the UPMC Heart and Vascular Institute. In this role, Haley assisted with the engineering of organ-on-a-chip devices to understand and treat cardiovascular pathogenesis. She used these systems to evaluate drug-laden microrobot localization and drug release efficacy as a demonstration of microrobots as targeted drug delivery systems.

A pivotal point in Dr. Fuller’s research career was a stint as a bioprocess engineer at the National Institute of Allergy and Infectious Disease (NIAID), where she was instrumental in conceptualizing DoE and high-throughput experimental approaches for vaccine candidate purification process optimization. Her efforts resulted in the development of clinical manufacturing processes, a high-throughput resin screen, and data generation for peer-reviewed scientific manuscripts.

Sheila earned her PhD in Pharmaceutical Sciences from the University of Pittsburgh’s School of Pharmacy, and Bachelor of Science degree from Pennsylvania State University. She has a breadth of experience in pre-clinical, clinical, and translational research focused on device, drug, biologic, and combination products for a range of indications. Additionally, she brings our clients more than five years of extensive experience in clinical trial management, regulatory submissions, pharmaceutical formulation, manufacture, characterization, and general laboratory procedures. Dr. Grab is highly adept at management consulting by juggling a variety of projects using her skills in scientific writing for SOPs, protocol development, grants, Investigator Brochures, Instructions for Use, and various other clinical-related documents, as well as regulatory research for US and international submissions. She serves as vice-chair of Young Women in Bio (YWIB) Pittsburgh Chapter and as a Women in Bio (WIB) Pittsburgh Chapter Member.

Dr. Nisha brings 20+ years of research experience spanning both industry and academia, in clinical and regulatory affairs as well as basic and translational sciences. Dr. Nisha earned her PhD from Carnegie Mellon University in biological sciences and is a former NIH fellow whose scientific pursuits include genetics, epigenetics, molecular biology, immunology, and pre-clinical drug development research.

Dr. Nisha has facilitated FDA submissions for both drugs and devices, and, more recently, contributed to the updates of 100+ products under the new European Medical Device Regulation (EU MDR) requirements. Dr. Nisha has a rare blend of drug development and medical device expertise in all aspects of translational science, federal grants, clinical development and operations, scientific writing, regulatory affairs, and project management. Additionally, she has experience with multiple indications: respiratory and sleep, cardiovascular, ophthalmology, dermatology, metabolic disorders, pediatric immune disorders, precision medicine, regenerative medicine, and digital health. Dr. Nisha also remains actively involved with community outreach that fosters programs in STEM.

Brian has 30 years of experience ranging from basic biological research, to software engineering, to mid- and upper-level management, with multiple C-level positions, including CEO and COO. Specific areas of expertise include artificial intelligence/machine learning, software as a medical device (SaMD), biologics manufacturing, user centered system design, V&V, hardware manufacturing, field install/training/maintenance, sales and marketing, audit, project management, process improvement, regulatory and quality. These efforts have occurred in large global multi-nationals, in mid-sized companies, in small companies, and in startups.

Dr. Sullivan focuses on the integration of multiple operational perspectives to guide clients toward approaches that simultaneously consider and avoid relevant pitfalls. A typical example includes optimizing a regulatory approach to consider detailed technology, operations, schedule and budget goals, and resulting constraints.