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For more than three decades, David has been an innovative and transformative leader with progressive accomplishments in Quality Engineering, Quality Assurance, and Quality Management for market-leading technology and medical device manufacturers. He brings to CRS a proven track record of assuring customer quality satisfaction and improving profitability by identifying critical priorities, marshaling commitment, and managing cross-functional teams to successfully execute. David is results-driven by solving complex problems, driving change, and fostering and enabling quality culture for learning and improvement.

Alethea brings 30-plus years of expertise in analyzing the intersection of healthcare innovation and policy; providing flexible clinical trial resourcing; developing sustainable corporate affairs programs and policies; training and managing resilient, high-performing clinical operations teams; mitigating risks of clinical trials; and facilitating transparent, accountable sponsor-CRO partnerships. She is the recipient of the 2017 Governor Tom Wolf Recognition in PA Life Sciences, 2017 Women in Bio P.O.W.E.R. Award, and 2017 Pittsburgh City Council Recognition in Life Sciences.

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Anna earned a bachelor’s degree in psychology Cum Laude with Honors in 2023, from the University of Pittsburgh, and established an interest in neuroscience research with brain injury patients. Anna worked for Dr. Anthony Kline at the Safar Research Center, where she studied the effects of pharmaceuticals on experimental traumatic brain injuries. Through this research, she had the opportunity to attend the SACNAS conference as a Travel Scholar and won an Outstanding Research Presentation award.

Ms. Carpio was published as a corresponding author in Experimental Neurology, for her research contributions to “A bridge to recovery: acute amantadine prior to environmental enrichment after brain trauma augments cognitive benefit.” She has experience as a clinical assistant in rehabilitating TBI patients, and as a peer specialist at Western Psychiatric Hospital, furthering her passion for neuroscience and psychology.

Julie earned her PhD from the University of Pittsburgh in Pathology, with a focus on intestinal stem cells and their link to intestinal cancer. When the opportunity came to join a local life sciences startup that had licensed a technology from the University of Pittsburgh, she embraced the challenge and quickly came to understand how it takes careful management of a cross-disciplinary team to navigate the often turbulent entrepreneurial waters.

Dr. Cramer then returned to her alma mater to work in commercial translation at the University of Pittsburgh’s Innovation Institute. Acting as liaison to the University’s close clinical partner, UPMC, Dr. Cramer managed diverse programs, including digital health and immunotherapy, to enable nascent technologies to mature into valuable intellectual property ready for licensing.

Frank has 30 years’ experience as a senior executive working in domestic and international regulatory compliance, inspection-readiness, regulatory negotiations, quality management systems, and new product development within start-up medical device companies, military applications, and diagnostic instrumentation.

Mr. Falcione has contributed more recently to the implementation of MDD Class IIb and III devices for CE approval, transition to EU MDR conformance, and FDA Class III Modular PMA submissions. Additionally, he led quality programs for inspection-readiness, on-site and virtual audits and inspections, and face-to-face regulatory meetings. He remains actively involved in teaching regulatory/quality and product risk management at local colleges and universities and contributing to the development of young entrepreneurs.

Ms. Foust earned a bachelor’s degree in biochemistry and molecular biology from The Pennsylvania State University. Ms. Foust began her career working at a CLIA-certified molecular medicine laboratory handling complex molecular assays and systems. She prepared sequencing libraries while also testing and evaluating new reagents and controls. Her career growth enabled her to move into GLP genetic toxicology assays, quality assurance, and report generation.

Kaysie moved from North Carolina to Pittburgh to work at Noveome Biotherapeutics (formerly Stemnion Inc.) where as a quality control analyst II, she spearheaded cGMP and cGLP work that supported product development. Her next move was with Interpace Diagnostics as a senior laboratory technologist, followed by a position as specialty laboratory technologist at the University of Pittsburgh Medical Center (UPMC) Genome Center. Prior to joining CRS, Ms. Foust worked at ALung Technologies in Quality Assurance.

In her spare time Kaysie volunteers for Lake Erie and Presque Isle clean-up initiatives and is passionate about supporting animal shelters.

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. Greiwe is a versatile life sciences expert who fuses regulatory, clinical, and medical writing in a unique combination few possess. He has 2+ decades of experience with developing regulatory strategy documents, clinical development plans, clinical protocol and investigator brochures, briefing documents, and producing regulatory submissions such as:

1. Pre-IND and IND Meetings
2. End-of-Phase 2 (EOP2) Meetings
3. Pre-NDA Meetings
4. Other Type C or D Meetings
5. Analysis of trends, regulations, and guidelines that may impact the preferred drug development approach
6. Gap Analyses

He works with clients to incorporate their strategies within regulatory submissions, and prepares, manages, and submits regulatory documents, including:

1. BLAs and NDAs in eCTD Format
2. Response to FDA Questions During Application Review
3. Initial IND Applications and IND Amendments
4. Safety Reports and Updates
5. Annual Reports
6. Requests for Special Protocol Assessment (SPA)
7. FDA Meeting Briefing Packages
8. Orphan Drug Designation Requests
9. Requests for Fast-Track Designation, Priority Review (and other types of applications for accelerated review)

Ally serves as Clinical and Regulatory Affairs Project Lead at CRS. She earned her doctorate of philosophy in the Program in Microbiology and Immunology at the University of Pittsburgh, working in the laboratory of Dr. John Alcorn at UPMC Children’s Hospital.

The focus of her research was how infection with respiratory viruses, particularly influenza, can damage the host airways and lead to increased incidence of secondary bacterial pneumonia. Additionally, she completed a project to predict length of hospitalization in pediatric patients admitted to the hospital for respiratory infections.

Yuki earned a bachelor’s degree in public health with a clinical trials research concentration, magna cum laude, from Kent State University in May 2020, with membership in the Alpha Lambda Delta Collegiate Honor Society. She also received the University Award, President’s Scholarship, and Trustee Scholarship.

Prior to joining CRS, Yuki worked for ALung Technologies and LivaLova, Inc. in clinical operations positions where she gained experience working on trial master files (TMFs), literature reviews, and clinical evaluation reports (CERs) for medical devices. She is dedicated to contributing to the CRS team and growing her skills in clinical research. In her spare time, Yuki enjoys pilates, hiking, and meditation.

As Project Lead, Sidney bridges the gap between clinical trials and regulatory strategy across multiple therapeutic areas, including infectious disease, oncology, rare diseases, and critical care medicine. She acts as lead for phase I-IV clinical trials for biologics and pharmaceuticals, pilot and pivotal medical device studies, healthy volunteer studies, and post-market real-world evidence (RWE) studies, with extensive experience managing international studies across Europe, Asia, and Australia.

Sidney earned her doctorate in Microbiology and Immunology from the University of Pittsburgh School of Medicine, where she conducted research on immune dysfunction and host-microbe interactions, resulting in several peer-reviewed publications. Outside of work, Sidney enjoys playing with her dog, yoga, bouldering, and keeping up with her favorite home renovation shows.

Dr. Laura Lund is an accomplished medical device development and commercialization expert, having spent significant time in the industry as a mechanical bioengineer, including extensive experience in global regulatory and clinical strategy, both pre- and post-market. She has expertise in journal publications, regulatory submissions, sales and marketing materials, IP development, training materials, investor decks, collaborations with medical advisory boards, and presenting at conferences. She is well-versed with the design, implementation, and regulatory requirements for pre-clinical in vitro and in vivo testing.

Dr. Lund’s therapeutic areas include drugs, biologics, and medical devices in the following areas: critical/intensive cardiopulmonary care, mechanical ventilation, ECMO, ECCO₂R, artificial hearts (LVAD, RVAD, TAH), intra-aortic balloon pumps, central venous catheters/cannulation, continuous dialysis, high-pressure contrast injection, imaging, digital therapeutics, COVID-19 in vitro diagnostics; COPD, ARDS, acute respiratory failure, asthma, cystic fibrosis, heart/lung transplantation; Digital Therapeutics, Software as a Medical Device (SaMD), In vitro Diagnostics (IVDs); 3D bioprinted regenerative medicine; central nervous system (CNS); oncology; and many more.