Jim Sergi is the Founder and the President of CSSi LifeSciences, a global drug discovery and technology development company providing fully integrated, specialized regulatory and clinical services for pharmaceutical and medical device companies. Prior to this role, Jim was the founder and managing partner of Bay Tower Capital, a life sciences merchant bank and the founder and CEO of ProED Communications, a healthcare services and drug development company. Jim has been responsible for over 85 successful NDA/BLA approvals and over 250 medical device approvals. His academic and medical experience includes Director of Experimental Therapeutics at the Cleveland Clinic Cancer Center, Associate Professor of Medical-Surgical Nursing at the Case Western Reserve University and Lecturer for Oncology at Cleveland State University. He has authored over 50 peer reviewed publications and has numerous issued patents. Jim serves a scientific reviewer for the NIH SBIR/STTR Commercial Readiness Program, as well as a mentor to the NIH/NHLBI and the NIH Larta FeedForward programs. He also serves as a scientific advisor and board member to numerous nonprofits, private equity and venture backed investment firms, including Defta Partners. Jim has an undergraduate degree in nursing from Edinboro University of Pennsylvania and graduate degrees from the University of Akron and Cleveland State University.
Chris Trizna is the President of CSSi, the only company in the global patient recruitment sector whose focus is on clinical operations, by increasing site performance and optimizing patient enrollment. Chris founded CSSi in 2005 with a mission to address the pharmaceutical industry’s need for site-specific patient recruitment and enrollment solutions. In 2010 Chris co-founded CSSi, a global patient enrollment company with experience in more than 47 countries, whose focus is providing country-specific enrollment expertise. As an industry thought leader, Chris has presented at numerous conferences and meetings and author of numerous industry leading publications. A devoted Washington Redskins fan, Chris enjoys playing soccer and coaching his kids’ sports teams. His “weekend satellite office” is often on a boat in the Chesapeake Bay, trying to catch the next big fish.
Dinar Dhond has over 25 years of experience in the information technology field, with experience in different facets of IT including: application development, system engineering, data center operations, etc. Prior to co-founding CSSi, Dinar has worked with Fortune 100 companies as part of Oracle, consulting on development and maintenance of mission critical systems, including, GE Aircraft Systems, OCLC, submitorder.com and World Duty Free. Dinar's project experience includes design and development of data warehousing systems, messaging architecture systems, and high-available database systems. Dinar's development experience in patient access programs include design and development of programs for various Fortune 500 companies. Dinar has several years of experience in development of hub-and-spoke architecture to connect various specialty pharmacies, healthcare providers and pharmaceutical clients for various manufacturer products. Dinar has held several executive leadership positions at Pharmaceutical Research Plus, Oracle and HealthStar Communications. Dinar's academic credentials include a BS in Computer Science and an MBA. Dinar is a devoted Ravens fan and continues to remain active in soccer, and as a coach for his children’s soccer teams.
Janice Cattano began her professional career as a Clinical Nurse Specialist for healthcare of women, with a primary focus on infertility treatment. She has worked in the worldwide medical device arena with experience ranging from disposable procedure trays for continuous abdominal peritoneal dialysis to tracheostomy care and NGS and in vitro diagnostics. Janice has deep subject matter expertise and proven experience with Class 1-3 medical devices. As product manager for both CPAP and disposables for Obstructive Sleep Apnea, her excellence in innovation was demonstrated by 8 issued patents. Previously, she was US product manager at SmithKline & French and worldwide product manager at Searle. Janice is experienced both in launching new products as well as being an integral member of interdisciplinary new drug development teams. As creator and director of a clinical research center for a large regional specialty group, she managed over 30 Phase I – IV clinical trials. She was responsible for protocol design, evaluation, contract negotiations, budgets, data management, quality assurance as well as patient care. She earned her BSN from Skidmore College and her MSN from the University of Pennsylvania.
Heidi Nelson-Keherly, PhD Vice President, Drug Discovery and Development
Heidi Nelson-Keherly is a 20+ year veteran of working with small and mid-size pharmaceutical and biotech companies to develop their drug programs in support of IND submission. She has managed over 300 drug development programs spanning preclinical lead optimization, pharmacokinetic and safety studies, bioanalysis, process scale up and development, as well as CMC and GMP. During her career, she has been involved with over 1,000 drug development programs. In addition, Heidi was responsible for several multi-therapeutic clinical research sites that participated in over 80 Phase I-IV clinical trials. Heidi holds a PhD in Molecular Biology from the University of Wisconsin.
Director, Preclinical Research and Drug Development
Ken Rose, BS Director, Preclinical Research and Drug Development
Ken Rose serves as the Director of Preclinical Development and is responsible for the successful execution, oversight, and completion of preclinical development projects. Ken has over 35 years of experience in the pharmaceutical, agricultural and specialty chemical industries. His experience consists of a broad range of operational, technical and support services responsibilities. Ken is an analytical chemist and has more than 20 years of drug development lab experience as well as more than 10 years’ experience managing entire drug development programs, including CMC, GMP, pharmacokinetic studies, safety toxicology studies, bioanalytical methods development and sample analysis to support IND, NDA and BLA submissions.
Joan Breslin is molecular biologist with over 15 years of academic research experience in a variety of disciplines including cell biology, protein biochemistry, microscopy/morphometric analysis, and statistics. She has authored IND, CTA, NDA, BLA and Orphan Drug Designation submissions. In addition, she has written original articles published in peer-reviewed journals, composed portions of numerous successfully funded grant proposals, and is experienced in editing manuscripts prior to submission. Joan earned her PhD in Anatomy and Cell Biology at the University of Cincinnati College of Medicine and completed her postdoctoral work as a Fellow in Pulmonary Biology at Cincinnati Children’s Hospital. Her undergraduate studies at Dickinson College provided rigorous training in composition and expository writing and fostered a lifelong affinity for the written word.
Dr. Bukowski is an emeritus staff at the Cleveland Clinic Foundation, and Professor of Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University. He was recently the Deputy Director of the Cleveland Clinic Taussig Cancer Center and Director of the Experimental Therapeutics at the Cleveland Clinic Cancer Center from 2001 to 2008 and is currently an emeritus physician in the Taussig Cancer Center. Dr. Bukowski is a fellow of the American College of Physicians and a member of numerous professional societies, including the American Society of Clinical Oncology, and the American Society of Hematology. He is a lifelong researcher with interests in biologic response modifiers, the biology of renal cell carcinoma, and new drug development and investigation. Currently, Dr. Bukowski serves as the chairman of the medical committee of the Kidney Cancer Association and chairman of its board of directors. Prior to joining CSSi, Dr Bukowski served as an industry consultant and advisor to the FDA and Chairman of the FDA Oncology Drug Advisory Board. He is the author of over 500 scientific papers.
Ernesto Chanona, PhD Director of Business Development
Ernesto Chanona serves as the Director of Business Development at CSSi LifeSciences. His role focuses on finding new opportunities through strategic partnerships with innovation hubs, international government agencies, academic researchers, and entrepreneurs. He also teaches at the Center for Biotechnology Education at the Johns Hopkins University. Ernesto trained as a cancer immunologist and developed immunotherapies against colorectal cancer and melanoma at the National Cancer Institute. Prior to joining CSSi LifeSciences, he led the business development efforts, at the Maryland Department of Commerce, that catered to the recruitment, expansion, and export activities of biotechnology companies. He holds an undergraduate degree in Biology from the Johns Hopkins University and a Ph.D. in pharmacology from the University of North Carolina at Chapel Hill.
Robert Decker, MS Associate Manager, Clinical Research
Robert is an Associate Clinical Project Manager at CSSi. He assists with the planning, design and conduct of clinical trials in conjunction with sponsor. He has managed clinical studies over the past 15 years for pharmaceutical companies such as BioMarin, Dow Pharma, Dey Labs, BioPharmX, and Genentech. Robert earned his Master’s Degree in Toxicology at the University of California, Irvine.
Tanya initially pursued a professional career in biotechnology at CryoLife, Inc., where she managed domestic and international regulatory approvals and indication expansions for human tissues, bioadhesive glues, and xenografts. Tanya continued her career by gaining marketing approval for infusion pumps, hyaluronic acid injections, single use and reusable surgical tools, and novel synthetic cartilage devices. Tanya has extensive experience in pre-Submissions and negotiations with FDA and has successfully authored IDEs, 510ks, down-classification requests, and most notably an original PMA. Tanya has over 15 years of experience specific to the start-up industry for Class I-III devices where she directed Regulatory activities essential to achieve value-driven milestones. Most recently at Cartiva, Tanya served a critical role as Sr. Director of Regulatory and Quality Affairs and was instrumental in all phases of product development, including pre-clinical testing, manufacturing, clinical testing, Quality System implementation, on site Quality audits, and PMA authoring and approval that ultimately resulted in Cartiva’s acquisition in 2018. Tanya earned her BS in Biology at Kennesaw State University. Additionally, Tanya has earned her Regulatory Affairs Certificate (RAC).
CSSi LifeSciences recognizes the need to promote patient advocacy, and as a result CSSi’s team expanded to include Deborah Hanna, Director, National Patient Advocacy. Her primary role is to develop outreach strategies and to build relationships with national, regional and local patient advocacy groups and other organizations that work with patients that fall within CSSi’s therapeutic clinical trials. She works closely with the Local Enrollment Specialist team to facilitate interaction between supported clinical trial sites and local patient advocacy opportunities. Deborah brings 20 years of experience with patient advocacy, with an expertise in Dementia, particularly Alzheimer’s disease. She is a facilitator with the Alzheimer’s Association and provides bi-monthly educational presentation series on topics of dementia. Deborah is the founder of the non-profit YES! Young onset dementia Education and Support. She has been a panelist speaker at various Maryland State Alzheimer’s conferences. Deborah brings the personal touch that research requires to reach targeted patients, while providing awareness and education necessary for enrollment.
Allison Huegel works with the Strategic Operations department at CSSi LifeSciences. Allison also serves as Chief Operating Officer for AxoProtego Therapeutics. Previously, Allison served as co-founder and Chief Operating Officer of Pro ED COMMUNICATIONS, INC., an international pharmaceutical and biotech health science communications company recognized by pharmaceutical industry and health authorities (ie, FDA) as best in class for expertise and service for commercial drug development. Allison oversaw corporate services include clinical and regulatory drug development, scientific and medical publications, medical meetings and event planning, continuing medical education (CME), creative and graphic design, and specialty marketing programs. Allison was responsible for corporate organization structure including finance, accounting, human resources, communication systems, physical facilities, meetings/events, and client troubleshooting. Allison personally devised the team approach that enabled clients to avail a brain trust of experts and staff to best support their product development life cycle.
Vice President, Regulatory Affairs - Medical Devices
Kenneth Kleinhenz, MS, MBA Vice President, Regulatory Affairs - Medical Devices
Kenneth Kleinhenz is the Vice President of Regulatory Affairs and Medical Devices at CSSi LifeSciences. Prior to joining CSSi LifeSciences, Ken was the head of global Regulatory Affairs and Quality Assurance at Cytori Therapeutics from 2005 to 2014. Previously, Mr. Kleinhenz worked for Becton Dickinson as the Chief Microbiologist for their Nebraska Vacutainer Systems facility. Mr. Kleinhenz has built and maintained multiple ISO 13485 and 21 CFR 820 compliant quality management system throughout his career. Mr. Kleinhenz has implemented novel US FDA, European CE Mark, and Japanese PMDA regulatory strategies for device-based cell therapies. Mr. Kleinhenz has obtained multiple global clinical trial approvals in the USA, Canada and Europe for cell therapy products used to treat cardiac disease, scleroderma, osteoarthritis, breast reconstruction / augmentation, and muscle injuries. Mr. Kleinhenz has written Design Dossiers and Clinical Evaluations for CE Class III electromechanical devices and enzymes, along with Class II bioresorbable implants for bone fixation, soft tissue fixation and adhesion prevention for CE Mark Approvals. Mr. Kleinhenz has also obtained multiple international device approvals in European Union, Australia, New Zealand, Russia, Ukraine, Israel, Serbia, Korea, Taiwan, China, Malaysia, etc. Mr. Kleinhenz is a veteran of the United States Navy, where he served as a Clinical Microbiologist at the Naval Hospital, San Diego from 1982 to 1988. Mr. Kleinhenz received his BS in Microbiology at the University of California, San Diego (UCSD) and his MBA at the University of Phoenix.
Regina Leung, MBA Vice President, Drug Development Services
Regina has over 25 years of achievement in leadership and business management in the healthcare, pharmaceutical (i.e., brand and generics) including the digital health and consulting industries. She has significant experience as a business strategist, managing complex consulting projects, and launching new innovative healthcare programs. Previously, Regina served as the Director of Bay Area Angel Network and Senior Director at Mc Kession Healthcare. Regina has proven leadership in building a strong organizational culture, and in attracting, mentoring and coaching talented staff for pharmaceutical companies, including Pfizer, Chiron, Gilead, etc. Regina received her MBA in International Business from University of Southern California.
Dr. Lye has been associated with the biomedical industry for nearly twenty years, including receipt of competitive grant awards at the undergraduate, graduate, and post-graduate levels as well as a research fellowship at Yale University. Prior to joining the CMEI family of corporations as Chief Medical Officer and Strategy and Innovation Officer, Kevin served as VP of Medical Affairs for a global pharmaceutical corporation and engaged with over eighty clinical trial sites worldwide for Phase II and III clinical studies. Before this, Kevin was VP and Chief Medical Officer of a technology-holding company, leading it through an evaluation of its intellectual property covering two pipeline products; he also spent over five years in the world of biomedical device development as the director of clinical research for a stem cell technology company, helping bring a stem cell isolation robot to defined markets and authoring first-in-man clinical trial protocols in orthopædic surgery, vascular surgery, cardiac surgery, plastic surgery, and other venues. Interacting with FDA and USPTO, managing intellectual property registrations, coordinating contract research organizations, and securing business development transactions are examples of how he has increased the value of groups with whom he has served. Kevin is privileged to have worked in the laboratories of and been mentored by luminaries such as James D. Otvos, PhD, founder of LipoMed, Inc.; Louis Argenta, MD, inventor of negative-pressure wound therapy devices used worldwide to heal complex wounds; and Irvin M. Modlin, MD, PhD, a renowned innovator and director of the Gastric Pathobiology Research Group at Yale. Kevin earned his medical degree from the Wake Forest University School of Medicine and his MBA from Hawaii Pacific University with highest distinction and also serves as an assistant professor at the John A. Burns School of Medicine of the University of Hawaii.
Diane Markesich, PhD Director, Translational Research
Dr. Markesich has 20 years of experience in pharmaceutical drug discovery and development, encompassing proof of concept and lead optimization, through Phase I human clinical trials. Her work has focused on helping start-up companies meet the demands of the early stages of the commercialization process, through outsourcing of preclinical research and CMC operations and obtaining non-dilutive funding from government and private investment sources. As an industry scientist, she has led target discovery and validation, pharmacodynamics, CMC and IND-enabling programs. Her expertise and broad knowledge base include gastroenterology, immunology, oncology, analgesics and inhaled drug development. Prior to joining CSSi LifeSciences, Diane held senior leadership positions with Pulmotect and Lexicon Pharmaceuticals. Dr. Markesich received her PhD in Biochemistry and Cell Biology from Rice University.
Kirtan Patel is responsible for the project management and project support for CSSi LifeSciences. Prior to joining CSSi, Kirtan served as a Program Director at National Pike Health Center where he helped implement a high-quality management system and fast-track business development by establishing strong partnerships in the local community. Afterwards, Kirtan joined Alight Solutions as an Associate Consultant where he provided an in-depth knowledge on public and private healthcare payers. Kirtan has received his first Master’s degree in Healthcare Leadership & Management from University of Texas with a certification in Health Information-Technology. In addition, Kirtan is currently pursuing his Master of Business Administration. With a strong leadership and educational background, Kirtan can provide meaningful insight to our clients.
Gabrielle St. Remy, MS Director, Public Relations & Marketing
Gabbie St. Remy is the PR & Marketing Director at CSSi, overseeing the strategy and execution of marketing plans and creatives for our client projects. Prior to CSSi, Gabbie served as the Marketing Team Lead for a telecommunications company, as well as a Project Manager for a creative agency. She has received a Master of Science degree from Northwestern University, Medill School of Journalism, with a focus in Integrated Marketing Communications.