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. Jim also serves as the GP of Tonic Bioventures, a corporate venture formation fund to accelerate and de-risk breakthrough drugs and medical devices to transform patient lives.
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 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.
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 a cell biologist with over 15 years of academic research experience in a variety of disciplines including protein biochemistry, light and electron microscopy/morphometric analysis, and statistics. During her five years of experience with CSSi LifeSciences, she has authored IND, NDA, BLA, and Orphan Drug Designation submissions, meeting requests and associated briefing documents, clinical protocols, and clinical study reports. Joan earned her PhD in Anatomy and Cell Biology from the University of Cincinnati College of Medicine and completed postdoctoral work as a Fellow in Pediatric Pulmonary Biology at Cincinnati Children’s Hospital Medical Center.
Amanda Bryant serves as the Business Development Associate for CSSi LifeSciences. She received a Master’s Degree in Business Administration Healthcare Management from Western Governors University. Prior to her graduate degree, Amanda has held over 10 years of experience in healthcare administration and program management. Prior to joining CSSi LifeSciences, her healthcare professional career served as a Hospital Program Director and Executive Assistant. She has versatile healthcare experience, holds a Nursing Assistant Certification and Telemetry Technician Certification. Amanda earned her Bachelor of Arts and Sciences Degree from Western Michigan University.
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.
Damian Daszynski serves as a Senior Business Development & Commercialization Associate for CSSi LifeSciences. His role focuses on executing business development and operational objectives that maintain pipeline growth and development through engagement and collaboration with internal and external clients and stakeholders. Damian trained as a medicinal chemist where he investigated the ocular, neural, and cellular biodistribution of novel neuroprotective small molecules and was selected as a Purdue Pharma Scholar at the University of Nebraska Medical Center. Prior to joining CSSi LifeSciences, Damian served as a Medical Science Liaison on the Eye Care team at Allergan, an AbbVie company. Damian holds an undergraduate degree in Chemistry from Creighton University and a Ph.D. in Pharmaceutical Sciences from the University of Nebraska Medical Center.
John Gustin serves as the Associate Director of Commercial Development at CSSi LifeSciences. His role focuses on managing clients’ projects, connecting clients with strategic partners, and building out CSSi’s project management processes. John is a trained breast cancer biologist and geneticist. While training at Johns Hopkins, he modeled and therapeutically targeted common cancer mutations. John recently completed his MBA in Finance at Loyola University Maryland and had previously managed the Maryland Innovation Initiative, which funds university technologies and start-ups within the State. He holds a BS in Chemical Engineering from the University of Maryland College Park and a PhD in Chemical & Biomolecular Engineering from the Johns Hopkins University.
Sunny Han assists with business development and commercialization support for CSSi LifeSciences. She received her MBA from the University of Virginia, Darden School Business and a Bachelor’s degree in Political Science from Loyola University Maryland. Currently, Sunny is the CEO of Han and Partners which she founded in May of 2022 to assist SMEs after working over 3 years at Yulchon Law firm as an advisor. Sunny worked for LigNex1, Korea’s largest defense company, as a consultant/advisor where she was responsible for developing relationships and opening new markets in the Middle East and in Asia. She also held the position of Senior Vice President in charge of Government, Public Relations, and Business Development. Prior to joining LigNex1, she was an International Consultant/Advisor in Washington, D.C., primarily focused on trade. As an entrepreneur, she also built and led exporting businesses focused on sales of a diverse range of raw materials to Korea, Indonesia and China. In her earlier career, Ms. Han worked for several investment-related firms as senior research statistician and analyst.
Les has been working with CSSi on key projects for almost 3 years and has over 35 years of international Quality Assurance (QA), Quality Control (QC), Operations, Regulatory, Quality Management Systems, Chemistry, Manufacturing and Controls (CMC), Analytical Development and Validation, and Process Development and Validation. He is a proven industry expert in biologics, pharmaceuticals, vaccines, advanced cell therapies, medical devices and combinatorial drugs. Les specializes in developing and managing complex, global projects using, whenever possible, face-to-face leadership and real-time problem-solving. Les has a history of developing the best possible sponsor/vendor partnerships to ensure on-time and on-budget delivery of products of the highest possible quality. Les has led several IND, NDA and BLA submission teams and written CMC sections for 20+ products. Les provides international auditing and qualifying services of manufacturers, laboratories and suppliers. He manages and trains clients on Quality Management, deviation and CAPA investigations, risk mitigations, root cause analysis and proof of effectiveness. Les can provide valuable financial services through due diligence assessments and process/cost modeling of real products, projects and sites for investors, acquisitions, mergers and contracting purposes. He develops, optimizes and manages effective business and regulatory strategies, as well as product development, and commercialization plans. Les provides expert advice to start-up and transitioning companies including well developed cost modeling, budgeting, risk analysis and risk mitigation, contract and QMS templates and building/training full quality management systems.
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 also serves as the GP of Tonic Bioventures, a corporate venture formation fund to accelerate and de-risk breakthrough drugs and medical devices to transform patient lives. 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.
Jose Madrid supports the business development and project management teams for CSSi LifeSciences. Jose received a dual Master’s degree in Healthcare Administration and Business Administration from the University of Houston – Clear Lake. Previously, Jose served as a Research Data Coordinator at MD Anderson Cancer Center, where he gained experience in translational research and clinical trial management. He is trained in Good Manufacturing Practices, Good Laboratory Practices, and is certified in Human Subjects Research and Lean Six Sigma. Jose holds an undergraduate degree in Biotechnology from the University of Houston. With a versatile and adaptable health care professional career, Jose is looking forward to assisting clients in their regulatory and developmental objectives.
Learn more about what sets us apart
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.
Bryce Whited has over 17 years of regulatory affairs experience and is an expert in all phases of product development, approval, and marketing of medical devices and combination products. He has extensive hands-on experience with U.S. regulatory submissions for devices, drugs and biologic products in addition to change control, risk management, nonclinical testing, and clinical trial design. Dr. Whited began his career as a lead scientific reviewer at the Food and Drug Administration, Center for Devices and Radiological Health, and subsequently held senior regulatory positions in the medical device industry. Bryce holds a Bachelors of Science in Materials Science and Engineering from Virginia Tech, and a Masters and Ph.D. in Biomedical Engineering from Virginia Tech / Wake Forst School of Biomedical Engineering and Sciences.
Helena has been in the Pharmaceutical Industry for over 38 years. She has extensive management, training, and development experience in GCP auditing and monitoring of all phases of clinical trials, domestic and overseas, for medical investigators in virtually every specialty and sub-specialty, including animal and devices research. She has expertise in the application, interpretation, and enforcement of CLIA, OSHA regulations, internal Standard Operating Procedures, FDA regulations and ICH-GCP. Helena has conducted multiple clinical site audits and GCP training in the United States, South America, Latin America and Eastern and Western Europa, and Asia; she also conducts GLP and GMP audits. She developed, implemented, and conducted applicable training and development activities and programs for management and non-management staff on an as needed basis in English and Spanish speaking countries, and served as GCP advisor worldwide. Helena retired in 2014 but continue working as a GCP and Auditor consultant for small biologic companies; she joined CSSi LifeSciences in 2022 in a part-time basis in the Medical Devices and Clinical Operations unit. She earned a BS in Psychology from the California Coast University and a Business Associate Degree from the Columbus State University in Ohio.