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President, CSSi LifeSciences
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 co-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. Lecturer for Oncology at Cleveland State University and Adjunct Faculty and Lecturer for biotechnology at Georgetown University and John Hopkins University Graduate Schools. 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, corporations, private equity and venture backed investment firms, including Defta Partners. Jim has an undergraduate degree in nursing from Edinboro University of Pennsylvania and a graduate degree from the University of Akron. Jim also serves as the GP of Tonic Bioventures, a venture formation life sciences fund to accelerate and de-risk breakthrough drugs and medical devices to transform patient lives. Jim enjoys open water swimming, fly fishing and cooking in his spare time.
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 in the healthcare of women, with a primary focus on infertility treatment. She has worked in the worldwide medical device arena and has experience in the development of products ranging from disposable procedure trays for continuous abdominal peritoneal dialysis to tracheostomy care. Janice has deep subject matter expertise and proven experience with Class I, II, and III 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 II – IV clinical trials. She was responsible for protocol evaluation and implementation, contract negotiations, budgets, data management, quality assurance as well as patient care. She earned a BSN from Skidmore College and her MSN from the University of Pennsylvania.
Heidi Nelson-Keherly is a 25+ year veteran of working with small and mid-size pharmaceutical and biotech companies to develop their drug programs in support of IND submission and beyond. Her regulatory experience spans both drugs and biologics and includes IND, NDA, and BLA filings as well as FDA Meetings (INTERACT, Pre-IND, Type C, Type D). She has managed over 300 drug development programs including preclinical lead optimization, pharmacokinetic and safety studies, bioanalysis, process scale up and development, as well as CMC studies. 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 and a BS from Duke University.
Ken Rose serves as the Executive Director of Preclinical Regulatory Affairs and is responsible for the successful execution, oversight, and completion of preclinical development projects. Ken has 35+ years of experience in the pharmaceutical, agricultural, and specialty chemical industries, and his experience consists of a broad range of operational, technical, and support services responsibilities. Ken is an analytical chemist and has 20+ years of drug development lab experience as well as 20+ years of experience program managing drug development programs across CMC and preclinical activities (Modules 1, 2, 3, and 4) to support IND, NDA and BLA submissions. Ken holds a dual Bachelor of Science degree in Chemistry and Mathematics from Cleveland State University.
Joan Breslin is a cell biologist with over 15 years of academic research experience in a variety of disciplines including protein biochemistry, cell biology, electron microscopy/morphometric analysis, and statistics. During her six years of experience with CSSi LifeSciences, she has authored regulatory documents for IND, NDA, BLA, and 510(k) submissions, Orphan Drug and Rare Pediatric Disease Designation requests, meeting requests and associated briefing documents, clinical protocols, and clinical study reports. Joan earned her PhD from the Department of Anatomy and Cell Biology at the University of Cincinnati College of Medicine and completed postdoctoral work as a Fellow in Pulmonary Biology at Cincinnati Children’s Hospital.
Amanda Bryant serves as the Business Development Associate for CSSi LifeSciences. She received an MBA Healthcare Management from Western Governors University. Before earning her graduate degree, Amanda gained over 10 years of experience in healthcare administration and program management. Prior to joining CSSi LifeSciences, her healthcare professional career included serving 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 Vice President of Business Development & Government Affairs at CSSi LifeSciences. His role focuses on finding new opportunities through strategic partnerships with innovation hubs, international government agencies, academic researchers, and entrepreneurs. 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 international trade efforts at the Maryland Department of Commerce that catered to the recruitment, expansion, and export activities of biotechnology, pharmaceutical, and medical device companies. He holds an undergraduate degree in Biology from Johns Hopkins University and a PhD in pharmacology from the University of North Carolina at Chapel Hill. In his spare time, he serves as an Adjunct Professor at Johns Hopkins University.
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.
John Gustin serves as the Director of Operations & Commercial Development at CSSi LifeSciences. He oversees Finance, Human Resources, and Project Management at CSSi LifeSciences. John is a trained breast cancer biologist and geneticist. While training at Johns Hopkins, he modeled and therapeutically targeted common cancer mutations. John also 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 advises and assists with business development and commercialization support for CSSi LifeSciences. Currently, Sunny is the CEO of Han and Partners which she founded in May of 2022 to assist SMEs after serving for 3 years as an advisor to Yulchon LLC, one of the top 5 law firms in Korea. Sunny worked for LigNex1, Korea’s largest defense company, as a Senior Vice President, 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, and served as an advisor after leaving the firm. Prior to joining LigNex1, she was an International Consultant/Advisor in Washington, D.C., primarily focused on trade and political advisor. As an entrepreneur, she also built and led exporting businesses focused on sales of a diverse range of raw materials to Korea, Indonesia, and Spain. In her earlier career, Sunny worked for several investment-related firms as senior research statistician and analyst. She received her MBA from the University of Virginia, Darden School of Business and a Bachelor’s degree in Political Science from Loyola University Maryland. She loves to play golf in her free time.
Les Johnson has spent over 3 decades helping to guide projects and products through their development life cycles, concentrating on the manufacture and formulation of products using the best qualified facilities and processes. Les is a recognized industry expert in all manufacturing related subjects for advanced therapeutics, cell therapies, biologics, pharmaceuticals and devices. He is best known for his ability to select, qualify, and manage contract manufacturers and labs, as well as build and manage manufacturing facilities. Les has great experience in the recovery of projects and products that have met unforeseen challenges regarding manufacturing, quality, costs, or logistics. He has designed, installed, and managed modular manufacturing and laboratories for cell therapies, and large-scale facilities for biologics and synthetic pharmaceuticals. Les uses a face-to-face style to work with staff, sponsors, contractors, service providers, and regulators anywhere in the world to find the best possible solutions to even the most complicated situations, always looking for the optimum path to success. Les also serves as CTO of Shock Therapeutics and CEO of Optimum Development Technologies.
Regina has over 25 years of experience in leadership and business management in the healthcare, pharmaceutical (brand and generics), digital health, and management consulting industries. She has significant experience as a business strategist, securing various licensing deals for clients and supporting them with product launch readiness and commercialization strategies. Previously, she served as Head of Payer Strategy and Analytics at Gilead Sciences, Senior Director at McKesson Oncology and Distribution, and as a Director at Bristol-Myers Squibb Oncology division. Regina started her career in a medical device company funded by Kleiner Perkins and assisted as the company exited to CVS Health. Regina received her MBA in International Business from the University of Southern California.
Jose Madrid serves as the Project Manager for the Medical Devices and Clinical Operations team and provides support to the Business Development and Project Management teams within CSSi LifeSciences. Jose holds a dual Master’s degree in Healthcare Administration and Business Administration from the University of Houston – Clear Lake and earned an undergraduate degree in Biotechnology from the University of Houston. Prior to joining CSSi LifeSciences, 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.
Diane Markesich has 20 years of experience in pharmaceutical drug discovery and development, guiding projects from 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, Diane 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, she held senior leadership positions with Pulmotect and Lexicon Pharmaceuticals. Diane received her PhD in Biochemistry and Cell Biology from Rice University.
Bryce Whited, PhD provides consultation to medical device, pharmaceutical, and biologics industry clients with expert regulatory strategy and implementation solutions for all stages of product development, marketing approval, and post-market compliance. Bryce has over 15 years of experience in the regulation and pre-market management of medical devices and combination products, including medical device design, development, design controls, and cGMP. He has extensive hands-on experience in preparing successful U.S. regulatory submissions (IDE, PMA, 510(k), de novo, and HUD/HDE) in addition to leading Pre-Submission and Pre-IND / Pre-NDA interactions with the FDA. He began his career as a lead scientific device reviewer at the FDA and subsequently held senior regulatory positions at Biotronik, Contego Medical, The Weinberg Group, and Nox Health. Bryce holds a Bachelor of Science degree in Materials Science and Engineering, and a Master of Science & PhD in Biomedical Engineering from Virginia Tech.
Helena Gomez serves as Clinical Research Manager at CSSi LifeSciences. Helena possesses extensive management, training, and development experience in GCP auditing and monitoring of all phases of clinical trials, domestic and overseas, in virtually every specialty and sub-specialty, including, but not limited to: Neurology, Dermatology, Cardiology, Allergy, Ophthalmology, Gastroenterology, Gynecology, Rheumatology, Infectious Diseases, Nephrology, Oncology and Pediatrics. Helena’s expertise includes the application, interpretation, and enforcement of CLIA, OSHA regulations, internal Standard Operating Procedures, FDA regulations, and ICH-GCP. She has conducted clinical site audits and GCP training in the United States, Mexico, Costa Rica, Germany, England, Belgium, China, South America, Latin America, Australia, New Zealand, and Netherlands.
Rosie Tilmont serves as the Business Development and Government Affairs Associate for CSSi LifeSciences. She joined CSSi in July 2023 after earning a Master’s degree in Biotechnology Enterprise and Entrepreneurship from Johns Hopkins University. At JHU, Rosie examined business topics through a biotechnology lens, including funding strategies, leadership and management, product development, marketing, intellectual property, project management, and law and ethics. She earned a Bachelor of Science degree in Neuroscience with minors in Business Administration and Spanish from Christopher Newport University. During her undergraduate and graduate education, Rosie pursued career-relevant internships and completed several consulting projects with life sciences organizations.