Where Concept and Science Deliver Hope
Ed Trappler has dedicated his professional career to the study, implementation and advancement of the science and technology of lyophilization. In 1992, he founded Lyophilization Technology, Inc. to continue his aspiration of establishing a source of scientific and technical services while expanding the knowledge and understanding of lyophilization within the industry. He is actively involved in Business Development, the Scientific Advisory Board, and Marketing.
Ed has over 40 years' experience in lyophilization that ranges from product development to equipment application engineering. His experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing, and parenteral production. Prior to founding the company, he served as a Systems Application Engineer for Hull Corporation. Ed received his Bachelor of Science degree in Chemistry from The College of New Jersey.
Active in promoting lyophilization in the health care industry, Ed has contributed chapters to six books and authored and presented numerous papers and courses in freeze drying across the North American, European and Asian continents. He has received numerous recognitions for contributions to the industry. He is an active member of the PDA, serving on a number of committees, including as chairperson of the Lyophilization Interest Group and Validation Task Force. The PDA awarded him the Gordon Personeous award for his long term contributions to the PDA and the James Agalloco award for his contribution to education. He is also a member of the AIChE, and has been active in and presents for the AAPS, ISPE, and ISL-FD.
Carrie Shults, Associate Director of Clinical Manufacturing, is responsible for working with and providing guidance to manufacturing staff and support to Project Directors and Quality Assurance for the production of Toxicology, Phase I and Phase II Clinical Trial Materials. She is also a member of the marketing team.
Ms. Shults has over 20 years of professional experience in academia and industry. She began her career in the molecular biology field of pulmonary medicine as a research scientist. Prior to joining LTI she held positions at Merck and GlaxoSmithKline. She started at LTI as a Project Director overseeing client projects. She was later promoted to Associate Director, Development Sciences responsible for scientific, technical, and quality oversight of all development activities.
Ms. Shults received a Bachelor of Science degree in Biology from Neumann University and has her Master of Science degree in Clinical Research from Drexel University. She has been published in the Journal of Clinical Investigation, Journal of Allergy and Clinical Immunology, and American Journal of Physiology, and has authored and presented abstracts and poster presentations for society meetings. Carrie is a member of AAPS, ACS, ISL-FD, and PDA.
Bob Cashman has recently joined Lyophilization Technology, Inc. as Vice President of Business Development.
Mr. Cashman has more than 30 years of Business Development experience in the sterile sector of the pharmaceutical industry, including senior management positions at AMRI, OsoBio, Catalent and West Pharmaceuticals. Mr. Cashman is well recognized within our industry; serving on the board of the Philadelphia Drug Exchange (PDE) as well as, a previous appointment to head the Scholarship Committee for the Drug Chemical and Allied Trade (DCAT) organization. He holds a bachelor's of science degree from Villanova University.
Alison Mutchler, Associate Director of Science and Technology, provides guidance and support to Project Directors and our clients to deliver high quality, safe and robust lyophilized drug product. While directing and managing scientific studies and technical projects for clients, she also directs applied research studies to further research in the field.
Alison has over 20 years of professional experience in academia and industry. Alison received her degree in Chemistry from Carnegie Mellon University. She started her career in Pharmaceutical Research at Pfizer in Groton, CT. During her 10 years at Pfizer she worked on developing solubility enhancing formulations including spray dried dispersions and self-emulsifying drug delivery systems for oral solid dosage forms before moving into parenteral drug development and lyophilization. Alison then took a position at Lyophilization Technology Inc. as a project director helping clients bring lyophilized drug products to market. After spending three years at GlaxoSmithKline in biopharmaceutical product development Alison rejoined LTI as the Associate Director of Science and Technology.
Amy M. Bosch has been with Lyophilization Technology, Inc. (LTI) for over 14 years and currently holds the role of Associate Director, Development Sciences. She oversees the Development and Process Laboratories, including management of the Development Technicians. She is responsible for scientific, technical, and quality oversight of development activities.
Amy began her career with LTI in 2004 as a Technician. Over the years, she was promoted to Senior Technician, Research Technician, Scientist I/II and to her current role as Associate Director, Development Sciences in 2019. She has been involved in managing client projects including product and process development, clinical and toxicological material preparation, technical support, and troubleshooting. Prior to joining LTI she held a position at GlaxoSmithKline.
Amy holds a B.S. degree from Millersville University in Biology. She has presented numerous poster presentations for industry events and has given lectures on Critical Quality Attributes of Lyophilized Products.
Denise Miller, Group Leader of Quality Assurance, is responsible for guiding the company in support of the preparation of Toxicology and Phase I/Phase II Clinical Trial Materials. This role requires directing, working with, and providing instruction to Quality Staff and support to Project Directors. In addition, as the Group Leader of Quality Assurance, she is to ensure the effective execution of the necessary procedures in completing a project using her working knowledge of appropriate methods, techniques, and compliance with all associated regulatory requirements.
Denise began her career with Lyophilization Technology, Inc. in 2008, joining the Quality Assurance Group in 2014. Over the years, through her experience and dedication to learning quality and understanding the different aspects of processing and lyophilization, she was promoted to Quality Assurance Associate, then Quality Assurance Compliance Specialist, and her current role as Group Leader, Quality Assurance.
Before joining LTI, Denise was an allied healthcare professional, working directly with patients in the field. This experience provides the additional patient-first dedication required when working with clinical material.
Denise has published and presented various presentations at focused industry events. She is also a member of the American Society of Quality (ASQ). Denise focuses on ensuring clients receive the highest quality and safe lyophilized drug products for their patients.
Kim A Michele holds the position of Finance Manager at Lyophilization Technology, Inc. overseeing the Accounting and Finance Operations of the company as this company continues to grow and expand all areas of operation. She began working with LTI in 2018 as a consultant. Kim has over 30 plus years of experience in Accounting, Business Analytics, Cash Management, Human Resources and Compliance Management. The majority of Kim's experience has been in the Retail Sector most recently for Sears Holdings Corporation located in Hoffman Estates, IL. She has held many titles and lead Business Analytic teams at District, Regional and Corporate levels and has served as a Senior Analyst and Corporate Operational Compliance Manager where her team developed a Retail Compliance Document to assist store locations to identify and correct deficiencies, while updating any changes that came about through updates to Federal, State and Local Laws and Regulations. This electronic document replaced a procedure manual that was in place for nearly 50 plus years. She has worked many years on transition projects converting manual systems to electronic/scan-based systems to improve operational efficiency and productivity. Kim's background also includes experience as a Controller in the Manufacturing Industry and a Consulting Engineering Firm in Western New York.
Kim has attended Holy Family University and the University of Hawaii (Manoa) and holds a BS Degree in Business Administration. She continues her pursuit of Knowledge while presently attending classes at Princeton University. Kim has served on Community and Educational Boards in the Delaware Valley and has been actively involved with the March Of Dimes, Lupus Foundation and the Variety Club both in Western New York and Philadelphia.
Ralph Shults is the Maintenance Team Group Leader. He has extensive experience in the maintenance, repair, and service of a wide range of machinery and equipment. His troubleshooting skills are exceptional in HVAC, refrigeration, and pressure systems especially when focusing on lyophilizers and steam sterilizers. He also has an extensive background in aseptic fill finish for lyophilized materials.
Ralph began his career in the United States Navy as an Aviation Support Equipment Technician. He leveraged off the skills and leadership in the military when he joined the pharmaceutical field as a Lead Manufacturing Technician and Lyophilization Operator at American Pharmaceutical Partners from 1998 through 2008. Ralph joined LTI in 2008 as a Clinical Manufacturing Technician II, quickly advancing to Lyophilizer Maintenance Technician, and his current role as Group Leader. He has completed several courses related to HVAC, refrigeration, PLC controls, and electrical fundamentals. Ralph's diligence, critical thinking, and hands-on mechanical aptitude has proved invaluable to LTI.
