CMC PHARMACEUTICALS - Key Persons
Art has had leadership roles in three start-ups including as Founder and CEO. With a broad science and business background, Art has particular strength in life sciences. He has 43 patents, numerous publications and his efforts have led to multiple commercial products. He serves on five boards and has previous board experience on 12 additional boards. He has been recognized with numerous awards, including induction into the National Academy of Inventors, the College of Fellows for both the Controlled Release Society and the American Institute for Medical and Biological Engineering. Art was elected to the National Academy of Engineering in 2021. He has a Ph.D. in Polymer Science and Engineering from the University of Massachusetts.
Art is currently serving CMC Pharma as a consultant on select commercial programs.
Casey Loveland has a background in marketing, working primarily in publishing and insurance since graduating with a degree in Communications from the University of San Diego. She transitioned into Pharmaceuticals 4 years ago to assist in the building of CMC Pharma and now involved in the day to day operations of the company.
Casey has used her organizational and planning skills to successfully set up and maintain the required licenses, insurances and procedures in order to operate a thriving company. Casey is a co-founder and current business manager at CMC Pharma.
Clark March has an MS from Virginia Commonwealth University / Medical College of Virginia and more than 30 years experience in the industry. He has extensive experience with chromatographic method development and validation of bio-analytical and content/impurity/dissolution methods, conducting projects under GLP/GMP conditions, communicating with sponsors and partners, dealing with FDA inspectors during laboratory audits, managing CROs and teaching and training junior scientists.
Clark's current role at CMC Pharma is to provide analytical chemistry oversight to all programs to ensure compliance with FDA regulations and expectations.
Don is a professional scientist who began his pharmaceutical career in 1995 holding several positions throughout from analytical bench chemist to leadership roles. After working in the pharmaceutical industry for over 24 years, he builds quality and integrity into products from early design and conception through commercialization. He is proficient in working with early stage to commercialized drug products; including the development, validation, and transfer of stability indicating analytical methods. He has utilized his extensive knowledge in directing and managing pharmaceutical Quality Control and Quality Assurance functions.
Don has performed analytical testing on hundreds of small molecule products from raw material to drug products for human use and participated in the execution of early to late-stage development of complex analytical methods. In Quality roles, he was an active member of committees providing direction for the development and sustainability of drug shortage finished dosage products. Don is currently the Lab Director at CMC Pharma responsible for all laboratory operations and supervision of CMC Pharma chemists.
Job Titles:
- Marketing & Business Development
Jared has an extensive background in marketing and was brought on to CMC Pharma to elevate the company's presence in the industry and to further improve client relations. Jared is responsible for all digital marketing efforts and is the main point of contact for PR, publications, and advertising opportunities.
In addition, Jared is typically the first person new customers will interact with at CMC. From there, Jared is actively involved in proposal preparation and contracting efforts and works closely with project managers and scientific staff throughout the execution stage to ensure that every client's needs and expectations are met and exceeded.
After spending the first 16 years of his career in academia as a lipid biochemist and marine biologist focused on vertebrate gastrointestinal digestion and absorption, John left to lead the drug delivery team at Genentech in 1985. After that he acquired extensive experience in Biotech industry drug delivery startups. He co-founded Inhale/Nektar Therapeutics in 1990, founded Dance Biopharm (now Aerami Therapeutics) in 2009, co-founded InCarda in 2009, and iPharma Limited in 2016, all specializing in inhalation of biologics and small molecules. In addition, John was the founding investor of Halozyme in 1999 and is presently CEO of Tesio Pharmaceuticals, two drug delivery companies specializing in injectable systems. Inhale's, lead product, Exubera won the Wall Street Journal's technical innovation of the year award in 2006. John is a Fellow of the Controlled Release Society (CRS) and received the CRS's Nagai Innovation Award in 2007.
Larry received a B.A. in Biophysics and his doctorate in Reproductive Biology from The Johns Hopkins University. After serving as a Research Scientist at ReProtect, LLC (Baltimore, MD), and a Senior Scientist at Epicyte Pharmaceutical (San Diego, CA), together with Dr. Kevin Whaley, he co-founded Mapp Biopharmaceutical and ZabBio, Inc. (San Diego, CA) and serves as President for both companies. He has been an adjunct faculty member of the Biodesign Institute at Arizona State University since 2004. Larry's career focus has been on the development of monoclonal antibody-based products to address unmet public health needs in infectious disease.
Job Titles:
- Special Projects Manager
- Chemical Engineer
Lisa Losch is a Chemical Engineer with 15+ years of experience in engineering, project management, and operations at manufacturing companies as well as the government and government contractors.
Her experience lies in strategizing and leading cross-functional teams to successfully execute complex projects including areas of sourcing, manufacturing, logistics, and cost control. She has exceptional attention to detail and organizational skills. Lisa is currently the Special Projects Manager at CMC Pharma.
Mary Kay has dedicated more than 25 years to the biopharmaceutical industry, holding senior executive leadership roles in support of scientific, clinical, regulatory, commercial, and strategic objectives across multiple therapeutic areas, including virology, diabetes, pain, and oncology supportive care. She has been an integral part of product design and development from early discovery, candidate selection, IND-enabling studies, clinical development and commercialization, and is an experienced project leader of multi-functional teams.
Mary Kay holds a B.S. from St. Edwards University and a Ph.D. in chemistry from the University of California, Berkeley. She is currently serving CMC Pharma as a consultant.
Job Titles:
- Director of QA & Tech Transfer
Matt has over 30 years of industry experience and has served in management and leadership capacities with leading pharmaceutical organizations specializing in contract manufacturing and proprietary branded drugs. Prior to joining CMC Pharma, he had the opportunity to lead key departments such as Research and Development, Quality Assurance, Project Management, Regulatory Affairs, Quality Control, and Microbiology. He worked for a company that progressed from 8 people to approximately 200 and added internal manufacturing capabilities. Matt's role evolved to include the implementation of the quality systems required to support an FDA-acceptable QC/RD laboratory and lead the Quality Unit in the buildout and commissioning of a state-of-the-art greenfield parenteral manufacturing site. Prior to his departure, Matt oversaw the submission of approximately 30 drug applications, resulting in the approval of over 10 ANDA's and 1 NDA.
Earlier in his career, Matt progressed primarily in Quality. In that period, he was given the opportunity to work on a wide variety of projects including the implementation and validation of complex software solutions such as LIMS and ERP, quality oversight in the renovation and qualification of a former device manufacturing site to a parenteral site, lead remediation efforts required to mitigate an FDA official action classification at multiple parenteral manufacturing facilities, and restructured a Quality Control laboratory to improve both compliance and efficiencies. During his tenure, these companies received approval of over 30 generic drug products and 15 NDA's
Matt holds a Bachelors of Science in Chemistry at the American Chemical Society accredited John Carroll University.
Job Titles:
- Co - Founder
- President
- Industry Scientist
- Pharma 's President
Dr. Radomsky is a pharmaceutical industry scientist and executive with nearly 30 years of experience in a broad scope of leadership, technical, regulatory, entrepreneurial, and consulting roles. His expertise results from his PhD in chemical engineering from The Johns Hopkins University and leading the formulation development, manufacturing, and commercialization activities of small molecule, peptide, and protein drugs. Mike focused his early research efforts on the development of using polymers to deliver drugs in a controlled release fashion and completed his dissertation on the use of polymers to deliver antibodies for the prevention and treatment of infectious diseases.
Mike has demonstrated success in advancing generic and innovator product pipelines from discovery to launch utilizing a wide variety of resources. By leading large and small groups of cross functional teams, he has developed a keen understanding of the unique dynamics between research, development, manufacturing, quality, clinical, and the regulatory functions required to develop and manufacture FDA regulated pharmaceutical products. He is a co-founder of CMC Pharma, and currently President of CMC Pharma serving as Principal Investigator for DoD funded and other research, development, and manufacturing programs.
W. Mark Saltzman is an engineer and educator. His research has impacted the fields of drug delivery, biomaterials, nanobiotechnology, and tissue engineering. This work is described in more than 300 research papers and patents. He is also the sole author of three textbooks: Biomedical Engineering, Tissue Engineering, and Drug Delivery. Saltzman earned his B.S. in chemical engineering from Iowa State University and his Ph.D. from MIT. He has served as a faculty member at Johns Hopkins University, Cornell University, and Yale University. Saltzman was appointed the Goizueta Foundation Professor of Chemical and Biomedical Engineering at Yale in 2002. He was the founding chair of Yale's Department of Biomedical Engineering and served in that role for 12 years. Since 2016, he has been the Head of Jonathan Edwards College, one of Yale's fourteen residential colleges.
Dr. Saltzman has been recognized for excellence in research and teaching: Camille and Henry Dreyfus Foundation Teacher-Scholar Award; the Allan C. Davis Medal as Maryland's Outstanding Young Engineer; the Controlled Release Society's Young Investigator Award and Founders Award; the Professional Progress in Engineering and Professional Achievement Citation in Engineering Awards from Iowa State University. He has been elected a Fellow of the American Institute for Medical and Biological Engineering; a Fellow of the Biomedical Engineering Society; a Member of the Connecticut Academy of Science & Engineering; a Fellow of the National Academy of Inventors; and a member of the US National Academy of Medicine and the US National Academy of Engineering. He has delivered over 300 invited lectures throughout the world.