Michael Mesa
President

Michael Mesa is no stranger to drug delivery system development. Following a four-year tour in the U.S. Air Force, he joined Rodana Research Corporation, where he initially agreed to stay for six weeks. However, after seeing the important work they were doing, he stayed with the Rodana team and launched a career that spanned over 40 years. He remained employed by Rodana’s successor organizations, Survival Technology Inc., Meridian Medical Technologies Inc., King Pharmaceuticals Inc., and Pfizer until 2011 when he formed Mesa Science Associates (MSA).
During this tenure, he gained valuable experience as a product engineer, supply chain manager, and product development executive. Within these roles, he was involved in the creation of the first ever epinephrine auto-injector, as well as antidote delivery systems that are used to protect soldiers who have been exposed to nerve agents. Mr. Mesa is now a named inventor on over 20 patents and extensions.
One important achievement acted as a catalyst for the founding of Mesa Science Associates. Mr. Mesa created what was later dubbed as the Quality Engineering Evaluation Program. In this effort, he and his team would visit suppliers to perform quality evaluations, educate the supplier teams on final product requirements, create process improvements, and develop improved specifications. The QEE team efforts were coordinated with his home factory quality teams and resulted in significant improvements in incoming component quality resulting in significantly fewer rejections of incoming materials. These efforts had positive impacts on the home plants’ efficiency and final product quality.
Michael Mesa’s experience with all levels of design, development, and manufacturing of auto-injectors opened the door to another important opportunity. He became the principal investigator for the development of the Antidote Treatment Nerve Agent Autoinjector (ATNAA), a dual chamber auto-injector that combines two important but incompatible antidotes into one device. With the dual-chambered device, the antidotes are kept separate in the device but apart throughout the single injection sequence including in the injection site. The ATNAA device ultimately morphed into the DuoDote system which is supplied to civilian first responders. Both unique systems are still available today.
In 2011, Mr. Mesa left Meridian/Pfizer to bring his dream to life and founded Mesa Science Associates (MSA). Since then, he’s grown the business to provide drug development solutions and services to customers worldwide and he has expanded the company’s reach into both human and veterinary products and now includes nasal delivery in the company’s field of expertise.
Ken Dretchen
Vice-President and Chief Science Officer

Dr. Kenneth Dretchen, Ph.D. has experience in several areas, including: pharmacokinetics, pharmacodynamics, and pre-clinical studies involving safety, efficacy and toxicity. He concurrently serves as Professor Emeritus and was the former Chair of the Department of Pharmacology and Physiology at Georgetown University Medical Center. There, he teaches pharmacology and physiology to medical students and residents in the Departments of Psychiatry and Anesthesiology. Previous positions at the university included his role as the Dean of Research for the Medical Center and the Senior Associate Vice President for Regulatory Affairs.
During the first three years of its existence, Dr. Dretchen served as an expert and advisor to the Department of Homeland Security for biological and chemical threat agents. From 2007 to 2010, he was a member of the National Biodefense Science Board, reporting directly to the Secretary of Health and Human Services. This board provided advice to the secretary on issues such as emerging and infectious diseases, chemical and biological threat agents, and H1N1 influenza.
His work also includes successful industry collaborations, including one of the largest defense contractors in the development of a rapid stand-alone detection system for biological threat agents based upon DNA analysis. This project resulted in vital developments of specific nucleic acid probes for anthrax, plague, and dengue fever.
Dr. Dretchen served as a consulting pharmacologist for King Pharmaceuticals on a study involving clinical trials to assess the pharmacokinetics and side effects of midazolam given intramuscularly via an auto-injector. The result of this study was a benefit to the treatment of seizures.
Tim Warneke
Vice President, Clinical Operations

Tim Warneke brings over 20 years of pharmaceutical development experience to the team. His previous roles range from large (Ciba-Geigy and Abbott Laboratories) to mid-size (King Pharmaceuticals) pharmaceutical companies and the world’s largest contract research organization (Quintiles).
Mr. Warneke has leveraged his expert knowledge of the Code of Federal Regulations, ICH Guidelines, Good Clinical Practice, and Good Laboratory Practice to provide operational excellence in support of numerous INDs and NDAs throughout his career. Operationally focused, he’s been responsible for clinical study conduct across all phases of pharmaceutical development. These range from single-center studies to large multinational clinical trials utilizing a wide array of therapeutic areas including:
- Cardiology/Vascular Diseases
- Dermatology
- Devices
- Endocrinology
- Gastroenterology
- Healthy Volunteers
- Hepatology (Liver, Pancreatic, Gallbladder)
- Infections and Infectious Diseases
- Musculoskeletal
- Nephrology
- Neurology
- Oncology
- Orthopedics/Orthopedic Surgery
- Pediatrics Podiatry
- Psychiatry/Psychology
- Pulmonary/Respiratory Diseases
- Rheumatology
- Vaccines
Mr. Warneke began his career at Northwestern University in the Department of Community Health and Preventive Medicine, coordinating the clinical activities of the landmark NHLBI-funded CARDIA study from its initial year in 1983 to 1988.