Dana Toops is President of Avema Pharma Solutions and Chief Science Officer of PL Developments. He has 30+ years of pharmaceutical industry experience, including positions at Upjohn, Pharmacia and Pfizer. His experience includes nine years of discovery R&D in infectious diseases and medicinal chemistry culminating in 14 publications and 6 granted patents. In addition, he has sixteen-plus years of experience in drug product and active pharmaceutical ingredients manufacturing (R&D to commercialization) in the areas of quality compliance, regulatory affairs, formulation development and project management with one formulation patent.
He has a strong working knowledge of US FDA and GXPs including participating in Type B and C FDA meetings, two NDAs managed from submission through approval including one REMS negotiation with FDA. Also successful with 15 ANDA submissions through the review and approval process with several pending application under review. He is an active member of Regulatory Affairs Professional Society, American Association of Pharmaceutical Scientist and was a participant on Consumer Health Products Association’s Manufacturing Controls.
Aaron Dely is the Senior Director of Global Research & Development at Avéma and PL Developments. He manages development activities to ensure that projects transition from research to commercialization. Avéma/PLD’s R&D Center is responsible for the development, scale-up, and commercialization of all solid-dose and liquid-dose, over-the-counter (OTC), Rx-ANDA, and Rx-branded pharmaceuticals.
Aaron has experience and expertise in processes associated with product development including Quality By Design, Design Control and Risk Management, and his group drives these processes through the project management and change management processes.
Prior to joining Avéma, Aaron worked at Azopharma and Andrx Pharmaceuticals where he was involved with developing controlled drug delivery systems and early stage formulation development.
Dr. Arthur D. Besteman, Ph.D. has over 22 years of experience working in pharmaceutical product development. He has worked for large pharma, CDMOs and specialty pharma focusing on analytical research and quality control. He started his career at Pfizer Central Research supporting projects from Phase 1 to post-commercial. His project work included method development and validation, polymorph characterization and controlled release delivery technology. He was involved in IND and NDA regulatory filings, including azithromycin and pregabalin.
He then moved on to a focus in developing transdermal products. He was involved in implementing new technologies to address increased regulatory scrutiny on this dosage form, including involvement in the review of the USP general chapter and workshop for transdermal and topical products. He wrote portions of ANDAs and NDAs as well as representing analytical development in FDA audits.
Arthur joined Avéma Pharma Solutions in February 2020, leading the analytical development team as Associate Director of R&D Analytical. The team has experience with many types of dosage forms including tablets, capsules, oral suspensions and gums.
Christopher Shores is a PMP-certified Experienced Pharmaceutical Portfolio Manager with a demonstrated history of working in the pharmaceuticals industry. Skilled in Pharmaceutics, Good Laboratory Practice (GLP), Contract Development, Change Control, Development, Validation, and GMP. Strong operations professional with a B.S. focused in Chemistry from University of Delaware. He joined Avéma/PLD in 2013 after holding positions at Azopharma and ISP.
Jaime A. López Méndez is Director of Quality at Avéma/PLD, joining the company in 2020. Jaime has over 25 years of experience working in the Pharmaceutical Industry. He has a wide knowledge Quality Control, Quality Assurance and Manufacturing process. He started his career as a Chemist at Shering Plough and later moved on to work in their manufacturing department as a Production Manager.
Throughout his career, Jaime has had opportunities that have gained him a vast experience in aseptic manufacturing process of Liquid and Lyophilized products, creams, ointments and gels, as well as solid dosage product (Capsules and Tablets) and non-aseptic products such as liquids solutions and suspensions. Wide experience working throughout Consent Decree remediation projects and in the development and implementation of Quality Systems; highly qualified in root cause analysis and CAPA Systems. Experience in regulatory inspections (FDA, MHRA, ANVISA, Japan BOH, Turkey BOH).
Jaime received his BS in Industrial Chemistry from the University of Puerto Rico.