Mark has held leadership positions in global contract research organizations (CROs) for the past 25 years, overseeing industry-leading client-relationships and supporting the development of numerous blockbuster drugs and medical devices, including three of the world’s top-selling drugs. As CEO of Avomeen, Mark fosters a positive and collaborative culture, championing Avomeen’s scientific team in harmony with our clients. He works closely with the senior leadership and project teams to ensure the company delivers on its promise to be an innovative and tenacious partner with exceptional client service, while ensuring compliance with rigorous regulatory standards.
Andrew has 20+ years of experience executing and managing analytical and product development programs, both internally and in external organizations. Avomeen clients regularly benefit from his expertise in analytical chemistry and product development, particularly in highly regulated areas, including pharmaceutical development and testing, food contact migration studies, extractables and leachables studies, food additive and food contact notification testing and registration, and pesticide and insecticide testing under FIFRA. With his sound perspective, Andrew has been sought out as an expert witness for industry litigation cases and has participated in FDA pre-notification conferences, FDA site audits, and trained FDA inspectors on analytical technology.
Derek epitomizes the role of an experienced client consultant, with expertise in both highly regulated and newly regulated industries and applications, such as nicotine and e-liquid analysis. Derek serves as Avomeen’s foremost expert in this space and his knowledge has been showcased in trade publications and regulatory focused conferences. His experience extends to a wide breadth of characterization techniques and the respective instrumentation and software. He has years of experience with pre-formulation development of small molecules and their physical properties and has designed and demonstrated large scale crystallization processes for a number of late discovery pre-clinical candidates. Derek continues to innovate and push forward in his field, keeping Avomeen at the leading edge of the life sciences.
Neelam’s diligence and intellect brings incredible value to Avomeen and to our clients. She has extensive experience in all CMC aspects of pharmaceutical products from preclinical testing and submission to 510(k)/IND/NDA modules to post-approval regulatory requirements. Neelam’s wealth of regulatory knowledge includes expertise in extractables and leachables for all product types, including drug-device combination products. Avomeen’s clients benefit greatly from her insight and expertise in cleaning validation and more. To all of this, Neelam brings 22+ years of pharmaceutical industry experience, primarily applying ICH and other regulatory guidance to build compliant systems.
Evan specializes in developing novel and superior formulations for a wide range of applications, including OTC and consumer products, industrial materials, paints and coatings, and household products. Each design is supported and validated with real world experiments to capture an accurate measure of performance. Evan works closely with a team of industry-leading formulators, and frequently leads the charge in R&D all the way through to product launch. He excels at scale-up and troubleshooting manufacturing equipment and manufacturing material improvements.
Hashim has more than 25 years of PD/CMC/MS&T experience with design and development of conventional, NDDS/alternate advanced/modified drug delivery systems, and platform technologies. He has led and maintained the oversight of the process of products from early development to commercialization, and his expertise has been sought for various dosage-form developments with an emphasis on delivering scalable, robust products. Hashim and Avomeen’s team of formulators routinely go above and beyond to deliver to our clients. He is a recognized expert on IND-ANDA-NDA-505b2 RA-QbD-filings and both conventional and QbD-based tech-transfer across global sites, holds 21 patents on drug formulation/process in the US and globally, and has more than 30 presentations-publications of his work in various symposiums/conferences.
Khanh provides clients with unparalleled expertise and tactical knowledge of protein biochemistry and molecular biology. Her experience extends from R&D to analytical method development, validation, implementation, method transfer, and optimization of test methods for the cGMP setting per USP and ICH guidelines. This understanding of the entire process helps guide successful and productive collaborations across different laboratories, sites, and functions. Khanh is also adept at protein expression and purification from E. coli and mammalian cells, in vitro potency assays, protein/DNA/peptide binding studies, ELISAs and other immunological methods, analytical chromatography, forced degradation studies, product quality investigations, and manufacturing investigations. Her technical background provides the foundation for effective authorship of analytical sections in BLAs and MAAs, as well as responses to requests and questions from the FDA, EMA, and PMDA.
Katie is in many ways the heart of Avomeen, having championed the company and its people for close to a decade. She combines her extraordinary operations capabilities with a deep understanding of client needs and proven process development strategies. Her broad range of experience includes strategic contract development, marketing and content development, and recruitment. Katie is responsible for establishing, employing, and expanding initiatives to broaden relationships and enrich Avomeen’s client experience.
Overseeing the core administrative functions of finance, IT and facilities, Ty is essential to Avomeen’s day-to-day operations. Drawing on close to 30 years of knowledge and expertise, he has ensured proper business controls and reporting in all aspects of the company for nearly a decade. His finance and IT experience span numerous industries including laboratory services, technology and manufacturing.
Carla has 10+ years of pharmaceutical industry experience and has been ASQ and CQA certified since 2015. Throughout her career, she has effectively coordinated all functions of an internal QA organization, including the development, implementation, and monitoring of quality systems and procedures. She has particular expertise in standardizing operations to improve compliance and performance and the use of risk assessments. Carla is well practiced in authorizing standardized documents and procedures, leading change control processes, reviewing and releasing analytical data for raw materials, intermediates and finished goods, providing deviation resolution approval, and supporting regulatory and client audits.
Lori is an integral member of the Avomeen team and provides support to many facets of the organization; first and foremost human resources. For close to 30 years, she has overseen various HR functions, including staff recruitment and retention, policy and procedures, environmental compliance and administration, and employee development and training. She oversees employee engagement at Avomeen and works across all functions to support and coordinate a number of initiatives, including training, safety, wellness, and professional development.