Valerie is an organized and self-motivated engineer who thrives in a collaborative team environment. Through her 5+ years as a Lead Reviewer and previously as an acting Senior Lead Reviewer at the U.S. Food and Drug Administration, she has demonstrated strong leadership and the ability to effectively and efficiently manage multiple complex regulatory submissions, including preparation for and presentation at a meeting of the Circulatory System Devices Panel.
Through Valerie’s graduate research experience at The University of Arizona and FDA, she has experience in the very early stages of product development. At UA, her dissertation work focused on the fabrication of a novel material for potential cardiovascular applications with specific laboratory experience in nanofibrous scaffold fabrication, cell-material interactions, and platelet activation. At The University of Arizona, Valerie also completed coursework related to teaching at the collegiate level, inclusive of coursework on how people learn and how to tailor messages to address different learning styles. This education instilled a strong value of communication, which is essential between team members, management, industry, and other stakeholders.
Currently Vice President of Regulatory Affairs of Almatica. Previously, was Head of Regulatory Affairs with responsibilities in building and leading global regulatory organizations. Early and late stage Regulatory experience in Diabetes, Oncology, Neurology, Infectious disease as well as experience in Combination Products , Generics and Diagnostic Imaging with U.S. Food and Drug Administration (FDA) and other leading Health Authorities in Life Sciences. Research and Development (R&D) industry experience in development of products from test tube to market . Degree in Chemistry and post-doctoral research in Oncology, strong R&D, business development and management experience in industry.
Mr. Antonetti holds a Masters of Science degree (M.Sc.) in Biophysics with a Specialization in Neuropharmacology. With more than 20 years of experience in the Regulatory Agency (Health Canada), Pharmaceutical and Medical Device industry, he has acquired extensive experience and understanding of the GMPs including sterile manufacturing, GCP and Medical Device Regulations. While at Health Canada, he worked in the Drug Investigation Unit, the Medical Device Unit and the GMP Inspection Unit where he was a member of the GMP Committee and contributed to the development and enhancement of Regulations, Policies and Guidelines, including Health Canada Guide-00069 on Temperature control. He currently holds the position of Executive Director, Regulatory Affairs & Quality Management – Safety, Health and Environment at Roche Diagnostics where he is responsible for all aspects of Licensing, Compliance, Quality and Safety. He is actively involved with MEDEC representing the Medical Device industry during meetings held with Health Canada and other stakeholders.
Contributes Warehousing and Distribution assistance to Country Programs work through short-term technical assistance trips, report development, and project implementation. Experienced in international project management, including contract and subcontract administration, budget development and tracking, recruitment, and operations oversight.
My goal now is to create and awareness in our supply chain min requirements how to transport Temperature sensitive goods especially on the Pharma Sector in the aircargo supply chain. Worked very close with Dupont to develop the cargo thermoblanket. Giving the shipper an understanding the difference between pax operation and cargoperation. Ensuring that forwarder and shipper of the pharma community have an understanding what the requirements are. Involved in various projects to ensure pharmaceutical companies switch to our company following the requirements set by the various authorities.
Michael Breen, PhD, is the Senior Director of Infectious Diseases and Oncology at GlobalData in Boston. He has over eight years of experience in market analysis, business intelligence, and providing strategic insight for the pharmaceutical industry. Prior to his current role, he was a Senior Analyst for Decision Resources Group, where he gained extensive experience writing in-depth reports and developing forecasts for a variety of indications, including rare and infectious diseases and vaccines. Michael has a BA in biology and biochemistry from Hunter College, and a PhD in biochemistry from Boston University School of Medicine.
Mr. Herjolfsson co-founded Controlant, a global company that offers next-generation Cold Chain solutions as a Service (CHaaS). He has driven the vision, culture, and growth of the company for the last 10 years.
Specialized in development of ophthalmic medical devices with strengths in clinical, regulatory and quality aspects. Has gained extensive experience in clinical research and clinical project management by leading high priority projects to successfully develop and launch best-in-class products in eye care business.
Has experience in building and defending regulatory strategies, as well successfully led and defended multiple internal and external audits, including FDA inspection and recall process.
Oversaw development of Human Factors Evaluations.
Has led high performing global, cross functional teams to respond to short term, immediate needs and developing strategies for long term sustainability by building R&D pipeline.
Proven success with Fortune 500 companies, as well as start-up firms.
Specialties:
Clinical product development, clinical operations, building and executing systems, strategies to streamline processes and improve efficiency.
Develop new strategic alliances and evaluating new technologies.
Organizational development.
