Premier Consulting Expands Team in Global Regulatory Affairs
Morrisville, N.C., November 7, 2022 — Premier Consulting, a business unit of Premier Research, has deepened its bench with the addition of four key global regulatory experts to its leadership team. This change strengthens Premier Research’s ability to deliver on its mission – helping small to midsize innovative biotech companies take their best ideas from molecule to market.
“We are very excited to complement our existing team with the addition of four vice presidents who broaden the specialized expertise of our multidisciplinary teams across the full spectrum of development services,” said Premier Consulting President Shari Medendorp, MPH. “Whatever product type a sponsor is developing, wherever a program is in the development lifecycle – from raising funds and creating a regulatory strategy to patient recruitment and data analysis – our experts have the experience and knowledge to help.”
These recent appointments include:
William Salminen, PhD, DABT, PMP, joins as VP, Nonclinical Safety and Toxicology. He has more than 20 years of drug development experience for an array of drug products and indications. He is board-certified in toxicology (DABT) and project management (PMP) and is a subject matter expert in nonclinical safety and toxicology support for drug product development. His experience includes regulatory strategy and advice, nonclinical safety, toxicology strategy and advice, U.S. FDA pre-Investigational New Drug (pre-IND) meetings, IND applications and maintenance, and new drug application (NDA) and biologics license application (BLA) submissions.
Salminen has significant experience with the regulatory, nonclinical, and clinical strategies involved with developing 505(b)(2) products and research experience in developing new biomarkers of drug-induced liver injury. He has served as the Director of the Center of Excellence for Hepatotoxicity at the FDA National Center for Toxicological Research, authored or co-authored numerous scientific publications, and presented his work through multiple channels.
Kimberley Cummings, PhD, RAC, joins as VP, Regulatory Affairs. She brings more than 20 years of regulatory affairs experience to Premier Consulting. Previously, Cummings was VP of a small biotech company focused on the development of treatments for a rare neuroendocrine disorder. Before that, she served as a regulatory consultant for 18-plus years, during which she provided leadership for the implementation and execution of regulatory strategies in all phases of drug development and numerous indications, often with a focus on rare diseases.
Greg Meyer joins as VP, Regulatory Affairs. He has been in the pharmaceutical, biopharmaceutical, and medical device industry for more than 30 years and has gained regulatory approvals in more than 20 countries. Meyer has represented companies during numerous interactions with the FDA, European national and EU regulators, and the Australian TGA and has worked on the development, submission, and commercialization of products in oncology, neurology, and dermatology. His specialty areas include biologics and drug-device combination products.
Matthew Nowland joins as VP, Regulatory Affairs. He is a GxP (Good Practice Guidelines) regulatory, clinical, and quality assurance professional with 30 years of experience serving companies in the healthcare field, including medical device, IVD (in vitro diagnostic), and pharmaceutical companies. He is knowledgeable in both medical device and drug development regulations, including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations.
Nowland has developed and advanced innovative technologies from surgical robotics to molecular diagnostics, biologics, blood products, and all classes of medical devices, both therapeutics and IVDs. He has also developed, executed, and managed global quality assurance programs and prepared and managed several successful global product registrations.
About Premier Consulting
Premier Consulting is a strategic product development and global regulatory consulting brand dedicated to supporting the specialized needs of emerging biotech and specialty pharma companies. These small to midsize companies are the very heart of drug development. Like them, we are dedicated to the patient journey and are driven by the challenges of bringing new life-saving technologies to market.
As a unit of Premier Research, we are informed by our Built for BiotechSM core capabilities and deliver end-to-end strategy, regulatory, nonclinical, CMC, quality, and commercial solutions that are best in class. With a customer-centric culture, we pair efficiency with quality as we guide sponsors every step of the way to commercialization. We tailor development plans to meet the most rigorous global regulatory requirements and deliver results for sponsors — and the patients they serve. Visit premierconsulting.com.