IPAC-RS Press Releases
IPAC-RS Announces New Board Leaders
WASHINGTON, DC – January 7, 2022 – The Board members of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) have elected Michael Needham as incoming Chair of IPAC-RS. Mr. Needham will serve a six-month term as Vice Chair and on June 1, 2022 will assume the role of Chair of the IPAC-RS Board, a two-year term. He will succeed current IPAC-RS Chair, Carla Vozone, PharmD, MBA, Vice President Strategy, Innovation and Partnerships Inhalation at Catalent Pharma Solutions, who is completing four years of leadership service to IPAC-RS and will become Chair Emeritus from June 2022-2024. IPAC-RS has also elected Dr. Jennifer Wylie to a two-year term as Vice Chair of the IPAC-RS Board of Directors. Dr. Wylie will assume the role of IPAC-RS Chair in June 2024.
“It is truly an honor to congratulate Mike Needham and Jennifer Wylie on being elected as Chair and Vice Chair of IPAC-RS. Mike and Jen have been dedicated leaders as Board members and I am confident they will build on the legacy of previous leadership and will expand the impact of the industry consortium in advancing regulatory science for orally inhaled and nasal products,” said Vozone. She continued, “Serving as Chair of IPAC-RS has been one of the most rewarding experiences of my career and I would like to express my gratitude to industry experts who continue to deliver projects that increase the collective knowledge of CMC aspects in OINDPs, collaborate with global regulatory agencies and create education resources for the industry.”
Mike Needham, BSc, MRSC, CChem, is Global Respiratory Product Development Manager at Kindeva Drug Delivery where he leads a team of scientists working on inhalation product development and science. His career in inhalation product development spans almost 30 years, primarily in the development of pMDI products and related device technologies. Mr. Needham has broad experience working on DPIs and other related technologies and has worked both for pharmaceutical companies and CDMOs. “I look forward to helping IPAC-RS remain the leading voice of the global orally inhaled and nasal drug product (OINDP) industry,” Needham said. “These past two years have highlighted the criticality of OINDPs and the companies that develop and manufacture these medical products. IPAC-RS will continue its important efforts to advance the global regulation and science of OINDPs and further its dedication to constructive collaboration with the broader OINDP community. I look forward to serving the IPAC-RS Board and working closely with leaders from industry, academic research institutions, and global regulatory authorities in advancement of patient care.”
Jennifer Wylie, Ph.D., is Director in the Analytical Research and Development department at Merck Research Labs. She has approximately 20 years of experience with orally inhaled dosage forms including DPIs, MDIs and nasal sprays. Dr. Wylie has managed both early and late-stage programs. She has a special interest in the preclinical space of inhalation programs. Dr. Wylie has been actively engaged in a number of IPAC-RS initiatives, with increasing roles of leadership. Dr. Wylie currently serves on the Steering Committee of the Product Quality Research Institute (PQRI) on behalf of IPAC-RS and has been an active member of PQRI’s inhaled BCS Working Group for several years. “I am honored to serve as IPAC-RS Vice Chair and to work closely with in-coming Chair, Mike Needham and current Chair, Carla Vozone. I have always been impressed with the breadth of initiatives that IPAC-RS sponsors – from its regulatory outreach groups that span agencies around the world to its numerous scientific and technical working groups focused on advancing the best science. IPAC-RS’s initiatives produce results that are relevant, timely and important. I am eager to help advance IPAC-RS’ strategic plan, including increasing collaboration with a broader range of stakeholders in the OINDP community.“
The International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) has been the leading global voice of the orally inhaled and nasal drug products (OINDP) industry for more than 20 years. Through joint research, benchmarking, collecting and analyzing data, and developing best practices, IPAC-RS advances and supports science-based regulatory approaches for OINDP, to ensure their availability, safety, efficacy, and quality. IPAC-RS works collaboratively across the industry and with external experts from regulatory agencies, standard-setting bodies, academia, pharmacopeias, healthcare providers, patient groups, and other stakeholders. IPAC-RS members are based around the world, and their activities are global, with region-specific projects in North and South America, Europe, and Asia. IPAC-RS shares its findings with the larger scientific and regulatory community through publications, online tutorials, in-person training courses, webinars, and conferences.
For more information, visit www.ipacrs.org.