Miksinski

Claire G Miksinski, age 85, Cornwall, NY View Details

Cities: Cornwall NY

Edward Miksinski, age 49 View Details

Sarah Pope Miksinski, Ph.D. - University Blog Service • utexas.edu

Bio: Sarah Pope Miksinski, Ph.D., recently started a new position as Senior Director and Group Manager, GMD, with Astra Zeneca. Miksinski was recently the Acting Director of CDER's Office of New Drug Products (ONDP), where her primary responsibilities included leadership of activities and operations related to quality review of newly­proposed drugs for clinical trials and U.S ...

Volunteer Profile: Regulatory Steering Committee Chair - Sarah Pope ... • ispe.org

After completing her doctoral degree at Oklahoma State University, Sarah Pope Miksinski received a fellowship at the National Institutes of Health. While working there, she realized that research was not the best career path for her.

PDF Regulatory Considerations for Antibody- Drug Conjugates • fda.report

Sarah Pope Miksinski, Ph.D. (ONDQA) Marjorie Shapiro, Ph.D. (OBP) OPS, CDER. AAPS (October 18, 2012) 2 ADC IND Submissions 0 10 20 30 93-97 98-02 03-07 08 - 9/12. 3 ADC Review Responsibility Master cell bank Drug Product Starting Material Starting Material Derivative Monoclonal Antibody component/intermediate

EMA Executive Director Discusses the Future of Innovation and ... • ispe.org

Miksinski returned to her point about the resources companies invest to prepare for communication with regulators. Even when the discussions are supposedly informal, companies pour huge amounts of time and energy into ensuring they can present their material as well as possible, which can make the process intimidating.

International Society for Pharmaceutical Engineering - ISPE • ispe.org

Sarah Pope Miksinski joined Gilead in July 2023 and serves as Executive Director in CMC Regulatory Affairs, where she leads a global team focused on regulatory advocacy for health authority submissions. She also contributes to global initiatives and represents Gilead in external roles, including on PhRMA's Global Quality and Manufacturing ...

PDF The Art of Engineering with Denise McIntosh - Custom Powder Systems • custom-powder.com

Sarah Miksinski: You did you did. In fact, the funny story is that I used to be Sarah Pope before I was married and I went from a relatively simple sounding last name to a very complicated last name. So you did well. Thank you. Denise McIntosh: Thank you. Well, I'd like to just share a little bit about how you and I got connected, and

Sarah Pope Miksinski | ISPE | International Society for Pharmaceutical ... • ispe.org

Sarah Pope Miksinski has been with AstraZeneca since February 2018 and is currently an Executive Director in CMC Regulatory Affairs, AstraZeneca. Her duties include leadership of a global team covering CMC regulatory strategy for development and commercial health authority submissions, as well as serving as a key contributor to several ongoing initiatives including benefit/risk, continuous ...

Sarah Pope Miksinski, PhD - PDA • pda.org

Sarah Pope Miksinski, PhD, is the Acting Director of the FDA's Office of New Drug Products (ONDP), in the Office of Pharmaceutical Quality (OPQ). She obtained her B.A. from Earlham College (1994), her doctorate in Organic Chemistry from Oklahoma State University (1999), and completed a postdoctoral fellowship from NIH (2000-2002). ...

Sarah Pope Miksinski, PhD - American Pharmaceutical Review • americanpharmaceuticalreview.com

Articles by Sarah Pope Miksinski, PhD. Patient Centricity, Risk Communication and Regulatory Considerations for Continuous Manufacturing. Tuesday, March 23, 2021 Continuous manufacturing is currently a hot topic in the pharmaceutical landscape despite the concept having been around for decades. One reason is that the majority of pharmaceutical ...