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Michele Dougherty
Vice President, CMC Biologics at DataRevive USA LLC
Professional Background
Michele Dougherty is a distinguished professional in the biopharmaceutical industry, known for her extensive expertise and leadership in regulatory affairs and tumor biology. As the Vice President of CMC Biologics at DataRevive USA LLC, Michele plays a pivotal role in managing and directing the company’s efforts towards the development of biologics, a crucial area of focus in modern medicine. Her career trajectory is marked by significant contributions to the regulatory landscape, particularly in ensuring that therapeutic biologics and biosimilars meet the highest standards of quality and efficacy.
Before her current position, Michele served as the Executive Director for CMC Regulatory at the same organization, where she oversaw critical regulatory submissions and interactions with government entities, shaping policies that guide the biopharmaceutical sector. Her experience extends deep into the corridors of the U.S. Food and Drug Administration (FDA), where she has held several prominent roles, including Science Policy Analyst, Review Chief of the Division of Biotechnology Products, and Product Quality Team Leader for Monoclonal Antibodies. Her significant tenure at the FDA has equipped her with unparalleled insights into the complexities of drug regulation, making her a sought-after expert in the field.
In addition to her regulatory roles, Michele has demonstrated a commitment to research during her postdoctoral fellowship at the National Cancer Institute (NCI) in Frederick. Here, she honed her skills in tumor biology, contributing to important research efforts aimed at understanding cancer pathology and treatment.
Education and Achievements
Michele holds a Doctor of Philosophy (Ph.D.) degree in Tumor Biology from Georgetown University, complementing her undergraduate studies in Zoology from Connecticut College. This strong educational foundation has been instrumental in her ability to bridge the gap between scientific research and regulatory practices. Her academic journey not only underscores her dedication to biological sciences but also positions her as a knowledgeable resource within the regulatory community.
Throughout her career, Michele has been recognized as a leading authority on issues surrounding therapeutic biologics, driven by her in-depth knowledge and practical experience. Her ability to navigate the complexities of drug development and regulatory submission processes has been vital in advancing innovative therapies and ensuring public safety.
Michele is particularly passionate about the role that comprehensive regulatory frameworks play in accelerating drug development timelines. She firmly believes that well-structured regulations can enable faster access to breakthrough therapies for patients while maintaining stringent safety and quality standards. Her contributions to the field have undoubtedly helped shape the policies that govern the biopharmaceutical industry today.
Notable Achievements
- Leadership at DataRevive USA LLC: In her current role as Vice President of CMC Biologics, Michele has spearheaded initiatives that streamline product development processes, ensuring that new biologics reach the market promptly and safely.
- Regulatory Impact at the FDA: While at the FDA, Michele was instrumental in enhancing the review processes for biologic products, working diligently to establish guidelines that are now industry standards. Her expertise in monoclonal antibodies has been especially influential, paving the way for numerous product approvals.
- Policy Development: As a former Science Policy Analyst, Michele has contributed to policies that emphasize the importance of innovation in drug development, particularly in the context of rapidly evolving biotechnologies. Her proactive approach has fostered a collaborative environment between industry stakeholders and regulatory bodies.
- Educational Contributions: Michele's background in biology and her experience at prestigious institutions have allowed her to mentor aspiring professionals in the biopharmaceutical field, fostering the next generation of scientists and regulatory affairs experts.
tags=[
Tumor Biology
Biopharmaceuticals
Regulatory Affairs
FDA
DataRevive USA LLC
Monoclonal Antibodies
Cancer Research
Biologics Development
CME Biologics
Doctor of Philosophy
Zoology
NCI Frederick
Executive Director
Science Policy Analyst
Career in Biomedicine
Healthcare Innovation
Public Health
Location
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