My Journey Through Drug Development for More Meaningful Change
Dr. Lauren Black, a distinguished scientist at Charles River Laboratories, spoke at the 2018 FAST Science Summit about her journey in drug development and the importance of understanding the FDA’s regulations for the safety of children. She emphasized the need for careful selection of drug candidates and the importance of patient advocacy in the drug development process. Dr. Black shared her personal experiences and highlighted the progress made in cell and gene therapies for rare diseases. She concluded by expressing her admiration for the work of the FAST community and their commitment to finding cures for Angelman Syndrome.
In this talk, Dr. Lauren Black shares her personal journey and experiences in drug development, specifically in the context of rare diseases like Angelman Syndrome. Dr. Black, a distinguished scientist at Charles River Laboratories, discusses the importance of understanding the FDA’s regulations and the need for collaboration between researchers, patients, and regulatory agencies to ensure the development of safe and effective drugs.
Background and Inspiration
Dr. Black’s involvement in the Angelman cause began when Dr. Yu, a respected scientist, recommended her as a valuable asset to the program. Impressed by her expertise and dedication, the Angelman community welcomed Dr. Black with open arms. Her background in both the FDA and the pharmaceutical industry allows her to bridge the gap between regulatory requirements and drug discovery, making her an invaluable resource for the Angelman community.
The Importance of FDA Regulations
Dr. Black emphasizes the importance of understanding and working with FDA regulations in drug development. She highlights the FDA’s role in ensuring the safety of patients and explains how researchers can use this knowledge to select the best drug candidates for rare diseases. By understanding the FDA’s requirements and collaborating with regulatory agencies, researchers can navigate the drug development process more effectively.
Lessons from Past Experiences
Drawing from her experiences in drug development, Dr. Black shares insights into the challenges and successes of developing drugs for rare diseases. She discusses setbacks and adverse events that can occur during clinical trials, emphasizing the importance of informed consent and patient safety. Dr. Black also highlights the progress made in cell and gene therapies, citing examples like Kymriah and Luxturna, which offer hope for the treatment of genetic disorders.
Applying Knowledge to Angelman Syndrome
Dr. Black encourages researchers and advocates for Angelman Syndrome to leverage the knowledge gained from previous drug development experiences. She emphasizes the importance of cross-applying scientific findings and using animal models to study the effects of potential treatments. By incorporating patient priorities and concerns into the drug development process, researchers can ensure that the selected drugs address the specific needs of the Angelman community.
Dr. Black concludes by expressing her admiration for the Angelman community and their dedication to finding a cure. She commends the work of FAST and encourages continued collaboration between researchers, patients, and regulatory agencies. Dr. Black’s insights and experiences serve as a valuable resource for the Angelman community as they navigate the drug development process and work towards meaningful change.
- Title: My Journey Through Drug Development for More Meaningful Change
- Author(s): Lauren Black
- Author(s)’ affiliation: Charles River Laboratories
- Publication date: 2019-01-10
- Collection: 2018 FAST Science Summit