Prior to law school, Barbara earned her Ph.D.
In 2016, Barbara was named to her alma mater Cardinal Stritch University's College of Arts and Sciences Advisory Committee.
She has held numerous positions within the Food and Drug Law Institute (FDLI), including serving as a member of the FDLI Board of Directors. She was a working group member for a grant awarded to the University of Maryland by the National Institutes of Health's (NIH's) Human Microbiome Project for the study of the federal regulation of probiotics.
#Two sigma client solution barbara professional#
Clients look to me to be able to translate their scientific discoveries into an actionable FDA strategy.īarbara has also served on various professional boards and groups. This results in better communication with clients because I speak their language. My training in science, biomedical ethics, and the law allow me to truly understand my client’s technologies. Preparing a request for designation (RFD) with FDA’s Office of Combination Products regarding product regulation as a drug or a medical device.īarbara has published and presented on numerous FDA-related topics, including 505(b)(2) NDAs INDs medical foods human cells, tissues, and cellular and tissue-based products (HCT/Ps) the Drug Supply Chain Security Act (DSCSA) and risk evaluation and mitigation strategies (REMS).Counseling a food producer on compliance with the Food Safety and Modernization Act (FSMA).Performing due diligence on a stem cell company for an investment group.Working with a European company to convert its CE-mark dossier for a medical device into a cleared 510(k) notification.Assisting the sponsor of an abbreviated new drug application (ANDA) with FDA’s notification that it refused to receive a first filer ANDA containing a Paragraph IV patent certification.Advising the sponsor of a new drug application (NDA) regarding the availability of three-year marketing exclusivity based on studies supporting the application.
Guiding a physician-investigator through the pre-investigational new drug application (IND) meeting and IND submission processes for a regenerative medicine product.Key examples of Barbara’s experience include: She has worked with clients on virtually all types of FDA-regulated products, including drugs (human and veterinary), biologics, regenerative medicine (cell and gene therapies), medical devices, foods (human and veterinary), and combination products. For example, Barbara works closely with Buchanan’s IP attorneys to create a holistic IP/FDA strategy that takes into account the company’s patent portfolio, FDA Orange Book listings, and FDA-granted regulatory exclusivity.īarbara assists clients with FDA regulatory matters arising before, during, and after product approval and marketing. She leverages her unique background, integrating science and biomedical ethics into her legal practice to create true value for her clients. Binzak Blumenfeld, Ph.D., helps clients make and execute on strategic decisions about FDA-regulated product approvals. In November, The Wall Street Journal reported the quantitative hedge-fund firm plans to spin off Two Sigma Private Investments into a business called Sightway Capital and register it with the SEC this month.Ī representative from Two Sigma declined to comment.Barbara A. Two Sigma has grown from $6 billion in 2011 to more than $50 billion in 2017. When she joined Two Sigma, CEO Nobel Gulati said Williams’ experience as an allocator, consultant, and trustee, “uniquely positions her to partner with our clients to develop asset allocation, risk optimization, and execution solutions.” Williams also spent 12 years as a senior consultant for large institutional investors at Wilshire Associates, and holds a Ph.D in finance from Arizona State University. Williams had been the CIO of Farmers Insurance after three years as head of insurance investment at Farmers. She was hired to focus on data- and technology-driven products, and to oversee the firm’s advisory business. She had joined the firm in July 2016 as the hedge fund’s first head of client solutions. Karyn Williams has left her role as managing director and head of client solutions at Two Sigma Investments LP.
0 kommentar(er)
