He has a well known experience in biomedical product-related public coverage issues, including Congressional investigations and FDA-related laws. CATHY L. BURGESSis a partner on the regulation firm of Alston & Bird, LLP in Washington, DC, and serves as the co-chair of the firm’s FDA Practice. Her follow focuses primarily on regulatory compliance, product and provide chain risk management, enforcement, and coverage matters associated to CGMP and QSR regulation of worldwide manufacturers. Burgess offers strategic counseling, conducts inside investigations and special audits associated to FDA compliance, and assists purchasers in designing compliance applications, internal audit applications, and different threat mitigation strategies.

DANIEL KRACOVis a partner in Arnold & Porter Kaye Scholer’s Washington, DC office, the place he co-chairs the firm’s Life Sciences & Healthcare practice. He helps life sciences manufacturers, commerce associations and early-stage ventures negotiate challenges relating to the development, manufacturing, approval and promotion of medication, biologics, medical units, and diagnostics. In addition to day-to-day regulatory counseling, he frequently handles excessive stakes investigations and enforcement proceedings, the development of worldwide compliance packages, and due diligence in financings, mergers, and acquisitions.

KKB Partner Suzan Onel shall be talking at American University Washington College of Law’s Health Law and Policy Summer Speaker Series on June 15, 2021. Suzan’s digital panel, “Latest Developments in Medical Device Regulation – Emerging Technologies in Digital Health,” will discuss medical applied sciences in digital health and supply a perspective on FDA oversight, regulation, and enforcement. Joining Suzan shall be Bakul Patel and Sonali P. Gunawardhana (Chief Counsel FDA & Regulatory, McKesson). A graduate of the University of New Hampshire School of Law with a concentrate on health regulation, Ms. Gunawardhana holds a master’s of law diploma from American University College of Law and a Certificate in Business Administration from Georgetown University. She additionally holds a master’s degree in public health from Boston University, a graduate degree from Webster University and an undergraduate diploma from Syracuse University. Served in FDA’s Center for Food Safety and Applied Nutrition, the place she was immersed in quite a few aspects of food security policy and regulatory implementation associated to the Food Safety Modernization Act .

He usually assists purchasers with GMP compliance, quality system implementation, and FDA remediation. He also assists the tobacco business in complying with the Deeming Rule requirements and ensuring compliance with the Family Smoking Prevention and Tobacco Control Act. Cirotta holds a Bachelor of Science degree in chemistry from the University of North Carolina at Greensboro and an MBA from the University of North Carolina at Chapel Hill. Prior to attending regulation faculty, she labored in the non-profit sector where she led community growth initiatives designed to handle varied public health points in Houston, Texas including working with well being care techniques, affected person advocacy groups, and underserved communities to help elevate consciousness about the significance of breast most cancers screening and remedy. She also co-founded the former Houston-based non-profit breast health screening and resource organization called My Place, A Women’s Health Resource Center. Ms. Gunawardhana will counsel meals and beverage, drug and device and dietary supplement companies on regulatory issues from Shook’s Washington workplace.

Sonali P. Gunawardhana has joined the life science group of Shook, Hardy and Bacon. The New to Food and Drug Law Group offers young professionals with as much as six years of expertise a possibility to attach, be taught from their peers, and improve their abilities. Individuals affiliated with member organizations, those snyders nursing home employed by the federal government, and regulation students are encouraged to take part. FDA depends on high-quality scientific data to support safety and effectiveness decisions.

Food and Drug Administration to supply clients detailed and sensible steerage on how to keep away from and resolve FDA regulatory challenges. Her follow focuses on FDA regulatory requirements for bringing medical gadgets and prescribed drugs to market in addition to how best to navigate post-approval regulatory necessities. Sonali assists each medical system and pharmaceutical companies to determine one of the best regulatory pathway in which to seek approval for his or her digital well being merchandise. FREDDY A. JIMENEZis Senior Vice-President and General Counsel at Celldex Therapeutics. At Celldex, he is a chief lawyer and compliance officer responsible for the development and execution of complete legal and compliance methods as properly as coordination of authorized services to support the R&D and commercial efforts of Celldex. Significant contributions have included leading the legal group supporting the acquisition and integration of Kolltan Pharmaceuticals, designing, and launching Celldex’s well being care compliance program, and revamping the contracting process.

Schnedar clerked for a choose on the US Court of Appeals for the Ninth Circuit and labored as a television reporter for native stations in New Mexico and Texas. She earned a BA with Distinction from the University of New Mexico and a JD with Honors from the University of Texas School of Law. DEAN R. CIROTTAis President of EAS Consulting Group where he’s liable for the day-to-day administration of the corporate.

Counsels purchasers in strategies for one of the best course of action when regulatory correspondence is issued by FDA, based mostly on her earlier expertise as Regulatory Counsel for the Division of Bioresearch Monitoring. During her 14 plus years within the Bay Area, Gross has been lively within the Oakland and Global communities. She served as a member of the Board of Directors for Black Women Lawyers of Northern CA, the Board of Directors for the North Oakland Community Charter School, and Equal Rights Advocates, as nicely as a mentor for women residents at Oakland Elizabeth House. Through the Firelight Foundation Inc., primarily based in Santa Cruz, she’s also served as a fundraiser for two CBOs (community-based organizations) situated in Lusaka, Zambia that provide HIV remedy and prevention providers for ladies and their households.

He is Vice-Chair of the Board for the Food and Drug Law Institute and is a graduate of Brandeis University and the Rutgers School of Law – Newark. CYNTHIA SCHNEDARis Executive Vice President of Regulatory Compliance at Greenleaf Health, where she offers strategic advice to shoppers in the life sciences business. She was formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research , the place she spearheaded efforts to protect the American public from unsafe and ineffective drug products by making certain that companies comply with federal requirements for quality and security. Schnedar beforehand served at the Department of Justice as Acting Inspector General and in different leadership positions focused on compliance and enforcement issues.

Ball is experienced in conducting internal investigations and advising firms on actions following the investigation. He emphasizes a team method to consumer problem fixing and manages matters to achieve client goals both financial and authorized. Office of Wiley Rein LLP. She draws on her almost 10 years’ expertise as an lawyer at the FDA to supply clients detailed and practical steerage on how to keep away from and resolve FDA regulatory challenges.