Baker & McKenzie LLP issued the following announcement on Oct. 7.
Baker McKenzie has added two partners focusing on FDA regulatory and biopharmaceutical compliance matters to the Washington, D.C. office. Veleka and Khelin were formerly with McDermott, Will & Emery, where Veleka was co-leader of the FDA practice. Veleka will serve as the Chair of the North America FDA Practice Group at Baker McKenzie.
Veleka brings more than 20 years of strategic and practical business and legal counsel to a wide span of biopharmaceutical companies, advising on FDA regulatory and compliance matters, including over 15 years of senior in-house counsel experience in leading biopharmaceutical companies. Veleka’s practice provides full coverage for clients, including, but not limited to, clinical trials and good clinical practices (GCP); current good manufacturing practices (cGMP), including quality systems and quality management programs; pharmacovigilance; advertising and promotion; licensing, development and collaboration agreements; and compounding and compliance and enforcement, including assistance with FDA 483 audits, responses to warning letters and assistance with corrective and preventative actions (CAPAs) and other FDA enforcement actions. In addition, Veleka regularly works with global biopharmaceutical companies, assisting in the development and implementation of corporate compliance and ethics programs. She also advises biopharmaceutical and private equity companies seeking to invest in or acquire compounding pharmacies, service-providers to the industry, including contract research organizations and contract manufacturing organizations, biopharmaceutical companies and divisions of major pharmaceutical companies.
Khelin focuses her practice on leading and counseling life sciences companies from product development through the product life cycle, with a particular focus on therapeutic product development plans and marketing applications for prescription drugs, including therapeutic biologics and generics. Khelin also advises clients on strategies for addressing critical regulatory matters, including inspection observations, untitled letters, warning letters, dispute resolution issues and advisory committee comments. Clients seek her counsel on developing innovative strategies for FDA regulatory approval, compliance with FD&C Act regulatory requirements for investigational and marketed products including current good manufacturing practices (cGMPs), promotion and marketing, supply chain and quality issues. Khelin regularly advises large, mid-size and emerging life sciences clients on a variety of transactional issues including acquisitions, divestitures, collaborations, clinical trials and related agreements. Her experience also includes counseling pharmaceutical and consumer product companies on cannabis and cannabis-derived product development and marketing plans. Khelin previously served as regulatory counsel at the FDA in the Center for Drug Evaluation and Research, in both the Office of Regulatory Policy and in the Office of New Drugs with the Therapeutic Biologics and Biosimilars Staff.
"We are excited to add Veleka and Khelin to our North American team," said Randy Sunberg, co-head of the Firm’s North America Life Sciences Group. "They bring a unique breadth of regulatory FDA expertise and key subject matter expertise that will allow us to continue to grow across our life sciences sector practice."
"This duo represents an outstanding opportunity for the firm," said Colin Murray, Baker McKenzie's North America Chief Executive Officer. "Having the right regulatory team in place when our clients want to expand or develop new market approaches is critical, and Veleka and Khelin bring such a depth of industry and FDA-related experience. They really enhance our offering to clients."
Veleka received her B.A. from Hampton University and her J.D. from University of South Carolina School of Law. Khelin received her B.S. from Hampton University and her J.D. from The George Washington University Law School.
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