Life Sciences Business Evolution Series – Report 1: How Digital Transformation and Data Are Shaping Business Models

Vanina Caniza is a partner in Baker McKenzie’s Buenos Aires office and the Global Chair of the Healthcare & Life Sciences Group. She advises a range of multinational, Latin America and Argentine clients in a variety of corporate and commercial law matters, with extensive experience in corporate compliance, commercial agreements, mergers & acquisitions and regulatory advice. Vanina has extensive knowledge in the pharmaceutical, biotech and medical device sectors. She completed postgraduate courses on Biotechnology at Universidad Torcuato di Tella (Buenos Aires) and on Health Law at Universidad de Buenos Aires. She was previously the Latin America Leader of the Healthcare & Life Sciences Group and also sits on the Steering Committee of the Firm’s Latin America Corporate Compliance Group. She is currently a professor in the CEC Compliance & Ethics Certification (AAEC-UCEMA).

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Henrique Kruger Frizzo joined the firm in 2004 and became a partner in 2014. He is the leader of the Life Sciences group and also integrates the Public and Regulatory Law group. He acts in the preparation of legal opinions and consultations on topics of his expertise, including tenders and contracts with the government, public service concession contracts and public-private partnerships. He has experience in complex negotiations with the government and assists clients in structuring effective government relationships. He also acts in the identification of irregularities and illicit acts in contracts and relationships with the government and in the area of sales to defense and public security agencies, including in the structuring of technological compensation agreements.
In the Healthcare sector, he advises pharmaceutical, medical device and other companies in the sector on a wide range of matters, including transactions involving commercial agreements and complex negotiations with the government and health technology transfer agreements. He also advises clients on market access strategies, including procedures for the incorporation of new health technologies into SUS and ANS, and represents companies in CMED administrative proceedings. Henrique prepares consultations involving clinical research and regulatory issues, reviews promotional materials, and acts in administrative litigation involving local health authorities and ANVISA. Additionally, he provides support in compliance issues, digital health and analysis of the constitutionality/legality of legislation. Due to his expertise, he participates in the drafting of bills of law and regulations for the industry.
In Public Law, Government Affairs, Regulatory and Compliance, he has extensive experience in corporate investigations, with a focus on government procurement and corruption, and their respective consequences in the civil and administrative areas. We assist clients in defining strategic decisions regarding the results of the investigation and participate in the defense before or during the negotiation with the civil and administrative police authorities responsible for the cases.

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Elisabeth White is a partner in Baker McKenzie's Sydney office. Elisabeth has over 15 years' experience as an intellectual property and regulatory advisor, focusing upon IP protection and enforcement with a particular emphasis on regulated industries and related disputes. Elisabeth is described in Asia Pacific Legal 500 as providing “decisive expert opinion and a pragmatic approach”. She has been featured in Best Lawyers - Intellectual Property listed annually since 2013.

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Randall Sunberg is a partner in the Corporate & Securities Practice Group and the Life Sciences Industry Group. He also serves as the co-head of the North America Life Sciences practice. Randy structures and negotiates complex collaborations, mergers and acquisitions, divestitures, joint ventures, and corporate partnering and licensing transactions, as well as equity investments and royalty monetization transactions for clients ranging from biotech startups to multinational pharmaceutical companies.

Adam Aft helps global companies navigate the complex issues regarding intellectual property, data, and technology in M&A and technology transactions. He is the lead of the Firm's North America Technology Transactions group and co-leads the group globally. Adam also served as a law clerk to the Honorable Leslie H. Southwick of the US Court of Appeals for the Fifth Circuit and the Honorable Theresa L. Springmann of the US District Court for the Northern District of Indiana.

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Anne has been with Baker McKenzie since 2001. Prior to that, she spent four years with the Australian Attorney-General's Department/Australian Government Solicitor mostly working on large IT projects.
In her time at Baker McKenzie, Anne has spent 18 months working in London (2007-2008) and, more recently, three years working in Singapore (2017-2020).

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Hiroshi Sheraton's practice covers all aspects of intellectual property law with a particular emphasis on contentious patent and trade mark matters and life sciences. Much of his work is cross-border in nature. He regularly co-ordinates pan-European and global IP litigation and advises clients on international IP strategies for patent litigation and brand protection. He represents clients in the UKIPO, EPO, OHIM, the English Courts and the CJEU. He has experience of IP matters across Europe and has litigated IP cases in Germany, France, Spain, Italy, the Netherlands, Belgium, Austria, Ireland, Northern Ireland and Luxembourg, the USA and Asia Pacific. Although he has a first degree in biochemistry and molecular biology, he covers all areas of technology from pharmaceuticals/biotech products and agrochemicals to electronics and software.

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Joanna Ludlam is a partner in the Dispute Resolution team in Baker McKenzie's London office, where she leads the market-leading Regulatory, Public & Media law team and also co-leads the office's Compliance & Investigations Practice Group. At an international level, she co-chairs the Firm's Global Compliance & Investigations Steering Committee. In 2016, Joanna was named as one of The Lawyer’s “Hot 100” for her practice, and is recognised by Legal 500 and Chambers & Partners.

Julia Wilson is a partner in Baker McKenzie's Employment & Compensation team in London and co-chair of the Firm's Workforce Redesign client solution. Julia also leads the employment data privacy practice in London. Julia advises multinational organisations on a wide range of employment and data protection matters. She is highly regarded by clients, who describe her as a “standout” performer who "knows how we think." A member of the Firm's Pro Bono Committee, she plays a lead role in the Firm's pro bono relationship with Save the Children International. She also collaborates with Law Works to deliver employment law training to solicitors who provide pro bono advice to individuals. Julia regularly presents and moderates panels on podcasts, webinars and in-person events, is often quoted in mainstream media, and authors articles and precedents for a range of industry and other publications.

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Khelin Aiken practices in the area of US Food and Drug Administration regulatory and compliance law. She leverages her deep understanding of the US Food Drug & Cosmetic Act, US Public Health Service Act and their implementing regulations along with her prior experience at the US Food and Drug Administration (FDA) to help clients develop and achieve their strategic business objectives. 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.

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