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This series of three reports is based on a survey conducted by Baker McKenzie in collaboration with Informa Pharma Intelligence and features insights from over 250 global respondents. Explore how pharma, biotech, medical devices and medtech companies plan to evolve their business models, shaping the future of the life sciences ecosystem.

Report 1: How Digital Transformation and Data Are Shaping Business Models

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As digital transformation reshapes business models with different emphases across regions, digitally enabled strategies are helping companies transition from product-only offerings to product-service hybrids, orient to patient mapping, pre-diagnostics solutions and enhancing treatment administration. These intertwined value chains are increasingly shaping the life sciences industry of the future.

In this report, explore:

  • How digitalization can accelerate the ability to provide better and more acute diagnoses, treatment and monitoring, as well as patient self-management
  • Why digital monitoring has implications ranging from supply chain management to the transfer and monetization of data as well as symptom tracking, among others
  • How to mitigate the risks involved in handling, storing and sharing sensitive data
  • Why digitalization poses a new and critical need for interaction among multiple stakeholders
  • How the role of regulators is essential in setting the pace going forward

Upcoming Reports

  • Report 2: Funding Growth and the Future of Life Sciences (Launching January 2022)
    How do life sciences companies intend to leverage new and existing sources of growth over the next 10 years? Explore the trajectory of life sciences companies’ funding as they seek to fuel inorganic growth.
  • Report 3: Shaping Growth — Collaboration, Supply & Manufacturing (Launching March 2022)

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Author

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).

Author

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.

Author

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.

Author

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.

Author

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.

Author

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). Anne is currently the Asia Pacific head of the International Commercial & Trade Group and global co-lead of the Firm's supply chain client solutions initiative.

Author

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.

Author

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.

Author

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.

Author

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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