Innovation, Collaboration, and Access to Capital: Key Takeaways from the Sidley Healthcare Investment Conference

At Sidley’s Healthcare Investment Conference on 12 September, speakers analysed the flow of capital across the global life sciences and healthcare ecosystem in panels discussing collaborative deals, sources of funding, the regulatory scrutiny of deals, and women’s health.

Five Governance Steps To Consider When Using Generative AI Within A Pharma Company

Pharma companies are looking to better understand how Generative AI (GAI) can facilitate innovation. Early adopters can gain distinct advantages while properly managing the top-of-mind potential risks discussed below. Francesca Blythe and Steve McInerney explain the corporate governance principles that should be considered.

Start Thinking About Human Rights and Environmental Impact of Subsidiaries and Value Chains

The impending EU Corporate Sustainability Due Diligence Directive (“CS3D”) means most EU and some non-EU life sciences companies should begin to assess their wider human rights and environmental impacts and rethink compliance programmes. Michele Tagliaferri explains.

Four Tips for Successful Development of Cell and Gene Therapies

Developing a cell or gene therapy (CGT) involves a range of regulatory considerations and challenges. Emily Marden and Jaclyn Fonteyne point to some key factors that are currently the focus of FDA attention and may merit consideration by sponsors early in the development process.

Seven Things Life Sciences Buyers and Sellers Should Know About CVRs

The life sciences industry has recently seen a proliferation of Contingent Value Rights (CVRs), the public M&A equivalent of the earnout used in private deals.  Sally Wagner Partin, Sharon Flanagan, and Hannah Brown explain what you need to know about them.

U.S. and EU Expand Mutual Recognition Agreement to Include Animal Drugs

Sites making animal drugs need to be inspection-ready, as a single inspection report can now be relied upon by regulators in both the U.S. and some EU member states. Multi-jurisdictional regulatory actions could ensue. Christopher Fanelli, Chris Boyle and Yuzhi Hu explain.

Five Tips for Bringing a Complex Digital Health Product to Market

Bringing a sophisticated digital health product comprised of a combination of hardware and software to market can be tricky. Meena Datta and Deeona Gaskin advise on how to do so successfully by factoring in FDA marketing and reimbursement pathways, including insurers and employer-sponsored health plans.

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