The Health Pod, Baker McKenzie's industry podcast series, highlights sector-specific issues and trends that affect healthcare and life sciences companies.
Episode 7: The Ins and Outs of Handling Material Non-Public Information
Healthcare and life sciences are among the most heavily regulated industries, and the US Securities and Exchange Commission continues to focus on healthcare and life sciences companies when it comes to disclosure and reporting requirements. If not managed carefully, the treatment and misuse of material non-public information can expose firms to significant liability and reputational risks. In this episode of The Health Pod, Amy Greer and Carol Stubblefield join David Wardell to discuss best practices when managing material non-public information including determinations of materiality, disclosure obligations, insider trading policies and 10b5-1 plans.
Episode 6: Japan Pharmaceuticals Market – Regulatory Landscape
With global pharma experiencing increasing levels of reorganization and M&A activity, our second installment of the Spotlight on Japan mini-series, with Mihoko Ida, a corporate partner based in Baker McKenzie's Tokyo office and Mami Ohara, a member of the Healthcare & Life Sciences Group with experience in corporate reorganizations, takes a closer look at the regulatory landscape of the Japanese pharmaceutical industry, including regulatory license frameworks, high-level implications of licensing in M&A transactions and other regulatory considerations.
Episode 5: Japan Pharmaceuticals Market – Distinguishing Features and Industry Practice
Japan accounts for approximately 7% of the global pharmaceuticals market and is the third-largest market in the world following the US and China. In the first installment of the Spotlight on Japan mini-series, Hideo Norikoshi, head of the Tokyo office’s Healthcare & Life Sciences industry group, is joined by Kei Matsumoto, IP Tech partner and industry specialist, and Ryosuke Tateishi, Healthcare & Life Sciences Compliance and Regulatory Counsel, to discuss the distinguishing features of the Japanese pharmaceuticals market, including an introduction to industry practices, the health insurance system, and the Market Authorizaton Holder (MAH) regulatory framework in Japan.
Episode 4: UK and EU Competition Law in Times of COVID-19 and Beyond
The COVID-19 crisis has required competition authorities to adjust their enforcement priorities and seen a temporary relaxation of certain competition laws in response to the pandemic. In this episode of The Health Pod, Irena Apostopoulos joins David Wardell to discuss the impact of the pandemic on competition law enforcement in the UK and EU in the healthcare and life sciences industry, as well as heightened compliance risks and the risk of dawn raids.
Episode 3: Alternative Arrangements for Biopharma Clinical Funding
The lengthy, expensive and complex nature of drug development has brought about the emergence of alternative funding entities to help boost R&D productivity, lower costs and mitigate risks. In this episode of The Health Pod, Randall Sunberg joins David Wardell in discussing how these investment companies are bridging the funding gap, and the types of agreements and due diligence involved in these arrangements.
Episode 2: COVID-19 Impact on Biopharma Clinical Development in the EU and Mexico
The disruptive impact of COVID-19 has forced the healthcare and life sciences industries to adapt in different ways. In this episode of The Health Pod, Els Janssens and Christian Lopez-Silva join David Wardell in discussing the effect COVID-19 has had on the management of clinical trials in the EU and Mexico and how the regulators have dealt with these impacts.
Episode 1: Health Canada and the FDA's Response to COVID-19
Resolving the health crisis demands an immediate response from regulatory agencies. In this episode of The Health Pod, Kamleh Nicola and Veleka Peeples-Dyer join David Wardell in discussing some of the most significant responses by Health Canada and the FDA to COVID-19.