The Health Pod, Baker McKenzie's industry podcast series, highlights sector-specific issues and trends that affect healthcare and life sciences companies.
Episode 14: Japan Medical Device Market - Distinguishing Features and Industry Practice
Japan's global strength in the medical device sector, aging population and wealth of know-how and technology make it a fascinating medical device discovery and development market. In this installment of our Spotlight on Japan mini-series, Chris Hodgens, Ryosuke Tateishi and Wabi Tanaka — members of the Firm's Healthcare and Life Sciences Industry Group who regularly advise medical device clients on transactional as well as regulatory and compliance matters — discuss key features and practices observed in the Japanese medical device industry, including the regulatory framework and necessary approvals, supply chain characteristics and medical device pricing.
Episode 13: Japan Medical Device Market - Healthcare Apps and Software as a Medical Device (SaMD)
We frequently receive regulatory questions about the increasing number and variety of healthcare apps being developed in Japan and elsewhere in the world. From a regulatory point of view, the most important issue is whether a particular app will be treated as a regulated medical device under the Pharmaceutical and Medical Devices Act (PMD Act). In this episode of our Spotlight on Japan mini-series, Ryosuke Tateishi, our regulatory and compliance partner, Mami Ohara, an industry specialist with experience in corporate transactions, and Fei Zhou, our finance and investment specialist, take a closer look at recent developments and introduce the regulatory landscape surrounding healthcare apps in Japan.
Episode 12: Japan Pharmaceuticals Market - Compliance
Compliance is one of the key factors for pharmaceutical companies in running a sustainable business in Japan. In our fourth installment of the Spotlight on Japan mini-series, industry specialists Ryosuke Tateishi, Mami Ohara and Rie Kuwabara, Healthcare & Life Sciences Compliance and Regulatory counsels based in Tokyo, take a closer look at the compliance issues in the Japanese pharmaceutical market, including enforcement trends, key compliance areas and requirements for establishing an appropriate compliance system.
Related resource: Sustainability Solutions for the Healthcare and Life Sciences Industries
Episode 10: Hyper-Hybridity: Defining a New Era of Digital Health Innovation
Digital healthcare plays a pivotal role in the future of patient care: the pandemic has accelerated digital health reforms and provided a plethora of opportunities for healthcare and life sciences, technology and financial companies. In Asia Pacific, in particular, a rapidly expanding population, an empowered and tech-savvy middle class and limitation on healthcare resources have created the perfect conditions for digital health innovation. In this episode of the Health Pod, Elisabeth White, head of the Asia Pacific Healthcare & Life Sciences Industry Group, joins Chung Seck, a partner from our Vietnam office, to discuss the key trends, opportunities, priority areas, barriers and potential collaboration pathways from our report, Hyper-Hybridity: Defining a New Era of Digital Health Innovation in Asia Pacific.
Episode 9: Japan Pharmaceuticals Market – Drug Development
With a strong pharmaceutical sector, an ageing population and a wealth of expertise, Japan is a fascinating drug discovery and development market. In our third installment of the Spotlight on Japan mini-series, Chris Hodgens, Real Estate Practice Group partner and industry specialist, Ryosuke Tateishi, Healthcare & Life Sciences Compliance and Regulatory Partner and Tsugihiro Okada, IP and Information Technology industry expert take a closer look at the drug development framework in Japan, including regulatory approval filing, clinical trial implementation and drug development collaboration.
Episode 8: Surviving and Thriving in the New Normal
As businesses resume operations and plan ahead to the post-pandemic world, in this episode of The Health Pod, Barry Thompson speaks to David Wardell about his perspective and insights on the importance of anticipating the potential litigation consequences of the pandemic, focusing on force majeure and related contractual obligations, product liability and crisis management with an eye towards the future.
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 Authorization 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.