US Life Sciences Industry in the 2018 Landscape: Significant Trends and Developments Explored!
Along with the life sciences industry’s fast evolution is the increasing scrutiny amidst regulatory uncertainties and complexities, thus, posing a range of challenges to the industry. Top issues for the industry include patient safety, cybersecurity, patent and other product protections, transparency in reporting, and pricing and market/patient access. Life sciences-related companies and professionals should ensure the efficiency and effectiveness of their risk and compliance programs to meet the applicable regulations.
Our panel of key thought leaders and practitioners brought together by The Knowledge Group will offer a discussion of the significant updates and trends surrounding these topics while presenting an in-depth analysis of its implications to the life sciences industry. Speakers will share risk mitigation strategies and best compliance practices to avoid the common pitfalls.
Key topics include:
- The Life Science Industry: An Overview
- Current and Emerging Regulatory and Product Protection Trends and Developments
- Implications to the Life Sciences Industry
- Practical Tips and Best Compliance Practices
- Common Risks and Pitfalls
- What Lies Ahead
Jur Strobos, Partner
Baker & McKenzie LLP
- ExUS GMP Inspections
- Future of Asian Contract Manufacturing
- Sharing Pre-Decisional Enforcement Information with European Authorities
- First Amendment and Escobar – Impact on Drug Promotion
- Drug Pricing
Chad E. Davis, Partner
- Developments in U.S. Patent Challenge Proceedings at the USPTO
- Recent Developments in the Law (including two U.S. Supreme Court Cases)
- Future Directions (proposed federal legislation)
- Trends in U.S. Patent Litigation
- Developments in the Law on Patent Eligible Subject Matter
Omar Robles, Senior Consultant
NERA Economic Consulting
- Developments in assessing non-cash reverse payments
- Trends in market definition
- Developments in assessing product hopping
Dr. Strobos provides life sciences companies with legal, regulatory, and policy advice on medical product development (drugs, biologics, tissues, cells, and medical devices). His practice spans early nonclinical and manufacturing issues through clinical development to enforcement. His practice includes licensing – a complicated bespoke process involving business structure clinical study roles, equity or royalty streams, performance measures, crafting objective milestones, joint steering committees, privacy, and ensuring that patient level clinical data are available to all parties, and supporting intellectual property partners in assessing the likelihood and ownership of new know-how or IP. Dr. Strobos can help with market valuation. With regard to marketing agreements of products that hold marketing authorization, Dr. Strobos can assist with crafting agreements that assure bilateral compliance with FDA regulatory requirements post-launch, how to craft and ensure coordination of the international marketing program, field-of-use definitions, and sharing of clinical data.
Dr. Strobos provides life sciences companies with legal, regulatory, and policy advice on medical product development (drugs, biologics, tissues, cells, …
Dr. Chad E. Davis counsels companies, investors, and entrepreneurs on intellectual property matters, especially patent matters. Dr. Davis has extensive experience in prosecution and strategic development of worldwide patent portfolios, intellectual property due diligence, risk assessment through, for example, validity and infringement analyses, post-grant patent proceedings, and intellectual property contracts.
Dr. Davis represents clients in a diverse range of technologies, including pharmaceuticals, drug delivery technologies, crystal forms, organic dyes, chemical processes, polymers, proteins, antibodies, stem cell technology, medical diagnostics, medical imaging, microfluidic devices, adhesives, analytical chemistry, foams, cosmetics, and optical technologies. For companies developing pharmaceuticals, Dr. Davis provides counsel through all aspects of the business cycle with particular acumen for developing and implementing strategies to maximize worldwide patent and regulatory exclusivities for the pharmaceutical product.
Dr. Chad E. Davis counsels companies, investors, and entrepreneurs on intellectual property matters, especially patent matters. Dr. Davis has extensive …
Dr. Robles is a Senior Consultant in NERA’s Life Sciences, Intellectual Property and Antitrust and Competition Practices. Dr. Robles actively consults on commercial success, harm resulting from patent infringement, the relevant antitrust market, reverse payment settlements, and damages resulting from such settlements. His engagements have included products approved in the U.S., Canada, and Latin America. In addition to publishing in top economic journals, Dr. Robles has taught at Harvard University, Georgetown University, and the University of Maryland, College Park. He is a recipient of Harvard’s prestigious Joseph R. Levenson Memorial Teaching Prize for Excellence in Undergraduate Teaching. Dr. Robles is a member of the Hispanic National Bar Association (HNBA), the Harvard Latino Alumni Alliance (HLAA) and the American Economic Association (AEA). Dr. Robles received his Ph.D. and M.A. in Economics from Harvard University and his M.B.A. from DePaul University.
Dr. Robles is a Senior Consultant in NERA’s Life Sciences, Intellectual Property and Antitrust and Competition Practices. Dr. Robles actively …
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Method Of Presentation:
Experience in life sciences law
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Areas of Professional Practice
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Baker McKenzie has been advising leading companies on the legal issues of doing business around the world since 1949. We have cultivated the global mindset, commercial pragmatism and collaborative relationships that it takes to deliver consistently world-class service tailored to the preferences of our clients worldwide. Our commitment to excellence and fluency makes a difference. It is the reason we have more leading lawyers listed in more countries in the Chambers Global Directory than any other firm. Chambers lists 23 of our practices in its global rankings of the world's leaders, and our IP Practice has been ranked Band 1 by Chambers Global since 2009.
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About NERA Economic Consulting
NERA Economic Consulting (www.nera.com) is a global firm of experts dedicated to applying economic, finance, and quantitative principles to complex business and legal challenges. For over half a century, NERA's economists have been creating strategies, studies, reports, expert testimony, and policy recommendations for government authorities and the world’s leading law firms and corporations. We bring academic rigor, objectivity, and real world industry experience to bear on issues arising from competition, regulation, public policy, strategy, finance, and litigation.