Sheppard's Nota Bene

Pharmaceutical companies are part of an industry indispensable to the survival of the human species – the health industry. They're also big business, especially considering the billions of dollars spent on research, innovation, and development of products in this space. We're taking a look at the changing nature of clinical trials and diving into how they are conducted, reported, regulated, and any compliance issues that might arise.

Joining me for this conversation is the Chief Strategy Office at TrialScope, Thomas Wicks. Thomas has over 18 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling, and submissions management and has been on the PharmaCM team since 2007.

What We Discussed in this Episode:

• How are clinical trial results harmonized and regulated uniformly given various industries in every country run trials?
• What do clinical trials and research entail?
• What is a Phase I trial and what is being measured during this phase?
• What do researches look for in Phase II and Phase III studies?
• Once a product makes it through the first three phases of research and study, what happens next?
• In what form are clinical trial results presented?
• Why was there a shift towards greater transparency in disclosures of pharmaceutical studies?
• How are European countries helping academic researchers?
• What type of information is required to be disclosed? Does it vary by type of company?
• With the coronavirus still spreading, how many clinical trials have been or are being conducted? What are the trials testing?

Contact Information:

Thomas's LinkedIn

[email protected]

Additional Resources:

www.CoronaClinicalTrials.com

Press Release

www.clinicaltrials.gov

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This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

As China picks up the pieces following the COVID-19 aftermath, we're taking a look at how China managed to swiftly bring the crisis under control throughout the country. Is there hope for other countries around the world that are struggling to contain the spread of the virus? What can we learn from China's response to the pandemic?

Joining me for this conversation is Michael Zhang, a partner in the Corporate Practice Group, Antitrust Practice Group and the Intellectual Property Practice Groups in Sheppard Mullin's Shanghai office. He has a deep understanding of China's legal system and business practices. Michael has broad experience in the areas of corporate law, antitrust law and intellectual property law in China.

What We Discussed in This Episode:

• How is the current COVID-19 pandemic a different experience from the SARS epidemic of the early 2000's?
• How was public transportation in China affected by the outbreak?
• How was the availability of essential supplies and household necessities affected?
• While toilet paper and sanitizer seem to be running low in the U.S., which products were in high demand in China?
• Are the responses to the outbreak varied based on culture?
• Where is China currently in the cycle of recovery?
• Which industries in China suffered the most? And which ones flourished?
• Should we have paid closer attention to the SARS outbreak to help guide us in our handling of COVID-19?
• What is the Chinese government doing to help boost the economy now?
• How is China dealing with any unemployment that resulted from the outbreak?

Contact Information:

Michael's Sheppard Mullin attorney profile

Thank you for listening!

Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, Google Play, or Spotify. It helps other listeners find this show.

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This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

The uncertainty of the novel coronavirus (COVID-19) has permeated every aspect of our society - personally and economically. As we continue to navigate this "new normal," we're taking a closer look at how the virus might affect all of the various players in the cannabis industry and discussing what cannabis businesses can expect over the next year.

Joining me for this conversation is Whitney Hodges. Whitney is a partner in the Real Estate, Land Use and Natural Resources Practice Group in the Sheppard Mullin San Diego office. She is the leader of the firm's Cannabis Industry Team and serves on the firm's Pro Bono, Recruiting and Diversity & Inclusion committees, as well as numerous industry specific teams.

What We Discuss in This Episode:

• How is the coronavirus going to affect the cannabis industry?
• Why 2019 didn't turn out to be as amazing for cannabis businesses as was anticipated?
• How has the lack of Federal legalities scared off potential investors in this space?
• Who are all of the various players in this cannabis industry?
• Will COVID-19 affect the cultivation and distribution of the cannabis plant?
• Had the virus not occurred, what could the industry have expected in terms of advancements?
• What type of creative marketing are cannabis businesses employing during this time?

Contact Information:

Whitney's Sheppard Mullin attorney profile

Sheppard Mullin's Coronavirus Insights page: https://www.sheppardmullin.com/coronavirus-insights

Thank you for listening! Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, Google Play, or Spotify. It helps other listeners find this show.

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This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

This conversation is out of this world! We're exploring the laws and regulations surrounding satellites and the space telecommunications industry. Our guest, Brian Weimer, joins us to share his insight on the growth of the satellite industry over the years and the steps required to obtain the appropriate licenses and clearances to launch a satellite into space.

Brian Weimer is a corporate partner in Sheppard Mullin's Washington, D.C. office and Leader of the firm's Communications Practice Group. Brian provides transactional and regulatory advice to clients in the telecommunications industry, with particular emphasis on satellite, wireless and media companies. He acts as corporate counsel to telecommunications companies in M&A and financing matters and also advises on Federal Communications Commission (FCC) regulatory issues presented by these transactions.

What We Discuss in This Episode:

• How large is the satellite industry?
• What is space law in general?
• What are the steps involved in launching a satellite company?
• Which countries are leading the charge when it comes to space law?
• Why would a company choose to establish its satellite business in a country other than the U.S.?
• What are the two types of satellite systems?
• How has the satellite industry changed over the last 3-5 years?
• What type of insurance is needed to launch a satellite into space?
• How can an attorney help a multinational gain market access in other jurisdictions?
• What are radio frequency spectrum licenses and how valuable are they?

Resources Mentioned:

International Telecommunications Union

Contact Information:

Brian's Sheppard Mullin attorney profile

Thank you for listening! Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, Google Play, or Spotify. It helps other listeners find this show.

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This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

2019 ushered in numerous changes and new initiatives at the U.S. Food and Drug Administration (FDA). From the increasing popularity of cannabis use to the rapidly evolving nature of artificial intelligence in medical devices, we're reflecting on some of the initiatives the FDA tackled in 2019 and exploring what lies ahead for the agency in 2020.

Joining me for this conversation is Allison Fulton. Allison is a partner in the Life Sciences and FDA team and is based in Sheppard Mullin's Washington, D.C. office. Allison advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food and cosmetic companies, in matters relating to the development, manufacture, and marketing of products regulated by the U.S. FDA.

What We Discuss in This Episode:

• What role does the FDA play in public health and safety, especially when epidemics like the coronavirus threaten global health?
• Are we all overreacting to the impact of the coronavirus? What is the right approach to addressing fears?
• What updates and changes were made by the FDA in 2019 under the new commissioner?
• The shifting public opinion regarding cannabis products and the impact on regulation
• How has the lack of data relating to CBD effected the progress of FDA regulation?
• Is the FDA still relevant when many cannabis product manufacturers already produce and distribute products without FDA regulation?
• What components of vaping products cause the most damage to the human body?
• What is the FDA doing to try to regulate vaping products?
• Is technology in medical products evolving at a faster rate than the FDA can keep up with?
• What is the FDA's post-market device regulation model?
• What are some of the major issues the FDA is likely to focus on in 2020?
• What safeguards exist to protect biologic innovators?
• What are compounding pharmacies and how can they help patients?

Contact Information:

Allison's Sheppard Mullin attorney profile

[email protected]

Thank you for listening! Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, Google Play, or Spotify. It helps other listeners find this show.

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Sheppard Mullin website

This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

As trade with our North American neighbors continues to evolve and grow, we're taking a closer look at the newly ratified United States-Mexico-Canada Agreement (USMCA) and examining how the new Agreement will impact trade among the three countries and globally.

Joining us for this conversation is Scott Maberry. Scott is an International Trade partner in the Government Contracts, Investigations & International Trade Practice Group in the firm's Washington, D.C. office. Scott counsels clients and litigates disputes in the areas of export controls, the Foreign Corrupt Practices Act (FCPA), anti-terrorism, economic sanctions, anti-boycott controls, anti-money laundering (AML), the Foreign Agents Registration Act (FARA), trade remedies including antidumping and countervailing duty (AD/CVD) matters, and Customs.

What We Discussed in This Episode:

• What are the big differences between NAFTA and the USMCA?
• What are the main new additions to the Agreement?
• How is the USMCA helping the auto industry?
• As the US economy naturally shifts from a manufacturing-heavy country to a service-based economy, is it unwise to hold on to old ways?
• How many new jobs will be created under the USMCA and in which industries?
• Does the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) support or oppose the USMCA? Why does it matter?
• Was it time for an updated Agreement? What was missing from NAFTA that is covered in this Agreement?
• Is this Agreement providing any protection for the environment?
• Which provisions in the USMCA specifically and solely benefit the automobile industry?
• How will the USMCA affect the economies of the three countries and the global economy?

Contact Information:

Scott's Sheppard Mullin attorney profile

www.globaltradelawblog.com

Thank you for listening! Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, Google Play, or Spotify. It helps other listeners find this show.

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Sheppard Mullin website

This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

As we check in on the Asian markets for the first quarter of the year, we're diving into various current events including the coronavirus epidemic, the Trilateral Summit between Japan, China, and Korea, and Carlos Ghosn's complaints of the Japanese criminal justice system.

Joining me for this discussion is Paul Kim. Paul is a graduate of the University of Chicago, with honors, and obtained his juris doctorate degree from Harvard University. Paul currently serves in private practice as a Corporate Partner in Sheppard Mullin's Seoul office advising clients on cross-border mergers and acquisitions (M&A), private equity, venture capital and securities transactions, restructurings and multi-jurisdictional disputes.

What We Discuss in This Episode:

• How is the coronavirus affecting daily life and business activities in various Asian countries?
• Is the fear over the coronavirus pandemic unsubstantiated?
• Can we compare this coronavirus to the SARS scare of the early 2000's? How are they different?
• How is the Chinese government reacting to and handling the epidemic?
• What was the purpose of the Trilateral Cooperation Vision for the Next Decade?
• What topics were discussed between the three nations at the Trilateral summit?
• Despite Russia's geographical proximity, why is it not more involved in the regional political and economic scene?
• What is happening with Carlos Ghosn, businessman and international fugitive?
• What complaints did Ghosn have with the Japanese criminal justice system?
• Are there differences between Japan's and the U.S.'s prosecutorial systems?

Contact Information:

Paul's Sheppard Mullin attorney profile

[email protected]

Thank you for listening! Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, Google Play, or Spotify. It helps other listeners find this show.

Be sure to connect with us and reach out with any questions/concerns:

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Sheppard Mullin website

This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

As the conversation around antitrust regulation continues to grow, especially given the current political climate and the growth of technology companies, now more than ever, multinationals must pay attention to evolving trends in this space.

Nate Soderstrom is a Senior Editor at the Capitol Forum, an online publication covering topics including consumer protection, antitrust enforcement, and government contracts. Nate leads the Forum's mergers and acquisitions coverage. He joined the Capitol Forum after five years as an associate in the Antitrust & Competition department of Skadden, Arps, Slate, Meagher & Flom, where he advised clients in antitrust matters relating to mergers and acquisitions, complex antitrust litigation, and government investigations.

What We Discussed in This Episode:

• Has antitrust become a bipartisan issue?
• How has antitrust evolved over the last decade?
• Has the focus of conversation about antitrust shifted to price and consumer welfare instead of bigness and concentration of power?
• Where does the current trend and desire to take on big tech companies stem from?
• Are big tech companies seen as a threat to our political system if they go unregulated?
• Is there tension between the First amendment and the regulation of big tech platforms?
• What is the real fear when it comes to leaving big tech companies unregulated?
• What is an appropriate response to regulating big tech companies? Would issuing a fine suffice? Is breaking up the companies necessary?
• How is Section 2 of the Sherman Act being used to challenge mergers?
• Have antitrust regulations always been political?

Contact Information:

[email protected]

(202) 601-2297

www.thecapitolforum.com

Thank you for listening! Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, Google Play, or Spotify. It helps other listeners find this show.

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Sheppard Mullin website

This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

As women in professional industries such as finance, healthcare, and law continue to make strides in breaking down barriers, there still remains great gender disparity when examining the leadership levels. I'm joined by Amanda Zablocki and Danielle Vrabie, founders of the Women in Healthcare Leadership Collaborative at Sheppard Mullin to explore the challenges and opportunities presented for women in the healthcare industry.

Amanda Zablocki is an attorney in the Corporate Practice Group in Sheppard Mullin's New York office and is a member of the firm's healthcare practice team. Amanda's practice is focused on representing healthcare and tax-exempt organizations on a wide range of business, regulatory and transactional matters.

Danielle Vrabie is an attorney in the Business Trials Practice Group in Sheppard Mullin's New York office and a member of the firm's healthcare practice team. Danielle represents corporate clients and individuals in complex commercial litigation and government and regulatory investigations throughout the country. She focuses much of her practice on serving healthcare and life sciences clients.

What We Discussed in This Episode:

• What are some of the challenges facing women in the healthcare industry?
• What led to the formation of the Women in Healthcare Leadership Collaborative?
• Has the number of women entering the medical profession increased over the years?
• What type of issues affect gender parity in various industries like law and business?
• What are the benefits of bringing together women in leadership positions from various industries to discuss salient issues facing their sectors?
• What type of events does the WHLC plan for women in leadership?
• Why is it important for men to join the WHLC initiative as well?

Resources Mentioned:

Michael's book recommendation - Passions of the Western Mind by Richard Tarnas

Contact Information:

Women in Healthcare Leadership Collaborative

[email protected]

Amanda's Sheppard Mullin attorney profile

Danielle's Sheppard Mullin attorney profile

Thank you for listening!

Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, Google Play, or Spotify. It helps other listeners find this show.

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This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

If you're interested in becoming a foreign investor or doing business in Mexico, you'll want to hear the salient tips shared by my Mexico markets experts on the show today, Laura Nava and Alejandro Moreno. From establishing the right connections to understanding business formalities and pace, we're diving deep with our quarterly Latin America and Mexico check in.

Laura Nava is a registered foreign legal consultant in California and is licensed to practice in Mexico and New York. She is a member of the Corporate and Labor and Employment Practice Groups in Sheppard Mullin's San Diego (Del Mar) and New York offices.

Alejandro Moreno is a senior associate in the Business Trial Practice Group in Sheppard Mullin's San Diego office. Alejandro practices general business and commercial litigation in both state and federal courts. He also has experience in private arbitration, having previously prevailed on behalf of his clients after full arbitration.

What We Discussed in this Episode:

• The sense of loyalty and camaraderie that exists throughout Mexican and Latin American markets and cultures
• What is the best way to start a conversation with someone you're hoping to do business with?
• Despite the friendly nature of business dealings, it's still important to "get everything in writing" with any business venture
• Is it necessary for business owners to speak Spanish when dealing with English-speaking Mexican or Latin American nationals? Why or why not?
• Will having the right "connections" help you with your business dealings in Mexico?
• Despite having the right "connections," should potential foreign investors into Mexico still comply with local laws?
• Why is social mobility a complex issue in Mexico?
• What are the differences in formalities when it comes to conducting business in Mexico?
• What is the role of notaries in Mexico and which business transactions require notarization?
• What is the pace of business like?

Contact Information:

Laura's Sheppard Mullin attorney profile

Alejandro's Sheppard Mullin attorney profile

Thank you for listening!

Don't forget to SUBSCRIBE to the show to receive every new episode delivered straight to your podcast player every Wednesday.

If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show in Apple Podcasts, Stitcher Radio, Google Play, or Spotify. It helps other listeners find this show.

Be sure to connect with us and reach out with any questions/concerns:

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Sheppard Mullin website

This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.