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Everything Life Sciences Companies Need to Know to Navigate the COVID-19 Pandemic

Apr
7
2020

Date: April 7, 2020

Time: 1:00PM - 2:00PM (EST)

Location: View the Webinar Recording

This was the first in a series of Life Sciences-specific webinars by Mintz and ML Strategies on a spectrum of legal issues companies are facing during this complicated period. The program covered issues of:

Employment Law

  • Families First Coronavirus Response Act 
  • Defining “Essential Business”
  • Responding to refusals to work
  • Communications regarding a positive test

FDA

  • Emergency use authorizations (EUAs) and enforcement discretion policies
  • Program setup for developers of potential COVID-19 therapeutics
  • Actions to help alleviate regulatory burdens on existing product sponsors in the life sciences industries

Clinical Trials

  • Regulatory authority accommodations for ongoing clinical trials that may be affected by COVID-19 and regional restrictions
  • Key considerations for sponsors and sites regarding ongoing and planned clinical trials

M&A

  • State of the M&A deal market
  • Impacts on deal processes and associated timeline
  • Allocating pandemic risk (MAC clauses come into focus)

Capital Markets

  • State of the public capital markets
  • Recent SEC developments related to COVID-19
  • Impacts on financing options for life sciences companies

Federal Legislation

  • Accessing funds for businesses creating COVID-19 diagnostics, therapeutics or vaccines
  • Financial assistance for businesses provided by CARES Act and other legislation

Speakers

Professional_Cropped_Fox_Joshua_Mintz

Joshua D. Fox

Moderator

Joshua D. Fox is a corporate attorney at Mintz who represents clients in milestone transactions and general corporate matters throughout the business lifecycle. He focuses on the life sciences (biotechnology, diagnostics, devices) and tech industry, including digital health, software, technology-enabled services, and consumer products.
Dianne specializes in counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research and counsels health care clients on he HIPAA Privacy Rule and Security Standards.
Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.

Speaker

Professional Cropped Mantell Marc Mintz

Marc D. Mantell

Speaker

Marc D. Mantell handles corporate and securities law matters at Mintz, primarily for technology clients. He represents companies, investors, underwriters, and other parties in mergers and acquisitions, securities offerings, debt financings, and other transactions.
H. Andrew Matzkin is an employment litigator at Mintz, and he provides counsel on labor and employment issues. Drew represents clients in life sciences, technology, industrial, and professional services before federal and state courts, arbitrators, and administrative agencies.
Professional Cropped Rudy John Mintz

John T. Rudy

Speaker

John T. Rudy is a Mintz Member who represents clients in capital markets transactions, securities, equity debt financings, and mergers and acquisitions. John's clients include public and private companies and investment banks. Before joining Mintz, he was an associate in a New York law firm.
Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.

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Apr
14
2020

FDA in the Time of COVID-19

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21
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Clinical Trials in the Time of COVID-19

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May
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