Constant analysis of risk is a critical part of the life sciences space. Improperly building a set of metrics or developing key KPIs are some of the main factors in determining the success and profitability of a company. With opportunities to digitize risk analysis, the automation provides companies the opportunity for time saving and accurate results.

Topics of discussion will include:

• Institute a system of risk based metrics meant to analyze measures of risk tolerance, incident and controls and mitigation
• Develop a system of KPIs to measure ongoing performance against previously set benchmarks
• Utilize artificial intelligence to automate the contract review process to categorize results in predefined classes of risk

Jerry Levine, Chief Evangelist and General Counsel, CONTRACTPODAI

The COVID-19 pandemic has seen a digital transformation to the work of both the legal departments of life sciences companies, as well as to the outside counsel who represent them. Gone are the ways of the past, and a new norm is emerging seeing both parties turn to current technologies in an effort to find more efficient and effective ways to increase productivity. With this transition occurring, it is critical for attorneys to be “future ready”.

Topics of Discussion Will Include:

• The evolving relationship between life sciences law departments and outside counsel
• Trends in technology adoption and their impact on productivity
• Role and expectation of technology usage in by outside counsel
• Ensuring the preparedness of a life sciences company to be “future ready”

Ken Crutchfield, Vice President & General Manager of Legal Markets, WOLTERS KLUWER LEGAL & REGULATORY US

COVID-19 has changed the way companies function within the life sciences space. White their adaptation has been a swift and effective one, agreements to and the implementation of clinical trials have seen a complete transformation to a virtual environment.

Topics of discussion will include:

• Discuss e-technologies utilized to review these contracts to ensure clearly defined roles for both sites and sponsors
• Utilize virtual methods to ensure an understanding of and agreement to patient consent documentation
• Define the role of a third party within the trial agreement and the access they have to select data records

While due diligence is nothing new to legal teams when it comes to the M&A of corporations, the process has traditionally lagged and delayed both the merger and the production of essential pharmaceuticals manufactured by the acquired company. With newly developed technologies, we have seen a rapid growth in the time for these processes to be completed, allowing the workflow process to remain intact.

Topics of discussion will include:

• Examine electronic FDA records of patent and exclusivity arrangements prior to the merger
• Assess digital reports of adverse event reporting and the need for warning labels
• Review prior marketing and sales records, including a review of government reimbursement forms, promotional review and potential violations of the anti-kickback statute

Paul Konney, Executive Vice President, General Counsel and Head of Global Regulatory Affairs, METAGENICS

One thing we all realize is that the next digital innovation in the life sciences space will be coming rather soon. While we may not know exactly what it is as of yet, we must be prepared to set the groundwork for it. Reviewing company policies and legal protections is essential when preparing for the next wave of the future.

Topics of discussion will include:

• Review ethical questions related to accountability, transparency and consent in the usage of artificial intelligence
• Ensure a company’s intellectual property rights over their AI developments, as well as their rights to use the AI technologies
• Adjust compliance programs to ensure employees receive the proper training for working with these technologies

Vahan Minassian, Director, Digital Compliance, PFIZER