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 GC Americas, CONTRACTPODAI

With the ever growing use of wearable technologies, including items such as blood pressure monitors and glucose meters, we see an increase in the number of potential liabilities facing manufacturers. With this in mind, manufacturers must be prepared for all legal challenges, including class action suits.

Topics of discussion will include:

• Assess risks related to defective designs of a product, inadequate warnings, software malfunctions and incorrect readings
• Examine potential liabilities surrounding software vulnerability and cyber security threats associated with data tracking
• Explore settlements surrounding the production and sale of wearable technologies and biomarkers

When picking up a prescription, the first thought of many is standing in line at a local pharmacy. However, innovation has seen the transformation of the pharmaceutical industry to a virtual environment. The amount of individuals filling prescriptions via the internet has grown exponentially, and with that legal teams must ensure their company’s meet the set of regulatory requirements prior to dispensing.

Topics of discussion will include:

• Evaluate the usage of “cyber doctors” and validating the information they must collect prior to writing electronic prescriptions
• Ensure compliance with DEA guidelines regarding the dispensing of controlled substance in a virtual environment
• Exploring the risks involved in the importation of medications from Canada via online platforms

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