Best practices in accounting for clinical trials

Jennifer Kyle (Moderator), Founder and CEO at Condor Software;
Jennifer Plotnick, Audit Partner at KPMG;
Chris Chan, VP, FP&A at IGM Bioscience

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Best practices in accounting for clinical trials

Clinical trial accounting affects your company’s runway, audit risk, strategic planning, and investor relations. And yet, getting it right is difficult, time-consuming, and prone to error. This panel will discuss clinical trial accounting, from the auditor and the sponsor side, as they share their experiences and best practices.

The panel will cover:

Accounting for outsourced R&D activities and investigator spend, focusing on the nuances of clinical trial accruals.
How to avoid a Critical Audit Matter for accruals in your audit with a standardized process and strong controls
Accrual reporting accuracy
Budget vs. Actual Variances
Overcoming challenges in data management, regulatory compliance and managing clinical trial costs with technology

Jennifer Kyle is the Founder and CEO of Condor Software. A former auditor, Controller, and CPA, Jennifer is on a mission to help biotech companies with their financial processes and provide them with better tools for clinical accruals & forecasting.

Jennifer began her career in accounting as a CPA and auditor for Ernst & Young before transitioning into finance and operations leadership at biotech organizations. She personally solved clinical financial management problems at several biotech organizations and was deeply impacted by family and loved ones at the intersection of life, death, and clinical trials. This inspired her to partner with a CTO to build software that empowers biotech teams to bring more life-saving therapies to market without being held back by billions of dollars lost in obscure data and financial processes.

What keeps Jennifer focused and driven is the promise she made to her father during his extra year of life an immunotherapy gave him for his NSCLC and the promise she gave to a dear friend, Steven, who was able to give life to his daughter, Ainsley, because of a clinical trial. Jennifer works long and hard alongside accountants, finance, clinical, and service providers to help these patients survive and kick cancer. As her father would always say, "where there's a will, there's a way." This is for him, Steven, and everyone out there who beat cancer or is fighting hard to survive. Jennifer is a licensed CPA in California and resides in San Diego. She graduated from University of South Florida with a Bachelor of Science in Business Management with an emphasis in Economics.

Jen Plotnick is an audit partner in the Boston office of KPMG LLP, a global professional services firm. Jen has 20 years of experience providing auditing and accounting services to her clients. She specializes in serving pre-clinical and clinical life sciences companies from Series A financing through IPO and secondary offerings. Jen resides near Boston, with her husband, two elementary aged children, and two dogs. She enjoys spending time with her family outdoors and is often skiing, hiking, biking, or cheering on her children and their sports teams.

Chris Chan is Vice President of Financial Planning & Analysis at IGM Biosciences, Inc. and, although he looks and acts like a toddler, has over 30 years industry experience, including 25 managing clinical trial & R&D finances for biopharmaceutical companies of various sizes. He holds an MBA from UC Berkeley’s Haas School of Business and is a Certified Management Accountant (CMA) & Certified Financial Manager (CFM). Chris has served as speaker and four-legged furniture at numerous industry conferences, and has authored multiple published articles on clinical trials budgeting, accruals, and outsourcing.