From The Editor | January 19, 2021

Is Your Definition Of Quality Culture The Same As The FDA's?


By Matthew Pillar, Editor, BioProcess Online


Steven Niedelman and Christina Markus boast more than 70 collective years of pharmaceutical regulatory experience, which will be on full display when they tell you where your quality culture may be falling short at the upcoming FDA/Xavier PharmaLink conference in March. Here’s a sneak peek.

During his 34 years working regulatory affairs for the FDA, Steve Niedelman saw a few things. By the time he retired from the agency as Deputy Associate Commissioner for Regulatory Affairs, he was overseeing the agency’s district offices and the Office of Criminal Investigations. He also served as co-chair of FDA’s Compliance Policy Council.

Thirty-four years prior, Steve started his career with the agency near the bottom rung, as a GS-5 investigator. Since then, he’s amassed an unparalleled collection of anecdotes about warnings, violations, crimes, fines, and repercussions that are likely to rattle any biotech executive.

Today, he puts those experiences to work for clients of King & Spalding, the law firm where he serves as Lead Quality System and Compliance Consultant. He also shares his extensive experiences with biotech leadership audiences at a host of the events put on by Xavier Health, including the upcoming FDA/Xavier PharmaLink conference slated for early March.

A principal element of Niedelman’s work at King & Spalding is support of the firm’s attorneys who specialize in serving pharmaceutical and biotech companies as they design compliance programs and face regulatory challenges. “I help lead remediation efforts when pharmaceutical companies have had issues arise, such as the receipt of FDA-483s at the conclusion of inspections, warning letters, and assisting in negotiating consent decrees,” he says. “More favorably, I also encourage and help clients that wish to proactively avoid those problems.”

When King & Spalding clients face situations such as initiating an FDA recall, responding to a warning letter, supplier quality issue, or inspectional issue, for instance, Niedelman assists in review of those scenarios to ensure the best course of remediation. Other times, he serves as an advocate before the FDA on issues King & Spalding and its clients wish to bring to the agency’s attention.

How A Culture Of Quality Mitigates Regulatory Scrutiny

Steve Niedelman
Steve Niedelman
During his upcoming presentation at the PharmaLink conference, Niedelman will moderate a session presented by speakers from FDA’s Office of Regulatory Affairs (ORA) and its Center for Drug Evaluation and Research (CDER) with concrete advice on how to mitigate the risk of regulatory intervention by building a culture of quality within your organization. “In defining quality, we often see disparity between the industry and the FDA,” he says. “We often see firms that think they are in great shape only to find that they fall short of FDA’s expectations. It’s natural to see some level of bias in a self-assessment,” he says. Niedelman offers the reminder that compliance with the cGMP is not the gold standard, it’s a baseline. More accurate measures of commitment to quality are seen in how thoroughly a company investigates nonconformance. “Do you conduct a thorough investigation, open up CAPAs, track and trend complaints, establish thresholds for escalation, and escalate appropriately, or do you conduct only limited evaluations and ignore the likelihood of a systemic issue?” he asks.  As the pharma industry has globalized, there are greater challenges to ensure appropriate oversight of suppliers, and in many cases firms have never visited their suppliers.  “They don’t even know what their suppliers look like,” he says.  FDA expects a company to understand where the bar is. They, as well as the public, expect compliance with the regulations and careful attention to the products they manufacture.  When patterns of non-compliance develop over time, FDA pulls together a broad picture of your company, and that picture reveals whether or not you’re addressing problems appropriately,” he says.

Clinical Trials: The Creativity/Compliance Conundrum

Chris Markus
Chris Markus
Chris Markus is one of the King & Spalding attorneys benefitting from Niedelman’s consultative support. A partner in the firm’s FDA and Life Sciences practice and Deputy Practice Group Leader at the firm, Markus focuses on federal and state regulation of drugs, biologics, biotechnology, and related products. She helps clients develop regulatory strategy, address enforcement matters, and vet business transactions such as by assessing the compliance of a company or a program that is an acquisition target.

Like Niedelman, Markus will be presenting at the upcoming FDA/Xavier PharmaLink conference. Her presentation will focus on the decentralization of clinical trials. More specifically, she’ll address efforts to drive flexibility in clinical trials access, such as enabling participation at or close to home, but considering how that flexibility might introduce regulatory risk and impacts on study structure and integrity. “Sponsors and the FDA alike want to make it easier for patients to participate in research, to help them avoid taking days off of work, to reach more widespread and diverse patient populations, and to maintain patient safety, particularly in the face of the COVID-19 pandemic,” she explains. “But, with those flexibilities and with evolving technologies come a range of compliance and oversight challenges. The FDA likes novel ideas, but sponsors must ensure they’re not breaking any rules.” Records access and compliance, state-specific medical practice laws, and data integrity are among the topics Markus will address in the context of maintaining compliance during clinical trial creativity.

“Building a culture of compliance is a global issue among early-stage biotechs,” says Markus. “Regulators know that the world is not perfect, and it is acknowledged that legal and regulatory requirements develop in stages.  We help emerging companies set up in a way that embraces flexibility while also developing compliant core structures on which to build.” 

Niedelman and Markus are part of an exceptional lineup of speakers at the upcoming FDA/Xavier PharmaLink Conference, including FDA Office of Pharmaceutical Quality Operations and Office of Regulatory Affairs Director Alonza Cruse, MHRA Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector) David Churchward, and many more. Learn more about Niedelman, Markus, and the work they do at King & Spalding, and be sure to register for the conference at which they’ll be presenting here.