Compliance Unlocked Podcast: Reflecting on 50 Years in Industry

Pete Gough is a globally known industry stalwart. In 2024 he celebrated 50 years in the pharmaceutical industry. Over the course of this episode, he looks back at many of his and the industry’s milestones. In this opening episode, he reflects on changes and challenges facing manufacturers.

You can watch the full episode of the podcast below, or you can watch featured highlights throughout the article.

Pete Gough’s career began in 1974 at Eli Lilly, where he worked as a quality control analyst. Reflecting on the early days of his career, Pete Gough described a pharmaceutical landscape that relied heavily on manual processes and rudimentary tools. High-Performance Liquid Chromatography

(HPLC) systems, now compact and highly efficient, were at the forefront but cumbersome and limited in their capabilities. Pete Gough recalled how laboratory practises often depended on the operator’s intuition, such as determining mixing endpoints by hand.

Advances in technology quickly transformed these practises. High-shear mixers replaced the manual planetary mixers that resembled a baker’s kneading process. Statistical Process Control

(SPC) became an essential method for ensuring product quality, enabling scientists to identify and address variability in real time. Pete Gough also highlighted the challenges of calculating standard deviations manually using slide-rule calculators, a painstaking process that modern software like Minitab has rendered almost instantaneous.

One of the most significant shifts during Pete Gough’s career has been the move from chemical-based drugs to biologics and advanced therapies. When Pete Gough entered the industry, pharmaceutical production was dominated by chemical synthesis. Over time, biologics—drugs derived from living organisms—emerged as the future of medicine. Since the late 1990s, cell and gene therapies have become critical in addressing complex diseases such as cancer and rare genetic disorders.

During the course of Pete’s conversation with NSF’s Samantha Atkinson, he emphasised that biologics represent a new frontier. These therapies have revolutionised treatment options, offering targeted approaches that were unimaginable decades ago. However, this transition has also brought unique challenges, including the need for specialised facilities and complex regulatory requirements.

Supply chain strategies have evolved in tandem with these technological advancements. In the 1970s, pharmaceutical companies often produced a variety of products at single, local manufacturing sites. Today, global centres of excellence focus on specific product types, creating efficiencies but also complicating logistics and regulatory oversight. Pete Gough described this transformation as a double-edged sword, with benefits in cost and quality but added challenges in maintaining consistency across regions.

Pete Gough’s deep involvement with regulatory bodies such as the International Council for Harmonization (ICH) provided him with unique insights into the industry’s evolution. A pivotal moment in his career was the 2003 ICH GMP workshop in Brussels, where he and other industry leaders presented a unified vision for modernising Good Manufacturing Practises (GMP). This collaboration between industry and regulators led to groundbreaking initiatives, including the development of ICH guidelines Q8 through Q14, which address quality by design, risk management, and lifecycle management.

''These guidelines have been instrumental in driving innovation while ensuring patient safety,'' Pete Gough said. He credited the workshop as a catalyst for regulatory harmonisation, which has grown significantly over the years. ICH has expanded from six members to twenty-three, with thirty-five observers, fostering collaboration across regions.

Despite these advancements, Pete Gough acknowledged ongoing challenges. Regulatory frameworks often struggle to keep pace with rapid technological developments, such as artificial intelligence and advanced therapies. He stressed the importance of continued dialogue and trust between industry and regulators, noting that mutual understanding is key to fostering innovation without compromising safety.

The UK’s departure from the European Union has had far-reaching implications for the pharmaceutical industry. He highlighted the challenges posed by regulatory divergence, particularly for UK-based manufacturers. While Northern Ireland benefits from unique arrangements that maintain alignment with EU standards, the broader UK pharmaceutical sector faces obstacles in attracting investment and maintaining competitiveness.

Pete Gough cited Eli Lilly’s decision to close its UK manufacturing and research sites in favour of Ireland as a stark example of Brexit’s impact. ''Why manufacture in the UK when you’d have to retest and certify products for the EU market?'' he questioned, emphasising the inefficiencies created by the current system.

However, during the course of the conversation with Samantha Atkinson, he also identified opportunities for the UK to lead in innovative areas like decentralised manufacturing. Legislative advancements in cell and gene therapy could position the UK as a global leader in this cutting-edge field, potentially outpacing the EU in adopting new production models. ''Brexit has its downsides, but it also offers the UK a chance to be more agile in responding to industry needs,'' he observed.

Beyond his technical contributions, Pete Gough expressed pride in mentoring and training the next generation of pharmaceutical professionals. Over two decades as a consultant, he has guided countless Qualified Persons (QPs) through their training and certification processes. Watching these individuals grow into industry leaders has been a source of immense personal satisfaction.

At a recent QP alumni meeting, Pete was honoured with a special award recognising his 50 years of service. Reflecting on this moment, he said, ''It was incredibly touching to receive such recognition from my peers and the professionals I’ve had the privilege to mentor.''

As he considered the future of the pharmaceutical industry, he emphasised the critical role of collaboration between regulators and companies. The rapid pace of technological advancement, particularly in fields like AI, demands an initiative-taking and flexible approach to regulation. ''Good communication and trust are essential,'' he noted, adding that global harmonisation efforts will be key to accelerating the delivery of innovative medicines to patients.

He also expressed optimism about the industry’s ability to tackle pressing healthcare challenges, from cancer to Alzheimer’s disease. Initiatives like ICH and the Innovative Licensing and Access Pathway (ILAP) are helping to streamline processes and bring life-saving treatments to market more efficiently

One of the features of the Compliance Unlocked podcast series is that each interviewee asks a question of the subsequent guest. In this instance Pete Gough poses a question to NSF’s Lynne Ensor about her time with the US FDA. What is the question? You will have to listen to episode 2 of the podcast series to find out!