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Strategies to Keep Pace Amid Rapid Changes in Drug Development – By Jeff Souza, President and CEO of BioBridges

Jeff Souza, President and CEO of BioBridges

Pharmaceutical companies are weathering rapid changes in drug development driven by upstream issues, downstream issues, and recently, the management and acceleration of programs during a worldwide pandemic. The scope of this includes resources that impacted supply chains and access to human resources and talent acquisition, exacerbating challenges in scientific and technical requirements in research and development, pre-determined regulatory processes and workforce volatility.

Workplace dynamics were forced to change and quickly adapt to the standards that were specific to a line of business or industry along with external factors such as cultural, economic, governmental, or regulatory influences. Talent shortages are rampant across all industries and now, it isn’t a question of where the work will be executed, but rather how, and if it will satisfy the needs of both existing and prospective workers.

Companies are developing measurement tools to evaluate the work and results productivity for their staff in its entirety as well as comparison studies with pre-, mid-, and post-COVID time frames against work product with volume, quality, and other measures specific to the business model. Others are evaluating employee satisfaction, recruitment strategies, and a wide range evaluation of the benefits offerings, based on interviews, offer acceptances or rejections, and exit interviews.

The overall health of the industry and its workforce relied on our collective ability to acclimate to this changing environment. Now, new pressures and expectations are being surfaced by life science companies as they continue to invest in innovative therapeutics due to the processes learned and adopted from the COVID-19 pandemic.

To optimize productivity and meet advanced expectations across the field of therapeutics, pharmaceutical companies must consider three key strategies:

Engage early and often in regulatory discussions

Despite there being new and emerging technological advances in drug development, it’s critical to understand that these advancements will not speed up the regulatory approval processes, nor does it mean regulatory agencies will approach the data with a less rigorous perspective.

While it may sound all too familiar, engaging early, often and proactively with regulatory affairs will mitigate the risk of late-stage delays and disruptions, which helps establish a clear execution plan for the development program. Collaboration between pharmaceutical companies and regulatory agencies, such as the Food and Drug Administration (FDA), is critical to ensuring drawbacks are addressed immediately and a drug reaches the market on schedule.

An increasing number of companies are outsourcing regulatory affairs activities as they recognize there are more efficient ways to manage their clinical trial programs and streamline their regulatory submissions. Pharma start-ups and emerging biotech companies may benefit from leveraging consultants who will help develop a regulatory strategy and roadmap to support their efforts, thereby releasing their in-house resources to focus on other clinical development objectives.

Collaborate with industry consultants who have a more holistic perspective

Industry players have begun to forge new collaborations and expand upon existing partnerships to better achieve short- and long-term development goals. Industry consultants and functional experts play an advisory role that can help pharmaceutical companies tackle operational burdens, expand geographical presence and increase therapeutic expertise and on-demand services.

A reliable partner, with extensive experience managing clinical development programs from start to finish, brings an unbiased approach to processes and understands when various experts will be needed at each stage. They can offer companies the ability to scale up or down at the right times and can be as involved or hands-off as a start-up desires.

Create an agile work environment to gain access to all-inclusive teams

Life, physical and social science occupations experienced the second-lowest unemployment rate (0.6%) out of all U.S. occupations as of April 2022. In order to succeed in the future of work, life science companies must address how they can become a more adaptable and agile organization by assessing how work is done, and how talent is sourced, trained and managed.

Remote offerings have become a key recruitment factor and, in many cases, a “make or break” for prospective hires. COVID-19 presented a confirmation that many professions and industries could survive and even thrive in a remote work environment, demonstrated by the many employees and consultants who made the transition to work remotely effectively and continue with the same or better productivity. In fact, those who spend 60-80% of their time working remotely experience the highest levels of employee engagement, which is directly correlated with productivity.

Consulting companies with a wide range of remote positions available for work that can be readily accomplished outside of the office may experience less difficulty in recruiting new and exceptional talent during the present resource drought. Historically, over many years working with highly specialized consulting services, it was always a dominant consideration to attract very highly qualified professionals, geographics notwithstanding, while avoiding the costly and operational burden of opening multiple offices.

Empowering workers to work from a location that best suits their needs promotes a better work/life balance, leading to increased employee retention. By eliminating location barriers and combining internal and external workers with specialized skills, companies can gain access to all-inclusive teams and tap into a wider talent pool.

Nevertheless–despite the challenges–to be competitive, employers need to not only accommodate remote work, but actively promote the idea along with providing support mechanisms heretofore not deployed to attract, retain, and support this more contemporaneous workstyle, which requires developing internal policies and establishing a general philosophy of management and hiring.

Change is inevitable and will continue persisting throughout 2023 and beyond. Pharmaceutical companies, start-ups and larger ones alike, should take advantage of these challenges and approach them as an opportunity to accelerate and deliver improved outcomes.

This truly is a new work world.

Editor’s Note: Jeff Souza is President and CEO of BioBridges, a clinical development professional services provider for emerging and established pharmaceutical, biotechnology and medical device companies.

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