Industry Insights from a Veteran

My entire professional career, beginning from graduation from college, has been focused on fee-for-service analytical services supporting the pharmaceutical and drug development industry on a global basis. My first 13 years were focused on the Good Manufacturing Practice (GMP) analytical services realm supporting laboratory activities that enabled formulation development, finished product testing, manufacturing, and a multitude of regulatory compliant services in this area. With this experience under my belt, I began to look for opportunities that allowed me to gain experience, expand my knowledge, and support drug development more broadly.

My path to bioanalysis: Never afraid of opportunities for change
I have always enjoyed challenges and have never been afraid of opportunities for change. Ten years ago, one such opportunity presented itself to move into the bioanalytical world. This was a fast-paced and evolving service area that offered new and exciting challenges with new regulations, new testing methodologies and an entirely new set of customers and sponsors with unique needs and challenges to deliver non-clinical and clinical data in support of trials and studies all over the world.

I have truly enjoyed bioanalysis and this segment of the drug development continuum. Our bioanalytical laboratories support drug development activities across the full spectrum from discovery all the way to commercialization. This broad spectrum of support is truly rewarding and engaging when we are active contributors in the realization and delivery of medicines that truly make an impact on patients' lives.

20 years of changes
Of course, we have all seen great advances in analytical testing equipment and methodologies which allow us to reach new levels of detection and capabilities which in turn enable greater flexibility to our sponsors in their drug development efforts. We have also seen evolutionary regulatory standards that ensure the accuracy, integrity and dependability of the data generated is of the highest quality.

However, what I have observed as the most impactful change in the industry over the last 20 years is the evolution of the relationship between pharma and the contract analytical service providers. Twenty years ago, the relationship was very much that of a pharma sponsor and a transactional service provider, and the interactions were very limited. To truly attain success long term, it was necessary for these interactions to evolve- and they have!

The evolution of the industry over the last 20 years has yielded a far more collaborative and partnership-based approach. This mindset coupled with the depth and breadth of scientific and regulatory excellence from contract service providers has revolutionized how we do business and how we provide solutions to unique testing challenges today. It is a very rewarding experience now to work with pharma partners in such a collaborative and engaging environment.

As partners, we are capable of so much more than we are as individual entities of a transaction. I am proud of where the industry has evolved to today.

Challenges in the pursuit of excellence
The greatest challenge facing bioanalysis today is no different than the challenges facing the pharma industry as a whole. We are all working collaboratively to find solutions to the question of how to get new medicines to market faster and to accomplish this with quality and efficiency in the most cost-effective manner possible.

Bioanalysis, with its unique perspective of providing analytical support across all phases and sectors of the drug development continuum experiences this challenge every day. The ever-evolving complexity of drug trials, combined with the innovative molecules and drug delivery vehicles only add more challenges in the pursuit of excellence in all categories.

At Q2 Solutions we recognize these challenges and what must be done to overcome them. We are collaborating with our pharma partners to identify how best to meet their evolving needs in the marketplace. We accomplish this with continued investment in our talented scientific team, in innovative technologies and a focus on how to develop and provide the best solutions possible for our partner's needs. For bioanalysis, this can be seen with our investment across our entire bioanalysis and ADME services portfolio with things like electronic laboratory notebooks, investment in high sensitivity and high resolution Mass Spectrometers and the growth and investment in our large molecule capabilities.

A future with even greater advances
I believe the future will continue to be very bright for bioanalysis and for the contract analytical service providers overall. The drug development industry remains very strong and viable with no signs of slowing down. We live and work in an era of great advances in software and scientific equipment. It is my expectation that the next 20 years will see even greater advances in our capabilities to drive more sensitive methods and enable even more advances in testing to support our partners' drug development needs.

Additionally, with the evolution of software and data sharing technologies I believe we will see even more advances in integrated data provision for faster decision making and more comprehensive solutions.

My plan for continued growth as a leader
One's growth as a leader is certainly a marathon and not a sprint. Personally, I always look for new challenges and opportunities that push me past my comfort level and into new areas that expand my experience and knowledge. This helps me to grow personally and professionally, and I can then use these experiences to help guide and develop my talented teams. On a granular level, I strive to learn from everyone with whom I have the opportunity to work. I observe, adapt and evolve based on what I see as best practices that other leaders, both within my organization and within our pharma partner organizations, do. Embracing the diversity of thought leadership and experiences in our industry today is crucial. Learning from others' experiences is key to success as a leader within this moving and evolving field.

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