Leading the Way to a Promising Future in Pharmaceutical Innovation!
Drug development is a complicated process that involves a series of steps, each with its own set of challenges and requirements. Historically, this process has followed a conventional path where drug sponsors engage multiple Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) to handle different phases or components of their research and development. Breaking away from the traditional fragmented approach that often delays progress in the industry, Altasciences stands out for its commitment to seamless integration and transformative solutions.
Altasciences, an integrated CRO/CDMO, provides pharmaceutical and biotechnology firms with a comprehensive solution for early-stage drug development, from lead candidate identification to clinical proof of concept and beyond. Operating across nine facilities in the U.S. and Canada, with an additional office in the UK, Altasciences delivers a reliable and adaptable strategy, and the full array of CRO support services, for preclinical and clinical pharmacology studies, including bioanalysis, formulation, manufacturing, and analytical services.
At the core of Altasciences’ mission is the dedication to removing barriers that impede the flow of critical data and insights in research and development, ultimately expediting the delivery of life-saving medications to those in need.
Steve Mason, the distinguished Co-Chief Operating Officer at Altasciences, is one of the leaders guiding this visionary path. With nearly three decades of experience in building preclinical businesses, Steve’s leadership ensures that all of Altasciences’ preclinical services and sites operate seamlessly with all departments.
Our recent interview with Steve offers a peek into his professional journey and Altasciences’ role in redefining drug development, setting new standards for excellence in every endeavor.
What inspired your interest in life sciences?
For as long as I can remember, I always wanted to know how things work. As a child, this naturally developed into a fascination with science. I was inspired by how chemistry and biology came together in disciplines like pharmacology, and how diseases and conditions could be treated by manipulating and modifying those processes. That is what led me to a career in drug development.
Can you share with our readers a brief overview of your professional journey?
In late 1999, I met Chris Perkin [CEO of Altasciences since 2010] while working at Huntingdon Research Centre in the UK, and shortly after, I moved to Montréal, Canada, to join the CRO at which Chris was the General Manager. Over the next few years, I built the Safety Pharmacology Department for that CRO and was then given the opportunity to move to China to establish their Shanghai preclinical facility. While I was in China, I moved to another CRO and became Vice President of Preclinical Services. In 2014, I joined Altasciences, as the General Manager for our clinical unit in Kansas City, before becoming Co-COO in 2017 and was given the responsibility of building the preclinical side of our business from the ground up.
Can you elaborate on Altasciences’ vision behind creating a flexible approach that eliminates the need for multiple service providers during the early stages of drug development?
Drug development has been traditionally conducted in one way: drug sponsors contracting multiple CROs and CDMOs to complete different aspects or phases of their research and development. For the sponsor, this has meant multiple contract negotiations, and data, project, and methodology transfers which take time, are prone to error, and can further prolong R&D timelines. Not to mention issues with barriers to communication and the burden of project management resting on the sponsor. Everything is siloed.
For an IND application, for example, a sponsor will require both preclinical data and several other regulatory documents, including the Investigator’s Brochure that the doctors will refer to for both clinical protocol writing and clinical conduct. Often, each requirement is handled separately, and small biotech and biopharma companies need to work with both preclinical and clinical CROs, as well as with consultants to help review that data and put it into a compliant format for the IND application.
At Altasciences, we safely remove the bottlenecks and gatekeepers that stop the data from flowing seamlessly and efficiently. We don’t cut corners—we simply remove the inefficiencies to help sponsors get better drugs to the people who need them, faster—that is always the end goal.
Why focus on the early phase?
We decided to focus on early-phase drug development because this is a complex and critical time in a sponsor’s journey. We knew that by integrating early-phase drug development, we could help sponsors reach critical milestones sooner, so that they can make informed decisions about the later phases of their journey.
What challenges do pharmaceutical and biotechnology companies commonly face during the early stages, and how does Altasciences address these challenges through its proven and flexible approach?
One of the bigger challenges that we see in early drug development are drug formulation (and sometimes availability), regulatory, and unexpected findings in both preclinical and clinical evaluations. In building Altasciences, we were very mindful that a full-service CRO should be able to help the client in resolving these potential hurdles. Our integrated approach enables our scientists and managers to proactively plan for and address short- and long-term challenges, which other, single-capability CROs are unable to do. We can safely expedite additional work. With our proprietary centralized scheduling tool and complementary program management, we can keep our clients informed of impacts on their overall timelines and suggest ways to mitigate those effects, in real-time.
Since taking on the role of Co-COO at Altasciences in 2017, how have you shaped the company’s vision and strategic direction in the evolving landscape of drug development?
When I first joined Altasciences in 2014, it was only a clinical CRO—with two clinical research facilities: one in Montréal, Canada, and the other in Kansas City, U.S.A. Altasciences was at the cusp of its evolution into a full-service, integrated early-phase drug development solution company. The strategic direction to enter the preclinical business was the next essential step in building Altasciences’ vision of being a one-stop, early-phase drug development solution. Within three years of me joining Altasciences, we had acquired our first preclinical site in Seattle, WA. Today, we have four preclinical facilities in the U.S.A.
Creating the bridge between the preclinical and clinical phases opened the path to eventually adding a third clinical unit and a CDMO facility to our coast-to-coast presence, as well as expanding our in-house bioanalytical capabilities and laboratories.
How has your experience in managing operations across different regions influenced Altasciences’ global strategy and presence?
Being on the ground in different regions has equipped me, and other leaders at Altasciences, with diverse insights into local markets, regulations, and cultural nuances. This has helped to inform Altasciences’ strategy by fostering adaptability, enhancing risk management, and optimizing supply chains, thus facilitating tailored approaches to customer needs.
In what ways has the company contributed to advancing the drug development process and bringing about positive changes in the industry?
At Altasciences, we’ve disrupted the CRO model as sponsors know it. We have provided them with a much-needed alternative to outsourcing early-phase drug development, helping to address and alleviate challenges encountered with the traditional paradigm. An integrated concept like ours had been talked about for years in our industry, but only Altasciences had the vision, team, and focus to make it a reality. As an integrated preclinical to clinical CRO/CDMO, we’re able to safely accelerate how a client’s drug moves through the various stages of development.
We coined our approach Proactive Drug Development and have discovered that by simplifying and integrating the outsourcing experience, we can accelerate a client’s drug development by up to 40%—the impact that could have on patients around the world is immeasurable. Our hope is that what we’ve been able to accomplish inspires others in the industry to further innovate and challenge the status quo.
How does Altasciences stay at the forefront of innovation to provide cutting-edge solutions for its clients?
Our field is constantly changing, with new therapies, evolving science, and the need to continually adapt our clinical trial methods to meet the demands of drug development. Early-phase studies have become increasingly more complex as there is more demand for early proof-of-concept explorations and the need to evaluate more data and endpoints in preliminary first-in-human studies. It is therefore critical to our success to be on the innovative edge of drug development, leading the way in novel approaches to drug development. Over recent years, we’ve made considerable adjustments as we’ve seen novel approaches such as psychedelics, gene therapies, and other treatment modalities become the pipelines of medicines in the future.
An effective way of ensuring we stay ahead is by speaking with our clients to ensure that we’re evolving with them and always improving and innovating to better meet their changing needs. In addition to regular meetings and check-ins with clients throughout our partnerships, our client experience (CX) team documents the client’s perception of their journey with us at all touchpoints—from searching for a CRO/CDMO to the last invoice. They listen, track, and analyze client feedback through various means, such as satisfaction surveys, audits and visits, and governance meetings. This CX data is reviewed by executive leadership on a regular basis to determine how we can drive improvements and design a better overall experience for our clients.
How has the company strategically navigated its global presence?
In just the last five years, we’ve made significant acquisitions to scale our services and capacity, expand our geographic reach, as well as meet the ever-evolving needs of our clients. For example, there was a high demand for preclinical studies, so we added three more preclinical facilities to our offering for a total of four across the U.S.A. In addition, we added a third clinical pharmacology unit in L.A. and expanded our existing bioanalytical labs, as well as acquired a CDMO facility in Philadelphia. With a total of nine facilities in Canada and across the U.S., an office in the UK, we have all time zones covered.
In 2022, we opened the office I mentioned in the UK—our first foothold in Europe—to better support our clients overseas. Since then, we’ve hosted three symposia overseas: the first in Switzerland in 2022 and two in England in 2023 and 2024. For our European clients who experience stringent processes and longer review times with the European Medicines Agency (EMA), our global presence provides them with the option of conducting their studies through two additional regulatory pathways with the U.S. FDA and Health Canada, each with their share of benefits.
As Co-COO, can you share a particular project you are especially proud to be part of?
We’ve spent a significant amount of time in the last couple of years working with the downsized Sinclair Nanopig™ as an alternative species for nonclinical toxicology testing. This has been a detailed project, collecting background data to support the use of this species for drug development; and we’re starting to see it take off now. Industry-wide, the use of swine in research to replace traditional species, such as dogs and nonhuman primates, is something we want to see accelerate and become more mainstream, and Altasciences is proud to be a leader in this space.
How does Altasciences align with the theme of innovation and excellence, and what sets it apart as a top solution provider in 2024?
We pride ourselves on challenging the status quo. Altasciences has successfully pushed change in an industry that has been historically slow to change. Our vertical and horizontal integration isn’t the standard in our industry. All our scientific operations report directly into the two co-chief-operating officers; myself and my colleague Marie-Hélène Raigneau ensure that, from preclinical studies to clinical trials, to bioanalysis and manufacturing, to regulatory affairs, all services and teams are moving in unison to deliver a seamless outsourcing experience for our clients.
Excellence is ingrained in our culture; in fact, it is one of Altasciences’ core values. We provide services and solutions of the highest quality and strive to exceed expectations, no matter the project’s size—whether a client partners with us for one study, one solution, or for an end-to-end program. As an integrated CRO/CDMO, our scientific and operational teams work together on a client’s project from the very beginning to the very end. Together, they build the client’s roadmap, anticipate, and mitigate potential roadblocks, and react in real-time as needed. Having this type of holistic visibility on a client’s drug development plan is unique and enables us to proactively plan and prepare for the next phase while the current phase is ongoing—for quicker and smoother transitions.
What are Altasciences’ key focus areas and strategic goals in continuing to be a leader in integrated drug development solutions?
A few focus areas for us is expanding our presence in Europe; continuing to nurture and grow our relationships with clients where we can partner for multiple research aspects and end-to-end programs (this is where clients can experience the greatest benefits of Proactive Drug Development); and finally, continuing to refine our solution offerings by listening to client feedback, which could mean further acquisitions and/or expansions to our facilities.
A strategic goal I can speak on in more detail has been the process of transitioning one of our most recent preclinical acquisitions to specialized late discovery and PK, with a focus on gene therapy, antibody, and cell-based therapies to add to our biologics’ capabilities. We believe that the future growth of Altasciences can be enhanced by connecting with our clients earlier in the drug development cycle, prior to regulatory studies, with the intention of partnering with them throughout their early-phase development journey.
Shine of Success
- Most recently, Altasciences was recognized with a 2024 CRO Leadership Award in the Capabilities category, as voted by clients in ISR’s annual CRO Quality Benchmarking survey. Altasciences has been consistently recognized by the CRO Leadership Awards in multiple categories since 2014.
- Steve Mason was named the Top 25 Executive of Montréal for 2023 by C-Suite Spotlight.
