Stacy Lindley is vice president and head of North America Emerging Biopharma at QuintilesIMS. In this role, Stacy leads strategic oversight and solution development for QuintilesIMS’ emerging biopharma clients across the enterprise. Supported by cross-functional colleagues within Business Development, Clinical Operations and the broader QuintilesIMS organization, she is responsible for working directly with emerging biopharma clients to deliver more precise and predictable programs designed to maximize commercial value.
Endpoints News recently named QuintilesIMS the top biopharma CRO in the world. What do you credit to your success?
At QuintilesIMS, we help our clients create solutions that drive healthcare forward whether they’re a small biotech or a big pharma company. This starts with the mindset that at the center of every trial are patients, and their safety is our top priority. We welcome the opportunity to provide support to our customers across all our capabilities, and have seen a shift from transactional relationships to more transformational ones.
We work with customers to create solutions that solve challenges, and we regularly adapt our approach to capitalize on both our customers’ strengths and our own. Our biotech clients appreciate that we can complement their particular management team with important experience regardless if they need the arms and legs to deliver a clinical trial or the advice of an experienced advisor to guide their commercial planning. With our recent merger, we now have, and can utilize tremendous amounts of data, analytics and technology to help customers answer the strategic questions they should be thinking about. As QuintilesIMS, we help inform critical milestones along the way, always thinking about the end goals and the patients who will benefit from access to treatment.
What value do CROs bring to the biopharma industry?
CROs are expanding the ways in which they can serve biotech and large pharma customers across the board, adding new capabilities and offerings for outsourcing. Many are going beyond just delivering clinical trials to being able to help customers along the continuum – from prioritizing assets, working on target product profiles, strategizing on clinical development plans and more. The best CROs act as strategic partners and advocates to these biopharma organizations, advising and streamlining all aspects of their business, from early stage considerations to developing and commercializing a drug. They dedicate themselves to understanding the specific requirements of a company and advocating for their needs throughout development.
How do you ensure a positive and productive Sponsor-CRO relationship?
It’s all about having a strong collaborative relationship with customers, taking the time to understand their priorities, preferences and constraints, no matter the size of the company. It’s not a one-size-fits-all model, so the most successful Sponsor-CRO relationship is one that’s tailored to support a company’s unique needs, and one where both parties engage early and often to help shape critical milestones along the way. Sponsors must be clear on what’s non-negotiable, and should honestly communicate their expertise and requirements.
CROs need to understand the sponsor’s culture and expertise in order to understand where they can add value, especially the capabilities they already have and want to maintain internally, versus what they’re willing to work with partners on. Communication preferences should also be shared early on, and adhered to throughout the relationship. When done correctly, a successful CRO will understand where the Sponsor should take the lead, and where they, as a partner, should step in to provide the guidance.
Why did you choose to speak at MassBio’s CRO/CMO Symposium? Why should the industry attend?
There’s a perception, particularly among pharma companies, that if you’re a large pharma you need to work with a large CRO, and if you’re a small biotech you must engage a small CRO – and we want to change that perception. For a small biotech, a full service CRO with end-to-end capabilities can be an ideal partner to provide that expertise and add value, and that’s what we’d like to communicate at MassBio’s CRO/CMO Symposium. We want to help biotech customers understand the value and expertise they can leverage from a large CRO, whether that’s thinking through a development plan or pulling together the insight to support a financial package to raise money. Working with an experienced partner enables our customers to focus on what matters, such as reducing the time to market.
To hear from QuintilesIMS directly, register for MassBio’s CRO/CMO Symposium.