Information in Action: DIA's Barbara Lopez Kunz

William Looney speaks with DIA Global Chief Executive Barbara Lopez Kunz to see how a key industry NGO is repositioning itself as the go-to place for the independent knowledge-driven insights that drive decisions in a business with no boundaries.

PE: You assumed the top post at DIA in September 2013. How would you describe the industry’s strategic and operational environment since your arrival? What impact has it had on your plans to move DIA forward, in a new direction?

Barbara Lopez Kunz

BARBARA KUNZ: My work in the life sciences extends back more than 20 years to the Battelle Institute and before that to DuPont, Thermo Fisher Scientific, and ICI. What drew me to DIA was its position as a neutral convener of the multiple stakeholders that together drive the industry’s principal mission: to ensure that safe and effective therapies are accessible to patients worldwide. DIA provides all participants the opportunity to engage with government leaders, public health authorities, industry, academia, patient advocates, and, increasingly, the payer community.

But we do not stop at engagement. We see DIA as a community that seeks to advance all parts of the system. We do this through our own constituency but also through strategic partnerships with other organizations that bring special expertise to the table. Overall, it’s an exciting time in the healthcare arena in terms of new science, where we have a much greater understanding of genetics and the pathophysiology of disease as a basis for generating new therapies and cures. DIA plays an important role in helping to realize the benefit of science for patients.

There are 7,000 new medicines in development today, more than any time in history. This is both an opportunity and a challenge. On the opportunity side, I see a heightened desire among innovators to apply good science in collaboration with other stakeholders, across borders. Industry is doing a better job finding out what the patient-the ultimate consumer of medicines-really needs. Academic institutions and patient groups are more empowered, leading to a greater emphasis on real health outcomes, both in the clinical care and R&D settings.

The challenge is connecting the dots-helping everyone work together to raise the quality and efficiency of care. Efficiency is particularly important, because drug development is lengthy and expensive. To accomplish this, advances on the clinical front must move in tandem with progress in regulatory science. Reliance on accepted scientific principles is critical. This is the best guarantor that new drug evaluation will be done in a timely manner, with due consideration of risk/benefit, and at an appropriate cost to patients and society.


Keeping pace with science

Do the national regulatory agencies have the resources and expertise to keep pace with scientific progress?

The last decade has seen a significant rise in investments in regulatory science. The brain drain of talent away from government service has slowed, while new tools like priority review, orphan-drug recognition, and breakthrough status have made the review process more relevant, predictable, and focused on real patient needs. This doesn’t mean that we can be complacent. Regulators I talk to are excited about leveraging big data analytics to improve the productivity of the new drug evaluation process as well as deliver measurable outcomes to patients. And the desire to work internationally and interagency is there, the outcome of which will be positive for patients.

The common thread here is how collaboration serves as a “force multiplier” in transforming great science into products that help patients. It accentuates the importance attached to your description of DIA as a convener, to help institutionalize best practices across the life sciences spectrum.

Kunz: Today’s catch-terms in health products regulation are convergence, harmonization, and mutual recognition. The growing sophistication of science needs to be accompanied by a similarly broad investment in training and capacity-building, so that key stakeholders outside the lab can keep pace. This is particularly true in the developing countries, where prioritization is key, given limited resources and the need to do work locally. The recognition that these issues must be addressed is there: a group of more than 30 heads of national drug regulatory agencies have formed the International Coalition of Medicines Regulatory Authorities (ICMRA) to drive forward the process of consensus- based standards internationally. We see this and the ICH (International Council for Harmonization) reform as very positive signs.

New focus on market access

Can you succinctly define the mission you now have for the DIA?

Our Board has set out the DIA mission very simply. DIA is a catalyzer of conversations- productive conversations- with all stakeholder groups. I emphasize the word “productive” as we are laser-focused on ensuring we move forward the complex processes intrinsic to developing and delivering new therapies. We provide thought leadership, grounded in a broadly framed, multi-functional perspective.

We no longer see our role as defined exclusively around the process of new drug development. In fact, our reach extends far beyond licensure. DIA today runs from pharmacovigilance to patient-reported outcomes and real-world evidence. We have an entire track of programming centered on the operational aspects of securing market access for a new product, and our membership now reflects this breadth of expertise.

We see DIA as an open innovation forum. Because we engage many leaders across the healthcare continuum, we not only are aware of trends, our constituency is knowledgeable and well-positioned to influence priorities and use of resources. The outcomes of our work are based on sound scientific exchange that happens amongst our members, volunteers, customers, and staff. We take on complex topics, such as drug repurposing, process innovation, and drug shortages.

Up to a fifth of industry spending on R&D now consists of activities conducted after the regulatory authority grants the marketing license. This also holds true for outlays that companies devote to the pre-IND (investigational new drug) side, for basic research, and in identifying patient needs at all stages of the development cycle. We also have a remit that extends beyond drugs to include all healthcare products-vaccines, medical devices, diagnostics, biologics, and small molecule drugs. One example is our current effort to raise awareness of the industry perspective on new medical device legislation in Europe and Japan.

DIA has come a long way since its founding in 1964 by a small group of like-minded professionals- motivated by the fallout from the thalidomide tragedy-to our position today as a global organization, with a membership exceeding 30,000.

Our mission continues to grow: a decade ago, who would believe that payers and patients would be a critical part of our constituency? Our Board wants DIA to be seen as a safe, unbiased environment, where all stakeholders convene on neutral turf to debate the issues, without constraints, and based on a solid scientific basis, to advance the conversation.

What are your current priorities and how are these working to advance the DIA mission?

In addition to serving as a convener, DIA is committed to improving the quality, relevance, timeliness, and accessibility of the content we share. Of these four measures of performance, accessibility is key. Hence, one of my priorities is to build a world-class communications technology platform that can be easily used wherever our members are today. Literally, they are everywhere, because DIA is a global organization, active in over 80 countries.

We are investing in updating our content management systems and have launched a suite of interactive learning management tools that will distribute DIA educational and thought leadership content to our members in all formats, from your desktop to mobile and ultimately in the cloud.

To that end, we have refreshed and repositioned our peer-reviewed journal, Therapeutic Innovation & Regulatory Science, under our Publications Editor-in-Chief, former FDA Deputy Commissioner Dr. Stephen P. Spielberg. The journal is the centerpiece of our publications portfolio, which also includes DIA Global Forum and DIA Daily, both of which collect and synthesize our best content worldwide and make it accessible to DIA members every day. Our country and regional con-  stituents are regular contributors to the Global Forum.

Selling solutions

KUNZ: We are also reexamining what we mean by content. DIA exists to create and share more than raw information. It is information applied-information that provides the knowledge to act and to execute responsibly. In fact, we no longer refer to DIA as the Drug Information Association. We use simply DIA, augmented with the tagline- Develop. Innovate. Advance. These are action-oriented words. The message is that DIA is no longer an organization geared to simply providing information about drugs. That’s way too passive for an industry undergoing disruptive change.

Our second priority is to better understand our members and their needs. We have conducted “voice of the customer” studies, focus groups, and surveys to provide trend-based analytics that will tell us what programming works best for each DIA audience, wherever they are geographically or in their profession or interests. We also rely on our Regional Advisory Councils of stakeholder representatives and experts in all the principal markets: the Americas, Europe, Middle East, Africa, China, Japan, India, and Southeast Asia. The feedback I get from them is candid and helps us to have perspective on the trends we discern from the data.

Events and training account for more than three quarters of our annual revenues of approximately $30 million. Hence, it is appropriate that we maintain our focus squarely on improving member services. One specific outcome that members are already seeing is a targeted approach to online engagement through our newly launched Community portal. This new platform allows us to deliver precisely what individual members say they want from us and eliminate the rest. People are busy. No one wants to keep receiving materials in which they are not interested, so we can tailor to individual interests. Also this platform encourages interactive problem-solving among members and provides the channel to communicate outcomes to our community and beyond.

In using the information on member needs and expectations, we will continue to customize our events. DIA’s annual meeting in Europe has been completely refreshed to include multiple formats, interactivity, opportunities for discussion and debate. Our meeting in the US is now truly a global convention, with diverse content, thought leaders, and attendees. And in Japan, China, and other countries in Asia, the Middle East, and Africa, DIA continues to invite key players to the table, to create the opportunity for discussion and action. We are proud that year after year, we see ever-increasing numbers of attendees at DIA events.

Our strategic priorities are supported through ongoing financial investments by DIA to ensure our members have access to state-of-the-art knowledge management tools to support their needs to access information, share knowledge, and advance science.

How do you break down the membership in DIA?

DIA’s representation is extremely broad. When I came to DIA, I took a deep dive to understand who our members are and what they need from us. Our events continue to attract senior industry people. But it was evident that continued vigilance is required to retain these high-level connections by ensuring our material was relevant to this audience.

On the opposite end, we have a solid base among younger industry professionals-those in the first five years of their careers. Students and leaders from academia are also counted in our numbers.

Both groups carry a strong interest in our education and professional development initiatives. But the heart of our membership remains working industry professionals with operational and regulatory responsibilities. Their interactions with DIA can be encapsulated in a single question: how do I take this rich content back to my office and put it to use in solving a problem or creating a new opportunity for my organization?

Are there gaps in the DIA membership base that you need to fill?

We are taking a closer look at stakeholders who work with us, but for various reasons are not active and are reaching out to them to encourage their engagement. In addition, there are three constituencies that have been very active and growing in DIA. The first is the patient community. DIA has been ahead of the times in bringing the patient voice into the policy, regulatory, and business conversation. But we need to do more.

Our goal now is to build more clarity around our mission to patients, not as a patient advocacy organization but as experts in the healthcare product arena so that they can become more involved and influential in the regulatory decision-making process. Working with DIA can help raise the bar on their effectiveness with other stakeholders in the innovative process.

The second constituency is market access-payers, health technology assessment agencies, and other stakeholders that are critical in defining the “value” of therapies, from launch right through to the end of the product life cycle. DIA wants to include their voices, extend our convener capabilities, and spread the learnings from our conversations with them.

The third is around the span of geography. DIA is committed to a much larger presence in Asia, Africa, and the Middle East, where key institutions in healthcare are relatively less developed compared to the industrialized world. We hold conferences in these geographies, and we plan to extend our working presence in these regions in the years ahead.

Given this broad remit, how does DIA make decisions?

Major issues that have a bearing on strategy or governance are addressed directly by our Board of Directors. But, as a global organization, we also seek direct input at the regional and country level. This is designed to ensure that our Board stays in touch with the grass roots constituencies around the world and can integrate their insights into our strategy. DIA is an organization of many voices. Decisions taken by the Board are executed locally, with a significant degree of discretion based on local culture and practice. We have coined the phrase “We are DIA” to describe this continuum from staff to volunteers to members to the thousands of people who see themselves as part of this exciting movement, interlinked and interdependent.

I expect the trend toward decentralization will accelerate as DIA adds to its functional capabilities in markets outside our US base. There has been a devolution of service functions like finance, IT, and HR to our five regional offices. These are located in the US (Horsham, PA), China (Beijing), Japan (Tokyo), India (Mumbai), and Europe (Basel), which is also responsible for managing DIA work in Eastern Europe , Africa, and the Middle East. Our big investments in communications technology are designed to create a seamless flow of interactivity as DIA membership roots extend to more countries.

Partner of choice

What role do external partnerships play in the DIA ’s plans for global growth?

We are doing some interesting things with organizations at the country level, where we have agreed to share DIA’s content to engage the local audience. Virtual technology allows us to do this on a significantly bigger scale. The aim is to make DIA the place to go to obtain relevant, high quality curated content on everything from the ins and outs of therapeutic discovery and product development to market access. We want DIA to be the essential “go-to” source for the latest and best insights available.

Partnering is how we intend to build capacity in regions of the world where expertise in drug regulation and development is lagging. For example, in Asia, DIA is focusing on training in the medical affairs function, helping countries to make the transition to a new selling model for drugs based on the technical knowledge of the science behind the therapy.

Can you highlight your leadership style? How do you place your stamp on the organization while encouraging the diversity and decentralization you cite as key drivers of the new global DIA?

I am very strategic. My job is to understand how best to energize DIA colleagues, volunteers, and members and to liberate their capabilities so that they move the needle collectively. Hearing the many insights from DIA’s broad community allows me to generate clear priorities and then to implement on those priorities. The DIA Board plays an active role in setting strategic direction and ensuring that our plan is distinctive but realistic.

Talented people are what makes DIA what it is, and I am a talent developer. Nothing is more rewarding than seeing people learn and grow-and fulfill their own dreams. Also, I like to have fun. I am told I bring enthusiasm to the workplace. Being authentic in your approach to colleagues and doing work that you really care about are big parts of that.

What are the achievements on which you expect your performance to be measured over the next several years?

First, high quality and dynamic content are going to be key. So establishing a rigorous approach to our content strategy is a top priority and one on which today’s DIA leadership will be assessed. However, content alone is ineffective unless it is coupled with a solid level of tailoring.

I want this leadership team to be seen as catalytic in making DIA the unrivaled global convener of people in healthcare to solve problems and advance regulatory science. You are going to see an even higher level of diverse stakeholders in our work. We believe that a high level of engagement with the patient community is essential. In addition, we are bringing payers into our circle to create a dialogue with the industry and government regulators. In other words, market access will have a designated seat at our table.

My third goal is to ensure DIA programming concentrates on the most important issues for our members. All of our public activities must be focused on yielding a tangible outcome. Being a convener means advancing the conversation so our stakeholders are in a position to decide and to act.