Regulatory strategy and compliance experts Tracy Rockney and Rob Merrill of OneSource Regulatory (OSR) talk to Dr. Nicola Davies about their free regulatory compliance and information platform, MyIndago (launched in October 2017), and why they think the industry needs it now.
NICOLA DAVIES: CAN YOU PAINT ME A PICTURE OF THE CURRENT REGULATORY COMPLIANCE LANDSCAPE?
Tracy Rockney: In today’s regulatory compliance landscape, there is more data available for evidence building; regulators are now more willing to make evidence-based and risk-based considerations. Consequently, the increasing number of medical devices and growing variety of pharmaceutical products has made compliance much more complicated. The information companies will need to meet compliance requirements that are typically disorganized and not easily searchable.
Rob Merrill: A key challenge we see lies within the smaller pharma companies that need the proper compliance and regulatory information framework to get started. However, it’s often difficult for them to determine where to turn to get the information they need. Where do they gather the right data? Do they need to hire additional compliance professionals? The early steps can be a real struggle.
WHAT ARE YOU DOING TO ADDRESS THESE CHALLENGES?
Rockney: Pharma companies are indeed very innovative, but that does not always mean adoption of the right technology that can enable professionals to do their jobs more effectively. So, we were interested in creating a technology that could ensure compliance professionals could perform their role more quickly, efficiently, and completely. We decided to create that kind of technology. That’s how we came up with a tool that could provide compliance solutions to pharma and biotech companies.
Merrill: To help small companies without much experience with compliance, we enter at the critical stage of their business where the company is trying to create a solid framework to develop and launch their product. We developed templates for policies and procedures that can be fitted according to a company’s specific requirements. We basically give companies a head start, which is important to have because there are certainly ramifications if they take one wrong step in compliance activities.
We always strive to be as efficient and effective in our work as possible. So, we came up with MyIndago so that everybody can have access to the information necessary to perform his or her jobs effectively. The word “indago” is Latin for search or find. This tool is to find the answers that can help us understand the regulatory environment better.
WHAT SPARKED THE CONCEPTION OF THIS INNOVATIVE TECHNOLOGY?
Merrill: The idea was spawned as we were attempting to understand how we could possibly bring technological tools to professionals in the areas of medical, regulatory, compliance, legal and advertising and promotions review. We wanted something that would make the professional’s job easier. This important technology was designed to be a repository of information allowing professionals to better understand regulatory precedents and understand what the government and regulatory authorities have taken issue with and what they are specifically looking for.
WHAT ARE THE STRATEGIC BENEFITS TO USING THE TOOL?
Rockney: Our staff at OSR, people we work with in the industry, and our peers all use technological tools like Google. Search tools make our lives easier and Google is something we have grown so accustomed to in our personal lives. Yet when we go to our work, we are unable to find the simplest pieces of information we need to complete our work or to make a critical decision. When we first thought of developing new compliance solutions, one question we asked was, “What do we need to be better at our job as a professional service consulting firm?” With that, we realized that the search tools the industry badly needed were just not there. So, we built a strategic tool for people to make better and more efficient decisions. Using this tool can empower our peers to stay one step ahead.
HOW CAN YOU MAINTAIN THIS PROMISE OF FREE INFORMATION?
Rockney: Right now, in our industry, technology is portrayed as a costly investment – even simple solutions don’t make it to the top of the list for most companies. The tool is free to use, and as we include more information in the platform, we expect it to facilitate a quicker return on investment in drug development. Cost can be a major hurdle in accessing FDA documents and information, but ours is the first free search-and-discussion platform for information on advertising and promotion and healthcare compliance. We like the idea of bucking the status quo by providing something of value for free!
Merrill: We also wanted to ensure that the tool was available not only to companies able to pay for similar tools but accessible to everybody. Given the current regulatory environment, we consciously decided to develop a tool that was free and that would remain free. The tool should continue to help anyone in need of compliance information and guidance.
CAN YOU TELL US MORE ABOUT THE PLATFORM’S COLLABORATIVE ELEMENT?
Merrill: It is designed to promote the creation and management of a community that shares best practices, insights, and resources. Cooperation, collaboration, and discussion are critical to keep the community alive and to ensure that outcomes of discussions benefit individual users.
Rockney: Also, as we were building the tool, one of the key things we were interested in was looking into how other industries were accelerating technology and innovation. Collaboration with each other and external partners was very important to understand what innovative elements we could bring to our industry.
WHAT BROUGHT THE TWO OF YOU TOGETHER TO TURN THIS SHARED VISION INTO A REALITY?
Rockney: I think we were brought together by a shared interest in solving the existing challenges in regulatory and compliance and a genuine desire to jumpstart and lead a meaningful dialogue. Rob and I saw a huge opportunity to support a community of users by leveraging our own expertise and that of others with proven industry experience in advertising and promotion compliance.
Merrill: At OSR, we believe it is important to have a basis for understanding the government’s actions and current thinking when it comes to regulations. We saw how little innovation was happening in this area. If we were going to effect change, we needed to provide much more than any other expert partnership was. So, together, we wanted to create a single place – free of charge to visitors – that would act as a repository of the most up-to-date regulatory letters and actions.
DO YOU HAVE ANY OTHER TECHNOLOGY-BASED INNOVATIONS IN THE PIPELINE?
Rockney: Our industry has been woefully underserved with access to high-quality technology applications at a reasonable price. We will continue to develop and offer free resources, and we will also be releasing fee-based applications. The key is that the technology needs to be easy to use, solve a problem for our industry, and be reasonably priced. We have some exciting projects in the pipeline, and we are looking for partners to beta-test our prototypes.
YOU ARE BOTH CLEARLY VERY PASSIONATE ABOUT HELPING PROFESSIONALS DO THEIR JOBS BETTER. WHY IS THIS SO IMPORTANT TO YOU?
Rockney: The job of regulatory affairs professionals is critical both to research and to commercial success, but they need a lot of support. It’s important to me that professionals are able to do better at their job because I know how challenging the work can get. I have 25 years of experience working within the pharmaceutical industry. Back then I didn’t have all of the right tools and technologies to fully answer all the questions I had. So, as a start, we built a tool that I wish I had access to while I was in pharma.
Merrill: Professionals are also consumers. The technology they use at work should make their professional lives easier. So, we were both drawn to the idea of using technology to enhance the regulatory affairs professional’s performance, promoting value-adding work for both the company and the industry.
FINALLY, WHAT DO YOU HOPE TO ACHIEVE?
Rockney: We expect everybody in the industry – regulatory, legal, medical, commercial, and others – to utilize MyIndago to search for the information relating to advertising and promotion. In the near future, we hope to provide access to more diverse FDA communications and enable a more global search on regulatory affairs information. We want people to view it as the Google of the pharma industry.
Merrill: Personally, I am very focused on innovation. The tool will hopefully become a catalyst for the development of additional resources and technological solutions that facilitate the exchange of ideas and best practices among users with the click of a button.
Dr. Nicola Davies is a psychologist and freelance writer.
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