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In this interview, Sudip Parikh, SVP and Managing Director of Americas at DIA Global, will discuss the latest industry trends, and how DIA NOW is helping to facilitate information across the clinical trials industry.
The global clinical trial regulatory environment is changing rapidly and is starting to converge. For example, topics such as artificial intelligence, gene-based therapies, and patient centricity are taking front stage at many global DIA forums. However, it can be a challenge to keep track of global perspectives except for those who are able to regularly attend global conferences. DIA recently launched DIA NOW, which is a platform that intuitively connects global DIA content with users. In this interview, Sudip Parikh, SVP and Managing Director of Americas at DIA Global, will discuss the latest industry trends, and how DIA NOW is helping to facilitate information across the clinical trials industry.
What trends or topics are you seeing that are novel in the clinical trials industry?
I am seeing a maturation of concepts that have been hinted at in the past years. On the technological side, everyone is thinking about how AI plays a role in drug development, from basic research all the way to regulatory submission and analysis embedded in pharmacovigilance. Industry personnel are thinking about how these new technologies can be applied in the drug development space including the clinical trials space, for example, blockchain applications in supply chain. We are also seeing the need for clinical trials design to matchup to new technologies; industry thought leaders and regulators are thinking of ways to design the right trial for a particular treatment or a disease state. On the disease front, it is about targeting, specifically, designing rare disease studies for a single mutation or a chronic disease. Additionally, we are seeing more patient-centric approaches between regulators and industry, as patients are now involved in novel therapy development. With the maturation of these novel concepts, we are seeing each of these concepts not only growing in their own silos but also coming together.
What trends or topics is FDA focusing on now?
I came to Washington 20 years ago and at that time the FDA had a different culture than today; today, the FDA is proactive. Their leaders are involved with patients and are continually engaging them with the industry and trying to be proactive about the maturation of technology. There are a couple of these important trends and topics, one is patient-focused drug development. It is coming with some push from Congress but also within the agency itself about understanding the value of endpoints, engaging with patients early in the drug development process, and understanding what is valuable to the patient. The second is anticipating technologies even before those technologies are submitted for review. Whether it's artificial intelligence, blockchain or other disruptive IT technologies that might be coming their way, the FDA is thinking and talking about this ahead of time. They don't have an answer yet, but they are listening, and they are engaging. The third is life-science technologies; this requires thinking about gene editing and adaptive trials ahead of time. The FDA is publishing about master protocols, immunotherapies and the value they have brought to oncology in scientific journals. Two years ago, before Scott Gottleib came into being the commissioner of the FDA, the President mandated cuts to FDA’s budget. Congress did not accept those cuts, but it was a manifestation of what the administration had thought of the FDA. With Gottlieb advocating for the agency, the President’s request saw an increase in the FDA budget by almost $400 million across different investments this year, such as AI and regulatory science.
Why are these trends important?
We are seeing a snowball effect that started 10-15 years ago as patient advocates first wanted hope. There was a lot of patient advocacy on behalf of the National Institutes of Health. An example of this is spinal muscular atrophy or Duchenne muscular dystrophy, which impact children, and 15 years ago there were no good therapies on the market. Parents came to us to talk about investing in basic research. It was then discovered that these diseases contained biological mechanisms that spawned the design of novel therapies that could treat and cure some of those diseases. Basic discoveries were made, and suddenly small companies emerged and novel therapies were brought to market from investments by larger biopharmaceutical companies. We recently saw the release of data in a gene editing technology that was creating dystrophin in children, a theorized deficiency that may cause those diseases. If that data holds up in the first patients that were given the genetic therapies, and if it is proven that a lack of dystrophin is what causes Duchenne and adding it back will help the disease, we may see a therapy that could potentially increase the lives of these children. We are seeing a mass effect where gene editing can work in that disease state, and suddenly there are investors who are interested in the promise of this therapy. The next step is to get through the regulatory process with a safe and effective drug. That is what is exciting about the DIA meetings; we have got the exciting basic research technologies and we are trying to develop the right types of clinical trials to get through the regulatory process. This is the place where we get together and talk in a neutral forum about how we are going to accomplish the goal of advancing innovation through novel regulatory pathways. People are passionate to come to DIA because they not only care about the success of their companies, but they also care about these molecules and tools in the hands of patients.
How is DIA helping to advance innovation?
Advancing therapies and regulatory science works within a global ecosystem; we have research taking place in the US but there are also investments in China, Europe, and Japan. Accordingly, DIA is a global organization. We attract personnel who are interested in advancing a therapy through global regulatory systems or where the therapy is at a maturing point where reimbursement and market access models are needed. Currently there are a host of small topics that are growing, such as Oligonucleotide based therapies, pharmacovigilance, and artificial intelligence.
DIA is also a content creation machine, and we want to provide global access to all of our content. We recently launched DIA NOW, which is a tool to dig into our content in a smart and sophisticated way and to be able to look at it in a timely way. If you want to hear the new head of the CFDA speak about her goals for the Chinese regulations, or her plans of creating a system that has innovative drugs and generic drugs being manufactured in China, you can search for and pull that thread through DIA NOW. We can slice our content in multiple ways: by disease state, country, biosimilars, and generics, to name a few. Additionally, you can follow that thread around the world. That can be done at the individual or at the organizational level so if the company wants to create a knowledge base for their employees in biosimilars, they can build that base on the content that is constantly updating around the world. All companies, and even regulators, are now thinking globally with China's ascension to the ICH, and they are just as invested in new global guidances, whether they come out of FDA, EMA or CFDA. So, it is about getting that common understanding and being able to scale it from an individual’s competence to the entire organization's competence because we work as a team. This is DIA’s 21st-century way of getting the content at the right time and in the right hands.
Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.