Headquartered in Philadelphia, TransCelerate has 30+ initiatives focused on improving the patient and site experience, enhancing sponsor efficiencies and drug safety and, as appropriate, harmonizing process and sharing information.
Outsourcing-Pharma caught up with Dalvir Gill, CEO at TransCelerate, to learn about the organization’s impact to date, its most notable achievements, and get a sneak peak at some upcoming announcements.
Outsourcing-Pharma (OSP): Could you tell us about some of the key challenges present in drug development 12 or more years ago, before TransCelerate was on the scene, that was the motivation to start this organization?
Dalvir Gill (DG): Drug development is a long and expensive business. It can take billions of dollars and a decade or more to develop a drug, prove it safe and effective and get it to patients. Within the last two decades, the era of obvious drug targets that produced many blockbuster drugs has diminished. It has become harder and costlier to find and develop new drugs. This situation is further compounded by skyrocketing costs associated with inefficient processes and systems that were previously tolerable but are now unbearable.
It became clear to heads of R&D at major pharmaceutical companies we needed to tackle these process and system inefficiencies together and not separately. Before TransCelerate, companies would confront such problems within their own organizations with mixed results because a single company, no matter how large, does not have the influence needed to make wholesale changes in the broader ecosystem. In addition, there was a growing understanding that some of the areas of drug development that needed attention were pre-competitive. In other words, there was no competitive reason to solve common process problems separately. In fact, these different solutions to common issues added to the overall inefficiency for regulators, investigative sites, CROs, patients and the industry itself.
We knew we could not continue this way. So, in 2012, 10 major companies came together and founded TransCelerate to help tackle common pre-competitive problems. We structured TransCelerate with governance and legal structure that could function pre-competitively within a fiercely competitive industry. We agreed to develop tangible, pragmatic and consumable solutions for common problems. We also decided to make our solutions publicly available under the principle of "a rising tide floats all boats."
Ten years later, we are 20 companies strong, and we have produced dozens of substantial solutions in everyday use across the drug development landscape. In all that time, we have not wavered from our overarching mission to bring new medicines to patients faster.
OSP: Please share some of the ways in which TransCelerate is working to help address those problems, including the tools and resources you’ve come up with.
DG: When we started this collaborative effort in drug development 10 years ago, we modeled it after successful examples in industries like aviation, banking and semiconductors. The most critical success factor was ensuring the member companies were intimately involved in identifying issues to tackle and, even more importantly, doing the actual work that produced solutions. Within a few months of inception, we agreed on a set of strategic priorities that became our guiding star. That clear focus has been part of our success.
We were deliberate with the mix of initiatives we chose. First, we needed intuitively obvious projects for everyone — collaboration was a no-brainer. These projects earned us early wins as we proved the biopharma industry was ready and capable of deep, pre-competitive collaboration. The second kind of initiatives would take a little longer to show results but were even more impactful. The final mix of projects we chose are "building-block" initiatives that would coalesce over time to create transformative value. To achieve ecosystem-wide change, we have partnered with regulatory agencies, site organizations, patient groups, technology companies and clinical research organizations.
Over the past decade, our efforts made dozens of solutions publicly available and addressed significant areas of inefficiency. Audiences outside our membership and in virtually every country that conducts clinical research have downloaded our solutions thousands of times.
One of our most important strategic priorities is improving the investigative site experience. We unburden these sites through tools that make it easier for them to conduct clinical trials, perform more efficient training via mutual recognition, find new clinical studies and exchange documentation and information through a single sign-on platform. They can be included in the world's best investigator registry and start studies faster than ever before.
In collaboration with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), we brought sanity to the field of risk-based monitoring over 9 years ago. To this date, it has been one of the most impactful initiatives we have completed. We created a comparator drug-sharing network that saved hundreds of millions in unnecessary costs, removed supply safety risks, eliminated the risk of counterfeit drugs in the supply chain and allowed companies to avoid bulk buying and stock-out risks.
We created the most detailed, granular and consumable clinical trial database that has ever existed. Its value to scientists, physicians, statisticians and society at large is not measurable in mere dollars. We create better protocols, better understand patients' geographic, ethnic and cultural variability before we even conduct studies and, most importantly, require fewer patients in our clinical trials with greater predictability. Our work in drug safety has improved patient safety by enhancing safety signal detection and increasing efficiency for the industry and regulatory agencies. We've sharpened the focus on the highest value safety information rather than wasting vast amounts of time on information that was proven not to add to a drug's safety profile.
In 2016, we launched BioCelerate, our subsidiary collaborative in preclinical research. BioCelerate is following the same path as TransCelerate's clinical and drug safety, allowing great strides in toxicology data sharing, common templates and collaboration with the FDA in a Public Private Partnership to use data standards.
We recently launched a project called Digital Data Flow, the culmination of years of work from the multiple "building block" initiatives I mentioned earlier. The clinical data standards work we did with the FDA and CDISC 9 years ago led to common protocol templates and the reuse of other clinical content like Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs). Our Digital Data Flow Initiative will help us capitalize on the value of beginning-to-end digital data flow in clinical trials. We are also collaborating with EMR vendors, FDA and HL7 on Vulcan to bring clinical practice data closer to clinical research data. We envisage a future world whereby healthcare, research data and information flow seamlessly, are not duplicated in multiple systems, are reusable for multiple purposes and substantially decrease the inefficiencies we see today.
OSP: Please talk about the industry’s attitudes toward collaboration—how has it changed over the years?
DG: Over the past 10 years, we have proven that real, effective change and collaboration can occur between sponsors and key stakeholders in drug development. We've demonstrated that there is a way to work together without sharing any competitive information, and by working together, we can bring medicines to patients faster.
For example, when the pandemic lockdown began in 2020, patients in studies all over the world could not get to their doctors and had difficulty accessing their study drugs. TransCelerate became the natural and trusted place for the industry to collaborate and solve these common challenges. This network has proven an invaluable resource to our members, with a robust list of topics they continue to discuss; most recently, a key issue was the impact of the Russia and Ukraine conflict on patients in clinical trials in Ukraine. We had a brand-new challenge as patients who enrolled in studies in Ukraine could not access their doctors, and others had relocated to another country altogether. These are the kinds of collaborative discussions that are now normal in the industry, and we are proud of the role TransCelerate has played in enhancing this collaborative spirit.
OSP: Why does it benefit "competitors" (like BMS, Merck, Lilly, and the like) to get together to work on such issues?
DG: Because they realize it doesn't make sense to waste resources competing on matters that do not contribute to the competitive business. They want to reduce spend and wastage on these non-competitive issues and repurpose these substantial resources toward more discovery, lower attrition rates, quicker and more efficient drug development and ultimately, allow their businesses to help patients waiting for new medicines. This is a win-win for all concerned.
OSP: Could you please share some of TransCelerate’s most notable/proudest accomplishments?
DG: One of the very first solutions delivered by our Site Qualification and Training program was our Good Clinical Practice (GCP) Training Mutual Recognition. It's a set of minimum criteria that enables voluntary and mutual recognition of GCP training across member companies. It reduces the burden on investigators and others by recognizing their GCP training across participating companies instead of separately for each company.
We’re also proud of the end-to-end efficiencies we’re advancing through our Clinical Content & Reuse clinical template suite. First launched with our Common Protocol Template, it enables sites to use a harmonized template and makes finding information in each sponsor's protocol easier. We collaborated with the FDA and NIH to standardize protocol templates. This collaborative effort reinforces the need for harmonized protocol formats and content that aligns objectives and endpoints with accepted data standards. In recent years, we've expanded our work on common templates to the Common Statistical Analysis Plan and the Common Clinical Study Report. All these tools are publicly available on our website.
I also commend our Digital Data Flow Initiative for its recent minimum viable product (MVP) release of the Study Definition Repository Reference Implementation (SDR RI). This groundbreaking work combines data standards and open-source technology to enable the flow of digital protocol data across systems involved in designing and executing a clinical trial. Developed in partnership with Accenture and Microsoft, the SDR RI is based on a Unified Study Definitions Model (USDM) developed by the Clinical Data Interchange Standards Consortium (CDISC). This solution aims to unlock information often trapped in protocols and other documents or siloed across multiple systems, to pass across systems through application programming interfaces (APIs). It is used and reused throughout the clinical development lifecycle. The software is open-source, and organizations can use it within an existing infrastructure. It holds enormous potential for the industry as a whole.
OSP: Specifically, how has TransCelerate tackled some of the global crises (such as the pandemic and the Ukraine war) that have impacted the industry?
DG: Diseases do not respect borders, nor should our efforts to combat them. During the pandemic, for example, we helped sponsors navigate the new normal by offering some existing solutions and accelerating the launch of others within our COVID-19 suite of tools. The pandemic necessitated innovative ways of working, which were a catalyst for establishing our Modernizing Clinical Trial Conduct Solutions to provide the industry with tools and best practices that enable patient optionality through decentralized trials and platform trials.
In addition, as mentioned earlier, we routinely host open forums for our members to share best practices. This collaboration was critical during the pandemic and has proven equally valuable for addressing the effects of other unplanned disruptions like human conflict and natural disasters. When Ukrainian patients in clinical studies ended up in other countries like Poland, we could not just abandon them. Some of these patients were in oncology studies, relying on their clinical trial medications for survival. However, there was no precedent for this situation at this scale. Under the collaborative umbrella TransCelerate provided, the industry quickly developed collective solutions that overcame these novel challenges.
OSP: Do you have any upcoming announcements you’d like to tell our readers about?
DG: Yes! First, I’d like to invite everyone interested to a Connectathon we're hosting from September 12-30 for our Digital Data Flow SDR RI tool. This virtual event aims to highlight companies that showcase real-world solutions that use digital data flow technology to produce, exchange or consume digitized study protocol data — like study definitions — using CDISC-developed data and technology standards.
Also, be aware that we will release the first solutions for our Privacy Methodology for Data Sharing Initiative this fall — including an educational toolkit for consent specific to clinical data reuse. We plan to release 20 other solutions across our portfolio between now and the end of the year.
Finally, I encourage everyone to check out our event calendar and take advantage of several free public webinars this fall.
The final word…
DG: We are just beginning the collaborative journey, and there is so much more to do. Despite all the tangible and intangible value we have already created, the coming years will be even more impactful. Our 10 years of investment are now leading to significant and transformative change that will forever improve how we develop drugs for patients.