Streamlining the Drug Development Process
Janice Chang, Senior VP, Global Operations, TransCelerate BioPharma, explains how pre-clinical collaboration hastens drug development.
Deconstructing the drug development process, the inefficiencies that impede or halt a product’s smooth path to approval become obvious. Efforts to widen the narrow bottleneck from the thousands of compounds currently being investigated, and those that will eventually make it to market, have largely focused on addressing these unnecessary inefficiencies.
The problems that each pharmaceutical company encounters inevitably overlap. Yet, heretofore, collaboration was a rarity in the highly competitive industry.
A non-profit organization, TransCelerate BioPharma has worked to ease the concern of skyrocketing costs that impede drug development, since its inception in 2012. Essentially functioning as a broad coalition of diverse industry partners, their goal is to improve the health of people around the world by simplifying and enhancing the research and development of innovative new therapies.
Senior Vice President, Global Operations, Janice Chang, says TransCelerate was born out of necessity. The destructive impact of high drug development costs meant that industry was left with no choice but to collaborate to streamline and simplify the process.
“We all know the drug development process is extremely complex, and I think as an industry we have been observing the increase in development costs for decades. The reality is that sponsors have been discussing opportunities to come together and collaborate to achieve efficiencies for years, but I think that because we, as an industry, are known to be so fiercely competitive, we have struggled to find a way in which we can collaborate effectively.”
TransCelerate’s founding members felt that the clinical trials execution domain is the area with the most inefficiencies and also the area that membership was most amenable to collaborate on at first.
“When you focus on clinical trials execution as a sponsor community, our members thought there was a real obligation for us to step up and take the lead in finding ways to streamline how we conduct those clinical trials. Only by doing so, will we find ways to free up resources – both in people and funding – to focus on where the real innovation should be the science.”
TransCelerate is in itself extremely efficient. It has what Chang calls a “lean infrastructure”; although she runs global operations, she also wears several other hats within the organization.
There is one key element of design that differentiates TransCelerate from other consortia. The members not only contribute funding, they also contribute “top talent” – that is, their leaders bring their expertise to TransCelerate initiatives.The organization currently has 14 active initiatives focusing on clinical development processes and each of these efforts are led and driven by more than 500 plus such resources from the member companies.
We don’t operate in a vacuum… We proactively engage with key stakeholder groups, such as the health authorities, the research sites and other industry consortia such as EFPIA and the Clinical Trials Transformation Initiative. Our goal is to move the needle across the clinical research ecosystem and we recognize we can’t do that alone.
“This is how they come together as a sponsor community. The membership identifies problems we want to solve as an industry and together we develop the solutions to address these problems,” explains Chang.
Industry principles apply; Chang and team manage these initiatives with the same discipline when it comes to timeline, budget, and resources.
“It is no different to how our member companies manage their own internal projects. We manage our projects with the same discipline.”
Chang is careful to point out that the individuals working on the various initiatives do not do so in isolation, and collaboration with other stakeholders is a cornerstone of their work. Their input and feedback are crucial.
“We don’t operate in a vacuum… We proactively engage with key stakeholder groups, such as the health authorities, the research sites and other industry consortia such as EFPIA and the Clinical Trials Transformation Initiative. Our goal is to move the needle across the clinical research ecosystem and we recognize we can’t do that alone.”
We have now established a common framework for high-quality risk-based monitoring by bringing together the best thinking from our 19 member companies, and we have been able to raise the bar in a consistent manner across the industry.
Through observing feedback received across various initiatives, Chang states that the health authorities welcome the opportunity to aid in problem-solving exercises for the industry, as they are feeling much of the same pressures when it comes to innovative medicines.
An immediate impact
The relatively youthful company has already had a visceral impact on the clinical research sphere, and some of their early initiatives have now been widely adopted. One such example is risk-based monitoring; this allows organizations to target site-monitoring activities for which risks can be best managed and deliver the greatest benefit to the study. The hoped-for knock-on effect is to become more effective and efficient in using resources and reducing costs, while increasing quality and patient safety.
Chang says that while this concept has been around for years, individual trial sponsors were each doing it in slightly different ways.
“We have now established a common framework for high-quality risk-based monitoring by bringing together the best thinking from our 19 member companies, and we have been able to raise the bar in a consistent manner across the industry.”
TransCelerate has actively gathered pilot studies that have been sanctioned by the FDA and review quarterly metrics from those active studies. Through these learnings, they know that most of their members, as well as academic research sites and other technology vendors are adopting a risk-based monitoring system per the guidance and framework established by TransCelerate.
When it comes to trial sites, huge efficiencies in terms of training, such as good clinical practice (GCP) training, are also being achieved.
“If you are an investigator site, and you are conducting studies for four different sponsor companies, once you’ve completed GCP training for one sponsor company, you are issued a certificate – you don’t have to repeat that training for another three years. When it comes to GCP training, everyone has to have it, but how different is it at the end of the day,” says Chang, adding that they have issued over 125,000 certificates so far. “That’s 125,000 training sessions that don’t have to be carried out for another three years.”
The use of this framework is expected to reduce the time spent by each site and improve the quality of information provided on non-protocol-specific forms for clinical trials. By reducing burden to on-site personnel, they are able to better focus on the patients throughout the clinical trials.
Protocol design is another area “where everybody feels the pain”, Chang continues. Tens of pages of protocol design make for a cumbersome process that does not allow changes to be tracked easily. With input from FDA, CDISC, and others, TransCelerate earlier this year launched its first common protocol template for trial sponsors, with common sections and common instructional text. The next step is to automate it, making it even more user-friendly.
Alleviating the burden
Chang stresses that TransCelerate does not just focus on creating efficiencies for trial sponsors; “we feel we have an obligation to alleviate the burdens placed on our research sites and improve the patient experience as well.”
Now a subset of TransCelerate’s members have decided to leverage its unique infrastructure, governance model and methodologies for preclinical research by launching BioCelerate. The six biopharmaceutical companies that will initially be involved in BioCelerate include Boehringer Ingelheim, Bristol-Myers Squibb, Lilly, GSK, Novo Nordisk and Shionogi & Co.
BioCelerate was created to address the challenge of getting products quicker to market, to ensure greater regulatory compliance and to boost efficiencies while reducing operational cost, as well as improving the predictive values of preclinical efficacy models for clinical outcomes.
The launch of BioCelerate had the support of the entire TransCelerate board and Chang says she believes this is because the model has already been proven – meaningful collaboration is possible, even within this historically competitive domain. The goal is to explore similar opportunities in the pre-clinical stages, which can be more complex, and lead to more ambiguity in terms of data.
“Individual member companies don’t have enough data or access to the right information to make informed decisions earlier on whether to move into clinical trials – which could lead to inefficiencies.”
A goal of BioCelerate is to identify where member companies can collaborate in terms of sharing data, to aid in an earlier and more accurate decision on proceeding with patient trials. This will lead to fewer ineffective trials on patients, and lends itself to the “fail early” mantra for industry.
The first initiative is in toxicology data sharing, which will utilize the FDA standard non-clinical data sharing format, collating toxicology data into a single data-sharing platform. Member companies who have agreed to share their data will have access to this communal data pool and can use the data sets and apply them internally to make better and more informed decisions on their own studies.
This addresses an unmet need for the industry, as well as having significant potential advantages for the patient community.
“Ultimately, the benefits will flow down to patients participating in clinical trials.”
BioCelerate is in its infancy, having only been launched in February of this year, but tangible outputs are expected quite soon, says Chang. She also believes that the success of TransCelerate will continue to grow, saying it is capable of much more. The next five years will see opportunities for the organization to expand across the research and development ecosystem.
“We serve as the catalyst for a wide, cross-industry collaboration. People just needed a safe platform, which we provided, not only for sponsors together but also regulators, research sites, CROs, and other industry groups to come to the table and work together. We started our journey in clinical, now we are moving to pre-clinical and we are exploring new frontiers and new options.”