Four Legitimate Reasons to Prioritize Speed in Drug Therapy Development and How to Move Fast Safely 

In the fast-paced, funding-constrained world of drug therapy development, finding the right balance between speed, quality, and cost is crucial. Investing time and money in thorough research and development (R&D) is imperative for successful clinical manufacturing; however, there are scenarios where drug therapy sponsors can and should intentionally prioritize speed to clinic.  

Why Prioritize Speed? 

As a therapy developer, you may choose to prioritize speed to do any of the following: 

  • Meet urgent needs of the patient population 
  • Align timelines and financial runway  
  • Gain a first mover advantage 
  • Protect intellectual property 

The challenge is to prioritize speed while identifying and mitigating risks that may increase your costs in the long run. It goes without saying that you must also find ways to prioritize speed without compromising patient safety. 

Start With a Hard Look at Your GMP-Readiness  

Before we dive into the legitimate reasons to prioritize speed and how to do it, you may want to take a look at BioCentriq’s eBook on how and why early-stage drug therapy developers should take careful steps to ensure they’re GMP-ready. Understanding these steps will help you arrive at a firm understanding of your own GMP-readiness so you can make informed decisions about where you are prioritizing speed and how to go about doing so in a manner that identifies and mitigates the risks associated with moving quickly. 

The steps we outlined in our eBook include:  

  • Being honest about your GMP-readiness level from the start 
  • Defining specifications, quality attributes, dosing strategies, critical process parameters, and more 
  • Examining whether you have done enough upfront work to reduce contamination, minimize risk, and speed up processing time 
  • Making sure you’ve assembled the best team possible 
  • Determining the most advantageous path to manufacturing 

Know Your Rationale for Speed 

While we advise you to read the eBook and do what you can to set yourself up for successful clinical manufacturing early on, we also recognize that sometimes you must prioritize speed. Let’s look at the reasons where prioritizing speed becomes a strategic and intentional choice, as opposed to a rookie mistake. 

1. Investor and Stakeholder Pressures 

It’s no secret that drug therapy development requires substantial financial resources, and sponsors rely on investors and stakeholders for support. You may prioritize speed to meet expectations and demonstrate progress to garner much-needed continued investor confidence and support. As a result, you may be in a rush to hit certain milestones, meet regulatory requirements, or obtain approvals to demonstrate to the investors and stakeholders that they’ve made a worthy investment that will yield healthy returns.  

2. Gaining a First Mover Advantage 

While the goal of all drug therapy sponsors is to meet the medical needs of those with few to no other options, the reality is that this industry is extremely competitive, rapid, and constantly evolving. As a sponsor, being the first to introduce a groundbreaking therapy can establish you as a leader and increase access to accelerated regulatory pathways. Plus, being the first to introduce a therapy targeting a specific indication or utilizing a unique mechanism of action gives you a powerful differentiator. By prioritizing speed, you can capture market share, secure investments, and build a solid foundation for future growth — things that all drug therapy sponsors, regardless of size and funding constraints, will always strive for. 

3. Intellectual Property Protection 

Patents grant sponsors a period of market exclusivity that naturally leads to a lot of revenue-generating opportunities, which is a position everyone wants to find themselves in. But the longer it takes to develop a drug therapy, the more time is potentially detracted from the market exclusivity period. Prioritizing speed allows you to maximize the time you’ll legally have for that market exclusivity, which allows you to build a loyal customer base and establish a strong brand before potential competitors come onto the playing field.  

4. Addressing Urgent, Unmet Medical Needs 

Of course, the goal of everyone in this industry must be acknowledged as a true and constant need for speed. With patients around the world suffering from life-threatening conditions or diseases with no effective treatments, accelerating the development process is of prime importance. Incredible stories like Emily Whitehead’s story serve to remind us why this race against time is so necessary. 

Find Ways to Move Fast Responsibly 

Now that we’ve examined four legitimate reasons you may choose to accelerate certain steps, let’s examine how you can go about doing that conscientiously and strategically without compromising the quality, safety, or efficacy of your therapy.  

Streamline Project Management 

Implementing efficient project management techniques is one of the ways to chip off time for all phases of drug development. You should establish clear timelines, milestones, and deliverables, allowing for effective coordination and collaboration among interdepartmental teams — all things that are far from trivial. By optimizing project management practices, you can minimize delays, ensure proper resource allocation, and create a sense of urgency throughout the development process. 

Seek Regulatory Expertise and Engagement 

You can seek the help of a regulatory expert to help navigate changing guidelines and requirements specific to your therapy. By aligning their development plans with regulatory expectations early on, sponsors minimize the risk of regulatory roadblocks, which can eat up huge amounts of time; expedite the review and approval process; and ultimately accelerate the therapy’s path to market. 

Build Strategic Partnerships Based on Transparency  

Forming a partnership with a proven, transparent, and collaborative contract development and manufacturing organization (CDMO) will enable you to leverage their specialized skill sets, access advanced technologies, and tap into existing infrastructure and resources. By combining and complementing each other’s resources and knowledge, you and the right CDMO can accelerate various aspects of drug development, including preclinical studies, clinical trials, manufacturing processes, and data analysis. The goal here is not to replicate what each team already brings to the table, but to partner with a CDMO that fills in the gaps in your team’s knowledge, experience, and skills. 

Run Parallel Development Tracks 

It also may be possible to work on multiple stages of drug development simultaneously rather than sequentially, an approach that can massively decrease the overall timeline. For instance, if preclinical studies are underway, you can already start planning and preparing for clinical trials that should begin shortly thereafter.  

Leverage Existing Assets Through Platforms 

Platforms offered by CDMOs consist of pre-existing assets that you can leverage on your path to clinical manufacturing. They provide standardized, reliable systems that can streamline processes, enhance reproducibility, increase success rates, and more. As a collaborative CDMO specializing in cell and gene therapy, BioCentriq offers the LEAP™ Advanced Therapy Platform, which is the perfect example. Sponsors who leverage LEAP™ minimize up-front investment in process development, reduce risk, accelerate timelines, and lower the cost of IND-enabling studies and clinical production. This is made possible by utilizing pre-existing master batch records, established SOPs, trained personnel, quality analytical methods, and more, empowering sponsors to get to clinic in as little as six months.  

You can download the LEAP™ Platform Overview here if you’d like to learn more. 

Bottom Line: Strike a Balance 

It is important to note that while prioritizing speed can be the right decision or simply the only option, you must not compromise patient safety or the quality of the therapy. But with careful planning and management, strategic partnerships that provide technical and regulatory insight, and by leveraging platforms, you can strike that balance to accelerate the delivery of transformative therapies while maintaining safety and upholding efficacy standards.  

As long as the choice to prioritize speed is intentional, and you do not bypass the upfront work of getting GMP-ready by mistake, it is possible to get to clinic faster without sacrificing quality and safety. 

If you are a drug therapy sponsor looking to accelerate your path to clinic, BioCentriq may be the right fit for you. With the LEAP™ Advanced Therapy Platform, rapid tech transfers, experienced personnel, and an established track record of successfully manufacturing complex cell therapies and releasing quality drug products for use in active clinical trials, BioCentriq has capacity for 2023 manufacturing. Click here to contact us today, and we’ll set up a time to discuss your path to clinical production.