Early Development
Supporting your indication selection and assessment of different acceleration strategies are part of what we do exceptionally well at NDA.
We help you maximize the value of your asset based on the data you already have and the regulatory and market opportunity that can be leveraged. Pediatric and orphan drug strategies are second nature to us, just like getting your trial approved.
Each Phase of Development comes with its own unique challenges. Read more about some of the challenges you will face during this phase and the NDA solutions by clicking on them below.
Challenge: Indication Selection
Are you assessing in what indication your product will have the greatest market potential and do the most good? Are you considering whether an orphan indication or a broader one is the best for your product?
Solution
At NDA we have been working with orphan indications ever since their pathways were introduced. Our consultants can support you every step of the way, from assessing the broader market landscape and the acceptance by regulators and payers, to assisting you in filing for orphan status when a limited indication is to be preferred.
Challenge: Accelerated Pathways
Would you like to understand how your product can take advantage of accelerated development pathways? Are you aware of the many options that exist to accelerate product development in the US and EU?
Solution
NDA’s experienced consultants can guide you through the different acceleration options available across jurisdictions and support you in creating a regulatory roadmap that makes use of these mechanisms to optimize the path of your product and minimize its time to market.
Challenge: Unique Product
Are you developing a product without precedent? Does it have a novel mode of action or maybe it’s an ultra-rare indication? Are you wondering what the regulators’ expectations will be and whether they will be realistic?
Solution
At NDA we have worked with dozens of unique and groundbreaking products. Reflecting the views and practices of the regulatory agencies our advice has guided constructive dialogue and eventually approval. Incorporating this input into strong development plans gives you a clear path for your program and for your product to reach the patients waiting for it.
Challenge: Exit Strategies & Value Maximization
Have you taken your product as far as you’ve intended? Would you rather want to focus on your next product candidate and let someone else take your product to market? Would you like to maximise the value of your asset before partnering or exit?
Solution
Regardless of whether you have a post Phase I or Phase II exit strategy or want to take your product all the way, we strongly recommend thinking with the ultimate end in mind. At NDA we can help you crystalise your product’s road to market and maximise the value of your package before you invite partners or investors to take it.
How can we help you?
Proving the concept
The early stages of clinical development really put you, your team and your product to the test – this is where you will find out if the promise of your hypothesis is feasible. Is your product really safe? Does it make a difference to those you want to treat?
Having managed the transition from pre-clinic to clinic you know what transformation is about and your network of partners and collaborators are continually expanding. It has to, since you’ll rely on many of them for some of the most crucial activities that your company is performing.
Now is the time to demonstrate that your product does what it’s intended to do, but also that there is a market waiting for it at the end of development.
Selecting who to treat = selecting your market
In many cases, the mechanism of action of a single molecule can be used to address multiple conditions. Not only must you take the unmet medical need that your product can address into account, but what market this would result in. Choosing an orphan designation would force additional considerations such as:
- What would the regulatory incentives mean for you?
- How would the smaller trial sizes affect your cost and time to execute?
- What would it do to your projected sales?
At NDA we support you in this important decision, by helping you assess the clinical merits, leveraging the regulatory advantages and comparing your asset to your competitors labels. Once selected, we take any orphan indication to the regulator with you and help you secure an orphan drug designation, a label that is proven to work as another important value inflection point for your company.
As children are a priority population for many indications, particularly in genetic disorders often addressed by novel advanced therapies, we also specialize in paediatric strategies and the paediatric investigation plans that come with them.
Regulatory acceleration – cutting your time to market
The FDA, EMA and many other regulatory agencies across the world now offer accelerated regulatory pathways for innovative and important therapies. Not only does this hold the promise of a lighter regulatory burden, but more importantly it offers a faster path to the market and the patients in need of your treatment.
Armed with one of our Regulatory Roadmaps you will be able to visualize your path to regulatory approval, taking all the opportunities for expedited pathways and agency interactions and support into account.
This will be particularly important should you have a product without regulatory precedent. Our advice has guided constructive dialogue with, and eventually approval from, the regulatory agencies from dozens of highly differentiated and unique products. We love walking the path not tread!
What is your exit strategy?
The market is not a place for all biotech companies, and many don’t even plan to go there at all. Developing for a Phase II exit and developing for taking your product all the way should however have a lot in common.
Preparing your plans and development activities to generate the best possible evidence from a scientific and market perspective, will ultimately maximise the value of your asset and your company at the time of sale. Develop with the ultimate end in mind, whether for the patient, or for the partner.
NDA support this process in a similar way to our other strategic support; by crystalising your vision and your plans in concise documentation that speaks as much to the external investor as it does to the operational team. Let us help you raise the value of your hard work.
Our services include
- Indication Selection
- Orphan Drug strategy and designations
- Paediatric strategy and planning
- Acceleration strategies & Expedited Pathways
- Regulatory Roadmap
- Quality Target Product Profile
- Risk Management Planning
Contact Us
Your drug development needs are unique
Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.
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