From fund-raising through regulatory interactions and preparation for your first in human trials, the regulatory aspects of drug development add value to your asset.
Defining your road to market and utilizing regulatory milestones to demonstrate the value of your product, are some of the opportunities that we at NDA support to make you successful.
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.
Is your company runway restricting your development plans? Are you actively fundraising? Are you looking to increase the chances to attract meaningful investment to your company?
Demonstrating a clear road to market in multiple jurisdictions, and taking regulatory and market access concerns and opportunities into account can significantly enhance the value and attractiveness of your program. At NDA we excel at creating and documenting value-adding, evidence generating strategies and Target Product Profiles that guide your program and attract stronger investors.
Challenge: Translational Strategies
Would you like to better understand how to create a translational strategy to demonstrate meaningful clinical benefits? Are you concerned about how to assess, document and mitigate the scientific, clinical and regulatory risks of your program?
NDA’s translational science team excels at assessing and developing translational strategies, taking the data at hand into account, to move your product from preclinical proof of concept and into the clinic. Through our risk-based approaches, we help you better understand dose and concentration-response relationships and immunogenicity related risks.
Challenge: Regulatory Interactions
Does your program need external validation? Do you need to demonstrate progress to your shareholders and investors? Do you require scientific input into your program?
Scientific Advice from regulatory agencies offer an opportunity to move your program forward, gain significant insights into the regulators’ view of your development plans and give you meaningful milestones and talking points regarding your development strategy. At NDA we’ve prepared for hundreds of agency interactions to help ensure optimal outcomes.
Challenge: First-in-Human Trials
Are you considering entering into your very first human trials? Are you wondering what key considerations you should make at this stage, what’s required for trial initiation and what you can wait with?
At NDA we have supported the translation of preclinical data into robust trial enabling packages for over 15 years. We support every step of the strategic and regulatory process, from risk management strategies to submission of trial enabling applications (IND/CTA) in multiple jurisdictions. So that you can focus on your program and your CRO can focus on your trial.
How can we help you?
The beginning of an exciting journey
From discovery to verifying your fundamental hypothesis in a non-clinical model is an exciting journey. If done well it sets you up for the beginning of the next phase of your company – translation of your findings into the human body to initiate your first human trial. Should you be successful in demonstrating the clinical need of your discovery you will be able to label yourself a clinical stage biotech.
This process starts with a spark – a bright idea that might transform the lives of the patients that you could potentially treat. Now you have to prove that your idea is more than an idea, it is indeed a treatment whose mechanism of action and safety profile is so good it can be used in trials on human subjects.
Evidence for science, evidence for funding
Demonstrating that you have a solid scientific case is not enough for your idea to attain a value in the eyes of an investor. You must have a road to market, whether it is for yourself or a future partner. At NDA we support you through the process of defining your product and its Quality Target Product Profile, enabling more objective evaluation of your asset. We support the development of your pre-clinical, clinical and regulatory plans, to supplement the value of your asset and demonstrate that there is a clear path to the next value inflection point.
Paving the way to the clinic
Once funding is secured, we support your translational activities by ensuring that your product is adequately characterized from a safety, mechanistic and quality point of view, and that the evidence you are generating is adequate to provide a path into human trials. We review the data from your pre-clinical activities and advice you on the extent to which they support your claims and how to present them to a regulatorto secure approval for your first clinical trial.
Navigating the regulatory maze
With the case clearly stated, we support your regulatory interactions, from early communication with the regulator, be it in the US or in Europe, all the way through to submitting your IND/CTA. Having been an integral part of your team, our regulatory experts are then positioned to respond to any question posed back by the regulator in response to your application, to ensure a successful outcome and a clean study start.
When you partner with NDA at this stage, you know you have a travel companion that has travelled this road before and that will remain with you until you’ve reached your final destination.
Our services include
- Opportunity Analysis
- Target Product Profile
- Lead Candidate Selection
- Translational Strategy
- IND-Enabling Safety Studies
- First in Human Strategy
- Clinical Proof of Concept
- Immunogenicity Risk Assessment
- PV Strategic Advice
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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