For early-stage pharmaceutical and biotech startups, the path from scientific idea to Investigational New Drug (IND) application can feel daunting. Limited resources, evolving regulations, and aggressive timelines often collide with the need for scientific rigor and compliance. Yet, with the right structure and planning, the journey to IND can be both achievable and efficient.
As the new year begins, now is the ideal time to step back and ensure your development roadmap is sound. Below is a practical, step-by-step checklist to help early-stage teams move confidently from concept to IND submission—and position their science for visibility, credibility, and funding.
1. Validate the Scientific Rationale
Before investing heavily in development, ensure your program is built on a strong scientific foundation.
Key considerations:
- Clearly defined unmet medical need
- Robust mechanism of action supported by literature or early data
- Competitive landscape and differentiation
- Preliminary target validation and proof-of-concept data
This step is critical not only for development success, but also for establishing a compelling scientific narrative for investors, partners, and future publications.
2. Define the Target Product Profile (TPP)
A well-articulated Target Product Profile serves as the strategic anchor for your program.
Your TPP should outline:
- Intended indication and patient population
- Route of administration and dosing expectations
- Desired efficacy and safety benchmarks
- Differentiation versus standard of care
The TPP guides decisions across nonclinical, CMC, and clinical development—and ensures alignment between scientific objectives, regulatory strategy, and long-term value creation.
3. Build an Integrated Development and Communications Strategy
Early-stage companies often underestimate the importance of integration—not only across development functions, but also across scientific communication and investor readiness. IND success depends on alignment between nonclinical, CMC, regulatory, clinical planning, and how the story is told externally.
At this stage:
- Define the nonclinical program required to support first-in-human dosing
- Establish a preliminary clinical development plan
- Align timelines and dependencies across workstreams
- Identify gaps in internal expertise and plan for external support
- Build out a scientific advisory board
- Begin planning for white papers, scientific publications, and data narratives that can evolve as the program matures
Strategic planning upfront reduces downstream delays and ensures your data can be leveraged effectively for both regulatory and funding milestones.
4. Execute IND-Enabling Nonclinical Studies
Nonclinical development is one of the most time- and cost-intensive phases leading up to IND.
Core activities typically include:
- Pharmacology and proof-of-concept studies
- GLP toxicology studies in relevant species
- Safety pharmacology (e.g., cardiovascular, respiratory, CNS)
- PK/PD and bioanalytical method development
Importantly, these data sets often form the backbone of early white papers, conference abstracts, and investor materials, helping to raise awareness and support fundraising efforts while maintaining scientific and regulatory integrity.
5. Establish a Fit-for-Purpose CMC Strategy
Chemistry, Manufacturing, and Controls (CMC) is often a bottleneck for early-stage startups.
Key CMC considerations:
- Selection of drug substance and drug product manufacturing pathways
- Scale appropriate for Phase 1 to Phase 2 clinical supply
- Stability programs to support clinical use
- Documentation aligned with IND expectations (not commercial scale)
Clear documentation and data traceability also support credible external communications and diligence discussions with investors and partners.
6. Engage with Regulatory Authorities Early
Early regulatory engagement can de-risk development and clarify expectations.
Common early interactions include:
- Pre-IND meetings with the FDA
- Regulatory pathway and jurisdiction assessment
- Agreement on nonclinical and CMC plans
- Feedback on first-in-human study design
Regulatory feedback can also inform how and when data are shared publicly, ensuring consistency between regulatory strategy, publications, and investor messaging.
7. Prepare IND Documentation – Including Investigator's Brochure
The IND is more than a compilation of data—it is a cohesive scientific and regulatory narrative that supports safe initiation of clinical trials.
Core IND components include:
- Module 1: Administrative and regional information
- Module 2: Summaries (where applicable)
- Module 3: CMC documentation
- Module 4: Nonclinical study reports
- Module 5: Clinical protocol and investigator information
A critical component supporting clinical trial conduct is the Investigator’s Brochure (IB). The IB consolidates nonclinical and clinical data, safety findings, and dosing rationale to inform investigators, ethics committees, and regulators. Developing a strong IB early supports site activation, aligns stakeholders, and provides a scientifically sound reference that can evolve as new data emerge.
8. Operational, Investor, and Visibility Readiness for First-in-Human Trials
IND clearance is only the beginning. Readiness at this stage should extend beyond clinical operations to include scientific visibility and capital strategy.
Final checks include:
- Site and vendor selection
- Establishing principal investigators and KOLs
- Clinical trial material release
- Safety monitoring and pharmacovigilance setup for Phase 2 and beyond
- Clinical operations and data management readiness
- Development of press releases, PR strategy, and investor communications aligned with IND and trial initiation milestones
Strategic communication—grounded in validated data and regulatory alignment—plays a critical role in raising awareness, supporting fundraising, and advancing programs from bench to bedside.
Moving Forward with Confidence
Reaching IND is a defining milestone for any early-stage pharma startup. It signals scientific credibility, operational maturity, and readiness to advance into the clinic. By following a structured, step-by-step approach—and integrating development, regulatory, and communication strategies—startups can reduce risk, control costs, accelerate timelines, and strengthen their position with investors and partners.
As you plan your year ahead, ensure your path from idea to IND is intentional, integrated, and execution focused. The right foundation today sets the stage for clinical, commercial, and financial success tomorrow.
Move Faster to IND with Alphanumeric
From strategy to submission—and beyond—Alphanumeric supports early-stage pharma and biotech companies with IND-enabling regulatory strategy, Investigator’s Brochure and IND medical writing, white paper and publication support, and scientific communications aligned to investor and PR milestones.
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Learn more about how we can guide you through your unique set of needs @ Alphanumeric.com.