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.
Before investing heavily in development, ensure your program is built on a strong scientific foundation.
Key considerations:
This step is critical not only for development success, but also for establishing a compelling scientific narrative for investors, partners, and future publications.
A well-articulated Target Product Profile serves as the strategic anchor for your program.
Your TPP should outline:
The TPP guides decisions across nonclinical, CMC, and clinical development—and ensures alignment between scientific objectives, regulatory strategy, and long-term value creation.
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:
Strategic planning upfront reduces downstream delays and ensures your data can be leveraged effectively for both regulatory and funding milestones.
Nonclinical development is one of the most time- and cost-intensive phases leading up to IND.
Core activities typically include:
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.
Chemistry, Manufacturing, and Controls (CMC) is often a bottleneck for early-stage startups.
Key CMC considerations:
Clear documentation and data traceability also support credible external communications and diligence discussions with investors and partners.
Early regulatory engagement can de-risk development and clarify expectations.
Common early interactions include:
Regulatory feedback can also inform how and when data are shared publicly, ensuring consistency between regulatory strategy, publications, and investor messaging.
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:
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.
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:
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.
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.
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.
Start your IND journey with Alphanumeric.
Learn more about how we can guide you through your unique set of needs @ Alphanumeric.com.