Drug Development 101
What Is Drug Development?
Drug development is the process of discovering, testing, and getting approval to use a new medicine. The goal is to find treatments that help people with a disease while making sure the benefits are greater than the risks.
Early Lab Work
Impact on Living Systems
Testing in Humans
What Does It Take to Bring a Rare-Disease Therapeutic to Patients?
For every 15,000 potential treatments explored in early research, only one may ultimately earn FDA approval.
Bringing a single program forward can take 10–25 years and could require anywhere from $65M–$300M in investment.
That level of time, cost, and risk means industry cannot pursue every promising idea – especially in rare diseases, where patient populations are small and the path to proof can be especially complex. Companies must make difficult decisions about which programs are most likely to succeed and sustain their development pipeline.
That is why early philanthropic investment matters: it helps researchers take the critical first shots on goal that industry often cannot take alone
Phases of Drug Development:
Discovery & Development
Scientists study the biology of a disease and identify a possible way to intervene.
Pre-Clinical
Before testing begins in people, researchers evaluate the candidate in laboratory studies and usually animal studies.
Clinical Trials
If the early evidence supports human testing, the developer submits an Investigational New Drug application, or IND, to the FDA. Clinical trials commonly progress through 3 phases.
FDA Review & Approval
FDA reviews the full package: clinical results, laboratory and nonclinical data, manufacturing quality, product labeling, and the overall benefit–risk profile.
To Patients
Drug is available on the market.
FAST Drug Development Accelerator
FAST created AS²Bio, a drug development accelerator, to pursue an integrated approach to drug development, leveraging collective expertise, resources, data, and vital networks to provide a “bridge” for new technologies so they can move safely, from proof-of-concept to first-in-human. Each AS program will be part of a structured and supportive ecosystem with the purpose of leveraging managerial talent and resources across all.