Drug discovery and NCEs:
Each year, CDER approves series of new drugs and biological products. Some of these products are often innovative new products that never before have been used in clinical practice. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act. According to Medscape the ratio of researched drugs to eventually approved therapies at between 5,000-to-1 and 10,000-to-1. Nonetheless, if a drug manages to gain FDA approval, the cumulative direct and indirect expenses are huge. As per estimated study performed by a well-known university, the true cost to bring a drug to market was US$2.56 billion. This figure is inclusive of just shy of $1.4 billion in average out-of-pocket costs to the drug developer, as well as $1.16 billion in time costs, which are essentially the expected returns that investors forgo while a drug is in development.
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Drug discovery and NCEs: Conference Speakers
Recommended Sessions
- Drug discovery and NCEs:
- Pharma Market Research:
- Pharmaceutical Manufacturing, Scale Up and Tech transfer:
- Bioequivalence and Bioavailability:
- Clinical Pharmacy and Pharmacy Practices:
- Clinical trials and Pharmacovigilance:
- Novel Drug Delivery Systems, Biomarkers & Drug Targets:
- Pharmaceutical Manufacturing and Pharmacoeconomics:
- Pharmaceutical Packaging and Logistics:
- Pharmaceutical Sciences:
- Pharmacoeconomics:
- Pharmacogenomics and Pharmacoepidemiology:
- Pharmacology and Toxicology:
- Regulatory Authority Compliance:
- Technology in Pharma Sciences:
- Active Pharmaceutical Ingredients:
- Analytical strategies for pharmaceutical products:
- Formulations and NNDS:
- QC & QA: Quality control and Quality assurance:
- Quality by design(QbD) approach
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- Targeted Therapies - Personalizedmedicine-2025 (Switzerland)
- Technology in Pharma Sciences - MedTech-2025 (Switzerland)
- Telemedicine - Personalizedmedicine-2025 (Switzerland)
- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- The Role of CROs in Clinical Trial Execution - Clinical Trials-2026 (UK)
- Toxicological Impacts of Air and Water Pollution - Euro Pharmacology 2025 (France)
- Toxicology and Safety Pharmacology - Pharmacology-2025 (Spain)
- Toxicology: Mechanisms and Risk Assessment - Euro Pharmacology 2025 (France)
- Transdermal and Intradermal Delivery Systems - Drug Delivery-2025 (Netherlands)
- Translational Research - Personalizedmedicine-2025 (Switzerland)
- Trending: Digital Health and Telemedicine for Rare Care - ORPHAN DRUGS 2025 (France)
- Types of Formulations - Formulations 2025 (France)
- Vaccine Delivery Technologies - Drug Delivery-2025 (Netherlands)
- Vaccine Development Against Bacterial Pathogens - Euro Antibiotics 2025 (Netherlands)
- Vaccine Drug Delivery Systems - PHARMACEUTICA 2025 (Germany)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Veterinary Pharmacology - Pharmacology-2025 (Spain)
- Women in Rare Disease Leadership and Science - ORPHAN DRUGS 2025 (France)