The Economics of Drug Discovery.pptx....

Drug discovery is an expensive and lengthy process, costing between **$1.5 billion to $2.6 billion** per drug and taking **10-15 years** from research to market. The high costs stem from extensive research, clinical trials, regulatory compliance, and high failure rates, with **90% of drugs failing** in trials. Pharmaceutical companies rely on patent protection and premium pricing to recoup R&D costs and fund future research. Recent strategies to reduce costs include biotechnology advancements, AI, outsourcing, and faster regulatory approvals. Despite high risks, successful drugs, especially blockbuster drugs, help balance the economic burden of discovery and innovation.

1. "The Economics of Drug Discovery" Presented by :- Md Nabeeluddin Karigar M-pharm 2 nd semester Dept of Pharmacology G.Pulla Reddy College of Pharmacy Date : 13/09/2024

2. INTRODUCTION TO DRUG DISCOVERY Drug discovery is a complex process that involves the identification, development, and commercialization of new medications. This presentation will provide a comprehensive analysis of the economic impacts and strategies involved in drug discovery. Economics is a social science that focuses on the production, distribution, and consumption of goods and services.

3. Creation of new drug involves:- Drug discovery (Research): Identification of a potential therapeutic target Selection of a single molecule for testing in humans. Drug development: Preclinical studies that support initial clinical trails through approval of the drug by regulatory authorities. Commercialization (Marketing): Product Therapeutic application Sales.

4. •Drug discovery is the area of research and development to the most amount of time and money. The process can involve scientists to determine the germs, viruses, and bacteria that cause a specific disease or illness. • The time frame can range from 3-20 years and costs can range between several billion to tens of billions of dollars. Research teams attempt to break down disease components to find abnormal events/processes taking place in the body. Then they detect the chemical compound for treatment. • After "discovery" and a creation of a chemical compound, pharmaceutical companies move forward with the Investigational New Drug (IND) Application from the FDA. After the investigation into the drug and given approval, pharmaceutical companies can move into pre-clinical trials and clinical trials.

5. • Drug discovery and pre-clinical trials focus on non- human subjects and work on animals such as rats. This is the most inexpensive phase of testing. • The Food and Drug Administration mandates a 3 phase clinical trial testing that tests for side effects and the effectiveness of the drug with a single phase clinical trial costing upwards of $100 million. • After a drug has passed through all three phases, the pharmaceutical company can move forward with a New Drug Application from the FDA. In 2014, the FDA charged between 1 million to 2 million for an NDA. • A new study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average cost was $1.3 billion, which was much lower compared to previous studies, which have placed the average cost of drug development as $2.8 billion.

6. R&D Function % of cost involved Discovery 20% Preclinical Testing 15% Clinical Trials 50-60% Phase I Trials (10-15%) Phase II Trials (15-20%) Phase III Trials (25-30%) Post-Approval Costs (Phase IV and Surveillance) (5-7%) IND & NDA (5-10%) Others (2-5%) TOTAL 100%

7. . Aducanumab ( Aduhelm ) (Biogen) Type: Monoclonal antibody for Alzheimer's disease. Approval: FDA approval (2021) under the accelerated approval pathway. Cost: $2.5 - $3 billion . Drivers: High-cost late-stage trials, controversial regulatory processes, and large-scale safety monitoring . Example of a recent drug discovery

8. The present day cost involve in drug discovery • The usage of modern computational process has reduced the time period involved in drug discovery • The combined chemistry and high throughput screening method are capable of synthesizing and screening thousands of compound virtually thus the time and cost involved in this process has been reduced. • The in silico Screening technology has also helped in screening lead identify virtually. • But still cost involved in drug discovery process is high and various measure are taken to reduce it.

9. Drug Repurposing Finds new uses for existing drugs, bypassing early-stage discovery. Reduces time to market from 10-15 years to 3-7 years. Cost savings: 40-60% . Collaboration and Partnerships Academic-industry and public-private partnerships share R&D costs. Reduces duplication of efforts and utilizes shared infrastructure. Adaptive Clinical Trial Designs Modifies trials based on interim results to reduce unnecessary phases. Decreases patient numbers and trial durations. Cost reduction: 20-30% .

10. References: Cox PA, Balick MJ. The ethnobotanical approach to drug discovery. Scientific American. 1994 Jun 1;270(6):82-7. 2. Wouters, Olivier J.; McKee, Martin; Luyten, Jeroen (2020). "Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018".. 3. Francis H. Spiegel, The economics of Pharmaceutical Research and Development: An Industry Perspective https://www.ncbi.nlm.nih.gov/books/NBK234300/.

11. Thank you