Global Clinical Research Solutions Across Therapeutic Areas | Clival Database

1. GLOBAL DRUG DEVELOPMENT TRENDS www.clival.com

2. www.clival.com INTRODUCTION The process of drug development is dynamic part of science and technology, which is controlled by regulation and policy, and market & customer requirements. Analyzing the current trends in drug developmentis helpful for the health care stakeholders, such as active pharmaceutical companies, researchers, and policy makers, because the global health care industry is evolving.

3. PRECISION MEDICINE AND PERSONALIZED THERAPIES Precision medicine, also called targeted or individualized medicine, provides medical care based on the traits of a given patient with genetic, behavioral, environmental traits, etc. CAR-T CELL THERAPY GENETIC TESTING An increasing number of pharmaceutical companies are beginning to integrate tests to identify patients who might respond to certain medications, as well as cancer drugs targeted for instance. The target treatment, chimeric antigen receptor T-cell (CAR-T), represents an example of an individualized treatment method, which is created specifically for a patient’s cancer. www.clival.com

4. www.clival.com REGULATORY CHANGES Regulatory bodies are equally responding to the changing face of drug development. The FDA, EMA and other agencies are easing approval procedures and introducing new regulations to clear the path to development of new remedies. These changes are intended to strike a delicate middle ground between the requirements of safety and effectiveness on the one hand and the pressures for speed and new product launches on the other.

5. www.clival.com ACCELERATED DRUG DEVELOPMENT AND REGULATORY PATHWAYS Fast-Track Approvals Approval authorities such as the FDA and EMA among others are embracing expedited approval routes to new drugs. These include Fast Track, Breakthrough Therapy Designation and Priority Review to enable the companies to get the lifesaving treatments to the market more quickly. Adaptive Trial Designs Interim analysis allows modifications to specific trials to occur while underway, and these are called adaptive trial designs.

6. www.clival.com GLOBALIZATION OF DRUG DEVELOPMENT Cross-Border Collaborations With the globalization of drug development, firms are in the process of venturing into strategic alliances to tap knowledge expertise from different countries and markets. Regulatory Harmonization Harmonization also entail the enhancement of efficiency in the mutual recognition of the various country’s regulatory standards for drugs. The international organization that can oversee the promotion of consistency are there such as the International Council for Harmonization (ICH).

7. www.clival.com RISING COSTS AND ECONOMIC PRESSURES Cost Challenges Development costs, currently projected at over USD 2.6 billion per new chemical entity, are forcing companies to look for better paradigms for drug development. Innovative Financing Models In order to overcome the problems connected with financing, new financing models are emerging like venture philanthropy and crowdfunding.

8. CLINICAL TRIAL REGULATIONS AROUND THE GLOBE UNITED STATES Clinical trial regulation and policies are not identical around the globe, however, they are designed to capture concerns relating to the safety and effectiveness of the trial, and the ethical considerations within the trial process. EUROPEAN UNION JAPAN INDIA www.clival.com

9. www.clival.com CONCLUSION The global drug development environment is changing dynamically based on new technologies, the changes in the regulatory provisions involved. For now, stakeholders should use new trends like precision medicine, integration of digital health, as well as partnerships in redefining treatment therapy.

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