Ophthalmic Drug Discovery and Development: Regulatory Aspects of Patient Focused Drug Development in Ophthalmology

This article provides an update on new development of China Bioanalysis Forum (CBF). CBF became a member association of Chinese Pharmaceutical Association (CPA) at the end of 2019. The official ceremony and first scientific symposium were held in Shanghai on 18 September 2020. The president of Chinese Pharmaceutical Association and representatives from industry, Contract Research Organization (CRO), hospitals and academic institutes attended the ceremony. Seven experts in the field gave presentations on various topics including Drug Metabolism and Pharmacokinetics (DMPK) and bioanalytical support in drug discovery and development as well as experience in Traditional Chinese Medicine research. With the continuous growth of research and development in China, it is well acknowledged that bioanalysis provides critical support for new innovative medicines and generic drug development in the region.

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The Stages of Drug Discovery and Development Process

Asian Journal of Pharmaceutical Research and Development ◽

10.22270/ajprd.v7i6.616 ◽

2019 ◽

Vol 7 (6) ◽

pp. 62-67 ◽

Cited By ~ 3

Author(s):

Amol B Deore ◽

Jayprabha R Dhumane ◽

Rushikesh Wagh ◽

Rushikesh Sonawane

Keyword(s):

Clinical Trials ◽

Drug Discovery ◽

Drug Development ◽

Development Process ◽

Regulatory Requirements ◽

Drug Discovery And Development ◽

Biological Targets ◽

New Drug ◽

Initial Discovery ◽

New Research

Drug discovery is a process which aims at identifying a compound therapeutically useful in curing and treating disease. This process involves the identification of candidates, synthesis, characterization, validation, optimization, screening and assays for therapeutic efficacy. Once a compound has shown its significance in these investigations, it will initiate the process of drug development earlier to clinical trials. New drug development process must continue through several stages in order to make a medicine that is safe, effective, and has approved all regulatory requirements. One overall theme of our article is that the process is sufficiently long, complex, and expensive so that many biological targets must be considered for every new medicine ultimately approved for clinical use and new research tools may be needed to investigate each new target. From initial discovery to a marketable medicine is a long, challenging task. It takes about 12 - 15 years from discovery to the approved medicine and requires an investment of about US $1 billion. On an average, a million molecules screened but only a single is explored in late stage clinical trials and is finally made obtainable for patients. This article provides a brief outline of the processes of new drug discovery and development.

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Accelerating safe drug development: an ideal approach to approval

Hematology ◽

10.1182/asheducation-2013.1.24 ◽

2013 ◽

Vol 2013 (1) ◽

pp. 24-29

Author(s):

Michael R. Grever

Keyword(s):

Drug Discovery ◽

Drug Development ◽

Hematologic Malignancies ◽

Therapeutic Strategies ◽

Cancer Drug ◽

Task Completion ◽

Close Monitoring ◽

Design Strategies ◽

Drug Discovery And Development ◽

Therapeutic Research

Abstract Although enormous progress in therapeutic research has improved the lives of patients with hematologic malignancies, these earlier achievements resulted from strategic combinations of agents with unique mechanisms of action and nonoverlapping toxicities. Continued investment in the modern era of drug discovery and development will focus on targeted therapies. Targeting of specific molecular pathways is expected to achieve effective tumor cell reduction with less overall toxicity. The translational processes involved in moving novel therapeutic strategies from the laboratory toward the clinic require close monitoring. The efforts in both cancer drug discovery and development will require extensive collaboration among basic scientists, clinical investigators, and regulatory scientists. The transition from older methods of therapeutic research will require laboratory support to define eligible patients based upon their pretreatment profile. The principles of preclinical drug development based upon decades of experience in predicting toxicity and designing therapeutic strategies are still needed to insure that safety is a high priority. The opportunities for developing novel targeted combination therapies in uniquely profiled patients will hopefully enable successful breakthroughs. Several concrete examples of exciting new agents are discussed here. Defining the predicted mechanism of resistance to these new targeted agents will enable investigators to subsequently design strategies to circumvent resistance with effective combinations. Drug discovery and development are complex and expensive, so efficiency and cooperation in task completion must be tracked.

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Developing Novel Anticancer Drugs for Targeted Populations: An Update

Current Pharmaceutical Design ◽

10.2174/1381612826666201124111748 ◽

2020 ◽

Vol 26 ◽

Author(s):

Tadesse Bekele Tafesse ◽

Mohammed Hussen Bule ◽

Fazlullah Khan ◽

Mohammad Abdollahi ◽

Mohsen Amini

Keyword(s):

Drug Discovery ◽

Drug Development ◽

Anticancer Drugs ◽

Anticancer Drug ◽

Development Process ◽

De Novo ◽

Drug Repurposing ◽

Drug Discovery And Development ◽

Probability Of Success ◽

Selection Of

Background: Due to higher failure rates, lengthy time and high cost of the traditional de novo drug discovery and development process; the rate of opportunity to get new, safe and efficacious drugs for the targeted population including pediatric patients with cancer becomes sluggish. Objectives: This paper discusses the development of novel anticancer drugs focusing on the identification and selection of target anticancer drug development for the targeted population. Methods: Information presented in this review was obtained from different databases including PUBMED, SCOPUS, Web of Science, and EMBASE. Various keywords were used as search terms. Results: The pharmaceutical companies currently are executing drug repurposing as an alternative means to accelerate the drug development process that reduces the risk of failure, time and cost, which takes 3-12 years with almost 25% overall probability of success as compared to de novo drug discovery and development process (10-17 years) which has less than 10% probability of success. An alternative strategy to the traditional de novo drug discovery and development process, called drug repurposing, is also presented. Conclusion: Therefore, to continue with the progress of developing novel anticancer drugs towards the targeted population, identification and selection of the target to the specific disease type is important considering the aspects of the age of the patient and the disease stages such as each cancer types are different when we consider the disease at a molecular level. Drug repurposing technique becomes an influential alternative strategy to discover and develop novel anticancer drug candidates.

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Book Review of Drug Discovery and Development. Volume 2. Drug Development Drug Discovery and Development. Volume 2. Drug Development . Edited by Mukund S. Chorghade . John Wiley & Sons, Hoboken, NJ . 2007 . xvii + 381 pp. 18 × 26 cm. ISBN 978-0-471-39847-6 . $99.95.

Journal of Medicinal Chemistry ◽

10.1021/jm800307t ◽

2008 ◽

Vol 51 (9) ◽

pp. 2869-2869

Author(s):

Manfred E. Wolff

Keyword(s):

Drug Discovery ◽

Drug Development ◽

Drug Discovery And Development

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From Target Identification to Drug Development in Space: Using the Microgravity Assist

Current Drug Discovery Technologies ◽

10.2174/1570163816666190112150014 ◽

2020 ◽

Vol 17 (1) ◽

pp. 45-56 ◽

Cited By ~ 9

Author(s):

Martin Braddock

Keyword(s):

Drug Discovery ◽

Drug Development ◽

Drug Targets ◽

Space Shuttle ◽

Target Identification ◽

Space Station ◽

Space Environment ◽

Drug Discovery And Development ◽

Unique Nature ◽

Microarray Analyses

The unique nature of microgravity encountered in space provides an opportunity for drug discovery and development that cannot be replicated on Earth. From the production of superior protein crystals to the identification and validation of new drug targets to microarray analyses of transcripts attenuated by microgravity, there are numerous examples which demonstrate the benefit of exploiting the space environment. Moreover, studies conducted on Space Shuttle missions, the International Space Station and other craft have had a direct benefit for drug development programmes such as those directed against reducing bone and muscle loss or increasing bone formation. This review will highlight advances made in both drug discovery and development and offer some future insight into how drug discovery and associated technologies may be further advanced using the microgravity assist.

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Fragment based drug design

Physical Sciences Reviews ◽

10.1515/psr-2018-0162 ◽

2022 ◽

Vol 0 (0) ◽

Author(s):

Rahul Ashok Sachdeo ◽

Tulika Anthwal ◽

Sumitra Nain

Keyword(s):

Drug Discovery ◽

Drug Design ◽

Drug Development ◽

Drug Candidate ◽

Fundamental Theory ◽

Drug Discovery Process ◽

Structure Based Drug Design ◽

Drug Discovery And Development ◽

Causes Of Disease ◽

Added Benefit

Abstract Rational approaches towards drug development have emerged as one of the most promising ways among the tedious conventional procedures with the aim of redefining the drug discovery process. The need of current medical system is demanding a much precise, faster and reliable approaches in parallel to faster growing technology for development of drugs with more intrinsic action and fewer side effects. Systematic and well-defined diagnostic studies have revealed the specific causes of disease and related targets for drug development. Designing a drug as per the specific target, studying it in-silico prior to its development has been proved as an added benefit to the studies. Many approaches like structure based drug design, fragment based drug design and ligand based drug design are been in practice for the drug discovery and development with the similar fundamental theory. Fragment based drug design utilizes a library of fragments designed specifically for the concerned target and these fragments are studied further before screening with virtual methods as well as with biophysical methods. The process follows a well-defined pathway which moulds a fragment into a perfect drug candidate. In this chapter we have tried to cover all the basic aspects of fragment based drug design and related technologies.

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Synthesis of Salicylate and Salicylamide Alcohols for the Preparation of Phosphorodiamidates and Ifosfamide Prodrugs.

Oriental Journal Of Chemistry ◽

10.13005/ojc/370205 ◽

2021 ◽

Vol 37 (2) ◽

pp. 295-301

Author(s):

Ashutosh Pal

Keyword(s):

Drug Discovery ◽

Drug Development ◽

Anticancer Agents ◽

Parent Drug ◽

Chemotherapeutic Agents ◽

The Body ◽

Drug Discovery And Development ◽

Release Drug ◽

Different Types ◽

Derivatives Of

Pro drugs are derivatives of drug substance which gives parent drug or release drug when it breaks inside the body by the presence of suitable enzyme,and then exert desired pharmacological effect. For many years, prodrug strategy has been developed enormously to solve many unwanted drug properties. In drug discovery and development, prodrugsare well-known pharmacokinetic effects of pharmacologically nimbleproducts. Almost10% of drugs permitted whole worldare classified as prodrugs, where the application of a prodrug method duringinitial stages of drug development is an emergent fashion. Phosphorodiamidates prodrugs are well known anticancer agents particularly against leucomia. To improve the selectivity of the chemotherapeutic agents and reduce systemic toxicity, I herein report different types of salicylate and salicylamide alcohols for the preparation of phosphorodiamidates and ifosfamide prodrugs.

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Success factors in drug discovery and development

Advances in Precision Medicine ◽

10.18063/apm.2016.02.002 ◽

2016 ◽

Vol 1 (1) ◽

Author(s):

Björn Wallmark

Keyword(s):

Drug Discovery ◽

Drug Development ◽

Population Health ◽

Success Factors ◽

Effective Drug ◽

Personal Perspective ◽

Drug Discovery And Development ◽

Drug Companies ◽

Start Up ◽

Do So

The article aimed to give a personal perspective on drug discovery and development. The author has worked both in Big Pharma as a scientist and manager and more recently also in start-up biotech companies. Drug companies have played a major important role in improving population health and will continue to do so. The hurdles and costs for drug development have continuously risen without a parallel enhancement of productivity. There is no single explanation for this and the article outlines success factors and hurdles for effective drug development. Aspects of the external and internal environments that influence Big Pharma productivity is outlined and discussed.

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