The book, intended for biomedical researchers, attempts to foster a comprehensive understanding of the elements that impact scientific research, such as clinical trial design, communication, and publication methods.
It introduces the process of idea generation and creative/critical thinking, leading to the development of key concepts that coalesce into theoretical constructs and working hypotheses. The book systematically delineates research phases associated with a bench-to-bedside translational approach, providing the full depth and breadth of drug discovery and development: design, synthesis, and optimization of drug candidates interacting with targets linked to diseases, as well as clinical trial design to acquire substantial evidence of efficacy and safety for candidate drugs in the target patient population.
New and evolving topics such as artificial intelligence, machine and deep learning, drug repurposing approaches, and bioinformatics, are incorporated into the text as these features are becoming integrated into drug research and development. Additionally, it covers publication strategies, including literature search, manuscript preparation, data presentation, relevant discussion, editorial processes, elements of peer review, and bibliometrics. Finally, the book addresses grantsmanship, key strategies for building effective networks, mentorships, maintaining research integrity, and forging career advancement opportunities, including entrepreneurship.
About the Author: Gowraganahalli Jagadeesh, Ph.D. has worked for more than three decades for the US Food and Drug Administration as a Senior Expert Pharmacologist in the Office of Cardiology, Hematology, Endocrinology, and Nephrology at the Center for Drug Evaluation and Research. He was an Adjunct Scientist at the NIH, Bethesda while working at the FDA. He had also taught at Banaras Hindu University, Varanasi, India, and was a Canadian Heart Foundation Fellow and NIH staff scientist (at Northeastern University, Boston). Dr. Jagadeesh received B. Pharm, MSc and Ph.D. degrees from RGUS-Bengaluru, All-India Institute of Medical Sciences-Delhi, and BHU, respectively. He is currently a Distinguished Visiting Professor at College of Pharmaceutical Sciences, Dayananda Sagar University, Bengaluru; and a visiting professor at College of Pharmacy, Adichunchanagiri University, BG Nagara, Karnataka; and College of Pharmaceutical Sciences, Manipal Academy of Higher Education (Deemed-to-be University), Manipal, India. More than 60 scientific papers, including book chapters, have been authored by him, and he has edited three books as well.
Pitchai Balakumar, M.Pharm., Ph.D. is working as Professor & Director, Centre for Scholarly Scientific Training and Publishing, The Office of Research and Development, Periyar Maniammai Institute of Science & Technology (Deemed-to-be University), Vallam, Tamil Nadu, India. Previously, he was a Professor of Pharmacology at King Khalid University, Saudi Arabia, and Senior Associate Professor and Head of Pharmacology Unit at the Faculty of Pharmacy, AIMST University, Malaysia. He was the Visiting Scientist at the University of Montreal, Canada in 2009. Prof. Balakumar's name has been featured, for the third consecutive time (since 2020), among the World Ranking Top 2% Scientists in the Field: Pharmacology & Pharmacy, based on a study done by Stanford University scientists. He obtained M.Pharm and Ph.D. degrees in Pharmacology specialized in Cardiovascular Pharmacology from Punjabi University-Patiala, Punjab, India. He has two decades of teaching, research and editorial experience in the field of Cardiovascular-Renal Sciences, and trained several graduates in India and abroad. He has published around 125 scientific papers (over 5350 citations with h-index 40), and received several awards and honors for excellence in overall academic and research performance. Along with two senior scientists from the US FDA, Prof. Balakumar edited a reference book titled 'Pathophysiology and Pharmacotherapy of Cardiovascular Disease' published by Springer in 2015. He also edited a number of focused Special Issues in cardiovascular sciences. Prof. Balakumar is a 'Consulting Editor' at Pharmacological Research-Elsevier.
Fortunato Fred Senatore, MD, PhD, FACC received his bachelor degree in biochemistry and master degree in biomedical engineering from Columbia University, and Ph.D. in chemical engineering from Rutgers University. He served as an assistant professor of chemical engineering at Texas Tech University and focused on artificial organ research and biocompatible prostheses. He attended medical school at the Texas Tech University School of Medicine during his tenure at the Texas Tech University School of Engineering. He trained in Internal Medicine at the Mayo Clinic and Cardiology at Harvard University-Massachusetts General Hospital. He served in the pharmaceutical industry with increasing levels of responsibility for 17 years where he conducted and supervised clinical research in cardiovascular disease, renal disease, and endocrinology. He subsequently joined the FDA in the Division of Cardiology and Nephrology and has been serving as Medical Officer since 2012. For the past four years, he has been serving as Lead Physician.
