Business cultures that join employees around a meaningful and shared ambition, and which allow employees to feel that their work is important, have a better chance of succeeding in this high performance-driven marketplace. We believe people in the biomedical professions seek out and stay with employers that have a clear agenda for the greater good.
RW Malone MD, LLC strives to bring meaningfulness to what we do, and to teach meaningful workplace management and team-building in our proposal development processes. Many companies have been transformed by the experience of working with our processes. This is one aspect where we make a difference, add value, and why people are glad to work with us.
Biomedical professionals don’t simply want to feel “happy”. As employees, they typically want to feel their jobs give meaning to their life, and to the lives of others. Meaningful workplace cultures build on a foundation of employees who are engaged, productive and excited about their work. Creating such teams of people, who motivated by working for the common good, is crucial to creating more meaningful workplace environments where people thrive and grow. This approach is typically less about the individual, and more about the culture. When employees go to work each day knowing that what they do is meaningful, that their opinions matter, that their work makes a difference, and that they enjoy the company of their colleagues, then employees truly become part of a broader workplace community. Productivity goes up, projects get accomplished and goals are met.
Robert W. Malone, M.D., M.S.
Dr. Malone is a specialist in writing, developing, reviewing and managing vaccine, bio-threat and biologics clinical trials and clinical development strategies. He has been involved in developing, designing, and providing oversight of approximately forty phase 1 clinical trials and twenty phase 2 clinical trials, as well as five phase 3 clinical trials. He has served as medical director/medical monitor on approximately forty phase 1 clinical trials, and on twenty phase 2 clinical trials, including those run at vaccine-focused Clinical Research Organizations. He has served as principal investigator on some of these. Examples of his infectious disease pathogen advanced (clinical phase) development oversight experience include HIV, Influenza (seasonal and pandemic), Plague, Anthrax, VEE/EEE/WEE, Tularemia, Tuberculosis, Ebola, Zika, Ricin toxin, Botulinum toxin, and Engineered pathogens, In many cases, this experience has included vaccine product development, manufacturing, regulatory compliance, and testing (manufacturing release and clinical) aspects. In most cases, his oversight responsibilities have clinical trial design, regulatory and ethical compliance, and laboratory assay strategy, design, testing and performance. His direct bench research and research laboratory oversight (Principal Investigator) experience include development and performance of a variety of laboratory tests including ELISA and Plaque Assay-based tests. For many years his client list included one of the largest domestic US immunogenicity clinical laboratory testing companies.
In August 2014, colleagues at the Department of Defense/Defense Threat Reduction Agency asked Dr. Malone to step in and help manage the Ebola project and develop the contracts necessary to move the "orphan" PHAC/rVSV ZEBOV vaccine forward quickly. Dr. Malone got the project on track, recruited organizations to team with USAMRIID/WRAIR to develop the immunoassays, put WHO leadership in touch with Pentagon leadership to expedite the initial WRAIR clinical trials, recruited the government of Norway to help fund the clinical research, recruited a management team, helped write and edit the clinical trials developed by the World Health Organization and lead the development of the BARDA and DTRA contracts - yielding over 200M$ in resources. Dr. Malone’s early involvement in this project allowed for a licensed vaccine to be developed very rapidly.
Dr. Malone has extensive research and development experience (bench to bedside) in the areas of pre-clinical discovery research, clinical trials, vaccines, gene therapy, bio-defense, and immunology. He has over twenty years of management and leadership experience in academia, pharmaceutical and biotechnology industries, as well as in governmental and non-governmental organizations. He has also provided confidential commercial intelligence gathering, evaluation and analysis services under subcontract to three major international vaccine development and manufacturing companies.
Scientifically trained at UC Davis, UC San Diego, and at the Salk Institute Molecular Biology and Virology laboratories, Dr. Malone is an internationally recognized scientist (virology, immunology, molecular biology) and is known as one of the original inventors of “DNA Vaccination.” Dr. Malone holds numerous fundamental domestic and foreign patents in the fields of gene delivery, delivery formulations, and vaccines. He received his medical training at Northwestern University (MD) and Harvard University (Clinical Research Post Graduate) medical schools, and in Pathology at UC Davis, He has over fifty peer-reviewed publications, has been an invited speaker at over thirty-five conferences, has chaired numerous conferences and he has sat on or served as chairperson on numerous NIAID and DoD vaccine-focused study sections.
Dr. Malone is an internationally recognized discovery research scientist known for his pioneering work as one of the original inventors of “DNA Vaccination.” Dr. Malone holds numerous fundamental domestic and foreign patents in the fields of gene delivery, delivery formulations, and vaccines. He has over fifty publications (most of them peer-reviewed) and over fifty peer-reviewed abstracts. He has been an invited speaker at over thirty conferences, has chaired numerous conferences and he has sat on numerous federal study sections. Dr. Malone has twice been selected for presentations at the World Health Organization (Geneva), once in the area of influenza vaccine discovery, development, and manufacturing, and once in the area of Zika medical countermeasure development. He also attended and participated in high level WHO meetings concerning advanced development and testing of the Ebola vaccine during the recent African outbreak.
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Jill Glasspool Malone, Ph.D.
Dr. Glasspool has experience in preclinical, regulatory, and clinical project management, with special expertise in public policy and Federal regulatory issues. She has held supervisory and management positions in the biotechnology industry and academia, and holds an extensive publication record. Jillis involved in research and consulting as well as being responsible for managing accounting, finance activities, and business development. In 2016, Jill graduated from Harvard Medical School Global Clinical Scholars program (a post doctoral program).