RW Malone MD, LLC

biotechnology, Vaccines and biologics consultant

AREAS OF PRACTICE:

• MEDICAL AFFAIRS

• REGULATORY AFFAIRS

• EXTENSIVE EXPERT WITNESS EXPERIENCE

• GOVERNMENT CONTRACTING

• BUSINESS TO BUSINESS SOLUTIONS

• BUSINESS TO GOVERNMENT SOLUTIONS

• GRANT, CONTRACT AND PROPOSAL WRITING

• CLINICAL TRIALS DEVELOPMENT

• CLINICAL TRIALS AND DATA MANAGEMENT

• PUBLIC POLICY ANALYSIS AND GUIDANCE

• BIOTECHNOLOGY INVESTMENT AND DUE DILIGENCE

• RISK ANALYSIS AND MITIGATION

• MILESTONE AND DRUG DEVELOPMENT TIMELINES

• VACCINE DEVELOPMENT

• PROJECT PLANNING AND MANAGEMENT

• BIODEFENSE AND VACCINE DEVELOPMENT

• PRODUCT DEVELOPMENT

• INVESTOR AND ENTREPRENEUR SUPPORT

• COMMERCIAL INTELLIGENCE

• PUBLIC SPEAKING

• OTHER SERVICES AVAILABLE UPON REQUEST

RW Malone MD LLC is focused on helping our clients succeed in this performance driven marketplace.

RW Malone MD, LLC is unique blend of detail oriented, efficient and value oriented processes grounded in deep and broad technical capabilities. This enables the synergy required to move projects and product development teams forward by complementing and supporting core client expertise in a cost-effective manner.

RW Malone MD, LLC has a bedrock commitment to bring the systematic computational analysis of data to our work, whether it be designing a clinical trial or due diligence on a product.  We take pride in in our ability to gather, analyze and distribute accurate and relevant intelligence regarding products, customers, competitors, business environment and even organizations. Our methodical approach brings added value to our client's tactics, decisions and operationsRW Malone MD, LLC strives to bring meaningfulness to what we do, and to teach positive 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.

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.

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.

RW Malone MD, LLC’s was co-founded and managed by Dr. Malone. The inventor of mRNA vaccines and one of world’s foremost experts on messenger mRNA therapeutics - having invented the field in 1988, Dr. Malone has extensive research and development experience 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.

Dr. Malone is a specialist in clinical research, medical affairs, regulatory affairs, project management, proposal management (large grants and contracts), vaccines and biodefense. This includes 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.

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 mRNA vaccination and DNA Vaccination. His discoveries in mRNA non viral delivery systems are considered the key to the current COVID-19 vaccine strategies. 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 school, and in Pathology at UC Davis.

Dr. Malone has close to 100 peer-reviewed publications and published abstracts and has over 12,000 citations of his peer reviewed publications, as verified by Google Scholar.  His google scholar ranking is “outstanding” for impact factors. He has been an invited speaker at over 50 conferences, has chaired numerous conferences and he has sat on or served as chairperson on numerous NIAID and DoD study sections.

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