Ashwani Khanna
Summary
I have PhD life science (IMMUNOLOGY). Based on my research and written experience with more than 100 publications in the areas of cardiovascular, renal and cancer, I have extensive knowledge and understanding of current biomedical research as I have a record of serving as a funded Principal Investigator in; translational and clinical sciences. I have conducted and published original studies on the effect of tobacco on heart failure, organ transplantation and neurological diseases. Diligent and organized professional with strong scientific and regulatory research and review background and years of basic, experimental, pre-clinical and clinical research experience in cardiovascular, transplantation, heart failure, renal and cancer related diseases. I also possess extensive experience in drug discovery, delivery and the development of molecular diagnostic assays. Experience in teaching and mentoring students and a vast knowledge in grant review and review of human research protection proposals. I have knowledge of measures and analytic approaches used to identify challenges and track improvements in advancing health equity and address social and economic determinants of health. Knowledge of Healthcare Landscape, including Medicare: I have extensive knowledge of healthcare landscape. Since, I started my PhD program, I have worked in medical centers and schools and worked with healthcare professionals at The Rockefeller University, New York; Cornell University Medical College, New York; Medica College of Wisconsin, Milwaukee; University of Maryland, Baltimore and Defense Health Agency. I have PhD in Rhematic Heart Disease and have over the decades performed clinical studies in organ transplantation, heart failure, kidney disease and breast cancer. Developed protein and monoclonal antibodies-based therapeutics and molecular diagnostic assays for breast cancer and transplant rejection. I have conducted single and multi-center clinical trials as a Principal and Co-Principal Investigator. I have learnt about the Medicare system and have familiarized myself with this system. Familiarity with Emerging Technologies within Healthcare. I am familiar with the ongoing emerging technologies within healthcare. As a regulatory professional, I have reviewed the functionalities of wearable medical devices such used by the patients suffering from heart diseases, traumatic brain disorders, PTSD, diabetes and others. These devices operate virtually and data is collected, transmitted and analyzed by the providers. Other example is the digital therapeutics that are designed to prevent, manage, or treat behavior-modifiable conditions such as diabetes, overweight and obesity, mental health conditions, and Alzheimer’s disease. COVID era have also allowed the development and frequent usage of Telemedicine, one of the other emerging technologies within healthcare. As a Subject Matter Expert and Sr. Clinical Advisor at HHS/ASPR and JPEO/DoD, I interacted with stakeholders regarding distribution of therapeutics and vaccines Possess experience within the healthcare industry, including compliance requirements, patient-centered design, and collaboration with stakeholders. I have some experience in healthcare industry such as working of the hospital, patient care etc. I have extensive experience in compliance acquired as a regulatory professional. I have gained knowledge of Human (patient) Centered Design (HCD)that clearly involves the individual patients about whom clarity of the needs is ascertained, then ideas are shared to solve the problems and needs then the strategies are developed to help patients that are implemented to obtain positive results. Knowledge of Healthcare Systems and Medicare complexities, including policies, regulations, and processes: I have the knowledge of Healthcare systems including complexities, priorities and regulations such as the major achievement of healthcare system is the focus on Improving Health, specifically for the patients who suffer from the underlying chronic conditions such as diabetes, heart disease, and obesity; handle racial disparities for the treatment of under privileged population; expansion of telehealth and In-Home Hospital Services specifically for the elderly and disable population and the integration of all the important systems to better assist the patients dependent on Medicare Familiarity with Health IT Standards, such as HL7, FHIR, and HIPAA, is important: I will be able to learn these specific programs as I learnt the CDC, HHS and DoD specific programs and applied those to day-to-day work Meetings: I have organized, conducted, initiated and participated in meetings both virtually and in person. I have experience and knowledge to collaborate with leadership to develop a comprehensive strategy that aligns with the overall business strategy as well as advise on best practices and emerging trends to drive continuous improvement and innovation I have published 100 original scientific articles with nearly 5000 citations with h-index of 5 and i10-index of 67. I am an innovative and strategic thinker, as I have developed newer strategies to develop recombinant and antibody-based therapeutics, mechanism of immunosuppressive drugs, diagnostic assays and others. I have always been a team player, and skilled communicator with strong interpersonal skills who can liaison and collaborate. As a Human Subject Protection professional and a clinical researcher, I have expert knowledge of GCP/HSP standards and policy. As a clinical researcher, I participated in single and multiple clinical trials and as an IRB specialist and HSP professional, I gained knowledge of clinical trial issues and enforcement activities
Overview
14
14
years of professional experience
Work History
Sr. Clinical Advisor
Joint Program Executive Officer Chemical Biological, Radiological and Nuclear Defense (JBRND)
12.2022 - Current
- Acquisition of vaccines and therapeutics, inventory management, maintenance, distribution, contingency support, and product support
- Logistics, product support policies and procedures against current performance metrics and make recommendations on policy and/or process improvements
- Communicating with clients through written reports and oral presentation
- Preparation and finalizing correspondence including letters, memoranda, briefings, speeches, presentations, meeting minutes, and reports
- Support development and control of correspondence packages including preparation and coordination as requested via task management system and ensure timely responses.
Subject Matter Expert
HHS Coordination Operations Response Element (H-CORE) Assistant Sect of Preparedness and Response (ASPR)
12.2021 - 12.2022
- Acquired experience in experience in inventory management, maintenance, distribution, contingency support, and product support
- Some experience in logistics, product support policies and procedures against current performance metrics and make recommendations on policy and/or process improvements
- Expertise in Communicating with clients through written reports and oral presentation
- Experience in preparation and finalizing correspondence including letters, memoranda, briefings, speeches, presentations, meeting minutes, and reports
- Ability to support development and control of correspondence packages including preparation and coordination as requested via task management system and ensure timely responses
- Ability to ensure the successful execution of general office duties: maintain paper and electronic files and databases, photocopy, fax and prepare mailings
- Coordinate maintenance of common office equipment and supplies along with IT systems refresh coordination and compliance
- Performed other additional duties as assigned by senior executives, the administrative staff director, or civilian/military advisors
- Maintained confidential or sensitive information and documents
- Streamlined the process to coordinate with Federal Entities (Bureau of Prison (BOP); Department of Defense (DoD); Department of State (DoS); Immigration and Customs Enforcement (ICE); and Indian Health Services (IHS); National Institute of Health (NIH); Peace Corp (PC) and Veterans Administration (VA) to provide COVD-19 therapeutics
- Followed the program structure, and designed allocation/threshold/top-off and distribution models and coordinate the distribution of COVID-19 therapeutics to these FEs
- Developed cordial and mutual relationships with Federal Entity Point of Contacts (customers) for better communications and to provide desired support
- Maintained data and records systematically and properly
- Presented data to the leadership in a systematic manner
- Created templates and SOPs for better performance and collection of desired information.
Research Officer
University of District of Columbia
06.2021 - 11.2021
Subject Matter Expert Human Research Protection
Defense Health Agency/Research Regulatory Oversight Office HRPP (Contractor)
03.2020 - 02.2021
Human Subjects Protection Scientist
General Dynamics Health Solutions (GDHS) Contractor for DVBIC ans Human Research Protection Office (HRPO) Office of Research Protections (ORP) US Army Medical Research & Materiel Command (USAMRDC) Fort Detrick, Maryland
07.2017 - 08.2020
Compliance Specialist
Office of Naval Research
12.2019 - 03.2020
Uniformed Services University of the Health Sciences, DoD Human Subject Protection Specialist
Bethesda, MD
03.2017 - 07.2017
Department of Navy Human Subject Protection Program, Education and Training Specialist (Contractor)
Falls Church VA
06.2015 - 03.2017
Scientist in Department of Neurology
University of Maryland, Baltimore
09.2010 - 05.2011
US Army Command, Brooke Army Medical Center, San Antonio TX, Human Subject Protection Specialist
June 2014
06.2015
Employer: University of Maryland, Baltimore, MD, IRB Analyst
August 2012
07.2013
Employer: University of Maryland, Baltimore, MD, Scientist in Pathology Department
June 2011
05.2012
Employer: University of Maryland, Baltimore, MD, Associate Professor in Cardiology
August 2006
05.2010
Employer: Maxwell Sensors, Santa Fe Springs, CA, Principle Scientist
May 2006
06.2006
Employer: Marquette University, Milwaukee, WI, Visiting Professor
August 2005
05.2006
Employer: Medical College of Wisconsin, Milwaukee, WI, Associate Professor/Assistant Professor
September 1996
08.2005
Employer: The Rogosin Institute/Cornell University Medical College, Ithaca, NY, Immunologist
November 1990
08.1996
Rockefeller University, New York
October 1984
11.1990
OncoDetect Inc. President and Chief Scientific Officer
8/13-5-14
Education
B Sc - Biology
Punjab University Chandigarh India
M Sc - Human Biology
Punjabi University Patiala India
Ph .D - Immunology & Immunochemistry
Postgraduate Institute of Medical Research
Chandigarh, IndiaSkills
- Extensive knowledge and understanding of current biomedical research
- Strong scientific and regulatory research and review background
- Experience in teaching and mentoring students
- Vast knowledge in grant review and review of human research protection proposals
- Knowledge of healthcare landscape, including Medicare
- Familiarity with emerging technologies within healthcare
- Experience within the healthcare industry, including compliance requirements and patient-centered design
- Knowledge of healthcare systems and Medicare complexities, including policies, regulations, and processes
- Familiarity with Health IT Standards, such as HL7, FHIR, and HIPAA
- Experience in organizing and conducting meetings
- Innovative and strategic thinker
- Team player with strong interpersonal skills
- Expert knowledge of GCP/HSP standards and policy
- Experience in clinical research
- Ability to effectively communicate in writing and orally
Editorialboard
The Open Transplantation Journal
Grantsupport
- Faculty Development Award, Principal Investigator, Induction of Cyclin Inhibitor p21 by Cyclosporine and Tacrolimus: Demonstration with TGF- and p21 Gene Knock-out Cell Lines, American Society of Transplant Physicians, 07/1/98, 06/30/99, 25000
- Research Grant, Principal Investigator, Molecular Mechanisms of the Anti-proliferative Effects of Tamoxifen: Implicating Cell Cycle Inhibitors ANTI- TGF- and p21, American Cancer Society, MCW, 07/1/98, 06/30/99, 17500
- Research Grant, Principal Investigator, Role of TGF and Inflammation in Breast Cancer, Wisconsin Breast Center Show House, 07/1/02, 06/30/03, 25000
- RO-1, Principal Investigator, TGF- and Immunosuppression in Organ Transplantation, NIH/NIAID 1RO1 AI41703-01A2, 09/1/99, 06/30/03, 600000
- RO-1, Co-Principal Investigator, Molecular targets of Nitric Oxide in cardiac transplants, NIH /NHLBI, 07/1/02, 06/30/06
- RO-1, Co-Principal Investigator, iNOS Posttranslational Regulation in Cardiac Rejection, NIH /NHLBI, 03/15/06, 02/28/10
Experiencereviewinggrantapplications
- American Heart Association (cardio renal study section)
- NIH study section ZRG1 IMM-G (10) B
- NIH Special Emphasis Panel (IMMUNOLOGY) 2012
- American Society of Transplantation Grants and Awards
- Congressionally Directed Medical Research Program (Department of Defense)
Abilitytocommunicateinwriting
I have demonstrated strong ability to effectively communicate in writing because over the last 30 years, I have written and published 100 scientific articles, reviews and book chapters.
Abilitytocommunicateorally
I have a strong ability to effectively communicate orally, because presented more than 200 scientific presentations at different national and international meetings and given invited talks.
Manuscriptreviewer
- Circulation
- Journal of Immunology
- Transplantation
- American Journal of Transplantation
- Pharmacology Experimental Therapeutics
- Nephrology Dialysis Transplantation
- Journal of American Society of Nephrology
- Journal of Heart and Lung transplantation
Clinicalresearchexperience
I have performed a number of preclinical and clinical studies in cardiovascular, renal and cancer related diseases suggesting my excellent qualitative and quantitative analytical skills in conjunction with my experience in design and interpretation of preclinical and clinical research projects utilizing the scientific method.
Timeline
Sr. Clinical Advisor
Joint Program Executive Officer Chemical Biological, Radiological and Nuclear Defense (JBRND)
12.2022 - Current
Subject Matter Expert
HHS Coordination Operations Response Element (H-CORE) Assistant Sect of Preparedness and Response (ASPR)
12.2021 - 12.2022
Research Officer
University of District of Columbia
06.2021 - 11.2021
Subject Matter Expert Human Research Protection
Defense Health Agency/Research Regulatory Oversight Office HRPP (Contractor)
03.2020 - 02.2021
Compliance Specialist
Office of Naval Research
12.2019 - 03.2020
Human Subjects Protection Scientist
General Dynamics Health Solutions (GDHS) Contractor for DVBIC ans Human Research Protection Office (HRPO) Office of Research Protections (ORP) US Army Medical Research & Materiel Command (USAMRDC) Fort Detrick, Maryland
07.2017 - 08.2020
Uniformed Services University of the Health Sciences, DoD Human Subject Protection Specialist
Bethesda, MD
03.2017 - 07.2017
Department of Navy Human Subject Protection Program, Education and Training Specialist (Contractor)
Falls Church VA
06.2015 - 03.2017
US Army Command, Brooke Army Medical Center, San Antonio TX, Human Subject Protection Specialist
June 2014
06.2015
Employer: University of Maryland, Baltimore, MD, IRB Analyst
August 2012
07.2013
Employer: University of Maryland, Baltimore, MD, Scientist in Pathology Department
June 2011
05.2012
Scientist in Department of Neurology
University of Maryland, Baltimore
09.2010 - 05.2011
Employer: University of Maryland, Baltimore, MD, Associate Professor in Cardiology
August 2006
05.2010
Employer: Maxwell Sensors, Santa Fe Springs, CA, Principle Scientist
May 2006
06.2006
Employer: Marquette University, Milwaukee, WI, Visiting Professor
August 2005
05.2006
Employer: Medical College of Wisconsin, Milwaukee, WI, Associate Professor/Assistant Professor
September 1996
08.2005
Employer: The Rogosin Institute/Cornell University Medical College, Ithaca, NY, Immunologist
November 1990
08.1996
Rockefeller University, New York
October 1984
11.1990
OncoDetect Inc. President and Chief Scientific Officer
8/13-5-14
B Sc - Biology
Punjab University Chandigarh India
M Sc - Human Biology
Punjabi University Patiala India
Ph .D - Immunology & Immunochemistry
Postgraduate Institute of Medical Research
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