Selected Presentations & Publications
including IMPACT LLC Experts
Challenges for Life Sciences Research, Development, & Delivery
Edwards, B., Hugman, B., Tobin, M., Whalen, M.
Enabling Speaking Up is essential to assure a Safe System.
Drug Safety (journal of the International Society of Pharmacovigilance). In peer review. 2011.
“The Global Relationship: Corporate Social Responsibility (CSR), Ethics, & Clinical Research.”
2nd Annual Executing Global Clinical Trials Conference, Philadelphia, PA. 2011.
Offices of Minority Health/HHS Conference on Women and Minorities in Clinical Research
Washington, DC. 2011.
Whalen, M., Goebel, P.
From Silos to Bridges in Clinical Research.
The Monitor (the journal of the Association of Clinical Research Professionals). 2010.
Olsen, A., Whalen, M.
Rx for Industry: REMS and Safety as Paradigm.
Drug Discovery. 2010
“Personalized Medicine – A Webinar Dialogue.”
IBC Life Sciences Conference. 2009.
Scientific Advisory Board and Dialog 1 Moderator.
Olsen, A., Whalen, M.
Public Perceptions of the Pharmaceutical Industry and Drug Safety: Implications for the Pharmacovigilance Professional.
Drug Safety (the journal of the International Society of Pharmacovigilance). 2009.
“The Culture of Safety and the Core Clinical Research Team: Investigators/Coordinators.”
Academy of Pharmaceutical Physicians & Investigators/ACRP Global Conference, Denver, CO. 2009.
“Understanding Adverse Events: Going Behind and Beyond the Report.”
Clinical Research Conference, Northwestern University Medical School, Chicago, IL. 2009.
Whalen, M., Edwards, B., Mather, J.
GCP Challenges for 2008 and Beyond.
Journal of GxP Compliance. 2008.
“Public Perception on Industry & Drug Safety: Implications for a Culture of Safety.”
Institute for International Research, Drug Safety & Risk Management Conference, Washington, DC. 2008.
Keynote.
“Much Ado about Safety: A Crisis for Research ?”
Clinical Research Conference, Northwestern University Medical School, Chicago, IL. 2008.
“Safety Culture in Clinical Research Organizations: What it is.”
Academy of Pharmaceutical Physicians & Investigators/ACRP Global Conference, Boston, MA. 2008.
Edwards, B., Olsen, A., Whalen, M., Gold, M.
Guiding Principles of Safety as a basis for Developing a Pharmaceutical Safety Culture.
Current Drug Safety. 2007.
“Risk Management: A Public, an Enterprise, and a Business Challenge.” Institute of Validation Technology Risk Management Conference, Jamesburg, NJ. 2006.
“HIPAA.”
NCHICA [an Academic Medical Center Consortia of North Carolina], Research Triangle Park. 2004.
“Public Understanding of Clinical Research.”
Drug Information Association Annual Conference, Washington, DC. 2004.
“IRBs, Human Research Protections, and Community Healthcare.”
Illinois Association of Healthcare Attorneys, Chicago, IL. 2004.
“Public Understanding of Clinical Research.”
Public Responsibility in Medicine and Research Annual Conference, San Diego, CA. 2004.
“The Public (Mis)Understanding of Clinical Research” and “Scientific Research or Marketing Gimmick ? Legal, Regulatory, and Ethical Aspects of Post-Marketing Studies.”
Drug Information Association Annual Meeting, San Antonio, TX. 2003.
“Conflicts of Interest Issues in for-profit IRBs.”
The Hastings Center, Garrison, NY. 2003.
“Risk Management.”
Institute for International Research, Boston, MA. 2003.
Session Chair.
White paper: Review of CIOMS Working Group VI
(at the request of and for Dr. Sidney N. Kahn, member of CIOMS Working Group VI), authored by Kryder, A., Whalen, M. 2003.
“Human Subjects Protection in the Former Soviet Union” Workshop.
International Science and Technology Council (ISTC)/U.S. Department of Health and Human Services, Pushchino, Russia. 2002.
Technology
“A Consumer Perceptions on Drug Safety - Major Survey Findings.”
American Medical Informatics Association/ Pharmacovigilance Multi-Sector Conference, Reston, VA. 2007.
“Safety – What IS being done about it ?”
CDISC International Interchange, Bethesda, MD. 2007.
“Conference Roundtable Discussion on Informatics and Safety.”
American Medical Informatics Association, Washington, DC. 2006.
“Ethical and Other Aspects of Clinical Trials Registries & Databases.”
Drug Information Association Euromeeting, Paris, France. 2006.
Whalen, M.
Registries and Databases: Toward ‘Transparency’ ?
Journal of GxP Compliance. 2006.
White Paper: Clinical Trials Registries and Databases
(from the Summit on “Bio-Pharmaceuticals for the 21st Century: Responsibility, Sustainability and Public Trust,” sponsored by Fordham University), authored by Steering Committee including Whalen, M. 2005.
White Paper: eClinical Trials and IRBs for Sponsors
authored by principals of MarCon Global Data Solutions, Chesapeake Research Review, Inc. (including Whalen, M.), and C-DISC. 2002.
“e-Clinical Trials.”
Vision in Business, Tampa, FL. 2002.
“Electronic Clinical Trials and Electronic Business.”
Drug Information Association/TACTICS, Philadelphia, PA. 2002.
Program Committee/Session Chair.
“Including the IRB in Electronic Explosion to Enhance Patient Safety in e-Clinical Trials.”
Vision in Business, Madrid, Spain. 2001.
Khin-Maung-Gyi F, Whalen, M., Kush R.
Electronic Data Capture Issues for IRBs: Administrative and Regulatory.
DIA Journal. 2001.
“Integrate the IRB into e-Trials.”
Center for Business Intelligence, Philadelphia, PA. 2001.
“Electronic Clinical Trials.”
Drug Information Association/C-DISC, Savannah, GA. 2000
Program Committee and Track Chair.
Compliance & Accreditation
“What Sponsors and CROs Need to Know about Accreditation.”
Drug Information Association Annual Meeting, Washington, DC. 2005.
“Sponsors & HRPPs: Mutual Benefits of Accreditation.”
Association for the Accreditation of Human Research Protection Programs (AAHRPP) Annual Accreditation Conference, Atlanta, GA. 2005.
Speers, M., Whalen, M.
Accreditation of Human Research Protections Programs [HRPPs]: A Validation Approach for GCPs ?
Journal of GxP Compliance. 2005.
“IRBs and HRPPs: An Overview & Crisis.”
University of Maryland School of Nursing, Baltimore, MD. 2005.
“HRPPs.”
Institute for Validation Technology, Washington, DC. 2004.
Whalen, M., Khin-Maung-Gyi, F.
Human Research Protections and Good Clinical Practice (GCP): The Relationship Among GCP, the Auditing Process, and Institutional Review Boards.
Journal of GxP Compliance. 2003.
“GCPs and IRBs.”
National Capital Area Regional Society of Quality Assurance, Rockville, MD. 2002.
“Sponsor Audits of IRBs: An Executive Roundtable Discussion.”
Institute for International Research, Philadelphia, PA. 2001.
Goebel, P., Whalen, M., Khin-Maung-Gyi, F.
What a Form 483 Really Means.
Applied Clinical Trials. 2001.
“Considering the IRB Perspectives on Vaccine Development.”
Barnett International, Arlington, VA. 2000.
“Strategies for Collaborating with IRBs in the New Millenium.”
Barnett International, Philadelphia, PA and La Jolla, CA. 2000.
Co-Chair.
“Auditing for GCP Compliance” & “Addressing the Challenges in Informed Consent Regulation Compliance.” Institute for International Research, Bethesda, MD. 2000.
Pre-Conference Workshop co-designer/-presenter and session presenter.
Patient/Subject Enrollment & Retention
“Realizing Structural Change Management for Patient Recruitment Success.”
DIA Headquarters Conference, Horsham, PA, 2009.
Program Committee and Co-facilitators.
“Creating a Value Proposition for the Potential [Research] Participant and Their Family.” Webinar.
Drug Information Association, Patient Recruitment Series. 2008.
Whalen, M., Khin-Maung-Gyi, F.
Recruitment of Research Subjects.
Revised Chapter in Institutional Review Board Management and Function, 2nd Edition (Jones and Bartlett). 2006.
“Vulnerable Subjects.”
Barnett International, Brussels, Belgium. 2004.
“Patient Recruitment Strategies.”
Drug Information Association, Philadelphia, PA. 2004.
Panel Chair.
“Patient Recruitment Compliance.”
Barnett International, Philadelphia, PA. 2004.
Khin-Maung-Gyi, F., Whalen, M.
Recruitment of Research Subjects.
Chapter in Institutional Review Board Management and Function (Jones and Bartlett). 2002.
“Global Patient Recruitment.”
Center for Business Intelligence, Washington, DC. 2002.
“Special Populations: How to Deal with the ‘Outliers.’”
Regulatory Affairs Professionals Society, Baltimore, MD. 2001.
Moderator.
Khin-Maung-Gyi F, Whalen, M.
Recruitment of Research Subjects.
Chapter in Amdur, R. et al, Institutional Review Board Management and Function (Jones and Bartlett). 2001.
“2nd Annual Effective Patient Recruitment to Accelerate Clinical Trials.”
Institute for International Research, Orlando, FL. 2000.
Workshops co-designer/presenter.
Ethics
“Ethical Aspects in Global Clinical Trials: Human Research Protections in the U.S.:
the Current State & the Future.”
Drug Information Association Euromeeting, Lisbon, Portugal. 2005.
Whalen, M., DeRenzo, E., Khin-Maung-Gyi, F.
Moral Courage.
The Monitor. 2005.
Khin-Maung-Gyi, F., Whalen, M.
Ethics, Clinical Research, and Human Research Protections: An Applied Approach.
Chapter in Responsible Research (ReMedica). 2005.
“A Framework for Making Ethical Decisions & Taking Action.”
Association of Clinical Research Professionals Annual Meeting, Orlando, FL. 2005.
“QA Professional as the Arbiter of Ethics or, Caught between a Rock & a Hard Place?”
Society for Quality Assurance, Orlando, FL. 2005.
“Moral Courage.”
Association of Clinical Research Professionals Annual Meeting, San Diego, CA. 2004.
Khin-Maung-Gyi, F., Whalen, M., Wambolt, A.
Ethical Considerations in Clinical Trials.
Quality Assurance Journal. 2004.
Whalen, M., Khin-Maung-Gyi F.
Subject Recruitment, Ethics, and the IRB.
New Chapter in Anderson, D., et al, A Guide to Patient Recruitment: Today’s Best Practices and Proven Strategies, 2nd Edition (CenterWatch). 2004.
Whalen, M., Khin-Maung-Gyi, F.
Human Research Protections & GCPs, II: Interpretations of GCPs -- Using Ethics to deal with a Thorny Side of Clinical Research.
Journal of GxP Compliance. 2004.
“Ethics in Drug Development.”
Pharmaceutical Education and Research Institute, Arlington, VA. 2004.
“Ethics in Clinical Research.”
Society for Quality Assurance Annual Meeting, Arlington, VA. 2003.
“IRBs.”
Barnett International, Philadelphia, PA. Co-Chair. 2003.
Khin-Maung-Gyi, F., Whalen, M., Goebel, P.
Misinformation in Clinical Research: A 21st Century Ethical Challenge.
Applied Clinical Trials. 2002.
“Strategies to Protect Human Subjects in Clinical Trials.”
Barnett International, Philadelphia, PA. 2001.
Whalen, M., Khin-Maung-Gyi, F.
Ethical and Confidentiality-based Issues in Patient Recruitment Today. Chapter in Anderson, D., et al, A Guide to Patient Recruitment: Today’s Best Practices and Proven Strategies (CenterWatch). 2000.
The Complete Guide to Informed Consent in Clinical Trials (PharmSource Information Services). 2000.
Expert Panel Member.
“Bioethics in Action: Ethical Dimensions of Clinical Trials for Non-Regulatory Professional.”
Drug Information Association, San Diego, CA. 2000.
Professional Life
Whalen, M., Fedor, C.
Reflections on Vocations, Professions, and Composing a Life.
The Monitor. 2007.
“Careers and Trends in Clinical Research: A Roadmap.”
Northwestern University/Drug Information Association, Chicago, IL. 2006.
Career Day Panel. College of Arts and Humanities.
University of Maryland, College Park, MD. 2006.
Moderator.
Whalen, M., Khin-Maung-Gyi, F., Smithwick, D.
Leadership Style and Values Chart the Course for an Entrepreneurial Journey.
Journal of Organizational Excellence. 2004.
Whalen, M.
Mentoring.
Clinical Researcher. Contribution to Roundtable Discussion. 2002.
Whalen, M., Khin-Maung-Gyi, F., Goebel, P.
The Professionalization of Clinical Research: A Continuum of Learning for Investigators, IRBs, IRB Administrative Staffs & Institutional Human Research Protection Authorities: One Approach.
The Monitor. 2001.
