Appendix B – FY 2005 OIVD Annual Report - Publications Presentations and Workshops

Publications

Bast RC, Lilja H, Urban N, Rimm DL, Fritsche H, Gray J, Veltri R, Klee G, Allen A, Kim N, Gutman S, Rubin MA, Hruszkewycz A. Translation Crossroads For Biomarkers. Clin Cancer Res 2005; 11: 6103-6108.

Harper CC, Philip R, Robinowitz M, and Gutman SI. FDA Perspectives On Pharmacogenetic Testing. Expert Review of Molecular Diagnostics 2005; 5: 643-648.

Hackett JL and Gutman SI. Introduction to the Food and Drug Administration
(FDA) Regulatory Process. Journal of Proteome Research 2005; 4:1110-1113.

Hausman ED and Altaie SS. Regulatory Aspects of Total Product Life Cycle. Diabetes Technology & Therapeutics 2004; 6:761-766.
Shi L, Tong W, Fang H, Scherf U, Han J, Puri RK, Frueh FW, Goodsaid FM, Guo L, Su Z, Han T, Fuscoe JC, Xu, ZA, Patterson TA, Hong H, Xie Q, Perkins RG, Chen JJ, Casciano DA. Cross-Platform Comparability of Microarray Technology: Intra-Platform Consistency and Appropriate Data Analysis Procedures Are Essential,   BMC Bioinformatics 2005 Jul 15:6 Suppl 2:S12.

Presentations and Workshops

Altaie SS. Pre-IDE process in IVDs. Annual Association of Medical Diagnostic Manufactures and FDA 510(k) workshop, Rockville, MD, April 19-20, 2005.

Altaie SS. OIVD’s Turbo 510(k) update, 32nd Annual Meeting of Association of Medical Diagnostics Manufacturers, Rockville, MD, April 21-22, 2005.

Altaie SS. 510(k) Decision Summaries and eSubmissions. Annual Association of Medical Diagnostic Manufactures and FDA 510(k) workshop, Rockville, MD, April 19-20, 2005.
Altaie SS. Critical Path Initiative in Medical Devices. RAPS 2005 Annual Conference and Exhibition, Baltimore, MD, October 16-19, 2005.

Akolkar PN and Hojvat S. Migration Studies. 4th Annual CBER/CDRH Harmonized Best Practices Workshop for In Vitro Diagnostics, Rockville, MD, June 30, 2005.

Becker RL. Biomarkers and Surrogate Endpoints: The FDA Perspective. IBC Biomarker Pipeline Conference, Boston, MA, March 14-15, 2005.

Becker RL. Urinary Neural Thread Protein Test For Alzheimer's Disease. FDA Staff Roundup on Alzheimer's Disease: Diagnosis to Treatment, Rockville, MD, August 31, 2005.

Benson CC. CLIA Update. RAPS Meeting, Washington, DC, October 12, 2004.

Chan MM. FDA Regulation of Biochips. 2nd KFDA-KRIBB Joint International Symposium on “International Harmonization on Biopharmaceuticals – Recent Trends in Research, Development and Evaluation Technology,” Seoul, South Korea, October 26-30, 2004.

Chan MM. Regulatory Perspectives in Pharmacogenomics. 1st Spanish Congress on Pharmacogenetics and Pharmacogenomics, Valencia, Spain, January 22-26, 2005.

Chan MM. Regulation of Pharmacogenomic Devices – OIVD Perspectives. University of Tokyo sponsored International Symposium on “Frontiers in Drug Development,” Tokyo, Japan, February 16-19, 2005.

Gutierrez A. FDA Regulation Opportunity or Hindrance, Alcohol Biosensors Annual Progress Meeting, Rockville, MD, July 21, 2005.

Gutierrez A. 510(k) Review II, DSMICA Workshop, Los Angeles, CA, September 30, 2005.

Gutman SI. Panel Member – Regulating and Reimbursing New Genetic Technologies: “What Manufacturers and Clinical Laboratories Need to Know,” American Association of Clinical Chemistry Audio conference, Atlanta, GA, October 13, 2004.

Gutman SI. Keynote Address: An Update on FDA Regulation of Medical Devices – Applications to the Management of Diabetes. Diabetes Technology Meeting, Philadelphia, PA, October 29, 2004.

Gutman SI. Review of Regulatory Framework for Chem/Bio Defense Diagnostic Countermeasures. Chem/Bio Warfare Defense Panel of the Threat Reduction Advisory Committee to the Department of Defense, Arlington, VA, November 5, 2004.

Gutman SI. FDA Perspective on Diagnostics – How to Prepare a Premarket Submission. Molecular Diagnostics – Market, Regulatory and Payer Requirements for Commercial Success, CBI and Boston Health Care Associates, Washington, DC, November 19, 2004.

Gutman SI. Approval of Pharmacogenomics Tests. Pharmacogenetics Research Network (PGRN) Steering Committee, Orlando, FL, March 2, 2005.

Gutman SI. FDA Regulation: Opportunity or Obstacle. Biomedical Marketing Association Gutman SI. Moderator: Experience with VGDS and Required PGx Submissions. Breakout Session, Pharmacogenomics in Drug Development and Regulatory Decision Making, Drug Information Association, Bethesda, MD, April 12, 2005.

Gutman SI. Update on OIVD. Annual Meeting of the Association of Medical Diagnostics Manufacturers, Rockville, MD, April 21, 2005.

Gutman SI. Genomics – Translating the Science into Regulatory Decision-Making – Interactive Round Table Discussion. FDA Science Forum, Washington, DC, April 27, 2005.

Gutman SI. The New CLIA waiver criteria. AACC, ACLA and ASCLS Audio Conference, Rockville, MD, May 4, 2005.

Gutman SI. Developing Standards for the Exchange of Genomic and Proteomic Data from Clinical Trials – The Regulatory Game Plan. American Society of Clinical Oncology, Annual 2005 Meeting, Orlando, FL, May 16, 2005.

Gutman SI. Panelist: ThinkTank II: Pharma/FDA Dialogue. The Biomarker World Congress 2005, Philadelphia, PA, May 24, 2005.

Gutman SI. Regulatory Issues in the Co-Development of Drugs and Diagnostics – Don’t Forget the Diagnostic! The Biomarker World Congress 2005, Philadelphia, PA, May 25, 2005.

Gutman SI. Panelist: ThinkTank IV: Exploiting the Synergy between Pharma and Diagnostic Biomarker Research. The Biomarker World Congress 2005, Philadelphia, PA, May 25, 2005.

Gutman SI. FDA Regulatory Perspectives – In Vitro Diagnostic Regulation. NCI Biosensor Symposium, Bethesda, MD, June 8, 2005.

Gutman SI. IVD Update. Reality of Regulatory Affairs, 8th Annual FDA-OCRA Educational Conference, Irvine, CA, June 16, 2005.

Gutman SI. FDA Regulation of In Vitro Diagnostic Devices: How To Turn The Critical Path Into A Yellow Brick Road. Plenary Session on Biomarkers, 13th Specialized Programs of Research Excellence (SPORE) Investigator’s Workshop, Washington, DC, July 9, 2005.

Gutman SI. Moderator: Clinical Validation. Microarrays in Transcriptional Profiling: A Joint John Hopkins/FDA/PhRMA Workshop, Rockville, MD, July 21, 2005.

Gutman SI. IVD Regulation by the FDA in the United States. U.S Regulation and Reimbursement of In Vitro Diagnostic Products, IFCC/ACCC Annual Meeting, Orlando, FL, July 24, 2005.

Gutman SI. Regulatory Issues for Genomic Tests: Shortening the Critical Path to market. Global Genomic Personalized Medicine – EduTrak, IFCC/AACC Annual Meeting, Orlando, F, July 26, 2005.

Gutman SI. The New Waiver Criteria: What They Mean to the Clinical Laboratory Industry Healthcare Forum, IFCC/AACC Annual Meeting, Orlando, FL, July 27, 2005.

Gutman, S.I., From Clinical Trials to Drug Approval. Genetic Alliance 2500 Annual Conference, Rockville, MD, July 29, 2005.

Gutman SI. Progress and Pitfalls in Development and Validation of Biomarkers – Regulatory Aspects. Standards, Methods, Assays, Reagents and Technologies (SMART) for Early Cancer Detection and Diagnostics, National Institute of Standards and Technology, Gaithersburg, MD, August 18, 2005.

Gutman SI. Panelist, Symposium I : Emerging Pharmacogenomic Tools and Their Utility in Benefit/Risk Assessment in Clinical Trials. 34th Annual Meeting American College of Clinical Pharmacology, Rockville, MD, September 11, 2005.

Gutman SI. and Hojvat S. FDA update and ASR’s/New Technology Submissions. The 8th Annual FDA-OCRA Educational Conference, Irvine, CA, June 16, 2005.

Hackett JL. FDA Perspective: Clinical, Regulatory, and QA Issues Related to Genomics. Regulatory Affairs Professional Society 2004 Annual Conference. Washington, DC, October 12, 2004.

Hackett JL. Pharmacogenomics: FDA and In Vitro Diagnostics. Personalized Medicine. Accelerating Dx/Rx Product Development, Center for Business Intelligence, Philadelphia, PA, June 27, 2005.

Harper CC. FDA Perspectives on Pharmacogenetic Testing. CHI 7th Annual Systems Biology Conference, San Francisco, CA, June 15, 2005.

Harper CC. The Roche AmpliChip CYP450 Microarray: A Summary of the Regulatory Process, Senate HELP Committee Briefing, Washington, DC, January 26, 2005.

Hojvat S and Toth-Allen J. In Vitro Diagnostic (IVD) Devices: How They Differ from Other Devices & How FDA Regulates Them. Association of Clinical Research Professional (ACRP), Orlando, FL, April 5, 2005.

Hojvat S. Human Specimen Repositories Requirements of 21 CFR Parts 50 & 56: Biological Specimens and Personal Data. Critical Path to New Medical Products: The Challenges In Protecting Human Subjects, Houston, TX, April 22, 2005.

Hojvat S. Office of In Vitro Diagnostic Device Evaluation and Safety General Compliance Update. The 8th Annual FDA-OCRA Educational Conference, Irvine, CA, June 16, 2005.

Hojvat S. FDA’s Current Thinking on GLP/GCP: Building Quality Into Device Clinical Trials. Quality Device Trials, “Microarrays in Transpotional Profiling”, DDA/John Hopkins/PhRMA, Rockville, MD, July 21, 2005.

Hojvat S. 510 (k) Review (1), DSMICA Workshop, Los Angeles, CA, September 30, 2005.

Hojvat S. FDA Regulation – Opportunity or Barrier? “Chips to Hits,” Boston, MA,
September 10, 2005.

Hojvat S. Microarrays Used for Pathogen Detection – An FDA Perspective. Boston, MA, September, 2005.

Pastel MS. FDA/CDRH Perspective on Regulatory Requirements for Array Bioinformatics. AACC's Lab 2007: Your Eye to the Future, October 21-22, 2004, Chicago IL.

Poole FM. Bacterial ID Systems: Quality Control and Regulations, an FDA Perspective. Clinical Laboratory Improvement Advisory Committee Meeting, CDC, Atlanta, GA, Feb 15-16, 2005.

Poole FM. Regulatory Framework for New Technologies in Vitro Diagnostic Devices. Biotechnology Seminar, US Military Academy, West Point, NY, May 5-6, 2005.

Scherf U. Pharmacogenomics in Drug Development and Regulatory Decision Making. Drug Information Association, Pharma Meeting, North Bethesda, MD, April 11-13, 2005.

Shively RG. Regulating IVDs for Emerging Infectious Diseases. Regulatory Affairs Professionals Society (RAPS) Annual meeting, Baltimore, MD, October 12, 2004.

Shively RG. Tools to Navigate In Vitro Diagnostic Critical Paths. American Society for Microbiology Biodefense Meeting, Baltimore, MD, March 2005.

Shively RG. Multiplexing with FDA. National Institute for Allergy and Infectious Diseases, NIH Multiplexing workshop, Bethesda, MD, June 27, 2005.

Shively RG. Postmarket Controls. CDC TB Expert Meeting/Workshop, Atlanta, GA, June 27, 2005.

Shively RG. FDA/OIVD Premarket Reviews. CDC (NCID), Atlanta, GA, September 8, 2005.

Simon KA. FDA Perspectives on Pharmacogenetic Testing. IBC's 4th Annual Conference, Molecular Diagnostics and Personalized Medicine, Boston, MA, September 12-15, 2005.

St.Pierre DJ. Introduction to OIVD. ORCA Meeting, Seattle, WA, March 15, 2005.

St.Pierre DJ. Compliance and Postmarketing Trends. Association of Medical Diagnostic Manufacturers, Rockville, MD, April 22, 2005.

St.Pierre DJ. Turbo 510(k) for In Vitro Diagnostic Devices. AdvaMed 15th Annual Submissions Workshop, Arlington, VA, May 24-25, 2005.

St.Pierre DJ. Update on OIVD. Orange County Regulatory Affairs Annual Meeting, Irvine, CA, June 1-4, 2005.

St.Pierre DJ. DSMICA Workshop, Introduction and Update on OIVD “Pre-IDE and De novo Applications,” Los Angeles, CA, September 30, 2005.

OIVD Standards Liaison Representatives

Altaie, Sousan Bautista, Josephine Bernhardt, Patricia Brill, Marieann Brindza, Larry Callaghan, James Carrington, Leonthena Chace, Nina Chappie, Marie Faison, Tremel

Gutman, Steven Hackett, Joseph Hausman, Ethan Ingram, Kenneth Mcgruder, Louise Moyer, Vicki Pinkos, Arleen Poole, Freddie Reeves, James Rheinheimer, Douglas

Robinowitz, Max Scherf, Uwe Selepak, Sally Shively, Roxanne Tezak, Zivana Valentine, Fredricka Wright, Kathleen Wilbon, Tonya Wood, Douglas