Pathogen Reduction Technologies for Blood Safety; Public Workshop Part 2
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UNITED STATES FOOD AND DRUG ADMINISTRATION PATHOGEN REDUCTION TECHNOLOGIES (PRT) FOR BLOOD SAFETY PUBLIC WORKSHOP Silver Spring, Maryland Thursday, November 29, 2018 2 1 PARTICIPANTS: 2 Welcome: 3 NICOLE VERDUN, M.D.. OBRR, CBER 4 Food and Drug Administration 5 Opening Remarks: 6 PETERS MARKS, M.D., Ph.D. CBER 7 Food and Drug Administration 8 SESSION 1: Blood-Borne Infectious Agents and Their Impact on Blood Safety: 9 SIMONE GLYNN, M.D., MPH, Moderator 10 NHLBI National Institutes of Health 11 Risks to Blood Safety From Infectious Agents: 12 MICHAEL BUSCH, M.D., Ph.D. 13 Vitalant Research Institute 14 Pathogen Reduction: An Overview of Policy Issues: 15 STEVE KLEINMAN, M.D. University of British Columbia 16 Pathogen Reduction Technologies for Platelets: 17 Current Status in the United States: 18 EDWARD SNYDER, M.D., FACP Yale University, Yale New Haven Hospital 19 PRT for Plasma in the United States: 20 JAMES AUBUCHON, M.D., FACAP, FRCP (Edin) 21 Bloodworks Northwest, University of Washington 22 3 1 PARTICIPANTS (CONT'D): 2 Panel Discussion: 3 MICHAEL BUSCH, M.D., Ph.D. Vitalant Research Institute 4 STEVE KLEINMAN, M.D. 5 University of British Columbia 6 EDWARD SNYDER, M.D., FACP Yale University, Yale New Haven Hospital 7 JAMES AUBUCHON, M.D., FACAP, FRCP (Edin) 8 Bloodworks Northwest, University of Washington 9 SESSION 2: Implementation of Pathogen Reduction Technology for Blood Products in the U.S.: 10 BILL FLEGEL, M.D., Moderator 11 NIH Clinical Center 12 Experience Implementing PRT: 13 DAVID REEVE, MBA, MHA American Red Cross 14 PRT Implementation in a Hospital-Based Blood 15 Center & Acceptance by Hospital Staff: 16 BILL FLEGEL, M.D., Moderator NIH Clinical Center 17 Impact of PRT on Platelet Quality, Count, and 18 Clinical Implications: 19 DANA DEVINE, Ph.D. Canadian Blood Services 20 Considerations for Implementing Solvent/ 21 Detergent-Treated, Pooled Plasma Into a Hospital System: 22 4 1 PARTICIPANTS (CONT'D): 2 CLAUDIA COHN, M.D., Ph.D. University of Minnesota 3 Health Economic Considerations for Pathogen 4 Reduction Technologies: 5 BRIAN CUSTER, Ph.D., MPH Vitalant Research Institute 6 Panel Discussion: 7 DAVID REEVE, MBA, MHA 8 American Red Cross 9 DANA DEVINE, Ph.D. Canadian Blood Services 10 CLAUDIA COHN, M.D., Ph.D. 11 University of Minnesota 12 BRIAN CUSTER, Ph.D., MPH Vitalant Research Institute 13 SESSION 3: Pathogen Reduction Technologies for 14 Whole Blood and Red Blood Cells: 15 RAYMOND GOODRICH, Ph.D., Moderator Colorado State University 16 Optimal Pathogen Reduction System for Blood 17 Safety: Is It a Dream?: 18 RAYMOND GOODRICH, Ph.D. Colorado State University 19 Clinical Experience With Pathogen Reduction for 20 Red Blood Cells: Completing the Trial: 21 RICHARD BENJAMIN, M.D., Ph.D., FRCPath Cerus Corporation 22 5 1 PARTICIPANTS (CONT'D): 2 State of PRT for Whole Blood: 3 ANNA RAZATOS, Ph.D. Terumo BCT 4 PRT of Red Cell Products: Impact on Biochemical 5 and Viability Parameters in Humans: 6 JOSE A. CANCELAS, M.D., Ph.D. Hoxworth Blood Center, University of Cincinnati 7 Panel Discussion: 8 RICHARD BENJAMIN, M.D., Ph.D., FRCPath 9 Cerus Corporation 10 ANNA RAZATOS, Ph.D. Terumo BCT 11 JOSE A. CANCELAS, M.D., Ph.D. 12 Hoxworth Blood Center, University of Cincinnati 13 14 * * * * * 15 16 17 18 19 20 21 22 6 1 P R O C E E D I N G S 2 (8:04 a.m.) 3 DR. VERDUN: Good morning. I think 4 we're try and get started because we have a very 5 packed schedule. So good morning. My job today 6 is to welcome all of you. We're very, very 7 excited to have everyone here. So on behalf of 8 FDA, CBER and the Office of Blood Research and 9 Review, welcome. 10 At the core of our mission and the 11 office is the safety, obviously the safety of the 12 blood supply. And so this pathogen reduction 13 technologies for blood safety really gets to the 14 core of our mission. 15 And we're quite excited that all of you 16 are here to participate. We are hoping that this 17 will foster innovation and discussion and move 18 things forward in terms of safety. That is really 19 at the core of our mission and our goals. 20 I'm doing to do something a little bit 21 unusual this year at this meeting. And I'm going 22 to do acknowledgements up front because we have a 7 1 lot of people that really worked quite hard to put 2 this together. 3 And I really would like to first 4 acknowledge CD Agrea. So, thank you CD for 5 spearheading this and for putting this together. 6 He really took sort of an idea and put it all 7 together and made it happen. So I really would 8 like to say a thank you to you for that. 9 In addition, CBER organizing committee. 10 We have several external advisors that are listed 11 on the slide. And also several people that helped 12 to support the travel and otherwise as listed. 13 So again, thank you all for being here. 14 I'm going to turn it over to Dr. Peter Marks for 15 some opening remarks on pathogen reduction 16 technologies for blood safety. And thank you. 17 DR. MARKS: Thanks very much again. We 18 really appreciate everybody traveling here. This 19 is obviously a very important area to our center. 20 Blood products are potentially 21 lifesaving for a variety of different acute and 22 chronic conditions. And those range from people 8 1 who have experienced trauma, trauma victims, to 2 supportive care for cancer patients. 3 However, transfusion-transmitted 4 infections remain among the most significant 5 potential complications of blood transfusions, 6 despite major advances in risk reduction that have 7 been accomplished by a combination of donor 8 screening and laboratory testing. 9 Year round global infectious risks 10 include hepatitis B, C, and HIV. And local risks 11 include West Nile virus and Babesia, and obviously 12 there are a whole host of other pathogens that I 13 haven't mentioned. 14 And for platelets arrived from whole 15 blood or by apheresis, which are generally stored 16 at room temperature, there is the issue of 17 bacterial contamination risk. 18 So although testing can mitigate the 19 risk of transfusion-transmitting infectious 20 diseases, it comes at both a cost and it's not 21 perfect. 22 In addition we have continually emerging 9 1 pathogens which continue to challenge us to put in 2 place new testing which, obviously, brings with it 3 associated costs and, again, challenges the blood 4 supply. 5 So pathogen reduction technologies 6 address this risk or aim to address this risk from 7 viral and bacterial pathogens. But current 8 technologies, which tend to use either a nucleic 9 acid binding agent and ultra violet light, they 10 are -- although a significant advance, they are 11 yet to be perfect. 12 And that's because they either have 13 inadequate inactivation of certain pathogens or 14 because they lead to decrement in product yield, 15 or because they can't be used on whole blood, 16 which could then be separate into all the 17 different components. 18 So we think that, at least, and we look 19 forward to having discussion today. At least our 20 thinking is that the ideal pathogen reduction 21 technology would be able to be performed 22 relatively simply on whole blood, would allow that 10 1 whole blood to be separated into the various 2 components, much in the way that it is currently 3 into -- in current practice minimally disrupting 4 current blood banking practices. 5 And it would also then lead to an 6 activation of a very broad array of DNA and RNA 7 viruses. We know that no technology is going to 8 technology is going to get everything. But we'd 9 like to see something that could get the majority 10 of things that would ultimately potentially allow 11 us to start to conceive, think about starting to 12 peel back off of the viral testing which we do, 13 and bacterial testing which we do on products, 14 which would then allow us to just try to get to a 15 place where it was a cost-efficient or potentially 16 even cost- beneficial intervention. 17 So given this importance to public 18 health and to the safety and availability of the 19 blood supply, our center at FDA really wants to 20 work with a variety of stakeholders to advance 21 this technology. 22 And we look forward to working with all 11 1 of you over the coming years to try to advance 2 pathogen reduction technologies to really 3 hopefully bring us to a place where we have the 4 kind of a blood supply that is protected against 5 pathogens that emerge like the next Zika virus 6 without having to scramble to put in place testing 7 because we feel confident in the ability of a 8 pathogen reduction technology to protect against 9 those pathogens. 10 So thank you again. We look forward to 11 a robust discussion and we will obviously after 12 this workshop, we'll be following up too. 13 So thanks again. 14 DR. GLYNN: Good morning. My name is 15 Simone Glynn. I'm from NHLBI. And I have the 16 privilege of being the moderator for the first 17 session, which I think is going to be quite 18 exciting.