1. About
Scientific & Regulatory Affairs leader with 17 years of FDA experience in recombinant proteins, plasma derivatives, cell and gene therapies
Skilled in all aspects of CMC and clinical strategy, with a vision for risk-based regulatory success and compliance
Expertise in bridging manufacturing & clinical programs and surrogate endpoints
Recognized expert in international assay development, WHO reference standards, and assay harmonization
25 years of research and innovation in thrombosis and bleeding
Energizer
Contact information: via LinkedIn https://www.linkedin.com/in/mikhail-ovanesov-779796b/
2. Links to regulatory work with FDA
Head of FDA laboratory & research program (about research program and review division)
FDA-PPTA-NHLBI Workshop (2011): Risk mitigation strategies to address potential procoagulant activity in immune globulin products (organizer and co-chair)
WHO hearing (2019): development of product-specific reference materials (co-chair and organizer)
CDER/CBER public workshop (2018): Product development in hemophilia. [Transcript.] (organizer and moderator)
ROCTAVIAN (2023) gene therapy (link is coming; reviewer; press release)
HEMGENIX (2022) gene therapy (reviewer, BLA approval memo)
SEVENFACT (2019) recombinant protein (chair, BLA approval memo)
ANDEXXA (2018) recombinant protein (chair, BLA approval memo)
IDELVION (2016) recombinant protein (chair, BLA approval memo)
COAGADEX (2015) plasma derived protein (chair, BLA approval memo)
RIXUBIS (2013) recombinant protein (chair, BLA approval memo)
Evidence of the link between thrombosis and immune globulins
International collaborative project on thrombogenicity assay standardization
FDA Guidance, Human Gene Therapy for Hemophilia (author: activity assays)
3. Invited talks with FDA
Parenteral Drug Association (PDA). Advanced Therapy Medicinal Products Conference, Regulatory perspective on phase appropriate validation of analytical methods, June 8, 2023, Baltimore, MD
CDER Small Business & Industry Assistance (SBIA), Regulatory Education for Industry (REdI) annual conference, Safety-related impurities in plasma-derived products, June 9, 2022, CDER/CBER, Silver Spring, MD
European Pharmacopeia, Expert Group 6B Blood Products, Global Working Group (GWG) for the measurement of procoagulant activity of immunoglobulins. Study group for thrombin generation tests (SG-TGT), March 16, 2022, EDQM, remote meeting
Pathogen Reduction Testing - OBRR Research program special seminar, Helpful Hemostasis Testing: Meeting Regulatory Needs, March 2, 2022, CBER, Silver Spring, MD
CBER Course: New Reviewer Training, Chemistry, Manufacturing and Controls review responsibilities for biologics license applications, May, 2023; March 2022; October & May 2021; October 2020; October & April 2019; Silver Spring MD
CBER OTAT: AAV Working Group meeting, Coagulation Factor Testing: meeting our regulatory needs, February 23, 2022, CBER, remote meeting
CaSSS WCBP annual meeting, Considerations for setting specifications: CBER reviewer experience, January 25, 2022, Washington, DC
IBC Well Characterized Biologics & Biological Assays annual meeting, Detection of stability change in frozen drug substance and efficient stability monitoring of drug product, October 25, 2021, Washington, DC
WHO Expert Committee on Biological Standardization (ECBS) 72nd meeting, Summary of the WHO hearing on the development of product-specific reference materials for Coagulation Factor VIII and Factor IX products, October 19, 2020, Teleconference
WHO Hearing on product-specific reference standards for new coagulation factor VIII and IX concentrates, US FDA perspective on product-specific reference reagents for new coagulation factor VIII and IX concentrates, November 7-8, 2019, Geneva, Switzerland
Working Group of WHO Collaborating Centres (CC), Product-specific reference reagents for new coagulation factor VIII and factor IX concentrates. CBER perspective, February 22, 2019, Silver Spring, MD
CaSSS WCBP annual meeting, Product-specific reference reagents for new coagulation factor VIII and factor IX concentrates, January 30, 2019, Washington, DC
The National Institute for Biological Standards and Control (NIBSC), Impact of assay discrepancies on regulation of products for hemophilia: factor concentrates and gene therapies, November 23, 2018, Potters Bar, UK
CBER OCBQ/DBSQC seminar, Coagulation factor products: Potency determination and related complications, May 7, 2018, FDA, Silver Spring, MD
CaSSS Bioassays annual meeting, Case study: discrepant potency assays for coagulation factor products, April 16-17, 2018, Silver Spring, MD
6th Meeting of the WHO CCs to support the development of WHO biological reference preparations for in vitro diagnostic devices and blood products, Need for product-specific reference reagents for new coagulation factor VIII and IX concentrates, April 12, 2018, FDA, Silver Spring, MD
Research seminars at Paul-Ehrlich-Institut, Germany. Safety and efficacy of plasma protein therapeutics regulated by the U.S. FDA’s Office of Tissues and Advanced Therapies: Potency of coagulation factor concentrates, January 16, 2018,
Research seminars at Paul-Ehrlich-Institut, Germany, Application of thrombin generation assay for evaluation of coagulation factor concentrates, thrombogenicity of coagulation factor XIa, January 15, 2018, Paul-Ehrlich-Institut, Langen, Germany
ISTH 2017 Congress & Annual SSC Meeting, The Scientific and Standardization Committee (SSC) FXI & the contact system session: FXIa contamination of IVIG, July 9, 2017, Berlin, Germany
CBER Science Impact Series, Connecting impurities in Immune Globulin products with thrombotic adverse events, September 27, 2016, Silver Spring, MD
PPTA Immunoglobulin stakeholder forum on procoagulant activity methods, Managing Procoagulant Impurities in IG Products - FDA perspective, September 7, 2016, Rockville, MD
CBER Science Symposium 2016, Thrombotic adverse events following immune globulin administration: uncontrolled clot growth as a potential mechanism, May 24, 2016, Silver Spring, MD
FDA/CDRH Division of Immunology and Hematology Devices seminar, Strategies of potency determination for coagulation factor VIII and factor IX products, November 24, 2014, Silver Spring, MD
IBC's 18th WCB annual meeting, Strategies of potency determination for new generation blood products, November 3, 2014, Washington, DC
EMA-EDQM Meeting on Establishment of Common Test for Procoagulant Activity of Immunoglobulins, Detection of procoagulant impurities in immune globulin products, March 18, 2014, Strasbourg, France (teleconference)
IBC WCB annual meeting - Product and process variants & impurities, Changing the manufacturing process to remove impurities and monitoring product quality using relevant lot release assays, October 22, 2013, Washington, DC
WHO CCs meeting, OBRR participation in the WHO collaborative laboratory study on Factor IX products, April 16, 2013, Strasbourg, France (videoconference)
Seminar of the NIH Department of Transfusion Medicine, Thrombogenicity of blood-derived products, March 1, 2013, Bethesda, MD
CaSSS WCBP annual meeting, Thrombotic adverse events and procoagulant impurities in immune globulin products, January 31, 2013, Washington, DC
FDA Science Board meeting, Laboratory investigation that identified the cause of thromboembolic events in patients receiving immunoglobulin treatments, October 3, 2012, Silver Spring, MD
CBER-BIOSafe Special Biologics Working Group: New endpoints for safety and efficacy in preclinical studies of CBER-regulated biologics, Thrombogenicity and immune globulin products: bedside to bench and back again, June 1, 2012, White Oak, MD
EMA/EDQM Meeting: Study on procoagulant activity of IVIGs, IG products and thrombosis: current FDA considerations, April 25, 2012, Strasbourg, France
ISTH congress, Regulation of clot growth by factor XI through the generation of thrombin inside the clot, July 25, 2011, Kyoto, Japan
ISTH congress, Association of factor XIa with intravenous immune globulin products implicated in thrombotic adverse events: biochemical root cause investigation, July 27, 2011, Kyoto, Japan
FDA-PPTA-NHLBI Workshop: Risk mitigation strategies to address potential procoagulant activity in immune globulin products, Laboratory investigations of products associated with thrombotic events., May 17, 2011, Rockville, MD FDA/NHLBI/PPTA Public Workshop archive of presentations and meeting transcripts:
FDA-PPTA-NHLBI Workshop: Risk mitigation strategies to address potential procoagulant activity in immune globulin products, Thrombin generation tests - technical challenges., May 18, 2011, Rockville, MD
FDA CBER PharmTox Working Group meeting, Hemostasis assays from a regulatory perspective, March 17, 2011, Rockville, MD
CaSSS Bioassays: Scientific Approaches & Regulatory Strategies, In search of assay(s) for the assessment of hemostasis, November 08, 2010, Bethesda, MD
PPTA-FDA Liaison Meeting, IGIV and thrombotic events, September 10, 2010, Bethesda, MD
Gordon Research Conference on Hemostasis. Hot topics session, Regulation of clot growth by Factor XI through the generation of thrombin inside the clot, July 28, 2010, Waterville Valley, NH
4. Publications
Parunov LA, Liang Y, Lu Q, Shibeko AM, Tucker E, Lee TK, Ataullakhanov FI, Scott D, Ovanesov MV. Thrombogenic potential of picomolar coagulation factor XIa is mediated by thrombin wave propagation. Blood Advances 2023 In Press
Jackson JW, Parunov LA, Monteil DT, Ovanesov MV. Effect of wavelength and filter set choices on fluorogenic thrombin generation assay: considerations for interlaboratory differences. Res Pract Thromb Haemost 2022;6(7):e12805
Shestopal SA, Parunov LA, Olivares P, Chun H, Ovanesov MV, Pettersson JR, Sarafanov AG. Isolated variable domains of an antibody can assemble on blood coagulation factor VIII into a functional Fv-like complex. Int J Mol Sci 2022;23(15):8134
Katneni U, Alexaki A, Hunt R, Katagiri N, Hettiarachchi G, Kames J, McGill JR, Holcomb DDF, Athey J, Lin B, Parunov LA, Kafri T, Lu Q, Peters RT, Ovanesov MV, Freedberg D, Bar H, Komar AA, Sauna ZE, Kimchi-Sarfaty C. Structural, functional, and immunogenicity implications of F9 gene recoding. Blood Adv 2022;12;6(13):3932-3944
Parunov LA, Shea ME, Liang Y, Surov SS, Chattopadhyay M, Lee TK, Scott DE, Ovanesov MV. Thrombin generation test based on a 96-channel pipettor for evaluation of FXIa procoagulant activity in pharmaceuticals. Nat Protoc 2021;16(8):3981-4003
Chang WC, Jackson JW, Machlus KR, Wolberg AS, Ovanesov MV. Fluorescence artifact correction in the thrombin generation assay: Necessity for correction algorithms in procoagulant samples. Res Pract Thromb Haemost 2021;5(3):447-455
Chun H, Pettersson JR, Shestopal SA, Wu WW, Marakasova ES, Olivares P, Surov SS, Ovanesov MV, Shen RF, Sarafanov AG. Characterization of protein unable to bind von Willebrand factor in recombinant factor VIII products. J Thromb Haemost 2021;19(4):954-966
Ovanesov MV, Jackson JW, Golding B, Lee TK. Considerations on activity assay discrepancies in factor VIII and factor IX products. J Thromb Haemost 2021;19(9):2102-2111.
Ovanesov MV, Williams SC, Nübling CM, Dodt J, Hilger A, Maryuningsih Y, Gray E. Summary of the WHO hearing on the development of product-specific reference materials for coagulation factor VIII and factor IX products. Biologicals 2020:67:88-93
Liang Y, Jackson JW, Surov SS, Parunov LA, Scott D, Lee TK, Ovanesov MV. Detecting factor XIa in immune globulin products: Commutability of international reference materials for traditional and global hemostasis assays. Res Pract Thromb Haemost 2020;5(1):211-222
Xu Y, Liang Y, Parunov L, Despres D, Eckhaus M, Scott D, Ovanesov M, Struble EB. Combined thrombogenic effects of vessel injury, pregnancy and procoagulant immune globulin administration in mice. Thrombosis J 2020;18(1):32
Chang WC, Jackson JW, Machlus KR, Wolberg AS, Ovanesov MV. Comparative analysis of thrombin calibration algorithms and correction for thrombin-α2macroglobulin activity. J Clin Med 2020;9(10):3077
Parunov LA, Surov SS, Chattopadhyay M, Liang Y, Lee TK, Ovanesov MV. Thrombin generation assay modifications needed for its application to monitoring of replacement therapy for haemophilia. Haemophilia 2021;27(1):e129-e132
Jackson JW, Surov SS, Liang Y, Parunov LA, Ovanesov MV. Effect of pH on thrombin activity measured by calibrated automated thrombinography. Res Pract Thromb Haemost 2020;4(5):944-945
Jankowski W, McGill J, Lagasse HAD, Surov S, Bembridge G, Bunce C, Cloake E, Fogg MH, Jankowska KI, Khan A, Marcotrigiano J, Ovanesov MV, Sauna ZE. Mitigation of T-cell dependent immunogenicity by reengineering factor VIIa analogue. Blood Adv 2019;3(17):2668-78
De Paoli SH, Tegegn TZ, Elhelu OK, Strader MB, Patel M, Diduch LL, Tarandovskiy ID, Wu Y, Zheng J, Ovanesov MV, Alayash A, Simak J. Dissecting the biochemical architecture and morphological release pathways of the human platelet extracellular vesiculome. Cell Mol Life Sci 2018;75(20):3781-801
Ovanesov MV, Menis MD, Scott DE, Forshee R, Anderson S, Bryan W, Golding B. Association of immune globulin intravenous and thromboembolic adverse events. Am J Hematol 2017;92(4):E44-E45
Parunov LA, Surov SS, Yideng L, Lee TK, Ovanesov MV. Can the diagnostic reliability of the thrombin generation test as a global hemostasis assay be improved? The impact of calcium chloride concentration. Haemophilia 2017;23(3):466-475
Shestopal SA, Hao JJ, Karnaukhova E, Liang Y, Ovanesov MV, Lin M, Kurasawa JH, Lee TK, Mcvey JH, Sarafanov AG. Expression and characterization of a codon-optimized blood coagulation factor VIII. J Thromb Haemost 2017;15(4):709-720
Leiderman K, Chang W, Ovanesov M, Fogelson AL. Synergy between tissue factor and exogenous factor XIa in initiating coagulation. Arterioscler Thromb Vasc Biol 2016;36(12):2334-45
Tegegn TZ, De Paoli SH, Orecna M, Elhelu OK, Woodle SA, Tarandovskiy ID, Ovanesov MV, Simak J. Characterization of procoagulant extracellular vesicles and platelet membrane disintegration in DMSO-cryopreserved platelets. J Extracell Vesicles 2016;5:30422
Jha NK, Shestopal SA, Gourley MJ, Woodle SA, Liang Y, Sarafanov AG, Weinstein M, Ovanesov MV. Optimization of thrombin generation test components to measure the potency of factor VIII products. Haemophilia 2016;22(5):780-9
Xin K, Chang WC, Ovanesov MV. Interconnectedness of global hemostasis assay parameters in simultaneously evaluated thrombin generation, fibrin generation and clot lysis in normal plasma. Thromb Res 2016;140:132-9
Kotarek J, Stuart C, De Paoli SH, Simak J, Lin TL, Gao Y, Ovanesov M, Liang Y, Scott D, Brown J, Bai Y, Metcalfe D, Marszal E, Ragheb JA. Subvisible particle content, formulation, and dose of an erythropoietin peptide mimetic product are associated with severe adverse post-marketing events. J Pharm Sci 2016;105(3):1023-7
Parunov LA, Soshitova NP, Ovanesov MV, Panteleev MA, Serebriyskiy II. Epidemiology of venous thromboembolism (VTE) associated with pregnancy. Birth Defects Res C Embryo Today 2015;105(3):167-84
Parunov LA, Surov SS, Tucker E, Ovanesov MV. The effect of corn trypsin inhibitor and inhibiting antibodies for FXIa and FXIIa on coagulation of plasma and whole blood: comment. J Thromb Haemost 2015;13(8):1527-30
Ekezue BF, Sridhar G, Ovanesov MV, Forshee RA, Izurieta HS, Selvam N, Parunov L, Jain N, Mintz PD, Epstein J, Anderson SA, Menis M. Clotting factor product administration and same-day occurrence of thrombotic events, as recorded in large healthcare database during 2008-2013. J Thromb Haemost 2015;13(12):2168-79
Kurasawa J, Shestopal S, Woodle SA, Ovanesov MV, Lee TK, Sarafanov AG. Cluster III of the low-density lipoprotein receptor-related protein 1 binds activated blood coagulation factor VIII. Biochemistry 2015;54(2):481-9
Sridhar G, Ekezue BF, Izurieta HS, Selvam N, Ovanesov MV, Divan HA, Liang Y, Golding B, Forshee RA, Anderson SA, Menis M. Immune globulins and same-day thrombotic events as recorded in a large health care database during 2008 to 2012. Transfusion 2014;54(10):2553-65
Shibeko AM, Woodle SA, Mahmood I, Jain N, Ovanesov MV. Predicting dosing advantages of factor VIIa variants with altered tissue factor and lipid-dependent activities. J Thromb Haemost 2014;12(8):1302-12
Menis M, Sridhar G, Selvam N, Ovanesov MV, Divan HA, Liang Y, Scott D, Golding B, Forshee R, Ball R, Anderson SA, Izurieta HS. Hyperimmune globulins and same-day thrombotic adverse events as recorded in a large healthcare database during 2008-2011. Am J Hematol 2013 Dec;88(12):1035-40
Woodle SA, Shibeko AM, Lee TK, Ovanesov MV. Determining the impact of instrument variation and automated software algorithms on the TGT in hemophilia and normalized plasma. Thromb Res 2013;132(3):374-80
Liang Y, Woodle SA, Shibeko AM, Lee TK, Ovanesov MV. Correction of microplate location effects improves performance of the thrombin generation test. Thrombosis J 2013;11(1):12
Kurasawa JH, Shestopal SA, Jha NK, Ovanesov MV, Lee TK, Sarafanov AG. Insect cell-based expression and characterization of a single-chain variable antibody fragment directed against blood coagulation factor VIII. Prot Express Purif 2013;88(2):201-6
Shibeko AM, Woodle SA, Lee TK, Ovanesov MV. Unifying the mechanism of recombinant FVIIa action: dose-dependence is regulated differently by tissue factor and phospholipids. Blood 2012;120(4):891-9
Dashkevich NM, Ovanesov MV, Balandina AN, Karamzin SS, Shestakov PI, Soshitova NP, Tokarev AA, Panteleev MA, Ataullakhanov FI. Thrombin activity propagates in space during blood coagulation as an excitation wave. Biophys J 2012;103(10):2233-40
Daniel GW, Menis M, Sridhar G, Scott D, Wallace AE, Ovanesov MV, Golding B, Anderson SA, Epstein J, Martin D, Ball R, Izurieta H. Immune globulins and thrombotic adverse events as recorded in a large administrative database in 2008 through 2010. Transfusion 2012;52(10):2113-21
Panteleev MA, Balandina AN, Lipets EN, Ovanesov MV, Ataullakhanov FI. Task-oriented modular decomposition of biological networks: trigger mechanism in blood coagulation. Biophys J 2010;98(9):1751-61
Ovanesov MV*, Panteleev MA, Sinauridze EI, Kireev DA, Plyushch OP, Kopylov KG, Lopatina EG, Saenko EL, Ataullakhanov FI. Mechanisms of action of recombinant activated factor VII in the context of tissue factor concentration and distribution. Blood Coagul Fibrinolysis 2008;19(8):743-755 [*Corresponding author]
Ovanesov MV, Ayhan Y, Wolbert C, Moldovan K, Sauder C, Pletnikov MV. Astrocytes play a key role in activation of microglia by persistent Borna disease virus infection. J Neuroinflammation 2008;5:50
Ovanesov MV, Moldovan K, Smith K, Vogel MW, Pletnikov MP. Persistent Borna Disease Virus (BDV) infection activates microglia prior to a detectable loss of granule cells in the hippocampus. J Neuroinflammation 2008;5:16
Pletnikov MV, Ayhan Y, Nikolskaia O, Xu Y, Ovanesov MV, Huang H, Mori S, Moran TH, Ross CA. Inducible expression of mutant human DISC1 in mice is associated with brain and behavioral abnormalities reminiscent of schizophrenia. Mol Psychiatry 2008;13(2):173-86, 115
Pletnikov MV, Ayhan Y, Xu Y, Nikolskaia O, Ovanesov M, Huang H, Mori S, Moran TH, Ross CA. Enlargement of the lateral ventricles in mutant DISC1 transgenic mice. Mol Psychiatry 2008;13(2):115
Qi L, Carbone KM, Ye Z, Liu T, Ovanesov MV, Pletnikov MV, Sauder C, Rubin SA. Genetic contributions to influenza virus attenuation in the rat brain. J Neurovirology 2008;14(2):136-42
Pedras-Vasconcelos JA, Puig M, Sauder C, Wolbert C, Ovanesov M, Goucher D, Verthelyi D. Immunotherapy with CpG oligonucleotides and antibodies to TNF-alpha rescues neonatal mice from lethal arenavirus-induced meningoencephalitis. J Immunology 2008;180(12):8231-8240
Ovanesov MV, Vogel MW, Moran TH, Pletnikov MV. Neonatal Borna disease virus infection in rats is associated with increased extracellular levels of glutamate and neurodegeneration in the striatum. J Neurovirology 2007;13(3):185-94
Pletnikov MV, Xu Y, Ovanesov MV, Kamiya A, Sawa A, Ross CA. PC12 cell model of inducible expression of mutant DISC1: new evidence for a dominant-negative mechanism of abnormal neuronal differentiation. Neuroscience Res 2007;58(3):234-44
Tokarev AA, Krasotkina YuV, Ovanesov MV, Panteleev MA, Azhigirova MA, Volpert VA, Ataullakhanov FI, Butilin AA. Spatial dynamics of contact-activated fibrin clot formation in vitro and in silico in haemophilia B: effects of severity and Ahemphil B treatment. Math Model Nat Phenom 2006;1(2):124-137
Ovanesov MV, Sauder C, Rubin SA, Richt J, Nath A, Carbone KM, Pletnikov MV. Activation of microglia by Borna Disease Virus infection: an in vitro study. J Virol 2006;80(24):12141-8
Panteleev MA*, Ovanesov MV*, Kireev DA, Shibeko AM, Sinauridze EI, Ananyeva NM, Butylin AA, Saenko EL, Ataullakhanov FI. Spatial propagation and localization of blood coagulation are regulated by intrinsic and protein C pathways, respectively. Biophys J 2006;90(5):1489-500 [*Authors contributed equally]
Ovanesov MV*, Ananyeva NM, Panteleev MA, Ataullakhanov FI, Saenko EL. Initiation and propagation of coagulation from tissue factor-bearing cell monolayers to plasma: initiator cells do not regulate spatial growth rate. J Thromb Haemost 2005;3(2):321-31 [International Society for Thrombosis and Haemostasis (in Chapel Hill, NC) honored this paper as the best coagulation manuscript published in 2005 by first authors younger than 35 years of age; *corresponding author]
Ananyeva NM, Lacroix-Desmazes S, Hauser CAE, Shima M, Ovanesov MV, Khrenov A, Saenko EL. Inhibitors in hemophilia A: mechanisms of inhibition, management and perspectives. Blood Coag Fibrinol 2004;15(2):109-24
Ovanesov MV, Lopatina EG, Saenko EL, Ul’yanova LI, Plyushch OP, Butilin AA, Ataullakhanov FI. Effect of factor VIII on tissue factor-activated spatial clot growth. Thromb Haemost 2003;89(2):235-42
Sinauridze EI, Volkova RI, Krasotkina YuV, Ovanesov MV, Ataullakhanov FI. Systems without stirring: a new model for studying the spatial dynamics of fibrin clot growth. Tromboz, gemostaz i reologija 2003;2(14):25-35 [in Russian]
Ovanesov MV*, Krasotkina JV, Ul’yanova LI, Abushinova KV, Vorob’ev AI, Plyushch OP, Domogatskii SP, Ataullakhanov FI. Hemophilia A and B are associated with abnormal spatial dynamics of clot growth. Biochim Biophys Acta 2002;1572(1):45-57 [*Corresponding author]
Korotina NG, Ovanesov MV, Plyushch OP, Kopylov KG, Lopatina EG, Saenko EL, Butylin AA, Ataullakhanov FI. Spontaneous clots in normal plasma and plasma of patients with hemophilia A. Gematologia i transfuziologia 2002:47(3);26-9 [in Russian]
Abushinova KV, Azhigirova MA, Plyushch OP, Kopylov KG, Severova TV, Fetisova LV, Ovanesov MV, Tentsova IA. Pharmacokinetic investigation of the new antihemophilic drug Ahemphil B. Problemy gematologii i perelivania krovi [Problems of hematology and blood transfusion] 2000:1;25-9 [in Russian]
5. Planning and chairing professional workshops
Session panelist: Parenteral Drug Association. 2023 Advanced Therapy Medicinal Products Conference. June 8, 2023. Baltimore, MD
Workshop co-chair: Plenary workshop - ICH Q6B and clinical relevance vs. clinical experience. CaSSS Well Characterized Biological Products (CaSSS WCBP) annual meeting. January 2022. Washington, DC
Regulatory session panelist: IBC Well Characterized Biologics & Biological Assays (IBC WCB & BA) annual meeting. October 2021. Washington, DC
Session panelist: CMC strategies to expedited program development - regulatory perspectives. CaSSS CMC Strategy Forum North America. October 2020. Videoconference
Meeting co-chair & organizer: WHO hearing on product-specific reference standards for new coagulation factor VIII and IX concentrates. November 2019. Geneva, Switzerland
Workshop moderator: Blood products workshop – issues related to potency assay standardization. CaSSS WCBP annual meeting. January 2019. Washington, DC
Session co-chair: Patient-centric stability and expiration dating - a global view. CaSSS WCBP annual meeting. January 2019. Washington, DC
Meeting planning committee & session chair: CDER/CBER public workshop - Product development in hemophilia. 2018. Silver Spring, MD
Meeting planning committee & panelist: CDER/CBER OCE mini symposium - Endpoints in hemophilia gene therapy studies. May 2018. Silver Spring, MD
Session presenter & panelist: Regulators: what’s on your mind? CaSSS Bioassays annual meeting. April 2018. Silver Spring, MD
Session co-lead: Commercial product quality (process drift) - impacts on comparability, specifications and biosimilarity. CaSSS WCBP annual meeting. January 2018 Washington, DC
Workshop co-lead: Blood products workshop on gene therapy treatments for hemophilia A and B. CaSSS WCBP annual meeting. January 2017 Washington, DC
Meeting organizer & session chair: PPTA & FDA/USP/EDQM Immunoglobulin stakeholder forum on measurement methods for procoagulant activity of immunoglobulins. September 2016. Rockville, MD
Workshop co-chair: Development activities (early and late phase) workshop - I just received breakthrough, now what do I do?” CaSSS WCBP annual meeting. January 2016. Washington, DC
Workshop facilitator: Quality by Design (QbD) workshop. CaSSS WCBP annual meeting. January 2015. Washington, DC
Workshop co-lead: Blood products workshop. CaSSS WCBP annual meeting. January 2014. Washington, DC
Panelist: IBC WCP annual meeting. October 2013. Washington, DC
Panelist: CaSSS CMC Strategy Forum: Reference standards for therapeutic proteins – Current regulatory and scientific best practices and remaining needs. 2013. Washington, DC
Session panelist: CaSSS WCBP annual meeting. January 2013. Washington, DC
Working group panelist: CBER-BIOSafe Special biologics working group. 2012. Silver Spring, MD
Meeting co-chair & organizer: FDA/NHLBI/PPTA public workshop: Risk mitigation strategies to address procoagulant activity in immune globulin products. May 2011. Gaithersburg, MD
6. Professional honors and awards
2022 CBER global public health award “For continual leadership and representation of CBER in international collaborative studies to develop reference standards and harmonize assays for products to treat bleeding disorders”
2021 CBER group public health achievement award - Gene therapy guidance document development teams: “For outstanding public health achievement as exemplified by the publication of six final guidance documents on gene therapy product development”
2021 CBER group human capital investment award - CBER new reviewer & medical device training team: “For exceptional leadership and innovation developing and delivering all-virtual CBER New Reviewer and Medical Device Reviewer Training Programs during the COVID Public Health Emergency”
2020 CBER group policy development award - Dried plasma guidance working group: “For exemplary collaboration and expeditious publication of a guidance document informing development of dried plasma products intended for transfusion, in response to public health needs”
2019 FDA awards presented at the agency level - Commissioner’s special citation: French freeze-dried plasma EUA review group: “For outstanding contributions in completing the review of an EUA allowing the Department of Defense to use French Freeze-Dried Plasma during an emergency”
2015 CBER group award - CBER/OBRR White Oak move: “For outstanding effort in supporting the Office of Blood Research and Review’s transition to FDA’s White Oak campus”
2014 FDA group recognition honor award (crosscutting) - FDAAA safety labeling changes working group: “For significant contributions for improving the safety of two classes of blood products through leveraging and collaboration of scientific expertise within the Centers”
2012 FDA award for excellence in analytical science: “For laboratory investigation that identified the cause of thromboembolic events in patients receiving immunoglobulin treatments, which led to immediate product withdrawal from the market”
2011 CBER/FDA group recognition award - IGIV and thrombotic adverse events team: “For identifying prothrombotic activity in an IGIV product linked to serious adverse events, and for subsequent actions taken to protect patients and enhance product safety”
7. Member of working groups
Co-chair: International Society on Thrombosis and Haemostasis (ISTH), Scientific and Standardization Committee (SSC), subcommittee on the standardization of thrombin generation assays (2022-present)
FDA Liaison: USP expert group on factor VIII and IX potency assays (2020-present)
FDA representative: WHO-ISTH Standards Liaison Group (2017-present)
Chair & FDA representative: Global Working Group’s Study Group on standardization of thrombin generation assays for procoagulant activity of immunoglobulin products (2017-present)
FDA Representative: European Pharmacopoeia Group of Experts No. 6B (Human blood and blood products) (2017-present)
FDA Subject Matter Expert: WHO Expert Committee on Biological Standardization (ECBS) (2010-present)
Member of the National Heart Lung and Blood Institute (NHLBI) Working Group: Toward the rational design of optimally functional non-immunogenic factor VIII therapeutics (2015)
Member of the NHLBI Working Group: Standardization of global hemostasis assays (2011-2012)
Member of the NHLBI Working Group: Can global assays address current and future challenges in therapeutic monitoring of hemophilia A? (2011)
8. Quality laboratory work at FDA
18 WHO/NIBSC International Standard (IS) collaborative studies since 2011
USP (USA), EDQM (EU), NIBSC (UK) and U.S. FDA Global Working Group (GWG) on Investigation on assays for procoagulant activity of immunoglobulin products (2015-present)
NIBSC Collaborative study on the comparability of new factor VIII products with WHO international standards (2015)
WHO/NIBSC Collaborative study to investigate the comparability of recombinant and new generation factor IX products with WHO international standard for FIX concentrate (2013)
EMA-FDA-NIBSC immunoglobulin thrombogenicity assay harmonization studies (2 studies, 2011-2013)