Critical Steps for Approval of Adjuvanted Pandemic Vaccines
|
|
- Patience Riley
- 5 years ago
- Views:
Transcription
1 Critical Steps for Approval of Adjuvanted Pandemic Vaccines Gary Grohmann 8th Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers March 2015, Sao Paulo, Brazil 1
2 Background Adjuvants (immune potentiators or immunomodulators) have been used for decades to improve the immune response to vaccine antigens More than one adjuvant can be used Aimed at enhancing, accelerating and prolonging the specific immune response towards the desired response to vaccine antigens Adjuvants can be employed to optimise a desired immune response: induction of cytotoxic or helper T lymphocyte responses and promote antibody responses. 2
3 3
4 Background: Adjuvant Landscape Mineral salts, e.g., aluminium hydroxide and aluminium or calcium phosphate gels. Oil emulsions and surfactant based formulations, e.g., MF59, QS21 (purified saponin), AS02 (oil-in-water emulsion + MPL + QS-21), Montanide ISA-51 and ISA-720. AS03 (oilin-water emulsion squalene, α-tocopherol, polysorbate 80) Particulate adjuvants, e.g., virosomes (unilamellar liposomal vehicles incorporating influenza haemagglutinin), AS04 (MPL, Al. phosphate) 4
5 Background: Adjuvant Landscape ISCOMS (structured complex of saponins and lipids), Microbial derivatives (natural and synthetic), e.g., monophosphoryl lipid A (MPL) Endogenous human immunomodulators, e.g., hgm-csf or hil-12 (cytokines that can be administered either as protein or plasmid encoded), Immudaptin (C3d tandem array) Inert vehicles, such as gold particles 5
6 Licensed Vaccines with Adjuvants From Nature Reviews Immunology 11, (December 2011) 6
7 Vaccine regulatory pathway Preclinical In vitro, animal immunogenicity, protection, toxicity Clinical trials (Concurrent nonclinical) Phase I Phase II Phase III healthy adults (18-50 years old) Several hundred subjects subjects to detect adverse events with incidence of 1/100-1/1000 vaccinated subjects, more for specific issues (70,000+ for Rotateq ) Registration All quality, nonclinical and clinical data evaluated for safety and efficacy Postregistration Phase IV Passive surveillance, phase IV clinical trials (booster, new population), pregnancy register, lot testing
8 Regulatory guidelines for vaccines Vaccine type Most vaccines All vaccines Vaccines for infectious disease, in pregnant women, women of childbearing potential, men Recombinant DNA protein vaccines Guideline EMA: Note for guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465/95, 1997) WHO: Guidelines on nonclinical evaluation of vaccines (WHO Technical Report Series, no. 927, 2005) WHO: Guidelines on clinical evaluation of vaccines: regulatory expectations (WHO Technical Report Series, no. 924, 2004) FDA (CBER) Guidance for industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications (2006) ICH: Preclinical safety evaluation of biotechnology-derived pharmaceuticals S6(R1) (2011)
9 Regulatory Guidelines for Adjuvanted vaccines Guidelines EMA: Guideline on adjuvants in vaccines for human use (2005) Guideline on pharmaceutical and biological aspects of combined vaccines (CPMP/BWP/477/97) cell substrates (CPMP/ICH/294/95) Viral safety (CPMP/ICH/295/95), rdna proteins (CPMP/ICH/139/95). nucleic acid (CPMP/BWP/3088/99) - WHO: Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines - ICH Note for Guidance on Statistical Principles for Clinical Trials (ICH topic E9) - Points to Consider on Multiplicity Issues in Clinical Trials (CPMP/EWP/908/99)
10 Critical First Steps Be familiar with the guidelines Communicate regularly and meet with the relevant NRA Be aware of any local NRA guidelines Have a complete chemical description of the Adjuvant(s) the function of each adjuvant and/or each component should be described to the extent that it is known 10
11 Critical First Steps Proposed or actual manufacture of the adjuvant should be described in detail Special attention should be given to the source material NOTE the Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents (EMEA/410/01) DEFINE parameters that are critical in conferring the correct physical, biochemical, biological or adsorptive properties of the adjuvant Generate Stability data 11
12 Critical Steps: Pre clinical studies for adjuvanted vaccines The increased/modified immune response with the adjuvanted vaccine should be demonstrated in a relevant animal model. Toxicity studies with the adjuvant alone for adjuvants with no existing toxicology data, and/or adjuvant-only group in adjuvanted vaccine repeat-dose toxicity study. Markers of inflammation useful pivotal organs: heart, lung, brain, liver, kidney, reproductive organs, spleen, thymus, bone marrow, lymph nodes Local tolerance consider the possibility of late granulomas with particles and mineral oils Assess local and regional tolerance for intranasal, oral vaccines. If the adjuvant itself is immunogenic, tests may be indicated for hypersensitivity e.g. passive cutaneous anaphylaxis, active systemic anaphylaxis assays, IgE measures, and dermal sensitization potential. Test the adjuvant for pyrogenicity EMA. Guideline on adjuvants in vaccines for human use (2005). WHO. Guidelines on the nonclinical evaluation of vaccine adjuvants 12
13 Critical Steps: Pre clinical studies for adjuvanted vaccines Non-clinical immunogenicity data are expected Dose-response Comparative studies to assess the effect of a new adjuvant with reference to a vaccine antigen alone or adjuvanted Studies in two different animal models 13
14 Critical Steps: Clinical Studies The inclusion of an adjuvant in a vaccine must always be justified It is critical that the amount of adjuvant used in the vaccine is appropriate to enhance the immune response to the antigen(s) The studies should involve a comprehensive assessment of the potential effects of the adjuvant on the immune response to all antigens that are to be included in the final product. The potential that the adjuvant itself might be immunogenic should be explored. 14
15 Clinical Studies The assessment of the humoral immune response should include the detection and titration of functional antibodies against an international standard (WHO or equivalent). Immunoglobulin subclass responses should be investigated. It may also be appropriate to estimate other properties of the antibody response such as avidity. Assessment of the cell-mediated component of the immune response is considered important. 15
16 Dose-finding studies Generate sufficient data to demonstrate that the amounts of adjuvant and antigen that are chosen for further study represent an acceptable balance between immune responses and the risk of adverse effects these studies should be performed in the target population for the vaccine. 16
17 Clinical Trials Clinical trials should be randomised, double blind, controlled trials will likely involve only an assessment of immune responses against validated immunological correlates for protection Trials should be performed in the final target population. Conservative stopping rules for the individuals and the entire study need to be in place. 17
18 Safety The safety data should show the likely rates of reactions that may be expected based on the known properties of the adjuvant(s) and antigen(s). In some cases, it may be appropriate that the data focus on immune mediated reactions. The risk-benefit relationship for the adjuvanted product should be at least as favourable as for the non adjuvanted product. A post-marketing surveillance program should in place 18
19 Conclusions Communicate with the NRA Know the relevant guidelines and regulations Nonclinical safety assessment essential pharmacology and toxicity testing with careful biological and chemical characterization of the adjuvant and the antigen Two species Clinical studies and clinical safety assessment essential The added value of the adjuvant in the formulation be demonstrated. importance of the risk-versus-benefit assessment 19
Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines
Annex 2 Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines Introduction 61 Background 62 Scope 62 General considerations 63 Terminology 65 Part A. Manufacturing and quality
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use 1 2 3 London, 23 July 2009 EMEA/CHMP/BMWP/301636/2008 4 5 6 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT
More information340 Index. ISCOM, see Immunostimulating complex Iscomatrix, see Immunostimulating complexmatrix
Index 337 Index A A-B-A nonionic block copolymer adjuvant, see CRL-1005 Adjuvant, see also specific adjuvants advantages, 8, 9 classes, 4, 5 clinical trials, Center for Biologics Evaluation and Research
More informationStrategies for Assessment of Immunotoxicology in Preclinical Drug Development
Strategies for Assessment of Immunotoxicology in Preclinical Drug Development Rebecca Brunette, PhD Scientist, Analytical Biology SNBL USA Preclinical Immunotoxicology The study of evaluating adverse effects
More informationGuidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines. Proposed guidelines
0 0 0 0 WHO/DRAFT/NCE_Adjuvanted vaccines/ April 0 ENGLISH ONLY Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines Proposed guidelines NOTE: This document has been prepared
More informationLondon, 11 October 2006 Doc. Ref. EMEA/CHMP/BWP/271475/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency 1 2 London, 11 October 2006 Doc. Ref. 3 4 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) 5 DRAFT 6 7 GUIDELINE ON POTENCY TESTING OF CELL BASED IMMUNOTHERAPY MEDICINAL
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 22 February 2006 EMEA/CHMP/BMWP/42832/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON SIMILAR
More informationFDA Perspective on the Preclinical Evaluation of Biological Therapies for Cancer
FDA Perspective on the Preclinical Evaluation of Biological Therapies for Cancer Yongjie Zhou, M.D., Ph.D. FDA/CBER/OCTGT/DCEPT Yongjie.zhou@fda.hhs.gov isbtc Global Regulatory Summit October 29, 2008
More informationS9 Nonclinical Evaluation for Anticancer Pharmaceuticals
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create
More informationCOMMITTEE FOR HUMAN MEDICINAL PRODUCTS (CHMP)
European Medicines Agency Evaluation of Medicines for Human Use London, 16 June 2005 EMEA/CHMP/94526/2005 COMMITTEE FOR HUMAN MEDICINAL PRODUCTS (CHMP) ANNEX GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 22 February 2006 EMEA/CHMP/BMWP/94528/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) ANNEX TO GUIDELINE
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 25 July 2002 EMEA/ COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE
More informationGuideline on the use of adjuvanted veterinary vaccines
1 2 3 21 June 2018 EMA/CVMP/IWP/315887/2017 Committee for Medicinal Products for Veterinary Use (CVMP) 4 5 Draft Draft agreed by Immunologicals Working Party (IWP) 01 March 2018 Adopted by CVMP for release
More informationCOMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE 1 : DNA VACCINES NON-AMPLIFIABLE IN EUKARYOTIC CELLS FOR VETERINARY USE
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Veterinary Use CVMP/IWP/07/98-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE 1 : DNA VACCINES
More informationComments and suggestions from reviewer
Comments and suggestions from reviewer Page 1 of 13 Title: WHO Guidelines on the Quality, Safety, and Efficacy of Biological Medicinal Products Prepared by Recombinant DNA Technology: WHO/rDNA_DRAFT/12
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON PHARMACEUTICAL AND BIOLOGICAL ASPECTS OF COMBINED VACCINES
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit London, 23 July 1998 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON PHARMACEUTICAL
More informationConsiderations in Product Development with Advanced Therapies and Cancer Vaccines
Considerations in Product Development with Advanced Therapies and Cancer Vaccines Thomas Hinz Head of Section Therapeutic Vaccines Paul-Ehrlich-Institut hinth@pei.de Thomas Hinz, October 29, 2008, San
More informationMAIN OUTCOMES OF DISCUSSION FROM WHO CONSULTATION ON NUCLEIC ACID VACCINES. I. Knezevic, R. Sheets Feb, 2018 Geneva, Switzerland
MAIN OUTCOMES OF DISCUSSION FROM WHO CONSULTATION ON NUCLEIC ACID VACCINES I. Knezevic, R. Sheets 21-23 Feb, 2018 Geneva, Switzerland CONTEXT OF DISCUSSION WHO Consultation held to determine whether the
More informationRegulations of Biologics in Taiwan
Regulations of Biologics in Taiwan Churn-Shiouh Gau, Ph.D. Executive Director, Taiwan 2013/2/13 1 Outlines Regulation of Drugs in Taiwan - Organizations Regulations for Marketing Approval for Drugs including
More informationInternational Consortium For Innovation & Quality in Pharmaceutical Development
International Consortium For Innovation & Quality in Pharmaceutical Development s on Draft Guidance: FDA Draft Guidance: Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment (draft
More informationGuideline on similar medicinal products containing somatropin. Draft agreed by BMWP March Adopted by CHMP for release for consultation May 2005
28 June 2018 EMEA/CHMP/BMWP/94528/2005 Rev. 1 Committee for Medicinal Products for Human Use (CHMP) Annex to Guideline on similar biological medicinal products containing biotechnology-derived proteins
More informationFDA Draft Guidance on Immunogenicity Testing
FDA Draft Guidance on Immunogenicity Testing Susan Kirshner, Ph.D. Associate Chief, Laboratory of Immunology Division of Therapeutic Proteins OBP/CDER/FDA EBF 2010 Guidance for Industry Assay Development
More information[DOCKET NO. 96N-0400] Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications
[DOCKET NO. 96N-0400] Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications For further information about this document, contact: Valerie A. Butler Center for Biologics
More informationMAINTENANCE OF THE ICH GUIDELINE ON NON-CLINICAL SAFETY STUDIES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS FOR PHARMACEUTICALS M3(R1)
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE MAINTENANCE OF THE ICH GUIDELINE ON NON-CLINICAL
More informationNUVEC. Non-viral adjuvant delivery system for vaccines and cancer treatments. Allan Hey, Head of CMC, N4 Pharma Ltd
NUVEC Non-viral adjuvant delivery system for vaccines and cancer treatments Allan Hey, Head of CMC, N4 Pharma Ltd 1 N4 Pharma plc o Established in 2014 o Listed on Alternative Investment Market (AIM) in
More informationComparative Study of Regulatory Requirements for Biologics Filing in United States and European Union
Comparative Study of Regulatory Requirements for Biologics Filing in United States and European Union Mr. Shashi Kumar Yadav Assistant Professor Sri Indu Institute of Pharmacy Hyderabad Outline Introduction
More informationNovavax RSV F Vaccine is composed of a recombinant near full length F protein
Magnitude and Durability of Anti-F IgG and Palivizumab-Competitive Antibody (PCA) Responses One Year Following Immunization with RSV F Nanoparticle Vaccine Adjuvanted with Aluminum Phosphate, or a Novel
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Evaluation of Medicines for Human Use London, 22 February 2006 EMEA/CHMP/BMWP/32775/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) ANNEX TO GUIDELINE ON SIMILAR BIOLOGICAL
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL BIOSIMILAR MEDICINES QUALITY, NON-CLINICAL AND CLINICAL REQUIREMENTS This guideline is intended to provide recommendations to applicants wishing to submit applications for the
More informationDivision of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm Rockville, MD 20852
Reference No.: FDAA10017 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 VIA WEB SUBJECT: Approval Pathway for Biosimilar and Interchangeable
More informationDRAFT GUIDELINE ON SIMILAR MEDICINAL PRODUCTS CONTAINING RECOMBINANT INTERFERON ALPHA
European Medicines Agency London, 18 October 2007 Doc. Ref. EMEA/CHMP/BMWP/102046/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT GUIDELINE ON SIMILAR MEDICINAL PRODUCTS CONTAINING RECOMBINANT
More informationOral vaccines to protect patients against Clostridium difficile infection
Oral vaccines to protect patients against Clostridium difficile infection Jonathan Kearsey: Leads To Development Antibiotics and their alternatives-fixing and feeding the pipeline Project number: 601810
More informationDoc. Ref. EMEA/CHMP/VWP/141697/2009 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT
European Medicines Agency 1 London, 0 April 00 Doc. Ref. EMEA/CHMP/VWP//00 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT GUIDELINE ON QUALITY, NON-CLINICAL AND CLINICAL ASPECTS OF LIVE RECOMBINANT
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE NON-CLINICAL DEVELOPMENT OF FIXED COMBINATIONS OF MEDICINAL PRODUCTS
European Medicines Agency London, 24 January 2008 Doc. Ref. EMEA/CHMP/SWP/258498/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE NON-CLINICAL DEVELOPMENT OF FIXED COMBINATIONS
More informationA. TRIAL IDENTIFICATION
PROTOCOL INFORMATION ON A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE CONDUCTED IN A THIRD COUNTRY (i.e. a country outside of the EEA) Note: To ensure consistency the numbering of this form is
More informationICH Topic S 6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. Step 5
European Medicines Agency March 1998 CPMP/ICH/302/95 ICH Topic S 6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Step 5 NOTE FOR GUIDANCE ON PRECLINICAL SAFETY EVALUATION OF BIOTECHNOLOGY-DERIVED
More informationGUIDELINES FOR GENERATING PRE-CLINICAL AND CLINICAL DATA FOR r-dna BASED VACCINES, DIAGNOSTICS AND OTHER BIOLOGICALS, 1999
Biotechnology is poised for economic and social progress in the developed and developing countries. The biotechnology research, development and applications are growing at a rapid rate. This would lead
More informationExpectations for Biodistribution (BD) Assessments for Gene Therapy (GT) Products
Expectations for Biodistribution (BD) Assessments for Gene Therapy (GT) Products Approved by the IPRP Management Committee on 3 June 2018 12 April 2018 Table of Contents 1. Position Statement... 3 2. Executive
More informationBiosimilar Monoclonal Antibodies: Registration Requirements. Henry M. J. Leng
Biosimilar Monoclonal Antibodies: Registration Requirements Henry M. J. Leng Disclaimer This presentation is given in my personal capacity and represents only the author s personal views and does not represent
More informationGuide to the investigational medicinal product dossier
Guide to the investigational medicinal product dossier Item type Authors Publisher Other Irish Medicines Board (IMB) Irish Medicines Board (IMB) Downloaded 1-May-2018 07:31:12 Link to item http://hdl.handle.net/10147/96980
More informationInterplay of Cells involved in Therapeutic Agent Immunogenicity. Robert G. Hamilton, Ph.D., D.ABMLI Professor of Medicine and Pathology
Interplay of Cells involved in Therapeutic Agent Immunogenicity Robert G. Hamilton, Ph.D., D.ABMLI Professor of Medicine and Pathology Disclosure The author works with Amicus on an immunogenicity project
More informationLinker p. 177 Helper Lipid p. 178 Delivery to Target Cells p. 180 Cell Entry p. 182 Receptor-Mediated Uptake p. 182 Endosomai Release p.
Overview of Regulatory Expectations for Introducing Novel Therapies into Clinical Trials Introduction p. 1 Roles of Regulatory Scientists p. 2 Product Development and Availability p. 2 Data Requirements
More informationGuideline for the quality, safety and efficacy of follow-on biological medicinal products
Guideline for the quality, safety and efficacy of follow-on biological medicinal products 1. Introduction A follow-on biological medicinal product (hereinafter referred to as FOBMP) is considered as a
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 27 April 2006 CPMP/BPWG/575/99 Rev. 1 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE CLINICAL
More informationFDA Perspective on the Preclinical Development of Cancer Vaccines
FDA Perspective on the Preclinical Development of Cancer Vaccines Richard D. McFarland Ph.D., M.D. Medical Officer CBER/OCTGT/DCEPT mcfarlandr@cber.fda.gov Cancer Vaccine Clinical Trials Workshop Alexandria,
More informationICH Considerations. Oncolytic Viruses September 17, 2009
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH Considerations Oncolytic Viruses September 17, 2009 1. Introduction Oncolytic viruses
More informationNonclinical Data to Support FIH Clinical Trials for Cancer Immunotherapies. Whitney S. Helms, PhD IOM, February 29,2016
Nonclinical Data to Support FIH Clinical Trials for Cancer Immunotherapies Whitney S. Helms, PhD IOM, February 29,2016 Disclaimer The views disseminated in this talk are my own and do not necessarily represent
More informationRecommendations to assure the quality, safety and efficacy of recombinant hepatitis B vaccines
Annex 4 Recommendations to assure the quality, safety and efficacy of recombinant hepatitis B vaccines Replacement of Annex 2 of WHO Technical Report Series, No. 786 and Annex 4 of WHO Technical Report
More informationNew proposal from the EC:
New proposal from the EC: Gene therapy medicinal product means a biological medicinal product which has the following characteristics: a. it contains an active substance which contains or consists of a
More informationAdaptive Immunity: Specific Defenses of the Host
PowerPoint Lecture Presentations prepared by Bradley W. Christian, McLennan Community College C H A P T E R 17 Adaptive Immunity: Specific Defenses of the Host The Adaptive Immune System Adaptive immunity:
More informationVaccines based on Recombinant Proteins and Adjuvant Systems: GSK's malaria vaccine candidate as a case study.
Vaccines based on Recombinant Proteins and Adjuvant Systems: GSK's malaria vaccine candidate as a case study. CMC Forum Vienna May 25-27 Vaccine workshop M.-C. Uwamwezi, Senior scientist Regulatory Affairs,
More informationGuidance for Industry
Reprinted from FDA s website by Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product DRAFT GUIDANCE This guidance document is being distributed for comment
More informationAnnex 4. Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology
Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology Replacement of Annex 3 of WHO Technical Report Series, No. 814 Introduction 177
More informationGuideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics
Provisional Translation (as of April 19, 2013) PFSB/ELD Notification No. 0304007 March 4, 2009 To: Prefectural Health Department (Bureau) From: Evaluation and Licensing Division, Pharmaceutical and Food
More informationPaving the way for Non-Clinical Bioanalytical Partnerships Louise Angell
Paving the way for Non-Clinical Bioanalytical Partnerships Louise Angell Content Overview of non-clinical immunogenicity testing for biologics Regulatory guidance Bioanalytical considerations Risk based
More informationICH CONSIDERATIONS Oncolytic Viruses
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 ICH CONSIDERATIONS Oncolytic Viruses 20 November 2008 EMEA/CHMP/GTWP/607698/2008
More informationDr. S. Harinarayana Rao
Dr. S. Harinarayana Rao Theatre, Indian Habitat Centre, New Delhi July 30 31, 2013 Introduction Classification ICH 6 guidelines Innovative methods RCGM and EMEA Challenges Conclusion What is a biopharmaceutical
More informationIntroduction to clinical trials
Introduction to clinical trials Definition of a clinical trial A research activity that involves administration of a test treatment to some experimental unit in order to evaluate the treatment. Key words
More informationICH Considerations Oncolytic Viruses ONCOLYTIC VIRUSES (EMEA/CHMP/ICH/607698/2008) TRANSMISSION TO CHMP November 2008
European Medicines Agency October 2009 EMEA/CHMP/ICH/607698/2008 ICH Considerations Oncolytic Viruses ONCOLYTIC VIRUSES (EMEA/CHMP/ICH/607698/2008) TRANSMISSION TO CHMP November 2008 TRANSMISSION TO INTERESTED
More informationRegulatory Issues and Drug Product Approval for Biopharmaceuticals
Regulatory Issues and Drug Product Approval for Biopharmaceuticals Vinod P. Shah, Ph. D. FIP Scientific Secretary Biotech 2007 Southern African Regional and International Regulatory Biotechnology Workshop
More informationGuidelines on Similar Biologic: Regulatory Requirements for Marketing Authorization in India
Guidelines on Similar Biologic: Regulatory Requirements for Marketing Authorization in India 1 2 Content Message Foreword 1. Introduction 2. Background & Objectives 3. Applicable Regulations and Guidelines
More informationPharmacology. Chatchai Chinpaisal, Ph.D. Department of Pharmacology and Toxicology, Faculty of Pharmacy, Silpakorn University.
Pharmacology Chatchai Chinpaisal, Ph.D. Department of Pharmacology and Toxicology, Faculty of Pharmacy, Silpakorn University. 1 PHARMACODYNAMIC STUDIES A. Primary pharmacodynamics primary action in target
More informationHarmonizing clinical trials for Biogenerics. Dr. Akhilesh Sharma M.D.;C Clin. Research & P.V. (UCBC - USA & Luton - UK)
Harmonizing clinical trials for Biogenerics Dr. Akhilesh Sharma M.D.;C Clin. Research & P.V. (UCBC - USA & Luton - UK) Senior Vice President & Global Head Global Medical Affairs (C.M.O) Dr. Reddy's Laboratories
More informationRe: Docket No. FDA-2009-D-0006 S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
1201 Maryland Avenue SW, Suite 900, Washington, DC 20024 202-962-9200, www.bio.org April 20, 2009 Dockets Management Branch (HFA-305) Food and Drug Administration 5600 Fishers Lane, Rm. 1061 Rockville,
More informationRegulatory Challenges for the Licensure of Future Vaccines
Regulatory Challenges for the Licensure of Future Vaccines Tong Wu, Ph.D. Bacterial & Combination Vaccine Division, BGTD, Health Canada June 26-29, 2018, Seoul, Korea, the Global Bio Conference 1 Disclaimer
More informationGuideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating
1 2 3 26 July 2018 EMEA/CHMP/BMWP/31329/2005 Rev 1 Committee for Medicinal Product for Human Use (CHMP) 4 5 6 7 Guideline on similar biological medicinal products containing recombinant granulocyte-colony
More informationRSV Vaccine Development Status Update
Photo: PATH/Doune Porter RSV Vaccine Development Status Update WHO RSV Surveillance Pilot 18-20 Dec 2017 Washington DC Deborah Higgins PATH Photo credit CENTER FOR VACCINE INNOVATION AND ACCESS PATH RSV
More informationCLINICAL CONSIDERATIONS FOR EVALUATION OF FOR PREQUALIFICATION 1. Points to consider for manufacturers of human vaccines
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 CLINICAL CONSIDERATIONS FOR EVALUATION OF VACCINES FOR PREQUALIFICATION 1 Points to consider for manufacturers of
More informationDevelopment Stage of Therapeutic Vaccines: The Regulator s View
Development Stage of Therapeutic Vaccines: The Regulator s View Thomas Hinz Head, Section Therapeutic Vaccines Paul Ehrlich Institute, Germany thomas.hinz@pei.de 1 DISCLAIMER This is the personal views
More informationOncology Biopharmaceuticals and Preclinical Development: Evolving Regulatory Challenges
The content of this presentation reflects the opinion of the speaker and does not necessarily represent the official position of CDER Oncology Biopharmaceuticals and Preclinical Development: Evolving Regulatory
More informationGuideline on repeated dose toxicity
18 March 2010 CPMP/SWP/1042/99 Rev 1 Committee for Human Medicinal Products (CHMP) Guideline on repeated dose toxicity Draft Agreed by Safety Working Party May - December 2007 Adoption by CHMP for release
More informationIntroduction to clinical trials Magnus Kjaer
Introduction to clinical trials 2016-01-20 Magnus Kjaer One Definition of Clinical Trial NIH 2014 A research study in which one or more human subjects are prospectively assigned to one or more interventions
More informationImmunogenicity: Impact on the Design of Clinical Trials for Biosimilars
Immunogenicity: Impact on the Design of Clinical Trials for Biosimilars Alexander Berghout, M.D., Ph.D. Head Global Clinical Research and Development Sandoz Biopharmaceuticals BMWP/BWP Workshop on Immunogenicity
More informationModulation of Immune Response in Lambs
Modulation of Immune Response in Lambs A.S. Leaflet R1473 Jose O. Lopez Virella, graduate research assistant, M. L. Kaeberle, professor, veterinary microbiology Mamadou Niang, graduate research assistant.
More informationIntroduction of Development Center for Biotechnology TAIWAN
Introduction of Development Center for Biotechnology TAIWAN DCB Nonprofit Organization Founded in 1984 Funded Mainly by Ministry of Economic Affairs (MOEA), National Science Council and the Industry 394
More informationPreclinical Development of Biologics: Case-by-case, so get off of my case!
Preclinical Development of Biologics: Case-by-case, so get off of my case! Northeast Chapter SOT David Jacobson-Kram, Ph.D., DABT Office of New Drugs Center for Drug Evaluation and Research FDA October
More informationImmunogenicity. How to deal with? Nathalie Macé Sanofi, Biomarkers & Biological analyses Unit
Immunogenicity How to deal with? Nathalie Macé Sanofi, Biomarkers & Biological analyses Unit Club Phase I, 22 March 2016 1 Outline Introduction to immunogenicity Analytical challenges for immunogenicity
More informationINTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE November 2004 Revised June 2009 SEX-RELATED CONSIDERATIONS IN THE CONDUCT OF CLINICAL
More informationICH Topic S 8: "Immunotoxicity Studies for Human Pharmaceuticals"; Umsetzung in die Praxis
ICH Topic S 8: "Immunotoxicity Studies for Human Pharmaceuticals"; Umsetzung in die Praxis Dr. Christoph Specht Scientific Director vivo Science GmbH Fabrikstraße 348599 Gronau Germany lab@vivoscience.de
More informationASSESSING THE EFFICACY AND SAFETY OF NORMAL INTRAVENOUS IMMUNOGLOBULIN PRODUCTS FOR MARKETING AUTHORISATIONS
ASSESSING THE EFFICACY AND SAFETY OF NORMAL INTRAVENOUS IMMUNOGLOBULIN PRODUCTS FOR MARKETING AUTHORISATIONS Guideline Title Assessing the Efficacy and Safety of Normal Intravenous Immunoglobulin Products
More informationGuideline on similar biological medicinal products containing interferon beta
1 2 3 15 December 2011 EMA/CHMP/BMWP/652000/2010 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 Guideline on similar biological medicinal products containing interferon beta 7 Draft Draft
More informationIMMUNOLOGY Receptors of T cells are TCR T Cell Receptors which are present on the cell surface of T lymphocytes.
IMMUNOLOGY - 4 - What is an ANTIGEN? It is a molecule that can be recognized by a receptor and combine with it specifically and the receptor here is the one either produced by B cells or T cells: Receptors
More informationToxicology - Problem Drill 24: Toxicology Studies in Pharmaceutical Development
Toxicology - Problem Drill 24: Toxicology Studies in Pharmaceutical Development No. 1 of 10 1. regulates all the drugs products manufactured and sold in the USA. (A) EMEA (B) IND (C) FDA (D) NDA (E) OSHA
More information参考資料. Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products. Draft
参考資料 1 2 3 4 5 Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products Draft 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Table of contents 1.
More informationPreclinical study. Assist.Prof. Witthawat Wiriyarat Faculty of Veterinary Science, Mahidol University
Preclinical study Assist.Prof. Witthawat Wiriyarat Faculty of Veterinary Science, Mahidol University Overviews Principle of animal use Biological activity/pharmacodynamics Animal species and model selection
More informationNon-clinical Assessment Requirements
Non-clinical Assessment Requirements Presented by: Maria Nieto-Gutierrez Safety and Efficacy of Medicines/Human Medicines Development and Evaluation An agency of the European Union Contents: Relevance
More informationWhat can be done from regulatory side?
Federal Agency for Medicines and Health Products (FAMHP) What can be done from regulatory side? 9th Annual ecopa Workshop November 29-30, 2008, Brussels Dr. Sonja BEKEN Non-Clinical Assessor, Registration
More informationRisk Assessments for Host Cell Protein Control Strategies: CDER Experiences
Risk Assessments for Host Cell Protein Control Strategies: CDER Experiences Laurie Graham FDA/CDER Office of Pharmaceutical Quality (OPQ) Office of Policy for Pharmaceutical Quality (OPPQ) 1 Disclaimer
More informationUpdate on the new immunogenicity guideline in the EU
Update on the new immunogenicity guideline in the EU draft 2016 EBF, Lisbon 27 th September 2016 Venke Skibeli, Senior Scientist, PhD Norwegian Medicines Agency, Member of the CHMP - BMWP, EMA, London
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT GUIDELINE ON THE NON-CLINICAL DEVELOPMENT OF FIXED COMBINATIONS OF MEDICINAL PRODUCTS
European Medicines Agency Pre-Authorisation Evaluation of Medicines for Human Use London, 13 October 2005 Doc. Ref. CHMP/EMEA/CHMP/SWP/258498/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
More informationImplications for Preclinical and Clinical Programs. Novartis Pharmaceuticals Oncology Business Unit June 2, 2011
EU Biosimilarityi il it Guidance Implications for Preclinical and Clinical Programs Shefali Kakar Novartis Pharmaceuticals Oncology Business Unit June 2, 2011 Biologics are more complex than small molecules
More informationScientific Considerations in Demonstrating Biosimilarity to a Reference Product. Guidance for Industry
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
More informationCOMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)
The European Agency for the Evaluation of Medicinal Products EMEA/CVMP/550/02-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) GUIDELINE ON REQUIREMENTS FOR CONCURRENT ADMINISTRATION OF IMMUNOLOGICAL
More informationOSWG s Role in Shaping the Regulatory Development of Oligos - A Potential Model for Moving Forward -
OSWG s Role in Shaping the Regulatory Development of Oligos - A Potential Model for Moving Forward - David H. Schubert VP, Regulatory and Quality Outline What? Background and History Who? How? OSWG Committees
More informationDetection of toxicity to reproduction for human pharmaceuticals. Explanatory slides agreed by EWG members
Detection of toxicity to reproduction for human pharmaceuticals Explanatory slides agreed by EWG members 2 October 2017 International Council for Harmonisation of Technical Requirements for Pharmaceuticals
More informationGuideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg)
23 July 2015 EMA/CHMP/BPWP/410415/2011 rev 1 Committee for Medicinal Products for Human Use (CHMP) Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular
More informationQuality, Safety and Efficacy of Follow-on Biologics
Quality, Safety and Efficacy of Follow-on Biologics Teruhide YAMAGUCHI Division of Biological Chemistry and Biologicals National Institute of Health Sciences 2009.9.28 London Quality, Safety and Efficacy
More informationInterested parties (organisations or individuals) that commented on the draft document as released for consultation.
21 February 2013 EMA/92876/2013 Committee for Medicinal Products for Human Use (CHMP) Overview of comments on 'Guideline on non-clinical and clinical development of similar biological medicinal products
More informationClinical Evaluation Phases 1,2,3,4
Clinical Evaluation Phases 1,2,3,4 Matt Laurens, MD MPH Associate Professor of Pediatrics Center for Vaccine Development Institute for Global Health University of Maryland School of Medicine February 1,
More informationRe: Docket No. FDA-2015-D-1246: Draft Guidance on Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment
July 13, 2015 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2015-D-1246: Draft Guidance on Investigational Enzyme Replacement
More information