Presentation - Phase 1 & BA/BE Process Flow

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Info Kinetics

Timelines, Regulatory Process

Gesundheit & Medizin Technologie Business

Info Kinetics Sdn Bhd /Clinical Research Centre Connecting Research & People Phase 1 Study BA/BE Study May 2010 These materials are CONFIDENTIAL and PROPRIETARY and for your review only. This presentation is subject to revision as required as new information is obtained. Please respect the sensitive nature of this document by limiting its distribution, protecting the contents and refraining from making additional copies.

Full Services Under One Roof Pantai Hospital Penang Data Management & Reporting Protocol Development BE Study Phase 1 Study IRB / IEC Applications Bioanalytical Regulatory Applications Subject/Patient

Quality Milestones Info Kinetics is the first CRO is Pan-Asia to achieve ISO9001:2000 and OECD GLP accreditation 2003-2004 2005-2006 2007-2008 2009-2010 2001-2002 ,[object Object]

GCP Inspection by French regulatory authorities (Afssaps)

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Regulatory Compliance in Pharmaceutical Development: GLP & GMP Jeffrey G. Sarver, Ph.D. MBC 3100 March 8, 2016 email questions to: [email protected] * Food and Drug Administration (FDA)Agency of U.S. Department of Health and Human Services (HHS)Protect public health and provide essential public servicesOther HHS agencies include: CDC, NIH, Medicare/MedicaidFDA responsible for assuring safety and efficacy of: Human Drugs - Center for Drug Evaluation and Research (CDER)Veterinary Drugs - Center for Veterinary Medicine (CVM)Biological Agents - Center for Biologic Evaluation and Research (CBER)Medical Devices - Center for Devices and Radiological Health (CDRH)Food/Supplements/Cosmetics - Center for Food Safety and Applied Nutrition (CFSAN) Manufacture Market Drug NDA FDA Review Clinical Trials I, II, III IND FDA Review Preclinical Testing Drug Discovery Drug Development/Approval ProcessIND – Investigational New Drug application (3-6 yr, $5M-$10M)FDA Approval → Proceed into Clinical Trials (~30% from preclinical tests)Clinical Hold → Collect More data or End DevelopmentNDA – New Drug Application (9-12 yr, $500M-$1B)FDA Approval → Drug Enters Market (~8% from preclinical tests)Not Approved → More Data or Adjust Application or End Development Basic Research + Target Discovery Preclinical Testing RequirementsMechanism of Action (in vitro) and Efficacy (in vivo)General Toxicology: Single and Repeated Dose (in vivo)Genotoxicity/Mutagenicity (in vitro/in vivo)Carcinogenicity (in vivo)Reproductive Toxicology/Teratology (in vivo)ADME (in vitro)/Pharmacokinetics (in vivo)Additional Safety TestingCore: Cardiovascular (hERG), Respiratory, CNSOther tests as needed based on structure, mechanism, general tox Additional Information for INDChemistry, Manufacturing, and Controls (CMC)Structure, physical propertiesSynthetic method and scale-upPurity, identification of impuritiesDosage form/route, formulation, preparation, packagingClinical Study ProtocolsPrevious Human Experience (if available) FDA Guidance Documents Information on suggested: testing methods, analyzing and summarizing data Can be found at: http://www.fda.gov/RegulatoryInformation/Guidances/Searching can be difficult/tedious, use appropriate filters:Product → Drugs (or Biologics)FDA Organization → CDER (or CBER)Document Type → Guidance DocumentsExample Guidance Documents available on Blackboard:Genotoxicity TestingCardiotoxicity (hERG) TestingChemistry, Manufacturing, and Controls (CMC) for Phase I DrugMaximum Safe Starting Dose for Clinical Testing International Council on Harmonization (ICH)Harmonize procedures for evaluating/reporting safety, efficacy, CMC in multiple regions/countriesRegulators and industry representatives from participating regions collaborate to generate internationally acceptable guidelinesImprove efficiency of drug testing/reporting requirements for approval in multiple countriesOriginally Europe, Japan, U.S.Other countries adopting IC ...

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