orphan drug

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Orphan Medication Status in Japan (Orphan Item Approvals) Key offerings: Create Technique and Certification to Acquire Orphan Medication Status in Japan Identify regulating path Literature Look for the Industry (the variety of individual and healthcare practice) Identify Unmet Medical Needs for Orphan Products Consultation with KOLs in Japan Negotiate with MHLW (Ministry of Wellness, Work and Welfare) Manage Medical Trials File NDA for Orphan Products Support Integrating Initiatives for Orphan Products Apr 14, 2010 PLC Appointed as JETRO US Medical Business Advisor Pacific-Link Consulting (PLC) ..

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Designating an Orphan Product: Biotechnology and drugs consultant support for The Orphan Drug Act by Pacific-Link Consulting. Contact us: San Diego, CA 92127 Phone: 858-335-1300…

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Page 1: Orphan Drug

Orphan Medication Status in Japan (Orphan Item Approvals)Key offerings: Create Technique and Certification to Acquire Orphan Medication Status in JapanIdentify regulating pathLiterature Look for the Industry (the variety of individual and healthcare practice)Identify Unmet Medical Needs for Orphan ProductsConsultation with KOLs in JapanNegotiate with MHLW (Ministry of Wellness, Work and Welfare)Manage Medical TrialsFile NDA for Orphan ProductsSupport Integrating Initiatives for Orphan Products

Apr 14, 2010PLC Appointed as JETRO US Medical Business AdvisorPacific-Link Consulting (PLC) ..

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Our consultants have particular expertise with obtaining Orphan Drug Designations in Japan and the United States for novel biologics and drugs with a successful track record of approves through the PMDA and FDA. We also specialize in Japanese Bridging Strategies and clinical trial applications in Japan for Orphan Drug products. Pacific-Link is committed to support clients in meeting their business objectives, project milestones and customizes our approach to the needs of the client company.

Orphan Drug

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Pacific-Link Consulting can help the clinical improvement needs for our customer's starting clinical trials. Key offerings: Regulatory Strategy Development and ConsultationJapanese Orphan Drug Designation and Bridging StrategiesMedical and Technical writing for reg. submissions (e.g. CSRs, CMC Sections, Module 2 Summaries)Preparation of electronic Common Technical Dossier (eCTD) applications for submission to Health AuthoritiesInvestigational New Drug Applications (INDs) and Investigational Medicinal Product Dossiers (IMPDs) in the Unites States, Japan and Europe

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Our expert Regulatory staff can develop strategic regulatory plans, facilitate Agency in the United States and Japan.

Key offerings: Orphan Drug & Designation prepare documentsRequest and hold meetings

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Dr. Tanimoto is a pharmaceutical professional with over 15 years of experience in clinical research and development of biotechnology products. She is the Managing Director for Pacific-Link Consulting providing a range of development services to biotechnology and pharmaceutical companies.

Orphan Drug

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Ms. Joyce Reyes is an executive with over 15 years of Regulatory Affairs and Quality Assurance experience in various roles at both small and large biotechnology or pharmaceutical companies. Ms. Reyes has extensive experience in cell and viral production processes and has been in both manufacturing and quality assurance roles prior to joining regulatory groups at various companies.

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Orphan Drug Designation in Japan (Orphan Product Approvals)

· Develop Strategy and Documentation to Obtain Orphan Drug Designation in Japan · Identify regulatory path · Literature Search for the Market (the number of patient and medical practice) · Identify Unmet Medical Needs for Orphan Products · Consultation with KOLs in Japan · Negotiate with MHLW (Ministry of Health, Labor and Welfare) · Manage Clinical Trials · File NDA for Orphan Products

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Full Project ManagementManage Manufacturing site and prepare study drug for clinical trialManage GLP Toxicology StudiesWork with Academia on Preclinical ProgramFDA Interactions and Consultation

Pre-Pre IND ConsultationPre-IND MeetingMultiple informal discussions, consultations and negotiation

Early FDA Interactions and PreIND MeetingFile NIH RACFile INDClear INDPrepare and conduct Phase I/II Stud

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An overview on Japan Orphan DesignationIn Japan, drugs and medical devices could be designated as orphan drugs or medical devices based on the Article 77-2 of the Pharmaceutical Affairs Law. This was in the event that they are expected for use in fewer than 50,000 patients in Japan. For which there is a high medical necessity. They are designated by the Minister of Health, Labor and Welfare based on the idea of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC). •Japan Orphan Designation does not immediately prompt promoting approbation. •The objectives and diagram of the system are described beneath.

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The basis of the designation system

The MHLW Orphan drug/medical apparatus system had establisheddrugs and medical devices to be used for the treatment of troublesome to-treat diseases and (AIDS) had not been sufficiently created. This was despite the high medical needs because the amount of patients was small. With the diversification of open healthcare needs, safe and quality medical products were obliged to be supplied to patients as soon as possible. As needs be, there is a huge increase in rising open expectations and the changing circumstances of drug and medical-mechanism research and improvement. It had been chosen to take special measures to support and push research activities for the advancement of orphan drugs/medical devices.

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Criteria for designation

The Minister of Health, Labor and Welfare may designate drugsand medical devices satisfying the accompanying criteria as orphan drugsmedical devices. This was in the wake of getting applications for Orphan Drug from the applicants. The amount of patients who may use the drug or medical mechanism should be lessthan 50,000 in Japan. The amount of patients could be estimated based on the report of Health and Labor Science Research or the information published by solid scientific societies. The amount of patients with a challenging to-treat disease is sometimes troublesome to estimate correctly because of absence of research on the patient populace.

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Pacific-Link Consulting Services8195 Run of the Knolls CourtSan Diego, CA 92127Phone: 858-335-1300