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製品開発プログラム

Past RFP

GHIT Fund RFP Product Development Platform 2018-002

The GHIT Fund announces an investment opportunity for the development of new medicines, vaccines, diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects should address health needs in the developing world or fill a gap in global health technologies for infectious diseases. The proposed collaboration projects should be no more than two years in duration and may focus on a broad array of R&D activities, including:

 

- Lead optimization

- Preclinical Development (in-vivo studies, formulation development, chemistry and process validation)

- Clinical Development (Phase 1, 2, or 3 studies, manufacturing scale-up)

- Activities to support licensure and WHO prequalification

 

Interested applicants can find detailed information on the RFP and the Intent to Apply form below.


RFP and Intent to Apply

Key RFP Milestone Dates

RFP Release

July 20, 2018

Intent to Apply

No later than 10:00 am Tokyo time on August 10, 2018

Submit via Editorial Manager® for Product Development Platform

(http://www.editorialmanager.com/ghitfund/)

Q&A

No later than 10:00 am Tokyo time on September 3, 2018

Submit questions to RFPResponse@ghitfund.org

Email Subject Line: GHIT-RFP-PD-2018-002_Questions

Full Proposal Due

No later than 10:00 am Tokyo time on September 7, 2018

Submit via Editorial Manager® for Product Development Platform

(http://www.editorialmanager.com/ghitfund/)

Proposals Evaluation and Interview Processes

September 2018 - February 2018

Award Notification to All Applicants

February 2018

Investment Agreement Fully Executed (Awarded Proposals)

March 2018

GHIT Fund RFP Product Development Platform 2018-001

The GHIT Fund announces an investment opportunity for the development of new medicines, vaccines, diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects should address health needs in the developing world or fill a gap in global health technologies for infectious diseases. The proposed collaboration projects should be no more than two years in duration and may focus on a broad array of R&D activities, including:

 

- Lead optimization

- Preclinical Development (in-vivo studies, formulation development, chemistry and process validation)

- Clinical Development (Phase 1, 2, or 3 studies, manufacturing scale-up)

- Activities to support licensure and WHO prequalification

 

Interested applicants can find detailed information on the RFP and the Intent to Apply form below.

 


RFP and Intent to Apply

Key RFP Milestone Dates

RFP Release

January 12, 2018

Intent to Apply

No later than 10:00 am Tokyo time on February 1, 2018

Submit via Editorial Manager® for Product Development Platform (http://www.editorialmanager.com/ghitfund/)

Q&A

No later than 10:00 am Tokyo time on February 19, 2018

Submit questions to RFPResponse@ghitfund.org

Email Subject Line: GHIT-RFP-PD-2018-001_Questions

Full Proposal Due

No later than 10:00 am Tokyo time on February 26, 2018

Submit via Editorial Manager® for Product Development

Platform (http://www.editorialmanager.com/ghitfund/)

Proposals Evaluation and Interview Processes

February 2018 - July 2018

Award Notification to All Applicants

July 2018

Investment Agreement Fully Executed (Awarded Proposals)

August 2018

GHIT Fund RFP Product Development Platform 2017-002

The GHIT Fund announces an investment opportunity for the development of new medicines, vaccines, diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects should address health needs in the developing world or fill a gap in global health technologies for infectious diseases. The proposed collaboration projects should be no more than two years in duration and may focus on a broad array of R&D activities, including:

 

- Lead optimization

- Preclinical Development (in-vivo studies, formulation development, chemistry and process validation)

- Clinical Development (Phase 1, 2, or 3 studies, manufacturing scale-up)

- Activities to support licensure and WHO prequalification

 

Interested applicants can find detailed information on the RFP and the Intent to Apply form below.


RFP and Intent to Apply

Key RFP Milestone Dates

RFP Release

July 25, 2017

Intent to Apply

No later than 10:00 am Tokyo time on August 21, 2017

Submit via Editorial Manager® for Product Development Platform

(http://www.editorialmanager.com/ghitfund/)

Q&A

No later than 10:00 am Tokyo time on August 17, 2017

Submit questions to RFPResponse@ghitfund.org

Email Subject Line: GHIT-RFP-PD-2017-002_Questions

Full Proposal Due

No later than 10:00 am Tokyo time on September 19, 2017

Submit via Editorial Manager® for Product Development Platform

(http://www.editorialmanager.com/ghitfund/)

Proposals Evaluation and Interview Processes

September 2017 - February 2018

Award Notification to All Applicants

February 2018

Investment Agreement Fully Executed (Awarded Proposals)

March 2018

GHIT Fund RFP Product Development Platform 2017-001

The GHIT Fund announces an investment opportunity for the development of new medicines, vaccines, diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects should address health needs in the developing world or fill a gap in global health technologies for infectious diseases. The proposed collaboration projects should be no more than two years in duration and may focus on a broad array of R&D activities, including:

 

- Lead optimization

- Preclinical Development (in-vivo studies, formulation development, chemistry and process validation)

- Clinical Development (Phase 1, 2, or 3 studies, manufacturing scale-up)

- Activities to support licensure and WHO prequalification

 

Interested applicants can find detailed information on the RFP and the Intent to Apply form below.


RFP and Intent to Apply

Key RFP Milestone Dates

RFP Release

October 7, 2016

Intent to Apply

No later than 10:00 am Tokyo time on November 10, 2016

Submit via Editorial Manager® for Product Development Platform

(http://www.editorialmanager.com/ghitfund/)

Q&A

No later than 10:00 am Tokyo time on December 26, 2016

Submit questions to RFPResponse@ghitfund.org

Email Subject Line: GHIT-RFP-PD-2017-001_Questions

Full Proposal Due

No later than 10:00 am Tokyo time on January 13, 2017

Submit via Editorial Manager® for Product Development Platform

(http://www.editorialmanager.com/ghitfund/)

Proposals Evaluation and Interview Processes

January 2017 - July 2017

Award Notification to All Applicants

End of July 2017

Investment Agreement Fully Executed (Awarded Proposals)

Mid-September 2017

GHIT Fund RFP Product Development Platform 2016-002

The GHIT Fund announces an investment opportunity for the development of new medicines, vaccines, diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects should address health needs in the developing world or fill a gap in global health technologies for infectious diseases. The proposed collaboration projects should be no more than two years in duration and may focus on a broad array of R&D activities, including:

- Lead optimization

- Preclinical Development (in-vivo studies, formulation development, chemistry and process validation)

- Clinical Development (Phase 1, 2, or 3 studies, manufacturing scale-up)

- Activities to support licensure and WHO prequalification

Interested applicants can find detailed information on the RFP and the Intent to Apply form below.


RFP and Intent to Apply

Key RFP Milestone Dates

RFP Release

July 1, 2016

Intent to Apply

No later than 10:00 am Tokyo time on July 28, 2016

Submit via Editorial Manager® for Product Development

Platform (http://www.editorialmanager.com/ghitfund/)

Q&A

No later than 10:00 am Tokyo time on August 23, 2016

Submit questions to RFPResponse@ghitfund.org

Email Subject Line: GHIT-RFP-PD-2016-002_Questions

Full Proposal Due

No later than 10:00 am Tokyo time on September 1, 2016

Submit via Editorial Manager® for Product Development

Platform (http://www.editorialmanager.com/ghitfund/)

Award Notification to All Applicants

No later than February 10, 2017

GHIT Fund RFP Product Development Platform 2016-001

The GHIT Fund announces an investment opportunity for the development of new medicines, vaccines, diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects should address health needs in the developing world or fill a gap in global health technologies for infectious diseases. The proposed collaboration projects should be no more than two years in duration and may focus on a broad array of R&D activities, including:

 

- Lead optimization

- Preclinical Development (in-vivo studies, formulation development, chemistry and process validation)

- Clinical Development (Phase 1, 2, or 3 studies, manufacturing scale-up)

- Activities to support licensure and WHO prequalification

 

If you are interested in applying for the platform, please see RFP.


RFP and Intent to Apply

Key RFP Milestone Dates

RFP Release

October 1, 2015

Intent to Apply

No later than 10:00 am Tokyo time on November 16, 2015 Submit via Editorial Manager® for Product Development Platform (http://www.editorialmanager.com/ghitfund/)

Q&A

No later than 10:00 am Tokyo time on December 18, 2015 Submit questions to RFPResponse@ghitfund.org 
Email Subject Line: GHIT-RFP-PD-2016-001_Questions

Full Proposal Due

No later than 10:00 am Tokyo time on January 6, 2016 Submit via Editorial Manager® for Product Development Platform (http://www.editorialmanager.com/ghitfund/)

Award Notification to All Applicants

No later than August 1, 2016

GHIT Fund RFP Product Development Platform 2015-002

The GHIT Fund announces an investment opportunity for the development of new medicines, vaccines, diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects should address health needs in the developing world or fill a gap in global health technologies for infectious diseases. The proposed collaboration projects should be no more than two years in duration and may focus on a broad array of R&D activities, including:

 

- Lead optimization

- Preclinical Development (in-vivo studies, formulation development, chemistry and process validation)

- Clinical Development (Phase 1, 2, or 3 studies, manufacturing scale-up)

- Activities to support licensure and WHO prequalification

 

If you are interested in applying for the platform, please see RFP.


RFP and Intent to Apply

Key RFP Milestone Dates

RFP Release

June 22, 2015

Intent to Apply

No later than 10:00 am Tokyo time on August 5, 2015

Submit via Editorial Manager® for Product Development Platform

 

Q&A

No later than 10:00 am Tokyo time on September 1, 2015

Submit questions to RFPResponse@ghitfund.org

Email Subject Line: GHIT-RFP-PD-2015-002_Questions

Full Proposal Due

No later than 10:00 am Tokyo time on September 9, 2015

Submit via Editorial Manager® for Product Development Platform 

Award Notification to All Applicants

No later than February 12, 2016

GHIT Fund RFP Product Development Platform 2015-001

The GHIT Fund announces an investment opportunity for the development of new medicines, vaccines, diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects should address health needs in the developing world or fill a gap in global health technologies for infectious diseases. The proposed collaboration projects should be no more than two years in duration and may focus on a broad array of R&D activities, including:

 

- Lead optimization

- Preclinical Development (in-vivo studies, formulation development, chemistry and process validation)

- Clinical Development (Phase 1, 2, or 3 studies, manufacturing scale-up)

- Activities to support licensure and WHO prequalification

 

If you are interested in applying for the platform, please see RFP.


RFP and Intent to Apply

Key RFP Milestone Dates

RFP Release

February 6, 2015

Intent to Apply
No later than 10:00 am Tokyo time on March 13, 2015
 
Q&A
No later than 10:00 am Tokyo time on March 30, 2015
Submit questions to RFPResponse@ghitfund.org
Email Subject Line: GHIT-RFP-PD-2015-001_Questions
Full Proposal Due
No later than 10:00 am Tokyo time on April 3, 2015
Award Notification to All Applicants

No later than August 1, 2015

GHIT Fund RFP Product Development Platform 2014-002

The GHIT Fund announces a funding award opportunity for the development of new medicines, vaccines, or diagnostics for neglected tropical diseases (NTDs) that are prevalent in the developing world. Proposed projects should address NTD-related health needs in the developing world or fill a gap in global health technologies focused on NTDs. 

 

In April 2014, the GHIT Fund endorsed the 2012 London Declaration on Neglected Tropical Diseases and joined its signatories, representing NGOs, pharmaceutical companies, government agencies, and academic-research sectors, in commitment to the eradication, elimination, and control of NTDs in the world’s poorest populations. In line with this commitment, This RFP will focus specifically on “Combatting Neglected Tropical Diseases (NTDs)."

(For your referernce; www.ghitfund.org/about/mediacenter/pressdetail/detail/81)

 

The proposed collaboration project may include R&D activities from pre-clinical research (post-lead optimization) through licensure. More specifically, we seek to fund a portfolio of innovative collaboration projects, such as:

      ■ Pre-clinical development (e.g., lead-optimization, in-vivo studies, formulation development, chemistry and process validation)

      ■ Clinical development (e.g., Phase 1, Phase 2, Phase 3, manufacturing scale up)

      ■ Activities to support licensure and WHO pre qualification 

 

If you are interested in applying for the grant, please download RFP related documents.


RFP and Intent to Apply

Key RFP Milestone Dates

RFP Release

13th June, 2014

Intent to Apply

From 10:00am Tokyo Time on 16th June, 2014

To 10:00 am Tokyo Time on 18th August, 2014

Submit GHIT RFP 2014-002 Intent To Apply using our online submission system (http://www.editorialmanager.com/ghitfund/)

Q&A

Submit Questions to RFPResponse@ghitfund.org no later than 11th September, 2014.

Email Subject Line: GHIT Fund-RFP-2014-002 Questions

Full Proposal Due

No later than 10:00 am Tokyo Time on 18th September, 2014

Award Notification to All Applicants

No later than 16th February, 2015

GHIT Fund RFP Product Development Platform 2014-001

The GHIT Fund announces a funding award opportunity for the development of new medicines, vaccines, diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects should address health needs in the developing world or fill a gap in global health technologies for infectious diseases. The proposed collaboration project may include R&D activities from pre-clinical research (post-lead optimization) through licensure. More specifically, we seek to fund a portfolio of innovative collaboration projects, such as:

  • ・Pre-clinical development (e.g., lead-optimization, in-vivo studies, formulation development, chemistry and process validation)
  • ・Clinical development (e.g., Phase 1, Phase 2, Phase 3, manufacturing scale up)
  • ・Activities to support licensure and WHO prequalification

If you are interested in applying for the grant, please download RFP related documents.


RFP and Intent to Apply

Key RFP Milestone Dates

RFP Release

February 3, 2014

Intent to Apply

10:00 am March 17, 2014
Submit GHIT_RFP_IntentToApply.doc to RFPResponse@ghitfund.org
Email Subject Line: GHIT-RFP-2014-001 Intent to Apply

Q&A

Submit Questions to RFPResponse@ghitfund.org
no later than 10:00 am April 7, 2014
Email Subject Line: GHIT-RFP-2014-001 Questions

Full Proposal Due

10:00 am Tokyo Time April 15, 2014

Award Notification to All Applicants

No later than September 1, 2014

GHIT Fund RFP Product Development Platform 2013-002

The GHIT Fund announces a funding award opportunity for the development of new medicines, vaccines, diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects should address health needs in the developing world or fill a gap in global health technologies for infectious diseases. The proposed collaboration project may include R&D activities from pre-clinical research (post-lead optimization) through licensure. More specifically, we seek to fund a portfolio of innovative collaboration projects, such as:

  • ・Pre-clinical development (e.g., lead-optimization, in-vivo studies, formulation development, chemistry and process validation)
  • ・Clinical development (e.g., Phase 1, Phase 2, Phase 3, manufacturing scale up)
  • ・Activities to support licensure and WHO prequalification

If you are interested in applying for the grant, please download RFP related documents.


RFP and Intent to Apply

GHIT Fund RFP Product Development Platform 2013-001

The GHIT Fund announces a funding award opportunity for the development of new medicines, vaccines, diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects should address health needs in the developing world or fill a gap in global health technologies for infectious diseases. The proposed collaboration project may include R&D activities from pre-clinical research (post-lead optimization) through licensure. More specifically, we seek to fund a portfolio of innovative collaboration projects, such as:

  • ・Pre-clinical development (e.g., lead-optimization, in-vivo studies, formulation development, chemistry and process validation)
  • ・Clinical development (e.g., Phase 1, Phase 2, Phase 3, manufacturing scale up)
  • ・Activities to support licensure and WHO prequalification

If you are interested in applying for the grant, please download RFP related documents.


RFP and Intent to Apply

|製品開発投資のプロセス

process1

申請者

Intent to Apply Formの提出

公募案件 (RFP)へ申請を希望する機関は、RFPの応募期間内に、Editorial Manager® (オンラインシステム)からIntent to Apply (ITA) Formの提出が必須となります。上記の方法で提出がなされなかったITA Formまたはプロポーザル (申請書)は、受け付けることはできません。ITA Formは、公募案件の内容が決定次第、GHIT Fundのウェブサイトにおいて公表されます。
※Intent to Applyとは、プロポーザルを提出する前の段階で、GHIT Fundの公募案件に対して申請する意志をGHIT Fundに伝えることを指します。ITAの審査は、各RFP毎に個別かつ単独で行われているため、複数回応募、あるいは提出後の取り消しが以後のRFPにおける審査に影響を及ぼすことはありません。

process2

GHIT Fundマネジメントチーム

事前審査

ITA Formを提出した申請者には、受理確認のメールが送られます。GHIT Fundマネジメントチームは、提出されたITA Formの内容が申請要件の研究対象に沿ったものであるかを確認し、申請内容が申請要件に沿っていない場合は、申請プロジェクトの内容が審査対象外であることが申請者に伝えます。指定された提出期限までに問題点を改善した場合には、ITA Formの再提出が可能です。

process3

申請者

プロポーザルの提出

申請者は必要事項を記入し、定められた期限までにEditorial Manager®からプロポーザルを提出することが求められます。提出されたプロポーザルを修正することはできません。プロポーザル提出後は以下のような基準に基づいてGHIT Fundマネジメントチームが事前審査を行います。Proposalの審査は、各RFP毎に個別かつ単独で行われているため、複数回応募、あるいは提出後の取り消しが以後のRFPにおける審査に影響を及ぼすことはありません。

  • パートナーシップは、GHIT Fundの資格基準を満たしているか
  • プロジェクトの目的は、RFPに明記された研究対象の範囲に沿ったものであるか
  • プロポーザル一式がすべて揃い、書類に不備がないか

process4

外部審査員

プロポーザルの評価

事前審査を通過したプロポーザルは、少なくとも3名の外部審査員によって評価が行われます。外部審査員とは、グローバルヘルスR&Dに精通し、客観的な基準に基づきプロポーザルを評価することができる専門家で、申請者との個人的、専門的、金銭的関係がないことを事前に書面で宣言することが求められます。外部審査員は、以下のような基準に基づいてプロポーザルを評価します。

  • 科学的、および技術的価値(Scientific and technical merit)
  • 生み出されるインパクト(Potential impact)
  • パートナーシップとプロジェクトマネジメント(Partnership and project management)

process5

選考委員会

インタビューの実施と投資案件の推薦

外部審査員による評価の集計結果とGHIT Fundの選考委員会の評価に基づき、各案件は評価スコアによって順位付けされます。その中から、上位の申請者が選考委員とのインタビューに招待されます。選考委員会はプロポーザルと製品開発の計画を評価の上、理事会に対して推薦する投資案件を選定します。

process6

理事会

審議・承認

選考委員会により選定された案件は、その後理事会によって審議され投資案件の承認へと進みます。理事会はポートフォリオ戦略を考慮した上で、リスクを最小限に抑えるために、マイルストーンに基づいて投資を行います。

process7

GHIT Fundマネジメントチーム&製品開発パートナー

審査結果通知・契約締結・投資

理事会での承認後、GHIT Fundマネジメントチームからすべての申請者に対して、メールにて選考結果を通知します。採択された案件の申請者は、採択通知が届いてから1ヶ月以内に、全製品開発パートナー署名済みのGHIT Fundとの契約書、並びに、各パートナーの役割と責任が明確に定義されたパートナー間の共同研究開発契約書をGHIT Fundに提出する必要があります。これらの条件が満たされない場合には契約が無効になる可能性がありますのでご注意ください。申請者は、製品開発パートナーの中から、代表機関(投資受領機関)を選択する必要があります。代表機関はプロジェクトの成果に対する責任を負い、代表機関における責任者は連絡窓口として、GHIT Fundとのコミュニケーションを行います。

process8

GHIT Fundマネジメントチーム

モニタリングと評価の開始

契約を締結しプロジェクトが開始すると、GHITマネジメントチームはモニタリングと評価を開始します。プロジェクトに関するデータと情報がシステム上で管理されます。

process9

GHIT Fundマネジメントチーム&製品開発パートナー

モニタリングと評価

投資案件の進捗状況を把握するため、GHIT Fundは年に2回、全ての投資案件の進捗確認を実施します。これにより、各案件におけるマイルストーンの達成度を確認し、投資の継続、変更、または終了の決定を行います。このモニタリングと評価を通じて、製品開発パートナーはウェブサイト上のシステムを用いて進捗報告を提出し、その報告をもとに、GHIT Fundマネジメントチームとの電話会議を行います。