'19.08.06, ̿Ǿ
ͳġȯڿ ο ġ ȸ !
- ÷Ƿ ÷ܹ̿Ǿǰ 82 ȸ ȸ
- å Ʒ Ƿ ġ
- ä ÷ܹ̿Ǿǰ ֱ ü
(ľó) ÷ܹ̿Ǿǰ ֱ ü - ռǾǰ ٸ ÷ܹ̿Ǿǰ Ư µ ä롤˻硤ó ϴ ü 㰡 żϰ, ÷ܹ̿Ǿǰ ǰ 㰡 Ⱓ ǹȭմϴ.
÷ܹ̿Ǿǰ : ִ ․ Ǵ ڸ ̿Ǿǰ, ÷Ƿ ǰȭ (ġ, ġ, ) - , ÷ձ ǰ ʱ з ϰ, ġ ȯڵ ġ ȸ Ȯ븦 Ͽ ÷ܹ̿Ǿǰ ո 㰡・ɻü մϴ.
÷ܹ̿Ǿǰ ո 㰡・ɻü : ( ɻ) ߾ 㰡ڷḦ ̸ ɻ (켱 ɻ) ٸ Ǿǰ 켱Ͽ ɻ (Ǻ 㰡) ߴ ȯ ȯ Ǵ 쿡 Ͽ ġ Ȯ(3) ӻ 2 ӻ ڷ 㰡
() å Ʒ Ƿ ӻ ǽ ü - ܱ ӻ Ͽ ϴ ȯ ġ ġϴ 쿡 Ƿ ġ ϴ.
÷Ƿ: ü ̿Ͽ ջ ⸦ ġᡤü Ǵ Ű Ƿ - ӻ ǻ åӰ ȯ Ǹ ñ, , ȿ Ҽ ȸ ɻ縦 ľ ϸ, ηκ Ƿ ǽ մϴ.
- ȯ θ Ͽ ̻ , ӻ ǹȭ, 豺 Ⱓ ƴ å Ʒ ߡ ü ǹȭ
- Ƿ ߱ ȯ ɼ ϱ ȯڿ ӻ û ˴ϴ.
ǽ Ƿ ȯڿ û (10)
(KoBIA) ѱ̿Ǿǰȸ - ÷ܹ̿ (ռǾǰ ߽) ü Ͽ Ǵ ǰ㰡 ü踦 ÷ܹ̿Ǿǰ Ư ´ ü ϰ, 㰡ɻ ȭϸ, ä ܰ ˴ϴ.
- ϰ 1 ĺ ˴ϴ. ǰǾǰó Ǻδ ü Ͽ, ȯڵ ȯ濡 Ϸ ġȸ ֵ ּ ȹ̸, ѱ̿Ǿǰȸ , Ģ ļġ Կ ־ ǰ ݿ ֵ â Դϴ.
- 2019 3 ΰ ǥ () Ǿǰ డ ȡ üȭϿ () Ǿǰ ؿ ο ϴ ϰ, ǰ ȸ Ǵ 1ȸ븸 ִ ûǰ 1ȸ Ǵ ȸ ż ϴ Ÿ Ϻ ̺ Ϸ
ֿ
- . () Ǿǰ డ ( ǥ1 2ȣ )
- . ǰ ȸ Ǵ 1ȸ븸 ִ ̳ ûǰ 1ȸ Ǵ ȸ
ż( ǥ1 2ȣ (2)())
- . ( ǥ1 4ȣ)
(1) ؿ ϴ 쿡 డ (2) ռ․Ǿǰ Ⱓ 1 ϰ, ȸ 3 Ⱓ
ִ2 (3) 翡 Ⱓ ϴ ȸ Ǹ 2 ѵ
Ⱓ
- Ǿǰ ӻ ǽñ ٷΰ
- ӻüм Ȳ ٷΰ
- ӻ() ٷΰ
- üǰ ؼ ('19-29ȣ) 'üǰ ؼ ħ' ٷΰ
CAR-T ġ Ŵ 㰡ɻ ڷ (ǰ ӻ)2019. 7. ǰǾǰ * image reference: MayoClinicNews ȿ 鿪 븮ǥ (Surrogate marker)2019. 7. ǰǾǰ * image reference: National Hog Famer CFZ533 / ı ִ ȯ ܿ CFZ533 뷮 ȿ ϱ 48, 6, , , ٱ ӻ(TWINSS) / ѱƼ() / 2019-07-30 / 2 ؿ ӻ (clnicaltrials.gov 2019.07.30~2019.08.05)
<̱> Drug: CUE-101 / A Phase 1 Study in Patients With HPV+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma / Head and Neck Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Carcinoma / Cue Biopharma / NCT03978689 / Phase 1 70
ؿ 㰡 (clnicaltrials.gov 2019.07.16~2019.07.22)
<̱> NubeqaNDA #212099 / darolutamide / Ź /BAYER HEALTHCARE PHARMACEUTICALS INC / 07/30/2019 TURALIONDA #211810 / PEXIDARTINIB / Ź / DAIICHI SANKYO INC / 08/02/2019
<> Cufence / Trientine dihydrochloride /Hepatolenticular Degeneration / 25/07/2019
LysaKare / L-Arginine Hydrochloride, L-Lysine
Hydrochloride / Radiation Injuries / 25/07/2019
2019 ICH ̵ ǰǾǰ KoBIA(ѱ̿Ǿǰȸ), KRPIA ְ Quality α & ! <Ÿ >- Big C 2019 ̿õ ۷ι ۷, ۵þ 庼, 8 20(ȭ) 9 [Click]
- Biosafety Verification System of Biologics GMP facility Workshop 2019, зϾ ưȣ, 8 21() 14[Click]
- 4 ô, ǰ Ȳ 㰡 , ѱ̿ȸ, 8 22() 14 [Click]
- CPhI Korea 2019, ڿ,8 21()~23() [Click]
KoBIA ȸ ȫ ȳ [Click] - [-DIA] ICH Workshop, ư, 9 6() [Click]
# ž α (CIDD Program) - CIDD : Consulting for Innovative Drug Development
- ()óžళ
- Ⱓ: 2019 7 15()~8 23()
+ Dynamic BIO [̿Ǿ ȹ] ۷ιа + Ϻ ȭƮƮ ġ ػ ַλ ϰ ֽϴ. ǰ ϴ ַλ ֽø ȸ ֵ ġ ȹԴϴ. ǰ ۺθ û 帳ϴ. ( yejikoh@kobia.kr / edu@kobia.kr ) |
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