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Welcome to the Drug and Biologics Development Committee

Mission

The purpose of this committee is to provide opportunities to drug researchers, developers and service providers through collaboration, networking and education.

Events

Watch here for upcoming events!

Information


Developers
(select company name to access web site)

Research

Target Identification (ID) or Validation (V)

Compound  Screening 

Pre-IND & Regulatory Planning

Preclinical Testing

Formulation and Pilot Production

IND Preparation

Clinical Trials
(PI –III)

UO DESIGNMEDIX (Malaria, infx dz) DESIGNMEDIX
(Malaria,infx dz)
DESIGNMEDIX (Malaria, infx dz) DESIGNMEDIX (Malaria, infx dz) NAJIT TECHNOLOGIES (Vaccine dvlpmnt) PROVIDENCE (Oncology) SIGA
 (Phase 1, infx disease)
OHSU SIGA
(Infx dz - biodefense)
SIGA
(Infx dz - biodefense)
SIGA
(Infx dz)
SIGA
(Infx dz - biodefense)

ARTIELLE (Celiac Disease) PROVIDENCE (Phase 1-2, oncology)
PROVIDENCE (Oncology) OTRADI
(Infx dz, oncology, etc.)
OTRADI
(Infx dz, oncology, etc.)
OTRADI
(Infx dz, oncology, etc.)
OTRADI
(Infx dz, oncology, etc.)


ARTIELLE (M.S., Phase 1)
DESIGNMEDIX (Malaria, infx dz) VIROGENOMICS (Cancer, RSV)
KINONE (Oncology) KINONE (Oncology)


SIGA
(Infx dz - biodefense)


UbiVac
(Cancer)
ARONORA (stroke, heart attack, sepsis)


OTRADI
(Infx dz, oncology, etc.)


ARONORA (Stroke, heart attack, sepsis) PROVIDENCE (Oncology)





PROVIDENCE (Oncology) NAJIT TECHNOLOGIES (Vaccine dvlpmnt)





NAJIT TECHNOLOGIES (Vaccine dvlpmnt) ARTIELLE (Uveitis, Stroke)





IDBiopharma (Biodefense, anti-virals) NPI (Stroke)


Research

Target Identification (ID) or Validation (V)

Compound Screening

Pre-IND & Regulatory Planning

Preclinical Testing

Formulation and Pilot Production

IND Preparation

Clinical Trials
(PI –III)

BASi UO (ID) OHSU
BSR/PKCORE
Microrite BASi OHSU BSR/PKCORE (Testing only) GZP BASi
(Assays and kits)

OHSU (ID)
Phase1two3 OSHU
(Non-GLP)
SYNTHETECH
(chemistry process dvlpmnt & opt)
Microrite CTI
(Clinical CRO)



GZP GZP
(Strategic planning)
Lacamas Laboratories (Chem. production) Phase1two3 OHSU
(Clinical site)



Harris Group Inc (Quality Systems Integration)
BASi
(Testing)
Harris Group Inc (CMC/IMPD preparation) SYNTHETECH (Chemistry process dvlpmnt & opt)





Harris Group Inc (Process and Facility design)
GZP
(Strategic planning)







Harris Group Inc
(Processes & Facility Engineering)


Development Stage - Independent Service Providers

Staffing Services


Business and Legal Services

Facility Support


Regulatory Support

  • Ground Zero Pharmaceuticals (Strategic Planning for nonclinical, CMC, Clinical; Medical Writing; submission preparation; FDA representation; Audits)

  • Harris Group Inc (Quality Systems Integration, IND/CMC Assistance, Validation Master Planning)