Amgen
Amgen is a biotechnology pioneer committed to discovering, developing, manufacturing, and delivering innovative human therapeutics. Focused on high unmet medical needs, Amgen leverages advanced genetics and biologics manufacturing to improve health outcomes worldwide. Since 1980, it has grown into the world's largest independent biotech company, reaching millions of patients and developing a pipeline of potential breakthrough medicines.
Industries
Nr. of Employees
Very Large (1000+)
Amgen
Thousand Oaks, California, United States, North America
Products
PCSK9‑inhibiting monoclonal antibody (LDL-C lowering)
A fully human monoclonal antibody that binds PCSK9 to increase LDL receptor availability and reduce LDL-C levels; developed for subcutaneous administration with multiple dosing regimens and studied across Phase 2/3 and extension trials.
IL‑17 receptor‑targeting monoclonal antibody for plaque psoriasis
A human monoclonal antibody that binds the IL‑17 receptor to inhibit signaling from multiple IL‑17 ligands; developed for subcutaneous administration and evaluated in pivotal Phase 3 psoriasis trials.
Bispecific T‑cell engager immunotherapy constructs for B‑cell malignancies
Bispecific constructs designed to engage cytotoxic T cells and target B‑cell antigens; evaluated in Phase 2 and confirmatory studies for relapsed/refractory and minimal residual disease settings and progressed to regulatory approval in defined indications.
Peptibody angiopoietin/Tie2 pathway inhibitor for oncology
A peptibody developed to bind angiopoietin-1 and -2 and inhibit interaction with the Tie2 receptor; evaluated in intravenous oncology dosing schedules and Phase 3 studies.
Proteasome inhibitor regimen for relapsed multiple myeloma
Intravenous proteasome inhibitor evaluated in combination regimens for relapsed multiple myeloma; demonstrated improvement in progression-free survival in a randomized Phase 3 study.
HGF/MET pathway‑targeting monoclonal antibody candidate (development terminated)
A monoclonal antibody developed to inhibit HGF/MET signaling that underwent clinical evaluation in advanced gastric cancer and was discontinued following independent safety review.
PCSK9‑inhibiting monoclonal antibody (LDL-C lowering)
A fully human monoclonal antibody that binds PCSK9 to increase LDL receptor availability and reduce LDL-C levels; developed for subcutaneous administration with multiple dosing regimens and studied across Phase 2/3 and extension trials.
IL‑17 receptor‑targeting monoclonal antibody for plaque psoriasis
A human monoclonal antibody that binds the IL‑17 receptor to inhibit signaling from multiple IL‑17 ligands; developed for subcutaneous administration and evaluated in pivotal Phase 3 psoriasis trials.
Bispecific T‑cell engager immunotherapy constructs for B‑cell malignancies
Bispecific constructs designed to engage cytotoxic T cells and target B‑cell antigens; evaluated in Phase 2 and confirmatory studies for relapsed/refractory and minimal residual disease settings and progressed to regulatory approval in defined indications.
Peptibody angiopoietin/Tie2 pathway inhibitor for oncology
A peptibody developed to bind angiopoietin-1 and -2 and inhibit interaction with the Tie2 receptor; evaluated in intravenous oncology dosing schedules and Phase 3 studies.
Proteasome inhibitor regimen for relapsed multiple myeloma
Intravenous proteasome inhibitor evaluated in combination regimens for relapsed multiple myeloma; demonstrated improvement in progression-free survival in a randomized Phase 3 study.
HGF/MET pathway‑targeting monoclonal antibody candidate (development terminated)
A monoclonal antibody developed to inhibit HGF/MET signaling that underwent clinical evaluation in advanced gastric cancer and was discontinued following independent safety review.
Services
Clinical development services (Phase 1–4)
End-to-end clinical development including protocol design, multicenter execution, randomization, blinding, data collection and long-term extension studies for programs of varying scale.
Regulatory submission and compliance support for biologics
Preparation of regulatory dossiers, management of orphan and expedited designation processes, and engagement with health authorities for BLA/MAA submissions.
Biologics manufacturing and supply chain support
Manufacturing strategy, CMC development and scale-up to support clinical and commercial supply for antibody- and protein-based therapeutics.
Safety monitoring and pharmacovigilance services
Active safety surveillance, adverse event collection and regulatory reporting, including management plans for therapy‑specific risks such as cytokine release syndrome and neurological toxicities associated with immunotherapies.
Scientific communications and regulatory publication support
Preparation of manuscripts, conference posters and oral presentations, and coordination of medical affairs activities to disseminate clinical and translational data.
Development support for bone-targeted biologics and skeletal complication indications
Preclinical-to-clinical development, dosing strategy, and regulatory support for therapies that target osteoclast-mediated bone resorption to treat hypercalcemia of malignancy and prevent skeletal-related events.
Clinical development services (Phase 1–4)
End-to-end clinical development including protocol design, multicenter execution, randomization, blinding, data collection and long-term extension studies for programs of varying scale.
Regulatory submission and compliance support for biologics
Preparation of regulatory dossiers, management of orphan and expedited designation processes, and engagement with health authorities for BLA/MAA submissions.
Biologics manufacturing and supply chain support
Manufacturing strategy, CMC development and scale-up to support clinical and commercial supply for antibody- and protein-based therapeutics.
Safety monitoring and pharmacovigilance services
Active safety surveillance, adverse event collection and regulatory reporting, including management plans for therapy‑specific risks such as cytokine release syndrome and neurological toxicities associated with immunotherapies.
Scientific communications and regulatory publication support
Preparation of manuscripts, conference posters and oral presentations, and coordination of medical affairs activities to disseminate clinical and translational data.
Development support for bone-targeted biologics and skeletal complication indications
Preclinical-to-clinical development, dosing strategy, and regulatory support for therapies that target osteoclast-mediated bone resorption to treat hypercalcemia of malignancy and prevent skeletal-related events.
Expertise Areas
- Clinical trial management
- Biologic therapeutics development (monoclonal antibodies and peptibodies)
- Bispecific T-cell engager immunotherapy
- Oncology and hematology drug development
Key Technologies
- Monoclonal antibodies
- Bispecific T-cell engager constructs
- Peptibody (peptide–Fc fusion) therapeutics
- PCSK9 pathway inhibition