Clinical Support

 

Clinical Support

Almac Diagnostic Services has a dedicated medical team of 14 staff led by Professor Richard Kennedy, Global VP and Medical Director. Professor Kennedy is GMC registered and a Fellow of the Royal College of Physicians. He is registered under CLIA, CAP and CLEP as a medical lab director.

(1) Clinical Testing

Almac can provide medical support for the setup and delivery phases of clinical trials including

  • Review of assays to ensure appropriate application prior to and during patient testing 
  • Assessment of medical risks associated with use of clinical assays
  • Review of Patient Information and Consent forms
  • Medical support for Pharma partners and clinical trial sites during the study

(2) Pathology

Almac have a team of Pathologists who can deliver

  • Histopathological review of clinical samples to ensure they are appropriate type & quality for specific assays
  • Estimation of tumour, necrotic, stromal and normal content
  • Mark-up of samples to allow macrodissection

(3) Commercial Support

As part of the commercialisation activities for CDx Programmes, Almac’s Medical team:

  • Support pharmaceutical partners in the planning for product launch
  • Oversee the building of a dedicated medical affairs team to support commercialisation of the CDx

(4) Clinical Education

Almac’s Medical Team has appointed and managed several Scientific Advisory Boards in Colon, Breast and Ovarian Cancer with KOLs and have engaged with Patient Advocacy Groups to inform product development and meet market requirements.

They have also worked with co-operative groups such as EORTC, NSABP, SWOG and CALGB to support assay development and publications.

Publications

Some examples of key publications Almac Diagnostic Services has been involved in:

Validation of the DNA Damage Immune Response Signature in Patients With Triple-Negative Breast Cancer From the SWOG 9313c Trial

In-depth Clinical and Biological Exploration of DNA Damage Immune Response as a Biomarker for Oxaliplatin Use in Colorectal Cancer

Activation of STING-Dependent Innate Immune Signaling By S-Phase-Specific DNA Damage in Breast Cancer

Molecular Subgroup of Primary Prostate Cancer Presenting with Metastatic Biology

DNA Repair Deficiency in Breast Cancer: Opportunities for Immunotherapy

Immune Activation by DNA Damage Predicts Response to Chemotherapy and Survival in Oesophageal Adenocarcinoma

Activation of MAPK signaling results in resistance to saracatinib (AZD0530) in ovarian cancer

Results of a phase II clinical trial of 6-mercaptopurine (6MP) and methotrexate in patients with BRCA-defective tumours

Defining an IBD-like subgroup in consensus molecular subgroups of colorectal cancer and transcriptomic biomarker development for at-risk patients.

A Novel Role for Cathepsin S as a Potential Biomarker in Triple Negative Breast Cancer

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