Therapeutic Area Experience
Work & Therapeutic Area Experience
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NAME: Debbie Jordan
POSITION: Medical Writer and Clinical Research Consultant
Therapeutic area / Indication |
Summary of Product Type |
Work carried out |
ANAESTHETICS |
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| Gas anaesthesia | Nitrous oxide | Preparation of 16 slide kits and summaries of 25 published papers. Production of internet training course. |
ANTI-INFECTIVES |
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| Hospital acquired infection | Macrocyclic antibiotic | Production of Clinical Summary, Clinical Overview and other documents for US and EU submissions |
| Hospital acquired infection | Macrocyclic antibiotic | Production of Briefing Books for three Scientific Advice meetings (EU and US) |
| Acne | Topical antibiotic | Production of Clinical Summary and Clinical Overview for submission |
| Acne | Topical antibiotic | Production of clinical trial report |
| Urinary tract infections (3 studies) |
Quinolone antibiotic | Clinical protocol development and production of clinical trial reports |
| Multiple indications (12 studies) |
Beta-lactam antibiotic | Protocol writing, project management, writing final reports |
| General | Beta-lactam antibiotic | Writing Investigator brochure then yearly updates |
| General | Beta-lactam antibiotic | Expert report for submission |
| General | Beta-lactam antibiotic | Integrated summaries of safety and efficacy |
| Multiple indications (8 studies) |
Carbapenem antibiotic | Protocol writing, project management, writing final reports |
| General | Carbapenem antibiotic | Investigator brochure |
| Urinary tract infections | Quinolone antibiotic | Production of clinical trial report |
| Pneumonia | Quinolone antibiotic | Production of clinical protocol, 2 interim reports and final clinical study report |
| Fungal infections | Anti-fungal therapy | Production of clinical study report and manuscript for publication |
| Pneumonia | Penicillin | Production of clinical trial report and manuscript for publication |
| Urethritis | Quinolone antibiotic | Production of protocol and clinical trial report |
| General | Antimicrobial resistance | Production of 2 manuscripts |
| Respiratory infections | Sustained release antibiotic | Investigator brochure |
ANTI-INFLAMMATORY |
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| NSAID | Generic product | Clinical Summary and Overview based on literature |
ANTI-VIRAL |
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| HIV infection | Nucleoside inhibitor | Protocol development for 2 studies |
| HIV infection | Combination product | Risk/benefit assessment |
BLOOD AND SUPPLEMENTAL PRODUCTS |
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| Haemostasis post-surgery (3 studies) |
Fibrin glue | Production of protocols, investigator brochure and final study reports |
| Parenteral nutrition | IV nutrition post-surgery | Production of Safety Summary for CTD |
CARDIOVASCULAR |
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| Raynaud's syndrome | Topical vasodilator | Production of clinical trial report |
| Hypertension (2 papers) | Angiotensin II antagonist | Production of manuscripts for publication |
| Hypertension | Angiotensin II antagonist | Patient narratives |
| Hypertension | Angiotensin II antagonist | Integrated summary of safety and MRP responses |
| Hypertension | Angiotensin II antagonist | Production of manuscript for publication |
| Hypertension | Aldosterone antagonist | 9 slide kits based on study reports |
| Hypertension | Angiotensin II antagonist | Investigator brochure and CTX |
| Hypertension | Angiotensin II antagonist | Project management of regulatory submission process and writing clinical summary and overview documents |
| Acute coronary syndromes | Registry | Production of manuscript for publication |
| Thrombosis | Low molecular weight heparin | Production of 25 slide kits |
| Thrombosis | Low molecular weight heparin | Production of 2 manuscripts for publication |
| Angina | New class | Clinical summary and overview (CTD format) |
| Cardiovascular disease | Imaging | 4 case reports for publication |
| Hypertension | Angiotensin II antagonist | Production of Briefing Book for Scientific Advice meeting |
| Hypertension | Angiotensin II antagonist | 16-page supplement for British Journal of Cardiology |
| Hypertension | Angiotensin II antagonist | Large Phase IV outcomes study |
CNS |
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| Sedative (3 studies) | Sedative/hypnotic/anxiolytic drug | Phase I protocol development |
| Parkinson's disease | Oral therapy | Patient narratives |
| Parkinson's disease (3 studies) |
Oral therapy | Protocol development |
| Parkinson's disease | Nasal delivery system | Production of 2 study reports |
COLD REMEDIES |
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| Common cold (3 products) |
Combination therapy for symptom relief | Updating regulatory dossiers |
COMPUTING |
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| Electronic data capture | - | Production of training manuals |
DERMATOLOGY |
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| Facial lines | Neurotoxin | Production of 2 clinical study reports and 18 manuscripts for publication |
| Facial lines | Neurotoxin | Production of 11 abstracts and 7 posters for conferences |
DIABETES |
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| Diabetes | Oral therapy | Production of 4 clinical study reports |
| Diabetes | - | Production of two sections for book on diabetes (sections on PK and treatment options) |
| Diabetes | Oral therapy | Production of 2 phase I clinical study reports |
| Diabetes | Injectable insulin | Production of 2 clinical study reports and 2 manuscripts |
GASTROINTESTINAL |
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| Laxatives | Oral therapy | 2 manuscripts |
| Ulcerative colitis | Oral therapy | Production of clinical summary |
| Ulcerative colitis | Oral therapy | Production of clinical study report and clinical summary |
| Constipation | Oral therapy | Protocol development |
| Constipation | Oral therapy | Paediatric Investigational Plan |
HORMONE THERAPY |
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| Hormone replacement therapy (2 studies) |
HRT patch vs oral therapy | Production of clinical study reports |
| Hormone replacement therapy (2 papers) |
HRT patch vs oral therapy | Production of manuscripts for publication |
| Hormone replacement therapy | HRT patch | Production of clinical study report, Clinical Summary and Clinical Overview for CTD submission |
HYPERCHOL-ESTEROLAEMIA |
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| High cholesterol (3 studies) |
Oral therapy | Production of phase I reports |
| High cholesterol | Oral therapy | Production of clinical study report (phase III) |
| High cholesterol | Oral therapy | Production of clinical summary for CTD submission |
| High cholesterol (2 studies) |
Oral therapy | Production of 2 study reports |
HYPERHIDROSIS |
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| Axillary sweating (2 studies) |
Neurotoxin | Production of clinical trial reports, integrated summaries of efficacy and safety |
| Sweating | Neurotoxin | Preparation of 13 manuscripts and a consensus paper for publication |
NEPHROLOGY |
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| Renal dialysis | Dialysis infusion | Production of clinical trial report |
| Pruritus | Dialysis infusion | Production of efficacy summary and Paediatric Investigational Plan |
NEUROLOGY |
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| Spasticity | Neurotoxin | Production of 18 manuscripts for publication |
| Spasticity | Neurotoxin | Production of 20+ summaries of publications as sales detail aids |
| Tics | Neurotoxin | Production of 2 manuscripts for publication |
| Headache | Neurotoxin | Production of clinical trial report and 4 manuscripts |
| General | Neurotoxin | Production of 5 papers for journal supplement |
| General | Neurotoxin | Production of 6 abstracts and posters for conferences |
ONCOLOGY |
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| Lung cancer | Chemotherapy | Production of clinical trial report |
| Breast cancer | Monoclonal antibody | Conference report |
| Colorectal cancer | Chemotherapy | Production of manuscript for publication |
| Breast cancer | Cisplatin chemotherapy | Project management of phase I and II programme |
| Bladder, ovarian and lung cancer (3 studies) | Cisplatin chemotherapy | Clinical protocol development and production of clinical trial reports |
| General | Cisplatin chemotherapy | Investigator brochure |
| Bladder and lung cancer (2 studies) |
Photodynamic therapy | Clinical protocol development and production of clinical trial reports |
| Bone marrow transplants | Cytokine therapy | Clinical protocol development and production of clinical trial report |
| Myelosuppression | Cytokine therapy following chemotherapy | Project management of phase I and II programme (12 studies) |
| Breast cancer | Chemotherapy | Production of clinical trial report |
| Breast cancer | Chemotherapy | Review of current treatments |
| Lung cancer | Chemotherapy | Review of current treatments |
| Metastatic cancer | Chemotherapy | Production of 2 clinical trial reports |
| Rhabdomyosarcoma | Chemotherapy | Production of clinical trial report |
| Ewings sarcoma/PNET/DSRT | Chemotherapy | Production of clinical trial report |
| Leukaemia | Chemotherapy | CTD summaries |
| Prostate cancer | Chemotherapy | Protocol development |
| Prostate cancer | Diagnostic test | Protocol development |
| Breast cancer | General | Review paper for nurses |
| Breast cancer | Chemotherapy | Clinical Overview |
OPHTHALMOLOGY |
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| Dry eye disease (2 studies) |
Eye drops | Production of two study reports |
| Glaucoma | Eye drops | Production of Clinical Summary (CTD format) |
| Glaucoma | Eye drops | Production of Clinical Summary (CTD format) |
PAIN |
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| Sprains | Topical gel | Production of 2 clinical trial reports |
| Dental pain relief | Oral painkiller | Production of clinical trial report |
| Pain associated with itching | Topical gel | Production of clinical study report |
| Sprains and contusions | Topical gel | Protocol development |
PARENTERAL NUTRITION |
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| Adult and paediatric supplement | Intravenous infusion | Production of safety summary |
PHASE I |
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| General | Healthy volunteers | Production of over 40 study reports and 4 Investigator Brochures |
RESPIRATORY |
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| Asthma (4 studies) | Oral vs inhaled drug | Production of clinical trial reports. Abstract and slides for conference |
| COPD | Inhaler | Production of clinical trial report |
SOPs |
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| Producing 2 sets of SOPs for 2 European offices of US companies | ||
| Updating clinical and regulatory SOPs for CRO | ||
| Producing integrated set of US/European SOP | ||
| Production of new SOPs based on European Clinical Directive | ||
SURGERY |
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| Liver transplant surgery | Haemostatic drug + device system | Clinical protocol development |
| Knee replacement surgery | Haemostatic drug + device system | Clinical protocol development |
| Hip replacement surgery | Haemostatic drug + device system | Clinical protocol development |
| Liver transplant surgery | Anti-rejection drug | Coding of data |
| Local anaesthetic for minor surgery | Injectable | Production of 2 clinical study reports |
UROLOGY |
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| Benign prostatic hyperplasia (2 studies) |
Oral drug therapy | Production of clinical trial reports |
| Benign prostatic hyperplasia | Oral drug therapy | Updating Investigator Brochure |
| Benign prostatic hyperplasia | Oral drug therapy | Production of clinical trial report |
| Urological devices | - | Book on the urological devices market |
| Urinary incontinence | Neurotoxin | Preparation of manuscript and conference abstract and poster |
VACCINES |
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| Flu vaccine | - | Production of 3 protocols and an Investigator Brochure |
| Herpes vaccines | - | Production of protocol, 2 clinical trial reports and an Investigator Brochure |
| Hepatitis vaccines | - | Production of 2 protocols |
WOUND CARE |
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| Diabetic ulcers | Wound care debridement solution | Study report |
| Diabetic ulcers | Wound care dressing | Study report and 2 papers |
| Ulcers | Graft material | Study report |