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

   
Gas anaesthesia Nitrous oxide Preparation of 16 slide kits and summaries of 25 published papers. Production of internet training course.

ANTI-INFECTIVES

   
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

   
NSAID Generic product Clinical Summary and Overview based on literature

ANTI-VIRAL

   
HIV infection Nucleoside inhibitor Protocol development for 2 studies
HIV infection Combination product Risk/benefit assessment

BLOOD AND SUPPLEMENTAL PRODUCTS

   
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

   
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

   
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

   
Common cold
(3 products)
Combination therapy for symptom relief Updating regulatory dossiers

COMPUTING

   
Electronic data capture - Production of training manuals

DERMATOLOGY

   
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

   
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

   
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

   
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

   
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

   
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

   
Renal dialysis Dialysis infusion Production of clinical trial report
Pruritus Dialysis infusion Production of efficacy summary and Paediatric Investigational Plan

NEUROLOGY

   
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

   
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

   
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

   
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

   
Adult and paediatric supplement Intravenous infusion Production of safety summary

PHASE I

   
General Healthy volunteers Production of over 40 study reports and 4 Investigator Brochures

RESPIRATORY

   
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

   
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

   
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

   
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

   
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

   
Diabetic ulcers Wound care debridement solution Study report
Diabetic ulcers Wound care dressing Study report and 2 papers
Ulcers Graft material Study report