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Davies et al. Lipidome Analysis in Brain and Peripheral Plasma Following Milk Fat Globule Membrane Supplementation in Rodents. Mol Nutr Food Res
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Bolger et al. Evaluation of an increased strut porosity silicate‐substituted calcium phosphate, SiCaP EP, as a synthetic bone graft substitute in spinal fusion surgery: a prospective, open‐label study. Eur Spine J
Harrison et al. Increasing the incidence of drain‐free day‐case mastectomies with the use of a fibrin tissue sealant; data from a single surgical center in the United Kingdom. Breast J
Mokawem et al. Lumbar interbody fusion rates with 3D-printed lamellar titanium cages using a silicate-substituted calcium phosphate bone graft. J Clin Neuriscience
Fellström et al. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet
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Emmanual et al. Constipation in older people: A consensus statement. Int J Clinical Practice
Berlin et al. EP3/FP dual receptor agonist ONO-9054 administered morning or evening to patients with open-angle glaucoma or ocular hypertension: results of a randomised crossover study. Br J Ophthalmol
Everson et al. Sofosbuvir With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection. Annals Intern Med
Lawitz et al. A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1–4 hepatitis C virus. Journal of Viral Hepatitis
Molina et al. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. Lancet
Planko et al. Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection. Annals Int Med
Smucker et al. Assessment of sicap-30 in a rabbit posterolateral fusion model with concurrent chemotherapy. The Iowa Orthopaedic Journal
Eastell et al. Morning vs evening dosing of the cathepsin K inhibitor ONO-5334: effects on bone resorption in postmenopausal women in a randomized, phase 1 trial. Osteoporos Int
Suto et al. Safety,Tolerability,and Pharmacokinetic Profile of the Novel Translocator Protein 18kDa Antagonist ONO-2952 in Healthy Volunteers. Clin Therap
Vidall et al. Impact and management of chemotherapy/radiotherapy-induced nausea and vomiting and the perceptual gap between oncologists/oncology nurses and patients: a cross-sectional multinational survey. Supportive Care in Cancer
Eastell et al. Effect of ONO‐5334 on Bone Mineral Density and Biochemical Markers of Bone Turnover in Postmenopausal Osteoporosis: 2‐Year Results From the OCEAN Study. J Bone Mineral Res
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Zhang et al. The efficacy and safety of ropinirole prolonged release tablets as adjunctive therapy in Chinese subjects with advanced Parkinson’s disease: A multicenter, double-blind, randomized, placebo-controlled study. Parkinsonism and Related Disorders
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Lopez et al. Eight weeks of supplementation with a multi-ingredient weight loss product enhances body composition, reduces hip and waist girth, and increases energy levels in overweight men and women. J Int Soc Sports Nut
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Emtestam et al. Treatment of distal subungual onychomycosis with a topical preparation of urea, propylene glycol and lactic acid: results of a 24-week, double-blind, placebo-controlled study. Mycoses
Faergemann. Kerasal nail clinical studies demonstrate early visible improvement in nails damaged by onychomycosis. Podiatry Management
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Thomas et al. Chronic Treatment with the Dipeptidyl Peptidase-4 Inhibitor BI 1356 [(R)-8-(3-Amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione] Increases Basal Glucagon-Like Peptide-1 and Improves Glycemic Control in Diabetic Rodent Models. J PHARMACOL EXP THERAP
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Thomas et al. (R)-8-(3-Amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione (BI 1356), a Novel Xanthine-Based Dipeptidyl Peptidase 4 Inhibitor, Has a Superior Potency and Longer Duration of Action Compared with Other Dipeptidyl Peptidase-4 Inhibitors. J PHARMACOL EXP THERAP
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Gunthorpe et al. Characterization of SB-705498, a Potent and Selective Vanilloid Receptor-1 (VR1/TRPV1) Antagonist That Inhibits the Capsaicin-, Acid-, and Heat-Mediated Activation of the Receptor. J PHARMACOL EXP THERAP
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MacManus et al GW433908/ritonavir once daily in antiretroviral therapy-naive HIV-infected patients: absence of protease resistance at 48 weeks. AIDS
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Standing et al. Changes in referral patterns to cardiac out-patient clinics with ambulatory ECG monitoring in general practice. Br J Cardiol
Cass et al. The bioavailability of the novel nonnucleoside reverse transcriptase inhibitor GW420867X is unaffected by food in healthy male volunteers. J Clin Pharmacol
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McDowell et al. Exacerbation Profile and Risk Factors in a Type-2–Low Enriched Severe Asthma Cohort: A Clinical Trial to Assess Asthma Exacerbation Phenotypes. Am J Resp Crit Care Med
Hardman et al. Changes to working practices in medical communications during the COVID-19 pandemic: Insights from two surveys. Medical Writing
Harrison et al. Impact of the COVID-19 Pandemic on Clinical Trial Conduct: Lessons for the Future. f1000Research
Nar et al. Action of Dipeptidyl Peptidase‐4 Inhibitors on SARS‐CoV‐2 Main Protease. ChemMedChem
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Efimov et al. The effect of azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19): an open-label, multicentre, interventional clinical study. Drugs Context
Hardman et al. Challenges of working from home during the COVID-19 pandemic: A survey to inform working practices. Medical Writing
Heaney, et al. Composite type-2 biomarker strategy versus a symptom–risk-based algorithm to adjust corticosteroid dose in patients with severe asthma: a multicentre, single-blind, parallel group, randomised controlled trial. Lancet Respiratory Medicine
Hardman et al. Ten tips for promoting your research. Cardiovasc Endocrinol Metab
Rengelshausen et al. How to Interpret an Investigator’s Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum.
Tancoš et al. Programmed death ligand 1 protein expression, histological tumour differentiation and intratumoural heterogeneity in pulmonary adenocarcinoma. Pathology
Kahn et al. The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting October 2019: Impending Change, Innovation, and Future Challenges. Front Pharmacol
Rodriguez‐Mañas et al. Effectiveness of a multimodal intervention in functionally impaired older people with type 2 diabetes mellitus. J Cachexia, Sarcopenia Muscle
Breithaupt-Grögler et al. The New First-in-Human EMA Guideline: Disruptive or Constructive? Outcomes From the First EUFEMED Discussion Forum. Front Pharmacol
Hardman et al. European Federation for Exploratory Medicines Development Lyon Conference 2019: The Changing Landscape of Early Medicines Development—Be Prepared. Frontiers Pharmacol
Hanratty et al. A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial. Trials
Van Bortel et al. EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management. Frontiers Pharmacol
Reijntjes et al. The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting 2018: Brexit and Other Challenges in Early Phase Drug Development. Frontiers Pharmacol
Hardman and Serginson. Ready! Aim! Fire! targeting the right medical science journal. J Cardiovasc Endocrinol
Heaney et el. Research in progress: Medical Research Council United Kingdom Refractory Asthma Stratification Programme (RASP-UK). Thorax
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Dubrey et al. Sarcoidosis: The links between epidemiology and aetiology. Medical Journal
Rodriguez‐Mañas et al. An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes - the MID-Frail study: Study protocol for a randomised controlled trial. Trials
Hardman and Dubrey. New therapies in the management of type 2 diabetes. Br J Hosp Med
Wierzbicki et al. New therapies to reduce low-density lipoprotein cholesterol. Current Opin in Cardiol
Doyle et al. Midodrine: use and current status in the treatment of hypotension. Br J Cardiol
Dubrey et al. Cardiovascular medication in women and urinary continence. Geriatric Med
Wierzbicki et al. Drugs in development for the management of dyslipidaemia. Future Prescriber
Wierzbicki et al. Inhibition of pre-protein convertase serine kexin-9 (PCSK-9) as a treatment for hyperlipidaemia. Expert Opin Inv Drugs
Wierzbicki et al. New lipid-lowering drugs: An update. Int J Clin Prac
Hardman and Dubrey. Development and potential role of Type-2 sodium-glucose transporter inhibitors for management of type 2 diabetes. Diabetes Ther
Hardman et al. Sodium-Glucose Co-transporter 2 inhibitors: From apple tree to ‘sweet pee’.Current Pharma Design
Wierzbicki et al. Future challenges for microsomal transport protein inhibitors. Curr Vasc Pharmacol
Weirzbicki et al. Clinical aspects of the management of HIV lipodystrophy. Br J Diab Vasc Dis
Wierzbicki et al. HIV lipodystrophy and its metabolic consequences: Implications for clinical practice. Current Med Res Opin
Moore et al. Pharmacokinetics and tolerability of GW420867X, a Nonnucleoside Reverse Transcriptase Inhibitor, following Single Escalating Doses in Healthy Male Volunteers. Journal of Clinical Pharmacology
Wierzbicki et al. The Apolipoprotein E2 Allele Modulates Activity and Maximal Velocity of the Sodium–Lithium Countertransporter. Am J Hypertens
Hardman et al. Correction for the adverse influence of sodium-potassium cotransport on apparent sodium-lithium countertransport activity in human erythrocytes. J Pharmacol Tox Meth.
Falcoz et al. Pharmacokinetics of GW433908, a prodrug of amprenavir, in healthy male volunteers. J Clin Pharmacol
Hardman and Purdon. The cardiological complications associated with HIV infection and acquired immune deficiency syndrome (AIDS). Br J Cardiol
Hardman and Lunnon. The current status of antihypertensive treatments: into the new millennium. Expert Opin in Pharmacother
Moore et al. Pharmacokinetics and safety of escalating single and repeat oral doses of GW420867X, a novel non-nucleoside reverse transcriptase inhibitor. Europ J Clin Pharmacol
Moore et al. Pharmacokinetics and tolerability of profile of GW420867X, a non-nucleoside reverse transcriptase inhibitor, following single escalating doses in healthy male volunteers. J Clin Pharmacol
Wierzbicki et al. Relation between sodium–lithium countertransport and hypertriglyceridemia in Type V hyperlipidemia.Am J Hypertens
Hardman et al. Erythrocyte sodium-lithium countertransport in African American women. J Hum Hypertens
Hardman and Noble. Apolipoprotein E gene polymorphism and sodium-lithium countertransport activity. Metabolism
Hardman et al. Sodium-lithium countertransport activity is linked to chromosome 5 in baboons. Hypertens
Dubrey and Hardman. Natriuretic peptides and heart failure: diagnosis, prognosis and treatment. Br J Cardiol
Wierzbicki et al. Effects of lipids in patients with familial hypercholesterolaemia on the kinetics of the sodium-lithium countertransporter. J Hum Hypertens
Hardman et al. Urinary retinol binding protein (RBP) excretion and erythrocyte sodium-lithium countertransport (SLC) activity in a cohort of healthy normotensive subjects. J Hum Hypertens
Hardman et al. Enhanced activity of the sodium lithium countertransporter in patients with cardiac syndrome X: a potential link between cardiac syndrome X and metabolic syndrome X. J Am Coll Cardiol
Wierzbicki et al. Transport of phytanic acid on lipoprotein in Refsum’s disease. J Inherited Metab Dis
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Hardman et al. Erythrocte Na+/Li+ countertransport and Na+/K+ -2Cl- co-transport in essential Hypertension
Wierzbicki et al. Na,Li-Countertransport and ethnicity. American Journal of Hypertension
Hardman et al. Erythrocyte sodium lithium countertransport (SLC) activity and retinol binding protein (RBP) in healthy normotensive subjects. Clin Sci
Hardman et al. Urinary retinol binding protein (RBP) excretion and erythrocyte sodium-lithium countertransport (SLC) activity in a cohort of healthy normotensive subjects. J Hum Hyperten
Hardman et al. Characterization of the erythrocyte sodium-lithium countertransporter; limitations and assumptions of traditional and kinetic methodologies. J Memb Biol
Hardman et al. Influence of plasma phytanic acid levels in Refsum’s disease on the behaviour of the erythrocyte membrane sodium-lithium countertransporter. Euro J Clin Inves
Hardman et al. Erythrocyte Na+/Li+ countertransport and Na+/K+ -2Cl- co-transport in essential hypertension. Clin Sci
Hardman et al. Kinetic characteristics of the erythrocyte sodium-lithium countertransporter in black normotensive subjects compared with other ethnic groups. J Hum Hypertens
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Chalkley et al. Reductions in blood lead in school children since the phase-down of the use of lead in petrol. Clinical Science
Chalkley et al. Iron deficiency in a cohort of school children living within the inner-city London area. Clinical Science
Hardman et al. Comparison of traditional and bicarbonate lithium loading methods on the characteristics of the sodium-lithium countertransporter (SLC). Clin Sci
Wierzbicki et al. Transport of phytanic acid on lipoproteins in Refsum’s disease. Clin Sci
Wierzbicki et al. Sodium-lithium countertransport in patients with Refsum’s disease. Clin Sci
Chalkley et al. Effects of exposure to lead and cadmium on metabolism of vitamin D3 in smelter workers. Clin Sci
Hardman et al. Influence of plasma phytanic acid levels in Refsum’s disease on the behaviour of the erythrocyte membrane sodium-lithium countertransporter. Clin Sci
Wierzbicki et al. Triglyceride not insulin resistance principally determines sodium-lithium countertransport activity in patients with hyperchylomicronaemia. Am J Hypertens
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Hardman et al. Erythrocyte sodium-lithium countertransport (SLC) activity and retinol binding protein (RBP) excretion in healthy normotensive subjects. Clin Sci
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Tim established Niche Science & Technology in 1998 following a number of
years in clinical trials research and medical writing. From the
beginning, Niche represented Tim’s vision for a different kind of
company, one in which talented scientist-writers are directly involved
in clients’ projects. More recently, Niche expanded its repertoire to
include project management, which now represents a significant and
growing part of the company’s activities.
A hands-on and highly inspirational leader, Tim radiates a determination
born of many years’ training on the athletics track, and the same desire
for success displayed in his sporting career pervades every aspect of
his working life.
Tim retains the scientific bent and inquiring mind that emerged from his
academic training in pharmacology, and he continues to be a prolific
writer, publishing widely cited papers on his favoured area of diabetes
in prestigious journals.
An indefatigable individual, Tim’s drive and commitment has made Niche
the successful company that it is today and a respected name in medical
communications.
Ammar has been the Business Manager and IT supervisor at Niche for the
last 6 years. During this time, he has been responsible for coordinating
client projects and managing office systems. He also ensures the smooth
running of company software and hardware and is our point of contact for
all IT issues.
Ammar has a broad range of experience which comes from running his own
website development and post-production business. This has brought
valuable skills to Niche and an alternative perspective to much of what
our company does.
With a distinctly positive approach to problems and the energy and
humour he brings to the office, Ammar’s dynamism makes an invaluable
contribution to the success of Niche.
Karen has spent her professional career working in the pharmaceutical
industry in both contract research organisations and blue chip pharma
companies. Over this time Karen has become a vastly experienced clinical
research project manager. She has been involved in various stages of the
development of biopharmaceutical and chemical compounds. Karen excels at
hands-on trial coordination of early phase studies in a variety of
therapeutic areas. Through her extensive knowledge of regulations and
thoroughness in her work, clients have come to rely on her for support
during regulatory and due diligence audits. Over the last 4 years Karen
has also been involved with the management of our in-house quality and
training systems, ensuring we meet ICH GCP and EU clinical trials
directive requirements.
Away from work, Karen’s varied interests include logic puzzles and cake
decorating (our team particularly appreciate the cakes). Something not
many people know about her is that she is also a prolific knitter who
now proudly sports a winter coat that took a full 3 months to
produce.
Perhaps the most wonderful quality that Karen displays is her practical
common sense which, when coupled with calmness in the face of pressure
and her incredible attention to detail, makes her a safe pair of hands
for any project.
An experienced and accomplished medical writer, Justin has been working
at Niche Science & Technology since 2001, and has been Head of Medical
Writing since 2008. He previously worked at one of the top global
pharmaceutical companies, writing and submitting manuscripts, and as a
Senior Medical Writer at a large CRO. As Head of Medical Writing, Justin
manages the workflow, budgets and output quality of the writing group,
while mentoring newer members of the team.
Unbeknownst to most people, Justin lives on a smallholding with pigs,
chickens and bees, and regularly brings in produce to share with his
colleagues.
There is nothing Justin likes better than a glass of homebrewed cider,
which whets his appetite for his favourite pastimes including watching
rugby, cooking (multiple bird roast anyone?) and tramping over the
Brecon Beacons.
Justin exudes approachability, and is an ever-present source of
managerial support and organisational skills.
Ruth has been Finance Manager at Niche for 7 of the last 10 years,
managing company accounts, contracts and invoicing. She also deals with
all aspects of payroll and employee records. In recent years, she has
been in charge of maintaining quote and contract trackers, and she has
developed and implemented comprehensive financial and budgetary
monitoring systems for forecasting company budgets.
A trained biologist with an honours degree in pharmacology from King’s
College London, as a postgraduate Ruth conducted research in the
anti-inflammatory and anti-nociceptive fields and published several
peer-reviewed papers on these subjects.
Ruth’s talents extend beyond the lab and something not many people know
about her is that she is an extremely proficient exponent of the
bassoon, achieving Grade 8 at a young age and playing with the Richmond
Youth Symphony Orchestra, while on the sporting front her competitive
side has been known to emerge when playing on the Wii with her three
sons.
At Niche we adopt a set of cultural values that are inherent to
everything we do. These translate into a dedication to service that is
appreciated by our clients and our colleagues. These values not only
drive our professional and personal interactions, but also serve to
inspire our team to achieve our single most important differentiator -
our clients' satisfaction.
Our Values
Integrity: We do what is right for our clients
and colleagues, striving to treat every individual with care and
respect.
Commitment: We apply our dedication, extensive experience and passion to
fulfil the needs of our clients.
Teamwork: We use collaborative approaches to fully engage and exploit the
industry experience contained within both client and Niche teams to
deliver client requirements.
Learning: We embrace the opportunity to learn new and creative ways of
fulfilling the needs of our own clients. We share winning practices and
coach for success.
Professionalism: We uphold the highest ethical standards and collectively we take
responsibility for our actions.
Empowerment: We generate success through personal initiative, skills
development and mutual support.
Satisfaction: True job satisfaction derives from
the knowledge that you have had the opportunity to fully engage your
skill set to deliver an excellent piece of work.
Ayad was born in Baghdad and obtained his Bachelor’s degrees in Medicine
and Surgery from Baghdad Medical School.
Ayad was the first to use a therapeutic antibody to treat cancer. After
his PhD in Cancer Immunotherapy from Southampton University, he worked
at the Children’s Bone Marrow Transplantation Unit, Westminster Hospital
conducting pioneering work in children with Leukaemia’s and various
genetic disorders.
For the last 20 years Ayad has led Global Clinical Development and
Medical Affairs of several drugs and vaccines, working in the US,
Switzerland and the EU and has been involved in over 300 clinical
trials.
For more information on Ayad's career
see here...