Publications with acknowledged Niche Science & Technology Contributions

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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

2014
2013
2012
2011
2010
2009

Fuchs et al. Concentration-dependent plasma protein binding of the novel dipeptidyl peptidase 4 inhibitor BI 1356 due to saturable binding to its target in plasma of mice, rats and humans. J Pharmacy Pharmacol

Rungby. Inhibition of dipeptidyl peptidase 4 by BI-1356, a new drug for the treatment of beta-cell failure in type 2 diabetes. Expert Opin Investig Drugs

Klein et al. The challenge of developing novel pharmacological therapies for non-alcoholic steatohepatitis. Liver Int

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

Daley-Yates et al. Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two dry-powder inhalers delivering a combination of salmeterol 50 ug and fluticasone proprionate 250 ug: Implications of establishing bioequivalence of inhaled products. Clin Therap

Williams et al. Effects of food and antacids on the pharmacokinetics of eltrombopag in healthy adult subjects: Two single-dose, open-label, randomized-sequence, crossover studies. Clini Therap

Jenkins et al. Eltrombopag, an oral thrombopoietin receptor agonist, has no impact on the pharmacokinetic profile of probe drugs for cytochrome P450 isoenzymes CYP3A4, CYP1A2, CYP2C9 and CYP2C19 in healthy men: a cocktail analysis. Eur J Clin Pharmacol

Pulido et al. Long-Term Efficacy and Safety of Fosamprenavir plus Ritonavir Versus Lopinavir/Ritonavir in Combination with Abacavir/Lamivudine over 144 Weeks. HIV Clin Trials

Lister et al. Pharmacokinetics, Safety, and Tolerability of Ascending Doses of Sublingual Fentanyl With and Without Naltrexone in Japanese Subjects. J Clin Pharmacol

2008
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2004

Barnett et al. A placebo-controlled crossover study comparing the effects of nateglinide and glibenclamide on postprandial hyperglycaemia and hyperinsulinaemia in patients with type 2 diabetes. Diab, Ob Metab

Gathe et al. SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients. AIDS

Currie et al. Evaluation of the future supply and demand for blood products in the United Kingdom National Health Service. Transfusion Med

McEwan et al. Evaluating the performance of the Framingham risk equations in a population with diabetes. Diabet Med

Evans et al. Should we routinely measure a proxy for insulin resistance as well as improve our modelling techniques to better predict the likelihood of coronary heart disease in people with type 2 diabetes? For debate. Diab, Ob Metab

Currie et al. The financial costs of hospital care for people with diabetes who have single and multiple macrovascular complications. Diab Res Clin Prac

Currie et al. Comparative estimates of the financial burden to the UK health system of hospital care for people with and without diabetes in the year before death. Diab Res Clin Prac

Wood et al. A 42-week open-label study to assess the pharmacokinetics, antiretroviral activity, and safety of amprenavir or amprenavir plus ritonavir in combination with abacavir and lamivudine for treatment of HIV-infected patients. Clin Infect Dis

Vibhagool et al. Triple nucleoside treatment with abacavir plus the lamivudine/ zidovudine combination tablet (COM) compared to indinavir/COM in antiretroviral therapy naïve adults: results of a 48-week open-label, equivalence trial (CNA3014). CURRENT MED RES OPIN

MacManus et al GW433908/ritonavir once daily in antiretroviral therapy-naive HIV-infected patients: absence of protease resistance at 48 weeks. AIDS

Rodriguez-French et al. The NEAT Study: A 48-Week Open-Label Study to Compare the Antiviral Efficacy and Safety of GW433908 Versus Nelfinavir in Antiretroviral Therapy–Naïve HIV-1-Infected Patients. J Acquir Immune Defic Syndr

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Niche Science & Technology Publications

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2022
2021
2020
2019
2018
2017

Hardman and Serginson. Ready! Aim! Fire! targeting the right medical science journal. J Cardiovasc Endocrinol

2016
2015

Reijntjes S et al. Bariatric surgery in obese older people: Useful or not? Cardiovasc Endocrinol

2014
2013

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

2012
2011
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2008
2003
2002

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

2001
2000
1999
1998

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

Hardman and Wierzbicki. Na,Li-countertransport and ethnicity American Journal of Hypertension

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

Chalkley et al. Benign Hyperbilirubinaemia in Tuvaluan Schoolchildren. Clin Sci

Chalkley et al. Relationship of Mean Cell Volume and Blood Lead in London Schoolchildren at Low Lead Levels. Clin Sci

Hardman et al. Erythrocyte sodium-lithium countertransport (SLC) activity and retinol binding protein (RBP) excretion in healthy normotensive subjects. Clin Sci

Chalkley et al. Blood lead levels and indices of anaemia in London schoolchildren. Clin Sci

Hardman et al. Cation transport in Bartter’s syndrome. J Hypertens

 
 

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Dr Tim Hardman,
Managing Director

tim.hardman@niche.org.uk

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.

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Ammar Moussa,
Business Manager

ammar.moussa@niche.org.uk

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.

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Karen Chalk,
Head of Clinical Project Management

karen.chalk@niche.org.uk

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.

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Dr Justin Cook,
Head of Medical Writing

justin.cook@niche.org.uk

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.

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Ruth Hardman,
Finance Director

ruth.hardman@niche.org.uk

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.

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The Niche Team

info@niche.org.uk

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.

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Dr Ayad Abdul-Ahad,
Chief Medical Officer

ayad.abdulahad@niche.org.uk

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...