Ali Hutton

A highly-motivated individual, with a broad skill set and experience in scientific writing, medical communications, quality control (pharmaceutical sector), clinical science, clinical dietetic practice (NHS and private), research project design and management, clinical trials (CTs), internal auditing, sales, marketing, and regulatory affairs.

PROFESSIONAL PROFILE

• A highly-motivated individual, with a broad skill set and experience in scientific writing, medical communications, quality control (pharmaceutical sector), clinical science, clinical dietetic practice (NHS and private), research project design and management, clinical trials (CTs), internal auditing, sales, marketing, and regulatory affairs.
• Currently employed full-time as a Clinical Science Dietitian at Vitaflo International Ltd., an innovative clinical nutrition company, specialising in Foods for Special Medical Purposes (FSMPs).
• Detail-focused and skilled in the writing of comprehensive clinical and scientific documentation, as well as convincing, evidence-based justifications for product nutrient levels to support market applications.

Scientific Writing and Communication

• Working closely with market access consultants to produce Payer Value Stories for FSMPs, to identify the health problem, outline the clinical benefits of the product, and build a case for reimbursement.
• Responsible for composition of Product Information Brochures (for submission to research ethics committees), CT documentation (e.g. protocols, case report forms (CRFs)), and FSMP product use guides for HCPs.
• Interpretation and summarisation of CTs and research findings, and translation of scientific information into clear and concise non-clinical language, for use patient-education resources, marketing and promotional materials, website content, and sales team and HCP education.
• Performing online literature surveys and critical appraisal of scientific literature to produce evidence-based clinical rationales and clinical backgrounds for CT protocols, internal documents and regulatory submissions.
• Completion of Effective Writing for Biomedical Professionals course.
• Commissioned by Network Health Digest, a HCP magazine, to write articles for HCPs on topics such as the ketogenic diet in the management of epilepsy and bone health in coeliac disease (CD), and by Free-From Heaven, a popular consumer magazine, to write an article explaining the scientific evidence around a gluten versus wheat-free diet in a non-clinical and consumer-friendly manner.

• Development and implementation of external training courses for GPs and pharmacists across the UK in the effective management of CD, covering biochemistry (diagnosis and monitoring), DEXA scans and appropriate prescription of products.
• Invited to present, as a specialist gastroenterology dietitian, on the relevant clinical and biochemical markers involved in the management of high output stomas and short bowel syndrome, at a training course for NHS gastroenterology nurses and consultants.
• Invited to present at the annual Alkaptonuria Society (a non-profit patient support and research organisation) patient day on a new product for use in the dietary management in alkaptonuria (AKU), a rare inborn error of metabolism.
• Liaise with medical affairs team and brand managers to produce PowerPoint presentations to train global sales and marketing teams on products new to the market.

• Bachelor of Science (BSc) (Hons) in Industrial Biochemistry
• Master of Science (MSc) research project to evaluate a commercial peanut enzyme-linked immunosorbent assay (ELISA) test kit when applied to peanut-spiked biscuits.
• Quality Control analyst in current Good Manufacturing Practice (cGMP) facilities.
• Experience in various wet-chemistry analytical techniques.
• Internal sales support for supplier of analytical laboratory systems in the pharmaceutical industry.

• Lead dietitian in several CTs to support regulatory submissions for product market registration. 
• Attendance at Institute for Clinical Research’s (ICR) Introduction to Clinical Trials & Clinical Trials Practice Course in November 2021.
• Review and clinical approval of validation documentation and product non-conformances.
• Working with Regulatory Affairs team to harmonise product formulations and labels to reduce inter-country barriers to trade.

• Working as part of a multidisciplinary team: Market Access, Quality Control, New Product Development, Medical Affairs, Marketing, Regulatory and Clinical Operations Team.
• Working closely with the Marketing team to develop patient and HCP resources and to provide evidence to substantiate key messages in product value propositions.
• Collaboration with key opinion leaders (KOLs) in AKU to produce a disease-awareness educational presentation for HCPs working in the field of inborn errors of metabolism.
• Flexibility; can work autonomously, as part of a team and under pressure.

2016 – Present Vitaflo International Ltd | Clinical Science Dietitian

2016 Vitaflo International Ltd | Medical Affairs and Marketing Dietitian 

• 6-month temporary position
• Responsibility for product-related helpline queries from HCPs, patients and colleagues.
• Development of marketing and educational materials for HCPs and patients.

• Providing dietetic expertise to patients with gastroenterological (GI) conditions.
• Development and implementation of training sessions on CD management to locum GPs and GPs from Cheshire-based surgeries.

• Regional Product Manager for a prescription gluten-free food company.
• Clinical review and approval of company sales and marketing resources.
• Company representative at CD clinics and gluten-free events around the UK. 
• Coordination of company's advocates in North of England and Scotland.
• Development and implementation of CD professional update sessions for UK-based pharmacists.

• Management of dietitian-led CD clinic and gastroenterology clinic.
• Liaising with the NHS Clinical Commissioning Group (CCG) to gain funding to develop and manage CD group education sessions. 
• Involvement in audits, as well as policy, resource and service development.
• Development and implementation of evidence-based internal training sessions for other HCPs (doctors, nurses, pharmacists and dietitians).

• Provision of dietetic input in the areas of care of the elderly, surgery, renal, diabetes and paediatrics, in both inpatient and outpatient settings, resulting in a broad clinical experience.

• Project title: “The Effect of Food Composition on the Performance of a Commercially-Available Peanut Allergen Immunoassay”.
• Evaluation of performance of a commercial peanut ELISA test kit when applied to peanut-spiked biscuits, following modification of the fat and sugar content, and fat type.
• Self-managed project; initial planning and design of experiment, execution of project, and setting of realistic timelines. 
• Quantitative research, with a repeated measures design.

2004-2005 Takeda Ireland Ltd | Quality Control Analyst

• Testing of raw materials and finished product at a manufacturing facility for Active Pharmaceutical Ingredients (APIs) to ensure they conform to release specifications.
• Use of various analytical techniques including dissolution, High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and disintegration and hardness testing.
• Adherence to cGMP standards and training new analysts.
• Preparation of laboratory for inspection by Food and Drug Administration (FDA).

• Internal sales representative for supplier of laboratory equipment to pharmaceutical industry and university research facilities.
• Preparing price quotations and tender applications, and processing sales for analytical laboratory systems including HPLC, GC, autotitration, thin layer chromatography (TLC), microscopes and weighing.
• Internal support for field sales product specialists.

(Co-operative education placement)

• Testing of raw materials at a cGMP manufacturing facility for APIs to ensure compliance with the required specification for use in the finished product.
• Use of GC, Karl Fisher, rotary evaporation, and disintegration and hardness testing.

EDUCATION

2008-2009 University of Chester

MSc Human Nutrition & Dietetics

2006-2008 University of Chester

PgDip Human Nutrition & Dietetics

2002-2003 University of Limerick, Ireland

PgDip Entrepreneurial Management

1998-2002 University of Limerick, Ireland

BSc (Hons) Industrial Biochemistry

1992-1998 St Leo's College, Carlow, Ireland

Leaving Certificate, Chemistry, Biology, Mathematics, Art, German, English, Irish

Hobbies and Interests: Cycling, camping, open water swimming, stand up paddle boarding, music, crafts, gardening and theatre.