and want medical support to speed up market access and maximise your return? a Medical Affairs and Clinical Research consultancy with a difference

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1 Are you. A Medical Device Company A larger Borderline company with a small medical department A Biotechnology start-up An Advanced Therapies Company A Clinical Nutrition Company and want medical support to speed up market access and maximise your return? Your best partner is Wyfold Medical a Medical Affairs and Clinical Research consultancy with a difference A UNIQUE COMBINATION OF TALENTS With personal histories in clinical research, but also in clinical practice, medical affairs, marketing and general management, we understand your need for the right clinical data, and how important this information is for your patients, for market access and for the business. A UNIQUE EXPLOITATION OF UNEXPECTED SYNERGIES With personal diverse experience in several, albeit related, industries (pharmaceutical, biotechnology, medical technology, clinical nutrition, combination and borderline companies) we can offer you ideas for and the development of unexpected research synergies and business collaboration. A UNIQUE OFFERING FOR SPECIAL CLIENTS We specialise in the set up of advisory boards, interaction with key opinion leaders, product launches, product repositioning, redesign and relocation of slow-moving clinical trials, Reimbursement studies, QOL studies, QALY calculation.

2 COMPANY INFORMATION Philosophy The founder Clients SERVICES OFFERED Interim Services Clinical Trials Product positioning Reimbursement LEGAL INFORMATION Wyfold Consultancy Ltd - Incorporated in England and Wales in 2001 Company Registration number VAT Registration number CONTACT DETAILS 2 Wyfold Cottages Wyfold Reading RG4 9HX UNITED KINGDOM Telephone Mobile Website Lfumi@aol.com

3 PHILOSOPHY Fortune Magazine wrote, in the 1980s, about Leadership: The manager administers, the leader innovates. The manager maintains, the leader develops. The manager relies on systems, the leader relies on people. The manager counts on controls, the leader counts on trust. The manager does things right, the leader does the right thing. Also among consultants and the service industry, you will find many people who will do things right for you. We shall always try to do the right thing. Our philosophy is, also, to be always fast, focused, flexible and friendly. We can charge competitive professional fees per hour or per day, monthly retainers or fees per project, depending on the type of assignment and the client s requirements. Fees per project are always linked to the end result, insomuch as this depends on our performance. For every project or assignment, timelines and consequent fees are agreed in advance with the client, and every effort is made to stick to the agreed terms. Every agreement is in writing with an engagement letter and a detailed proposal, exchanged before the start of the project. However, the course of a project is often changed by external factors. These can include: changes in the client s needs and programmes unavailability of test products changes of regulations and guidelines unexpected results of clinical trials other causes of force majeure In all these cases we have the flexibility to re-discuss and re-negotiate our terms and timelines. The size of our company always ensures a direct and personal relationship with a principal consultant. We always try to ensure a mutually satisfactory and enjoyable collaboration.

4 THE FOUNDER Dr Lucio Fumi, MD. Fully registered and licenced for Medical Practice in the UK and in Italy, Dr Fumi obtained his medical qualifications in Trieste (Italy). He has 26 years experience in medical affairs and clinical research in the healthcare industry, gained in a series of senior appointments in international companies such as Baxter Healthcare, Clintec Nutrition, ConvaTec / Bristol-Myers Squibb, Hospira / Abbott and Nutricia / Danone. Before joining the industry, he worked as a clinical geriatrician.

5 CLIENTS Acrobot, UK (clinical study design and management for innovative orthopaedic surgery robotic devices) Amgen Europe, Switzerland (innovation workshops on novel biotechnology treatments for osteoporosis) Astellas Pharma, South East Europe (interim medical director for 6 months - set up of medical and regulatory affairs department in the new affiliate) Baxter, Medication Delivery Division (medical affairs, clinical studies, medical expert reporting, market research on European and Global projects in the areas of enteral and parenteral nutrition, medication delivery, thalassaemia, oncology, infection control) Biopheresis, Germany (part-time, interim Chief Medical Officer role: clinical development of Oncosorb, a biotechnology product for advanced forms of cancer) Bio-surgical, UK (clinical and marketing research programmes in Europe for colorectal surgery devices) Brovedani Group, Italy (pilot clinical trials of novel needle-free devices for the intradermal delivery of insulin in patients with Diabetes Mellitus) Clasado, UK (part-time, interim medical director role for second generation GOS prebiotics) Cooke Consultants, US (market research and reimbursement strategy in Europe for innovative hearing aids and stoma therapy products) Dideco, Italy (set up of multicentre clinical trial and orphan drug registration programme for a novel drugdevice combination for the treatment of Cystic Fibrosis) Dieta Doc, Italy (set up of a pilot clinical trial of a novel slimming diet for overweight individuals) Fresenius, UK (medical education programme for the Home Care division iron chelation therapy) Gyrus Medical, UK (clinical research programmes for innovative urology devices for the treatment of Benign Prostate Hypertrophy) International Biomedical Systems, Italy (clinical trials, regulatory and marketing support of coronary stents) Lamellar Therapeutics, UK (clinical research and regulatory affairs for innovative biotechnology products in cancer immunology and fibrin pathophysiology) Nestlé Clinical Nutrition, UK (reimbursement clinical studies for enteral nutrition products in paediatric populations) Pfizer Consumer Healthcare, UK (clinical trials strategy, literature review and expert reports for novel ophthalmic medical devices) Plan-1-Health, Italy (clinical research programmes and pilot studies of innovative colorectal surgery devices) RanD Biotech, Italy (part-time, interim Chief Medical Officer role: treatment in extracorporeal circulation of acute hepatic failure, acute renal failure; regional cancer therapy in abdominal cancers HIPEC, melanoma and sarcoma) Reed Smith, US (European registration of Human-derived Therapeutic Products for the treatment of ophthalmic disease) Second Sight Medical products, US (European reimbursement strategy for Active Implantable Medical Devices for the treatment of blindness in Retinitis Pigmentosa)

6 Sirtex, Australia (European reimbursement strategy for Active Implantable Medical Devices for the treatment of liver metastases) Stanmore Implants Worldwide, UK (clinical research programme for innovative orthopaedic surgery devices) Ventracor, Australia (European reimbursement strategy for Active Implantable Medical Devices for the treatment of cardiac failure)

7 INTERIM SERVICES Part-time and Interim Services in Medical Affairs: Medical Director / Chief Medical Officer The medical support of marketed products represents an established function within the pharmaceutical and biotechnology industry, and is now gaining increasing importance also in the medical device industry. Clinical research does not cease once a product has been placed on the market. The analysis of postmarketing data and experience can provide valuable information on the therapeutic profile and on possible new indications. Adverse reactions must be handled in compliance with legal requirements and the information acquired must be shared within the medical community. Medical education of the sales force and of the medical end user is essential for the best use of all products. Some companies, especially in the medical device industry, do not have a medical director or a medical department, or have a structure that requires the outsourcing of some functions. We can provide this type of activity on a contract basis, per single and identified project, or cover interim or part-time assignments as medical director or chief medical officer.

8 CLINICAL TRIALS In clinical research, like in many other areas, among consultants and CROs, you will find many people who will do things right for you. We shall always try to do the right thing. Doing things right in clinical research is extremely important (Good Clinical Practice, control, paperwork, reliability). But doing the right thing is more important. Without the right study question (what do you want to prove? What do you want to claim?), without the right patient population, without the right comparator, even the best conducted study will lead you nowhere. Also, one must remember that the principal reason for conducting clinical trials is to comply with regulatory requirements and have a product registered or otherwise approved. However, there can be many other good reasons for a healthcare company to conduct clinical research. Clinical studies are often the only instrument that can be used to obtain the best possible payment for medical products under increasingly stringent reimbursement systems. The benefits coming from scientific publications in peer-reviewed, specialised medical journals often represent another reason to conduct a clinical trial. A convincing paper: (a) enhances the image of the product and the company (b) constitutes one of the best available marketing instruments (c) provides one of the most visible forms of intellectual protection (d) reinforces the legal value of a patent (where applicable) (e) contributes to creating medical awareness and clinical guidelines.

9 PRODUCT POSITIONING Correct product positioning is a major element of a successful marketing program. Knowledge of the market, the competition, prevailing techniques and new trends in a specific therapeutic area is a fundamental prerequisite for a correct positioning. We can conduct market research in any given therapeutic area, collecting data on the size of the market, different therapeutic approaches and key players; establish market priorities based on clinical outcome and cost/benefit analysis; obtain information from clinical trials to aid in proper product positioning or provide additional marketing opportunities for the product; re-launch a product by targeting opinion leaders to act as investigators in important markets; obtain professional advice for potential modifications or extension of indications; reposition a product in a different therapeutic area.

10 REIMBURSEMENT The issue of reimbursement and pricing has become a critical factor in the successful marketing of a new product. The worldwide cost of healthcare has increased enormously with the ageing of the population, the availability of new technologies and pharmaceutical products, the focus on prevention. This has forced health authorities and health insurers to find ways of cutting costs and to establish priorities. New rules and budget-limitation measures are enforced to influence the decision-making process within hospitals, private medical practices, and the home care market. For this reason the necessity to prove the cost / effectiveness of one product over another has become vital for the placement of a new product on the market. We can identify the appropriate gold standard for each treatment to be used as a comparator in controlled studies; identify direct and indirect costs associated with different forms of treatment; design clinical studies comparing different treatment entities, for example drugs, devices, or alternative treatment methods; select the appropriate quality of life (QOL) instrument for the disease and the treatments considered; design and manage comparative outcome studies, with built-in cost/effectiveness, cost/benefit and quality-adjusted lifeyears (QALY) analyses; identify and manage the relationship with regulatory agencies and public and private reimbursement bodies, even in niche areas such as Medical Device Agencies, or NICE and the ACBS in the UK.