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Clinical Evidence

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Due Diligence

Out & In Licensing

Product Profitability Analysis

Intellectual Property Review

Bespoke Market Research

Assessing New Markets

Market Valuation

Current Market Monitoring

Competitor Analysis

Product Commercial Evaluation

Distributor Identification

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Some of Our Network

Andrew Adams

Managing Director, Wound Market Consulting

More than 30 years' experience in bringing wound care products of many and diverse technologies to market across a range of European countries.

Experienced in start-ups and product development as well as in bringing mature products to new markets. Previous roles and experience include Regional Vice-President for ConvaTec for Scandinavia and Central & Eastern Europe; Managing Director of Insense Ltd (biotech and woundcare), non-executive director on medical device start-ups, fund-raising for new businesses.

Andrew is a member of the European Wound Management Association (EWMA).

European Wound Management Association

Wounds International

Tissue Viability Society

Societe francaise et francophone des plaies et cicatrisations

Deutsche Gesellschaft fuer Wundheilung und Wundmanagement

Sharmila Savatherajan.

Clinical Trial Administrator, Wound Market Consulting

Sharmila Savatherajan has a BSc in Biomedical science from Royal Holloway University London. She has strong scientific knowledge and is involved in conducting literature reviews, compiling clinical evaluation reports and clinical research management.

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Our Associates

Wound Market Consulting's associates have backgrounds in major woundcare companies such as ConvaTec, KCi, Smith & Nephew, in technology-based start-ups and in regulatory and health provider organisations.

We continue to expand our network of associates and welcome approaches from anyone who can demonstrate a results-orientated track record in any field of the woundcare industry including the prevention of wounds.

Magdalena Esteve

Magda Esteve has over 20 years of global medical experience in marketing and sales management, new business development and implementation with multinational companies including Urgo in Spain.

For the past 14 years she has worked in the wound care products arena, where she has been responsible for marketing and product development in companies including MSD, Hartmann and Urgo. Currently she manages distribution of wound care & Epidermolysis Bullosa (EB) products across Spain.

Magda has a comprehensive understanding of global healthcare markets and commercial, regulatory and reimbursement opportunities and challenges. She is familiar with the primary Wound Societies in Spain as well as the 17 different Spanish health systems and is fluent in Spanish, English, French and conversational Italian.

Dr Jonathan Hughes, PH.D

Dr Hughes has more than 32 years of worldwide regulatory and clinical affairs experience across medical devices, combination products and human / veterinary pharmaceuticals.

Following completion of his PhD in veterinary pathophysiology, Jonathan began his career in regulatory affairs at A H Robins. He subsequently held regulatory affairs positions in drug and device companies, including Smith & Nephew, Glaxo, Bristol-Myers Squibb and ConvaTec.

Jonathan has served on two European Commission Expert Working Groups on the Drug / Device Borderline and Device Classification. With 23 years of combined regulatory experience in wound care companies, Jonathan specialises in regulatory strategy, regulatory and clinical development pathways, worldwide regulatory submissions and training. He has worked with all the major international regulatory agencies, in particular US FDA, Japanese PMDA, Chinese NMPA, Notified Bodies and EU Competent Authorities.

Jonathan is a Fellow of the regulatory professional organisation, TOPRA, and is a regular contributor on numerous educational and training programmes, delivering lectures and acting as advisor for two medical technology MSc courses (at the University of Hertfordshire and Cranfield University) and a MRes course with Newcastle University.

RNDr. Jiri Letal

Dr Letal is a Statistician with more than 30 years experience in biometrics, including 15 years in clinical trial statistical analyses and 15 years in biometrics research & lecturing.

He has worked at several international CROs and pharmaceutical companies including Advanced Drug and Device Services (France), Janssen Pharmaceuticals of JNJ (Belgium) and Grunenthal (Germany) in a variety of therapeutic areas including; immunology, neurology, physiology, oncology, gastroenterology, haematology, dermatology, podiatry and pain management. He manages the statistical tasks across clinical trials phase I-IV., including interactions with regulatory authorities, acting as a trial biostatistician ensuring that clinical trial deliverables meet: state-of-the-art statistical methodology, regulatory requirements, operational efficiency and full alignment with the overall clinical strategy of the respective project. He has been the principal statistician for more than 20 multicentre clinical projects and a primary administrator of two analytical Euro Conferences. He is also a long standing member of the International Society of Clinical Biostatisticians (ISCB).

His strengths include SAS programming and statistical methodologies of generalized mixed models, linear and nonlinear regression analysis, survival analysis, categorical analysis, multivariate methods, FDA and ICH guidelines (including CDISC standards) and the design of data processing, programming and statistics SOPs. He is also a long standing member of the International Society of Clinical Biostatisticians (ISCB).

Dr Joanne James

Consultant: Pre-Clinical / Clinical Development

Joanne is a multi-award-winning scientist focussed on strategic development for start-ups/ SMEs. She has a proven innovation track record across medical devices/pharmaceuticals.

With more than 22 years of experience in translational medicine, specialising in wound healing, tissue repair and inflammatory disease, she maintains a thorough knowledge of the wound cascade and the global competitor landscape.

Joanne gained her PhD from the University of Aberdeen, as Piper Alpha Research Scholar, with a secondment to the Academic Medical Centre, Amsterdam. She has held lectureships and led research programmes at the Wound Healing Research Unit, University of Wales, and the Institute of Dentistry, Barts & the London School of Medicine. She retains an Honorary Senior Lectureship (Associate Professor) at the William Harvey Research Institute, Queen Mary University London.

She previously led a multi-project portfolio from raw patents through prioritisation of clinical development strategy, pre-clinical studies and product development, to successful completion of a multi-centre RCT of healing in the diabetic foot. Expansion of the patent portfolio, together with positive results allowed a 4.2M equity-raise in 2014 and a further 20M in 2018.

Joanne advises on pre-clinical evidence and clinical study design towards regulatory approval and commercialization. She is an associate member of the CCRA.

Barry Willemsteijn

Barry Willemsteijn has more than 25 years clinical and business experience in woundcare across Europe. Having been Head nurse in surgical intensive care (University hospital Leiden, Netherlands), the founder and former President of the Dutch Wound Care Association (WCS) and holding Marketing and Sales positions at ConvaTec, Dermagenics Europe and Beese Medical.

His key strengths include product development (i.e. clinical testing; CE regulation - Post Market Surveillances) and business development (i.e. acquisition of distribution partners; marketing and sales planning; training skills) and an extensive network of key contacts in European woundcare associations and organisations.

Giuseppe Mancullo

Giuseppe Mancullo has more than 28 years business experience in the Medical Devices arena. He developed his carrier within Smith and Nephew Italy managing various departments; logistics, customer care, marketing & market access and serving different business areas: Wound Care, Ortho-Reconstructive, Ortho-Arthroscopy, Ortho-Trauma.

For the past 18 years he focused on the wound care industry leading product launches projects, development of communication platforms (Quaderni di Forum), supporting the development of new therapeutic concepts (TIMECare) and participating to Board of Clinical Associations (past lay member of Board Committee of CORTE). In the last 5 years, his roles have included Market Access and BI management for Wound Care and Orthopedic businesses.

His areas of expertise also include strategic marketing and institutional relations with clinical referents and health governance.

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