Clinical Translation and Commercialisation of Nanomedicine

Course summary

Clinical Translation and Commercialisation of Nanomedicine



Overview

Nano-scale medicines, sensors, implants and imaging modalities have the potential to revolutionise health care. By 2011 the global nanomedicine market was reported to be $72.8 billion and this figure is predicted to reach $130 billion by 2016 [1]. The scientists and entrepreneurs who survive and prosper amidst such remarkable impact and growth are those who have the best comprehension of the pathway to market. Ensuring your innovative nanotechnologies have the optimal opportunity to fulfil their potential requires an understanding of the regulatory, financial, clinical and commercial challenges faced. The Clinical Translation and Commercialisation of Nanomedicine course aims to provide this understanding. The course will encourage students and researchers to think about the entire pathway of testing and commercialising their scientific ideas, and to introduce them to issues surrounding regulation, intellectual property and financing. Lecturers with expertise and experience in each of these key spheres will provide important insights, whilst case-studies will be lead by entrepreneur scientists who have successfully navigated the pathway.

[1]http://www.etp-nanomedicine.eu/public/news-events/news-archive-1/new-market-research-report-nanotechnology-in-medical-applications-the-global-market

The Clinical Translation and Commercialisation of Nanomedicine course can be taken alone, with or without academic credit, or as part of the MSc in Nanotechnology for Medicine and Health Care.

Please send me an email about future Clinical Translation and Commercialisation of Nanomedicine courses.

The Clinical Translation and Commercialisation of Nanomedicine course will provide students with the opportunity to gain knowledge and understanding of:

  • The pre-clinical, clinical and regulatory pathways required for approval
  • Market and intellectual property assessment
  • Mechanisms and sources of finance
  • Notable case studies

Programme details

This intensive five-day course is taught face-to-face with online support and written assignments. Students will be assessed on practical applications of this course, creating a successful business plan, performing regulatory and market analysis and exploring ways of financing.

Each of the five days has a dedicated theme and will start with an introductory lecture, followed by lectures, case studies and discussions led by subject specialists from the University of Oxford and guest lecturers from other universities, companies and organisations.

Module content:

Day 1: Pre-clinical to clinical testing

  • Introduction to the translation pathway, examples and challenges
  • Pre-clinical testing ethics
  • Pre-clinical testing models
  • Clinical Trials Phase I and II
  • Clinical Trials Phase III and Market Approval

Day 2: Ethics, safety and regulation

  • Nanomedicine ethical issues
  • Manufacturing and quality assurance of nanomedicine products, the absolute requirement for GMP
  • Current regulatory approach to nanomedicines
  • MHRA, EMEA, FDA process and example rulings
  • Regulatory classification, device / drug / implant / injectable

Day 3: Product protection and commercial potential

  • Intellectual property, including patent strategy and patent search
  • Introduction to markets
  • Industry specifications, competition and analysis of the healthcare, nanomedicine and bionanotechnology markets
  • Assessing the market and commercial potential for maximum impact; risk and return

Day 4: Financing

  • Net present value, raising capital, funding projection and financing rounds
  • Securing private investment
  • Securing investment from public sources
  • Introduction to elevator pitches and panel presentations
  • Nanomedicine networks and institutions

Day 5: Case studies and exercises

  • Metrics of success and failure, exit strategies
  • Learning from notable nanomedicine successes and failures
  • Case study – Oxford SME with a medical nanotechnology
  • Small group exercise

Certification

Short course participants who do not wish to undertake the assessed work required for academic credit, but who do satisfy the course participation requirements, will receive a certificate of completion.

Those successfully completing the course with academic credit can apply to receive a CATS point transcript.

Accommodation

Accommodation is available at the Rewley House Residential Centre, within the Department for Continuing Education, in central Oxford. The comfortable, en-suite, study-bedrooms have been rated as 4-Star Campus accommodation under the Quality In Tourism scheme, and come with tea- and coffee-making facilities, free Wi-Fi access and Freeview TV. Guests can take advantage of the excellent dining facilities and common room bar, where they may relax and network with others on the programme.

IT requirements

This course uses the Department’s online assignment submission system and online courseware. In order to prepare and submit your course assignments you will need access to the Internet and a computer meeting our recommended minimum computer specification. Students of this course may use the student computing facilities provided in Departmental buildings.

Fees

Short course in Nanotechnology: £2135.00
Students on MSc in Nanotechnology for Medicine and Health Care: £1795.00

Funding

Details of funding opportunities, including grants, bursaries, loans, scholarships and benefit information are available on our financial assistance page.

Payment

The course fee includes:

  • Tuition;
  • Course materials through our virtual learning environment (VLE);
  • Access to the Bodleian Libraries e-Resources;
  • Refreshments and lunch on each day of the course.

Before making your application for this short course, please ensure that you have read the terms and conditions which can be found to the right of this page.

Please see the MSc in Nanotechnology for Medicine and Health Care page for more information regarding fees when taking this course as a part of the MSc Programme.

Tutor

Prof Robert Carlisle

Course Director and Tutor

Robert Carlisle is an Associate Professor in Biomedical Engineering and head of the Drug and Vaccine Delivery group within IBME. After completing a BSc in Biochemistry, an MSc in Toxicology and a PhD in Gene Delivery at Birmingham University, he worked for 8 years within the Department of Clinical Pharmacology and the Department of Oncology at the University of Oxford.

The majority of his work has been concerned with achieving systemic delivery of anti-cancer agents for the treatment of metastatic cancer. This has included the development and testing of novel nano-scale non-viral and viral gene delivery systems and liposomal agents for the delivery of conventional chemotherapeutics. Research within his labs covers the full scope of therapeutic design, formulation and testing with emphasis on how the specificity and efficacy of therapy can be improved.

Assessment methods

Assessment will be based on submission of written assignments, totalling not more than 4,000 words in length. The assignments are submitted online.

Academic credit

Those wishing to may apply to take the course with accreditation. The University of Oxford Department for Continuing Education offers Credit Accumulation and Transfer Scheme (CATS) points for the course.

Students wishing to complete the Clinical Translation and Commercialisation of Nanomedicine course with academic credit need to satisfactorily complete the coursework assessments. Attendance of a minimum of 80% of the course is required. Students fulfilling these requirements are eligible to earn credit equivalent to 20 CATS points which may be counted towards a postgraduate qualification.

Application

Application deadline: three weeks before the commencement of the course.

We strongly recommend that you download and save files before completing to ensure that all your changes are saved.

This course requires you to complete the application form below, and submit it alongside a copy of your CV. If you are applying to take this course for academic credit you will also need to complete section two of the reference form and forward it to your referee for completion. Please note that if you are not applying to take the course for academic credit then you do not need to submit a reference.

Please ensure you read the guidance notes before completing the application form, as any errors resulting from failure to do so may delay your application.

Selection criteria

To apply for this short course you should:

  • have a degree in a science or engineering discipline or medicine / pharmacy; and
  • have some practical experience in a related field; and
  • be able to demonstrate an interest in nanotechnology; and
  • be able to demonstrate a suitable level of English (if this is not your first language).