BIOPHARMACEUTICAL DEVELOPMENT

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2 contents MSc Biopharmaceutical Development 03 University of Leeds and Covance 04 Industry-relevant training course 06 Module details 08 Learning and teaching 12 Assessment 12 Facilities 13 Professional and career development 14 Leeds for Life 14 Entry requirements, How to apply, Application deadline and Scholarships 15 MSc Biopharmaceutical Development Many pharmaceutical companies are expanding their biopharmaceutical capability, which is creating demand, and thus opportunities, for talented, well-trained people. At the same time, these companies report difficulties in recruiting employees with relevant skill sets and those with broad industrial experience are greatly sought after. To address this skills gap, the University of Leeds and Covance have formed a partnership to fast-track talented scientists into roles within the biopharmaceutical industry. Biopharmaceutical drugs are an emerging class of medicine in the pharmaceutical industry that have grown in popularity owing to their clinical effectiveness, low level of side effects and economic performance (seven of the top 10 drugs by sales revenue in 2013 were biopharmaceutical). Important Information Information provided by the University, such as in presentations, University brochures and on the University website, is accurate at the time of first disclosure. However, courses, University services and content of publications remain subject to change. Changes may be necessary to comply with the requirements of accrediting bodies or to keep courses contemporary through updating practices or areas of study. Circumstances may arise outside the reasonable control of the University leading to required changes. Such circumstances include industrial action, unexpected student numbers, significant staff illness (where a course is reliant upon a person s expertise), unexpected lack of funding, severe weather, fire, civil disorder, political unrest, government restrictions and serious concern with regard to the transmission of serious illness making a course unsafe to deliver. After a student has taken up a place with the University, the University will look to give early notification of any changes and try to minimise their impact, offering suitable alternative arrangements or forms of compensation where it believes there is a fair case to do so. Offers of a place to study at the University will provide up-to-date information on courses. The latest key information on courses, entry requirements and fees can be found at ac.uk/coursefinder. Please check this website before making any decisions. The University of Leeds and Covance have formed a partnership to co-deliver a new MSc Biopharmaceutical Development to train future leaders in the biopharmaceutical industry. In 2015, biopharmaceutical drugs generated revenues of $170bn in a pharmaceutical industry worth $1tn. 2 3

3 University of Leeds and Covance A partnership to train the next generation of scientists Faculty of Biological Sciences One of the top 100 universities in the world (QS World University Rankings, 2016) The University of Leeds and Covance have formed a partnership to train future leaders in the biopharmaceutical industry. Together we have developed an MSc course that covers the full process of biopharmaceutical drug discovery and development through to the commercial launch of products. It is the only course in the UK that has been co-designed and delivered by industry that to focus exclusively on this sector. It will provide a springboard for high-quality life science graduates wanting to start a career in this industry. This unique professional training course has been designed and developed to attract the best scientists with clear leadership potential. It capitalises on the strengths of both organisations. You will be taught by internationally renowned academics working at the forefront of their fields in the areas of science that underpin drug development and by senior clinicians, scientists, lawyers and department heads from industry who are involved in drug development every day. The development of biopharmaceutical products covers medicinal products manufactured using live cells. The process differs significantly from classical (small molecule) drug development, where the manufacturing methods are synthetic organic chemistry. This dedicated course will accelerate the development of professionals for this industry. Covance The Faculty of Biological Sciences is one of the leading bioscience faculties in the UK, with research and teaching that competes with the best institutions worldwide. Our position among the UK elite for bioscience research was confirmed in the results of the recent Research Excellence Framework (REF), where we were ranked 6th in the country for research impact. We are a member of the prestigious Russell Group of 24 research-intensive universities, and one of the top 100 universities in the world (QS World University Rankings, 2016). Our research tackles global challenges in medicine, health, biotechnology and enterprise. Our academics, often in partnership with industry, are working on vaccine and drug development, tissue repair and replacement, and tackling antibiotic resistance to name just a few areas. We are investing in the latest technology and facilities to carry out cutting-edge research and engaging with employers to ensure that our teaching combines a research-based education with the needs of the bioscience employment sector. We place a premium on equipping our students to succeed in an increasingly global market and giving them the drive and desire to make a difference in the world. Our partnership with Covance to deliver a sector-leading Masters course is testament to our dedication to increasing the impact and relevance of what we do. Covance is the world-leading drug development business of Laboratory Corporation of America Holdings (LabCorp). It is dedicated to advancing healthcare and delivering Solutions Made Real by providing high-quality nonclinical, clinical and commercialisation services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development. Covance s broad experience and specialised expertise means it is in a unique position to supply insights that go above and beyond testing. All of the top 50 prescription drugs in the marketplace today have been developed with the help of Covance. 4 5

4 Biopharmaceutical Development Pathway Biopharmaceutical Drug Discovery Manufacturing Biopharmaceuticals Biopharmaceutical Development: Preclinical Biopharmaceutical Development: Clinical Commercialising Biopharmaceuticals Research Project/ Placement Integrated Drug Development Plan Practical Skills for a Regulatory Environment Key benefits of the MSc Biopharmaceutical Development: Industry-relevant training course The course provides an understanding of large molecule drug development, focusing on each of the major steps in the process: discovery, manufacturing, preclinical testing, clinical trials, market access, and the regulatory and legal framework that ensures safe practice and the development of safe and effective medicines. There is a strong emphasis on practical laboratory skills, the execution of these skills in a regulated environment, and the performance of projects in effective and well-run teams. The course is 20 months in duration. It is fast-paced, covering the campus-based taught elements in six to seven months, followed by a 12-month work placement involving a research project where you will experience at first hand the working environment of this industry. Our expectations and ambition for our students are high. We will expect you to flourish in a fast-paced, project-led learning environment, where you will exhibit the confidence, attitudes and drive of ambitious young professionals and deliver results commensurate with those looking for in future leaders of this industry. Industry-relevant training designed to fast-track talented scientists into industry An integrated understanding of the full biological drug development pathway A deep understanding of the regulatory framework Access to cutting-edge practical technologies A 12 month paid position in industry as part of the course World-leading tutors from academia and industry Gain skills valued by industry in a project-led learning environment 6 7

5 UNIVERSITY OF LEEDS AND COVANCE Module details Biopharmaceutical Development Pathway This module provides an in-depth introduction to biologics manufacturing. Setting the scene for the full course, this module provides an overview of the drug development pathway, from research and development to marketed product, focusing on biologics (antibodies, vaccines, gene therapy, ADCs). You will be introduced to the medical, scientific and economic drivers costs, number of leads, attrition rate associated with drug development. The module outlines the regulatory framework for biologic drug development, including GLP, GCP and GMP, and provides a context for these through reference to landmark cases. Biopharmaceutical Drug Discovery This module provides an outline of the principles of drug discovery of biological molecules (as distinct from small chemical molecules) with teaching and advice from scientists working in the biopharmaceutical industry. It addresses issues related to upstream processing (cell lines and culture systems), downstream processes (product purification), analytics (chemical analysis of products), formulation, quality assurance and safety compliance. Biopharmaceutical Development: Preclinical This module provides an introduction to the preclinical testing requirements for biologics and how this enables clinical development and ultimately marketing application. The different testing requirements for different biological products (eg monoclonal antibodies, recombinant proteins, gene therapy products and vaccines) are discussed and you will gain an understanding of the analytical techniques used to examine pharmacokinetics, toxicokinetics and anti-product antibodies. You will have the opportunity to critically appraise the preclinical development strategies for a range of candidate molecules and identify go/no-go points to develop an understanding of the decision-making process on whether to continue or stop a project. It considers the drug development pipeline at the preclinical stage: Integrated Drug Development Plan druggable target identification target validation biologic drug formats biological libraries and screening for target hits assay development lead identification hit-to-lead optimisation preclinical disease modelling. The module will introduce you to the team-based analytical process used by industry before commencing a drug development project. This includes target identification and justification, a basic understanding of the path forward and the best mode of action (eg format of the biologic, naked antibody, immunoconjugate, peptide, ADC, etc). An integrated drug development plan is submitted to the regulator (eg FDA) to gain permission to progress a drug to human clinical trial. The module introduces the concept of critical decision-making based on incomplete data and offers an understanding of the challenges faced by the biopharmaceutical industry when bringing new biologic drugs to market. This module is project based, with students working in teams to produce a drug development plan. This plan integrates all the preclinical aspects of a particular biopharmaceutical product, establishing the evidence base supporting its safety and efficacy and the appropriateness of planned clinical trials. Teams will develop a target product profile for a drug, construct an integrated development plan (manufacturing, non clinical and clinical), take feedback from a regulatory authority and submit an investigational new drug (IND) proposal to the regulator. Manufacturing Biopharmaceuticals 8 9

6 Biopharmaceutical Development: Clinical This module provides an outline to the principles of clinical trial design and conduct in the biologics development setting. The emphasis is on understanding the practical issues that arise through real-life examples, backed up with the relevant theory. It expands on the introduction provided in the Biopharmaceutical Development Pathway module, and link the Preclinical Biopharmaceutical Development and Commercialisation of Biopharmaceuticals modules, providing grounding in the basic specialist knowledge and skills required by the biopharmaceutical industry. Commercialising Biopharmaceutical Products This module explores how economic value is captured in the biopharmaceutical industry. It focuses on salient intellectual property rights (IPR) and the external drivers that influence business decisions (economic, societal, technological, legal). Working in teams, students will take part in projects that evaluate an opportunity from the IPR perspective (freedom to operate, creative solutions), and create an opportunity business model (OBM) to exploit a particular biotechnological breakthrough. In addition, students will formally evaluate the teamwork and leadership performance of themselves and their team whilst delivering these projects. Practical Skills for a Regulatory Environment Students follow a programme of experiments and analyses applying techniques used to characterise biopharmaceuticals modelled on quality guidelines such as ICH Q6B. The module covers chromatography for protein purification, analyses of aggregation and protein stability to in vitro interaction analysis and cell-based activity assays. You will learn about the importance of working to instruction and record-keeping for a regulatory environment. Research Project/Placement The course offers you the opportunity to undertake work and research experience in industry for 12 months or a placement based in the University research laboratories involving a collaborative project developed and co-supervised by an industry partner. Placement opportunities will range across a variety of departments/functions (discovery, manufacturing, preclinical testing, clinical safety and efficacy). All placements will include an original research project, which constitutes a substantial portion of the credits leading to your higher degree. It will also give you the opportunity to experience work within the industry and identify roles that suit you best. You will commence your project in May, seven months after the start of the course and complete it by the following April/May. Graduation is scheduled immediately thereafter, making you available for employment immediately after your placement

7 Facilities Learning and teaching We provide the very best learning resources and academic support, and our teaching draws on the University s world-class research base and highly qualified professionals from industry. Teaching methods align with activities performed in industry (teamwork, project management, report writing, presentations to clients/regulators/senior management, short deadlines, scenario planning, dynamic plans, etc). This course will challenge you to think creatively, solve problems and develop strong communication and teamwork skills. You ll experience a wide range of teaching methods, including formal lectures, interactive workshops, problem-solving, practical classes and demonstrations. There will be extensive use of real-life, industryspecific case studies to illustrate theoretical and practical concepts and multiple opportunities to work in teams, including the opportunity to lead a team. The topic is highly interdisciplinary, and modules are led and taught by academic staff from four different faculties of the University (Biological Sciences, Business, Mathematics and Physical Sciences, Medicine and Health). We compile a research seminar programme each year, from the seminar programmes of each of these four faculties, to extend the remit of the course and to provide exposure to emerging technologies and approaches. Assessment The course is assessed through coursework and project work, with deadlines for assignments distributed throughout the course. We use a range of different formats for these assignments, including written reports, oral presentations, group exercises, individual exercises and self-reflection. Where possible, the focus of an assignment is aligned with activities in the industry (report to a client, submission to regulator, taking advice from regulator, report to senior management). One module, Practical Skills in a Regulated Environment, has a practical exam, which covers experimental techniques, data analysis and compliance with regulatory protocols. You will have access to our impressive facilities that support our research and teaching. You will be taught in modern class settings, many with interactive facilities (for active learning in the classroom) and most with lecture-recording capability. Lectures will be recorded routinely and published to the class through our Virtual Learning Environment (VLE), which also serves as a centralised repository of course materials and information. The University of Leeds has outstanding laboratory facilities for protein chemistry research, many of which will be accessed during this course. In particular, you will work in the Biomolecular Interaction Suite (expression, purification and biophysical analysis of proteins) and the Fluorescence Activated Cell Sorting Facility. You will visit industrial facilities to examine the scale-up of processes required in industry and work within the facilities of leading drug companies in your placement. You will also benefit from our outstanding libraries and extensive computing facilities across campus, equipped with specialist software for dynamic learning. Access cutting-edge practical technologies relevant to biopharmaceutical development 12 13

8 Professional and career development Entry requirements The course is designed to train talented scientists wishing to pursue a career in drug development in the international biopharmaceutical industry. You will be exposed to senior industrialists working as tutors throughout the course and can take this opportunity to obtain career advice. Furthermore, you will work in industry full-time for 12 months, which represents an outstanding opportunity to develop a competitive career plan. On completion of the course, you will have the relevant knowledge and experience to fast-track your career as, for example, an analytical scientist, project manager, or coordinator, in areas such as research, quality control, manufacturing, project management, non clinical, clinical, and market access. Leeds for Life We take personal and career development very seriously. Our proactive Industrial Advisory Board advises us on what they look for in graduates and on employability-related skills within our courses. The Faculty s Employability and Professional Development Officer will ensure you are aware of events and opportunities to increase your employability. In addition, we have an excellent Careers Centre offering a wide range of services (CV preparation researching jobs, roles and companies; interview training; careers fairs). Leeds graduates have an excellent reputation amongst employers. The University is ranked 3rd in the UK and top 20 in the world for graduate employability (QS Graduate Employability Rankings, 2016). Leeds for Life is a University-wide initiative, designed to ensure you get the very best personal development support during your time here. At the heart of Leeds for Life is personal tutoring. You ll have regular and structured meetings with your personal tutor who will guide your academic and personal development. They ll help you to talk clearly and confidently about your experiences and the knowledge and skills you develop. The initiative also brings together lots of co curricular opportunities, including access to the Leeds Network, where you can make contact with our alumni community. They can help your career planning by providing you with an invaluable insight into their career path and chosen industry. How to apply Normally a 2:1 honours degree or equivalent in a biological sciences subject, bioprocessing or biochemical engineering, but relevant experience may be taken into account. In addition, applicants will need to demonstrate leadership potential, which could be evidenced from academic, sporting, volunteering or other professional experience. We would encourage you to apply as early as possible, so you can apply for funding, accommodation and a visa, if appropriate. Before you apply, we recommend you take some time to read our latest admissions policy for this course at biopharmecuticaltraining Applying for a postgraduate course is easy. You can apply online and track your application at each stage of the process at Along with your application form, we also require a copy of your degree certificate (if applicable), your undergraduate degree transcripts, your CV and two academic references. In addition, we require a personal statement from you, which might include details of your education, interests and experience. You will also need to provide two short audio or video recordings (90 seconds each) covering a) you and your suitability/candidacy for the course, and b) your leadership potential and experience/ style/achievements. These will be used as part of our assessment and shortlisting process. Application deadline The deadline to apply for a place is 31 March, Successful candidates will normally be invited to attend an interview within four weeks of the application deadline. Candidates will be informed of the outcome as soon as possible. The interview will be a full day, comprising an introduction to the course and the selection process, a tour, a series of assessed group activities and a formal (panel) interview. Applicants who require a Tier 4 (general) student visa are not permitted to study this MSc Biopharmaceutical Development. This course includes a mandatory work placement that consists of more than 50% of the total length of the course. The UKVI Home Office will not issue a visa if the duration of any work placement exceeds 50%. Further information can be found at Applications from international candidates who do not require a Tier 4 visa are welcomed and encouraged. Please contact our Taught Postgraduate Admissions team directly: fbspgt@leeds.ac.uk Scholarships A number of postgraduate scholarships are available for UK, EU and international students, from the University of Leeds, and from external sponsors. Eligibility for scholarships and bursaries will vary according to the scholarship

9 Faculty of Biological Sciences University of Leeds Leeds, LS2 9JT