This book lays out - in a simple straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts with outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur.
Working in a company demands different skills from those required to conduct research in a university setting and the book concentrates on the key skills required in managing research projects. The book emphasises the importance of concentrating on market needs from as early a stage as possible and how to plan for success rather than hope that it arrives. Managing high performance scientific teams in a company setting is also a highly skilled business that needs careful thought and planning.
A successful product will ultimately engage areas of expertise beyond that of even the most multi-skilled laboratory scientist. Finding partners to support or license the onward development of a compound is a key step for ensuring the survival and growth of the company. Most licensees or investors will expect some clinical validation for a new product and this will involve clinical and regulatory input. The key to success is to get this advice in as early as possible in the product development process. This practical book leads the reader through what needs to be done, who you need to talk to and what questions you might need to ask.
• No other 'how to' manual exists for this sector
• Written by a range of expert professionals in each area, all in one book
• Is the only 'bench to bedside' book covering the whole spectrum of development
• Covers key business and managerial skills
• Will be especially useful to biotechnologists in areas away from major biotech clusters, who may not have easy access to such information
- Introduction and overview - so you want to manage in biotech?; skills, knowledge expertise; know yourself; a few points to consider; the business plan and why is planning so important?
- Money, raising it, keeping it, spending it - grants; angel investor; VC; some pointers on financial management
- The basics of protecting your intellectual property - patents; what to patent; when to patent; patent and publication Technology transfer - what technology transfer is looking for; license or spin out?
- Managing innovation - can innovation be managed?; principles of project management?
- Managing scientists, 'herding cats - being your own consultant; dealing with high performance teams and individuals
- Buying in and selling on - portfolio management; balancing risk; identifying needs; searching for opportunities; getting your product noticed; how to value a project; due diligence
- Regulatory aspects of new therapies - read this first; overview of the regulatory process; dealing with regulatory bodies; special topics for biotechs: biologicals, biosimilars, orphan diseases
- Clinical trials: design and practice - start with the patient in mind; trial design; phase 1; phase 2; what does my data mean?
People working in management in biotech; would be entrepreneurs; people working in biotech away from major US and European clusters (Australasia, India and China) where mentoring and experience is not always available.
Dr O'Neill has had a career of more than 20 years working in neuroscience research in the pharmaceutical industry, working for Merck, Laboratorios Almirall and Eli Lilly. Michael's career has given him an expert knowledge of neuroscience balanced with a strong grasp of strategic principles drug discovery and development.
Michael has authored over 80 papers, book chapters, patents and abstracts. He has presented his work at major international scientific conferences. He has held an adjunct appointment and has supervised PhD students at various leading universities.
Michael is an accomplished research leader with extensive program and portfolio management experience. He has lead specialist and multidisciplinary teams in the UK, Europe and in the US. As a consultant Michael has helped companies of all sizes from university start-ups to Fortune 500 companies. This book is the distillation of all that experience.