Resources
This section serves as a dynamic extension to the printed book for all readers and educators. Click on plus '+' signs below to see more details in each section.
The example syllabus (available from the author by request) envisions a project based inter-disciplinary course with students from science, engineering and business. The final project submission is a presentation and written product commercialization roadmap (not a business plan). The students benefit by application of the principles in the book to a concrete product.
However, the exercises at the back of each chapter can also be used to construct a set of deliverables/homework assignments in the class if a project is not chosen.
Typical courses where this book is useful:
- a biotechnology entrepreneurship course
- a capstone design or product development course in biotechnology or biomedical engineering
- part of a business school curriculum on biotechnology business
- an exec MBA course for device or drug sector executives
- a technology transfer training course focused on biomedical technologies
- self-guided course for entrepreneurs who wish to create a product development roadmap
Slide Deck With Textbook Images
A slide deck (powerpoint format) with all the figures from the text book is available from the publisher or by request from the author.
Case Studies
The following case studies are suggested to be used with each chapter. Please also refer to the links below for additional reading associated with specific chapters.
- Life Sciences Revolution. HBS 9-602-118
- The pharmaceutical industry: challenges in the new century. HBS 9-703-489
- Note on understanding and valuing intellectual property. Ivey Publishing 9A95B012
- Technical Note: Intellectual property- the ground rules. Kellogg (KEL 140)
- Survivor Scios - Reality biotech (Anatomy of a growing biotech company). Kellogg (KEL 070)
- Connectics and Relaxin (company strategy, management strategy of trial failure). Stanford (E-200)
- Serono (implementation of a balanced scorecard for employee incentives and company strategy). Babson (BAB043)
- Fred Khosravi and Access Enclosure (entrepreneur's dilemma - grow or sell the medical device company). Harvard (HBS N9-806-044)
- Intuitive surgical - negotiating the deal (new medical device venture organization and financing). Harvard (HBS 9-202-094)
- Diagnostic Genomics (business strategy and reimbursement). Harvard (HBS 9-302-004)
- Drug eluting stents: a paradigm shift in the medical device industry (technology development and market and business strategy). Stanford (OIT-50)
- deCode Genetics: Hunting for genes to develop drugs (privacy of genetic information and business model). Harvard (HBS 9-706-040)
- Surface Logix (new drug venture based on discovery technology - business model strategy). Harvard (HBS 9-802-050)
- We’ve got rhythm! Medtronic corporation’s cardiac pacemaker business. Harvard (HBS 9-698-004)
- Guidant: Cardiac Rhythm Management Business (A) and (B). Harvard (HBS 9-698-021 and HBS 9-698-024)
- Immusol and Novartis. Harvard (HBS 9-303-038)
- Eli Lilly. Harvard (HBS 9-698-010)
- Ethics: a basic framework. Harvard (HBS 9-307-059)
- Biomedical Ethics. Harvard (HBS 9-603-079)
- GlaxoSmithKline: Reorganizing Drug Discovery (A and B). Harvard (HBS 9-605-074)
- Aspect Medical Systems. Harvard (HBS 9-600-076)
- Amgen Inc’s Epogen. Harvard (HBS 9-706-454)
- Biogen Unchained. Harvard (HBR Reprint F00305)
- I've got rhythm - Selling cardiac rhythm management devices. Harvard (HBS 9-304-012)
- Genomic Health: launching a new paradigm shift and an innovative new test (diagnostic test and reimbursement structure). Stanford (OIT-49)
- Myriad and Oncormed and the marketing of the first genetic tests for breast cancer susceptibility. Stanford (BME-3)
- Diagnostic Genomics (business strategy and reimbursement). Harvard (HBS 9-302-004
- Drug eluting stents: a paradigm shift in the medical device industry (technology development and market and business strategy.) Stanford (OIT-50)
Discussion Forum
The forum is currently set up as blog for updates, additional cases and educators exchange, and is a living and dynamic extension of the book. Visit the Discussion Forum to see the various topics that have been opened up.
Websites - Links for additional reading
RPI Library webpages with databases and additional resources and links : these library webpages are developed and maintained by the RPI librarians for use with the book; the site has excellent database links for statistics, hints on searching for industry and market data etc...
- RPI Library webpages with databases and additional resources and links : this website is developed and maintained by the RPI librarians and has excellent database links for statistics, hints on searching etc...
- www.bio.org – Biotechnology Industry Organization
- www.phrma.org – Pharmaceutical Research and Manufacturers Association
- www.medicaldevices.org - Medical Device Manufacturers Association
- www.advamed.org - the world's largest medical technology association representing manufacturers of medical devices, diagnostic products and medical information system
- RPI Library website on market, industry, regulatory and entrepreneurship information.
This website was developed by the RPI librarians for the course titled "Commercializing Biomedical Technologies."
- RPI Library website on patent searching, links to USPTO and WIPO database etc.
This website was developed by the RPI librarians for the course titled "Commercializing Biomedical Technologies." - www.autm.net - website for Association of University Technology Managers
- www.uspto.gov - US patent and trademark office
- www.european-patent-office.org - European Patent Office
- www.patents.com/trademar.htm - Trademark link
- www.ladas.com/Trademarks/tmprot.html - Trademark link
- www.patentbaristas.com - Patent blog (an excellent blog for patent news and opinions)
- www.patentdocs.net/patent_docs - Biotech and Pharma-specific Patent Blog
- www.fda.gov/cder/ob/default.htm - Orange Book (Pharmaceutical product-related patent list)
- RPI Library website on market, industry, regulatory and entrepreneurship information.
This website was developed by the RPI librarians for the course titled "Commercializing Biomedical Technologies." - www.gpoaccess.gov/cfr - Code of Federal Regulations
- www.fda.gov - Guidance for management controls and quality
- www.fda.gov/cdrh/qsr/contnt.html - Device design controls details; excellent advice and guidelines for product development
- www.ich.org - International Conference on Harmonisation
- www.pharmweb.net/pwmirror/pwk/pharmwebk.html - A list of foreign regulatory bodies
- www.fda.gov - US FDA guidance and approval records for drugs, devices, diagnostics and combination products
- RPI Library website on market, industry, regulatory and entrepreneurship information.
This website was developed by the RPI librarians for the course titled "Commercializing Biomedical Technologies." - www.fda.gov/cder - starting point
- www.fda.gov/cder/foi/index.htm - Freedom of Information Act (Access detailed records on drug approval letters and reviews; also online now)
- www.fda.gov/cder/regulatory/applications/default.htm - Drug approval process overview
- www.fda.gov/cder/handbook/ - CDER handbook and regulatory guidance
- http://www.fda.gov/cdrh - Starting point at the FDA website
- http://www.fda.gov/cdrh/devadvice/ - Device Regulatory Pathway Advice
- http://www.fda.gov/cdrh/qsr/contnt.html - QSR Manual and design controls details; excellent advice and guidelines for product development
- http://www.fda.gov/cdrh/oivd/index.html - Starting point at FDA
- http://www.fda.gov/cdrh/oivd/regulatory-overview.html - regulatory process FAQs
- http://www.fda.gov/cdrh/oivd/guidance/1205.html - Analyte Specific Reagents guidance
- www.fda.gov/oc/combination - Office of combination products
GENERAL REGULATORY WEBSITES
DRUGS
DEVICES
DIAGNOSTICS
COMBINATION PRODUCTS
- RPI Library website on market, industry, regulatory and entrepreneurship information.
This website was developed by the RPI librarians for the course titled "Commercializing Biomedical Technologies." - ts.nist.gov/Standards/Conformity/stdpmr.cfm - Basics of standards in the US
- www.iso.org/iso/en/aboutiso/introduction/index.html - ISO website
- www.fda.gov/cder/guidance/pv.htm - Process validation guidance FDA
- RPI Library website on market, industry, regulatory and entrepreneurship information.
This website was developed by the RPI librarians for the course titled "Commercializing Biomedical Technologies." - www.cms.gov - CMS Centers for Medicaid and Medicare Services
- www.medpac.gov - MedPAC – advisory to Congress on Medicare
- www.cdc.gov/nchs/ - National Center for Health Statistics ( USA )
- www.bcbs.com - Blue Cross Blue Shield
