Seminar BIOL417/508:
Research and development in a biotechnology company
Spring 2013
Michiel J.T. van Eijk
Phone: +31 6 1308 8013 (international)
E-mail: michiel.van-eijk@keygene.com
Ancha Baranova
Phone: 571-334-1145
E-mail: abaranov@gmu.edu
Research and development (R&D) in a commercial environment is conducted with the aim to bring commercial success to the company. As a consequence, decision making about research- and product development equally takes into account scientific, innovation, business development and intellectual property (IP) perspectives. Examples of successful biotechnology inventions will be used as cases to introduce students to R&D in a company environment.
Specific emphasis will be given to plant biotechnology.
This course will provide insight into how research is performed in a project-based fashion. Students will develop practical skills in setting the milestones for company-run R&D project, and get acquainted with the budget planning and the monitoring of the project progress, the IP considerations, including topics of patenting opportunities and criteria, trade secrets, public disclosure, and the obstacles on the road to the commercialization of R&D project results.
Course requirements:
Grades in this seminar are based on the home work assignment (40%), your participation in class discussion (20%), and in-class exam (40%). Due to the condensed teaching of this class
(over the Spring break), the assignment will be distributed in advance of the class through the
Blackboard, but it is expected that the assignment is completed based on information taught in the Lectures. Hence the due date will be following Monday (first office day after the class is over). The printed homeworks are to be brought to MSN 3E1 mailbox at the Fairfax Campus
(Biology Office) for attention of Dr. Baranova and, in parallel, emailed to Prof. van Eijk
( michiel.van-eijk@keygene.com
)
Lectures:
Day 1 :
- introduction to Research and Development (R&D) process in industry using Keygene N.V. company as a study case
- an overview of a variety of career paths available in biotechnological industry
- Workshop: guided discussion on R&D success factors as well as commercial and career opportunities
Day 2:
detailed discussion of Amplified Fragment Length Polymorphism (AFLP
®
) and Whole-
Genome Profiling (WGP
TM
) technologies and their applications in agricultural biology
Drafting and evaluating a work plan for a research project in an industry environment
Workshop: defining research objectives, milestone planning, budget calculations, progress monitoring. How to deal with setbacks.
Day 3:

Guest lecture: “From R&D to business development in Biotechnology sector” by Dr.
Mark van Haaren (MBA), CEO Keygene Inc, Rockville MD.
Workshop: drafting a product plan; topical discussions on types and goals of the contracted research and on outlicensing of biotechnologies.
Day 4:
Intellectual properties: patents and trademarks.
Invention Disclosures
Patenting criteria - novelty, inventive step and industrial applicability; importance of reduction to practice (patent Examples) and how to write a patent claim.
Patent filing strategies
Enforcing a patent
Good Laboratory Practice implementations in R&D environment
Workshop; Q&A session about Intellectual Property aspects related to commercial R&D
Day 5:
Guest lecture, Dr. Cohava Geber, CEO SerpinPharma and Caerus Discovery
Discussion of the home-work assignment. Discussion of the research workplan format.
Course evaluation.
EXAM
Content of exam:
 40% of the grade will be awarded based on Final exam. Contents of the Final exam will be the “general reading” materials placed on the Blackboard as .pdf files and the subjects covered in-class. The exam will be in multiple choice format, on green scantron forms.
Homework assignment:
 Your homework assignment would be the writing of a 3 to 5 page Research and Development Plan that you will make using examples provided. For your proposed R&D Research, please look into Genetic
Engineering and Biotechnology News ( http://www.genengnews.com/ ) for topic inspirations, however, you should not feel limited by this source.
 IMPORTANT: for Research and Development Plan you may choose to work individually or as a group of two or three students (no more than 3). In such case you should submit ONE plan per group, and indicate that this is a group work with names of each student at the front page. The grade for groupwise Research and Development Plan will be identical for all group participants
 IMPORTANT: the skill of time management is a very important advantage for one trying to gain an employment in Biotechnology (or any employment, for that matter). That is why we strongly urge you to start working on home assignment BEFORE the class, at least in part of study group formation and the choice of the topic for Research and Development Plan. The
due date for this home work will be Monday
(first office day after the class is over). The printed homeworks are to be brought to MSN3E1 mailbox at the Fairfax Campus (Biology Office) for attention of Dr. Baranova and, in parallel, emailed to Prof. van
Eijk ( michiel.van-eijk@keygene.com
). In printed homework, the front page shall be hand-written signed by all group participants.
Literature placed on the Blackboard.

HONOR CODE:
 All students enrolled in this course are expected to strictly adhere to the University Honor Code which protects honest students and serves to maintain the academic integrity and reputation of George Mason
University, and by extension the value of the degree earned herein.

The Instructor is fully committed to supporting individual honesty and refusing to tolerate any form of dishonesty in accordance with the University Honor Code. Students are strongly encouraged to report any suspected Honor Code violations to the University Honor Code Committee.