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TIBBS Summer Series Session 4: Getting Things Done: How to do Science in an Industry Setting
Getting Things Done: How to do Science in an Industry Setting
Part I: Transitioning from a University Setting to Industry in a GLP Environment
Keynote Speaker: Patricia O’Brien Pomerleau, M.S., RQAP-GLP
Biography: Patricia O’Brien Pomerleau is a Registered Quality Assurance Professional in GLPs (RQAP-GLP) by the SQA. She has been in Quality Assurance (QA) for 30 years. Recently, she became a consultant. Before that, she was Director of Quality Assurance and managed the Archives at The Hamner Institutes for the Health Sciences in Research Triangle Park, NC for over 21 years. She has experience in QA and Good Laboratory Practice (GLP) regulations and has managed and directed a QA group for inspecting preclinical studies, performed in-house and at contract laboratories, under the GLP regulations in an FDA and EPA regulated setting. Her previous experience in QA includes Manager of QA for GLPs and GCPs at Rhone-Poulenc Rorer Pharmaceuticals. Patricia has given over 90 professional presentations, including invited lectures at the FDA National Training Course on the Non-Clinical (GLP) Biomedical Monitoring program. She is a member of the NCSOT, the NCCSQA and the SQA University and GLP Specialty Sections. Patricia earned her B.S. degree in Biology from Marymount College and her M.S. in Cellular Biology from Fairleigh Dickinson University.
Summary: Patricia gave some background information on why Good Laboratory Practices (GLPs) were established for industry, what regulations are in place to enforce them, and the agencies that enforce them. She also discussed her experiences as a Registered Quality Assurance Professional.
The History Behind Good Laboratory Practices (GLPs)
GLPs exist to ensure that the end product of a safety study that a company produces is valid and that the data behind it is not fraudulent. The establishment of the regulations was a result of a 1976 investigation by the Food and Drug Administration (FDA) into Industrial Bio-Test Laboratories (IBT). It was estimated that, at this time, IBT was performing 35 – 40% of all toxicology tests in the United States. The FDA’s investigation turned up many instances of incorrect documentation, data falsification, inadequately run studies, and no sponsor reviews, among other questionable practices. The original 1983 article on IBT’s poor conduct can be read here, courtesy of Planet Waves.
The investigation led to a senate hearing, in which it was deemed that IBT’s staff was unqualified, adequate documentation was not maintained, study plans either did not exist or were changed mid-way through, and they had major issues with animal care and protocols. There were inconsistencies in final reports and issues with archives, as well as data falsification. For example, a pathologist examining tissues for IBT found lesions but was forced to change this in his documentation by the company. The major issues that were identified were documentation and conduct.
Overall, the FDA and senate discovered that not all science was quality science. Based on the hearing, the senate concluded that non-clinical federal regulations for safety studies in industry were needed in order to protect the public. Good Manufacturing Practices (GMPs), which were put into place to ensure high-quality work in manufacturing, were taken and adapted for laboratory work, resulting in GLPs. The FDA first came up with these regulations in 1979, while the Environmental Protection Agency (EPA) developed two more sets.
Doing Science in a GLP-Regulated Environment
The GLP regulations are intended to support the pre-clinical safety of compounds. Although they are meant to assure the quality and integrity of the work, they do not assure or regulate science. The regulations establish standards for documentation and traceability of the work and focus on getting high-quality data into an archive where it can speak for itself in the future. This puts controls on pre-clinical studies. Both the FDA and EPA have inspection agents that visit companies to ensure they are meeting GLP requirements.
Where to find GLP regulations:
US FDA Code of Federal Regulations (CFR) 21 CFR Part 58
US EPA Toxic Substances Control Act (TSCA) 40 CFR Part 792
US EPA Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 40 CFR Part 160
Organisation for Economic Co-operation and Development (OECD) Principles of GLPs and Guideline Documents
Scientific Safety Study References
International Conference on Harmonisation (ICH) Guideline Documents on Nonclinical Safety Studies for Pharmaceuticals M3
FDA Guidance for Content and Format of Nonclinical Pharmacology/Toxicology Section of an Application
EPA Office Chemical Safety and Pollution Prevention (OCSPP) Harmonized Test Guidelines Series
The links above will help guide you through the GLP regulations and ensure that the study you design meets the required safety standards. Following is another set of useful resources to orient you to GLP requirements and prepare you for a GLP inspection:
FDA Application Integrity Policy You must perform your studies according to this policy or the FDA could pull your project’s approval
FDA Compliance Policy Guidance Manual for GLPs [7348.808] This is a useful checklist to ensure you are prepared for an inspection on your GLP compliance
FDA Compliance Policy Guidance Manual for GLPs; EPA Data Audit Inspections[7348.808A]
FDA List of GLP Inspection
This page lists the most recent inspections done by the FDA, the names of the companies inspected, and whether voluntary, required, or official action was taken regarding GLP compliance
This is useful to check before agreeing to work with a contract lab
This is a list of warning letters the FDA has written to non-compliant investigators and/or companies
Investigators and/or companies are given 15 days to correct their mistake; if not, they can be barred from conducting future studies
FDA Guidance for Content and Format of Nonclinical Pharmacology/Toxicology Section of an Application This will guide you through designing an effective pre-clinical study
FDA Exploratory Investigational New Drug Application (IND) Studies
FDA Content and Format of IND
FDA Content and Format of New Drug Application (NDA)
ICH Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 (R2) This is a good reference for the steps you will need to include in your studies in order to meet GLP standards
EPA GLP Standards Page
EPA GLP SOPs Page
EPA SOP for Audits for Determining Compliance of Studies with GLP Standards Requirements
EPA List of GLP Inspections
This is the EPA’s list of companies it has recently inspected
Companies are not ranked but their cases are either open or closed; if a case is open too long, it may indicate that the company is still attempting to correct non-compliance or is still communicating with EPA on issues
EPA TSCA GLP Enforcement Response Policy
EPA FIFRA GLP Enforcement Response Policy Violations of both the TSCA and FIFRA policies may result in fines and jail time
Series 870 – Health Effects Test Guidelines These guidelines will help you decide what techniques to use when investigating the health effects of your compound
OECD Series on Principles of GLP and Compliance Monitoring A list of downloadable papers on the OECD’s GLP principles
FDA, EPA, OECD Comparison Chart – GLPs A useful chart comparing the differences between FDA and EPA GLP regulations
North Carolina Chapter of the Society of Quality Assurance This local society usually has 4 meetings in the Research Triangle Park area per year and will keep you up to date on ethics, the GLP standards and many other topics
Differences Between Academic and Industry Settings in Light of GLPs
The chart below outlines the things we are used to working with in academia and how they are defined in industry under GLP regulations:
Part II: Intellectual Property Awareness Discussion
Speaker: David J. Levy, Ph.D., J.D., Of Counsel, Womble Carlyle Sandridge & Rice
Biography: Dr. David Levy is a patent attorney with a solo practice. He brings nearly 40 years of high-level pharmaceutical and life sciences patent experience to his practice. David created the U.S. Patent Group for pharmaceutical giant GlaxoSmithKline, and served as the company’s Vice President and Patent Counsel. Because of his background, David is in a unique position to advise general counsel on organizing and structuring patent teams and patent portfolios, particularly those related to the pharmaceutical industry. He provides strategic advice on patent portfolio approaches and other patent-oriented organizational issues, taking into account the organization’s structure and the legal and regulatory environment the company operates in. Prior to joining GlaxoSmithKline, David worked as patent counsel with Johnson & Johnson and with ICI Americas, Inc. David has extensive experience writing and prosecuting U.S. and foreign patent applications for corporate clients, managing patent litigation, including interferences, and in licensing pharmaceuticals as both the negotiator and author of licenses. He has significant experience in all phases of patent practice, particularly in pharmaceuticals and specialty chemicals.
Summary: David’s presentation focused on intellectual property and the process of patenting your idea.
Intellectual property is not tangible, although it can be perceived in something tangible. The chart below summarizes types of intellectual property and how the law protects them.
Richard C. Hsu, 2011
The following graphic summarizes the steps involved in patenting your idea:
David Levy, 2012
After coming up with a patentable idea, a provisional application must be filed with the U.S. Patent and Trademark Office. Twelve months later, a non-provisional application is filed and the patent becomes pending. It takes three to five years for the patent to be issued, but the resulting patent is active for twenty years. Maintenance fees are required during this time period at the time points indicated in the graphic above. In 1984, the Hatch-Waxman Act was passed, which extends the protection of a patent for up to five years beyond the initial twenty. Further, it made it easier for generic drugs to enter the market by requiring that they prove bioequivalence of their product to the patented product. This way, generic drug makers do not have to spend the money on clinical safety studies already done by the patented product, making it easier and cheaper for generic drugs to get to the market. The wording of the patent can also cover more compounds than were actually made. More information on the patenting process can be found here.
In 1980, the Bayh-Dole Act was passed. It created a uniform patent policy among the federal agencies that fund research, allowing universities to retain rights to inventions made with federal funding. More information on this act can be found here. It also encourages universities to collaborate with companies in order to develop inventions made with federal funding. Under the act, universities are expected to file patents on inventions they want to own and to give licensing preference to small businesses.
About the author: Dana Walsh is a second year graduate student in the Curriculum of Toxicology at the University of North Carolina at Chapel Hill. She works with Dr. Ilona Jaspers at UNC and Dr. David Diaz-Sanchez at the Environmental Protection Agency Environmental Public Health Division. Her research focuses on how air pollution affects the microorganisms inhabiting the airways and their relation to disease.
Posted by Dana Walsh at 9/07/2012 02:33:00 PM 1 comment: Links to this post
TIBBS Summer Series Session 3| How does my personality type determine my leadership style?
Part 1| MBTI Self-Assessment and interpretation
Speaker: O. Ray Angle, Director of University Career Services, University of North Carolina at Chapel Hill
Biography: Ray Angle has more than 20 years of experience in college career services and teaching. Ray was appointed Director of University Career Services in March 2010. He has served similar roles at Cal State East Bay, Webster University, Millikin University, Saint Louis University and Bradley University. He earned a bachelor’s degree in Business Education from Southern Illinois University-Carbondale and a master’s degree in College Student Personnel Administration from the University of Central Missouri. He has been actively involved in several professional associations including the National Association of Colleges and Employers (NACE), and has served as President of the Midwest Association of Colleges and Employers (Midwest ACE). He has been invited to speak domestically and internationally on a variety of topics including career and professional skill development and leadership.
Session Synopsis: In this session of the TIBBS Summer Series: Essential Skills for Success in Industry, Ray Angle emphasized the importance of understanding personality types when interacting with and leading a team. Using the Meyer’s Briggs Type Indicator (MBTI) Instrument, Ray explained how to perform a personality self-assessment. More information about the MBTI self-assessment and an example of the testing criteria can be found here.
According to the MBTI theory, personality type can be broken into four preference areas. These preference areas exist as a spectrum, and each person will have a tendency to associate with one side of the spectrum. The four preference areas are summarized below:
1. What is your energy source?
a. Extroversion: Energy is attained from outer world (i.e., other people, activities, things, etc.)
b. Introversion: Energy is attained from the inner world (i.e., thoughts, ideas, imagination, etc.)
2. How do you perceive and understand?
a. Sensing: Understanding is obtained by present or past sensory information and is reality-based.
b. Intuition: Understanding is based on insight, learned patterns and relationships, and may be more conceptual (i.e., “big picture).
a. Thinking: Decisions are made in an objective and logical manner.
b. Feeling: Decisions are made from the heart and are subjective.
4. How do you organize your life and interact with the outside world?
a. Judgment: Actions are planned.
b. Perception: Actions are more spontaneous and flexible.
Based on your preferences, a MBTI personality type is assigned and can provide insight on the ways you think and act within a team setting. Understanding MBTI personality types can help leaders learn how to communicate with their team most effectively. By recognizing that others may think and act differently based on their personality type, a leader can harness an individual’s strengths and skills for the betterment the team.
Part 3| Leading a team
Speaker: Robert L. St. Claire, III, Ph.D., Vice President, Chemistry, Qualyst Transporter Solutions, LLC
Biography: Dr. St. Claire has 26 years of experience in the fields of bio-analytical and analytical chemistry within the pharmaceutical and biotechnology industry. As a senior technical leader at Glaxo, Glaxo Wellcome, Triangle Pharmaceuticals, Gilead Sciences, and most recently, Qualyst Transporter Solutions, his primary focus has been in novel technology development, methods development, and teaching. His most notable accomplishments have been in the development of technology supporting analysis of intracellular metabolism. He holds bachelors and masters degrees in biochemistry and a doctorate in chemistry.
How does personality type affect team leadership?
Based on his many years of experience both as a team member and a team leader, Dr. St. Claire emphasized that personality type plays a key role in determining both leadership style and team success. Though a team represents a diversity of personality types and skills, the goal of the team is to accomplish a single objective. Thus, the challenge for a team leader is to recognize and channel the diverse skills of the team to achieve a common goal. Dr. St. Claire discussed how to lead a team, with a focus on teams generally no larger than 30 – 60 individuals in size. He noted that size is a very important determinant of the demands and expectations of a team leader. Not every leadership style is properly matched to the size and purpose of the team to be lead.
How can I be an effective team leader?
Dr. St. Claire’s advice for leading a team is to blend the practical and the ideal by combining managerial and leadership skills. At times, a team leader may need to act as a manager to establish organization, set rules, and address problems with specific team members. Other times, the team leader may need to inspire new ideas and make risky decisions. A good team leader must maintain focus in such a way that individual initiative and creativity are encouraged and rewarded. The key is to recognize and value the individual personalities and employ these diverse skills for the benefit of the team.
Dr. St. Claire also advises that there should be minimal separation and distinction between the team leader and the team. For example, a team leader may choose to maintain space in the lab and work directly with his/her team. This leadership style is often challenged by “higher ups” in management who may push you to do only management. Thus, a team leader may feel that this leadership style engenders feelings of loneliness, as the leader may not feel like a part of either group (the “front line workers” or “more traditional management”).
What is the reward of good leadership?
The reward of good leadership is an effective team when things get rough. The team leader must learn to manage fear and to absorb some of the fear and punishment to keep the team going. If the team leader minimizes separation from the team and puts the team and its objectives above his or her own personal interests, the members of the team will be more likely to trust the leader in tough times and achieve great things even in the face of adversity
What are the consequences of poor leadership?
With poor team leadership, the lower rankings may feel all the misery trickling down and falling on them. The team will often fail to achieve its goal, and team morale will be low.
How can students and postdocs “learn” leadership skills?
Graduate students and postdocs often have a poor understanding about leading a team because at this point in their training it is still all about their personal objectives. Many PhDs are thrust into a team leader position and may fail due to lack of leadership skills. Though some skills are inherent, most are formed by being part of an effective team and learning from the team leader. It is never too late to start working on your leadership skills, so take every opportunity to participate in team settings and practice leading a team.
Posted by Rebecca Bauer at 8/24/2012 03:01:00 PM No comments: Links to this post
TIBBS Summer Series Session 2: Communication and Professionalism
Part 1: Business Communication
Keynote Speaker: Mary Bennett, MBA, Leadership Consulting
Biography: Mary Bennett is a leadership consultant specializing in communications planning and training, strategic planning, strategic human resources, leadership development, media and investor relations, executive coaching, facilitation, conflict management, and organizational redesign. She has worked in large and small organizations primarily in the healthcare, pharmaceutical, and biotechnology fields. Mary is certified in Neurolinguistic Programming and Crucial Conversations, and has significant experience guiding companies through the human resource and organizational development challenges of large mergers and acquisitions. She has a BA in Behavioral Science from National Louis University and an MBA from Duke University.
Mary gave an interactive presentation on effective communication. Following are key points from her talk, which was titled “Connection: The Art of Communication”:
Connecting with the person to whom you are speaking is a crucial component of effective communication. We naturally know how to connect with others and understanding how we do this allows us to improve our communication skills. There are three important traits that can be developed to help make you better make connections: (1) Chemistry and rapport; (2) confidence and poise; and (3) credibility and integrity. These traits will be discussed in detail below.
1. Chemistry & Rapport
You can establish chemistry and rapport with another person by being aware of your use of body language, vocal inflection, and words. Your communication style (A), impact (B), and awareness (C) influence the connection you make with him or her.
A. Communication Styles:
There are three types of communication style. Most people have a dominant style even though they may use aspects of all three. The following chart outlines the three styles and how you can determine the dominant style of the person you are speaking with based on verbal and body language cues.
Ideas are images; learns best from pictures and graphics
Ideas are sounds or stories; learns well from verbal instructions and manuals
Ideas are feelings; learns by doing
Image words: “I see”
Sound words: “Sounds good,” “I hear you”
Action words: “I get it”
Up or staring into space
Being aware of these styles can help you improve communication with others. Knowing his or her style will guide you in how to present your ideas so that he or she effectively understands them.
B. Communication Impact:
The following pie chart details the importance of words, body movement, and voice in communicating with others. Your voice and body movement convey more meaning than the words you say.
Mary Bennett, 2012
C. Communication Awareness:
We naturally match others’ body language and voice in order to get in sync with the person with whom we are communicating. Being aware of these can help you increase the effectiveness of your communication.
Body Language Component
Pitch, speed, accent
Relaxed or rigid, leaning towards the person or away
Match pace and volume
Match duration of eye contact
Also be aware of cultural differences in body language. In the United States, we value personal space; however, people in other countries may be comfortable getting closer to you. Acceptable eye contact may also differ; in Western countries, people may be uncomfortable if eye contact is not made, whereas in other cultures it is polite to rest the eyes on the other person’s body.
2. Confidence & Poise
There are three useful components (A-C) of confidence and poise when communicating:
A. Know Your Stuff
· Be able to tell your story in “one contact, one page, and one touch."
Come up with a concise way to describe yourself and your work that someone meeting you for the first time will remember easily (“one contact”)
Develop an elevator speech; know what you want to say and how you want to deliver it
Having this prepared will help you focus on the other person and improve your connection with them
· Write and memorize your key messages
Find the answers to things you are afraid people will ask
Use the media test: make sure your 3 – 4 messages are things you would like quoted if the media contacted you
Remember that how you deliver your message is more important than the words you say
· Respond to challenges with curiosity
Your first response to a challenge may be fight-or-flight, but you can be curious instead
Be curious about what you are being challenged about and ask questions to understand your challenger
This will help you learn about, understand, and connect to your challenger
B. Practice Everything
· Find a role model and/or mentor that you respect and admire; emulate them and seek their advice.
· Practice content and connection
Practice connecting with strangers by striking up a conversation with people you meet in passing
Practice matching their body language and voice. Use your dominant style as a form of practice (e.g., for visual communicators: visualize the room, visualize how you will look, sound, and feel, visualize that you will behave and act in a confident manner; for auditory communicators, practice out loud; for kinesthetic communicators, act it out and find people with whom to practice)
· Have at least two people read any of your written materials for content, flow, accuracy, and impact
· Actively seek feedback and thank the giver
· Don’t make excuses or defend yourself; thanking the person doesn’t necessarily mean that you agree with them, but it will make it more likely that this person will give you honest feedback in the future
3. Credibility & Integrity
The following points will help you establish credibility and integrity in your communication skills:
· Use your matching and rapport building skills when communicating but also be genuine and authentic
· Be willing to admit when you don’t know something
· Speak positively or neutrally of other people; never speak negatively
· Be honest about what you can and can’t deliver; if you are willing to speak honestly about information that is negative, people will be more likely to trust your positive information
· Trust your internal moral compass and do what feels right
For more resources on effective communication, Mary Bennett suggests the website Way of the Mind as well as the book NLP at Work by Sue Knight. Online searches using “Neurolinguistic Programming” as key words will also help you find useful sources.
Part II: Communication Workshop
Keynote Speaker: Cathy Innes, Director, UNC Office of Technology Development
Biography: Cathy Innes received her BS in Industrial Engineering and Operations Research from the University of California, Berkeley. With several years of practical experience in manufacturing management and industrial engineering, she turned her focus on contract management and marketing before moving into the area of technology transfer. Cathy came to the Office of Technology Development at UNC-Chapel Hill to take on the role of Director with 14 years of experience in all facets of university technology transfer. In addition to her academic and experiential credentials, Cathy has been active in professional organizations related to university technology transfer, including the Association of University Technology Managers (Board of Trustees, 2003-2005), the Licensing Executives Society, Council for Governmental Relations, and the National Council of University Research Administrators. She is a frequent speaker at technology transfer conferences and seminars worldwide.
Summary: Cathy’s talk focused on the practicalities of communication in her career in technology transfer. She also gave some useful advice on refining your resume and cover letter and on preparing for interviews.
As the director of the Office of Technology Development, Cathy works at the interface of the academic and business worlds. These have two very different cultures and different ways to convey ideas. She helps researchers take their ideas and translate them into commercial opportunities. She listed some common pitfalls she encounters in speaking with these scientists:
Many bright scientists are good at writing about all the details of their project; however, in order to market their idea to businesses, they need to know how to convey its importance and why a company should care about it
The scientist should be able to take his or her idea and translate it to the business world: does it solve a problem? Does it make a process better, cheaper, or faster?
He or she should also be able to find a way to engage companies; the key is to make the connection quickly and then get into the science
In academia, there is time to discuss the intricate details; however, in industry, you need to get to the main point quickly by breaking down the concepts and thinking about what you really want your listener to take away about your research
If you were to come to Cathy seeking a job, she would be looking for the following:
A multifaceted job experience allowing you to interact with scientists and business people
Strong communication skills; since Cathy’s job is to talk about and understand why science matters, it is important to know what questions will get you the necessary information and understand why a business should care about a researcher’s work
An elevator pitch; use this to hone in on skills you have that are important in industry
Flexibility; Cathy spends her day switching gears between business and science in meetings, writing emails, giving presentations
Why business excites you; a lot of people like that business gets you closer to the product getting to the public and that you get to see results from your ideas
The ability to talk to people comfortably and easily
The ability to take a direct approach that is specific about the idea rather than the science; this helps non-science people understand it
Cathy’s tips for resumes and cover letters:
Conduct informational interviews with people who have the job you want; ask them what the position is like, what a day in their life is like, what skills are important for them, and how you might develop those skills
As a scientist, you may be making a career transition into the technology development field; you may not have direct experience but the skills you do have can translate to the field; be sure to stress what you’ve done, how it is relevant to the job, and why it is important to the person hiring you
Put yourself in the role of the employer; explain why you are valuable and how you can solve their problem
Your publications and research are less important here; emphasize your business skills and relevant experience, such as your communication skills and lab management experience
Make the content of your resume and interview fit your purpose
Keep in mind that the purpose of the resume is to get you an interview, so it doesn’t need to convey everything you’ve done; keep it to two pages
A CV is not appropriate in this field; busy technology development professionals will not have time to wade through 40+ pages, so narrow it down to what’s most important and relevant
A cover letter gives you the flexibility to highlight your key message and emphasize why the company should hire you; however, brevity and accuracy are important here
Network, network, network! Meeting people at events may help you build connections to find the job you want
Do your homework on the job; know what they’re looking for, what you bring, and how you are the best fit
Step away from your academic experience and focus on your transferrable skills, like communicating effectively, managing subordinates, and thinking critically and analytically
Stress your ability to comfortably talk with people; ask questions and show your curiosity
The employer is trying to assess you and whether you will fit into their culture
Evaluate your skill set; industry may be very different from academia, but it is likely that you have developed many transferrable skills
About the author: Dana Walsh is a UNC graduate student in the toxicology curriculum working on the effects of pollution on human health.
Posted by Dana Walsh at 8/17/2012 09:16:00 AM No comments: Links to this post
Biography: Dr. Robert Cook-Deegan, MD is the Director for Genome Ethics, Law & Policy at Duke University. He got received his medical degree from the University of Colorado and a bachelor’s degree in chemistry from Harvard College. Following two years of postdoctoral research on the molecular biology of oncogenes at the University of Colorado, Dr. Cook-Deegan was awarded an AAAS Congressional Science & Engineering Fellowship in 1982 and spent six years at the congressional Office of Technology Assessment. Dr. Cook-Deegan held several positions at The National Academies from 1991-2002, when he joined Duke’s faculty. Dr. Cook-Deegan wrote The Gene Wars: Science, Politics, and the Human Genome (New York: Norton, 1994) about the launching of the Human Genome Project.
Synopsis: Though the federal government is a vital source for research funding, the decisions and policies that govern scientific research often seem far removed from everyday research. Based on three decades of experience teaching and working at the intersection of science/technology and policy, Dr. Cook-Deegan delivered a candid look at working in science policy, with a few pointers about how to start a career in science policy.
How does the organization of academic and government institutions differ?
Academic institutions are based on a social dominance hierarchy and are organized into disciplinary silos. Though politics play a role in determining the academic hierarchy, competence and merit are usually the major determinants of your position. By comparison, most government institutions are organized into what Dr. Cook-Deegan describes as “tribes.” In government institutions, loyalty and trust count as much as competence and merit for determining your position. Additionally, though academic culture is heavily invested in written communication, oral communication is still the mainstay for politics. Thus, establishing a large network of personal references in government that can speak to your communication skills and trustworthiness is important for obtaining and maintaining a career in science policy.
What is the best way to get into science policy?
There are lots of science policy jobs, but most are obtained through social networks. Thus, the better question is “how does one break into the social network for science policy?” Beyond knowing someone already working for the government, nonprofit group, or trade group, a great channel into the network is through science policy fellowships, such as the American Association for the Advancement of Science (AAAS) and National Academies’ fellowships.
The AAAS Science and Technology Policy Fellowships and the Christine Mirzayan Science & Technology Policy Graduate Fellowship Program at the National Academies are designed to provide fellows with an opportunity to engage in science policy and learn about the process which informs U.S. science and technology policymaking. The AAAS fellowship is open to PhDs or other doctorates (and some other advanced degrees, depending on the sponsoring society) at all stages of their career. The AAAS places fellows in either congressional offices or government executive branch agencies for a one- to two-year tenure. The Christine Mirzayan fellowship matches graduate students, professional school students, and postdocs who have completed graduate studies (degree awarded within the last five years) with a mentor in one of the National Academies’ units for a 12-week experience. Since members of the National Academies serve as advisors to the federal government for scientific and technological matters, but are not actually part of the federal government, the Christine Mirzayan fellowship does not place fellows in federal agencies. Rather, the fellows work on policy projects underway at the National Academies.
Fellowship awards are merit-based, making the fellowships an excellent entry for policy novices to break into the DC social network and make connections. The fellows are not expected to have previous experience in science policy; however, some indication that applicants have an interest in science policy and demonstrate excellent social and communication skills is expected. One good way to show this is to write about science, technology, medicine or another technical field for a general audience, blog on policy issues, or do something to keep your interest alive and demonstrate it to others.
Once you are into the network, you are part of a community of trust, and you are apt to find opportunities you did not even know existed. Washington, DC is in constant ferment, as many members of the staff rotate through congressional offices and nongovernment organizations before heading off to other careers. Turnover is therefore generally high, although this is not as true in executive branch positions.
What are the typical daily activities for science policy jobs?
The only way to know the answer to this question is to experience it yourself. The daily activities differ based on your specific job and agency, and there is a wide variety in these activities. Some experiences are narrow, while others are quite broad. For example, if you work for the National Institutes of Health (NIH), you may work primarily on organizing peer review, writing program announcements, or otherwise helping design research programs that are fairly focused. Alternatively, if you work in the personal office of a member of Congress, you may cover health policy, science policy, and some constituency services.
With congressional offices, the daily activities depend on your supervisor (i.e., the Senator or Representative in Congress who is elected and gets to vote) and his or her committees. Daily life consists of meetings, reading, and communication via phone/email in order to gather information to pass onto the Senator/Congressman. For example, if the Senator/Congressman is part of the Senate Finance committee or House Ways and Means Committee, your job would consist mainly of reading news and technical data and writing memos for the senator/congressman to help them make decisions on tax policy or issues that arise in the entitlement programs. In contrast, if you work for the House Science Committee, you are likely to focus on holding hearings and advancing bills that “authorize” government action, but you would not have much direct influence over budget matters. In executive branch agencies, you would be working on the concerns of your immediate office, which will generally have a specific function.
Can you still engage in science policy and not work for a government agency?
Yes, in many ways. Many organizations in the policy network interact with government, but are nonprofit. Trade groups also often have science policy components (especially those in “high tech” fields such as biotechnology, medicine, space, telecommunications, computing and information technologies, environment, agriculture, or energy).
Science policy also works through many expert advisory bodies. The National Academies committees consist of experts in the field from many backgrounds who write reports to pass on to policymakers. AAAS also has many policy committees, and most agencies have many expert advisory groups. Thus, you can have a career in research and still participate in science policy if you are a scientific or technical expert.
What is the outlook for federal funding of science and technology?
In terms of research funding, Dr. Cook-Deegan feels that NIH and NSF (National Science Foundation) will survive relatively well because they are appreciated by Capitol Hill. Science, technology, and healthcare are recognized as vital for the U.S. economy and necessary to cure disease. However, the current financial situation for science in government agencies is nonetheless bleak. NIH and NSF may be spared some of the budget concerns that may afflict other programs, but it is unlikely to escape the next few years unscathed.
For government employees, morale is low as they are worried about shutdowns and furloughs and feel undervalued. Both political parties are running campaigns “against Washington,” and federal employees are regularly pilloried in the presidential campaigns. Many agencies are currently under a hiring freeze, and a freeze is quite common after presidential elections.
The silver lining is that the AAAS fellowship program is growing because the commitments are short term (1-2 years), AAAS does the brunt of the recruiting work for agencies, and AAAS fellows do valuable work but are not counted as federal employees. Agencies thus get talent vetted through a national network that does not come with a permanent commitment, making the science policy fellowships an excellent pathway into science policy networks, even during tough economic times.
Posted by Rebecca Bauer at 8/10/2012 11:00:00 AM 2 comments: Links to this post