Gimble J.M. Academia to Biotechnology: Career Changes at any Stage
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Personnel resources
for document control systems, 46
laboratory closures and, 116–117
ratios between students/fellows/
technicians, 98
recruitment in laboratory environment,
97–100
Pharmaceutical companies, 153
factors in choosing, 83
organizational hierarchy in, 89
postdoctoral fellowships at, 74
Pharmacology, documenting in product
design process, 41
Phase I cohort studies, 41–42
Phase II analyses, 42
Phase III analyses, 42
in biotech companies, 90
PhD thesis, timing of completion of, 81
Photomicrographs, 23
Physical resources, documenting, 50
Plant models, land grant universities and
studies on, 74
Plasmids
documenting, 52
inventories of, 94
Possible outcomes, 23
considering in manuscript format, 22
Postage costs, 107
Postdoctoral fellows, 7
award expectations in academia and
industry, 123–124
publication expectations for, 108
Postdoctoral positions
choice of mentor, 75–78
choosing, 73
cultural criteria for selecting, 75
defining goals for, 73
financial considerations in selecting,
81–82
institutional critieria for selecting, 74–75
intellectual criteria for, 80–81
interpersonal criteria in selecting,
75–78
negotiating agreements for, 80–82
personal criteria in choosing, 78–79
temporal considerations in selecting, 81
vs. biotechnology company
employment, 83–92
Postdoctoral salaries, 82
Postmarketing monitoring, in product
design process, 43–44
Preclinical development, in product
design process, 40
Preclinical outcomes, 37
Preclinical study findings, 41
Preliminary data, 23
in grant applications, 26, 29
Preliminary operations, 50
Preoperational requirements, 50
Preventive maintenance, 95
Principal investigators, in grant
applications, 17
Priority dates, 33–34
critical importance of, 34
Private research foundations, grants from,
17
Private universities, 74
revenue-generating endowments at, 75
Proactive approach
in patent applications, 19
to experimental protocols, 59
Procedures
documenting, 47
for experimental methods, 68–69
Process, patenting, 35
Product handling, in product design
process, 41
Product launches, 37
Product safety/purity/potency, 42
Product stability, in product design
process, 41
Productivity
communications and, 9
mentor expectations for postdoctoral
fellows, 80
of mentors’ laboratories, 76
Progress section, in grant applications, 26
Project management, 152–153
Project sponsors, 153
Promotion skills, 131–132
Proteomes, 28
Protocol and conduct of nonclinical
laboratory studies, in GLP
inspections/audits, 57
Protocols
documenting, 47
in laboratory setup, 96
Provisional Patent Application, 34, 36
Public disclosure
of laboratory closings, 114
patents and, 18
unauthorized, 18–19
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Public speaking skills, 3–5
Public universities, 74
Publications
expectations in academia and industry,
119–120
expectations in laboratory environment,
107–108
importance in academia and industry, 3
importance of frequency of mentor’s,
77
patent applications and, 18
recruiting via, 128
Publicly traded companies, 90
Purchasing officers, in laboratory
environments, 105
Q
Quality Assurance Unit (QAU), 47
in GLP inspections/audits, 55
Quality control/assurance, 47, 53
as biotech subculture, 12
in product design process, 41
role of standard operating procedures
in, 72
R
Racism, in hiring practices, 150
Radioactive materials, inventories of, 94
Rationales, in experimental protocols, 60
Raw materials, in product design process,
41
Reagents and solutions, in GLP
inspections/audits, 56
Record of invention, 33–34, 34
Records and reports, in GLP
inspections/audits, 57–58
Recruiting skills, 127–128
Reduced tuition payments, 82
Reduction to practice, 34
Reference letters, company policies
regarding, 133–134
References
checking in hiring process, 98
from current employers of job
candidates, 100
References section
for experimental methods, 68–69
in experimental protocols, 60
in grant applications, 26, 31
Reports, inventories of, 94
Reproducibility
role in good laboratory/manufacturing
practices, 46
role of standard operating procedures
in, 71
Research
as biotech subculture, 11
suddenness of priority changes in
biotech, 84
Research centers, in public universities,
74
Research foundations, grants from, 17
Research phase, in product design
process, 40
Research specialties, in biotech, 85–86
Resource allocation issues
at public vs. private universities, 75
in academia vs. biotech, 138
in grant applications, 29
Resource management, by job candidates,
101
Resources section, in grant applications,
26, 28
Responsibility, role in good
laboratory/manufacturing practices, 4
Responsibility lists, 103
Responsibility section, for experimental
methods, 68
Results section, in manuscript format, 22
Resumes, updating, 92
Retirement bonuses, 88–89
Retirement plan contributions, 107
Retroactive approach, in patent
applications, 18
Reviewing, of manuscripts and grant
applications, 19–20
Risk, in biotech vs. academia, 85, 140
Royalties, on patented information/
products, 35, 37
S
Sabbaticals, 109
Safety and efficacy studies, 42
Safety Update Report, in Biologics License
Application, 43
Salaries
in academia vs. industry, 138, 140
in laboratory environments, 106–107
routine increases in academia, 131
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Salary incentives, 82
in biotech vs. academia, 85, 88–89
Sales pitch, grant writing as, 25
Science, communication essential to, 1
Science, 80
Scientific method, manuscript design
according to, 21
Scooped patents, 33
Scope of studies, 17
for experimental methods, 68
Secretarial support costs, 107
Securities and Exchange Commission, 90
Security consciousness
in biotech companies, 90
in inventory systems, 96
Selection criteria, for postdoctoral
positions, 74–80
Self-confidence, critical in public
speaking, 3
Seminars
as recruitment tools, 128
public speaking skills in, 3
role in laboratory development, 109–110
Service costs, in laboratory environments,
107
Service manuals, 95–96
Sexism, in hiring practices, 150
Shared responsibilities, in laboratory
environment, 102–103
Shared-equipment grants, 121
Shipping costs
accounting for in grant applications, 27
avoiding redundant, 105
Sibling departments, interfacing with,
11–13
Sick leave benefits, laboratory closure
issues and, 115
Significance section, in grant applications,
26, 28
Situation knowledge, of job candidates,
101
Small Business Innovative Research
(SBIR) grants, 17
commercialization plan for, 30
Small Business Technology Transfer
(STTR) program, 17
Source materials, in product design
process, 41
Speaking engagements, expectations in
academia and industry, 123–124
Speaking skills, 3–5
Specific aims, 23
in grant applications, 26, 28
Speculation section, in experimental
reports, 65
Spreadsheets, use in laboratory setup,
93–95
Staff turnover, experimental protocols
and, 61
Stage fright, 5
Standard operating procedures (SOPs),
71–72
in laboratory setup, 96
relative importance in academia vs.
industry, 136
Standardization
of documents in experimental
protocols, 59
role in good laboratory/manufacturing
practices, 46
State funding, 75
Statistical methods, in determining
inducing factors, 61
Statistical significance, 23
Statistical tools, defining in grant
applications, 29
Statistics section, in Biologics License
Application, 43
Stock options, in biotech companies, 89,
139, 140–141
Strategic partnerships, 42
in biotechnology companies, 84
Stroke economy, 151
Structure, of communications, 6–7
Subcontract/consortium costs, in grant
applications, 31
Subjectivity, reducing in interpretation of
experimental results, 61
Summary of Invention, in patent
applications, 36
Summary tables, in grant applications, 26
Supply costs, in grant applications, 27
Support staff, 102–103
Surreptitious interviews, 110
T
Tables, 23
in grant applications, 26
Take home messages, 23
Tangible infrastructure, in choice of
postdoctoral mentor, 78
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Target audience, in grant applications, 27
Task delegation, 103–104
Teaching responsibilities, 153–154
and postdoctoral autonomy, 79
expectations in academia and industry,
122–123
in personal development, 153–154
Team building, 152–153
Technology Transfer Office, 34, 88
Telephone costs, 107
Tenure review committees, 120
Test and control article specifications, in
GLP inspections/audits, 57
Test methods, 67
Test protocols, 59
Test reports, 3
Test results, 30
Testing facilities operations, in GLP
inspections/audits, 56
Therapeutics, federal approval process
for, 39–44
Thomson-ISI, 23–24
Thought organization, 3
Time allocation issues, in grant
applications, 29
Timelines, in grant applications, 29
Timing
critical to patent applications, 19,
33–34
for beginning postdoctoral fellowships,
81
of invention, 34
Tissue specimens, inventories of, 94
Title of the Invention, 36
Trade secrets, 35
Transcriptomes, 28
Translational clinical research, 39
Troubleshooting, in experimental
protocols, 59
U
U.S. Department of Agriculture, 121
U.S. Department of Defense, target
audience for grant applications to, 27
U.S. Food and Drug Administration
(FDA), 39, 53
regulatory process for biotech
companies, 92
use of standard operating procedures
by, 72
U.S. Patent and Trademark Office
(USPTO), Provisional Patent
Application filings, 34
Unauthorized deviations, 47
Unemployment insurance, laboratory
closures and, 114
User-friendly inventory systems, 96
Utility, in patent applications, 34
V
Vacation benefits, laboratory closure
issues and, 115
Validation acceptance criteria, 50
Validation protocols, 49
Venture capitalists, 16, 84
biotech companies founded by, 90
Verbal communication skills, 2–6
Verification mechanisms, role in good
laboratory/manufacturing practices, 46
Veterinary accreditation bodies, 30
W
Word-of-mouth recruiting, 128
World Trade Organization (WTO), patent
conventions according to, 34
Written communications, 3–6
improving skills in, 5
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