“ “ Is There a Crisis in the Supply Is There a Crisis in the Supply of Qualified Pharmaceutical of Qualified Pharmaceutical Scientist Specialists in Product Scientist Specialists in Product Development and Related Development and Related Technologies?” Technologies?” Larry L. Augsburger, PhD. Larry L. Augsburger, PhD. University of Maryland University of Maryland Baltimore, MD Baltimore, MD Report of the AAPS Report of the AAPS armaceutical Technologies Secti armaceutical Technologies Secti ucation Committee ucation Committee
Transcript
““Is There a Crisis in the Supply of Is There a Crisis in the Supply of Qualified Pharmaceutical Scientist Qualified Pharmaceutical Scientist
Specialists in Product Development and Specialists in Product Development and Related Technologies?”Related Technologies?”
Larry L. Augsburger, PhD.Larry L. Augsburger, PhD.University of MarylandUniversity of Maryland
Baltimore, MDBaltimore, MD
A Report of the AAPS A Report of the AAPS Pharmaceutical Technologies SectionPharmaceutical Technologies SectionEducation Committee Education Committee
ChargeCharge• To seek ways to ensure the supply
of highly qualified pharmaceutical scientist specialists in product development and related technologies that meet current and future needs.
This charge was borne out of a sense that graduate programs in colleges of pharmacy are increasingly
failing to produce sufficient numbers of appropriately qualified specialists in product development and related pharmaceutical technologies and that the
pharmaceutical industry has been forced to recruit and train scientists from other disciplines.
Composition of CommitteeComposition of Committee• Ajaz Hussain, Ph.D.
Deputy Director, Office of Pharmaceutical Science, CDER, FDA
• James McGinity, Ph.D. Professor and Chair, Pharmaceutics, University of Texas
• Stephen Nail, Ph.D. Research Fellow, Lilly Research Laboratories
Michael Pikal, Ph.D. Professor and Chair, Pharmaceutics, University of Connecticut
• David Savello, Ph.D. Vice President, Cardinal Health Inc.
• Joseph Schwartz, Ph.D Professor/Director, Industrial Pharmacy Research, Phila. Coll.Pharmacy
• Larry Augsburger, Ph.D. (Chair) Shangraw Professor, Industrial Pharmacy/Pharmaceutics, Univ. of MD
• Anil Salpekar, Ph.D. (Ex Officio) Vice President, Solvay Pharmaceuticals Inc.
BackgroundBackground• Concern expressed as early as 1978 in a
Symposium of Teachers of Pharmacy (Pharmaceutics) held at the 25th National Meeting of the A.Ph.A. Academy of Pharmaceutical Sciences– lack of financial support and its impact, – potential negative impact of the growing
clinical emphasis in undergraduate programs in pharmacy
– types and sources of funding available Proceedings of the Joint Session of the AACP Section of Teachers of
Pharmacy (Pharmaceutics) with the A.Ph.A. Academy of Pharmaceutical Sciences, Academy of Pharmaceutical Sciences 25th National Mtg,
November 12, 1978.
BackgroundBackground• A 1981 survey of industrial managers and
academicians revealed an acute shortage of Ph.D. pharmaceutics scientists in industry, especially in the industrial/physical pharmacy area. – Shift in the interest of graduate students toward more
“biological-type” sciences– Movement of faculty during the previous 10 years more
toward biopharmaceutics and pharmacokinetics– Cost of investment in the equipment, space and faculty
needed for industrial pharmacy programs is prohibitive – Lack of support from both federal sources and the
industry itself.
R.V. Smith, “Doctoral Education for the Pharmaceutical Industry, Drug Devel. Ind. Pharm., 7(4): 461-482 (1981).
BackgroundBackground• 1990 AAPS Task Force on academic pharmaceutics:
– Pharmaceutics has provided much of the intellectual stimulus for the development of clinical pharmacy, but this did not result in students having an enhanced interest in academic pharmaceutics per se because most students enter pharmacy school to become pharmacy practitioners.
– If the “very substantial demand” for pharmaceutical scientists cannot be met by pharmacy schools, industry and academia will turn increasingly toward other discipline areas to meet manpower needs and attempt to compensate for lack of pharmaceutical education and training in such individuals by providing in-house and commercially available training programs.
Commentary: “Academic Pharmaceutics: The Challenge of Excellence,” AAPS Task Force report, Pharm. Res., 7(7): 782-785 (1990).
““This practice is unsound and could create a vicious This practice is unsound and could create a vicious cycle whereby the limited availability of newly graduated cycle whereby the limited availability of newly graduated pharmaceutical scientists eventually reduces the demand pharmaceutical scientists eventually reduces the demand for them…” for them…”
BackgroundBackground• In 1997, Alice Till, then president of GPIA
observed:
• Today’s graduate programs are “training the majority of students for the minority of industrial opportunities.” – Graduate programs are more and more focusing on
drug discovery, and that basic research is often emphasized over applied research.
– May be the result of specific faculty interests, funding issues or a lack of understanding of the wants and needs of industry,
– The net result is that programs in industrial pharmacy or pharmaceutical manufacturing have been de-valued, and programs in material science, formulation science or process science are uncommon.
A.E. Till, “Graduate Education in the Pharmaceutical Sciences: How Can It Better Meet the Needs of the Generic Pharmaceutical Industry?,” Pharm. Res. 14 (7), 837-838 (1997).
BackgroundBackground• Mooney (Pfizer Global R & D), addressed the
manpower needs of the European pharmaceutical industry at a 2001 EUFEPS workshop: – universities are not keeping up with the demands of the
pharmaceutical and healthcare industries for science and engineering graduates who can “rapidly contribute to success in the business environment,”
– the challenge “comes from balancing education in basic science with training in the emerging areas of science and technology”
– academia and industry will need to work together more synergistically
– multi-disciplinary programs are going to be more and more important
– government funding should be prioritized to take into account industry’s needs
K.G. Mooney, “Challenges Faced by the Pharmaceutical Industry: training Graduates for Employment in Pharmaceutical R & D,” Europ. J. Pharm. Sci., 12: 353-359 (2001).
• In a 2002 analysis, Triggle and Miller* – noted that “recent dramatic increases in the
federal support of biomedical research… is producing an excess of Ph.D. graduates in the biomedical sciences,” and
– suggest that this increase in graduate program enrolment is driven more by personnel needs of the academic research community and less by employment needs or even the educational needs of graduate students.
BackgroundBackground
*D.J. Triggle, K.W. Miller, “Doctoral Education: Another Tragedy of the Commons?,” Am. J. Pharm. Educ., 66, 287-294 (2002). [authors of the 1998 the report of the AACP Commission on the Future of Graduate Education in the Pharmaceutical Sciences]
One outcome of this situation is that the post-One outcome of this situation is that the post-doctoral fellowship has become a virtually doctoral fellowship has become a virtually required component of higher education in required component of higher education in
such disciplines.such disciplines.
‘‘First Step’ ObjectiveFirst Step’ Objective• To assess the current state of the
problem:– Who is doing technology and
formulation?– What is their educational background? – What is industry’s attitude, position and
needs with respect to the supply of qualified pharmaceutical scientists for product and process development.
MethodologyMethodology
• A web-based survey of the membership.
• A focused survey directed to executives in representative sectors of the industry.
Member SurveyMember Survey
• 5000 sent; 398 responses. • Targeted PT, PDD and BT AAPS sections. • Nearly 70% hold Ph.D. degrees • Nearly 60% of responders obtained highest
degree in an area of pharmaceutics (i.e., physical pharmacy, industrial pharmacy, dosage forms and drug delivery).
• Nearly 1/3rd managers, directors, section heads or their equivalent.
• More than half (53%) in the pharmaceutical industry for 11 years or more.
Currently available education/training of entry-Currently available education/training of entry-level Ph.D. pharmaceutical scientists is level Ph.D. pharmaceutical scientists is adequate preparation for positions in adequate preparation for positions in product development groups in the product development groups in the
pharmaceutical industry.pharmaceutical industry.
0%
10%
20%
30%
40%
50%
% Respondants
Stronglyagree
Agree NoOpinion
Disagree StronglyDisagree
Entry level scientists should have a strong Entry level scientists should have a strong background in preformulation and background in preformulation and materials science as well as unit materials science as well as unit
operations in manufacture of operations in manufacture of pharmaceutical products as part of their pharmaceutical products as part of their
Ph.D. program.Ph.D. program.
0%
10%
20%
30%
40%
50%
% Respondants
Stronglyagree
Agree NoOpinion
Disagree StronglyDisagree
A strong background in basic science is A strong background in basic science is sufficient for an entry level scientist since sufficient for an entry level scientist since materials science, processing and product materials science, processing and product
development experiences can be picked up development experiences can be picked up on the job.on the job.
0%
10%
20%
30%
40%
50%
% Respondants
Stronglyagree
Agree No Opinion Disagree StronglyDisagree
There is a current shortage of entry-level There is a current shortage of entry-level scientists with an appropriate background scientists with an appropriate background in product development and pharmaceutical in product development and pharmaceutical
technology.technology.
0%
10%
20%
30%
40%
50%
% respondants
Stronglyagree
Agree NoOpinion
Disagree StronglyDisagree
There is no shortage of suitably trained There is no shortage of suitably trained pharmaceutical scientists due to the current pharmaceutical scientists due to the current abundance of experienced pharmaceutical abundance of experienced pharmaceutical
Would prefer to hire Ph.D. level chemists and Would prefer to hire Ph.D. level chemists and chemical engineers and have them learn on chemical engineers and have them learn on
the job to fill current voids and needs for the job to fill current voids and needs for scientists in product development and scientists in product development and
Pharmaceutics graduate students entering product development groups need a strong
background in product development and drug delivery since current pressures on industrial scientists do not allow time to
mentor and train entry level pharmaceutics graduates.
0%
10%
20%
30%
40%
50%
60%
% Respondants
Stronglyagree
Agree NoOpinion
Disagree StronglyDisagree
Fewer colleges of pharmacy in the United Fewer colleges of pharmacy in the United States focus on the product States focus on the product
development/technology needs of the development/technology needs of the industry.industry.
0%
10%
20%
30%
40%
50%
% Respondants
Stronglyagree
Agree NoOpinion
Disagree StronglyDisagree
A decline in U.S. trained scientists will result A decline in U.S. trained scientists will result in the exportation of product development in the exportation of product development
activities to foreign countries. activities to foreign countries.
various levels of directors (42%), others (8%).• 30% response rate• >90% consider PT their primary section• In the pharmaceutical industry at least 11
years• Have Ph.D. (86%) or Masters degrees• 86% of all respondents degrees in
pharmaceutics (defined as physical pharmacy, industrial pharmacy, or product development)
What percentage of staff engaged in product What percentage of staff engaged in product development activities in your firm or development activities in your firm or division has an undergraduate degree in division has an undergraduate degree in pharmacy regardless of what discipline their pharmacy regardless of what discipline their advanced degree (s) are:advanced degree (s) are:
What percentage of staff engaged in product What percentage of staff engaged in product development activities in your firm or development activities in your firm or division has an advanced degree in division has an advanced degree in
What percentage of staff engaged in product What percentage of staff engaged in product development activities in your firm or development activities in your firm or
division only has an entry level or division only has an entry level or advanced degree in an engineering advanced degree in an engineering
field?field?
What percentage of staff engaged in product What percentage of staff engaged in product development activities in your firm or division development activities in your firm or division only has an entry or advanced degree in other only has an entry or advanced degree in other science fields (physical chemistry, physics, science fields (physical chemistry, physics, biochemistry, etc.)biochemistry, etc.)
On scale of 0 to 4 (0 = more qualified On scale of 0 to 4 (0 = more qualified candidates than openings; 4 = cannot fill candidates than openings; 4 = cannot fill current positions), how would you rate the current positions), how would you rate the level of difficulty in finding qualified people level of difficulty in finding qualified people
to fill product development positions?to fill product development positions?
0%
10%
20%
30%
40%
50%
% Executives
Least Most
Level of Difficultyin Finding Qualified People
Assuming 0–2 yrs experience, compare a Ph.D. in industrial pharmacy, pharmaceutical technology or related area to graduates of other science disciplines you have seen in the following attributes.
Assuming 4–6 yrs experienceAssuming 4–6 yrs experience, compare a Ph.D. in , compare a Ph.D. in industrial pharmacy, pharmaceutical technology industrial pharmacy, pharmaceutical technology or related area to graduates of other science or related area to graduates of other science disciplines you have seen in the following disciplines you have seen in the following attributes.attributes.
Summary AnalysisSummary Analysis• Entry-level product development scientists
should bring to the position a good basic sciences background, but, in particular, be strong in preformulation, materials science and unit operations.
• Firms increasingly have been forced to recruit and train scientists from other disciplines. – Executives report that 50% or less of product
development staff have undergraduate degrees in pharmacy and that 50% or less have advanced degrees in pharmaceutics/industrial pharmacy/pharmaceutical technology.
• There is not only a shortage of entry-level scientists with appropriate background in product development and pharmaceutical technology, but also a lack of suitably experienced pharmaceutical scientists seeking employment.
• Bringing the appropriate background to the job is preferable to having a good basic science background and “back-filling” these additional skills on the job.
Summary AnalysisSummary Analysis
• Entry-level Ph.D.s in industrial pharmacy, pharmaceutical technology or related areas bring a better mix of skills to the product development table than their counterparts from other science disciplines, and this advantage persist even after 4-6 years experience on the job.
• Firms go to extraordinary efforts to recruit for product development, using every means available, including going “deep” into the network. – 70% of executives reported the level of difficulty
in filling these positions to be 3 or higher on a 4-point scale (4 = greatest difficulty).
Summary AnalysisSummary Analysis
• The number of graduate programs in industrial pharmaceutics, product development and pharmaceutical technology is severely limited.– The focus of pharmacy school core
curricula has been shifting away from the basic sciences and toward preparing pharmacy practitioners.
– There is a lack of stable funding for industrial pharmacy graduate programs.
Educational IssuesEducational Issues
Educational IssuesEducational Issues• A dramatic increase in ‘practice’
faculty in colleges of pharmacy clearly reflects a shift in emphasis in pharmacy schools.
Number of Full-time Pharmacy Faculty by Discipline
Courtesy of Kenneth W. Miller, Ph.D., Vice President, Graduate Education , Research and Scholarship, AACP
• Yet, this relatively static number basic sciences faculty has produced a growing number of Ph.D.s, especially in pharmaceutics.
Educational IssuesEducational Issues
PhD Degrees Awarded by Discipline 1983-2003
0
20
40
60
80
100
120
140
160
180
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
Year
PCEU
MDCHM
PCOL/TOX
SADS/PP
OTHER
Courtesy of Kenneth W. Miller, Ph.D., Vice President, Graduate Education , Research and Scholarship, AACP
However, academic pharmacy is not necessarily rising to the challenge of supplying entry-level scientists with appropriate background in product
development and pharmaceutical technology.
Questions to be ResolvedQuestions to be Resolved• How do we create awareness in colleges
and universities of our needs and the incentives to develop and maintain programs in industrial pharmacy and technology?
– Corollary: How can stable funding be provided for such programs?
• How can FDA’s PAT and Pharmaceutical Quality Systems for the 21st Century initiatives be a ‘galvanizer’ for garnering support for and appreciation of the role of industrial pharmacy and technology?
• Will traditional academic programs in pharmaceutics or industrial pharmacy alone be sufficient to meet the scientific and technical challenges implicit in FDA’s new initiatives?
• Where (how) should pharmaceutical scientists specializing in product development and related technologies receive their training?
“Ensuring the Supply of Qualified Pharmaceutical Scientist Specialists in Product Development and Related Technologies That Meet Current and Future Needs”
