c



 
      


 


 



 


A Report of the AAPS

Pharmaceutical Technologies Section
Education Committee

˜

˜ 


 



 
 



% 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.

 
 
% Ajaz Hussain, Ph.D.
Reputy Rirector, Office of Pharmaceutical Science, CR
, FR
% ames McGinity, Ph.D.
Professor and Chair, Pharmaceutics, University of Texas
% Stephen Nail, Ph.D.

esearch Fellow, Lilly
esearch Laboratories
Michael Pikal, Ph.D.
Professor and Chair, Pharmaceutics, University of Connecticut
% David Savello, Ph.D.
Vice President, Cardinal Health Inc.
% oseph Schwartz, Ph.D
Professor/Rirector, Industrial Pharmacy
esearch, Phila. Coll.Pharmacy
%
arry Augsburger, Ph.D. (Chair)
Shangraw Professor, Industrial Pharmacy/Pharmaceutics, Univ. of MR
% Anil Salpekar, Ph.D. (Ex Officio)
Vice President, Solvay Pharmaceuticals Inc.
ï

% 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 oint 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.
ï

% 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
³biological-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
±
ack of support from both federal sources and the
industry itself.
R.V. Smith, ³Doctoral Education for the Pharmaceutical Industry, Drug
Devel. Ind. Pharm., 7(4): 461-482 (1981).
 ï

% 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 ³very 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: ³Academic Pharmaceutics: The Challenge of Excellence,´ AAPS

Task Force report, Pharm. Res., 7(7): 782-785 (1990).
ï

% In 1997, Alice Till, then president of GPIA
observed:
% Today¶s graduate programs are ³training 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, ³Graduate Education in the Pharmaceutical Sciences: How Can It
Better Meet the Needs of the Generic Pharmaceutical Industry?,´ Pharm.
Res. 14 (7), 837-838 (1997).
ï

% 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 ³rapidly
contribute to success in the business environment,´
± the challenge ³comes 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, ³Challenges Faced by the Pharmaceutical Industry: training
Graduates for Employment in Pharmaceutical R & D,´ Europ. . Pharm. Sci.,
12: 353-359 (2001).
ï

% 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.R. 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.
One outcome of this situation is that the post-
post-
doctoral fellowship has become a virtually
required component of higher education in
such disciplines.
*D. . Triggle, K.W. Miller, ³Doctoral Education: Another Tragedy of the Commons?,´ Am. .
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]
V 
 !" 
% 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.
°
% A web-based survey of the
membership.
% A focused survey directed to
executives in representative
sectors of the industry.
°! 
% 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.
 
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% 50 pharmaceutical executives targeted.
% Presidents (10%), vice presidents (40%),
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)
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% Undergrad degrees in pharmacy (regardless
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20%
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0-10% 11-25% 26-50% 51-75% >75%
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§




 
   


   













 

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% Executives
30%
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64%
% Staff having ONLY a degree in an
engineering field (entry level or advanced)
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% S  having degree(s) ONLY in
scieniic disciplines oher han
pharmacy or engineering


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% 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 ³back-
filling´ these additional skills on the job.
 



% 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 ³deep´ 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).
  




% 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.
  




% A dramatic increase in µpractice¶
faculty in colleges of pharmacy
clearly reflects a shift in emphasis in
pharmacy schools.


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1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003
Yer
  




% et, this relatively static number
basic sciences faculty has produced
a growing number of Ph.D.s,
especially in pharmaceutics.
`


 


180

160

140
Courtesy of Kenneth W.
120

PCEU
Miller, Ph.D., Vice
President, Graduate
100 MDCHM
PCOL/TOX
80 SADS/PP
OTHER Education , Research
60

40
and Scholarship, AACP
20

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!

% How do we create awareness in
colleges and universities of our
needs and the 
 
 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
µgalvanizer¶ 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?
 §


(3..4
§


(

³Ensuring the Supply of Qualified

Pharmaceutical Scientist Specialists
in Product Development and Related
Technologies That Meet Current and
Future Needs´