“Is There a Crisis in the Supply of Qualified Pharmaceutical Scientist Specialists in Product Development and Related Te

1. “Is There a Crisis in the Supply of Qualified Pharmaceutical Scientist Specialists in Product Development and Related Technologies?” Larry L. Augsburger, PhD. University of Maryland Baltimore, MD A Report of the AAPS Pharmaceutical Technologies Section Education Committee

2. Charge • 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.

3. Composition 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 LaboratoriesMichael 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.

4. Background • 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.

5. Background • 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).

6. Background • 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. “This practice is unsound and could create a vicious cycle whereby the limited availability of newly graduated pharmaceutical scientists eventually reduces the demand for them…” Commentary: “Academic Pharmaceutics: The Challenge of Excellence,” AAPS Task Force report, Pharm. Res., 7(7): 782-785 (1990).

7. Background • 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).

8. Background • 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).

9. Background • 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. One outcome of this situation is that the post-doctoral fellowship has become a virtually required component of higher education in such disciplines. *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]

10. ‘First 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.

11. Methodology • A web-based survey of the membership. • A focused survey directed to executives in representative sectors of the industry.

12. Member 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.

13. Currently available education/training of entry-level Ph.D. pharmaceutical scientists is adequate preparation for positions in product development groups in the pharmaceutical industry.

14. Entry level scientists should have a strong background in preformulation and materials science as well as unit operations in manufacture of pharmaceutical products as part of their Ph.D. program.

15. A strong background in basic science is sufficient for an entry level scientist since materials science, processing and product development experiences can be picked up on the job.

16. There is a current shortage of entry-level scientists with an appropriate background in product development and pharmaceutical technology.

17. There is no shortage of suitably trained pharmaceutical scientists due to the current abundance of experienced pharmaceutical scientists seeking employment.

18. Would prefer to hire Ph.D. level chemists and chemical engineers and have them learn on the job to fill current voids and needs for scientists in product development and pharmaceutical technology.

19. 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.

20. Fewer colleges of pharmacy in the United States focus on the product development/technology needs of the industry.

21. A decline in U.S. trained scientists will result in the exportation of product development activities to foreign countries.

22. Executive Survey • 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)

23. What percentage of staff engaged in product development activities in your firm or division has an undergraduate degree in pharmacy regardless of what discipline their advanced degree (s) are:

24. What percentage of staff engaged in product development activities in your firm or division has an advanced degree in pharmaceutics/industrial pharmacy/pharmaceutical technology?

25. What percentage of staff engaged in product development activities in your firm or division only has an entry level or advanced degree in an engineering field?

26. What percentage of staff engaged in product development activities in your firm or division only has an entry or advanced degree in other science fields (physical chemistry, physics, biochemistry, etc.)

27. On scale of 0 to 4 (0 = more qualified candidates than openings; 4 = cannot fill current positions), how would you rate the level of difficulty in finding qualified people to fill product development positions?

28. 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.

29. Assuming 4–6 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.

30. Summary 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.

31. Summary Analysis • 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.

32. Summary 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).

33. Educational Issues • 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.

34. Educational Issues • A dramatic increase in ‘practice’ faculty in colleges of pharmacy clearly reflects a shift in emphasis in pharmacy schools. Courtesy of Kenneth W. Miller, Ph.D., Vice President, Graduate Education , Research and Scholarship, AACP

35. Educational Issues • Yet, this relatively static number basic sciences faculty has produced a growing number of Ph.D.s, especially in pharmaceutics. 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.

36. Questions 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?

37. Questions to be Resolved • 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?

38. American Association of Pharmaceutical Sciences AAPS Workshop Spring, 2006Washington, DC “Ensuring the Supply of Qualified Pharmaceutical Scientist Specialists in Product Development and Related Technologies That Meet Current and Future Needs”