Linking Industry and Academia in Teaching Pharmaceutical Development and Manufacture:

LIAT-Ph

Prof. Anne Marie HealySchool of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin

1

A Knowledge Alliances Project

Project Introduction and Overview

LIAT-Ph Project

• Funded by the Executive Agency, Education, Audiovisual and Culture (EAEAC)

• 2-year education project: commenced October 2013

• A Knowledge Alliances project funded under the Lifelong Learning Programme – part of Erasmus programme/activity

2

LIAT-Ph: The Consortium – Full Partners

3

• Schools/Faculties of Pharmacy

– Trinity College Dublin, Ireland

– University of Belgrade, Serbia

– University of Ljubljana, Slovenia

– University of Helsinki, Finland

– Queen’s University Belfast, UK

• Industry

– Amebis Ltd., Dunshaughlin, Ireland

– APC Ltd., Dublin, Ireland

– Brinox inženering d.o.o., Medvode, Slovenia

– Innopharma Labs Ltd., Dublin, Ireland

– NIBRT, Dublin, Ireland

– Pfizer Ireland Pharmaceuticals, Dublin and Cork, Ireland

– Sigmoid Pharma Ltd., Dublin, Ireland

LIAT-Ph: Associate Partners

– PIER: Pharmacists in Industry, Education and Regulatory, Ireland

– Medicines and Medical Devices Agency of Serbia

– Slovenian Drug Agency

– Galenika ad, Serbia

– Hemofarm ad, Serbia

– KRKA d.d., Slovenia

– European Pharmaceutical Students Association (EPSA)

4

Why did the consortium wish to undertake this project?

• Industrial pharmacists should be equipped to respond to the challenges of the rapidly changing environment in which they work.

• They should be capable of working as part of a multi-disciplinary team comprising pharmacists, chemists and engineers, as companies seek an increasingly more integrated approach to the product development cycle.

• The necessity for partnership and closer collaboration between academia and industry has been recognised on the national, as well as wider, regional and EU level.

5

Pharmine project – previous LLP project

6

Pharmine project • A broad Advanced Masters in Industrial Pharmacy-type course was not

appropriate for pharmacists working in the pharmaceutical Industry

• Specialist post-registration courses appropriate to specific roles in the industry are required.

• The Pharmine project: identified the competencies required on Day 1 of registration for pharmacists entering the pharmaceutical industry.

• It was timely therefore that we reviewed the pharmacy curricula in the participant countries to determine:

(1) what competencies are currently being achieved by graduate pharmacists and

(2) where deficiencies exist in the current undergraduate curricula.

The academic and industrial partners would work together to identify and introduce teaching and learning strategieswhereby the required competencies can be met by pharmacy graduates entering the industry.

7

Other project drivers

• PEARs (Pharmacy Education and Accreditation Reviews) report in Ireland– emphasis on experiential learning

• Tempus PQPharm project - modernisation of the Postgraduate Qualification in Pharmacy in Serbia

• Obligation on pharmacists in industry to undertake continuing professional development (CPD)

8

Project rationale

• The consortium has specific expertise in the area of bio/pharmaceutical product development and this is the part of the drug product life cycle on which we focused.

• PhD students pursuing PhDs in pharmaceutics and pharmaceutical technology are ideally positioned to enter the pharmaceutical industry in a variety of roles. The consortium would develop courses and structure training appropriate for such students.

• As professionals, pharmacists in industry are obliged to undertake continuing professional development (CPD). The consortium was well placed to identify CPD needs of the industrial pharmacist.

• By considering the competencies required of:– the “Day 1” pharmacist, the PhD student and the pharmacist in

practice

we could identify and develop courses which are appropriate to the lifelong learning needs of the practising pharmacist.

9

Project Objectives

Objective 1

• Explore the learning needs of pharmacy students, at the undergraduate and postgraduate level and practising pharmacists, – in the different (participant) countries, – in relation to the competencies in industrial pharmacy

which have been identified through the Pharmineproject and

– in relation to any additional competencies identified by the industrial and academic partners in the context of current developments in the bio/pharmaceutical sector.

10

Objective 2

• Work together (academia and industry from all participant countries) on:– the development of curricula (content and

teaching/learning methods and educational materials)– that will ensure the required competencies for

industrial pharmacist are covered at an appropriate level.

– Focus will be placed on enhancing student engagement, developing problem solving skills and encouraging innovation and entrepreneurial thinking.

– Academic staff up-skilling will form part of the curriculum update and delivery process.

11

Objective 3

• Develop and deliver joint modules,

– as part of a structured PhD programme

– and/or continuing professional development courses

– for industrial pharmacists and other professionals working in the bio/pharmaceutical industry

– with a focus on bio/pharmaceutical product development and manufacture.

12

Meeting the Objectives

WP1: Project ManagementWP2: Pharmacy Undergraduate Curricula ReviewWP3: Pharmacy Undergraduate Teaching and Learning

Strategy Review and DevelopmentWP4: Pharmacy Postgraduate – Providing Skills for the

Future Industrial PharmacistWP5: Continuing Professional Development for the

Industrial PharmacistWP6: Conferences on a Competency Based Curriculum for

Industrial PharmacyWP7: Quality AssuranceWP8: DisseminationWP9: Exploitation of Results

13

Project Working Groups and Tasks

• Working groups

– Undergraduate

– Postgraduate

– CPD

– Dissemination and Publication

14

Develop proposals/strategies for the introduction of revised/new teaching material in a suitable format for inclusion in UG curricula

Develop courses, workshops, other educational material for PG students, academic staff, as CPD for practising industrial pharmacists

Major Project Events

15

Intensive Course 1:

Dublin

Intensive Course 2: Belgrade

Intensive Course 3:

Belfast

M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12

Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept

M13 M14 M15 M16 M17 M18 M19 M20 M21 M22 M23 M24

Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept

Conference 1:Portoroz

Conference 2:Helsinki

Student placements

Academic Workshop

Consortium Meeting

Student placements

Dissemination/Project Information

• Website: www.liatph.com

16

Project Tasks Undertaken to Date

• First LIAT-Ph Conference on a Competency Based Curriculum for Industrial Pharmacy – Portoroz, September 2014

• Second LIAT-Ph Conference on a Competency Based Curriculum for Industrial Pharmacy – Helsinki, September 2015

17

• 1½ day workshop involving all academic partners (as part of kick-off meeting)

• 1 day workshop involving all consortium partners (as part of kick-off meeting)

Undergraduate Working Group

• Curriculum analysis – identification of curriculum gaps vis-à-vis Pharmine report

• Surveys of (1) academics and (2) industrialists in participating countries concerning Pharmine competencies and relevance of competencies at undergraduate and postgraduate

• Revision of curricula in participating universities – separate presentation

18

Postgraduate/CPD Working Group

• Three Intensive Courses completed

– First Intensive Course on Biopharmaceuticals: hosted and delivered by NIBRT and Pfizer

– Second Intensive Course: Drug product development and manufacture within the QbD concept – hosted by University of Belgrade

– Third Intensive Course: Advanced oral drug product formulation, manufacture and characterisation – hosted by Queen’s University Belfast

19

• First Intensive Course: Biopharmaceuticals

20

• Second Intensive Course: Drug product development and manufacture within the QbD concept

21

• Third Intensive Course: Advanced oral drug product formulation, manufacture and characterisation

22

Postgraduate/CPD Working Group

• 6 x student placements with industry partners

• Development of 5 x CPD/online modules

– Preformulation

– Design of Experiments

– Advanced Granulation Methods

– Advanced Dissolution Testing

– Issues in Veterinary Dosage Forms Development

23

Project Dissemination Activities

• Article in Forum magazine (publication of the European Association for International Education [EAIE])

• Article in Industrial Pharmacy (publication of the Industrial Pharmacy Section of FIP)

• Article in PIER newsletter• Presentation by Jelena Parojčić (University of Belgrade) at 2nd Zagreb

International Conference on Pharmaceutical Sciences, 25-26 October 2013, Zagreb, Croatia

• Presentation by Svetlana Ibric (University of Belgrade) at the 2014 European Association of Faculties of Pharmacy (EAFP) Annual Conference, 22-24 May, Ljubljana, Slovenia

• Presentation by Anne Juppo (University of Helsinki) at 74th FIP World Congress of Pharmacy and Pharmaceutical Sciences, 31 August-4 September 2014, Bangkok, Thailand

• Presentation by Anne Juppo (University of Helsinki) at VI SerbianCongress of Pharmacy, 15-19 October 2014, Belgrade, Serbia

24

Project Goals to End of Year 2

• Undergraduate: Finalise Criterion Referenced Assessments (CRAs) for all levels of Undergraduate Course and distribute to all university partners – see Undergraduate Working Group Presentation

• Postgraduate/CPD: Complete and pilot e-learning CPD/online courses

• Dissemination– e-mail alert to European pharma universities - direct to website

– 9th Annual Symposium of Pharmaceutical Solid State Research Cluster (PSSRC)

– 2nd national QP Conference - Belgrade October 1st and 2nd

– LIAT-Ph open days in various participant Schools of Pharmacy - to present the project activities and outcomes

25

Thank you for your attention!

Questions?

26