Transcript Appendix II.pdfx

Bridging the Skills Gap for the
Pharmaceutical Industry in South Africa
Human Capital Outlook Implications for Skills
Development in the Pharmaceutical Sector
Johannesburg
May 27 2015
By Dr Skhumbuzo Ngozwana
Disclaimer
Any views or opinions expressed
herein are solely those of the
author and do not necessarily
represent those of any company.
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“A dwarf standing on the
shoulders of a giant can see
further than the giant”
Sir Isaac Newton – private correspondence to Robert Hooke
Outline
 Framing the Debate for Skills Development
 Challenges & Barriers of SA / Africa Based
Pharmaceutical Manufacturers
 Manufacturing processes & skills requirements
 Key research findings from the DTI Study
 Recommendations
Framework for Policy Alignment
Revise & Review curriculum
Facilitate international partnerships & collaboration
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Framing the Debate for the
Imperative for Skills
Development
High Disease Burden (current)
 25% of the global disease burden
75% of the global HIV/AIDS pandemic
90% of the malaria cases and deaths
9 countries (excluding North Africa) among the 22 countries with
the highest TB burden in the world.
MDR-TB and XDR-TB rated among the highest in the world.
Significant child mortality – diarrhoeal, measles, URTI
An emerging CD epidemic
Source: Mckinsey & Co, WHO, ADB, StopTB
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High Disease Burden (2030 Projections)
Diseases
Number
Hypertension
60 mil
Diabetes
18.6 mil
Cancer
1 mil (new cases annually)
Will surpass HIV / AIDS as leading
cause of death
Other (CNS, CVS, Resp.)
Source: WHO AFRO, Colin D Mathers & Dejan Loncar. Projections of Global Mortality and Burden of Disease from 2002-2030. PloS Medicine Nov 2006, Vol. 3, Issue 11
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Challenges of SA / Africa
Based Pharmaceutical
Manufacturers
SA / African Pharma at a Glance…
 Estimated at around $ 20 billion (RSA ~4.2b)
 IMS Health (Global Market Prognosis) 2010 Africa at 13,879 Bn USD & but expected
to reach $30 billion by 2016
 Growth has surpassed that initial projection & IMS predicts 45 bn by 2020
 Imports: +/- 95% of API & +/- 70% of FF
 Growing in double digits
 Growing focus on developing the sector across the
continent (PMPA, REC Plans, Country plans)
Source: IMS Health
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SA / African Pharma Sector Challenges
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Critical Lack of Skills
 Drug development (reverse engineering, NCE’s, novel combinations and
general formulation development)
 Drug testing (quality control and assurance)
 Regulatory medicine and supply chain regulation (pharmaco-vigilance,
GWP, GDP, DLP, GCP)
 Drug manufacturing (GMP, Lean manufacturing, plant operations and
maintenance)
 Pharmaceutical management (production planning, supply chain
management, entrepreneurship, governance, commercial law,
operations, financial management, sales and marketing efforts etc.)
 Lack of pharmaceutical policy expertise to address policy incoherence,
craft sector strategies etc.
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The impact of the lack of critical
Skills
 Inability to adopt “Leap-frogging” technologies to catch up (NSI)
 Weak regulatory systems – inability to regulate the pharmaceutical
industry across the entire value chain properly & registration delays
 Poor quality dossiers leading to registration delays
 Inability to formulate own products resulting in limited portfolios
 Lack of bioequivalence expertise and centres
 Poor quality production and the attendant problem of sub-standard
medicines
 Inefficient production with lots of wastage and a higher cost base
 Poor overall business management
 Total reliance on others for the supply of all our needs
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Manufacturing Processes &
Skills Requirements
Chemical
Synthesis
Fermentation
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Isolation
API
Extraction
INTERMEDIATES
Animal
tissue
RAW MATERIALS
Plants
Purification
Formulation
& packaging
FINISHED FORMULATION
Pharmaceutical Production Process Flow
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Biotech manufacturing process Flow
Tissue collection or
bacterial
fermentation or cell
culture
Tissue extraction
Cell separation
Cell culture fluid
clarification
Cell membrane
extraction
Bacterial capsule
extraction
Cell Lysis
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Cell purification
(downstream
purification)
Viral clearance &
aseptic filtration for
final vaccine
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Functions & disciplines
Functions
Disciplines
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Process Chemistry
Biosynthesis
Process Microbiology
Process Engineering
Process Design
Process Chemistry
Process Microbiology
Analytical chemistry R&D
Technology Transfer
Regulatory Affairs
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Manufacturing and Controls
Technology Transfer
Validation
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Process Engineering
Equipment Validation Engineering
Process Validation
Cleaning Validation
Computerised Systems Validation
Process Development
Process Design
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Functions & disciplines
Functions
Disciplines
Quality Assurance & Control
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Good Manufacturing Practice (GMP) for API Manufacturing
Plant Operations/ Manufacturing
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Process Engineering
Chemical Operations
Environmental Engineering
Operational Safety and Industrial Hygiene
Plant Maintenance
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Maintenance Engineering
Maintenance Planning
Plant Safety
Management
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Pharmaceutical Project Management
Materials Management
IP Management / Licensing
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Skills & Specialisations
Field of study
specialisations
Chemistry
Biological sciences
Life sciences
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API
Bio tech
Analytical
√
√
organic
√
synthetic
√
Microbiology
√
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molecular biology
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Biochemistry
√
Pharmacy (production & regulatory)
√
√
Pharmaceutical science
√
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Virology
√
Biotechnology
√
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Skills & Specialisations
Field of study
Cross cutting specialisations
Engineering
Management
Other
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API
Bio tech
Chemical
√
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Mechanical
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Electrical
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Business, project, data, logistics
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Law, IT,
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√
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Key Research Findings
Key findings
 No clear pharmaceutical industry strategy:
No shared vision & direction
Superficial understanding of the industry
 HET offering
Generic science qualifications (academic-oriented)
o Chemistry offering inadequate (analytical, synthetic, organic offered under general
chemistry)
o No regulatory, production, QC training in pharmacy curriculum
o No industrial applicability
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Key findings… 2
HET offering …
Strong on theory, weak on industrial practice
“ >3 years of OTJ training to become productive in
the pharmaceutical manufacturing environment“
Output quantities: no critical mass of skills
base
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Key findings… 3
2006 – 2008 averages
Enrolments
Graduates
Engineering
35 406
13%
Pharmaceutical science & Pharmacy
2 100
25%
Biological sciences
9 300
25%
Chemistry
11 170
28%
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Key findings… 4
Engineering
Pharma science &
pharmacy
Biological sciences
Chemistry
Total output (av. 2006 – 2008)
4 698*
537
2 112
1 685
Undergraduate
4 238
370
1 244
1 211
PGD & Honours
109
57
487
252
Masters
292
100
238
149
PhD
59
10
91
74
Master’s as % of total output
6%
20%
11%
9%
PhD as % of total output
1%
2%
4%
4%
* chemical, mechanical & electrical = 2 132
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Critical success ingredients
Industry
-collaboration
-R & D
-Training
HEIs
- Training
SET
Infrastructure
Research
Council
Success!
- R&D
policy &
regulatory
framework
- Tech transfer
Education
Funding &
incentives
- Basic universal
- Postgraduate
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Recommendations
Recommendations:
1. Create a Framework for
Policy Alignment – SA Core
Documents
Policy Alignment Framework
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National Development Plan 2050
 The plan articulates the vision for healthcare in South Africa as
follows:
 “We envisage that in 2030, South Africa has a life expectancy of at least 70 years for men and women…,
the quadruple burden of disease have been markedly reduced compared to the two previous decades”.
 The NDP also aspires to:
 Ensure that the population of under 20’s free of HIV / AIDS increases
 Progressively improve TB prevention and cure by 2030
 Reduce the prevalence of non-communicable chronic diseases by 28% by 2030 National
Development Plan: Vision for 2030.
 Calls for the government to invest in technological revolutions
of the 21st century - specifically highlighting biotechnology
and nanotechnology
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Dept. of Science and Technology’s
Bio-economy Strategy
 The key Strategic priorities as outlined in the Bioeconomy strategy
include the following:
to develop improved therapeutic and drug delivery systems to address priority
diseases
to develop new and improved vaccines and biologics
develop improved diagnostics
develop improved medical devices
strengthen clinical research and development capabilities, and
establish pharmaceutical manufacturing in the country
 Specifically, the Bioeconomy strategy calls for the prioritization of
drug development and proposes that this be pursued via publicprivate partnerships (PPPs).
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Department of Trade and Industry’s
Industrial Policy Action Plan (IPAP)
 IPAP identifies a number of priority sectors to be supported for
development in order to address South Africa’s health
challenges and dependence on imported products. IPAP
specific areas identified for extraordinary government support
are:
production of ARV API’s
production of vaccines
production of biological medicines
production of diagnostics and medical devices
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National Dept. of Health’s Strategic
Plan
 Mission
To improve health status through prevention of illness, disease and
promotion of healthy lifestyles, and to consistently improve the
healthcare delivery system by focusing on access, equity, efficiency,
quality and sustainability
 Core focus on improving access to affordable, safe, efficacious
medicines, including to newer therapies
 Has five key priority areas: HIV / AIDS, TB, Cancer, Maternal &
Child Health and Diabetes
 Has entered into a number of PPP / PPM projects
Biovac Institute – revive the declining vaccine production in RSA &
supply the EPI
Multiple PPP’s in the hospital sector
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Recommendations:
2. Develop a National Vision &
Strategy for the Sector
Recommendations
 Development of a National Vision & sector strategy
Informed by extensive sector research & consultations
Clear vision & growth path for the industry, aligned with key gov’t policies
(Trade & industry, DST, Health, MoE, Finance, etc.)
 Investigate the role that the NPC can play in skills planning &
development
 Adopt a cluster approach
 The Diaspora effect…..reverse brain gain (incentives,
conducive environment etc..)
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Adopt a Cluster Approach to Developing
local Pharma Sector
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Recommendations:
2. Review & Revise Training
curriculum
Strengthen STI related training
 Strengthen foundational education in STI related fields
 Review & reorientation of Pharmacy & Science, engineering curricula
 Strengthen & Incentivize Industry-Academia collaborations
 Tap into the African Diaspora
 Establishment of specialised pharmaceutical training / R&D institutes
 India NIPER / NCL / IICT, Nigeria’s NIPRD
 RSI SA
 Tanzania St Luke’s, MUHAS
 US Stephens Institute of technology
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Curriculum Review
 Formal training & Short courses / Seminars in:
Drug development (new chemical entities, novel combinations like FDC’s,
paediatric, delivery systems; and general formulation development)
Drug testing (quality control and assurance)
Drug approval (regulatory medicine) and supply chain regulation (PMS/
pharmaco-vigilance, Good Manufacturing Practice, Good Wholesaling
Practice, Good Distribution Practice, Good Laboratory Practice, Good Clinical
Practice)
Drug manufacturing (GMP, TPM, Lean manufacturing, plant operations and
maintenance)
Pharmaceutical management (production planning, supply chain
management, entrepreneurship, governance, commercial law, business
development, operations, financial management, pharmaceutical sales and
marketing etc.)
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Recommendations:
3. Create International
Partnerships & Strengthen
Collaboration
St Lukes Foundation
 St Luke’s Foundation offers an Industrial Pharmacy
Advanced Training postgraduate program (with Purdue
and Howard universities in the US).
Drug development and Regulatory quality Compliance
Drug Manufacturing Process (GMP)
Regulatory Documents and Generic Drug Approval submissions
Drug Discovery.
 St Lukes also offers basic, technicians certificate,
technician’s certificate and a diploma in pharmaceutical
science to pharmaceutical operators.
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AMRH & ANDI
 AMRH
Continental Technical Working Group on Regulatory Capacity Development (TWGRCD) operational since 2012
10 Regional Centres of Regulatory Excellence (RCOREs)
Pool of regulatory experts since Oct 2013
TWG embarked on the development of a harmonised curricula for regulatory capacity
development
 ANDI
32 Centers of Excellence across the continent (Drug
Discovery, Diagnostics, Devices Appropriate for our setting)
Ebola (Genome work & Rapid Diagnostics)
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Muhimbili University of the Health and
Allied Sciences
 MUHAS offers practical training for pharmaceutical
professionals in the areas of :
Formulation development
GMP
Process scale-up
Stability and analytical testing
Tableting and coating
Quality control of medicines
Sustained release formulations
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International Society for Pharmaceutical
Engineers
 International Society for Pharmaceutical Engineers (ISPE)
membership includes engineers, microbiologists, chemists,
QA/QC, production, process development, pharmacists,
regulatory and training personnel, academia, and suppliers;
exists for the sole reason of improving efficiency and best practices,
ISPE offers various training events across the world, and on-site at
companies, where leading industry experts impart knowledge and skills
to pharmaceutical teams from around the world.
ISPE also offers an extensive curriculum of online courses across various
manufacturing issues. A selection of some of the leading programs
offered by ISPE includes cleaning, manufacturing facilities, GMP,
HVAC, manufacturing (QRM, clinical trials, QA/QC, Q7A etc.) and
validation
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United States Pharmacopeial Convention
 USP’s Promoting the Quality of Medicines (PQM) initiative works with regulators to build
the capacity in medicine regulation to ensure that there are adequate quality assurance
measures in place.
 USP PQM offers National Medicines Regulatory Authorities (NMRAs) training and technical
assistance to formulate medicine regulation; strengthen regulation, and to introduce
good regulatory practices and international quality standards.
 USP Global Health Program - Centre for Pharmaceutical Advancement and Training
(CePAT), in Accra, Ghana .
 CePAT will become a centre of excellence for Sub- Saharan Africa (SSA) - build the human resources
needed to properly control the quality of pharmaceuticals in the region and to curb the scourge of
counterfeits and sub-standard drugs.
 This centre is intended to benefit regulators, medicines quality control laboratories, manufacturers, and
donor agencies and procurement organisations.
 USP, in collaboration with the WHO and the Global Drug Facility, also offers WHOprequalification training to African and other manufacturers from the developing world.
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International Conference on Harmonization
 The International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) offers training programs
around the world.
ICH’s guidelines have become recognised industry standards, and have
been adopted by regulatory authorities in countries such as Botswana and
South Africa.
Examples of the ICH guidelines include GMP, Stability, Qualification and
Validation, Pharmaceutical Quality System, Development and Manufacture
of Drug Substance among many.
 ICH has conducted various training programmes for African regulators; and the
SADC Regulator’s forum is represented in ICH and the organisation has invited
SADC regulators to sit on various its committees.
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World Health Organisation
 The WHO provides technical assistance and training
across various aspects of medicine regulation.
One of their key programmes is WHO prequalification program, which entails
working with NMRAs from developing countries
Offers a combined WHO PQ training program for industry and regulators that
is offered in conjunction with USP.
Training in pharmaco-vigilance
Development and validation of analytical test methods for the quality
screening of medicines.
Quality control & assurance of medicines.
Training of regulatory officials & quality control laboratory personnel.
Provision of support to member states in the establishment & management of
quality control laboratories.
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International Pharmaceutical Federation
 The International Pharmaceutical Federation (FIP) - global
federation of national associations of pharmacists and
pharmaceutical scientists.
provides various training services to its members around the globe.
 The FIP’s pharmaceutical sciences group’s key focus is
advancing pharmaceutical sciences through creation of global
networks for sharing knowledge and information between
pharmaceutical scientists.
 This group also conducts regulatory educational workshops in
developing countries.
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Drug Information Association
 The Drug Information Association (DIA) is a non-profit association that provides
professionals in the pharmaceutical, biotechnology, medical device, and
related industries a forum for facilitating knowledge exchange and collaboration through
among others:
 Education and training
 Meetings, conferences, webinars, online learning, and other events to foster knowledge
exchange, collaboration, and networking
 Publications and knowledge resources
 DIA, International Federation of Pharmaceutical Manufacturers Association (IFPMA),
African Regulatory Network and Gates Foundation jointly host an African Regulatory
Conference.
 aims to encourage greater harmonisation of regulatory requirements on the African continent
and covers a number of topics including; African Medicines Registration Harmonisation
(AMRH), management of variations, inspections/GMP/Quality, counterfeits/pharmacovigilance/safety, transparency/good regulatory practices, dossier evaluation (requirements,
frills, samples etc.) and clinical trials
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Dr Skhumbuzo Ngozwana
MBChB (UCT). MPharm Med (UP) MBA (GIBS)
MD – Metanoia Pharma Consulting
[email protected]
www.metanoia.co.za
+27 82 829 3832