Transcript Document

Strategic Health Innovation
Partnerships (SHIP)
Health Technology Assessment Conference
29th October 2014
www.ship.mrc.ac.za
What is SHIP?
• Launched in April 2013, SHIP is a new MRC unit based
on the Product Development Partnership approach
• With 9 staff SHIP’s goal is to seek,
manage and fund multidisciplinary
projects aimed at developing new:
 diagnostics and medical devices
 vaccines
 drugs
• SHIP’s focus is on addressing the
disease burden of Africa
How do we find and fund projects?
• 4 mechanisms for funding
– Through a Request for Applications Process (RFA)
– By specifically constructing consortia
• TB drug discovery program
• Malaria drug discovery program
• HIV vaccines NAB program
– Renewal of existing projects
– Strategic projects of funders
• Currently experimenting with structures and processes
– NIH type review
– Constantly evolving to promote improve best practice
Budget 2013 - 2015
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DST
Bill and Melinda Gates Foundation
DOH: (SAAVI) + operational
Anglo American Platinum
Newton Fund
Grand Challenges South Africa
Total
Leveraged Funding (UCT, MMV)
Total budget
90% committed for next 2 years.
R122M
R125M
R60M
R13M
R100M
R60M
R510M
R>150M
R650M
Governance
Priority
Setting
• Stakeholder
conference
• SAC advice
• Global status
• Review every
3 years
• SteerCo
approval –
minutes
Project
Extensions
Constructed
Consortia
MRC
EMC
Peer
Review
RFAs
• Standard RFA
template
• President input
• SteerCo approval
- minutes
• Manual or on-line
RFA process
• SHIP Proposal
and Budget
templates
• Final funding
approvals PFMA
requirement –
EMC minutes
• At least 2 (local &
international)
reviewers chosen by
Director & Programme
Managers
• SHIP Review template
SteerCo
Review
Prescreen
• Eligibility
criteria met
• Responsive to
RFA
SAC
Review
• Review peer
review scores
• Develop a shortlist of projects
• Portfolio
approach and
consider global
state of play
• Review SAC
recommendations
• Look at overall
SHIP strategy fit
and budget
• Finalisation of
project list for
EMC - minutes
SteerCo Composition
• MRC
• Richard Gordon
• DST – 3 seats
• Glaudina Loots
• Judy Coates (TIA)
• Andre Kudlinski (DTI)
Independent Chair:
CEO, SANAC
• DOH
• Anban Pillay
• BMGF
• Gilla Kaplan
• Lynda Stuart
• Anastazia Older Aguilar
Criteria is R10M per year per seat.
SteerCo TOR
• Key features:
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Serve for each year that the funding is provided
Quorum: half the members + 1
Decisions by a 66% majority vote
Meet on a quarterly basis
• Final Approval by MRC EMC – PFMA compliance
Current Project Portfolio
TB
• Bioinformatics: (1 project) SUN, UCT, SBM
• Drug
- Discovery: (1 project) UCT, Wits, K-Rith, SUN
- Clinical: Paediatric Levofloxacin formulation, SUN
• Diagnostics:
- PCR diagnostic. 30 min Readout: NWU
- Urine Based diagnostic: UCT
• Vaccines: (4 projects)
- Leveraging large pivotal trials (UCT, CAPRISA, Wits)
- Deploying systems biology methodologies (UCT)
- Investigating unconventional T cell immunity (Aurum)
Current Project Portfolio
HIV
• HIV drugs: 1 project, Wits
– Targeting latent HIV reservoirs with RNA technology
• HIV vaccines: (7 projects) NICD, Wits, UCT, CSIR
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Immunogen design: UCT, Wits
Broadly neutralising antibodies: NICD
Passive Immunity: NICD/Harvard
Biopharming to produce BNAbs: CSIR
Gene Therapy: Wits
Characterisation of breakthrough infections from HIV trials in
SA: UCT
– Functional cure (biosignatures in long-term non-progressors
and elite controllers): NICD
Current Project Portfolio
HIV
• HIV Prevention (1 project)
– Silver-based microbicide: CSIR
• Diagnostics (1 project)
– Vaginal inflammation diagnostic for HIV risk: UCT/CAPRISA
– HIV Resistance platform - UWC
• Platforms:
– Support for rhesus macaque colony at Delft
– SHIV challenge model and BLT mouse model development
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P5 Consortium
Several existing projects closing out
Community engagement
Support for WSU
Current Project Portfolio
Malaria:
• Drug Discovery R4M/yr (Matched by BMGF at UCT)
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Multidisciplinary drug discovery project
UCT, Wits, CSIR, UP
Entire life cycle of parasite
Current Project Portfolio
Non Communicable Diseases:
• Early diabetes diagnostic:
– Blood and Urine Based: MRC
– Funding clinical validation
• Early diabetes drug:
– Comprehensive pharmacology evaluation
– Vivo support model
• Pharmacogenomic projects:
– SUN: Breast Cancer
– UWC: Diabetes
• TOMPSA Triage
Current Project Portfolio
Maternal & Child Health:
• Triage Device: CPUT
– Funding clinical evaluation Phase 2
– DOH interest
• Opportunities:
– Umbiflow: POC Placental function Doppler device
• Co-Funding opportunities with PATH
– Oral Oxytocin: E-Cape, Fort Hare (USAID) for post partum
haemorrhage
– Vaginal tamponade: for post partum haemorrhage
– Milk Banking Project: KZN
Project Status: Overview
• Existing projects:
– Inherited 20 from BRICS, MRC and TIA, 15 complete 2013
• RFA 1: Drugs and Medical Devices
• RFA 2: Vaccines
• RFA 3: PGM metals
New Developments
New Developments
New Developments
Commercialisation of SHIP Related Technologies
Case Studies
The Technology Transfer Office
Purpose:
• To promote and implement the MRC’s IP Policy
• To effectively manage and commercialize IP developed by MRC researchers,
as required by the IPR Act;
• To collaborate on commercialisation issues with university TTOs where IP is
developed in extra-mural MRC research units;
• To effectively translate MRC research into new health policies, products,
processes and practises;
• To create awareness amongst MRC researchers on issues relating to
intellectual property
• To support other SHIP related activities
Socially Responsible Licensing
Definition: the transfer of intellectual property (through licensing) in a manner
that benefits the society at large or specific community (ensuring access) –
ethical ideology, maximising social benefits
Strategies
include desired outcome (i.e. humanitarian purpose) in the license and set milestones
for it to be achieved,
include mandatory sublicensing or march-in rights (Own march-in rts v/s State) for
when desired outcome is not met,
 specify pricing structure that ensures affordability/access in RSA/Developing
countries, e.g. differential pricing,
Transfer technology into Public-Private Partnerships (PPPs)
Enter into a Product-Development Partnership (PDP)
Create a spin-out company that meets your requirements & global access needs.
 exclude developing countries from license and implement a different strategy with
regard to developing countries (e.g PPPs, non-exclusive license)
 Require the licensee to grant sub-licenses in developing countries at a low or zero
royalty rate.
Mobile Clinic Design (SUN)
• Redesign process for mobile clinics to
improve
• functionality
• convenience
• modularity
• cost
• Licensed to WC DoH to utilise the
technology in
• Tender for Schools Mobile Screening
Project
• Western Cape Primary Care (eg below)
Historical projects
• Umbiflow = Umbilical Artery Doppler:
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Doppler software app
Uses Doppler waveform analysis for reliable and cost
effective antenatal screening
Evaluates blood flow in umbilical artery of foetus in the 3rd trimester of pregnancy
Enable decisions about ability of the placenta to provide sufficient nutrients and oxygen in
order to sustain the required foetal growth rate during 3rd trimester
Mobile-connected notebook:
Hosts Umbiflow app
Computer terminal for nurses at clinical level to generate and access EHR, book/refer
patients
Central database/ health information exchange
Store, filter, access EHR by authenticated users
Allows community health care workers to book patients, facilitate feed-back loop
Endotracheal Tube Retaining Device
 The Technology: Secure airway clamp
o single use, disposable, injection moulded device that mitigates the risks
associated with the endotracheal tube during all anaesthetics.
o ensure safer anaesthesia relating to endotracheal tube insertion, fixation
and removal (Teeth protection on laryngoscopy, Avoid endotracheal tube obstruction, bite
blocks prevent teeth occlusion, etc).
o provides added mental comfort to the anaesthetist in providing for a
safer procedure particularly with the ability to regain access to the
patient airway following glottal occlusion after tube removal.
 The Inventor: Anaesthetist with more than 10 000 delivered anaesthetics in
hospital
operating theatres.
 The Owner: Jirehsa Pty Ltd – MRC 25%, TIA 41% & A Taljaard (Inventor)
34%
 Stage of Development: Close to Market
o Various prototypes developed and tested by inventor & colleagues
o Requires final design iteration for formalised, independent clinical trial (1000 units
required, $200k)
o Followed by – setting up for manufacturing (ISO13485 certification, CE & FDA
registration, Setting up manufacturing plant, $1.5m – $3m)
 Intellectual Property Protection: Australia, France Germany, Ireland, Italy, South
Africa, Spain, United Kingdom, USA
 Market: Hospitals (Public & Private) & Anaesthetist practises
 Distribution: Medical distributors & Government procurement.
 Production Costs: about $8.5 per unit
Genetic Testing - Gknowmix
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MRC patent on genetic markers
for heart diseases
Top Projects
Formation of spin-out company Genecare (PTY) Ltd
Genecare closes, new business model developed –
Gknowmix(Pty) Ltd
Combines genetic testing, nutrition and lifestyle
Algorithm developed
Other genetic markers added
Agreements with pathology labs
Require buy-in from medical aid schemes
Expansion strategy
Global Health Innovation Accelerator (GHIA)
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Collaboration with PATH (US Non-profit organisation)
Purpose: joint research, development, manufacturing, introduction, and scale up
of innovative health technologies and programs that result in the reduction of
mortality and morbidity due to the burden of HIV and AIDS, TB, Malaria, NCDs
and challenges to maternal and newborn health (the Focus Areas) in South Africa
and the African continent.
Funding Opportunity:
Global Health
Innovation Hub
Strategic direction
Opportunity
Key Rationale
Expand PATH’s global
innovation expertise in
collaboration with MRC.
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Accelerate the scale-up of
diagnostics and medical
devices in SA.
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Take advantage of innovation that is
occurring in developing countries.
Strengthen the link between technology
development and local needs.
Leverage resources across the globe to
advance global health innovation.
Reduce the risk faced by the private sector
in entering fragmented markets for medical
devices, tools, and diagnostics.
Provide continuous funding to reduce
protracted timelines experienced with
piecemeal project funding.
7/7/2015
Thank you