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Supporting Biotechnology and Pharmaceutical companies enter global
markets sooner and cheaper
www.linear.org.au
Linear’s world class team of medical, scientific and commercial staff is dedicated to
supporting medical entrepreneurs
Servicing a global clientele from one of the most diverse cities in the world
Perth, bigger than San Diego, more
diverse than Boston
Quality
● ICH-GCP assured quality - data accepted
by all regulatory authorities
● 1st in Asia-Pacific for H-Index - measure
of scientific impact & productivity
Cost Efficiency
● 60% cheaper than the USA
● Generous Government R&D Tax Incentive
gives a cash refund of 43.5%
Speed
● No IND required to enter Phase 1
● Private Human Research & Ethics
Commitees (HREC) = IRB
● Start trials in 4-6 weeks
Australia - the premier destination for early phase clinical trials
Access global markets quicker and cheaper
In just 6 years, Linear has completed over 150 studies across every therapeutic area
Hollywood Private
Hospital
Sir Charles Gardiner
Hospital
Harry Perkins
Institue
Children's
HospitalUniversity of
Western
Australia
Located in the heart of the QEII Medical Centre
Click here for a 3D flythrough of our clinic (Password Linear3D)
● 600 bed Sir Charles Gardiner Hospital
● 738 bed Hollywood Private Hospital
● New $1.2billion Children’s Hospital
● University of Western Australia Medical School
Access to a broad investigator network
$9m state of the art facility in one of the largest health precincts in the Southern Hemisphere
Harry Perkins Institute of Medical Research
Lions Eye Institute
Sarich Neuroscience Research Institute
Participant database of over 12,000 volunteers
● Access to patient registries from any institution in Western
Australia
● Stable, heterogenous population
● Well defined patient populations (eg Cystic Fibrosis)
Continually exceeds recruitment expectations
PERTH
BUNBURY
BUSSELTON
ALBANY
GERALDTON
KALGOORLIE
ESPERANCE
Linear can recruit participants and patients from an entire collaboration network
Commercial in Confidence Oct 2016 Linear Clinical Research Ltd. www.linear.org.au
protocol
review
ethics
approval
register Australian
company (2-4 wks)
S.I.V.share draft
protocol & IB
services
Sponsor
2 4 6 8 1
0
1
2
Trial Startsign CDA
TGA
notification
recruitment
& screening
final protocol
& IB
open Australian
bank account (24hrs)
start
PISCF
WEEKS
T/C with
PI
finalize
PISCF
ethics
submission
(4-6 weeks)
can be compressed significantly depending on
stage of protocol and Australian company status
● Only phase 1 site able to perform Glucose Clamp Studies
○ Recently completed 8-way cross-over study involving 112 clamps in DM patients
● Top recruiter in a world-wide Fabry’s disease trial
● Australia’s first biosimilar trial (N=60)
● Fastest recruiting site in the world for a recent oncology study for Chinese sponsor
○ Recruited 34 patients between July ’15, Sep ’16
● Largest team of recruiting investigators for a multi-site respiratory study
○ 15 referring physicians
● Completed large Phase III vaccine study (N=330). F/up over 380 days
● Western Australia Industry Export Business Services Award 2 years running
Some of Linear’s recent achievements
cumulative patient enrollment
Oncology Team formed
Case Study - Oncology a global focus and a Linear speciality
Situation
Linear recognised a growing demand
for oncology studies combined with
increasing interest from its engaged
investigator network
Action
Formed a dedicated oncology team
which has grown to include an
oncology fellow, chemotherapy nurses
and network of oncologists including
international solid tumor expert
Professor Michael Millward
Results
Linear has now successfully enrolled
over 140 oncology patients into phase 1
trials Including being the fastest
recruiting site for a global oncology trial
for a Chinese sponsor (recruited 34
patients between July ‘15 and Sept ‘16)
Steve Gourlay, CMO, Principia, San Francisco, USA
"Linear was an outstanding partner for our phase one programs - always
professional and willing to go the extra mile."
Xu Ning, Zai Labs, Shanghai, China
“I am so happy to talk about Linear as we did have a great experience
working with you and your team. At the beginning we were wondering
whether Linear will give us priority because we are a small start-up company.
In fact, Linear does not only pay great attention to our project but also work
hard to establish and maintain great working relationship with Zailab. I have
got several calls from CEO and/or PI asking for my feedback regarding how
well the project was going on. I think Linear is a great phase I unit with the
most professional, responsible, and hard-working team members. We look
forward to having more projects to work with Linear in the near future.”
Claire Kaufman, Paradigm, Sydney, Australia
“With a very tight timeline for the study, we approached several
CROs, and found that Linear were most on board with us from the
very beginning…We were very impressed with the high level of
professionalism, attention to detail, and the team problem-solving
approach showed by all the staff at Linear. They also showed a high
level of personal interest in our development plans, and great care for
the integrity of the study – which can be hard to find in a field often
dominated by larger global companies. It is easy to recommend
them, and we would certainly work with Linear again in the future.”
Craig Cook, Midatech, Oxfordshire, UK
“The Phase I study we conducted with Linear was all of intricate,
intensive and novel. Despite these challenges, Linear were
impressive in their professionalism and commitment to delivering
results and ensuring the study was a success.”
What Linear’s global clients say
Please contact: Jayden Rogers, Global Partnering Lead
jrogers@linear.org.au
+61 432 895 109
Dougal Thring, Client Solutions and Proposals Lead
dthring@linear.org.au
+61 438 334 154
www. .org.au
Our experienced team of doctors, nurses and clinical trial specialist are here to help

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Linear Clinical Research Slides_Jan 2017

  • 1. Supporting Biotechnology and Pharmaceutical companies enter global markets sooner and cheaper www.linear.org.au
  • 2. Linear’s world class team of medical, scientific and commercial staff is dedicated to supporting medical entrepreneurs
  • 3. Servicing a global clientele from one of the most diverse cities in the world Perth, bigger than San Diego, more diverse than Boston
  • 4. Quality ● ICH-GCP assured quality - data accepted by all regulatory authorities ● 1st in Asia-Pacific for H-Index - measure of scientific impact & productivity Cost Efficiency ● 60% cheaper than the USA ● Generous Government R&D Tax Incentive gives a cash refund of 43.5% Speed ● No IND required to enter Phase 1 ● Private Human Research & Ethics Commitees (HREC) = IRB ● Start trials in 4-6 weeks Australia - the premier destination for early phase clinical trials Access global markets quicker and cheaper
  • 5. In just 6 years, Linear has completed over 150 studies across every therapeutic area
  • 6. Hollywood Private Hospital Sir Charles Gardiner Hospital Harry Perkins Institue Children's HospitalUniversity of Western Australia Located in the heart of the QEII Medical Centre Click here for a 3D flythrough of our clinic (Password Linear3D) ● 600 bed Sir Charles Gardiner Hospital ● 738 bed Hollywood Private Hospital ● New $1.2billion Children’s Hospital ● University of Western Australia Medical School Access to a broad investigator network $9m state of the art facility in one of the largest health precincts in the Southern Hemisphere Harry Perkins Institute of Medical Research Lions Eye Institute Sarich Neuroscience Research Institute
  • 7. Participant database of over 12,000 volunteers ● Access to patient registries from any institution in Western Australia ● Stable, heterogenous population ● Well defined patient populations (eg Cystic Fibrosis) Continually exceeds recruitment expectations PERTH BUNBURY BUSSELTON ALBANY GERALDTON KALGOORLIE ESPERANCE Linear can recruit participants and patients from an entire collaboration network
  • 8. Commercial in Confidence Oct 2016 Linear Clinical Research Ltd. www.linear.org.au protocol review ethics approval register Australian company (2-4 wks) S.I.V.share draft protocol & IB services Sponsor 2 4 6 8 1 0 1 2 Trial Startsign CDA TGA notification recruitment & screening final protocol & IB open Australian bank account (24hrs) start PISCF WEEKS T/C with PI finalize PISCF ethics submission (4-6 weeks) can be compressed significantly depending on stage of protocol and Australian company status
  • 9. ● Only phase 1 site able to perform Glucose Clamp Studies ○ Recently completed 8-way cross-over study involving 112 clamps in DM patients ● Top recruiter in a world-wide Fabry’s disease trial ● Australia’s first biosimilar trial (N=60) ● Fastest recruiting site in the world for a recent oncology study for Chinese sponsor ○ Recruited 34 patients between July ’15, Sep ’16 ● Largest team of recruiting investigators for a multi-site respiratory study ○ 15 referring physicians ● Completed large Phase III vaccine study (N=330). F/up over 380 days ● Western Australia Industry Export Business Services Award 2 years running Some of Linear’s recent achievements
  • 10. cumulative patient enrollment Oncology Team formed Case Study - Oncology a global focus and a Linear speciality Situation Linear recognised a growing demand for oncology studies combined with increasing interest from its engaged investigator network Action Formed a dedicated oncology team which has grown to include an oncology fellow, chemotherapy nurses and network of oncologists including international solid tumor expert Professor Michael Millward Results Linear has now successfully enrolled over 140 oncology patients into phase 1 trials Including being the fastest recruiting site for a global oncology trial for a Chinese sponsor (recruited 34 patients between July ‘15 and Sept ‘16)
  • 11. Steve Gourlay, CMO, Principia, San Francisco, USA "Linear was an outstanding partner for our phase one programs - always professional and willing to go the extra mile." Xu Ning, Zai Labs, Shanghai, China “I am so happy to talk about Linear as we did have a great experience working with you and your team. At the beginning we were wondering whether Linear will give us priority because we are a small start-up company. In fact, Linear does not only pay great attention to our project but also work hard to establish and maintain great working relationship with Zailab. I have got several calls from CEO and/or PI asking for my feedback regarding how well the project was going on. I think Linear is a great phase I unit with the most professional, responsible, and hard-working team members. We look forward to having more projects to work with Linear in the near future.” Claire Kaufman, Paradigm, Sydney, Australia “With a very tight timeline for the study, we approached several CROs, and found that Linear were most on board with us from the very beginning…We were very impressed with the high level of professionalism, attention to detail, and the team problem-solving approach showed by all the staff at Linear. They also showed a high level of personal interest in our development plans, and great care for the integrity of the study – which can be hard to find in a field often dominated by larger global companies. It is easy to recommend them, and we would certainly work with Linear again in the future.” Craig Cook, Midatech, Oxfordshire, UK “The Phase I study we conducted with Linear was all of intricate, intensive and novel. Despite these challenges, Linear were impressive in their professionalism and commitment to delivering results and ensuring the study was a success.” What Linear’s global clients say
  • 12. Please contact: Jayden Rogers, Global Partnering Lead jrogers@linear.org.au +61 432 895 109 Dougal Thring, Client Solutions and Proposals Lead dthring@linear.org.au +61 438 334 154 www. .org.au Our experienced team of doctors, nurses and clinical trial specialist are here to help