NZCR Newsletter #1

Nov 6, 2020 – One month into our NZCR journey!

We have received very positive initial feedback on our plan to build on the reputation of both ACS & CCST to become a preferred partner for clinical pharmacology research in the Asia-Pacific region.

Advantages: As the world of early phase clinical trials continues to evolve, we need to be responding by investing in quality and training, developing new in-house skills and utilising new technology as well as increasing our capacity including bed numbers. The combination of ACS and CCST will facilitate this development by allowing us to use the best of processes at each unit.

Steering Committee. We have formed a group with representation from both units to coordinate the integration process.

The objective for the SteerCo is to identify, prioritise and support the implementation of system/process changes so that we can work effectively across the different locations.

An early goal is to start introducing the NZCR brand and act as one entity to the outside world. That goal is likely still a few months away, but we are making good progress.

New Staff Positions Currently both sites are very busy, partly as a result of NZ’s successful Covid-19 management and we are recruiting additional help for both teams to meet the demand.

Additionally, our new Chief Financial Officer, George Morrissey, based in Auckland will start November 16 to assist with growth and development plans.

Looking ahead and to continue our growth we will be implementing a Business Development team to help raise the profile of NZCR, liaise with Sponsors/CROs and act as the go-to person for new trial feasibilities – watch this space.
Branding. We have established a new logo with branding guidelines and are working on a combined website to launch very soon.

We are excited by the opportunity for our new combined group. There are huge opportunities to help develop more new medicines and grow clinical trial activity in New Zealand. The next few months will be busy with study activities plus the integration work and we hope you will be able to bear with us as we are trying to realize these opportunities. We wouldn’t be able to do this without your assistance as well as the support of a great team of enthusiastic clinical researchers in Auckland & Christchurch and we are extremely grateful for this.

Christian & Chris

Pink Ribbon Morning Tea 2020

Nov 4, 2020 – The COVID-19 pandemic has changed most aspects of our life. People are working from home, kids are learning remotely, and we are unable to gather in large groups. But one thing hasn’t changed: Cancer continues. Every day, peoples’ lives are turned upside down when they hear the words: “You have cancer.” Each year 3,300 Kiwis are diagnosed and more than 650 will die of breast cancer.

We at ACS are helping to raise funds to support the NZ Breast Cancer Foundation. Join us at ACS on Monday, 9th November 2020 for a Pink Ribbon Morning Tea or support us by donating online at the link below:

www.takeaction.org.nz/page/acsteam

World-leading Early-Phase Clinical Research Units ACS and CCST join forces to form NZCR

Sep 8, 2020 – Auckland Clinical Studies Ltd (ACS), Christchurch Clinical Studies Trust Ltd (CCST) and Waterman Capital today announced the establishment of NEW ZEALAND CLINICAL RESEARCH (NZCR) through the merger of the two world-leading early-phase clinical research units. Waterman has acquired a majority stake in NZCR alongside its founding shareholders and management. Founding Director of CCST and ACS, Richard Robson, will become an adviser to the NZCR Board and retain a minor financial interest. Founding Director of ACS, David Cranna, will also retain a minor financial interest in NZCR while continuing with his business consulting company.

Established in 1999 and 2006 respectively, CCST and ACS are leading providers of clinical research services, with a combined capacity of 65 beds. Together the two organisations have conducted more than 500 studies to date including ground-breaking work in viral hepatitis under the leadership of Hepatologist Prof Ed Gane. NZCR will be one of the leading clinical research groups in Australasia, providing services to a global marketplace as well as playing a key role in the New Zealand medical community.

Matt Riley and Jacques Venter will join the NZCR Board to represent Waterman’s interests, which will be chaired by independent director Hamish McGregor. The NZCR senior management team will be led by current ACS Managing Director Dr Christian Schwabe, working closely with Dr Chris Wynne as Chief Operations Officer, and Prof Ed Gane as Chief Medical Officer.

The key attractions for Waterman included ACS’s and CCST’s outstanding global reputation, and the potential to further develop the New Zealand clinical research infrastructure with the promise of attracting more overseas Pharma and Biotech companies to this part of the world. This will result in better treatment options for patients in New Zealand.

Prof Ed Gane, NZCR Chief Medical Officer said, “Today marks a significant milestone for clinical research in NZ. Through this strategic merger, we are bringing together two of the most innovative and respected clinical research units to create a stronger research company with expanded capabilities and expertise.”

Board member Matt Riley added, “Together these companies can better serve their international clients through complementary skills, increased scale and flexibility. NZ is already an attractive location for all phases of clinical research and the NZ response to the current pandemic has further highlighted the excellent environment for clinical research here. Waterman is looking forward to working with the experienced ACS and CCST teams to further expand their capabilities for the benefit of NZ patients”.

For further information on NEW ZEALAND CLINICAL RESEARCH (NZCR) please contact Dr Christian Schwabe at christian.schwabe@clinicalstudies.co.nz or go to www.clinicalstudies.co.nz or https://www.ccst.co.nz

COVID-19

Oct 5, 2020

NZ continues to be successful in the reduction of new cases of Covid-19.

As of 11.59pm on Wednesday 7th October, the NZ Government has moved the whole of New Zealand to Alert Level 1.

ACS continues to provide full service clinical visits and recruitment.

We have robust processes in place to manage studies/participants through all alert levels. Infection control measures are in place across the organisation. These include physical distancing, cleaning of surfaces and personal protective equipment (PPE) use where appropriate.

ACS Director and Principal Investigator, Professor Ed Gane, named as one of five University of Auckland researchers most highly cited!

Nov 20, 2019 – The highly anticipated Web of Science Group 2019 list identifies scientists and social scientists who produced multiple papers ranking in the top one percent by citations for their field and year of publication, demonstrating significant research influence among their peers. This list includes ACS Director and Principal Investigator, Professor Ed Gane of the School of Medicine at The University of Auckland.

Read more Here

Jan Gaskin, Director, Site Management Delivery and Country Head New Zealand presenting the Certificate of Achievement to ACS Operations Manager Mary Ellis-Pegler

ACS stand out among IQVIA preferred clinical trial sites

May 24, 2018 – Auckland Clinical Studies has been recognized for superior performance and quality in clinical research in 2017.  After being selected by IQVIA In November 2016 as their first preferred partner clinical trial site globally, ACS is tremendously pleased how well the collaboration is progressing. Mary Ellis-Pegler, ACS Operations Manager, commented “In 2017, the team worked extremely hard on a number of very big projects with IQVIA. It is really nice to see the effort and quality being recognized by IQVIA,  a world leading CROs and recently selected as one of the 2018 FORTUNE “World’s Most Admired Companies. We especially enjoy the collaborative spirit of the partnership and look forward to many more successful projects in the future”

Top row, L-R: Ben Oldfield (ACS Principal Pharmacist), Amalini Jesuthasan (ACS Laboratory Manager), Janet Patterson (ACS Quality Manager)

Second row, L-R: Tara Shadbolt (ACS Charge Nurse), Katie Lim (ACS Quality/Regulatory Associate), Mary Ellis-Pegler (ACS Operations Manager)

Third row, L-R: Prof Ed Gane, Assoc. Prof Wai-Kay Seto, Wen-Jing Zhou (Manager, HKU Clinical Trials Centre), Dr Li Yang (Oncologist, HKU-Shenzhen Hospital), Dr Christian Schwabe (ACS Managing Director)

University of Hong Kong-Shenzhen Hospital delegation visiting ACS

March 7, 2018 – A delegation from the Clinical Trials Centre at The University of Hong Kong-Shenzhen Hospital, recently spent 3 days at Auckland Clinical Studies. Shenzhen Hospital is a large, modern public hospital in Futian District, Shenzhen, Guangdong, China and is one of the two teaching hospitals of the University of Hong Kong. The clinical trials centre is set to become a major player in early phase clinical research in China and came to Auckland to gain further insight into best practice phase 1 research recognizing ACS’ world-leading status in this setting.

 “ACS has an enviable global reputation not only based on their contribution to finding very effective new treatments for chronic hepatitis C, but also as a result of innovative studies in many other therapeutic indications including oncology rare diseases” – Associate Prof Wai-Kay Seto, Clinical Associate Professor at the Department of Medicine,The University of Hong Kong.

“This meeting provides a fantastic opportunity to build a strong collaboration between our two units, which should be mutually beneficial. In future, we could provide a combined force for securing ongoing early phase studies”. – Prof Gane, Professor of Medicine at the University of Auckland, New Zealand, Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital and Clinical Director of Auckland Clinical Studies

Symposium to celebrate 10yrs of ACS

ACS was established to provide a location for Auckland City Hospital clinical investigators for Phase I and Phase II studies. Over the last 10 years, ACS has grown to 35 beds and 80 staff (including 6 research physicians, 4 Pharmacists, 9 study coordinators, 40 nurses, 18 laboratory staff, transcriptionists and admin staff).

Close to 200 studies have now been performed across most ACH specialties including dermatology, gastroenterology, haematology, hepatology, infectious diseases, nephrology, neurlogy, paediatrics, oncology and respiratory medicine.

The symposium on 12th October 2017 at the Marion Davis Libraray at ACH was to celebrate the last 10yrs with Notable invited speakers including principal investigators from Auckland City Hospital and leaders from pharmaceutical industry.

ACS turns 10!

28 April 2017 – Auckland Clinical Studies (ACS) proudly celebrated 10 years as an early phase clinical pharmacology unit in Auckland, New Zealand. Providing outstanding quality service in clinical research, ACS has successfully completed >150 studies to date.

Highlights of achievements over the last 10 years for ACS and its staff included:

  • Been an integral part of an international search for a cure for hepatitis C and treated 1200 patients in NZ most of whom are cured of their disease now
  • Related to above, ACS Director Professor Ed Gane was awarded MNZM in 2011 New Year’s Honours for services to Medicine, the Health Research Council 2014 Liley Award for his work in hepatitis C and the 2017 NZ Innovator of the Year Award
  • Selected as Global Prime Site for Quintiles, the World’s largest Clinical Research Organisation

Congratulations ACS, and to many more successes to come!

Congratulations to Professor Ed Gane, the 2017 New Zealand Innovator of the year

Professor Ed Gane’s outstanding contributions to the development of a simple and potent cure for chronic Hepatitis C were recently recognized when he was named the 2017 New Zealand Innovator of the year.

The New Zealander of the Year Awards celebrate people who use their passion for New Zealand to make our country a better place. These awards are a wonderful opportunity to honor extraordinary Kiwis whose selflessness, creativity and vision make us proud to call New Zealand home.

Auckland Clinical Studies is very proud of Ed’s fantastic achievement and grateful to have been able to help Ed’s search for a better and more effective Hepatitis C treatment. We want to join Ed in thanking the 1000+ patients who participated in studies here, and whose contribution helped find a cure for more than a million patients around the world so far.

Eradication of the Hepatitis C virus infection in New Zealand and around the world is now really a possibility. This will require identifying the approximately 20 000 New Zealanders that harbour the virus without knowing it. Knowing Ed, we are confident he will find a way to tackle this challenge too.

For further information, visit http://nzawards.org.nz/awards/new-zealand-innovator-year/2017/ 

FDA Inspection

In May 2017 an FDA inspection occurred at ACS. For further information, please contact Mary Ellis-Pegler our Operations Manager mary.ellis-pegler@clinicalstudies.co.nz

Auckland Clinical Studies and QuintilesIMS Sign

Early Clinical Development Prime Site Alliance Agreement

ACS joins Christchurch Clinical Studies Trust as the first two ECD QuintilesIMS Prime Sites

Auckland, New Zealand – November 10, 2016 – Auckland Clinical Studies (ACS) this week became one of the first two early clinical development (ECD) centers to join the QuintilesIMS Prime Site program, a global network of highly qualified sites collaborating with QuintilesIMS to improve the speed, efficiency and quality of clinical research across all phases of development.

Through the agreement signed this week, ACS and QuintilesIMS will strategically collaborate to raise the efficiency and volume of ECD research conducted in New Zealand on behalf of biopharmaceutical and medical device companies.  ACS has worked with QuintilesIMS for 10 years; the Prime Site alliance will take that collaboration to the next level.

“The addition of Auckland Clinical Studies as one of our first ECD Prime Sites is testament to the quality of medical research in New Zealand,” said Vice President Ashish Jain, Global Early Clinical Development, QuintilesIMS.  “This alliance further strengthens our ability to meet our customers’ early clinical development needs in Asia Pacific across a wide range of therapeutic areas.”

The ultimate goal for both QuintilesIMS and ACS is to help companies develop better treatments faster and give more patients the option of participating in clinical research.   ACS joins Christchurch Clinical Studies Trust (CCST) as the Prime Site program’s first two ECD centers. CCST also signed an alliance agreement with QuintilesIMS earlier this week.

ACS has access to the large patient/volunteer population in Auckland, New Zealand’s largest city, with 2 million people. It is located directly opposite Auckland’s leading tertiary referral hospital, Auckland City Hospital (ACH), and has access to a full range of medical specialties and LabPLUS, ACH’s premier medical laboratory.  ACS also has access to many researchers from the Auckland School of Medicine and Auckland’s major tertiary hospitals who are keen to take part Phase I and II studies.

Supported by a robust and world leading ethical and regulatory framework in New Zealand, ACS is a world leader in early clinical development, particularly for studies requiring novel or complex designs.

QuintilesIMS is a leading integrated information and technology-enabled healthcare service provider worldwide, dedicated to helping its clients improve their clinical, scientific and commercial results. QuintilesIMS’s approximately 50,000 employees conduct operations in more than 100 countries.

Companies seeking to improve real-world patient outcomes through treatment innovations, care provision and access can leverage QuintilesIMS’s broad range of healthcare information, technology and service solutions to drive new insights and approaches.

These insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders in the development and approval of new therapies, and to identify unmet treatment needs and understand the safety, effectiveness and value of pharmaceutical products in improving overall health outcomes.

Professor Ed Gane receiving the 2014 Health Research Council of New Zealand’s distinguished Liley Medal

We would like to congratulate our colleague Professor Ed Gane for receiving the 2014 Health Research Council of New Zealand’s distinguished Liley Medal for demonstrating a safer, more effective treatment for people with hepatitis C virus. The Liley Medal recognises Professor Gane’s outstanding contribution to the health and medical sciences in the field of clinical hepatology. Professor Gane was the lead author on two very highly cited papers in the prestigious medical journal, New England Journal of Medicine, which showed that people could be cured of the hepatitis C virus in just 12 weeks using an antiviral treatment called sofosbuvir.

A significant proportion of the research leading to this prestigious award was conducted at Auckland Clinical Studies. We would also like to use this opportunity to thank the more than 500 patients who have participated in Hepatitis C studies at ACS over the last few years and have made this outstanding progress in the treatment of this devastating disease possible.

Medsafe site certified

Medsafe administers an approval scheme for clinical trials under Section 30 of the Medicines Act 1981 and ACS was one of the first sites in New Zealand to be approved and certified as a clinical trials site which has study participants in residence while clinical trial medicines are administered.