CRM Bulletin Issue 15: “Celebrating Clinical Trials” is out!

 

From CEO’s Desk

It is always an exciting time as we progress into the third quarter of each year because it is during this phase that we can see most of our efforts blossom into something of significance. At this juncture also, I would like to take this opportunity to highlight the fantastic achievements of our doctors in driving more high-quality clinical trials here in Malaysia. In recognising their contributions, we have held our annual Clinical Trials Day where we awarded them with the CRM Industry Sponsored Research Award – an award given to high achievers in clinical trials in Malaysia. We hope that with such awards, more people will step up their game in their respective fields.

As CRM is growing at a rapid pace, we recognise the importance of forging partnerships with global entities that are paving the way for better healthcare. To begin with, we have the National University Hospital Singapore (NUHS) team visiting the Director-General of Health, Datuk Dr. Noor Hisham in Malaysia. NUHS has also shown a strong interest to collaborate with Malaysia in clinical research and training. With this, we have reached another important milestone in our Phase 1 Realization Project. Next – with amazing help from our South Korean counterpart, C&R Research Inc. – the CRM team together with Datuk Dr. Noor Hisham went for a series of business networking meetings in Seoul. During the visit, we took the opportunity to promote Malaysia’s clinical research capabilities to the pharmaceutical companies in Korea in a bid to encourage them to conduct clinical trials here in Malaysia. I truly believe that by building trust with our current partners and expanding trust to our future partners, we will be able to position Malaysia as the site for sponsored research in this region.

As our faithful readers might know, one of our aims at CRM is to become a truly global research organisation. In line with our core values of Transparency, Honesty, Accountability & Trustworthiness, we strive to achieve the highest standards in the way we conduct our business.  As such, we are currently at the final phases of obtaining the ISO 9001:2015 accreditation, which we work very hard to obtain since last year. Being accredited with ISO 9001: 2015 will demonstrate the quality of management we are practicing within CRM and the consistent standard quality of clinical trials that are being conducted at all sites in Malaysia. We hope to achieve and obtain this accreditation by early 2019.

Finally, I would like to also take this opportunity to thank all of our people in CRM for striving hard in making the organisation a strong force it is today. For our readers, I hope you will enjoy reading this bulletin and will gain more insight on what we do, the kind of activities we conduct and most importantly, appreciate the efforts the whole community is putting in to make our world a better place to live in.

Dr. Akhmal Yusof
CEO, Clinical Research Malaysia

 

Embracing Digital Health

L-R: YBrs. Dr. Kalaiarasu M. Periasamy, Deputy Director, National Clinical Research Centre, Y.Bhg. Datuk Dr. Shahnaz Murad, Deputy General-Director of Health Malaysia (Research & Technical Support), YB. Dr. Lee Boon Chye, Deputy Minister of Health, YBrs. Dr. Akhmal Yusof, CEO of Clinical Research Malaysia, YBhg. Dato’ Dr. Goh Pik Pin, Director National Clinical Research Malaysia

KUALA LUMPUR, 24 September 2018 – The 12thNational Conference for Clinical Research (NCCR) brought together medical experts and researchers under one platform to understand the way digital technology can impact the Malaysian healthcare delivery system, thus potentially improving patient outcomes.

Annually held, the 12thNCCR showcased a rich and varied programme, with 20 renowned speakers from Malaysia, Singapore, China, Australia and the US. This year’s conference themed “Patient Centred Research – Digital Health” received more than 130 abstracts. The two-day conference was held at Hotel Istana and was officiated by the Deputy Minister of Health, Yang Berhormat Dr. Lee Boon Chye.

Dr. Lee Boon Chye, Deputy Minister of Health, Malaysia

“The digital transformation and revolution in health including embracing Industry Revolution 4.0 pose multiple challenges and we need to formalize strategies to progress ahead. These includes evidence, advocacy, ethics, policy and clinical practice. Evidence based medicine is the foundation in which delivery of healthcare rests on. Therefore, clinical research needs to expand to embark into translational research to ensure that the practical applications of digitalised healthcare provide relevant, effective and safe patient care,” said Dr. Lee Boon Chye.

The conference also provided an opportunity for local and international contract research organizations, pharmaceuticals and biotechnology and medical device companies to showcase and exhibit their products and services at various exhibition booths set up within the parameter of the conference area. The booths were flooded with delegates comprising of speakers, researchers, pharmacists, members of academia and clinical industry professionals during the two-day event.

CRC Named Lecture: Dato’ Dr. Amar Singh HSS

One of the conference’s highlight was the CRC Named Lecture which was delivered by Dato’ Dr. Amar Singh HSS, a senior consultant Pediatrician & Researcher and the former CRC Head of Raja Permaisuri Bainun Hospital, Malaysia.

More info on NCCR 2018, please visit www.nccrconference.com.my

Event Photos

Lee Wei Xin received CRM Education Scholarship

PETALING JAYA, 7 September 2018 – Clinical Research Malaysia (CRM) had the signing of CRM Education Scholarship Agreement between CRM and National Pharmaceutical Regulatory Agency – NPRA​ officer, Ms. Lee Wei Xin, signing witness on behalf of NPRA was Mr. Tan Ann Ling (Director of Enforcement Division) for the Phase I Realization Project (P1RP) earlier today.

Ms. Lee Wei Xin has been selected to receive a scholarship to further study Masters of Science in Clinical Pharmacology at the King’s College London, UK.

The signing was witnessed by Dr. Noraida Mohamad Zainoor (Senior Principal Assistant Director, NPRA), Ms. Zaleha Yusof (Head of Human Resource), Ms. Joanne Yeoh (Head of Clinical Operations) and Mr. Yau Yit Huan (Head of Finance and IT).

#CRMEducationScholarship #scholarship #advancingclinicalresearch #P1RP #askusaboutclincialtrials #NPRA

Celebrating Clinical Research Through the Clinical Trials Day 2018 & 2nd IKN Research Day

PUTRAJAYA, 5 September 2018 – Clinical Trials Day 2018 was held at the Institut Kanser Negara (IKN), its second time since its initiation last year, to celebrate patients, volunteers and medical professionals involved in clinical trials. Clinical Research Malaysia (CRM) partnered with Clinical Research Centre (CRC) and IKN to organise this momentous event in conjunction of IKN’s 5th anniversary.

This event was well attended by all stakeholders in the clinical research industry. Various talks by prominent research personalities and patient support talks were organised for the general public as well as for the medical personnel to raise awareness on the importance of clinical trials.

At the event, a CRM Industry Sponsored Research Award was given to high achievers in clinical trials here in Malaysia to recognize their contribution in industry sponsored research, as well as to spur and encourage more of such efforts. IQVIA™ Malaysia received the CRO of the Year Award for highest number clinical trials with trial site activation & recruitment number for the year 2017, Dr Shereen Ch’ng Suyin (Hospital Selayang) and Dr Wong Yoke Fui (IKN) received  the Top Recruiter Award for consistent performance in patient recruitment for clinical trials initiated in Malaysia for year 2017, Dr Voon Pei Jye (Sarawak General Hospital) received the Investigator of the Year Award for outstanding achievement as principal investigator in clinical trials for year 2017 and Institut Kanser Negara received the Clinical Trial Site of the Year Award for outstanding achievement in being among the top oncology trial site in Malaysia for year 2017.

The event was officiated by the Deputy Director-General of Health (Research & Technical Support), YBhg. Datuk Dr. Shahnaz Murad. Also present was the Director of Institut Kanser Negara, YBrs. Dr. Asmayani, CEO of CRM, Dr. Akhmal Yusof & the Deputy Director of CRC National, YBrs. Dr. Kalairasu Periasamy.

About “I AM AWARE” Campaign

The “I Am Aware” campaign is a public education programme about the importance of clinical trials. The campaign is initiated to promote understanding of the true benefits and risks of participation of clinical trials and to provide resources to help individuals make informed decisions about research involvement. Hence, we have organised activities such as roadshow to various public health clinics and public hospitals in Malaysia.

View more photos via our Facebook Page below:

Press Release: Malaysia Takes the Lead on a Public Health Approach to Hepatitis C with New Initiative to Enhance Diagnosis & Treatment

FRONT L-R: Dr. Akhmal Yusof (Chief Executive Officer of CRM) and Mr. Zachary Katz (Chief Access Officer of FIND), BACK L-R: YBhg Dato Dr. Goh Pik Pin (National Clinical Research Centre (CRC) Director), YBhg. Datuk Dr. Shahnaz Murad (Deputy Director-General of Health (Research & Technical Support)), YBhg Datuk Dr. Noor Hisham (Director-General of Health), YB Dr. Dzulkefly Ahmad (Minister of Health, Malaysia), Dr. Ying-Ru Jacqueline Lo (Head of Mission and WHO Representative to Malaysia, Brunei Darussalam and Singapore) and Dr. Francesco Marinucci (Head of HCV & HIV Unit, FIND). –Photo by FIND

PUTRAJAYA, 6 August 2018 – The Foundation for Innovative New Diagnostics (FIND) and Clinical Research Malaysia (CRM) today signed a Memorandum of Understanding (MOU) to collaborate in the research and development of an innovative Hep C diagnostic testing strategy.

CRM is a non-profit company owned by the Ministry of Health in Malaysia, and this work underscores the importance of research and development in the government’s pioneering efforts to tackle the disease. The initiative is being conducted in continuation of a partnership with the Drugs for Neglected Diseases initiative(DNDi) and forms part of a larger FIND project known as Hepatitis C Elimination through Access to Diagnostics (HEAD-Start), supported by Unitaid.  Malaysia is the only high-middle-income country included in the project.

‘It is a great honour to be part of this research and development effort with FIND, that will eventually lead to more cost efficient and earlier detection of the Hepatitis C. In line with our effort to be a globally trusted organization and participate in research that matters to the Malaysian population we will continue to strive our best to deliver together with our partner FIND”said Dr. Akhmal Yusof, Chief Executive Officer of Clinical Research Malaysia

Although the World Health Organization (WHO) has prequalified different types of HCV tests, screening vulnerable and hard-to-reach populations remains a challenge due to centralized health services, making it difficult to identify those with the disease who need to be linked to care and treatment. FIND will demonstrate the feasibility of using rapid diagnostic tests (RDTs) in decentralized primary healthcare facilities and provide technical assistance to the Ministry of Health in Malaysia to support the project.

“The introduction of RDTs and simpler diagnostic pathways is a critical step in scaling up hepatitis C care,”said Catharina Boehme, CEO of FIND. “This MOU with CRM allows us to work closely with the Malaysian government and ensure that the evidence generated can be used to inform national policy so that more people can know their status and enter the care cascade.”

All patients screened during the study with World Health Organization pre-qualified diagnostic tests and confirmed as having active HCV (viraemia) will be linked to care. Treatment will be provided:

  • either as part of an ongoing DNDiclinical trial, which is co-sponsored by the Malaysian Ministry of Health and designed to assess the efficacy and safety of a new, alternative treatment regimen combining sofosbuvir with the investigational drug ravidasvir. Results from the first stage of the trial published in April 2018 show this drug combination to be safe and effective, with extremely high cure rates for patients, including hard-to-treat cases;[1]
  • or by the Malaysian national HCV programme, which, following an ambitious treatment strategy to overcome the prohibitively high cost of HCV treatment in the country, now offers free hepatitis C treatment (sofosbuvir/daclatasvir) in 21 government hospitals.

The MoU was signed by Dr. Akhmal Yusof, Chief Executive Officer of CRM  and Mr. Zachary Katz, Chief Access Officer of FIND, and witnessed by the Minister of Health, YB Dr. Dzulkefly Ahmad, the Director-General of Health, YBhg Datuk Dr. Noor Hisham, the Deputy Director-General of Health (Research & Technical Support), YBhg. Datuk Dr. Shahnaz Murad, Head of Mission and WHO Representative to Malaysia, Brunei Darussalam and Singapore, Dr. Ying-Ru Jacqueline Lo, the Director of National Clinical Research Centre (CRC), YBhg Dato Dr. Goh Pik Pin and the Head of HCV & HIV Unit, FIND, Dr. Francesco Marinucci.

Press Conference held after the signing ceremony. –Photo by FIND

 

About Hepatitis C

HCV is one of the world’s most common infectious diseases, usually contracted through unsafe healthcare and injection drug use. Globally, more than 71 million people are chronically infected, over 80% of whom live in low- and middle-income countries (LMICs) – but only one in five people know they have the disease.[2]Around 400,000 people die every year, and the mortality rate is increasing, making it a global health priority: the World Health Organization (WHO) has set an ambitious target of viral hepatitis elimination by 2030.[3],[4]In Malaysia, HCV disease burden is high and predicted to rise steeply over the coming decades, leading to a projected 63,900 HCV-related deaths by 2039.[5]

 

About CRM

Established by the Malaysian Ministry of Health in 2012, CRM exists to advance global health solutions for a brighter, more hopeful future for the people by providing speedy and reliable end-to-end clinical research support for quality studies. CRM’s innate understanding of the local clinical research landscape with the international standards of operations coupled with fundamental backing of the government ministries provide us an incomparable advantage to work with partners from the nascent stages of development to materialisation of the end product, in order to deliver better treatment and high skilled job opportunities. For further information, please visit www.clinicalresearch.my

 

About FIND

FIND was established in 2003 as a global non-profit dedicated to accelerating the development, evaluation and delivery of high-quality, affordable diagnostic tests for poverty-related diseases, now including malaria, tuberculosis, HIV/AIDS, sleeping sickness, hepatitis C, leishmaniasis, Chagas disease, Buruli ulcer, non-malarial fever and diseases with outbreak potential, such as Ebola. FIND has partnered in the delivery of 20 new diagnostic tools and created an enabling environment for numerous others through the provision of specimen banks, reagent development and better market visibility. FIND also supports better access to new diagnostics through implementation, quality assurance and lab strengthening work. FIND has nearly 200 partners globally, including research institutes and laboratories, health ministries and national disease control programmes, commercial partners, bilateral and multilateral organizations, especially WHO, and clinical trial sites. For further information, please visit www.finddx.org

 

 

Media contacts

Clinical Research Malaysia: Mr Syed Hamzah, Business Development

T: +6(03) 7960 5153 (ext. 121)

hamzah@clinicalresearch.my

 

FIND: Sarah-Jane Loveday, Head of Communications
T: +41 (0) 22 710 27 88
M: +41 (0) 79 431 62 44
media@finddx.org


[1]DNDipress release, 12 April 2018. https://www.dndi.org/2018/media-centre/press-releases/new-affordable-hepatitis-c-combination-treatment-shows-97-cure-rate/(accessed 18 July 2018)

[2]World Health Organization. Global hepatitis report 2017. www.who.int/hepatitis/publications/global-hepatitis-report2017/en/(accessed 27 June 2018)

[3]World Health Organization. Disease burden and mortality estimates, 2000–2015. http://www.who.int/healthinfo/global_burden_disease/estimates/en/index1.html(accessed 27 June 2018)

[4]World Health Organization. Combating hepatitis B and C to reach elimination by 2030, May 2016. http://apps.who.int/iris/bitstream/handle/10665/206453/WHO_HIV_2016.04_eng.pdf;jsessionid=0B0881916BBDF9EB2B47D4B004DB7969?sequence=1(accessed 5 July 2018)

[5]Raihan R, et al. Euroasian J Hepato-Gastroenterol2017;7(1):65–67

First to Recruit Patient for ELIOS Trial Globally, Congratulations Sarawak General Hospital

Congratulations Dr. Voon Pei Jye and his clinical trial team for being the first site to recruit patient for ELIOS trial globally.

Hospital Sibu Top Enroller in APAC Region for Respiratory Study

Congratulations Dr. Toh Teck Hock and his study team from Hospital Sibu, Sarawak for being the Top Enroller in APAC region for a Respiratory Study with 20% more patients recruited! We wish a continued success for this study and upcoming trials. #toprecruiter #clinicaltrials #askusaboutclinicaltrial #advancingclinicalresearch #research #respiratory #pediatrics #children #Malaysia

Hospital Miri 2nd Top Recruiter Globally for Respiratory Study

Standing L-R: Dr Tey Chin Wei, Dr Koh Huah Chian, Dr Andy Tang Sing Ong. Seating L-R: Salina, Dato’ Dr Fam Tem Lom, Dr Desmond Samuel(PI), Wan Ainor.

Congratulations Hospital Miri, Sarawak for being the 2nd Top Recruiter Globally for a respiratory study recently. The study team is lead by Principle Investigator, Dr. Desmond Samuel and supported by 2 of CRM’s study coordinators Ms. Salina Lisang and Wan Ainor. We hope for more great success story from the site. Thank you for making Malaysia proud!

Dr Chua Ee Yong, Sub-PI

Dr. Lee Ling Yuin, Sub-PI

 

Clinical Research Malaysia Forms Two Global Partnerships and New Foreign Investments

L-R: Dr. Akhmal Yusof (CEO of CRM), Mr. Zabidi Mahbar (Executive Director of Strategic Planning (Manufacturing), Malaysian Investment Development Authority (MIDA), YBhg Datuk Dr. Noor Hisham Abdullah (Director General of Health, Malaysia), Dr. Hytham Al-Masri (President & CEO of Hematogenix) and Dr. Yooni Kim (Executive Director, Asia Operations, Novotech)

PUTRAJAYA, 20 April 2018 – Hematogenix, a global leader in integrated laboratory services, and Novotech, Australia’s largest independent contract research organization (CRO) have both signed a Memorandum of Understanding with Clinical Research Malaysia (CRM) to establish strategic partnerships in clinical research.

The inking of this MoU with Hematogenix will have the potential to set Malaysia apart from its Asia counterparts as Hematogenix intends to invest in setting up its central laboratory services (that focuses on cancer related research and clinical trials) in this country. Hematogenix is only one of a handful of providers of such services in the USA and a leader in immune-oncology testing for drug development. The establishment of their central laboratory services will be the first of such kind in the Asia region and is anticipated to be the largest globally in due time, surpassing the one in Chicago. Through its Asia operations, Malaysia can expect to attract more global clinical trials into the country, upscale the Malaysian medical talents and bring in more investments into the nation’s economy.  Read more

CRM’s Pilot Training Programme: Fundamental of Clinical Research & Practice

The Fundamental of Clinical Research & Practice, it’s CRM’s pilot training programme together with C&R Research Inc. (Korea). This 3 days training are packed with all-you-need-to-know about conducting clinical trials.

In our journey to be the global preferred site for clinical trial, we will need to equip our people with global standard practice in clinical research.

This is one of many trainings that we have in the pipeline and stay tuned for more future programmes conducted by CRM.

About This Training:
The Fundamental of Clinical Research & Practice Course is an introductory training that provides the fundamental information to understand clinical research. It includes Overview of Drug Development, Non-Clinical study, Trial Phases involved and the objective of every phases. The course will also cover the most important guideline in conducting clinical research, Principles of Good Clinical Practice and brief discussion of Roles and Responsibilities of players in clinical research (Institutional Review Board/ Independent Ethics Committee, Investigators and Sponsor).