Industry Dialogue 2019/2

CRM Industry Dialogue provides an avenue for Pharmaceutical companies (sponsors) and CROs to directly convey any issues, suggestions or opinions that they may have to CRM. Besides strengthening cooperation and networking between all parties, CRM also takes the opportunity to update the clinical research industry on local laws, guidelines and regulations. By bringing together these industry players, CRM uses this platform to connect with them and provide updates on its current and future activities.

Guest Speakers

We wish to express our sincere gratitude to our special guests, Dato’ Dr Goh Pik Pin (Director, Institute for Clinical Research) and Mr Ewe Kheng Huat (Executive Director of the Pharmaceutical Association of Malaysia (PhAMA))

Dato’ Dr Goh Pik Pin (Director, Institute for Clinical Research)

Mr Ewe Kheng Huat (Executive Director of the Pharmaceutical Association of Malaysia (PhAMA))

We also would like to thank our guest speakers Mr Normanshally Mohammad (Associate Director of Clinical Operations, Merck Sharp and Dohme), Mdm Aiza Adlina Abdullah (Senior Principal Assistant Director, NPRA), Dr Asyraf Syahmi Mohd Noor (MREC Secretariat), Mdm Aidahwaty Ariffin @ M. Olaybal (Head of Technical Evaluation Division, MDA) for sharing important updates with us today.

Mr Normanshally Mohammad (Associate Director of Clinical Operations, Merck Sharp and Dohme)

 

Mdm Aiza Adlina Abdullah (Senior Principal Assistant Director, NPRA)

 

Dr Asyraf Syahmi Mohd Noor (MREC Secretariat)

 

Mdm Aidahwaty Ariffin @ M. Olaybal (Head of Technical Evaluation Division, MDA)

Dialogue Session

We invited all of the special guests and speakers including our Senior Leadership Team (Dr Akhmal Yusof, Ms Joanne Yeoh, Ms Audrey Ooi, and Mr Yau Yit Huan) to have a dialogue session with the industry players. CRM has actively engaged and received feedback from the industry players in the dialogue session to move forward. We are also taking all the constructive feedback into consideration to improve our services and as an aspiration to deliver study with speed, reliability and quality.

Our humble gratitude to all that has make this event successful.

 

VOCAL Study, a Malaysian Perspective – InterVenn

By Ling Shen, Ley Hian, Kiat Yee and Clinical Science Team, InterVenn

Happy Malaysia Day (16th September 2019) to all Malaysians! On behalf of InterVenn Biosciences (InterVenn), I wish all Malaysians unity, prosperity, and importantly, happiness and good health! On this auspicious day, I would like to take some time to reflect on InterVenn’s efforts and contributions to women’s healthcare in Malaysia, and to reaffirm our commitment to reducing the burden of ovarian cancer, and improving the health and wellbeing of all Malaysian women.

Ovarian cancer is the fourth most common cancer among women in Malaysia. Unfortunately, due to the lack of effective tools for accurate early detection and confirmatory diagnosis, most women are diagnosed at an advanced stage, when the disease is less curable. In an effort to address this escalating problem, InterVenn (HQ in Redwood City, California) has established a strategic partnership with Clinical Research Malaysia (CRM) to conduct the VOCAL (Venn Ovarian Cancer Liquid Biopsy) clinical study in Malaysia, strengthening the capacity of our clinical studies as well as applicability of our study results in Southeast Asia, especially Malaysia. Read more

Congratulations to CRM Sponsored Research Award winners!

The CRM Sponsored Research Award is given out each year to outstanding Principal Investigators, clinical trials sites and the industry for their contribution in sponsored research to the nation. It is given to spur and encourage more of such efforts in the future. CRM would like to honour and acknowledge their dedication in participating in sponsored research and hope that they will keep up the good work. Congratulations to all CRM Sponsored Research Award recipients:

INVESTIGATOR & TOP RECRUITER OF THE YEAR

Dr Voon Pei Jye received the Investigator of the Year & Top Recruiter of the Year Award. For Investigator of the Year Award, he conducted the most studies that were initiated in 2018 and has the highest number of oncology trials in that year. He was also PI for 7 studies that was approved in 2018, one of which is a Phase 1, dose escalation study. He also co-authored in 3 publications in 2018 and 8 of his research findings were presented in ESMO Munich, ESMO Asia, World Conference on Lung Cancer, EndoBarcelona and Malaysia-Singapore Congress of Medicine.

For the Recruiter of the Year Award, Dr Voon has achieved first-patient-in within 100 days from site activation in 5 of his studies initiated in 2018. Four out of these 5 studies to date, have successfully reached its recruitment target.

 

CLINICAL TRIAL SITE OF THE YEAR

HOSPITAL PULAU PINANG

Hospital Pulau Pinang received the Clinical Trial Site of the Year Award for having conducted the highest number of sponsored research among all MOH sites. 27 sponsored research trials were conducted at this site in 2018, spanning 13 different therapeutic areas including areas of hematology, infectious disease, nephrology, gastroenterology, oncology and bioequivalence studies.

 

SPONSOR OF THE YEAR

Merck Sharp & Dohme (Malaysia) received the Sponsor of the Year Award for bringing in the highest number of studies that got initiated in 2018 and contributing to the highest value of sponsored research brought to the country.

 

CRO OF THE YEAR

IQVIA™ received the CRO of the Year Award with the highest number of studies and sites initiated in 2018 (9 studies and 22 sites), and having achieved over 71% of the total recruitment from the 22 sites activated.

Creating Awareness of Clinical Trials through Photography


KUALA LUMPUR
, 29 August 2019 – Clinical Trials Day 2019 was celebrated for its third consecutive year at the newly opened Women and Children’s Hospital Kuala Lumpur. This event, organized by Clinical Research Malaysia (CRM) in collaboration with Clinical Research Centre (CRC) of Kuala Lumpur Hospital, aims to elevate the awareness level of clinical trials among patients and the general public in the country.

During the event, an I AM AWARE Photography Series, featuring a photo collection of patients that had participated in a clinical trial, was launched by the Deputy Director-General of Health (Research & Technical Support), YBhg Datuk Dr. Christopher Lee Kwok Choong. The photography series portrays the different stages of a clinical trial patient’s life. The I AM AWARE campaign is one of the community outreach initiatives by CRM together with Universiti Kebangsaan Malaysia, CanWell Group as a strategic partner.

Clinical trials have been perceived as experimental testing and patients most often feel as though they are being used as guinea pigs. Despite the significant impact clinical trials has made on improving medical treatments, this misconception continues as the public’s understanding is limited due to lack of understanding of clinical trials.

In order to reach wider audiences at the national level, mobile exhibition roadshows will be touring the country at major public hospitals throughout the year to engage with patients. The photography series, comprising of stand-alone panels and booklets, showcases the core part of clinical trial which is the unsung heroes that have contributed to research that may improve medical treatments and move science forward.

Creating an Impactful Clinical Trials Day at Women and Children’s Hospital, KL

KUALA LUMPUR, 29 August 2019 – Clinical Trials Day 2019 was celebrated for its third consecutive year at the newly opened Women and Children’s Hospital Kuala Lumpur.

This event, organized by Clinical Research Malaysia (CRM) in collaboration with Clinical Research Centre (CRC) of Kuala Lumpur Hospital, aims to elevate the awareness level of clinical trials in the country, as well as to encourage participation of medical professionals in clinical research.

Clinical Trials Day is part of CRM’s ongoing efforts in enhancing the current clinical research ecosystem in the country by ensuring a robust pool of patients and volunteers for trials, while at the same time continuously investing in the infrastructure of qualified personnel, addressing the industry needs and promoting Malaysia as a hub for clinical research.

During this one-day event, Sponsored Research Award was given to individuals and organizations that have immensely contributed to clinical research in Malaysia. Dr. Voon Pei Jye, a Medical Oncologist from Sarawak General Hospital received the Investigator of the Year award as well as the Top Recruiter Award for his outstanding achievement in oncology trials last year.

The event was officiated by the Deputy Director-General of Health (Research & Technical Support), YBhg Datuk Dr. Christopher Lee Kwok Choong. Datuk Dr. Christopher touched on the importance of attracting sponsored research to the country as it provides access to ground-breaking as well as costly treatments that may not be available to patients outside of a clinical trial setting. He also commended the efforts and achievements of the doctors at Hospital Kuala Lumpur who have gone above and beyond their usual clinical practice to deliver clinical trials of good quality.

Congratulations! Hospital Seberang Jaya for being Top Recruiter in Malaysia

Congratulations! Hospital Seberang Jaya for the achievement of being the top recruiter in Malaysia for a neurology study recently. Kudos to our study coordinator team over in Hospital Seberang Jaya for contributing their effort in making it a success.

Congratulations! #TEAMCRM – PhAMA Annual Games 2019

Congratulations #TEAMCRM on the remarkable achievements in PhAMA Games 2019!

CRM successfully conduct the Research Proposal Writing Workshop

THANK YOU, PARTICIPANTS!

We would like to thank all our participants for the Research Proposal Writing Workshop by Dr. Masliza Mahmod! We hope all of you had gathered as much knowledge from Dr. Masliza these past 2 days.

Our heartiest appreciation to Dr. Mazliza Mahmod for accepting our invitation to conduct the workshop here with us. We thank you!

Not to forget our guest speakers Dr. Mahmoud Danaee & Dr. Ivy Chung from University of Malaya contributing your time to be with us.

Congratulations Oncology Department in HKL!

Congratulations! to Dr. Malwinder Singh Sandhu & his team over in Hospital Kuala Lumpur as the first recruiter globally for a breast cancer study on February 2019. Thank you team for making Malaysia #1!

Press Statement DG of Health 29 May 2019 – 72nd World Health Assembly

Resolution On ‘Improving the Transparency of Markets for Medicines, Vaccines, and Other Health Products’

The Ministry of Health Malaysia (MOH) welcomes a successful resolution laid out on ‘Improving the Transparency of Markets for Medicines, Vaccines, and Other Health Products’ at the World Health Organization 72nd World Health Assembly (WHA) held on 20th to 28th May 2019, Geneva. This was after intense negotiations with Member States to agree with the draft resolution proposed by Italy. Malaysia is one of the initial six (6) co-sponsors (Greece, Italy, Malaysia, Serbia, Spain and Uganda) to the resolution that gradually gained support from nineteen (19) countries (Andorra, Brazil, Egypt, Eswatini, Greece, India, Italy, Kenya, Luxembourg, Malaysia, Malta, Portugal, Russian Federation, Serbia, Slovenia, South Africa, Spain, Sri Lanka and Uganda).

Access to medicines and vaccines is a concern shared by all regions. Malaysia strongly supports the initiative to encourage more transparency and improved policies and actions to ensure fairer pricing and reduction of out-of-pocket payments. The Ministry believes that a sustainable fairer pricing system is needed for both health systems and pharmaceutical industries. This landmark agreement is a first step towards a more open dialogue about price transparency to improve access to medicines.

The resolution urged Member States to undertake measures to publicly share information on prices and reimbursement cost of medicines and improve the public reporting of the patent status information and marketing approval status, among others. A greater price transparency will add as another tool that will change the way drug prices are negotiated by governments and national health systems to fight against the rising cost of healthcare. The Ministry believes this move will help strengthen our government’s negotiating position and enhance our ability to obtain more affordable medicines for our people.

The Ministry has put in various measure to increase access to medicines such as pool procurement between inter-ministries, active price negotiations, as well as involvement in research and development (R&D) through partnership by Clinical Research Malaysia (CRM) with R&D institutions such as Drugs for Neglected Diseases initiative (DNDi). We will continue our efforts to improve universal access to medicines and affordable medicines, as one of the components in the National Medicines Policy, where the cost of drugs should not be a barrier for Malaysians to get quality health care. This is in line with our commitment of Universal Health Coverage (UHC), in which people’s interest come first to ensure universal access of medicine to the Malaysian people.

Our decision and motivation to support this resolution has always been our patients and the people of Malaysia. We hope to see more positive steps and policies in the near future to see the transparency resolution come to fruition.

Datuk Dr Noor Hisham bin Abdullah
Director General of Health
29 May 2019

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