HistoBlast: China Edition May 2020

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Multi-headed microscopy allows for efficient training and performance of reproducibility studies.

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High resolution whole slide images are routinely captured and available for remote viewing.

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Automated stainers for IHC and multiplex IHC testing. Our laboratory features Ventana, Dako, and Leica instruments.

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Automated H&E and cover slipping increases standardization and compatibility with digital scanning and analysis.


Histopathology Update

Now that our Jining team is back in the lab, equipment installation is ongoing and is on track to receive samples next month. In our IHC department, we currently have:

  • two (2) qualified and validated BenchMark ULTRAs,
  • one (1) DISCOVERY ULTRA,
  • a Tissue-Tek Prisma® Plus Automated Slide Stainer,
  • and a Tissue-Tek Film® Coverslipper from Sakura®.

Our digital pathology department is validating the 3D HISTECH Pannoramic 250 Flash III Scanner.

One of the instrument vendors remarked on our laboratory's large footprint and appearance. He commented:

"Your lab looks so nice, it is so different from other labs that I have visited. I can tell this will be a very professional lab. I will bring my senior manager to visit you and you will definitely be one of our most important customers."

It is our pleasure to introduce two of our Jining management team with whom you will likely work. These ladies are part of our Chinese laboratory management team and joined our Medical Director, Dr. Zhang Li-Jie to set up our laboratory. We asked them to share their backgrounds and their thoughts for the future of our Jining laboratory.

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Michelle Li
Clinical Operations & Project Management

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Susan Sun
Business Development

Tell us about your industry background.
Michelle Li (ML): I started my journey in clinical trials in 2009 at a central lab in Beijing, which had recently began to develop their anatomic pathology (AP) lab. In my 8 years as a project manager there, I witnessed the growth of the AP lab, managed quite a lot of AP projects, and worked closely with many global pharma companies. In addition to my PM role at the lab, I also took on roles in Contracts, Sourcing, etc., which helped me gain different perspectives and acquire different skills along the way.

Susan Sun (SS): In the past 20+ years, I have accumulated rich experiences in the global central lab industry from lab bench work, CAP/ISO15189 lab accreditation, people management, clinical trial protocol review, project management, and customer interaction. In 1996, I joined a top global central lab as one of the first 2 employees recruited in China. For three months, I trained in the USA before returning to China to set-up the lab with other pioneers. We earned the industry's first CAP accreditation in China in 2003. Two years later, I started working for another lab, leading them to obtain CAP accreditation (that same year). In October of 2010, I led daily operations for a Singaporean laboratory, returning a year later to China, where I worked in different functional teams for another global laboratory.

Why did you decide to join HGX Caprion?
ML: I obtained a pharmacy degree, but my passion is still the laboratory. Many years of project management experience made me realize that in order to be a good project manager, I needed to have an understanding and enthusiasm for science and technology. After learning about the strong testing capability and the high level of quality at HGX-Caprion, I decided to join HGX-Caprion 10 months ago. In speaking with my knowledgeable and experienced colleagues, I am more motivated to learn than ever before. The opportunity to be part of the start-up phase of a new lab and to be involved in the many aspects of the lab set-up was very attractive. I appreciate all the opportunities and challenges as we build a team with a solid foundation.

SS: I had some collaboration with HistoGeneX for a few tumor clinical studies while at previous companies. HistoGeneX’s leading technologies and their knowledge in histopathology greatly impressed me. In recent years, more clinical trials in China now focus on tumor treatments. Advanced technology and professional personnel play an important role in these clinical trials. HistoGeneX, as a leading company in these areas, drew me to join the HGX-Caprion China lab and I devote myself to set up a high-tech specialty lab in China.

Tell us about your role at HGX China. What are you looking forward to accomplishing?
ML: I am the first project manager at HGX-Caprion China, and I will work alongside my colleagues in Belgium, Montreal, and the US. Using our team’s great experience and my knowledge on Chinese clinical trial environment, we will build a knowledgeable and professional China PM team.

SS: I joined the Business Development team at HGX-Caprion China lab on January 1st of this year. My major roles include, but are not limited to, catching the most-updated market changes, understanding client needs, collecting HGX-Caprion solutions to resolve clients concerns, and bridging the communication between clients and internal teams. I am looking forward to my contributions to this new lab in China, helping our clients to mitigate issues in the clinical trials, and achieve the goals of both clients and HGX-Caprion as a company.

What are you looking forward to the most in the next 2-3 years?
ML: I believe the growth and development of an individual cannot be achieved without growth and development of its the team and company. In the next 2-3 years, we will build a very professional and strong PM team, validating our customer’s belief that they have come to the right people. On behalf of our customers, we will deliver the project with high quality, professional management, and efficient communication. Together with the team, we will make our collaborative contribution to clinical trial development and to the benefit of Chinese patients.

SS: Compared to other global central labs, HGX-Caprion lab is not the oldest. But I am very confident we will be the best in immune-oncology testing services in China in the next 2-3 years. We not only have the novel technology and platforms, but also employ passionate experts. Moreover, HGX-Caprion labs aim to provide the best possible lab services to our clients. We always treat every client’s feedback as the motivation to improve our services constantly.

What is your experience with HGRAC applications? How can the project management team support sponsor HGRAC submissions?
ML: HGRAC regulations have changed significantly in the past years making it a very important and unavoidable topic in Chinese clinical trials. Previously, I did some submission work to the authority and, at that time, the central lab could take that submission responsibility; prior approval was not required. However, after all the changes in recent years, HGRAC application has become an integral part of the clinical trial initiation process, independent of whether specimens will be exported or not. HGX-Caprion China is now registered on the HGRAC platform. We are also monitoring the regulations and are familiar with the required documentation, procedures, and deadlines. Importantly, we analyze both successful and failed cases to accumulate the necessary experiences.

We are pleased to be able to support you in these efforts through consultative phone calls, providing suggestions on the strategy of the application, reviewing applications, and providing comments or clarifications.

 

Flow Cytometry Update

The BD FACSLyric™ Clinical System from BD Bioscience has also arrived. BD Bioscience is providing us great support for training and reagent supply, including customized reagents.

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Image courtesy of BD Biosciences US website. BD and BD Logo are trademarks owned by Becton, Dickinson and Company.

We selected this 3-laser, 12-color system as our first platform in China. We will use it to serve you with our MDSC, TBNK, and other flow cytometry panels, leveraging its simplicity, flexibility, and automation.

The first panel will be our MDSC panel available in July. The MDSC Assay is a 4-color assay that measures the frequency of myeloid-derived suppressor cells (MDSCs) in whole blood. Our staff is presently being trained to perform this assay.

Following implementation of our MDSC assay, we will introduce our TBNK panels. For other assays, please utilize our assay transfer process, an efficient way to get your customized or required flow cytometry assay implemented at our Jining laboratory. In future issues, we will describe how we can develop customized flow cytometry assays for you.

Our team will provide local project management and will be able to support your HGRAC submissions. We have hired two technologists who will perform the testing at our Jining laboratory and have also initiated a search for a flow cytometry expert.

We will provide updates of our flow cytometry implementation in future issues of HistoBlast. We welcome your inquiries and comments.


Genomic Survey Results

We are pleased to announce that we will offer the genomics services below at our Jining laboratory. A huge thank you to many of you who supported us with our survey; this was very helpful. We will provide more specifics in a future issue.

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Feeback from our Chinese Clients

"It is fabulous to see your China lab’s pictures."

"Looking forward to the future collaboration with HistoGeneX-Caprion."

"It is very impressive to see those platforms and methodologies planned in your China lab."

"We have had very pleasant working experiences with your colleagues in previous studies. We are looking forward to working with them again in new studies."

For June 2020

In our next issue, we will provide the latest on:

  • WeChat (微信) channel for HistoGeneX-Caprion
  • Personnel, equipment, and processes
  • Biomarker menu updates and assay development
  • Genomics and Flow Cytometry updates
  • Interview with Dr. Michael Yuan

 

FAQs

Where can I find previous HistoBlasts? Find them here.

Who are some of the people in the Jining lab? We introduced some of our team here and here.

Have you seen the newest video of our laboratory space?

Do you have a capabilities presentation for Jining? Here is an informational presentation of our Chinese laboratory.

What biomarkers have been validated at HistoGeneX? Our biomarker assays can be found here. This is not an exhaustive list. Please This email address is being protected from spambots. You need JavaScript enabled to view it. to confirm the availability of your assay.

For a conversation about our laboratory, please contact your project manager, business development executive, or This email address is being protected from spambots. You need JavaScript enabled to view it..

You can send in additional questions This email address is being protected from spambots. You need JavaScript enabled to view it..