Team member introduction

[shstat1729]

Introduction to yourself.

[shstat1729]

박상호 (빌더) 스터디명 : From Fixed to Flexible: Your Guide to Adaptive & Master Protocols

Study Name

From Fixed to Flexible: Your Guide to Adaptive & Master Protocols

Greetings

Hello! I'm Sang Ho Park, and I've been active as a builder since the 7th. In the 7th, I led a study (Let-Biostat-Guidance-Guide-Us LBGGU) to learn clinical trial statistics guidelines. In the 8th, I conducted a basic causal inference study (Smart Causal Inference SCI). In the 9th, I studied real-world evidence guidelines. For the 10th, I would like to study adaptive design and master protocols.

Brief History

I graduated early from Chungnam National University with a degree in Physics (in 7 semesters) and studied Statistics (Bayesian major) in my Master's program in SungKyunKwan University. I worked as a statistician in the Department of Internal Medicine at Gangnam Severance Hospital, and currently, I am working as a statistical analysis researcher in the Department of Endocrinology and Metabolism at Samsung Medical Center. I am also pursuing a full-time doctoral program in the Department of Clinical Research Design and Evaluation at SungKyunKwan University. I have been consistently studying at Pseudo Lab since the 7th cohort because I want to work in regulatory science.

Current Interests

I want to work in regulatory affairs. I want to contribute to the launch of good medical devices and pharmaceutical products that are helpful to patients. To do so, I need to be familiar with regulatory guidelines. While participating in Pseudo Lab activities, I aim to consistently learn regulatory guidelines. In the 7th, I learned guidelines related to clinical trial statistics, and in the 8th, I studied causal inference, which is important for verifying efficacy and safety. In the 9th, I learned FDA, MHRA, MFDS (Ministry of Food and Drug Safety), and ICH guidelines related to real-world data/evidence. In the 10th, I want to learn about adaptive designs and master protocols, and create and share related protocols.

Special Experiences

Since my university days, whenever there was a study group I wanted to join, I actively created it and studied together with others. Philosophy study groups, statistics study groups, study groups in Pseudo Lab, etc... I learn a lot by organizing study groups myself and studying together.

Current Activities

Currently, I am writing papers and conducting statistical analysis as part of my doctoral program. While working on statistical analysis at Samsung Medical Center, I am also working with Rcpp for fast calculations, and doing web crawling for data collection. In addition, I am handling Samsung Medical Center's clinical data warehouse and National Health Insurance Service claim data. I am gaining diverse experiences here.

Hobbies

These days, when I exercise, I'm focusing on diversifying my heart rate zones. Before, I only did high-intensity exercise, but I've come to realize that moderate-intensity exercise (around 70% of maximum heart rate) also has its advantages, so I'm trying various challenges.
And participating in Pseudo Lab activities is also one of my hobbies.

[itssun01]

Introduction to yourself.

Hey y'all!

My name is Jeongsun Park, I go by Sun :)
Thank you Sang Ho, for this great opportunity. I am thrilled to start this journey with all of you to enhance our knowledge of adaptive design and master protocol.

Let me tell you a little bit about myself.
I practiced nursing in Toronto, Canada for about 10yrs, mostly in cardiology and ICU.
During the COVID era, I had a chance to reflect not only on the meaning of true happiness but also on what's important in my life: my family.
I decided to relocate back to Korea, and it's been about 4yrs since I settled.
Ever since, I have been working in the clinical trials field as a project manager. I managed global phase II studies with neurology indication, and now I am focused on trials with botulinum toxin.

The topic of the study that we are about to jump into is quite interesting. However, the concept is not acquainted to the majority (including myself), and lacking in the knowledge of what adaptive design is makes it more challenging to implement the concept into practice.

Long story short, I am super excited to join the study group! I do not have a background in IT, so I feel alienated in the interface of Github or Discord. While figuring out how to navigate the system, pleased to e-meet you!

Sun

[sychanmul]

Study Name

From Fixed to Flexible: Your Guide to Adaptive & Master Protocols

👋 Greetings

Hello~ I'm Sooyoung Kwak who works as a Biostatistician.
I am interested in studying adptive design methodology for my work.
I look forward to learning with people who have similar interests and work.

📜 A Brief History

Education

Biostatistics, Master of Science, University of Michigan
Biology, Bachelor of Science, Ohio State University

Career

(Previous) Biostatistical Reviewer, Medical Device Review Department, Ministry of Food and Drug Safety
(Previous) Lunit Biostatistician, responsible for statistical aspect of Medical AI(SaMD) Clinical Study for US FDA approval
(Current) JNPMEDI Biostatistician, provides statistical consulting for various MedTech clinical studies for regulatory approval

🤩 Current Interests

DCT(De-Centralized Trial), Regulatory Science regarding MedTech, Leadership, Running Blog

👾 A unique experience

I appeared on a scholarship quiz show in high school (similar to JEOPARDY) and became the final winner of the show.
As a keyboard player in a band, I performed at the Hall last summer.

⚔️ What I am doing now

I work for a company that provides consulting services to various MedTech companies who wish to have their products licensed by regulatory agencies (Korean Ministry of Food and Drug Safety, US FDA, European CE, etc.).
I specifically provide consulting services in biostatistics for the clinical studies required for marketing applications to these regulatory agencies.

[ChungsooKim]

Hi everyone,

I’m Chungsoo Kim, a Postdoctoral Associate in the Section of Cardiovascular Medicine and the Yale/YNHH Center for Outcomes Research and Evaluation (CORE) at Yale School of Medicine (New Haven, CT, USA).

My academic journey began in South Korea, where I earned my Doctor of Pharmacy (PharmD) degree from Ajou University College of Pharmacy in 2019. Driven by a passion for integrating data science with healthcare, I pursued a PhD in Biomedical Informatics at Ajou University’s Graduate School of Medicine, which I completed in 2024.

My research interests are centered on leveraging real-world data to enhance patient outcomes. Specifically, I focus on generating reliable evidence regarding medication effectiveness and safety by analyzing diverse data sources, including electronic health records and claims databases. Additionally, I am keen on applying artificial intelligence and digital health methodologies to clinical practice, aiming to predict individual drug effects and potential adverse events.

I participated in a study of RWD/RWE guidelines (also led by Sangho) last time, which was a great opportunity to review the guidelines and identify common elements for reliable evidence. I joined this study group to learn more about clinical trial protocols because I believe that understanding clinical trials is extremely helpful for evaluating drug effectiveness and safety using real-world data as well. I’m looking forward to learning a lot from all of you.

Outside of my professional life, I enjoy traveling and have visited countries like the United States, United Kingdom, France, Netherlands, China, Japan, and Taiwan. I also recently took up tennis, finding it a refreshing way to balance research and life.

I look forward to engaging discussions that can be learned about the adaptive design of clinical trial and master protocol.

[ICUKiller]

Dear everyone,

I'm HeeSeok YOO, I worked 3 years as a Registered Nurse in SICU, Seoul Boramae Hospital. Currently working as a SC(Study Coordinator), known as CRC(Clinical Research Coordinator) at Seoul National University Child Hospital(Respiratory&Allergy).

Since I started my new career, I'm participating in study that uses an AI deep learning model to identify abnormal breath sounds in pediatric patients. I took a AI & healthcare research training programs and won a first place team. (but hardly know about AI or python, etc.)

I started my new career to join clinical research(oncolgy), but It's hart to get a chance in my era. So I decided to study things that would be helpful, and medical statistics is one of them. I'm really curious about how medical data works. Through clinical background in ICU, I want to learn many thing from this project.
To understand smoothly SangHo's lecture and this project, I'll learn and study hard.
Thank you for giving me this opportunity.

Sincerly,
HeeSeok YOO