Scientific Program

Speakers & Session Details

September 09 (Wed)

W1: Mastering Risk-Based Monitoring & Quality Management

Title

[Workshop 1] 1. Mastering Risk-Based Monitoring & Quality Management Part1

Summary

Risk-based monitoring (RMB) approach has been adopted by many sponsors and contract research organizations(CROs) to enhance the safety and efficiency of clinical trials and improve data quality. However, we see the adoption has been slow and implementation has been challenging. In this session we will cover from RBM concept, methodology and process to site risk assessment which is important for assuring patient safety and data integrity. Also we will share the experiences and lesson learned during RBM implementation in global and local pharma companies. Finally we will present the RBM metrics evolved in TransCelerate member companies as a method of measuring the impact of RBM and some trends which could be considered for future preparation.

Chair

  • Chair : Yoon-Duk Han
  • Affiliation : Pfizer / TransCelerate
Country : KOREA, REPUBLIC OF
  • Chair : Hye-Jong Yoo
  • Affiliation : AstraZeneca
Country : KOREA, REPUBLIC OF

RBM overview & methodology: on-site, off-site & central monitoring(including Regulatory Guidance)

Eehwa PaeBristol Myers Squibb

KOREA, REPUBLIC OF

Bio Essay Eehwa Pae is Clinical Operations Manager who leads Korea Clinical Trial Monitoring group at Bristol Myers Squibb (BMS), Regional Clinical Operations since 2018. Before the current position, she was Site Manager who is the project manager for Asia hub(Korea, Taiwan, Singapore, Hong Kong, Thailand etc.) for 6 years at BMS. She had worked at Novartis Korea as CRA and CRM for 10 years. She is participating in Industry Collaboration as Committee member of Government Affairs in Korea Society for Clinical Development(KSCD) since 2014. She studied Nursing at Yonsei University(Seoul) until 1999.

Risk Management Planning - workshop

Hyewon SongSanofi

KOREA, REPUBLIC OF

Bio Essay Hyewon Song is currently heading Clinical Study Unit of Korea, in Sanofi. Hyewon has 17+ years in clinical operations, the last 15 years being with Sanofi where took various roles including clinical project leader with breadth of experience across various therapeutic areas from diabetes, cardiovascular, oncology and neurology, and a regional role as Investigator Network Manager of Asia Pacific with Strategy & Collaborations in Sanofi R&D to build and manage the partnership with Sanofi network sites.

Title

[Workshop 1] 2. Mastering Risk-Based Monitoring & Quality Management Part2

Summary

Risk-based monitoring (RMB) approach has been adopted by many sponsors and contract research organizations(CROs) to enhance the safety and efficiency of clinical trials and improve data quality. However, we see the adoption has been slow and implementation has been challenging. In this session we will cover from RBM concept, methodology and process to site risk assessment which is important for assuring patient safety and data integrity. Also we will share the experiences and lesson learned during RBM implementation in global and local pharma companies. Finally we will present the RBM metrics evolved in TransCelerate member companies as a method of measuring the impact of RBM and some trends which could be considered for future preparation. -

Chair

  • Chair : Yoon-Duk Han
  • Affiliation : Pfizer / TransCelerate
Country : KOREA, REPUBLIC OF
  • Chair : Hye-Jong Yoo
  • Affiliation : AstraZeneca
Country : KOREA, REPUBLIC OF

Mock site risk assessment - workshop

Ji-Hee KwonAstraZeneca

KOREA, REPUBLIC OF

Bio Essay She is Clinical Quality Manager of Site Management & Monitoring(SM&M) Korea in AstraZeneca. She received B.A (2008: Veterinary Medicine) from Seoul National University in Korea. She has worked in Clinical Development field for 13 years started from Pfizer and moved to AstraZeneca. During past 10 years in AstraZeneca, she has worked as CRA / Local Study Manager / Clinical Research Manager & Clinical Quality Manager and delivered many clinical trials in various therapeutic areas such as oncology, cardiovascular & respiratory. She is also member of TransCelerate Korea Country Network and is interested & passionate in new initiatives in clinical trial field.

Case study - Challenges & Opportunities (Global)

Sun-Ha ParkRoche

KOREA, REPUBLIC OF

Bio Essay Sun-Ha Park is Country Study Manager at Roche Korea. She has worked in clinical development filed for 11 years. She delivered many clinical trials in oncology & Neurology as CRA, SSUS, CSS and regional study manager since join at Roche in 2011.She started her career in clinical trial field as CRA at CRO. She majored in Nursing at Ewha Womans University by 2006.

Case study - Challenges & Opportunities (TransCelerate initiative)

Hyunju ParkCKD Pharmacy

KOREA, REPUBLIC OF

Bio Essay 2007 Master of Science Statistics at Korea University Graduate School 2007 Biometrics center, DreamCIS, Data Manager & Statistician 2011~2019 Biostatistics Tearm, Chong Kun Dang Pharm., Data Manager & Statistician 2020 ~ Ongoing Biostatistics Tearm, Chong Kun Dang Pharm., Data Manager & Statistician & Centralized Data Monitor

Measuring the impact of RBM & Future of RBM

Yoon-Duk HanPfizer / TransCelerate

KOREA, REPUBLIC OF

Bio Essay Yoon-Duk Han is Director of Clinical Site Operations for Korea and Philippines in Pfizer. She joined Pfizer in 2005 and has held various roles with focus on clinical operations field. Yoon-Duk has worked as Country Co-Lead for TransCelerate in Korea since 2018 to engage MFDS, KoNECT and key industry stakeholder to raise global awareness for TransCelerate initiatives and implement them in country level successfully. Yoon-Duk received her Bachelor’s degree in Pharmacy from Ewha Womans University and her MBA from Korea University Business School.

W2: Biotech Boot Camp

Title

[Workshop 2] 1. Biotech Boot Camp Part 1

Summary

-

Chair

  • Chair : James Lee
  • Affiliation : Bridge Biotherapeutics, Inc
Country : KOREA, REPUBLIC OF

From Idea to Inception

Jason Junghwe KooLB Investment

KOREA, REPUBLIC OF

Bio Essay Jason Junghwe Koo is Senior Managing Director of LB Investment, the Top-tier Korean Venture Capital. He graduated from Korea University, majoring in materials engineering in MS, and organic electron material in master's degree. He has 22 years of experience in venture capital and is also an expert in technology commercialization. As representative companies in biotech are Bridge Biotherapeutics which is the first NRDO (No Research Only Development) Kosdaq listed company, GPCR Therapeutics developing pharmaceuticals based on the cutting-edge knowledge of G Protein-Coupled Receptors (GPCRs) , and, Orum Therapeurics developing a new class of therapeutic antibodies.

Art of Fundraising

Jungseob ShinKB Investment

KOREA, REPUBLIC OF

Bio Essay Majored and received M.S. degree in Microbiology at Seoul National University. Started career as a research scientist in Hansol Institute of Science and Technology, and worked as a strategic planning team leader at Macrogen. After starting Venture Investment at KDB Capital, he is currently executive managing director of KB Investment.

Title

[Workshop 2] 2. Biotech Boot Camp Part 2

Summary

-

Chair

  • Chair : James Lee
  • Affiliation : Bridge Biotherapeutics, Inc
Country : KOREA, REPUBLIC OF

From Molecule to IND

Yun Jeong SongImmuneOncia

KOREA, REPUBLIC OF

Bio Essay Yun Jeong Song, M.D. is CEO of ImmuneOncia Therapeutics, a joint venture company established in 2016 between Yuhan (KR) and Sorrento Therapeutics (US). She is a U.S. board-certified rheumatologist and internist with a strong research basis in cellular/translational immunology with years of industry experience. Her previous positions include researcher at Washington University and NIAMS/NIH (U.S.A.), Clinical/Translational Leader at SAIT (Samsung Advanced Institute of Technology, Korea) and Clinical Research Director at Sanofi R&D.

How to Prepare IND

Kisuk KimC&R Research

KOREA, REPUBLIC OF

Bio Essay [Education] -YONSEI University, Master degree of medical science -Inha University, Baschelor’s degree of biotechnology [Professional Experience] -C&R Research, Inc.RA Manager -Korea Biomedicine Association.BD Manager -BIO-IT platform -Dynamic BIO [Certification] -Korea Certified Valuation Analyst -TCB technology evaluation(BIO) -Technology Transfer Agent -Public Korea Cost Analyst [Publication] -Toolkit for Preparation of IND dossier -Global clinical trial trend(CoGIB) -Biotech Investment Analyst

Project Management: Steering Ultimate Project Success with CROs

Jenny ShinSyneos Health

KOREA, REPUBLIC OF

Bio Essay Jenny Shin is an associate Project Director of Syneos Health, responsible for oversight of the conduct of a program or clinical studies ranging in size and complexity from single service studies to large full scope studies, multiple protocol projects, global projects and/or portfolio of projects. She is also experienced in management of FDA IND projects from gap analysis, CDP development, pre-IND meeting and IND submission as well as study execution in all phases of clinical research. Jenny Shin has 17 years' industry experience including 9 years project management experience from both CRO and Pharmaceutical Companies. She earned a bachelor's degree in nursing and a master's degree in public health, policy and management both in Yonsei University.

W3: 360º insight from Data to AI

Title

[Workshop 3] 1. Insight on BIO-Health DATA

Summary

R&D and innovation using data is becoming important and inevitable. In the pharmaceutical industry, more and more companies have dedicated departments and teams to handle the BIO-Health data efficiently. In this session, speakers will talk about managing/using BIO-Health data and real cases on adverse drug reaction with RWD.

Chair

  • Chair : Brian Jo
  • Affiliation : Evidnet
Country : KOREA, REPUBLIC OF
  • Chair : Sungho Won
  • Affiliation : Seoul National University
Country : KOREA, REPUBLIC OF

Data management for biomedical statistics and beyond

Sungho WonSeoul National University

KOREA, REPUBLIC OF

Bio Essay I am a biostatistician, and major in biostatics, statistical genetics and genetic epidemiology, etc. I am an associate professor at Department of Public Health Sciences, Seoul National University. I got my Ph.D. under the guidance of Prof Robert C Elston who is one of founders for genetic epidemiology, and developed statistical methods for genome-wide association analysis. Currently I am working on various statistical issues; (1) statistical method development for epidemiological studies, and genetic association analysis, (2) statistical analyses of clinical, epidemiological and genetic data. Last ten years, I published more than 40 papers for statistical methods, and around 90 papers for real data analysis. Detailed information can be found from http://healthstat.snu.ac.kr/swon.

Real data analysis of adverse drug reactions

Hyeon-Jong YangSoonchunhyang University Hospital

KOREA, REPUBLIC OF

Bio Essay Professor Hyeon-Jong Yang, M.D., Ph.D. Pediatric Allergy and Respiratory Center, Department of Pediatrics, Soonchunhyang University Seoul Hospital Director of SCH data innovation Center, Soonchunhyang University Seoul Hospital Professor Yang is a chief professor in the Department of Pediatrics, and director in the SCH data innovation center of Soonchunhyang University Seoul Hospital. He graduated from Soonchunhyang University College of Medicine in 1997, received Ph.D. from the same University in 2012. Prior to receiving his degree, he worked one year at Pediatric Asthma Epidemiology Research Unit of Mayo clinic as a research fellow with professor Young J. Juhn from 2010-2011. The scientific interests of prof. Yang are epidemiology and data science, particular in study designing in the field of allergy and respiratory disease. Recently, His work focused on the real-world research using common data model and healthcare big-data. He is actively involved in the project (OMOP CDM funded by Ministry of Trade, Industry and Energy and Sentinel CDM funded by The Korea Institute of Drug Safety and Risk Management) as a principal investigator of the Soonchunhyang Medical Center.

Title

[Workshop 3] 2. 360º insight on AI from basic concept to application

Summary

AI is increasingly applied to medical and clinical results analysis. In this session, we will look at examples that are used for new drug development along with the Recommendation model using AI.

Chair

  • Chair : Brian Jo
  • Affiliation : Evidnet
Country : KOREA, REPUBLIC OF
  • Chair : Sungho Won
  • Affiliation : Seoul National University
Country : KOREA, REPUBLIC OF

Coalescing Rich Information for Accurate Recommendation

U KangSeoul National University

KOREA, REPUBLIC OF

Bio Essay U Kang is an associate professor in the Department of Computer Science and Engineering of Seoul National University. He received Ph.D. in Computer Science at Carnegie Mellon University, after receiving B.S. in Computer Science and Engineering at Seoul National University. He won 2013 SIGKDD Doctoral Dissertation Award, 2013 New Faculty Award from Microsoft Research Asia, 2016 Korean Young Information Scientist Award, and four "best paper" awards including 2018 ICDM 10-year best paper award. He has published over 90 refereed articles in major data mining, database, and machine learning venues. He holds four U.S. patents. His research interests include big data mining, deep learning, and machine learning.

Target Discovery using AI Technology

Seonee NamSK C&C

KOREA, REPUBLIC OF

Bio Essay Seonee is a leader of the AI-based drug discovery platform services team and is currently developing target discovery services. She has experience in developing many medical/pharmaceutical services, such as AI antibiotic advisors and AI drug discovery. She is accredited Scrum Master and professional engineer qualifications.

W4 : Business Development 101 for Beginners

Title

[Workshop 4] 1. Overview of Business Development

Summary

-

Chair

  • Chair : Sung-Chun Kim
  • Affiliation : 범부처신약개발사업단
Country : KOREA, REPUBLIC OF
  • Chair : James Lee
  • Affiliation : Bridge Biotherapeutics, Inc
Country : KOREA, REPUBLIC OF

Business Development Overview and Global Trend

Lauren Young-Mi LeeHanmi Pharmaceutical

KOREA, REPUBLIC OF

Bio Essay Dr. Lee leads Hanmi’s Global R&D Innovation team which focus on innovative global partnership with Oncology & Immunotherapy and novel Platform based breakthrough therapy. Meanwhile, she seeks cutting edge science and innovative disease targets, drug candidates as well as technologies with global collaborations. Since she joined Hanmi, she worked as Head of Biology and Translational Research and Head of Global Strategy & Business Development. Before joining Hanmi, Dr. Lee focused her research at Dana-Farber Cancer Institute, Department of Cancer biology/ Harvard Medical School, on breast cancer stem cell, genome-kinases library development for new drug target with synthetic lethality and cell cycle inhibitors. She was a faculty member at Yonsei University, Department of Biotechnology and Translational Research Center for Protein Function Control and worked at Dong-A Pharm Research Center. She received her Ph. Degree at Seoul National University, School of Pharmacy on Drug transporters and Pharmacokinetics.

How to Prepare BD Activities

Younghwa KimAstraZeneca

UNITED KINGDOM

Bio Essay Dr. Younghwa Kim has 15 years of pharmaceutical industry experiences in the US, Asia, and currently the UK. Her experiences are broad spanning from discovery, early clinical development and R&D BD and strategy. She is an Immunologist by training having completed her Master’s Degree at Seoul National University and her PhD at Weill Cornell Medical School. She has a strong background in research having worked at Merck’s Immunology & Rheumatology laboratories. Prior to the current role, she also held a number of R&D BD/strategy roles at Green Cross Corporation, Pfizer and then AstraZeneca. Her current role as a principal clinical scientist includes responsible in building clinical development strategy, developing protocol and analysing the data to recommend investment decisions along the drug development processes starting from the candidate stage of a molecule to the end of P2 data interpretation. In her current role, she has successfully delivered two positive P2 studies that triggered two P3 studies.

How to Develop Contacts

Minjae ShinKairos Bioconsulting LLC

UNITED STATES

Bio Essay Minjae Shin has extensive experiences in pharma industry in Korea and USA over 14 years. Currently he is leading the Kairos which is a specialized boutique firm accelerating the global partnering and new drug development with cross-functional roles covering all the diverse areas from discovery to development. Prior to Kairos, he was the executive director in the business and product development at HanAll Pharmaceutical International where he was actively engaged for new drug developments in the various TA areas (auto-immune, ophthalmology, dermatology, and infectious diseases) and successfully out-licensed three biologics products by participating all the stages from developing contacts to legal contractual stages (as $606M cumulative deal size). He holds the master degrees of business administration at Carey Business School at the Johns Hopkins University and pharmaceutical science in pharmacy and bachelor of pharmacy at Sungkyunkwan University, Korea.

Title

[Workshop 4] 2. Negotiation & Alliance Management

Summary

-

Chair

  • Chair : Sung-Chun Kim
  • Affiliation : 범부처신약개발사업단
Country : KOREA, REPUBLIC OF
  • Chair : James Lee
  • Affiliation : Bridge Biotherapeutics, Inc
Country : KOREA, REPUBLIC OF

The Art of BD Negotiations

Hemmie ChangFoley Hoag LLP

UNITED STATES

Bio Essay Hemmie Chang co-chairs Foley Hoag's Life Sciences Group, closing more than $12 billion in deals in the past couple of years across diverse therapeutic areas. The Life Sciences Group represents more than a dozen Korean companies on licensing, intellectual property and US regulatory matters, including ABL Bio, Bridge Bio, Celltrion, Genosco, Intocell, LegoChem Biosciences, OliPass, OliX, Orum Therapeutics, PCL, SK Life Science and Yuyu Pharma in addition to large U.S.-based clients such as AbbVie, Alexion, Becton Dickinson, Biogen, Gilead, and Thermo Fisher, and also public U.S. Nasdaq listed companies such as bluebird bio, Calithera, Dicerna, Enanta and La Jolla. A native Korean, Hemmie was born in Seoul and graduated from Harvard Law School (on the Harvard Law Review) and Princeton University (Princeton School of Public and International Affairs). She recently represented Bridge Bio in its €1.1 billion collaboration and license agreement with Boehringer Ingelheim announced in July 2019; LegoChem Biosciences in its recently announced Iksuda deals and $400+ million Takeda/Millennium ADC collaboration announced in March 2019; and LG Chem Life Sciences in a $900+ million multi-target, strategic collaboration announced in November 2018 with CUE Biopharma. She also advised on OliPass’s Acceleron research collaboration and Dong-A’s $525 million Mer tyrosine kinase inhibitor deal with AbbVie. She has a wealth of experience in financial and deal comparables and welcomes the opportunity to help innovators with deal terms and creative structuring.

Doing a Deal with the Post-Deal Alliance in Mind

Summer ParkPharmaVentures

NEW ZEALAND

Bio Essay Summer has experience in healthcare business development, consultancy and public sector strategy, with a keen interest in the Asia-Pacific market. Since joining PharmaVentures, Summer has worked on licensing, valuation and strategy projects with pharmaceutical, biotech and diagnostics companies across North America, Europe and Asia-Pacific, including a number of South Korea's leading pharmaceutical and bioventure companies. Prior to joining PharmaVentures, she took part in developing the governmental growth plan for New Zealand’s start-up ecosystem. Summer has also won and worked on numerous projects to solve technical, market, and supply chain-related problems for technology businesses, and has experience in digital marketing. Summer holds a MSc Biomedical Sciences (First Class Hon.) from The University of Auckland. Her thesis was on "Human epidermal growth factor receptor (HER) signalling and its inhibition in malignant melanoma". Summer is a native English and Korean speaker.

Who can help BD activities?

Ted MoonRM Global Partners

KOREA, REPUBLIC OF

Bio Essay Ted Moon is Managing Director of RM Global Partners, holds over 20 years of global finance, business development, and law experience. Ted specializes in healthcare and life science sectors. He has significant cross border experience, especially in managing projects and facilitating investments in U.S., Israel and Korean companies. Ted has built a track record completing numerous innovative life sciences transactions, including over $2 billion in strategic transactions and over $300 million in private funding for start-ups. He has advised emerging biopharma/medtech venture companies as well as large corporations on their financial and strategic transactions including M&A, capital raising, strategic partnerships, and exit strategies including IPOs. Ted’s clients include large corporate groups such as AmorePacific Group on their mergers and acquisition matters and strategic investments. Ted also advised numerous biopharma and medical technology venture companies in US, Europe, Israel and Korea for their fundraising and strategic partnering with leading strategic and financial investors. For example, he successfully completed his assignment as an exclusive sell-side M&A advisor for AmorePacific Group in its sale of PacificPharma to Handok. Ted recently advised Bridge Biotherapeutics in entering into a collaboration and global license agreement for its autotaxin inhibitor BBT-877 to be developed for fibrosing interstitial lung diseases including IPF with Boehringer Ingelheim, with overall $1.3 Billion deal size. Ted is currently serving as managing member of an early stage biopharma fund, RMGP Biopharma Fund, investing with a unique biopharma incubator, FutuRx based in Israel, jointly owned and managed by the 3 global biopharma leaders i.e., J&J, Takeda Pharma and Orbimed. Ted received both a Bachelor of Arts in Business Administration and an MBA from Kyung Hee University (Seoul). He also earned an MBA from George Washington University and a J.D. from Temple University School of Law.

up