9th Annual Clinical Trial Supply East Asia 2024

The leading clinical trial supply conference in East Asia helping you enhance your end-to-end clinical strategy

3 - 4

December

2024
  • JW Marriott Hotel Seoul, South Korea
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Why attend?

Agenda

  • 3 Dec 2024
  • 4 Dec 2024
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8 AM

Registration and refreshments

8:40 AM

Chairperson’s opening remarks

8:45 AM

Choosing CRO and vendor partners as a small/midsize biotech sponsor: priorities and key considerations

  • How vital is knowledge of therapeutic area in CRO selection?
  • As a small biotech, is it beneficial to work with a smaller CRO or a large global CRO?
  • Ensuring your CRO and vendor partners prioritize your study

Speakers

Woohyung Wayne Lee
Director, Clinical Planning, GI INNOVATION

9:15 AM

Beyond Excel: Innovative Solutions for Clinical Supply Forecasting & Planning

• Identify critical areas often overlooked in clinical supply chains that lead to inefficiencies
• Explore the benefits and limitations of each type of tool: from excel-based to specialized forecasting tools dedicated to the clinical supply chain
• Gain practical insights from case studies that explore complex trial designs, waste management, monitoring processes, and adaptability to changes

Speakers

Antoine Remiot
Antoine Remiot, Senior Director - Global Business Development & Partnerships, Clinical Supply Optimization, N-SIDE
Laurent Verdickt
Laurent Verdickt, Senior Solutions Engineer, N-SIDE

9:45 AM

ICH E6R3 – What we need to know and do to optimize trial management

·       Familiarize with the major revisions and updates in ICH E6R3 guidelines compared to previous versions

·       Adopt standardized documentation practices to ensure consistency and compliance with ICH E6R3

·       Training and Capacity Building

Speakers

Maggie Lim
Clinical Quality Assurance Director (Asia Pacific), GSK

10:15 AM

Post-pandemic: Strategies to advance your journey in vaccine development

  • Trend of vaccine trials landscape
  • Leveraging Southeast Asia in vaccine development
  • Case study on expediting clinical development in a multi-regional vaccine study

Speakers

Chris Chong
Senior Director Clinical Services, Novotech

10:45 AM

Morning refreshments and networking

STREAM B: Clinical Trial Supply

11:30 AM

Evaluating the most recent cold chain challenges and strategies to streamline your supply chain

·       Addressing major challenges in international cold chain shipping, pitfalls to avoid

·       Utilizing advanced technology for complete remote temperature monitoring

·       What are the most recent developments and advancements in cold chain technology?

Speakers

KangPyo Lee
Vice President, Hanul TL

12 PM

NAVIGATING CLINICAL TRIAL SUPPLY CHALLENGES

In the ever-evolving world of clinical trials, navigating product sourcing and supply chain challenges is a formidable task.
Join this session to unravel the complexities of clinical trial supply, with expert tips for overcoming hurdles.

• clinical trial supply trends in Asia-Pacific
• early identification of clinical trial supply challenges,
• strategic supply and logistics planning,
• using market intelligence and global insights for informed decision-making,
• fostering collaboration for a successful clinical trial

Speakers

Karen Montgomery-Douglas
Regional Business Development Manager,Akesa
Con Konstantopoulos
Co-CEO, Akesa

12:30 PM

Selecting the optimal CMO Partner(Contract Manufacturing Organization)

·       Analyzing quality and financial considerations in your CMO selection

·       communication channels and effective collaboration between your team and the CMO partner

Speakers

Jandee Kim
Director Clinical Development, ADDPHARMA

1 PM

Lunch and networking

2:15 PM

Providing insights into recent updates on IATA Temperature Control Regulations and best practices for managing global logistics of temperature-controlled airfreight

  • Overview of the most recent changes to the IATA Temperature Control Regulations and their implications for clinical trial logistics
  • Insights into ongoing efforts to harmonize regulations across different regions and the impact on global supply chains
  • Discussing the integration of sustainable practices in temperature-controlled logistics

Speakers

Baek-Jae KIM
Country Manager Korea, IATA

2:45 PM

Reserved for the Event Partner

3:15 PM

Implementing an effective IRT system in your clinical trial supply chain to streamline supply planning and management

·       Overcoming challenges around implementation and use of a new IRT system

·       How to leverage your IRT systems effectively to get the most out of your technology

·       Selecting an IRT vendor that meets your needs: essential factors and considerations in supplier selection

Speakers

Hanuk Kim
Quality expert

3:45 PM

Afternoon refreshments and networking

4:15 PM

Ensuring clinical quality assurance in supply chain management: An integrated approach

·       Regularly auditing suppliers and manufacturing partners to ensure compliance with regulatory standards

·       Conducting regular training and workshops to align all parties on quality assurance standards and practices

·       Developing and maintaining detailed risk management plans

Speakers

Seunghyun Hong
Head of QA, GCPharma

4:45 PM

PANEL DISCUSSION: Discussing the necessity of orchestrating global supply chains to overcome potential delays

·       How can we foster trust and effectively manage risk when shaping strategic partnerships?

·       What factors should we consider in deciding which supply chain processes to outsource?

·       How a global orchestration model can enhance clinical supply operations?

Speakers

Fiona Barry
Editor-in-Chief and Director of PharmSource, GlobalData
KangPyo Lee
Vice President, Hanul TL
Hanuk Kim
Quality expert

5:15 PM

Chairperson’s closing remarks

8:15 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

STREAM B: Clinical Trial Supply

Speakers

Fiona Barry
Editor-in-Chief and Director of PharmSource, GlobalData

9 AM

State of the biopharma industry: the outlook for drugs, trials, and manufacturing

·       What’s coming in the pharma pipeline?

·       Drug manufacturing for clinical trials

·       Emerging trends: gene therapy, mRNA, and AI

·       Opportunities for contract development and manufacturing organisations (CDMOs)

Speakers

Fiona Barry
Editor-in-Chief and Director of PharmSource, GlobalData

9:30 AM

Reserved for the Event Partner

10 AM

Start-up pharma & biotech’s; Establishing a relationship, engaging with your supply chain and selecting the right partners for you

·       Identify key supply chain stages, from raw material sourcing to final product distribution

·       Conduct due diligence to assess supplier capabilities, reliability, and compliance with regulatory standards

·       Evaluate potential partners based on their expertise

Speakers

Dayeon Ko
Director of Clinical development, Enzychem Lifesciences

10:30 AM

Sharing strategies for effectively managing temperature during the transfer of IP (Investigational Products)

  • Overcoming common events of temperature fluctuation during distribution
  • Exploring efficient strategies for risk management
  • Partnering with specialized logistics providers experienced in handling temperature-controlled shipments

Speakers

Hye Jung Yang
Clinical Research Manager/Team Lead, MedPacto

11 AM

Morning refreshments and networking

11:45 AM

Considering new digital logistics tools to keep your supply chain running effortlessly

  • Utilizing AI technology to identify order processes and assure error-free delivery
  • Unpacking new concepts; supply by design, cross-functional alignment, self-qualification and relationship risk mapping
  • Using digital technology on site to keep locations open to prevent product deliveries from being delayed

Speakers

Clare tan
Director of Clinical Operations and Project Management, Tikva Allocell

12:15 PM

PANEL DISCUSSION: Mitigating unnecessary delays in clinical supply logistics: Challenges and Solutions

• Strategies to minimize delays in clinical supply Logistics
• Implementing effective communication through Huddles
• Practical Solutions for Streamlining Supply Chain Processes

Speakers

Fiona Barry
Editor-in-Chief and Director of PharmSource, GlobalData
Hye Jung Yang
Clinical Research Manager/Team Lead, MedPacto
Clare tan
Director of Clinical Operations and Project Management, Tikva Allocell

1 PM

Lunch and networking

2:15 PM

Prize Draw

Join us for a chance to win one of our prizes, including Apple products

2:30 PM

Speaker Hosted Roundtables

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Roundtable session lasts for 30 minutes and rotate

ROUNDTABLE 1: What key aspects of inspection readiness should we be considering right now?

Moon H. Kim, CTO, InnoCure Therapeutics Inc

ROUNDTABLE 2: Getting the best out of your sponsor – CRO partnership

Speakers

Moon H. Kim
Chief Technical Officer, InnoCure Therapeutics Inc

3:30 PM

Chairperson’s closing remarks

END OF CONFERENCE

Speakers

Select a speaker to learn more

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Moon H. Kim
Chief Technical Officer, InnoCure Therapeutics Inc
Moon H. Kim, PhD.
PhD: Medicinal Chemistry at SNU
MSKCC, SUNY Buffalo, Affymax, Exelixis in US
OncoVenture, IPK, ARIBIO, BiSiChem, VeraVerse in Korea
InnoCure Therapeutics, CTO

Session Details:

Speaker Hosted Roundtables

2024-12-04, 2:30 PM

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Fiona Barry
Editor-in-Chief and Director of PharmSource, GlobalData

Experienced healthcare editor with a demonstrated history of B2B journalism covering drug development, manufacturing, and the pharma industry. Skilled in editing, news writing, KOL interviews and financial journalism. Special focus on pharmaceutical manufacturing, clinical trials, rare disease and women's healthcare. Bilingual Glasgow/London-based English and French-speaking media professional with a Master of Arts (M.A.) in English from the University of Bristol.

Session Details:

PANEL DISCUSSION: Discussing the necessity of orchestrating global supply chains to overcome potential delays

2024-12-03, 4:45 PM

Session Details:

STREAM B: Clinical Trial Supply

2024-12-04, 8:55 AM

Session Details:

State of the biopharma industry: the outlook for drugs, trials, and manufacturing

2024-12-04, 9:00 AM

Session Details:

PANEL DISCUSSION: Mitigating unnecessary delays in clinical supply logistics: Challenges and Solutions

2024-12-04, 12:15 PM

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Maggie Lim
Clinical Quality Assurance Director (Asia Pacific), GSK

Maggie LIM has been in the clinical research industry for the last 26 years; she graduated from Singapore National University Pharmacy and took up Clinical Pharmacy postgraduate in Canberra Australia while working as a pharmacist in Singapore General Hospital.
She took an interest in Clinical Research and joined Eli Lilly as a CRA and study manager, specializing in early phase clinical pharmacology studies.
When the opportunity came to join GSK as a regional Asia-Pacific GCP trainer came in 2007, she covered training for R&D medical and clinical teams for 5 years before joining Global Clinical Quality Assurance in 2012,  and has since been managing a team of auditors delivering the QA strategized audits for the region.

Session Details:

ICH E6R3 – What we need to know and do to optimize trial management

2024-12-03, 9:45 AM

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Youngwook Kim
Associate Director, Investigator Engagement – Korea, Clinical Research Investigator Engagement, Delivery & Capabilities, Lilly Korea Ltd

YoungWook Kim serves as the Associate Director of Investigator Engagement for Korea within the Clinical Research Investigator Engagement, Delivery & Capabilities at Eli Lilly and Company. In this role, he is entrusted with the comprehensive oversight of investigator site management for clinical research across Lilly Korea. His responsibilities encompass a broad range of critical capabilities, including portfolio management, study feasibility assessment, site selection, patient enrollment, and monitoring.

Holding a Bachelor's degree in Pharmacy from Sahmyook University, he has cultivated a distinguished career that spans over 15 years in the pharmaceutical industry, with a particular focus on clinical operations. His professional journey has seen him undertake various roles, from CRA to Clinical Development Consultant, Clinical Operations Portfolio Manager, Clinical Information Process Automation, and Clinical Project Management. His experience covers a diverse geographical spectrum, including Korea, Emerging Markets, and Lilly Headquarters.

His extensive experience and deep commitment to the field are driven by a passion for enhancing the delivery of clinical research, with the ultimate goal of improving patient outcomes and advancing healthcare. His expertise and dedication are reflected in his approach to fostering innovation and efficiency in clinical research processes.

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Baek-Jae KIM
Country Manager Korea , IATA

BJ (Baek-Jae) Kim, Ph.D., is the IATA Country Manager Korea, based in Seoul, Republic of Korea. BJ leads a team of 3 (Mr. HT Lee, Ms. Anna Park, and Ms. Hyein Jeon) in the Korea field office work.

Prior to joining IATA in Aug 2019, BJ has about 25 years of aviation experience, including 6 years in United Airlines, 4 years in Air France, and 16 years in Qatar Airways as Airport Services Manager in ICN airport, the Republic of Korea.

BJ holds a Ph.D. and Master of Aviation Business Administration from the Korea Aerospace University (KAU) and a Bachelor's degree in Economics from Hankuk University of Foreign Studies (HUFS) in the Republic of Korea.

BJ is a citizen of the Republic of Korea. He is a Christian and married with 2 children. BJ enjoys hiking, mountain climbing, and other sports in his spare time.

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Woohyung Wayne Lee
Director, Clinical Planning, GI INNOVATION

Session Details:

Choosing CRO and vendor partners as a small/midsize biotech sponsor: priorities and key considerations

2024-12-03, 8:45 AM

View In Agenda
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KangPyo Lee
Vice President, Hanul TL

Session Details:

Evaluating the most recent cold chain challenges and strategies to streamline your supply chain

2024-12-03, 11:30 AM

Session Details:

PANEL DISCUSSION: Discussing the necessity of orchestrating global supply chains to overcome potential delays

2024-12-03, 4:45 PM

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Dayeon Ko
Director of Clinical development, Enzychem Lifesciences

Session Details:

Start-up pharma & biotech’s; Establishing a relationship, engaging with your supply chain and selecting the right partners for you

2024-12-04, 10:00 AM

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Hanuk Kim
Quality expert

Session Details:

Implementing an effective IRT system in your clinical trial supply chain to streamline supply planning and management

2024-12-03, 3:15 PM

Session Details:

PANEL DISCUSSION: Discussing the necessity of orchestrating global supply chains to overcome potential delays

2024-12-03, 4:45 PM

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Suntae Kim
Director, Clinical Development, Connext

Director, Clinical Development, Connext Co. Ltd.

 

Previously worked as CDO, MedGene Therapeutics Inc.;

Project Manager & Senior Director, KCRN Research;

Principal Scientist, G+FLAS Lifesciences;

Postdoc & Research Fellow, NCI, NIH;

Ph.D. in Biochemistry & Molecular Biology, Environmental Toxicology, Michigan State University;

BS & MS, Seoul National University

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Seongyun Bang
Chief Development Officer, Vice President, SPARK Biopharma

She has been an expert in drug development, clinical trials, projects, and quality control since 2001 and has worked in domestic pharmaceutical companies and global CRO, as well as university. He graduated from Seoul National University with B.S and Doctor degree and obtained Ph.D. from the CHA university.

And she served as a branch manager(country head), global task manager and quality manager in a Global CRO, PAREXEL International and as a professor at the University of CHA univeristy for five years from 2014, she has served as the head of the New Drug Development Division at Bioteches since 2020. she is currently leading clinical development as the head of development and vice president of Spark Biopharma.

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Jonghwan Bae
Director, Veraverse
  • EDUCATIONS 

2016.09 - PhD in Regulatory affairs, Department of Pharmaceutical Industry Management,

Chungbuk National University

2003.02 - M.S. in Biochemistry and Cell biology, Department of Biochemistry,

Konyang University

2001.02 - B.S. in Chemistry, Department of Chemistry,

Konyang University

 

  • EXPERIENCES 
  1. Korea Research Institute of Bioscience and Biotechnology (KRIBB)
  2. Neopharm. Co., Ltd.
  3. Bischem. Co., Ltd.
  4. Biopharm solutions. Co.Ltd.
  5. Veraverse Co.Ltd. - Currently employed

 

  • PUBLICATIONS
  1. Lee KB, Bae JH, Kim JS, Yoo YC, Kim BS, SKwak ST, KimYS, ”Anticoagulant Activity of Sulfoalkyl Derivatives of Curdlan”, Arch Rharm Res. 2001,24:109-13.
  2. Bae JH, Yoo YC, Kwak ST, Seo EY, Moon EH, Lee MJ, Lee KB, “Antiviral and anticoagluant activity of sulfoalkyl derivatives of curdlan “, Korean J.Lab Anin. Sci. 2001,02. 119-124.
  3. Bae JH, Kim GS, Yoo YC, Lee HY, Lee KB, ”The investigation of Synovial Fluid and Serum for Biochemical Markers of Joint diseases in the horse (Review)”, J Vet Clin. 2001,02:304-310.
  4. Bae JH, Yoo YC, Hong GH, Moon EH, Song GS, Lee KB, “Biochemical analysis of synovial fluid and serum to diagnose early joint diseases in equine”, Korean J.Lab Anin. Sci. 2004.05:37-43.
  5. Yeop YJ, Bae JH “Effect of an extraction solvent on the antioxidant of pine tree”, J. Soc. Cosmet. Scientists Korea. 2005.02.
  6. Jung M, Lee S, Park HY, Youm JK, Jeong S, Bae JH, Kwon MJ, Park BD, Lee SH, Choi EH, “Anti-ageing effects of a new synthetic sphingolipid (K6EAA-L12) on aged murine skin”, Exp Dermatol. 2011, 20(4):314-9.
  7. Sul GD, Park HJ, Bae JH, Hong KD, Park BD, Chun J, Jeong SK, Lee SH, Ahn SK, Kim HJ, “Preventive effects of multi-lamellar emulsion on low potency topical steroid induced local adverse effect.”, Ann Dermatol. 2013,25(1):5-11.
  8. Rho JK, Choi YJ, Kim SY, Kim TW, Choi EK, Yoon SJ, Park BM, Park E, Bae JH, Choi CM, Lee JC, “MET and AXL inhibitor NPS-1034 exerts efficacy against lung cancer cells resistant to EGFR kinase inhibitors due to MET or AXL activation”, Cancer Res. 2013, 10.
  9. Hong JY, Bae JH, Lee KE, Kim M, Kim MH, Kang HJ, Park EH, Yoo KS, Jeong SK, Kim KW, Kim KE, Sohn MH, “Antibody to FcεRIα Suppresses Immunoglobulin E Binding to High-Affinity Receptor I in Allergic Inflammation”, Yonsei Med J. 2016,57(6):1412-9.

 

  • PATENTS
  1. Lee KB, Bae JH “Method for extracting high purified hyaluronic acid for arthritis therapy from cocks comb”, 2003.05.
  2. Park BD, Yeom JG, Jeong SK, Bae JH, Kwon MJ, Kwak HS, Sin DM, Choi YH, “New anti-skin aging and wrinkle-treating agents and cosmetic compositions containing the same” , 2007.03.30.
  3. Park BD, Kwak HS, Jeong SK, Bae JH, “Human antimicrobial peptides promoter, method for preparing thereof and composition comprising the same as active ingredient”, 2008.04.01.
  4. Choi HS, Bae JH, Park HJ, Jeong SK, “Compostion comprising mycolic acid derivatives for anti-inflammatory activity”, 2009.10.12.
  5. Park BD, Yeon SJ, Kim UD, Bae JH, Kim MH, Kang HJ, Park EH, “Conjugate comprising soluble fragment of FcεRI and composition for treating allergy diseases mediated by IgE comprising the conjugate”, 2012.05.23.
  6. Park BD, Yeon SJ, Bae JH, Park EH, Kim UD, Kim MH, Kang HJ, Ryu GS, “FcεRI specific human antibody and composition for treatment or diagnosis of allergy disease comprising thereof”, 2012.05.30.
  7. Jeong SK, Kim BW, PARK BM, Jeon JE, Bae JH, “Heterocyclic compounds”, 2013.11.18.
  8. Park BD, Kim Y, Yang MG, Jeong SK, Bae JH, “Wound dressing comprising pseudo-dermal lipid”, 2014. 01. 07.
  9. Jeong SK, Bae JH, Park BM, “Composition for preventing hair loss or promoting hair growth”, 2015. 01.19.
  10. Jeong SK, Bae JH, Kim DH, “Composition for improving condition of scalp”, 2015.07.20.
  11. Jeong SK, Bae JH, Kim DH, “Composition for improving condition of damaged hair”, 2015.07.20.
  12. Yoon CH, Bae JH, Han CK, Kang HJ, Kim MH, Seo JB, “Fused ring heteroaryl compounds as ALK4/5 inhibitors”, 2018.10.
  13. Yoon CH, Bae JH, Han CK, Kang HJ, Kim MH, Seo JB, “Fused ring heteroaryl compounds as RIPK1 inhibitors”, 2019.09.
  14. Yoon CH, Bae JH, Han CK, Kang HJ, Kim MH, Seo JB, “Fused ring heteroaryl compounds as STING agonist” , 2020.01.
  • ORAL PRESENTATION
  1. Diagnosis method for degenerative joint disease of equine, The Korean society of veterinary science, 2001. 03.
  2. Effects of anti-microbial peptides stimulating molecules on epidermal permeability barrier function, The Korean Society for skin barrier research, 2007. 06.
  3. Effects of physiologic lipid mixture on epidermal anti-microbial peptides in experimental atopic dermatitis model, Asian Dermatological Congress, 2008.10.
  4. Overseas company visit program (France and Germany) – IR, 2024,09

 

  • IND SUBMISSION 
  1. FDA IND approval for Phase 2 (Alzheimer’s disease)
  2. FDA IND approval for Phase 2 (Diabetic Macular Edema)
  3. FDA IND approval for Phase 2 (Alzheimer’s disease
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Sung Young Lee
Senior Vice President, Head of Clinical Strategy and Operation, ImmuneOncia Therapeutics

-   MS (PhD course completion), RN, APN of Oncology

-   Experience in clinical trials for 22 years;

  • developed whole clinical regulatory package for new anti-cancer immunotherapy in ImmunoneOncia Therapeutics Inc. (current)
  • developed whole clinical regulatory package and gained the approval for biosimilars from EMA, FDA and PMDA in CELLTRION Inc.
  • developed the systemized data capturing module and clinical study conducting program in National Cancer Center Korea

-   Published 30 articles and 53 congress presentations (including The Lancet, Lancet Oncology, Lancet Hematology, etc)

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Seunghyun Hong
Head of QA, GCPharma

Session Details:

Ensuring clinical quality assurance in supply chain management: An integrated approach

2024-12-03, 4:15 PM

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SeungWoo Shin
AI drug discovery Team Leader, Daewoong Pharmaceutical

Education

1999.03 ~ 2005. 08 Ph.D., Department of Computer Engineering, Kyungpook National University
1997. 03 ~ 1999. 02 M.S., Department of Computer Engineering, Kyungpook National University

Professional Experiences

2021. 12 ~

2018. 12 ~ 2021. 12

2009. 03 ~ 2018.12

Daewoong Pharmaceutical / AI New Drug Discovery team leader

Syntekabio / AI New Drug Discovery team leader

SOONCHUNHYANG UNIVERSITY HOSPITAL / Academic Research Professor

2007.4 ~ 2009.2

2005.10~ 2007.03

Korea Institute for Advanced Study (KIAS) / Senior Researcher

Korea National Institute of Health, Genomics Research Center, Bioscience information team / Senior Researcher

Publications (Selected or Past 5 years)

○ A new algorithm for detecting Low-complexity regions in protein sequences, bioinformatics, pp 160-170, vol. 21, 2005

○ Asthma-Predictive Genetic Markers in Gene Expression Profiling of Peripheral Blood

Mononuclear Cells, ALLERGY ASTHMA & IMMUNOLOGY RESEARCH, pp 265-272, vol. 3, 2011

○ Differential gene expression profile in PBMCs from subjects with AERD and ATA: a gene

marker for AERD, Molecular Genetics and Genomics, pp 361-371, vol 287, 2012

○   A Highly Sensitive and Specific Genetic Marker to Diagnose Aspirin-Exacerbated Respiratory Disease Using a Genome-Wide Association Study, DNA AND CELL BIOLOGY, p1604-1609, vol 31, 2012

○ Genome-wide association study of aspirin-exacerbated respiratory disease in a Korean

population, Hum Genet, March 2013, Volume 132, Issue 3, pp 313–321

○ Elevation of Eosinophil-Derived Neurotoxin in Plasma of the Subjects with Aspirin-Exacerbated Respiratory Disease: A Possible Peripheral Blood Protein Biomarker, PLOS ONE, vol 8, 2013.

○ Exonic Variants Associated with Development of Aspirin Exacerbated, Respiratory Diseases,

PLOS ONE 9(11), 2014.

○ Genome wide identification and expression profile in epithelial cells exposed to TiO₂ particles, Environ Toxicol, 2015 Mar;30(3):293-300

○ Association between TAAR6 polymorphisms and airway responsiveness to inhaled

corticosteroids in asthmatic patients, Pharmacogenetic Genomics, 2015 Jul;25(7):334-42

○ Development of a genetic marker set to diagnose aspirin-exacerbated respiratory disease     in a genome-wide association study, Pharmacogenomics J. 2015 Aug;15(4):316-21

○ Clinical Characteristics of Exacerbation-Prone Adult Asthmatics Identified by Cluster

Analysis, Allergy Asthma Immunol Res, 2017 Nov;9(6):483-490

○ lung function trajectory types in never-smoking adults with asthma: clinical features and

inflammatory patterns, Allergy Asthma Immunol Res. 2018 Nov;10(6):614-627

 

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HyeJung Yang
Clinical Project Manager, MedPacto

Hyejung Yang is the Clinical Research Manager and Clinical Research Team Lead at MedPacto Inc,. She has almost 12 years of experience in Clinical Research Project management by local pharmaceutical companies.

 

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Elvira Suniega-Tolentino
Senior Clinical Trial Portfolio Manager (Asia), Nestle

Elvira Suniega-Tolentino is the Senior Clinical Trial Portfolio Manager for Singapore at the Nestlé Clinical Research Unit, responsible for end-to-end clinical project management and operational activities of Nestlé corporate clinical trials serving all Nestle Business Units.

Prior to joining Nestlé, Elvira was the Area Clinical Operations Manager for Abbott Nutrition R&D, Asia Pacific Center in Singapore for 11 years. Over the years, she has sharpened her expertise in the industry, bringing in thoughtful and strong competency into Nestlé’s clinical projects.

The combination of her expertise, leadership and passion for innovation strongly supports the continuous improvement and excellence of Nestlé’s clinical research activities to further unlock the power of food and enhance the quality of life for every consumer, today and for generations to come.

Social Links:

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Kyungdong Bae
KyungDong Bae, Chief Manufacturing Officer, ArtBlood, Korea
2023~Current: Chief Manufacturing Officer, ArtBlood, Korea
2000~Current: Expert Committee Member, Advanced Therapies (Bio5), United States Pharmacopeia (USP)
2018~2003:  Executive Director, Head of Manufacturing Operations, Helixmith, Korea
1998~2018: Director, Head of Vaccine Process and Analytical Development, Janssen Vaccines, Korea
1992~1988: Scientist, Process Development Department, Hanhyo Institute, Korea
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Karen Montgomery-Douglas
Regional Business Development Manager,Akesa

Karen Montgomery-Douglas | Commercial Development Manager | BSc (Biomedical), Grad. Dip. Medical Laboratory Science

Karen brings over 20 years’ experience in sales and business development in the clinical trials and laboratory sectors. With a strong background in managing global and Asia-Pacific sales strategies, Karen drives growth and fosters client relationships across the pharmaceutical and biotechnology industries. She has demonstrated leadership in developing robust business processes to support commercial objectives.

Session Details:

NAVIGATING CLINICAL TRIAL SUPPLY CHALLENGES

2024-12-03, 12:00 PM

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Con Konstantopoulos
Co-CEO, Akesa

Con Konstantopoulos | Founder and Co-CEO | BSc (Pharmacology, Physiology)

Con leverages over 25 years of expertise in international pharmaceutical supply chains. His strategic approach and innovative thinking have positioned Akesa as a leader in delivering bespoke solutions for clinical trials, enhancing outcomes and forging global partnerships.

Session Details:

NAVIGATING CLINICAL TRIAL SUPPLY CHALLENGES

2024-12-03, 12:00 PM

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Antoine Remiot
Antoine Remiot, Senior Director - Global Business Development & Partnerships, Clinical Supply Optimization, N-SIDE

Antoine Remiot is N-SIDE's Director of BD and Partnerships. Over the past years, Antoine has been sharing his enthusiasm for lean clinical supply chain management, waste reduction, and sustainability with various pharma partners he supported in their change management journey toward digitalization.
Antoine is passionate about leveraging data and AI to improve clinical supply efficiency. He gained expertise in forecasting, planning, IRT configuration, and end-to-end clinical supply chain optimization through his work on hundreds of trials on multiple indications.

Session Details:

Beyond Excel: Innovative Solutions for Clinical Supply Forecasting & Planning

2024-12-03, 9:15 AM

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Laurent Verdickt
Laurent Verdickt, Senior Solutions Engineer, N-SIDE
Laurent Verdickt is a Senior Solutions Engineer at N-SIDE, where he helps tackle everyday challenges in the clinical supply chain for biopharma companies. After spending years as a Medical Advisor at MSD and Viatris, he found his passion in the world of clinical supply at N-SIDE. He's especially interested in how digital tools can make the supply chain more efficient and, in the long run, improve patients' lives. Laurent loves finding practical solutions that have a real impact on healthcare.

Session Details:

Beyond Excel: Innovative Solutions for Clinical Supply Forecasting & Planning

2024-12-03, 9:15 AM

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Chris Chong
Senior Director Clinical Services, Novotech

Chris joined Novotech as Clinical Team Leader in 2013, to manage Hong Kong office from inception. He led expansion of Hong Kong team, positioning the company as one of active players in clinical research industry. He also had exposed to China and Taiwan for around a year. Since 2022, he has been heading the clinical operations team across Southeast Asia and Hong Kong and additionally oversees Clinical Lead function at department level for 2 years.

Chris has over 16 years industry experience in multiple settings including CRO, pharmaceutical and academic. In his career, he led various initiatives to improve efficiency and delivery, including the most recent one on implementing changes for trial subject recruitment. He is now driving the capability expansion and site relationship in Southeast Asia countries.

Chris holds a Master of Social Sciences from the University of Hong Kong

Session Details:

Post-pandemic: Strategies to advance your journey in vaccine development

2024-12-03, 10:15 AM

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Rohan Simon
Associate Director - Business Development, IROS by M42

Rohan Simon is the Associate Director for Business Development at the Insights Research Organization & Solutions (IROS) – the first homegrown Contract Research Organisation in the UAE. At IROS, Rohan is responsible for promoting the clinical research operations landscape in the UAE and the region.

With over two decades of experience in the pharmaceutical industry, Rohan has held senior roles across leading entities in the sector. Prior to IROS, Rohan was the Head of Clinical Trial Services at Alliance Healthcare (part of AmerisourceBergen), where he expanded the clinical trial supply from a UK-only business to a global scale and working closely with IQVIA to build its Clinical Trials Supply Chain services.

With a strong track record of building a business ground-up and implementing new services within a GxP environment such as manufacturing, clinical trials, and supply chain, Rohan was earlier associated with GSK Global Manufacturing & Supply in various roles and with Barts NHS Trust, specialising in oncology, clinical trials, and pharmacy manufacturing unit.

He is qualified as a pharmacist in the UK and has completed his Master’s in Pharmacy from the Aston University, Clinical Pharmacy Diploma at the Queens University, Belfast, and was named as production manager on a MHRA IMP & GMP License.

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Hyesung Shin
Director, Clinical Development Strategy, R&D Division, Aptabio

Hyesung Shin, managing director of TiumBio Co., Ltd has worked more than 23 years of experience in clinical trial development and operations.

She had worked during 13 years for global pharmaceutical companies at Eli Lilly, Novo Nordisk and Novartis and 6 years at Abbott for medical devices clinical development and had experienced in Korean Biotech companies of BioPharm Solutions, Aptabio Therapeutics, TiumBio for new drug development and managing phase I/II Clinical Trial.

The works focused on managing clinical trial plan for new drug development, regulatory Filing for FDA/EMEA/MFDS IND, orphan drug Designation, vender management including CRO/Clinical Supplies/CDMO and development of  market strategy.

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Renee Loredo
Senior Clinical Quality Assurance Manager, Global R&D Quality, CSL Ltd

Renee’s long professional journey in the pharmaceutical/biotechnology industry enabled her to work or support across multiple GxP areas. She has experiences in production quality control, clinical operations, operational quality management, pharmacovigilance, and clinical research quality assurance -  where majority of her exposure is and where she finds her drive.

Currently at CSL Ltd, Renee provides quality and qualification oversight of third parties involved in their clinical trials globally, manages audit program for specific clinical studies, performs audits, and supports regulatory authority inspections. She was previously with GSK, Quintiles, Eli Lilly, Pfizer, and Ciba-Geigy.

Renee obtained her Bachelor of Science in Pharmacy degree from the University of the Philippines Manila and resides in Melbourne, Australia.

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Joy Quinal
Head Clinical Quality Operations, Asia Pacific, CSL

Joy has over 20 years of experience in the pharmaceutical industry, working across a diverse range of cross-functional environments in Clinical Research & Development and Clinical Quality Management. Her expertise spans Good Clinical Practice (GCP), Good Vigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP), and Clinical Good Manufacturing Practice (cGMP).
Currently, Joy serves as the Head of Clinical Quality Assurance Operations for Asia Pacific and the Global Compliance Area Lead for Clinical Vendor Quality Management at CSL Limited, based in Australia.

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Chris Wallace
Head of Distribution EMEA, Argenx

Chris has over 35 years’ varied supply chain experience, having worked for several blue chip companies in a number of industries including 3rd party logistics services, automotive, medical device, nuclear fuels and biotech/pharmaceuticals.

Originally from the UK but now based in Switzerland, he has been involved in life science - biotech/pharmaceuticals & medical device - for over 20 years of his career and has latterly been SVP Global Supply Chain at Clover Biopharmaceutical before last year moving to Argenx as Head of Distribution EMEA.

He has developed, implemented and managed global healthcare supply chain strategies and operations on 6 continents. This has included different set-ups in multiple countries, including many in the Emerging Markets as well as the developed world.

Chris has a degree in economics from Manchester University, an MBA from Aston University and a postgraduate diploma from London University. In his spare time, he plays golf badly and loves to sample great Italian food and red wines!

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Luiz Barberini
Head of External Manufacturing Latin America, Bayer
  • Over 25 years’ experience in Logistics, Supply Chain, Procurement and Demand Planning areas.
    Solid knowledge and experience in the whole S&OP process and its KPI´s inter-relationships with stakeholders
  • Demand Planning process management - pre-S&OP, with Sales, Marketing, Trade Marketing, Industrial Planning and Finance and customized tool design for such process
  • Management skills: experience with multidisciplinary and international teams (Brazil / Latin America / US).
  • Experience in S&OP, 3PL and Supply Chain Organization projects' implementation
  • Strong experience with Pharmaceutical and Consumer companies and Brazilian distribution model / 3PL contracts
  • Solid team management skills, as well as Customer Service relationship and management
  • Teacher for major Post Graduation Schools - Demand Planning and Procurement/Negotiation areas

CSCP & CPIM APICS. Logistics & Supply Chain driven strategy. Distribution & Logistics, Demand Planning, S&OP, Procurement and Export experiences, focusing on Business necessities through effective leadership.

Working as External Manufacturing Operations Manager Latin America at Bayer, in charge for external partners for CHC Division. Previously as Relationship Associated Director at Merck , Logistics Manager at Takeda/Nycomed Pharma, focusing on demand management, planning and distribution activities. Also has worked as Pfizer´s Logistic Manager and EFD´s Supply Chain Manager. Souza Cruz´s Procurement Manager and Rhodia's Logistic Supervisor.

Specialties: Logistics, Supply Chain, Materials, Procurement , Services, Negotiation, 3PL contracts, S&OP, Demand Planning

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Paul Hingst
Supply Chain Consultant, Crinetics Pharmaceuticals

Paul is an experienced Clinical Supply Chain Professional with a 25-year career in the BioPharmaceutical industry.  His extensive career includes roles at major companies like Amgen and Thermo Fisher Scientific, where he honed his skills and made a significant impact.  He has served in varied roles from basic research and contract manufacturing to client services and account management.  He is a Principal Consultant and Co-Founder of Beacon BioPharm Associates, a clinical supply chain consulting firm, providing variable staffing solutions to small and mid-sized BioPharm clients.  Paul is an industry veteran and respected leader known for his expertise in clinical supply chain.

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Francesco Santo
Associate Director Global Clinical Supply Chain, HUYABIO

A highly experienced and passionate Clinical Supplies Project Manager, Francesco has dedicated the past 17 years to ensuring the seamless execution of clinical trials by optimizing supply chain operations. His deep commitment to this field is driven by a relentless pursuit of excellence in delivering life-saving treatments to patients worldwide.  Throughout his career, he has honed a diverse skill set, encompassing:

  • Strategic Supply Chain Management
  • Regulatory Compliance
  • Cross-Functional Collaboration
  • Risk Management
  • Innovative Problem-Solving

Francesco’s dedication to the clinical supplies industry is rooted in a profound understanding of the critical role it plays in advancing medical research and improving patient outcomes. He is committed to continuing his journey in this field, always striving to contribute to the betterment of global health.

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Arnaud Dourlens
Head of Clinical Trial Supply, Sanofi

Arnaud Dourlens is an Arts et Métiers engineer, he began his industrial career in the FMCG sector where he held growing responsibilities. Then he joined the LVMH group where he reorganized new product launches and industrial investments in the Make-up segment in order to adapt to the need for innovation and time to market, thus providing a competitive advantage. He then managed the entire portfolio of industrial launches and investments in Perfumes, Skincare and Make-up for Parfums Christian Dior Group. During his career Arnaud held a wide variety of industrial roles. He joined Sanofi in 2017 as Production Director of a major solid oral form production site (>2.5 billion € turnover). He has been a key player in the development of the continuous improvement mindset and in the transformation of the site through IT projects, investments and activity growth following the acquisition of Boehringer Ingelheim consumer healthcare portfolio. Since the beginning of 2020, he’s been the global head of Sanofi Clinical Supply Chain Operations, managing worldwide clinical supply teams involved in more than 300 clinical studies.

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Paul Larochelle
Director Global Clinical Supply Chain Planning, Takeda

Paul Larochelle has over 17 years of experience in a variety of positions within Clinical Supplies, including roles in clinical planning, production scheduling and planning, secondary packaging operations management, and business expert for a clinical inventory management system. Paul currently leads a team of Clinical Planning Leads at Takeda and is a member of the Global Clinical Supply Chain (GCSC) Leadership Team. He also oversees Takeda’s GCSC Post-PharmD Fellowship Program in partnership with the Massachusetts College of Pharmacy and Health Sciences (MCPHS). Paul’s prior organizations include Genzyme/Sanofi and Biogen, supporting therapies across all indications and stages of development.

In addition to his primary responsibilities, Paul served as a coordinator of Pharmacy Industry Fellowships for the Genzyme/Sanofi MCPHS Fellowship Program (2009-2014) and precepted over 50 pharmacy students interested in a career in industry for several schools. He is currently the Chair of the Dean’s Advisory Board for MCPHS Boston School of Pharmacy and a member of the Pharmacy Advisory Board for Western New England University. He is also a member of the Clinical Trial Supply Conference Series Advisory Board.

Paul completed a Post-PharmD Industry Fellowship in Clinical Research/Investigational Product Management with Genzyme/MCPHS, a Doctorate in Pharmacy from MCPHS, an MBA from Worcester Polytechnic Institute, and a degree in Biology from Providence College. Paul has also served previously as President of the Board of Directors for the Massachusetts Pharmacists Association (MPhA), and as President of the MCPHS Alumni Association.

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