DxRxPM Biotech Consulting

About Me

Yiu-Lian Fong, PhD, MBA

Broad and progressive R&D executive and leadership roles in pharmaceutical, biotechnology, and IVD (In Vitro Diagnostics, Dx) industries. Versatile experience in all phases of vaccine and therapeutic drug (Rx) development, including discovery, preclinical, FIH, Phases 1-3 and post approval, and in all stages of companion and complementary diagnostics (CDx/CoDx) and Dx/Rx co-development.

Wealth of experience in clinical biomarker (BM)  and clinical trial assay (CTA) development/implementation strategies to help fast-track all stages of drug development. Formulating and executing business strategies, TPP (Target Product Profiles) and and clinical utility studies to help demonstrate Dx/Rx product differentiations, drive reimbursements, enable market penetrations and/or geographic expansions. Experiences in successful regulatory submissions (IND, Pre-IDE, NDA, BLA, PMA, 510K, and CE IVDD).

Passion for driving scientific / technology innovations and precision medicine and saving lives.

Professional Experience

  • Founder, DxRxPM Biotech Consulting LLC (Feb 2024-present)
  • Senior Scientific & Corporate Strategy Advisor, MiRXES (Mar2023-present)
  • Chief Scientific Officer / Chief Strategic Officer, Wuxi Life Fountain Biotech (Sep2023-Mar2024)
  • Global Head, Clinical Biomarker & Diagnostic Strategy and Development, PH/CVM/Retina Janssen, J&J (2018- Mar23)
  • Global Head, R&D, Diagnostic Innovation, R&D & CLIA Lab Operation, Janssen, J&J (2015-18)
  • Division Vice President, R&D, Abbott (2013-2015)
  • Executive Director (2011-13), Director (2008-2011), R&D, Novartis Oncology, Novartis
  • Associate Director, R&D (2006-08), Novartis Vaccines and Diagnostics, Novartis
  • Associate Director (2004-2006), Sr. Scientists (2001-2003), Principal Scientist (1998-2001), Scientist (1996-1998), R&D, Chiron Pharmaceutics (1996-2001)
  • Faculty position (Researcher), Johns Hopkins Univ. (1994-96)

My Personal Journey

Constant learnings and adaptations with global leadership roles

Honors

  • ISO WG4 NGS Standardization Working Group Leader (July2023-Present, nominated by Enterprise Singapore))
  • Reviewer, BRPT Biomedgrant Application, Academia Sinica Taiwan, 2023. (https://www.sinica.edu.tw/News_Content/56/1839)
  • Committee member, Board of Science and Technology, Executive Yuan, Taiwan, R.O.C (2020-Present) (https://www.ey.gov.tw/Page/9277F759E41CCD91/e557f014-33b1-4ad3-b3cf-5b283316a8b6)
  • Global Working Group Leader, ISO WG4 NGS Standardization Working Group (July 2023-Present, nominated by Enterprise Singapore)
  • Reviewer, BRPT biomedgrant application, Academia Sinica Taiwan, 2023 (https://www.sinica.edu.tw/News_Content/56/1839)
  • Committee member, Board of Science and Technology, Executive Yuan, Taiwan, R.O.C (2020-Present) (https://www.ey.gov.tw/Page/9277F759E41CCD91/e557f014-33b1-4ad3-b3cf-5b283316a8b6)
  • Janssen Global Scientific Awards Review Core Committee (2015-2023)
  • Board of Visitors, Vanderbilt University School of Medicine Basic Sciences, US. (2019-Present) (https://medschool.vanderbilt.edu/basic-sciences/leadership/board-of-advisors/)
  • JLab core review committee and JLab expert consultant (JPal) (2015-2022)
  • Expert Consultant, Board of Science and Technology, Executive Yuan, Taiwan, R.O.C (2016-2020)
  • Committee member of the working group for miRNA standardization, Standards Development Organization, Singapore Manufacturing Federation, sponsored by Health Sciences Authority (2020)
  • Distinguished Alumni, National Tsing-Hua Univ. Taiwan (2016)
  • US NIH/NCI grant review committee for RFA-CA-13-015 “Cancer Detection, Diagnostics, and Treatment Technologies for Global Health (UH2/UH3)”, NIH, US (2014)
  • Scientific Advisory Council, Genetic Analysis, Life Technologies (known today as ThermoFisher Scientific) (2012-2014)

Awards

  • Received 8 consecutive J&J Leadership Imperative “Applause” awards ($1500 each) for major contributions to the Janssen Global Scientific Awards Review, 2015 – 22.
  • Received 3 J&J Leadership awards in 2022 related to PH clinical trial strategies and FDA submissions 
  • Received J&J “Ovation” Leadership Award (received $6000) for major contributions to “2021 PH DAS Renewal & Expansion Strategy”. 
  • Received J&J Leadership “Ovation” Award (awarded 3% base salary) for manor contributions to “Shape Dx strategies”, 2018
  • Received Novartis “2011 NIBR Team Award” for excellent science and teamwork on Everolimus Antibody Development (awarded $1000). 
  • Received 4 Novartis Awards for oncology CDX programs and due diligence effort for M&A (2011). 
  • Chiron: “Contribution Award” for successful regulatory filing and approval of Ultrio for HIV/HCV/HBV blood screening (2006); “Outstanding Performance” for exceeding program timelines (2005), “Inventor Recognition Award” (2004); “Outstanding Efforts” for accelerated HCV E1E2 vaccine Phase I/II IND (2001)
  • Chiron “Exception Award” for successful UK MCA filing and approval of Menjugate vaccine (awarded with $6500, 1999)

Honors, Awards & Accomplishments

2017 IFV-RSV Panel US FDA 510k clearance
CMC Lead for1999 MenC UK submission
Menjugate (MenC) Vaccine UK approval March2000
Utrio USFDA approval 2006 Oct 3
2018 Diagnostic Strategy
Phinder (PH signature) CE Mark 2022
1998 HCV Phase 1/2 trial
2011 Everolimus Antibody Development
2011 Above and Beyond Contribution
2011 M&A Due Diligence contribution
2023 J&J Retirement Certificate
2021 PH DAS Renew Strategy
2020-RD-Award-Review
2019 R&D Award Review
2021 R&D Award Review
2022 R&D Scientific Award Review
2011 Everolimus Ab Dev Lead NIBR Team Award
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Appointment Letter from the Executive Yuan, Taiwan for BTC Committee
Memento from Taiwan VP Chien-jen Chen 2018
Novartis Appreciation 2013
Distinguished Alumni, National Tsing-Hua Univ. Taiwan (2016)

Seminars & Presentations

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Photo Gallery

2018 Taiwan Presidential Pallace with Taiwan VP & Ministers
2018 Taiwan Presidential Pallace with Taiwan VP
2023 Taiwan BTC
2023 Taiwan BTC
2023 Taiwan BTC
2023 Taiwan BTC
2023 Taiwan BTC
2023 Taiwan BTC
2023 Taiwan BTC
2022 Taiwan BTC
2022 Taiwan BTC
2019 Taiwan BTC
2019 Taiwan BTC
2019 Taiwan BTC
2019 Taiwan BTC
2019 Taiwan BTC
2018WCP Kyoto
2018WCP Kyoto
2018WCP Kyoto
2018 Beijing University
2018 Beijing University
2018 BioKorea
2018 BioTaiwan
2018 BioTaiwan
2018 BioTaiwan
2018 RESI Panel
2018 Seoul Biohub
2018 Seoul Biohub
2018 Seoul Biohub
2018 Seoul Biohub
2016 WCLC
2018 Souel CDx workshop
2018 Taiwan Global Medtech
2018 Taiwan Global Medtech
2018 Taiwan Global Medtech
2016 Taiwan Tsing Hua Univ.
2014 BioAsia
2016 Toronto JLab with J&J CSO
2019 J&J PH TA Leadership Team
2014 Abbott Executives
2014 Abbott Executives
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We’ve worked with some of the best companies.

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