Organized by DahShu IDSWG Oncology
Date: Friday, May 1, 2026
Time: 8:30am – 5:45pm Eastern Daylight Saving Time (New York)
Virtual Attendance:
- Join Zoom Meeting
  https://sanofi.zoom.us/j/99789921767?pwd=j40l2myUql6kdIG7WrkVoPFO3geNUL.1
- Dial-In Zoom Meeting ID: 997 8992 1767
- Passcode: 315282
Lunch Break: 12:00pm – 1:00pm. FREE Buffet Lunch is sponsored.
FREE but require Registration Here.
- Deadline for in-person attendees: April 24, 2026.
- Deadline for virtual attendees: April 30, 2026.
- Dial-In information will be provided for registered participants prior to the event.
Parking: There are limited parking spots for FREE. Please contact Hong by email: hong.wang@sanofi.com for FREE parking reservation. If there is no more free parking, you can park at the garages close to the office building for about $10.
Posters
- You are encouraged to submit posters. Poster presenter must be in-person.
- Poster Abstract: Deadline April 24, 2026. Authors will be notified regarding poster acceptance decisions prior to the event.
- Poster Submission: Click here for poster size guidelines and to submit your poster abstract.

Objective

We are excited to announce an upcoming Key Opinion Leaders (KOL) Roundtable Discussion focused on “Biomarkers in Oncology Clinical Development.” This event brings together leading experts from academia, industry, and regulatory agencies to discuss how biomarker-driven strategies are transforming oncology drug development—from early discovery to late-phase clinical trials.

During this interactive session, panelists will explore key topics including biomarker-based patient selection, translational study design, regulatory considerations, and integration of data science and AI in biomarker discovery. Attendees will gain valuable insights into current challenges, innovative methodologies, and future directions that are shaping precision oncology.

Whether you are a clinician, statistician, data scientist, or regulatory professional, this roundtable offers a unique opportunity to learn from leaders, exchange perspectives, and network with peers driving innovation in cancer research.

Join us as we advance the conversation on leveraging biomarkers to bring safer, more effective therapies to patients faster.

Keynote Speaker

Margaret Gamalo, PhD, FASA, is the Vice President and Statistics Head for Inflammation, Immunology & Specialty Care at Pfizer Global Product Development. She brings extensive expertise in biostatistics, regulatory science, and end-to-end clinical development across various disease areas in both adult and pediatric populations. Before joining Pfizer, she served as a Research Advisor in Global Statistical Sciences at Eli Lilly and Company and as a Mathematical Statistician at the Food and Drug Administration. As a Fellow of the American Statistical Association, she has led several industry initiatives, including scientific workgroups on Statistics in Pediatric Drug Development and the Statistical Perspective on AI/ML in Pharmaceutical Development within the Biopharmaceutical Section. She also chaired the Pediatric Innovation Task Force at the Biotechnology Innovation Organization and contributed to the European Forum for Good Clinical Practice– Children’s Medicine Working Party, which provided guidance on the inclusion of adolescents in adult research. She has held various positions in the Biopharmaceutical Section of the American Statistical Association and the Society for Clinical Trials. In addition to her leadership roles, Meg serves as the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Statistics in Biosciences. She has authored over 70 peer-reviewed scientific publications in areas such as Bayesian methods, evidence synthesis, win statistics, causal inference, and pediatrics among others.

Statistician Panelists

AI Panelist

Clinical Panelists

Jean Fan, MD, MSc. CMO, TransThera Sciences

Translational Medicine Panelists

Regulatory Affairs Panelists

Program Schedule (April 30 – May 1, 2026)

Time (EDT)	Session	Speakers
April 30, 2026 Evening 6:00PM – 8:00PM	Pre-KOL Event: Organization Committee & Industry Dinner	—
08:30AM – 09:00AM	Session 1: Opening Remarks & Keynote	Opening Remarks (Gina D’Angelo) & Keynote (Margaret Gamalo)
09:00AM – 10:20AM	Session 2: Biomarkers in Early Drug Development: From Target Identification to Preclinical Validation	*Moderator:* Erica Tong *Questions:* Revathi Ananthakrishnan^V, Sutan Wu^P Panelists: Liz Garrett-Mayer Shuguang Huang Mohini Rajasagi Kaveri Suryanarayan Ryan Hartmaier Antreas Hindoyan V = questions from virtual audience; P = questions from in person audience
10:30AM – 12:00PM	Session 3: Methodologies for Prognostic and Predictive Biomarker Identification and Evaluation	*Moderator:* Di Ran *Questions:* Xiaowen Tian^V Li Liu^P Panelists: Gina D’Angelo Paul Newcombe Jean Fan Heng Zhou Jonathon Vallejo Pedtro Torres-Saavedra Hari Sankaram
12:00PM – 1:00PM	Sponsored Buffet Lunch	Poster & Social Mixer
01:00PM – 02:20PM	Session 4: Advanced Biomarker-Driven Clinical Trial Designs	*Moderator:* Cindy Lu *Questions:* Kevin Dobbin^V Gina D’Angelo^P Panelists: Liz Garrett-Mayer Heng Zhou Antonio Tito Fojo Cong Chen Hongfang Wang Jai Pandey Olga Kholmanskikh Yaji Xu
02:30PM – 03:55PM	Session 5: Companion diagnostic (CDx) and case-studies	*Moderator:* Shuguang Huang *Questions:* Pat Mitchell^V, Li Liu^P Panelists: Kui Shen Ryan Hartmaier* David Zhang Jean Fan* Jai Pandey Mohini Rajasagi Cheng Cui* Olga Kholmankskikh * Case-Studies
04:05PM – 05:30PM	Session 6: Leveraging Artificial Intelligence and Machine Learning for Biomarker Discovery and Prediction	*Moderator:* Manjari Narayan *Questions:* Yujun Wu^V, Hong Wong^P Panelists: Etai Jacob Kui Shen Margaret Gamalo Jonathon Vallejo Hongfang Wang Cheng Cui Danielle Townsley
05:30PM – 05:45PM	Closing Remarks and Opportunities	Closing remarks and Opportunities (Gina D’Angelo, Hong Wang, Philip He) JSM 2026 Gathering @Boston

Program Committee

Location

Sanofi conference center, 100 Morris St, Morristown, NJ 07960

Free Parking

Advance Booking Required with Sanofi Security

1. Sanofi M Station Parking Garage (Onsite):
100 Morris St, Morristown, NJ 07960

2. Sanofi Overflow Parking – Headquarters Plaza Garage (3–5 min walk):
52 Headquarters Plaza, Morristown, NJ 07960

Public Parking (approx. $10/day)

SP+ Parking: (Approximately 3-min walk to the Sanofi building and NJ Transit station)

10 Lafayette Ave, Morristown, NJ 07960

Public Transit

NJ Transit – Morristown Station:

Approximately a 5-minute walk to the Sanofi office (1-hour commute from Penn Station (NYC) or Hoboken)

Airports

Newark Liberty International Airport (EWR) (Preferred) – ~20 miles

2. LaGuardia Airport (LGA) – ~45 miles

3. John F. Kennedy International Airport (JFK) – ~55 miles

Hotel

Hyatt Regency Morristown (9 mins walk, 3 mins drive)

3 Speedwell Ave, Morristown, NJ 07960 Tel. (973) 647-1234

Best Western Plus Morristown Inn (21 mins walk, 7 mins drive)

270 South St Morristown, NJ Free Breakfast. Free WiFi. ‎Contact Us · ‎Call +1-855-229-5934

Snack and Drink/Coffee

Light snack and drink/coffee are provided for whole day conference.

Call for Papers (I): Special Collection – Oncology Precision Medicine and Biomarker Development

Please consider to submit your manuscripts to the special collection at Pharmaceutical Medicine, published by Springer Nature, with guest editors including Philip He, PhD, Daiichi Sankyo; Gina D’Angelo, AstraZeneca, PhD; Hong Wang, PhD, Sanofi; Heng Zhou, PhD, Merck; Danielle Townsley, MD, Amgen. The special collection is open to the public, regardless whether attending the event. When submit, please indicate it is for the special collection: Oncology Precision Medicine and Biomarker Development.

Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. For details about its aims and scope, click here.

Call for Papers (II): Special Issue – Statistical Methods in Precision Medicine

Please consider to submit your manuscripts to the special issue at Pharmaceutical Statistics, published by © John Wiley & Sons Ltd. The special issue is open to the public, regardless whether attending the event. Stay tuned for more details here.