November 02, 2024

https://pharmaceuticalintelligence.com/2024/11/01/real-time-coverage-advancing-precision-medicine-annual-conference-philadelphia-pa-november-12-2024/

Real Time Conferecence Coverage: Advancing Precision Medicine Conference Philadelphia PA November 1,2 2024 Deliverables

Posted in Artificial Intelligence Applications in Health Care, Big Data, Bio Instrumentation in Experimental Life Sciences Research, Cancer Genomics, Cancer-Immune Interactions, Circulating Tumor Cells (CTC), Conference Coverage with Social Media, Deep Learning, Immuno-Oncology & Genomics, Machine Learning, Personalized and Precision Medicine & Genomic Research, Pharmacogenomics, Precision Cancer Medicine, Proteomics, REAL TIME Conference Coverage Twitter's Hashtags and Handles per Presentation/session, Scientific & Biotech Conferences: Press Coverage, Transcriptomics, Uncategorized, tagged 10X genomics, Advancing Precision Medicine, cancer genomics and therapy, clinical omics, Machine Learning (ML), molecular tumor board, oncology, personalised cancer therapy, personalised treatment, precision oncology on October 21, 2025| 1 Comment »

Real Time Conferecence Coverage: Advancing Precision Medicine Conference Philadelphia PA November 1,2 2024 Deliverables

Curator: Stephen J. Williams, Ph.D.

Below are deliverables in form of real Time conference coverage from the Advancing Precision Medicine Confererence held this year in Philadelphia, PA. The meeting brought together scientists and clinicians to discuss the challenges faced in implementing genomics and proteomics into precision medicine decision making workflow. As summarized by a future release at the 2025 ASCO, there are many issues and hindrances to incorporating data obtained from sequencing to make a personalized medicine strategy. The meeting focused on two main disease states: oncology and cardiovascular however most of the live meeting notes are from the oncology tract. In general it was discussed there are three areas which need to be addressed to correctly and more frequently incorporate precision medicine and genomic panel testing into clinical decision making workflow:

access to testing panels and testing methodology for both doctors and patients
expert interpretation of results including algorithms needed to analyze the data
more education of molecular biology and omics data and methodology in medical school to address knowledge gaps between clinicians and scientists

The issues can be summarized by a JCO report to ASCO in 2022:

Helen Sadik, PhD, Daryl Pritchard, PhD https://orcid.org/0000-0003-2675-0371 dpritchard@personalizedmedicinecoalition.org, Derry-Mae Keeling, BSc, Frank Policht, PhD, Peter Riccelli, PhD, Gretta Stone, BS, Kira Finkel, MSPH, Jeff Schreier, MBA, and Susanne Munksted, MS. Impact of Clinical Practice Gaps on the Implementation of Personalized Medicine in Advanced Non–Small-Cell Lung Cancer. 2022: JCO Precision Oncology; Volume 6. https://doi.org/10.1200/PO.22.00246

Personalized medicine presents new opportunities for patients with cancer. However, many patients do not receive the most effective personalized treatments because of challenges associated with integrating predictive biomarker testing into clinical care. Patients are lost at various steps along the precision oncology pathway because of operational inefficiencies, limited understanding of biomarker strategies, inappropriate testing result usage, and access barriers. We examine the impact of various clinical practice gaps associated with diagnostic testing-informed personalized medicine strategies on the treatment of advanced non–small-cell lung cancer (aNSCLC).

The authors used a Diaceutics’ Data Repository, a multisource database including commercial and Medicare claims and laboratory data from over 500,000 patients with non–small-cell lung cancer in the United States. They analyzed the number of patients with newly diagnosed aNSCLC who could have, but did not, benefit from a personalized treatment. The analysis was focused on identifying the gaps and at which steps during care did gaps existed which precipitated either lack of use of precision medicine testing or incorrect interpretation of results.

Their conclusions were alarming:

Most patients with aNSCLC eligible for precision oncology treatments do not benefit from them because of clinical practice gaps. This finding is likely reflective of similar gaps in other cancer types. An increased understanding of the impact of each practice gap can inform strategies to improve the delivery of precision oncology, helping to fully realize the promise of personalized medicine.

The links to the live meeting notes are given below and collection of tweets follow (please note this meeting did not have a Twitter hashtag)

Real Time Coverage Advancing Precision Medicine Annual Conference, Philadelphia PA November 1,2 2024

Real Time Coverage Morning Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

https://pharmaceuticalintelligence.com/2024/11/01/real-time-coverage-morning-session-on-precision-oncology-advancing-precision-medicine-annual-conference-philadelphia-pa-november-1-2024/

Real Time Coverage Afternoon Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

https://pharmaceuticalintelligence.com/2024/11/01/real-time-coverage-afternoon-session-on-precision-oncology-advancing-precision-medicine-annual-conference-philadelphia-pa-november-1-2024/

Real Time Coverage Morning Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 2 2024

https://pharmaceuticalintelligence.com/2024/11/04/real-time-coverage-morning-session-on-precision-oncology-advancing-precision-medicine-annual-conference-philadelphia-pa-november-2-2024/

Tweet Collection

Tweet Collection Advancing Precision Medicine Conference November 1,2 2024 Philadelphia PA

Gerald Batist, MD, Director, Segal Cancer Centre, Jewish General Hospital; Director, McGill Centre for Translational Research in Cancer; Professor, Department of Oncology, McGill University

Real Time Conference Coverage: Advancing Precision Medicine Conference, Early Morning Session Track 1 October 4 2025

Posted in Anti-tumor necrosis factor drugs (TNF inhibitors), BioIT: BioInformatics, NGS, Clinical & Translational, Pharmaceutical R&D Informatics, Clinical Genomics, Cancer Informatics, Cancer Genomics, Cancer Informatics, Cancer-Immune Interactions, Circulating Tumor Cells (CTC), Clinical Genomics, COVID-19, Evidence-based decision-making, Genomic Expression, Immuno-Oncology & Genomics, Immunotherapy, Inflammasome, KRAS Mutation, Metabolic Immuno-Oncology, Microbiology, REAL TIME Conference Coverage Twitter's Hashtags and Handles per Presentation/session, SARS-CoV-2 Viral Variants, TP53 - Germline mutations, Translational Research, Translational Science, tagged : Immunotherapies, cancer genomics and therapy, cfDNA, ctDNA Liquid Biopsy, gut microbiome, human microbiome, molecular tumor board, multiomics platforms, spatial omics, theranostics on October 4, 2025| Leave a Comment »

Real Time Conference Coverage: Advancing Precision Medicine Conference, Early Morning Session Track 1 October 4 2025

Reporter: Stephen J. Williams, PhD

Leaders in Pharmaceutical Business Intellegence will be covering this conference LIVE over X.com at

using the following meeting hashtags

#AdvancingPM #precisionmedicine #WINSYMPO2025

8:55 – 10:35

SESSION 1

Precision For All:

Global Access, Real Cases, and Implementation Science

8:55-9:15

Results and Future Direction from WIN’s Data Science Paper

9:15-9:55

When Precision Gets Personal: WIN Consortium International Molecular Tumor Board Live

Wafik S. El-Deiry, MD, PhD, FACP, Chair, WIN Consortium, Director, Legorreta Cancer Center Brown University, Director, Joint Program in Cancer Biology, Brown University and Brown University Health; Associate Dean, Oncologic Sciences, Warren Alpert Medical School, Brown University; Attending Physician, Hematology/Oncology, Brown University Health Mencoff Family University; Professor of Medical Science, Professor of Pathology and Laboratory Medicine, Brown University; Professor, American Cancer Society Research Professor

Razelle Kurzrock, MD, FACP, Chief Medical Officer, WIN Consortium; Professor of Medicine, Associate Director, Clinical Research, Linda T. and John A. Mellowes Endowed Chair of Precision Oncology, MCW Cancer Center and Linda T. & John A. Mellowes Center for Genomic Sciences and Precision Medicine

Notes from Live Tumor Board from Live Tweets

Tumor board Live… Molecular profiling great for identifying synthetic lethal combinations work very well… Many oncologist not accepting recommendations of molec tumor board

Tumor board Live . Oncologists don’t always accept tumor board recommendations based on molecular profiling… Dr Baptiste at first felt constrained to use single agent but WINTER combo trial with molec profiling better

Tumor board Live… Oncologist may give pushback when molecular therapeutic targets identified.. like when methylomics give a result and tumor board suggest temazolamide

Tumor board Live… Oncologist may give pushback when molecular therapeutic targets identified.. like when methylomics give a result and tumor board suggest temazolamide

Tumor board Live… Oncologist may give pushback when molecular therapeutic targets identified.. like when methylomics give a result and tumor board suggest temazolamide

Pemetrexemed not always working but MTAP inhibitions may work

Tumor board Live… Discussion of ovarian cancer case women first presented with CRC BRCA mut but failed PARP inhibitor board is looking at immunotherapy NGS IHC performed

#WINconsortium

Fusions being detected by RNAseq at rate of 100 per month

Tumor board Live…. Theranostics are becoming part of molec tumor board … Radio labeled dual diagnostic therapeutic antibodies

Tumor board Live… Molecular profiling great for identifying synthetic lethal combinations work very well… Many oncologist not accepting recommendations of molec tumor board

Lillian Siu, MD, President, AACR 2025-2026; Director, Phase I Clinical Trials Program; Co-Director, Robert and Maggie Bras and Family Drug Development Program Clinical Lead, Tumor Immunotherapy Program; BMO Chair, Precision Cancer Genomics, Princess Margaret Cancer Centre Professor of Medicine, University of Toronto

SESSION 2

Expanding the Precision Frontier

9:55-10:25

Precision Oncology in the Immunotherapy Era: Biomarkers and Clinical Trial Innovation

Princess Margaret CC went to Merck got pembrolizumab from them but built a team platform of clinicians and scientists to work on INSPIRE trial
$11 million of grants, 13 major papers, great team science
did ctDNA from liquid biopsy and also looked at methylation patterns in cfDNA
looked at IFN stimulation and outcome to pembrolizumab
retro transposable elements found in INSPIRE program, maybe a predictor of immune sensitivity
they were able to correlate some of their findings with spatial omics
using spatial data they could look at hot versus cold head and neck cancer
factors for response to immunotherapy: TMB, t cell infiltrate, PDL1 etc
using AI with IHC slides as well as NGS data sets
as clinical trials become multiomics and AI with multiomics platforms data sharing will be critical for success

10:25 – 10:35

The Microbiome and Its Role in Cancer Development and Treatment Response

Sabine Hazan, MD, CEO, Ventura Clinical Trials; CEO, Progenabiome

microbiome research at the infancy so we don’t know much when comes to oncology
we need to compare microbiome between persons using NGS and other omics
we all have different microbiome even though microbiome ‘healthy’
lots of factors affect microbiome including surgery
families are similar in their microbiome but when looking at Alzheimers there are differences
first lab to find whole COVID in the stools
virus was different in different people, difference spike proteins. Virus mutates from lung to stool (gut)
in intrafamily patients had different microbiome upon COVID infection
bifodobacteria was found as a major part of microbiome altered in COVID but also lots of other diseases
lots of examples of host microbial symbiosis
they had an instance with throat tumor treated with microbiome and tumor receded without chemo
in a glioblastoma microbiome adjustment helped but changed positive response to immunotherapy

https://www.advancingprecisionmedicine.com/

Conference Coverage 2025 Advancing Precision Medicine Conference, Philadelphia PA October 3-4 2025

Posted in Cancer Genomics, Cancer Informatics, Cardiovascular Pharmacogenomics, Circulating Tumor Cells (CTC), Clinical & Translational, Clinical Genomics, Conference Coverage with Social Media, Genomic Expression, Precision Cancer Medicine, REAL TIME Conference Coverage Twitter's Hashtags and Handles per Presentation/session, Scientific & Biotech Conferences: Press Coverage, tagged Advancing Precision Medicine, Biomarker discovery, biomarker panels, Cancer Genomics, cancer genomics and therapy, cardiogenomics, functional proteomics, liquid biopsy, Personalized and Precision Medicine & Genomic Research on October 2, 2025| 1 Comment »

Conference Coverage 2025 Advancing Precision Medicine Conference, Philadelphia PA October 3-4 2025

Reporter: Stephen J. Williams, PhD

The Annual Advanced Precision Medicine Conference will be held at the Pennsylvania Convention Center October 3-4 2025 in Philadelphia PA. Advancing Precision Medicine is an organization dedicated to provide education and discourse among medical professionals to advance the field of precision therapeutics and diagnostics in cancer, cardiovascular, and other diseases. The Annual symposium is held in Philadelphia.

The event will consist of two parallel tracks composed of keynote addresses, panel discussions and fireside chats which will encourage audience participation. Over the course of the two-day event leaders from industry, healthcare, regulatory bodies, academia and other pertinent stakeholders will share an intriguing and broad scope of content.

This event will consist of three immersive tracks, each crafted to explore the multifaceted dimensions of precision medicine. Delve into Precision Oncology, where groundbreaking advancements are reshaping the landscape of cancer diagnosis and treatment. Traverse the boundaries of Precision Medicine Outside of Oncology, as we probe into the intricate interplay of genetics, lifestyle, and environment across a spectrum of diseases and conditions including rare disease, cardiology, ophthalmology, and neurodegenerative disease. Immerse yourself in AI for Precision Medicine, where cutting-edge technologies are revolutionizing diagnostics, therapeutics, and patient care. Additionally, explore the emerging frontiers of Spatial Biology and Mult-Omics, where integrated approaches are unraveling the complexities of biological systems with unprecedented depth and precision.

Leaders in Pharmaceutical Business Intellegence will be covering this conference LIVE over X.com at

using the following meeting hashtags

#AdvancingPM #precisionmedicine #WINSYMPO2025

APM is a mission-driven team dedicated to advancing clinical practice through education in precision medicine, oncology, and pathology. Our expert-led programs bring together clinicians, pathologists, pharmacists, nurses, and researchers from across the country.

What We Offer

In 2025, we’re proud to offer three specialized event series—each tailored to a different corner of the healthcare ecosystem:

Register here for the 2025 Conference: https://www.advancingprecisionmedicine.com/apm-home/apm-annual-conference-and-exhibition-in-philadelphia/

Where discovery meets application – and science transforms lives.

What’s New in 2025?

Four Specialized Tracks:

Track 1 – 2025 WIN Symposium: Progress and Challenges in Precision Oncology
Presented in partnership with Advancing Precision Medicine

As the official 2025 WIN Symposium, this dedicated track will explore the evolving landscape of precision oncology, highlighting both groundbreaking advances and the ongoing challenges of translating molecular insights into clinical impact. Curated by the WIN Consortium, the program will feature global leaders in cancer research, diagnostics, and therapeutic innovation—offering a comprehensive view of how precision medicine is reshaping oncology across tumor types and care settings.

Track 2 – Day 1 – Multi-Omics Integration, Day 2 – Precision Medicine Outside of Oncology

From genomics and transcriptomics to proteomics and metabolomics—this track highlights how multi-layered data is revolutionizing systems biology and clinical decision-making.

Diving into applications across cardiovascular, neurology, rare disease, infectious disease, and other therapeutic areas where precision tools are reshaping clinical practice.

Why Attend?

Cutting-Edge Innovation: Explore AI-powered solutions, multi-omics workflows, clinical trial design, and real-world implementation.
Renowned Speakers: Hear from global thought leaders in translational research, biotech innovation, and personalized therapeutics.
Dynamic Format: Keynotes, fireside chats, panels, and audience-interactive discussions across four concurrent tracks.
Unmatched Networking: Collaborate with scientists, startups, executives, regulators, and investors shaping tomorrow’s care.
Philadelphia Advantage: Centrally located near premier academic institutions, hospitals, incubators, and venture capital networks.

Who Should Attend?

Researchers, clinicians, data scientists, regulatory experts, startup founders, investors, tech transfer professionals, and healthcare leaders.

Let’s advance a future that is more predictive, preventive, and precise—together.

Keynote Speaker

William Kaelin, Jr, MD

2019 Nobel Laureate
Sidney Farber Professor, Harvard Medical School and Dana-Farber Cancer Institute

View Profile

2019 Nobel Laureate

Sidney Farber Professor of Medicine at Harvard Medical School and Dana-Farber Cancer Institute

Senior Physician-Scientist at Brigham and Women’s Hospital

Howard Hughes Medical Institute Investigator

William Kaelin is the Sidney Farber Professor of Medicine at Harvard Medical School and Dana-Farber Cancer Institute, Senior Physician-Scientist at Brigham and Women’s Hospital and Howard Hughes Medical Institute Investigator. He obtained his undergraduate and M.D. degrees from Duke University and completed his training in Internal Medicine at the Johns Hopkins Hospital, where he served as chief medical resident. He was a clinical fellow in Medical Oncology at the Dana-Farber Cancer Institute and later a postdoctoral fellow in David Livingston’s laboratory, during which time he was a McDonnell Scholar.

A Nobel Laureate, Dr. Kaelin received the 2019 Nobel Prize in Physiology or Medicine. He is a member of the National Academy of Sciences, the American Academy of Arts and Sciences, the National Academy of Medicine, the American Society of Clinical Investigation, and the American College of Physicians. He previously served on the National Cancer Institute Board of Scientific Advisors, the AACR Board of Trustees, and the Institute of Medicine National Cancer Policy Board. He is a recipient of the Paul Marks Prize for cancer research from the Memorial Sloan-Kettering Cancer Center; the Richard and Hinda Rosenthal Prize from the AACR; the Doris Duke Distinguished Clinical Scientist award; the 2010 Canada International Gairdner Award; ASCI’s Stanley J. Korsmeyer Award; the Scientific Grand Prix of the Foundation Lefoulon-Delalande; the Wiley Prize in Biomedical Sciences; the Steven C. Beering Award; the AACR Princess Takamatsu Award; the ASCO Science of Oncology Award; the Helis Award; the Albert Lasker Basic Medical Research Prize; the Massry Prize; the Harriet P. Dustan Award for Science as Related to Medicine from the American College of Physicians.

Dr. Kaelin’s research seeks to understand how, mechanistically, mutations affecting tumor-suppressor genes cause cancer. His laboratory is currently focused on studies of the VHL, RB-1, and p53 tumor suppressor genes. His long-term goal is to lay the foundation for new anticancer therapies based on the biochemical functions of such proteins. His work on the VHL protein helped to motivate the eventual successful clinical testing of VEGF inhibitors for the treatment of kidney cancer. Moreover, this line of investigation led to new insights into how cells sense and respond to changes in oxygen, and thus has implications for diseases beyond cancer, such as anemia, myocardial infarction, and stroke. His group also showed that leukemic transformation by mutant IDH was reversible, setting the stage for the development and approval of mutant IDH inhibitors, and discovered how thalidomide-like drugs kill myeloma cells by degrading two otherwise undruggable transcription factors,

2025 Steering Committee

Presentations

A diverse group of more than 90 key opinion leaders will convene to explore the critical forces shaping the future of healthcare. Representing a range of disciplines—including genomics, bioinformatics, clinical research, biopharma, technology, and investment—these experts will lead discussions on the latest advancements and challenges in precision medicine.

Topics will include the evolution of genomic sequencing technologies, ethical considerations in managing patient data, the integration of AI in diagnostics, and strategies for translating innovation into clinical practice. The inclusion of investors and strategic partners will also bring a vital perspective on funding models, commercialization pathways, and the acceleration of cutting-edge therapies. Together, these voices will offer a comprehensive view of the trends transforming personalized healthcare on a global scale.

Networking Opportunities

Our precision medicine event, hosting over 500 attendees, offers invaluable networking opportunities. Bringing together professionals, researchers, and industry leaders, the event facilitates engaging discussions, knowledge-sharing, and potential partnerships, driving advancements in precision medicine.

Why Exhibit

Exhibiting at the event provides a unique opportunity to showcase your cutting-edge solutions and connect with key stakeholders in the rapidly advancing field of personalized healthcare. As an exhibitor, you’ll gain visibility among industry leaders, researchers, and professionals, allowing you to forge strategic partnerships, highlight your contributions to precision medicine, and stay at the forefront of innovations shaping the future of healthcare. Don’t miss the chance to position your company as a leader in this dynamic and transformative space, driving meaningful collaborations and contributing to the advancement of precision medicine.

THE LOCATION

APM Annual Conference 2025

Pennsylvania Convention Center
1101 Arch Street
Philadelphia, PA 19107

Registration Fees

Student – free
Academic/Government/Non-Profit – free
Healthcare Providers – free
Investors – free
Vendor/Technology Provider $999

Other Live Conference Proceedings can be found on this Online Open Access Journal at:

Press Coverage

including a list of previous conference at:

Part Two: List of BioTech Conferences 2013 to Present

including Live Coverage of the 2024 Advancing Precision Medicine conference at:

Real Time Coverage Advancing Precision Medicine Annual Conference, Philadelphia PA November 1,2 2024

https://news.cision.com/let-em-know-ab/r/resitu-strengthens-c-suite-with-new-ceo-as-it-prepares-for-commercialization-of-its-breast-tumor-rem,c4140424

Resitu Medical Sets Stage for Breakthrough in Breast Tumour Removal

Posted in Breast Cancer - impalpable breast lesions, Cancer - General, Cancer and Current Therapeutics, CANCER BIOLOGY & Innovations in Cancer Therapy, Cancer Informatics, cancer metabolism, Cancer Prevention: Research & Programs, Cancer Screening, cancer-general, Cancer-Immune Interactions, Circulating Tumor Cells (CTC), Immunodiagnostics, Immunotherapy, interventional oncology, Personalized and Precision Medicine & Genomic Research, Population Health Management, Genetics & Pharmaceutical, Precision Cancer Medicine, Surgical Procedure, tumor microenvironment, tagged Breakthrough Devices, Breakthrough Science, breast cancer, surgery, tumor on May 2, 2025| Leave a Comment »

Resitu Medical Sets Stage for Breakthrough in Breast Tumour Removal

Curator: Dr. Sudipta Saha, Ph.D.

Resitu Medical, a Swedish company specializing in minimally invasive breast tumour removal, has announced the appointment of Stefan Sowa as its new Chief Executive Officer. Strategic leadership is being strengthened as the company moves towards commercialization in both European and American markets.

A novel electrosurgical device, designed to excise entire breast lesions during the biopsy procedure, is being developed by Resitu. The device is intended to minimize the need for open surgery by allowing intact removal of tissue with minimal bleeding, guided by real-time ultrasound imaging. Preclinical studies are currently being conducted, and preparations for FDA clearance and CE marking are underway.

ISO 13485 certification for the design, development, manufacturing, and sales of the device has been successfully obtained. Investment has been secured from major shareholders, including Novoaim, ALMI Invest Stockholm, and STOAF, to support the finalization of the product and the initiation of serial production for clinical trials.

Through the use of its technology, false negatives are hoped to be reduced, while patient outcomes and diagnostic accuracy are expected to be significantly improved. The burden on healthcare systems may also be alleviated by minimizing the need for recalls and secondary biopsies.

Positive attention has been garnered at major medical conferences, with workshops hosted at events such as the Uppsala Breast Meeting, and favourable media coverage has been achieved. With Stefan Sowa at the helm, Resitu’s innovative device is poised to transform breast cancer management practices globally.

References

https://www.resitu.com

https://www.who.int/news-room/fact-sheets/detail/breast-cancer

https://pharmaceuticalintelligence.com/2019/02/13/tumor-ammonia-recycling-how-cancer-cells-use-glutamate-dehydrogenase-to-recycle-tumor-microenvironment-waste-products-for-biosynthesis/

https://pharmaceuticalintelligence.com/2016/04/10/lipids-link-to-breast-cancer/

https://pharmaceuticalintelligence.com/2016/03/14/rapid-regression-of-her2-breast-cancer/

Unlocking the Next Quantum Leap in Precision Medicine – A Town Hall Discussion (CME Eligible)

Real Time Coverage Afternoon Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

Posted in and Bioethics, Artificial Intelligence - Breakthroughs in Theories and Technologies, Artificial Intelligence Applications in Health Care, Artificial Intelligence in CANCER, Big Data, BioBanking, Biomarkers & Medical Diagnostics, Cancer Genomics, Cancer Informatics, Childhood cancer, Clinical Diagnostics, Clinical Genomics, Conference Coverage with Social Media, FDA, FDA Regulatory Affairs, Health Economics and Outcomes Research, Health Law & Patient Safety, Healthcare costs and reimbursement, Liquid Biopsy Chip detects an array of metastatic cancer cell markers in blood, Machine Learning, Natural Language Processing (NLP), Next Generation Sequencing (NGS), United States, tagged AI in Healthcare, Biomarker discovery, biomarker panels, FDA, genomic panels, genomics, health costs, healthcare models, Predictive Cancer Biomarkers on November 1, 2024| Leave a Comment »

Coverage Afternoon Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

Reporter: Stephen J. Williams, Ph.D.

Co-Chairs

Amanda Paulovich, Professor, Aven Foundation Endowed Chair
Fred Hutchinson Cancer Center

Susan Monarezm Deputy Director ARPA-H

Henry Rodriguez, NCI/NIH

Eric Schadt, Pathos

Ezra Cohen, Tempus

Jennifer Leib, Innovation Policy Solutions

Nick Seddon, Optum Genomics

Giselle Sholler, Penn State Hershey Children’s Hospital

Janet Woodcock, formerly FDA

Amanda Paulovich: Frustrated by the variability in cancer therapy results. Decided to help improve cancer diagnostics

We have plateaued on relying on single gene single protein companion diagnostics
She considers that regulatory, economic, and cultural factors are hindering the innovation and resulting in the science way ahead of the clinical aspect of diagnostics
Diagnostic research is not as well funded as drug discovery
Biomarkers, the foundation for the new personalized medicine, should be at forefront Read the Tipping Point by Malcolm Gladwell
FDA is constrained by statutory mandates

Eric Schadt

Pathos

Multiple companies trying to chase different components of precision medicine strategy including all the one involved in AI
He is helping companies creating those mindmaps, knowledge graphs, and create more predictive systems
Population screening into population groups will be using high dimensional genomic data to determine risk in various population groups however 60% of genomic data has no reported ancestry
He founded Sema4 but many of these companies are losing $$ on these genomic diagnostics
So the market is not monetizing properly
Barriers to progress: arbitrary evidence thresholds for payers, big variation across health care system, regulatory framework

Beat Childhood Cancer Consortium Giselle

Consortium of university doctors in pediatrics
They had a molecular tumor board to look at the omics data
Showed example of choroid plexus tumor success with multi precision meds vs std chemo
Challenges: understanding differences in genomics test (WES, NGS, transcriptome etc.
Precision medicine needs to be incorporated in med education.. Fellowships.. Residency
She spends hours with the insurance companies providing more and more evidence to justify reimbursements
She says getting that evidence is a challenged; biomedical information needs to be better CURATED

Dr. Ezra Cohen, Tempest

HPV head and neck cancer, good prognosis, can use cituximab and radiation
$2 billion investment at Templest of AI driven algorithm to integrate all omics; used LLM models too

Dr. Janet Woodcock

Our theoretical problem with precision and personalized medicine is that we are trained to think of the average patient
ISPAT II trial a baysian trial; COVID was a platform trial
She said there should there be NIH sponsored trials on adaptive biomarker platform trials

This event will be covered by the LPBI Group on Twitter. Follow on

using the following meeting hashtags

#AdvancingPM #precisionmedicine

#AdvancingPM #precisionmedicine

Real Time Coverage Morning Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

Posted in Big Data, Biomarkers & Medical Diagnostics, Cancer Genomics, Childhood cancer, children, Circulating Tumor Cells (CTC), Clinical Genomics, CRISPR/Cas9 & Gene Editing, Diagnostics and Lab Tests, FDA, FDA Regulatory Affairs, Health Economics and Outcomes Research, Liquid Biopsy: Circulating Tumor Cells in Urine and Blood, Personalized and Precision Medicine & Genomic Research, Precision Cancer Medicine, REAL TIME Conference Coverage Twitter's Hashtags and Handles per Presentation/session, tagged Advancing Precision Medicine, ALS, ctDNA Liquid Biopsy, disease models, genetic diseases, genetic panels, health economics, health equity, Health insurance, liquid biopsy, Molecular Diagnostics, oncology, precision medicine, Rare diseases, Reimbursement for Molecular DIagnostics on November 1, 2024| 1 Comment »

Real Time Coverage Morning Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

Reporter: Stephen J. Williams, Ph.D.

Notes from Precision Medicine for Rare Diseases 9:00AM – 10:50

Precision Medicine and markers Cure models vs disease models Dr Ekker from UT MD Anderson

UT MD Anderson zebrafish disease model program now focusing more on figuring the mechanisms by which a disease model is reverted to normal upon CRISPR screens
Traditional drug development process long and expensive
2nd in class only takes 4 years while 3rd in class drugs take only 1.5 years
Health-in-a-fish: using a CRE system to go from disease to normal
The theory is making a CRE or CURE avatar; taking a diseased zebrafish and reverse engineering the disease genome
He used transposon based CRE mutational mutants with protein trap and 3’ exon trap (transposon based mutagenesis)
He reverted the diseased gene by CRE
He feels that can scale up to using organoids to develop more cure based models

FDA Christine Nguyen MD regulatory perspective of framework of drug approval for rare diseases

1 in 10 Amercians have rare diseases; 70% genetic and half are children
Due to Orphan Drug Act in 2023 half of novel drugs approved for rare diseases
CDER and FDA 550 unique drugs for over 1000 rare diseases
Clinical and surrogate validated endpoints are important for traditional approvals
For accelerated approval need predictive surrogate endpoint of clinical benefit
For accelerated approval needs completion of a confirmatory trials so FDA has new authority under FDORA; FDA can dictate trial milestones
Candidate surrogate endpoints: known to predict (validated) for traditional approval but reasonably likely to predict for accelerated approval
Does surrogate endpoint associated with a causal pathway? Also important to understand the magnitude of benefit so surrogate should be quantitative not just qualitative
RDEA is a series of 3 public workshops at FY2027 to promote innovation and novel endpoints and guidance

Frank Sasinowski FDA regulatory flexibility beyond One Positive Adequate and Well Controlled Trial

As we move to rare diseases we may only have one well controlled study so FDA feels we need new regulatory frameworks and guidelines especially for rare disease clinical trails especially with precision medicine
Accelerated approval does not mean your evidence is any less stringent that traditional approval (only difference is endpoint but quality of evidence the same)

Confirmatory evidence is a primary concern
In 2021 FDA coordinated with the two divisions CBER and CDER
Sometimes a primary endpoint shows positive benefit but secondary endpoints may not; FDA now feels that results from one well designed AWC gives confirmatory evidence
FDA can be flexible by taking in consideration the quantity and quality of confirmatory evidence and the totality of evidence
So pharmacology studies, natural history etc. can be enough
For a drug like Lamzede for mannosidosis there were no positive endpoint studies or for ADA SCID disease there was other compelling evidence
The FDA does have flexibility when it comes to advanced precision medicines and ultr rare diseases

10:50 Do we Really Need Liquid Biopsy? A Panel Discussion on the Issues Hampering the full Adoption of Liquid Biopsy

In Mexico leading cancer is colorectal but only have the FIT test and noone except one organization who issupplying health access
Access to precision medicine is a concern: the communication between the patient, who is pushing this more than healthcare, needs to be coordinated better with all stakeholders in care
We also need to educate many physicians even oncologists (like in Virginia) a better understanding of genetics and omics
FT3 consortium does testing to therapy (multistakeholder group comprised of patient advocacy groups); focus on amplifying global efforts to increase access; they are trying to make a roadmap to help access in other countries; when it comes to precision medicine it is usually the nurses that are aksing for training because they are usually the first responders for the patient’s questions
In rural areas just getting access to liquid biopsy is a concern and maybe satellite sites might be useful because the time to schedule is getting worse (like 3 or more months)
A recent paper showed that liquid biopsy may actually perpetuate health disparities and not ameliorate them
BloodPAC: there are barriers to LB access and adoption so consortium felt that there were many areas that need to be addressed: financial, access, disparities, education
ctDNA to define variants was the past focus; there is growing realization that there are representatives populations in your R&D studies
Submission of data to BloodPac is easier to do for tissue not for liquid biopsy; there is lack of harmonization across many of these databanks
Reimbursement: is a barrier to access for liquid biopsy
Illumina: challenge finding clinical utility for payers; FDA approval is not as hard; show improved outcomes for patients; Medicare is starting to approve some tests but the criteria bar keeps changing with payers;
How do we leverage the on-market data to support performance of your diagnostic test or genomic panel

This event will be covered by the LPBI Group on Twitter. Follow on

using the following meeting hashtags

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Real Time Coverage Advancing Precision Medicine Annual Conference, Philadelphia PA November 1,2 2024

Real Time Coverage Advancing Precision Medicine Annual Conference, Philadelphia PA November 1,2 2024

Reporter: Stephen J. Williams, Ph.D.

Source: https://www.advancingprecisionmedicine.com/apm-annual-conference-and-exhibition-in-philadelphia/

This event will be covered by the LPBI Group on Twitter. Follow on

using the following meeting hashtags

#AdvancingPM #precisionmedicine

The Advancing Precision Medicine (APM) Annual Conference 2024 will take place at the Pennsylvania Convention Center in Philadelphia, November 1-2, 2024. Located in the heart of the biopharma ecosystem and with easy access to some of the most renowned academic and research institutions in the world, the APM Annual Conference 2024 will attract all segments of the precision medicine landscape.

his event will consist of three immersive tracks, each crafted to explore the multifaceted dimensions of precision medicine. Delve into Precision Oncology, where groundbreaking advancements are reshaping the landscape of cancer diagnosis and treatment. Traverse the boundaries of Precision Medicine Outside of Oncology, as we probe into the intricate interplay of genetics, lifestyle, and environment across a spectrum of diseases and conditions including rare disease, cardiology, ophthalmology, and neurodegenerative disease. Immerse yourself in AI for Precision Medicine, where cutting-edge technologies are revolutionizing diagnostics, therapeutics, and patient care. Additionally, explore the emerging frontiers of Spatial Biology and Mult-Omics, where integrated approaches are unraveling the complexities of biological systems with unprecedented depth and precision.

Whether you are a seasoned researcher, a dedicated clinician, or a visionary industry professional, this conference serves as a vibrant hub of knowledge exchange, collaboration, and innovation. Elevate your expertise, expand your network, and chart the course of your career trajectory amidst a community of like-minded individuals. Join us as we embark on this transformative journey, where the possibilities are as limitless as the potential of precision medicine itself.

Agenda – What’s on when

Day 1 – Friday, Nov 1

Day 2 – Saturday, Nov 2

November 01, 2024

7:30 – 8:25

Registration and Check-in Meeting Room 203 Philadelphia Convention Center

8:25 – 8:30

Welcome and Introduction

8:30 – 9:00

Opening Keynote

Advancing Precision Medicine in the Prevention and Treatment of Cardiometabolic Disease (CME Eligible)

Daniel Rader, Penn Medicine and Children’s Hospital of Philadelphia

9:00 – 10:20

9:00-10:20

Diagnosis to Treatment – A Case Study in Non Small Cell Lung Cancer

Moderator: Jason Crites, Assurance Health Data

Miriam Bredella, NYU Lagone Health

Rob Dumanois, Thermo Fisher Scientific

Joe Lennerz, BostonGene

9:00-9:20

Scaling Precision Therapeutic Development for Rare Disease (CME Eligible)Landscape Overview (CME Eligible)

Marni Falk, CHOP

9:20-9:40

Prognostic Biomarkers and Preclinical Modeling – the Cost of Inaction (CME Eligible)

Stephen Ekker, University of Texas at Austin

9:40-10:00

Regulatory Perspective on Rare Disease Drug Approvals and Efficacy Endpoints (CME Eligible)

Christine Nguyen, FDA

10:00-10:20

FDA’s Regulatory Flexibility Beyond One Positive Adequate & Well-Controlled Trial (CME Eligible)

Frank Sasinowski, Hyman, Phelps & McNamara

10:20 – 10:50

Networking, Exhibits and Product Presentations

10:25-10:35 PRODUCT PRESENTATION 204C

The Genexus Integrated Sequencer System:
NGS Results in 24 hours for Oncology Genomic Profiling

Jeff Smith, Thermo Fisher Scientific

10:35-10:45 PRODUCT PRESENTATION 204A

Shifting the Paradigm in Patient Management with MRD Testing: Why Evidence-Generated Performance and Experience is Key

Karen Lin, Natera

10:50 – 12:50

10:50-11:50

Who Needs Liquid Biopsy? Opportunities to Increase Access and Improve Outcomes

Nicole St. Jean, GSK

Phil Febbo, Veracyte, Inc.

Andrea Ferreira-Gonzalez, Virginia Commonwealth University

Lauren Leiman, BloodPAC

Nicole Sheahan, Global Colon Cancer Association

11:50-12:50

Advancing Digital Pathology and Precision Medicine – Where Are We Now?

Shruti Mathur, Genentech

Luke Benko, Roche Diagnostics

Kimberly Gasuad, JK Life Sciences

Eric Walk, PathAI

10:50-11:10

Real World Data vs Multi Modal Omics Data for Therapeutic Discovery (CME Eligible)

Adam Resnick, CHOP

11:10-11:30

An Academic Perspective on Rare Disease Target Discovery to Commercial Treatment Development (CME Eligible)

Hakon Hakonarson, CHOP

11:30-11:50

NCATS Perspective on Success and Failures of Drug Repurposing for Rare Disease (CME Eligible)

PJ Brooks, NIH

11:50-12:10

Pharma Perspective and Realities (CME Eligible)

Sundeep Dugar, Rarefy Therapeutics

12:10-12:50

A Panel Discussion: Scaling Precision Therapeutic Development for Rare Disease (CME Eligible)

Marni Falk, CHOP

Stephen Ekker, University of Texas at Austin

Christine Nguyen, FDA

Frank Sasinowski, Hyman, Phelps & McNamara

Adam Resnick, CHOP

Hakon Hakonarson, CHOP

Sundeep Dugar, Rarefy Therapeutics

PJ Brooks, NIH

12:50 – 1:50

Lunch & Product Presentations

1:10-1:25 PRODUCT PRESENTATION 204C

The Power of ctDNA Testing in Therapy Selection and Recurrence Monitoring

Taylor Jensen, LabCorp

1:50 – 3:50

1:50-3:50

Unlocking the Next Quantum Leap in Precision Medicine – A Town Hall Discussion (CME Eligible)

Co-Chairs

Amanda Paulovich, Fred Hutchinson Cancer Center

Henry Rodriguez, NCI/NIH

Eric Schadt, Pathos

Participants

Ezra Cohen, Tempus

Jennifer Leib, Innovation Policy Solutions

Susan Monarez, ARPA-H

Nick Seddon, Optum Genomics

Giselle Sholler, Penn State Hershey Children’s Hospital

Janet Woodcock, Former FDA

1:50-2:50

Advancing Precision Medicine in Non-Oncology Therapeutic Areas

Moderator: Mike Montalto, Amgen

Scott Friedman, Mt. Sinai

Sana Syed, University of Virginia

Lei Zhao, Amgen

2:50-3:20

Towards a Precision Neuroimmunology Platform (CME Eligible)

Amit Bar-Or, Penn Medicine

3:20-3:50

3:50 – 4:20

Networking and Exhibits

4:20 – 6:15

4:20-4:45

Precision Medicine, What’s So Difficult? The Interplay & Complexities of Delivering on the Promise of Precision Medicine (CME Eligible)

Sarah Hersey, BMS

4:45-5:30

Realizing Novel Treatment Paradigms with ctDNA-MRD (CME Eligible)

Mark Roschewski, NCI

5:30-6:30

The Potential Benefits of Next-day NGS for the Future of Precision Oncology

Allison Eck, Doylestown Health

Harry Erba, Duke Cancer Institute

Jeff Smith, Thermo Fisher Scientific

4:20-4:45

Advancing Precision Medicine: Polygenic Risk Scores and Beyond (CME Eligible)

Dokyoon Kim, Penn Medicine

4:45-5:30

The Rocky Road to Clinical Trial Diversity (CME Eligible)

Ysabel Duron, The Latino Cancer Institute

Porscha Johnson, PJW Clinical Pharmacy Consulting

Victor LaGroon, Department of Veterans Affairs

5:30-6:15

In the Rising Age of Women’s Health, How Do We Build Diagnostics to Last?

Oriana Papin Zoghbi, AOADx

Sarah Huah, Johnson & Johnson

6:30 – 7:00

Evening Keynote

Reimagining Health Equity in the Era of Precision Medicine (CME Eligible)

Rick Kittles, Morehouse School of Medicine

7:00 – 7:45

Cocktail Networking Reception

November 02, 2024

8:00-8:55

Registration and Check-in Meeting Room 203 Philadelphia Convention Center