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Archive for November, 2024

SNU-BioTalk 2025: Symphony of Cellular Signals in Metabolism and Immune Response – International Conference at Sister Nivedita University, Kolkata, India on 16 & 17 January 2025

SNU-BioTalk 2025: Symphony of Cellular Signals in Metabolism and Immune Response – International Conference at Sister Nivedita University, Kolkata, India on 16 & 17 January 2025

Joint Convenor: Dr. Sudipta Saha (Member of LPBI since 2012)

About the Conference:

The International Conference on ‘Symphony of Cellular Signals in Metabolism and Immune Response’ focuses on the complex signalling pathways governing cellular functions in health and disease. It will explore the cellular mechanisms that regulate metabolism, immune responses, and survival, highlighting advances in medical science and biotechnology. Bringing together leading experts and emerging researchers, the conference will feature keynote lectures, panel discussions, research presentations, and interactive sessions, all designed to foster collaboration and innovation. By promoting an exchange of ideas, the event aims to drive transformative insights and solutions that impact human health and sustainable healthcare practices.

The conference will also be livestreamed on YouTube and Facebook

This programme will also host I-STEM: Indian Science, Technology and Engineering facilities Map (I-STEM) is a dynamic and interactive national portal for research cooperation.

Thrust areas:

  • Intracellular signalling processes of cellular metabolism
  • Signalling pathways in physiological and pathological processes
  • Signalling in innate and adaptive immunity

Conference Webpage: https://www.snuniv.ac.in/snu-biotalk-2025/

NU-BioTalk 2025 Abstract Submission Form: https://forms.gle/ygdGqtuBGa7DEhDFA

SNU-BioTalk 2025 Registration Form: https://forms.gle/unasPpByLmYwrRBM6

Programme Schedule:

YouTube Links of Live Telecast:

Day 1:

Day 2:

Media:

Newspaper:

The Telegraph – Click to View

 

Abstract Book

Scan to Download:

Click: 

Abstract Book

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

Reporter: Stephen J. Williams, Ph.D.

9:20-9:50

How Can We Close the Clinical Practice Gaps in Precision Medicine?

Susanne Munksted, Diaceutics

Studies are showing that genetic tests are being ordered at a sufficient rate however it appears there are problems in interpretation and developing treatment plans based on omics testing results

 

  • 30 % of patients in past and now currently half of all patients are not being given the proper treatment based on genomic testing results (ASCO)
  • E.g. only 1.5% with NTRK fusions received a NTRK based therapy (this was > 4000 patients receiving wrong therapy)
  • A lung oncologist may only see one patient with NTRK fusion in three years

 

Precision Medicine Practice Gaps

48% of oncologist surveyed  agreed pathologist needs to be more informed and relevant in the decision making process with regard to tests needing to be ordered

95% said need to flip cost issues ; what does it cost not to get a test … i.e. what is the cost of the wrong therapy

We need a new commercialization model for therapeutic development for this new era of “n of one” patient

9:50-10:15

Implementation of a CLIA-based Reverse Phase Protein Array Assay for Precision Oncology Applications: Proteomics and Phosphoproteomics at the Bedside (CME Eligible)

Emanuel Petricoin, George Mason University

There are some tumor markers approved by FDA that cant just be measured by NGS and are correlated with a pathologic complete response

 

  • Many point mutations will have no actionable drug
  • Many alterations are post-genomic meaning there is a post translational component to many prognostic biomarkers
  • Prevalence of point mutation with no actionable mutation is a limit of NGS
  • It is important to look at phospho protein spectrum as a potential biomarker

 

Reverse phase protein proteomic analysis

  • Made into CLIA based array
  • They trained centers around the US on the technology and analysis
  • Basing proteomics or protein markers by traditional IHC requires much antibody validation so if the mass spectrometry field can catch up it would be very powerful
  • With multiple MRM.MS there is too low abundance of phosphoproteins to allow for good detection

 

They  conducted the I-SPY2 trial for breast cancer and determining if phosphoproteins could be a good biomarker panel

  • They found they could predict a HER2 response better than NGS
  • There were patients who were predicted HER2 negative that actually had an activated HER2 signaling pathway by proteomics so NGS must have had a series of false negatives
  • HER2 co phosphorylation predicts pathologic complete response and predicts therapy by herceptin
  • They found patients classified as HER2 negative by FISH were HER2 positive by proteomics and had HER2 activation

10:15-11:10

Liquid Biopsy MRD to Escalate or De-escalate Therapy (CME Eligible)

Adrian Lee

Adrian Lee, UPMC

Marija Balic, UPMC

Howard McLeod

Howard McLeod, Utah Tech University

Muhammed, Murtaza, University of Wisconsin-Madison

 

11:15-11:25  PRODUCT PRESENTATION  204A

SpaceIQ™ – Powering Next Generation Precision Therapeutics with AI-Driven Spatial Biomarkers

Dusty Majumdar, PredxBio 

Single Cell and Spatial Omics

 

  • Single cell transcriptomics technology have been scaled up very nicely over the past ten years
  • Spatial informatics field is lacking in innovations
  • Can get a terabyte worth of data from analysis of one slide

11:25-11:35  PRODUCT PRESENTATION  204C

10x Genomics

11:40-12:35

Transcriptomics and AI in Transforming Precision Diagnosis

Maher Albitar, Genomic Testing Cooperative

Transciptomica and AI:Transforming Precision diagnosis

-The Genomics Testing Coopererative at www.genomictestingcooperative.com

 

Advantages of transcriptomics

– mutation frequency and allele variant detection now at 80% (higher sensitivity in mutation detection)

 

– transcriptomics has good detection of chromosomal translocations

– great surrogate for IHC and detect splicing alterations

– can use AI to predict % of PDL1 in tumor cells versus immune cells

– they have developed a software UMAP (uniform manifold approximation and projection) to supervise cluster analysis

– the group has used AI to predict prognosis and survival using transcriptomics data

Marija Balic, UPMC

Andrew Pecora, Hackensack University Medical Center 

12:35-1:00

The Impact of Multi-Omics in the Context of the APOLLO-2 Moonshot Program (CME Eligible)

 

 

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

Reporter: Stephen J. Williams, Ph.D.

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

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

@Pharma_BI

@StephenJWillia2

@Aviva1950

@AdvancingPM

using the following meeting hashtags

#AdvancingPM #precisionmedicine

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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

@Pharma_BI

@StephenJWillia2

@Aviva1950

@AdvancingPM

using the following meeting hashtags

#AdvancingPM #precisionmedicine

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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

@Pharma_BI

@StephenJWillia2

@Aviva1950

@AdvancingPM

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.

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.

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

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

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

Jason Crites

Moderator: Jason Crites, Assurance Health Data

Miriam Bredella, NYU Lagone Health

Robert Dumanois

Rob Dumanois, Thermo Fisher Scientific

Joe Lennerz

Joe Lennerz, BostonGene

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 GasuadJK 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

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

Marni Falk, CHOP

Stephen Ekker, University of Texas at Austin

Christine Nguyen, FDA

Frank Sasinowski, Hyman, Phelps & McNamara

Adam Resnick, CHOP

Hakon Hakonarson

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

Amanda Paulovich, Fred Hutchinson Cancer Center

Henry Rodriguez

Henry Rodriguez, NCI/NIH

Eric Schadt

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

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

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

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

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