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8:30AM–12:00PM, January 28, 2015 – LIVE – Morality, Ethics & Public Law in PM, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

Reporter: Aviva Lev-Ari, PhD, RN

 

Real Time Conference Coverage with Social Media

@Computer History Museum by Dr. Aviva Lev-Ari, PhD, RN

8:30AM – 9:00AM         David H. Persing, Cepheid

The Digital Miasma: Detection and Monitoring of Emerging Infections in the 21st Century

LIVE FROM THE PODIUM 

• It started with TB Test, now used in Infectious diseases based on Germ Theory
• Cholera Epidemic – The Ghost map – Cholera was named Miasma = dehydrations – source of Cholera in SOho near sewage septic tank, household situated near the pump had the first Miasma affected victims
• Digital Miasma – The machine that help end TB, 11/2011
• Sputum viscose specimen – in a sealed cup for DNA analysis: requirement to de-activate the life bacteria befor open cap for DNA analysis
• NEJM – Epert MYB/RIF – Rapid Molecular Detection of TB and Rifamin
• GeneXpert – diagnostics kit: Sputum, stool, blood, BAL, CSF, urine swabs
• GeneXpert System: module GX-1, GX-2, GX-4, GX-16, GeneXpert Infinity – data goes directly to Medical Record
• Impact of Rapid Testing: Demonstration Studies: Decentralized testing: more results reported same day
• Dedecntralized testing:- Fewer MDR TB
• Policy Impact – WHO endorse Expert system in 2010 –
• Today 7500 systems deploed at global locations
• South African Miner Testing for TB
• RemoteXpert cloud-based Dx monitoring
• Precision medicine and infectious disease dat placed into the Cloud – actionable Policy on Human Health
• Decentralized data architecture: HBDC Release
• 2011 17,000 patients 2014 1Million
• Data mining Capability by location, time, % scaling, Over time
• Device GeoLocation
• Impact of Testing and Technology
• TB Prevalence and drug resistence
• Site and staff monitoring tool
• “Google Flu” and “Flu near you”
• Xpert Edola – Sierra Leone
• Ebola testing, Challenges
• Xpert Ebola
• Sexual health Clinic in London: Patient Notificcation
• Next-gen technology max medical impact: closer to Patients

Personalized Medicine Patent Law Update

9:00AM –  9:30AM  – Catherine Polizzi, Morrison & Foerster (Chair)

• Thoughts on Strategy
• Summary: USPTO has loosened its guidelines for examination of subject matter eligibility
• only SUBSET OF MOLECULE not monopolizing the law of correlation
• 2014 Interim Eligibility Guidance Quick Reference Sheet
• Does the claim recite additional elements that amount to significantly more than the judicial exception: well understood routine
• Is natural product “markedly different” rom the naturally occuring products – structure, function, other properties
• Sequences of molecule
• December 2014 – Guidance post Alice, supersedes March 2014 Guidance
• March 2014 – Guidance post Myriad and Prometheus  – direction to Laws of Nature and products of nature
• 2010 – Interim guidance post Bilski – machine transformation is helpful…
• USPTO Struggle to keep up

1. Simple correlation better,
2. Companion Diagnostics: Identify then treat – will do well
3. Biomarkers are Methods will have hard time
4. US vs ex-US strategy
5. Trading eligibility for divided infringement

LIVE FROM THE PODIUM

Michael Shuster, Fenwick & West

• Patent office and in Court on behalf of companies to recover damages of patent infringement
• Patent eligibility Subject matter Recap: Who ever invents or discovers any new and useful process, machine, manufacture, composition of matter
• Exceptions:

1. abstract ideas
2. tie up usage of subject matter
3. Matter of Nature; Laws of Nature and products of nature

• Unprecedented level of Supreme Court Focus on Patent Eligibility Law
• LabCorp v. Metabolite (2006)
• Bilski v. Kappos (2010) (unanimous)
• Mayo v. Prometheus (2012) (unanimous)
• Assc for Mol. Pathology v. Myriad (2013)
• Alice Corp. v. CLS Bank (2014) (unanimous)

Jose J. Haresco, JMP Securities

• Myriad Stock Price profile as a result of Circuit Court decision

1.  If company plans to go Public
2. short interest — public bet on more competition and price drops
3. diversification a rapid pace of product introductions, and channel strength have become an important aspect of the story

• Foundation Medicine

1. Roche acquisition price increase
2. NEW business model for value creation – How many test are added to the DB
3. drive value from the data component
4. Planning the IPO

• BREATH AND RAPID PRODUCT LINE
• BULL CALLS
• BEAR CALLS
• Platform vs. Proprietary Diagnostics
• Short Interest vs Days to cover
• Competition: Proprietary Diagnostics will do better than Platform
• Public Diagnostics Compensations: Diversified, better valuations

Conclusions

• Myriad scaleable technology
• test volume and leverage data – bioinformatics
• pipeline of innovation
• Key drivers: Regulatory, scalability innovations,
• small caps product new issued – Investors like that
• greed to fear – Big growing markets – listen to opportunities
• price/performance
• Fear: No one wants to miss the opportunity to make money

9:30AM – 10AM Panel, Q&A

Jose: assumes FDA will come down  –  did not happened

Schuster:

• origin of disease , if better understood – business convergence

Polizzi:

• SW companies vs Life Sciences – Focus in IP will have a longer life time is an IT Component in Proprietory DIagnostics

 

 

Morality, Ethics & Public Law in PM

 

10:30AM – 10:45AM George Lundberg, CollabRx (chair)

Personal Morality, Societal Ethics, and Public Law in Personalized Medicine

LIVE FROM THE PODIUM 

• PERSONAL MORALITY
• SOCIETAL ETHICS
• PUBLIC LAW

AMA – CEJA – Principles

SPJ

HI Ethics

eHealth Code of Ethics – May 2000: Candor quality

• N of One = Me
• Shift from Paternalism: Dr. Know it alll Dr. Information Dr. Interpretation Collaboration
• Need for new codes of ethics: PM, telemedicine, Medical Mobile Apps, Social Media, Lab tests, Right to Try
• Self governance – Essence of Professionalism

10:45AM – 11:00AM Jodi Halpern, UC Berkeley

Innovative Ethical Approaches to Personalized Medicine

LIVE FROM THE PODIUM 

• Distributive Justice in Personalized Medicine
• Efficiency: Prevention, Care and Cure
• Increasing Health Disparities
• Health Innovators have societal responsibilities
• Oragon: Rationing of healthcare to MedicAID Patients – Negative implications to society
• Fair chance of dissent life
• Impartiality,
• Highest Priority is for Children, Chronomically ill — they have a less than — Fair chance of dissent life
• Condition if RARE, does not means not to offer fair share
• Promotion of Personalized medicine
• Empathy Expert

11:00AM – 11:15AM Patrick McCormick, AMA

Patients, Physicians & Personalized Medicine: Ethical Implications of New Clinical Possibilities

LIVE FROM THE PODIUM

• CEJA & Code of Ethics
• AMA: Health care informed by clinical, genetic and environmental
• new context:

1. Consent: Informed and Voluntary,
2. Confidentiality – Privacy
3. Access to care – minimize health care disparities – Genomics has benefits – all need to have access to
4. Stewardship: MD equilibrium – regulatory, stackholders
5. DTC Genetic Testing: Interaction outside the MD -Patient relations – Data is externally proceed
6. Patenting: Genetic research – better medical treatment and technologies
7. Granting patent protection should not hinder this goal

• Vaccination: an example: HPV adolescence vaccination, or of RNs and Allied Health Care Professionals
• Accountability, Medical Codes, Licensing,

11:15AM – 11:30AM Hank Greely, Stanford University

The Biggest Problem with Personalized Medicine

LIVE FROM THE PODIUM

• PM will lead to relief of human suffering

The Problem in PM

• More said than done, the bliss is minimal,
• disconnection between the hype and the results
• Genetically, Genomically, Omically
• Genomic Level: Payoff five years away in the last 20 years
• Pharmacogenomics for Anticaugulation –  No difference if Genomics is involved
• FoundationMedicine – we do not know the payoff
• Making difference in People life: Inersia,
• Payors need to be conveinced that it is for real
• Communication with Patients – through Videos
• Healthcare outcomes, better research is needed – not to compromise Privacy

 

Leveraging Cloud Technology to Optimize PM

 

11:30AM – 11:45AM Pravene Nath, Stanford Health Care

Cloud Technologies for the Delivery System: Opportunities and Challenges

LIVE FROM THE PODIUM

• Personalized experience of the Patient leads to satisfaction, loyalty, lifelong relations
• Customers: MDs, RNs, employees of the Hospital
• Internal Customer loyalty
• External Customers: PORTAL for the entire continuum: Patients, families,
• Online engagement with using the Portal: Favorable results – system integrators: Amazon Web Services, box, Epic, Abode, LIVEPERSON
• SW Design of the Portal: Mobile apps Integration of Patient life wiht Stanford HealthCare
• ClickWell Care – Complete Primary Care Online: Personalized care
• Test bed: +1Million Patients a year
• Partnering success
• Vision of the Future

 

11:45AM – 12:00PM Kathryn Lee Blair, Seven Bridge Genomics

The Cancer Pan-Genome in the Cloud

LIVE FROM THE FLOOR

• SW to improve the sequencing process
• cancer Genomics Cloud – @genomicscloud, sbgenomics.com/cancer-genomics-cloud
• # patients # Significant genes with tumor types – Frequency of genes: In Nature, Broad Institute
• Sequencers vs Data in TB: 2017: 6,000 Sequencers
• Graph Genomes – 97% of variance in DB
• Reference Sequence, Variant Sequence – divergence Kurai (Submitted)
• Current Model: TCGA – stored in one location, copy to your local and sequence in your private environment
• Three cancer genomics cloud pilots at Broad, System Biology Institute and at Seven Bridge Genomics
• TCGA: interoperability
• # of insertions total Known: Linear, Graph
• Cancer at the cellular level: Personal Reference – Tumor A, Primary, Tumor A and B
• SUnding MCI, Genomics Institute

 

 

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