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Archive for the ‘Biotechnology’ Category


Reporter and Curator: Dr. Sudipta Saha, Ph.D.

 

RNA plays various roles in determining how the information in our genes drives cell behavior. One of its roles is to carry information encoded by our genes from the cell nucleus to the rest of the cell where it can be acted on by other cell components. Rresearchers have now defined how RNA also participates in transmitting information outside cells, known as extracellular RNA or exRNA. This new role of RNA in cell-to-cell communication has led to new discoveries of potential disease biomarkers and therapeutic targets. Cells using RNA to talk to each other is a significant shift in the general thought process about RNA biology.

 

Researchers explored basic exRNA biology, including how exRNA molecules and their transport packages (or carriers) were made, how they were expelled by producer cells and taken up by target cells, and what the exRNA molecules did when they got to their destination. They encountered surprising complexity both in the types of carriers that transport exRNA molecules between cells and in the different types of exRNA molecules associated with the carriers. The researchers had to be exceptionally creative in developing molecular and data-centric tools to begin making sense of the complexity, and found that the type of carrier affected how exRNA messages were sent and received.

 

As couriers of information between cells, exRNA molecules and their carriers give researchers an opportunity to intercept exRNA messages to see if they are associated with disease. If scientists could change or engineer designer exRNA messages, it may be a new way to treat disease. The researchers identified potential exRNA biomarkers for nearly 30 diseases including cardiovascular disease, diseases of the brain and central nervous system, pregnancy complications, glaucoma, diabetes, autoimmune diseases and multiple types of cancer.

 

As for example some researchers found that exRNA in urine showed promise as a biomarker of muscular dystrophy where current studies rely on markers obtained through painful muscle biopsies. Some other researchers laid the groundwork for exRNA as therapeutics with preliminary studies demonstrating how researchers might load exRNA molecules into suitable carriers and target carriers to intended recipient cells, and determining whether engineered carriers could have adverse side effects. Scientists engineered carriers with designer RNA messages to target lab-grown breast cancer cells displaying a certain protein on their surface. In an animal model of breast cancer with the cell surface protein, the researchers showed a reduction in tumor growth after engineered carriers deposited their RNA cargo.

 

Other than the above research work the scientists also created a catalog of exRNA molecules found in human biofluids like plasma, saliva and urine. They analyzed over 50,000 samples from over 2000 donors, generating exRNA profiles for 13 biofluids. This included over 1000 exRNA profiles from healthy volunteers. The researchers found that exRNA profiles varied greatly among healthy individuals depending on characteristics like age and environmental factors like exercise. This means that exRNA profiles can give important and detailed information about health and disease, but careful comparisons need to be made with exRNA data generated from people with similar characteristics.

 

Next the researchers will develop tools to efficiently and reproducibly isolate, identify and analyze different carrier types and their exRNA cargos and allow analysis of one carrier and its cargo at a time. These tools will be shared with the research community to fill gaps in knowledge generated till now and to continue to move this field forward.

 

References:

 

https://www.nih.gov/news-events/news-releases/scientists-explore-new-roles-rna

 

https://www.cell.com/consortium/exRNA

 

https://www.sciencedaily.com/releases/2016/06/160606120230.htm

 

https://www.pasteur.fr/en/multiple-roles-rnas

 

https://www.nature.com/scitable/topicpage/rna-functions-352

 

https://www.umassmed.edu/rti/biology/role-of-rna-in-biology/

 

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LIVE 2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies, Friday, May 17, 2019 from 8:00 AM to 5:00 PM EDT

 

Wasserstein Hall, Milstein West (2019)

Petrie-Flom Center

23 Everett St., Rm. 327

Cambridge, MA 02138

https://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference

This year’s conference is organized in collaboration with Nita A. Farahany, Duke Law School, and Henry T. Greely, Stanford Law School.

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Editor-in-Chief, Open Access Online Scientific Journal, http://pharmaceuticalintelligence.com

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2019 Petrie-Flom Center Annual Conference: Consuming Genetics:

Ethical and Legal Considerations of New Technologies

AGENDA NOW AVAILABLE! 2019 Petrie-Flom Center Annual Conference image

 May 17, 2019 8:30 AM – 5:15 PM
 Conferences
 2018-2019
Harvard Law School, Wasserstein Hall, Milstein West (2019)
1585 Massachusetts Ave., Cambridge, MA

Register for this event

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2019 annual conference: “Consuming Genetics: The Ethical and Legal Considerations of Consumer Genetic Technologies.” This year’s conference is organized in collaboration with Nita A. Farahany, Duke Law School, and Henry T. Greely, Stanford Law School.

 

Description

Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing.

Already the global genetic testing and consumer/wellness genomics market was valued at $2.24 billion in 2015 and is expected to double by 2025 to nearly $5 billion. The rise of direct-to-consumer genetic testing and DIY kits raise questions about the appropriate setting for these activities, including a concern that delivering health-related results directly to consumers might cause individuals to draw the wrong medical conclusions. At the same time, advances in CRISPR and other related technologies raise anxieties about the implications of editing our own DNA, especially as access to these technologies explode in the coming years.

In an age where serial killers are caught because their relatives chose to submit DNA to a consumer genealogy database, is genetic privacy for individuals possible? Does the aggregation of data from genetic testing turn people into products by commercializing their data? How might this data reduce or exacerbate already significant health care disparities? How can we prepare for widespread access to genetic editing tools?

As these questions become more pressing, now is the time to re-consider what ethical and regulatory safeguards should be implemented and discuss the many questions raised by advancements in consumer genetics.

This event is free and open to the public, but space is limited and registration is required. Register now!

#DTCgenome

@PetrieFlom

@pharma_BI

@AVIVA1950

Agenda

8:30 – 9:00am, Registration

A continental breakfast will be available.

9:00 – 9:10am, Welcome Remarks

9:10 – 10:10am, Consumer Genetic Technologies: Rights, Liabilities, and Other Obligations

  • Gary Marchant, Regent’s Professor, Sandra Day O’Connor College of Law and Director, Center for Law, Science, and Innovation, Arizona State University (with Mark Barnes, Ellen W. Clayton, and Susan M. Wolf) – Liability Implications of Direct-to-Consumer Genetic Testing
  1. Insurance may not cover BRCA genetic testing even for Patients with diagnosis of Breast cancer
  • Anya Prince, Associate Professor of Law, University of Iowa College of Law and Member of the University of Iowa Genetics Cluster – Consuming Genetics as an Insurance Consumer
  1. Life insurance company initiated genetic testing: (a) Gatekeeping policy underwriting new comer applicants (b) Wellness Employer wellness programs incentivize healthy behavior Incorporate genetic testing into wellness Programs Test for preventing genetic conditions Like BRCA, Lynch syndrome, preventable – win/win proposition –>>> Healthier employees. Studies show shift of cost from employer to employee and employer have access to genetic information of employees.
  • Life Insurance – JH Vitality program, get Apple watch if meet goals, premium is lower – incentive
  • DTC companies beginning to market to Insurance
  • Employment Legal Landscape:
  1. legal regulations
  • Jessica RobertsProfessor, Alumnae College Professor in Law, and Director of the Health Law & Policy Institute, University of Houston Law Center – In Favor of Genetic Conversion: An Argument for Genetic Property Rights
  1. Ownership right to Genetic Property rights of the Information, consented to transfer or abandonment
  2. Conversion – Informed consent
  3. Family not in treatment relationship with the Researcher – Court rejected the claim family donated to research unfair benefir of the Hospital from the data and tissue donated
  4. Claim of conversion – Common Law
  5. Gene by Gene Family Tree DNA
  6. Courts shows a newfound openness to claims for genetic conversion
  7. claims for genetic conversion will not stifle reaserch or create moral harms
  8. consumers genetics, claims for genetic conversion are actually necessary to adequately protect people’s interests in their DNA
  • Moderator: I. Glenn CohenFaculty Director and James A. Attwood and Leslie Williams Professor of Law

10:10 – 10:20am, Break

10:20 – 11:40am, Privacy in the Age of Consumer Genetics

  • Jorge Contreras, Professor, College Of Law and Adjunct Professor, Human Genetics, University of Utah – Direct to Consumer Genetics and Data Ownership
  • Seema MohapatraAssociate Professor of Law, Indiana University Robert H. McKinney School of Law – Abolishing the Myth of “Anonymous” Gamete Donation in the Age of Direct-to-Consumer Genetic Testing
  • Kayte Spector-Bagdady, Assistant Professor, Department of Obstetrics and Gynecology and Chief, Research Ethics Service, Center for Bioethics and Social Sciences in Medicine (CBSSM), University of Michigan Medical School – Improving Commercial Health Data Sharing Policy: Transparency, Accountability, and Ethics for Academic Use of Private Health Data Resources
  • Liza VertinskyAssociate Professor of Law, Emory University School of Law and Emory Global Health Institute Faculty Fellow (with Yaniv Heled) – Genetic Privacy and Public Figures
  • Moderator: Nita FarahanyProfessor of Law and Professor of Philosophy, Duke Law School

11:40am – 12:40pm, Tinkering with Ourselves: The Law and Ethics of DIY Genomics

  • Barbara J. EvansMary Ann & Lawrence E. Faust Professor of Law and Director, Center on Biotechnology & Law, University of Houston Law Center; Professor, Electrical and Computer Engineering, Cullen College of Engineering, University of Houston – Programming Our Genomes, Programming Ourselves: The Moral and Regulatory Limits of Self-Harm When Consumers Wield Genomic Technologies
  • Maxwell J. MehlmanDistinguished University Professor, Arthur E. Petersilge Professor of Law, and Director of the Law-Medicine Center, Case Western Reserve University School of Law, and Professor of Biomedical Ethics, Case Western Reserve University School of Medicine (with Ronald A. Conlon) – Governing Non-Traditional Biology
  • Patricia J. ZettlerAssociate Professor, Center for Law Health and Society, Georgia State University College of Law (with Christi Guerrini and Jacob S. Sherkow) – Finding a Regulatory Balance for Genetic Biohacking
  • Moderator: Henry T. Greely, Director, Center for Law and the Biosciences; Professor (by courtesy) of Genetics, Stanford School of Medicine; Chair, Steering Committee of the Center for Biomedical Ethics; and Director, Stanford Program in Neuroscience and Society, Stanford University

12:40 – 1:20pm, Lunch

Lunch will be provided.

1:20 – 2:20pm, Regulating Consumer Genetic Technologies

  • James Hazelpostdoctoral fellow, Center for Genetic Privacy and Identity in Community Settings (GetPreCiSe), Vanderbilt University Medical Center – Privacy Best Practices for Consumer Genetic Testing Services: Are Industry Efforts at Self-Regulation Sufficient?
  • Scott SchweikartSenior Research Associate, Council on Ethical and Judicial Affairs, American Medical Association and Legal Editor, AMA Journal of Ethics – Human Gene Editing: An Ethical Analysis and Arguments for Regulatory Guidance at Both the National and Global Levels
  • Catherine M. SharkeyCrystal Eastman Professor of Law, NYU School of Law (with Kenneth Offit) – Regulatory Aspects of Direct-to-Consumer Genetic Testing: The Emerging Role of the FDA
  1. Genetic predisposition – BRCA I & II – approved Testing
  2. Pharmaco-genetic Test authorization – incorrect interpretation, incorrect action based on results
  3. Regulatory model, pathway
  4. False positive and False negative BRCA I & II
  5. 23&Me – huge DB, big data who controls the data
  6. Across regulatory – liability issues on who own big data
  • Moderator: Rina Spence, President of SpenceCare International LLC

2:20 – 2:30pm, Break

2:30 – 3:50pm, Consumer Genetics and Identity

  • Kif Augustine-AdamsIvan Meitus Chair and Professor of Law, BYU Law School – Generational Failures of Law and Ethics: Rape, Mormon Orthodoxy, and the Revelatory Power of Ancestry DNA
  1. Complex Sorrows: Anscestry DNA – 20 Millions records. Complete anonymity and privacy collapsed
  • Jonathan KahnJames E. Kelley Chair in Tort Law and Professor of Law, Mitchell-Hamline School of Law – Precision Medicine and the Resurgence of Race in Genomic Medicine
  1. precision medicine – classification of individuals into subpopulations that differ in their susceptability to a particular disease
  2. Blurring DIversity and Genetic Variation, Empirical and Normative Inclusion
  3. NHGRI – underrepresented of diversity in the community of genomics research professional is a socioeconomics issue not a genetics one – underrepresentation in DBs
  4. What does Diversity mean?
  5. Underrepresentation not race: Scientific workforce, recruitment sites recruitment cohort, Ancestry, Genetic variation, responsibilities for disparities
  6. Genetic Diversity rare alleles ->> actionable alleles
  • Emily LargentAssistant Professor, Department of Medical Ethics and Health Policy and Senior Fellow, Leonard Davis Institute of Health Economics, University of Pennsylvania – Losing Our Minds? Direct-to-Consumer Genetic Testing and Alzheimer’s Disease
  1. Protect people and knowledge about one’s disease
  2. AD & APo-E Gene, e-2, e-3, e-4 – Carriers increase risk to AD too 40%
  • Natalie RamAssistant Professor of Law, University of Baltimore School of Law – Genetic Genealogy and the Problem of Familial Forensic Identification
  1. Opt in to share genetic data on the platforms opt in national DB
  2. Genetic relatedness is stickier than social relations
  3. Voluntary sharing of genetic information – no other party can protect genetic information of any person, thu, if shared voluntarily
  4. Geneology is involuntarily disclosure of genetic information
  5. Familial Forensic Identification – Privacy for information held by Telephone companies
  6. Involuntarily Identification by genomic and genetic data genetic markers
  • Moderator: Carmel Shachar, Executive Director, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics and Lecturer at Law, Harvard Law School
  1. Genetic relatedness

3:50 – 4:00pm, Break

4:00 – 5:00pm, The Impact of Genetic Information

  • Leila Jamal, Genetic Counselor, Division of Intramural Research and Co-Investigator, Centralized Sequencing Initiative, National Institute of Allergy and Infectious Diseases and Affiliated Scholar, Department of Bioethics, National Institutes of Health (with Benjamin Berkman and Will Schupmann) – An Ethical Framework for Genetic Counseling Practice in the Genomic Era
  1. Genetic Counseling – to benefit the patient, positive autonomy, benefiecence – how potentially impactful is the Test Information
  2. Nondirectiveness – Why?
  3. distance from eugenics + abortion politics
  4. persons ans patient autonomy – non-interference
  5. Genetic and Genomics Testing: Prenata, Pediatric, Vancer, other: Cardiology, Neurology, Hematology, Infectious diseases, pharmaco genomics, DTC, Ancestry
  6. Pre- Test Genetic Counseling – information and testing need, indication for testing
  7. Post-Test
  8. Informational Burden low vs high: Likely pathogenic, Pathogenic vs benign – natural history data
  9. potentially high impact – Testing that can reveal an action to be taken
  10. Relation with Patient close vs distant – recommendation based on best evidence +guidelines available
  11. Institutional role of Counselor
  • Emily Qian, Genetic Counselor, Veritas Genetics (with Magalie Leduc, Rebecca Hodges, Bryan Cosca, Ryan Durigan, Laurie McCright, Doug Flood, and Birgit Funke) – Physician-Mediated Elective Whole Genome Sequencing Tests: Impacts on Informed Consent
  1. DTC
  2. Physician-initiated Genetic Testing
  3. Physician-initiated DTC
  4. Informed consent is a process: Topics covered – possible results & consequences
  5. Health Care Provider (HCP) Demographics: Neurology
  6. Analysis: Family Name
  7. Informed consent – who is responsible
  8. Consumers
  • Vardit Ravitsky,@VarditRavitsky  Associate Professor, Bioethics Programs, Department of Social and Preventive Medicine, School of Public Health, University of Montreal; Director, Ethics and Health Branch, Center for Research on Ethics – Non-Invasive Prenatal Whole Genome Sequencing: Ethical and Regulatory Implications for Post-Birth Access to Information
  • Moderator: Melissa UvegesPostdoctoral Fellow, Harvard Medical School Center for Bioethics
  1. Clear conceptual approach
  2. Prioritize privacy/open future banning NIPW vs right to know unrestricted NIPW, prioritizing parental autonomy ->> allowing restrictions to be built in

5:00 – 5:15pm, Closing Remarks

 

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Center for Bioethics at Harvard Medical School and the Oswald DeN. Cammann Fund at Harvard University.

SOURCE

http://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference

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