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Archive for the ‘Conference Coverage with Social Media’ Category


Tweets and Re-Tweets by @Pharma_BI ‏and @AVIVA1950 at 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 @Harvard_Law

 

Tweets by @Pharma_BI ‏and @AVIVA1950

  1.   Retweeted

    AMAZING conference on Genomics and Ethics

  2. Amazing Conference LIVE 2019 Petrie-Flom Center Annual Conference: : and Considerations of New Technologies, Friday, May 17, 2019 from 8:00 AM to 5:00 PM EDT via

  3. Concluding remark cited by ⁦⁩ ⁦ Great Panel on the Impact of Genetic Information new conceptual approach prioritizing parental autonomy with restriction built in

  4. ⁩ ⁦ NIPT test for fetal sex blood type Trisonomy Whole Genome-wide analysis routinization of procedure READY at Birth impact intrafamilial discrimination babySeqProject G2P ⁦

  5. Leila Jamal, NIAID Pre- Test Genetic Counseling – information and testing need, indication for testing Post-Test Informational Burden low vs high: Likely pathogenic, Pathogenic benign – natural history data potentially high impact

  6. Leila Jamal, NIAID benefit the patient, positive autonomy, benefiesence – how potentially impactful is the Test Information Nondirectiveness – Why? distance from eugenics + abortion politics persons and patient autonomy

  7. Leila Jamal, NIAID Genetic and Genomics Testing: Prenata, Pediatric, Vancer, other: Cardiology, Neurology, Hematology, Infectious diseases, pharmaco genomics, DTC, Ancestry

  8. Emily Qian, Genetic Counselor, Veritas Genetics – Physician-Mediated Elective Whole Genome Sequencing Tests: Impacts on Informed Consent DTC Physician-initiated Genetic Testing Physician-initiated DTC Informed consent is a process

  9. ⁩ ⁦ Recommendation based on best evidence guidelines available

  10. Natalie RamGenetic Genealogy and the Problem of Familial Forensic Identification Familial Forensic Identification – Privacy for information held by Telephone companies Involuntarily Identification by genetic data genetic markers

  11. Natalie Ram, Assistant Professor of Law, University of Baltimore School of Law – Genetic Genealogy and the Problem of Familial Forensic Identification Opt in to share genetic data on the platforms opt in national DB

  12. Natalie Ram, Univ of Baltimore School of Law Genetic relatedness is stickier than social relations Voluntary sharing of genetic information – no other party can protect genetic information of any person, thu, if shared voluntarily

  13. ⁩ ⁦ gene APO-E e-2, e-3, e-4 If e-4 variant risk AD is 40% 23andMe since 2011 rest for e-4 unlock result # copies of e-4 are present little clinical value post diagnosis recommendation do not depend on e-4

  14. Jonathan Kahn, Precision Medicine and the Resurgence of Race in Genomic Medicineprecision medicine – classification of individuals into subpopulations that differ in their susceptability to a particular disease

  15. Kif Augustine-Adams, BYU Law School – Generational Failures of Law and Ethics: Rape, Mormon Orthodoxy, the Revelatory Power of Ancestry DNAComplex Sorrows: Anscestry DNA – 20 Millions records. Complete anonymity and privacy collapsed

  16. Regulating Consumer Genetic Technologies Conclusions: DTC policies are over the place, FDA poised to regulate Big Data, Human Genomics Somatic vs Germline are key distinctions NY Dept Health 3rd Party Certification in Genomics

  17. Scott Schweikart, 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 National and Global Levels

  18. Catherine M. Sharkey, The Emerging Role of the FDA Genetic predisposition – BRCA I & II approved Testing Pharmaco-genetic Test authorization incorrect interpretation, incorrect action based on results False positive and False negative

  19. Scott Schweikart, AMA Ethical concernsTechnologiesCRISPR-Cas-9 Somatic vs GermlineAMA: Individual liberty (1) Autonomy & Gene Editing (2) Non-maleficence and Beneficence (3) Social Justice Treatment vs Enhancement National Regulations

  20. Patricia J. Zettler, Regulators can do: Promote self regulations vs restrict community labs Drugs: premarket approval by FDA 11/2017: any use of CRISPR is subjected to regulation Bio hacking materials are distributed outside channels

  21. Patricia J. Zettler, FDA agency – regulation can’t reach everything, Not seen wide range abuse, FDA encourage learning and information dissemination and Educate

  22. Maxwell J. Mehlman, Governing Non-Traditional Biology On-Line gene editing equipment CRISPR-Cas9 – IGEM – international Competition in community of Scientists Biological weapons – issues of Prior Art impeding patentability may come up

  23. Maxwell J. Mehlman Harm to subjects Biosafety Safety Phase I Gene drives in Human?? – Human gene editing: “Nanoparticle and liposomal delivery” and “Allelic drive using CRISPR”

  24. ⁩ ⁦ regulatory options: liabilities, legal requirements industry restrictions on access to material community labs, NTB IRBs self-governing bodies FBI surveillance

  25. Barbara J. Evans Is it FDA duty on Cosmetic enhancement Genome is Software, US is not good in regulating software The Harm Principle, Legal Paternalism benevolent vs non-benevolent Legal Moralism – no body is harmed but it’s just wrong

  26. Barbara J. Evans Multiple Agencies: In the 80’s on Future Products of Biotechnology: EPA, FDA, USDA, OSHA, CPSC, NIH, NEPA, ESA, APA Skepticism that compulsory regulation for compliance with norms

  27. Barbara J. Evans Regulatory Challenges Citizen Science and DIY Bio democratization of science and medicine narrative, new frontiers for institutional science narrative nostalgia narrative, political narrative: “hacker” portrayals

  28. in Preparing for Future Products of Biotechnology, NAS

  29. Seema Mohapatra, AAbolishing the Myth of “Anonymous” Gamete Donation in the Age of Direct-to-Consumer Genetic TestingAnonymous sperm donation Sell sperm $30 – $130 per sample – industry is thriving due to donor anonymity last 3 years,

  30. Seema Mohapatra, 2.6 million Ancestry DNA only to keep donor Anonymity Donor-Conceived Individuals at age 18 can identified the DonorLegal landscape ART – no federal laws regarding UT and WA [medical disclosure about the donor

  31. Nita Farahany, Professor Law, Philosophy Duke Law School need new Framework if anonymity is dead, most uses are diverted for medicinePrivacy is improving, ACA – protects from preexisting conditionsIndividual costs vs societal benefits

  32. Liza Vertinsky Courts: Pushing the boundaries: (1) Privacy (2) publicity rights (3) property (commodificationPresidential Figures: Infidelity gene, gambling geneLegal pathways Junk DNA Law enforcement databasesAlternative legal framing

  33. Kayte Spector-Bagdady, Data coming into Academia – Genetic data partnerships Academia (41% NIH funding) and Industry: Use of existing private data, company performs analysisPatients: using data and specimens in ways they do not wish

  34. Kayte Spector-Bagdady, to secondary research: stay anonymousPublic health covers Informed consent forms – conceptualize for secondary research protocols Transparency In BioBank Research 67% commercialization of biospecimens agree

  35. Property and Health Data: Excludability, Alienability and Divisibility, Valuation and compensation, Unstewarded and Orphan data, duration, tracking Propertization of medical information effect on biomedical research

  36. Genetic “Property” Statues: @CO – genetic information pertain to the individual health data – common law Personal Property vs Information as Property object

  37. direct consumer protection may get that by Claim of conversion – Common Law Genetic Testing companies are protected by three legal laws consumers as employees face genetic information been accessed by employers via Wellness Programs

  38. Courts shows a newfound openness to claims for genetic conversion claims will not stifle reaserch or create moral harms consumers genetics, claims for genetic conversion necessary to adequately protect people’s interests in their DNA

  39. ⁩ ⁦ three new regulations of ownership of genetic test information ownership even Dx of breast cancer Insurance may not cover BRCA testing

  40. ⁩ ⁦ employment law and genetic testing property ownership

  41. 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 donatedClaim of conversion – Common LawGene by Gene Family Tree DNA

  42. Insurance may or may not cover BRCA testing Law suit on that matter is pending

  43. 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 Testing

  44. 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 i

 

 

RE-TWEETS

 

  1.   Retweeted

    Max Mehlman thinks “DIYBio” is problematic b/c often team efforts; “biohacking” has negative connotations. Suggests “non-traditional biology.”

  2.   Retweeted

    In reviewing how reviewed various tests, Catherine Sharkey discusses how some were reviewed through De Novo and others through 510(k) pathway and benefits and drawbacks of each.

  3.   Retweeted

    . invokes THE CONE OF SILENCE. NO MORE DATA FROM THIS TALK! Medical/scientific publishing norms are weird.

  4.   Retweeted

    A very full house today (480 people registered!) for the Consuming Genetics conference . opening a day that promises to be fascinating. Kudos also for selecting hot topics and amazing speakers.

  5.   Retweeted

    Talking about her ⁦team’s ⁩ paper ⁦⁩ shows most patients want notification of commercial use of biospecimens, most are uncomfortable about profit from biospecimens, but feel better if reinvested in research.

  6.   Retweeted

    You don’t have to identify as a biohacker to understand their goals, interests, and culture.

  7.   Retweeted

    Blog post about about my upcoming presentation at Petrie-Flom Center’s upcoming Consumer Genetics conference this Friday, May 17.

  8.   Retweeted

    Incredibly difficult topic.

  9.   Retweeted

    I asked Maxwell Mehlman how he envisioned biohackers could form an IRB-style review process. One suggestion was to engage with insitutional IRBs. Raise your hand if you think an establishment IRB would approve enhancement experiments? (I don’t…)

  10.   Retweeted

    Gene editing has become cheaper, easier to do in community labs. Max Mehlman ⁦⁩ compares it to where Steve Jobs and Bill Gates began with the personal computer. But US gov has listed as a “weapon of mass destruction”

  11.   Retweeted

    Thanks to for hosting another great conference!

  12.   Retweeted

    “Diversity” means a LOT of different things–it’s very easy to slip back and forth (problematically) between molecular/genetic diversity and social constructs of race. Just using “diversity” elides and blurs important concepts. – Jonathan Kahn @

  13.   Retweeted

    Audience member during Q&A calls the first group of talks “very very interesting — and terrifying.” That’s what we’re here for, folks. These issues are real and we’re happy you’re here to talk about them with us.

  14.   Retweeted

    Just FYI my research showed you cannot waive statutory nondiscrim rights (under GINA or others) but can waive right to judicial forum to decide if there has been a violation (2009 Pyett v 14 Penn Plaza decision-ie case after GINA-overturned 30 years of precedence)

  15.   Retweeted

    FYI in Perlmutter & Peerenboom, the claim was not ownership in the DNA material. It was in the genetic information contained within it

  16.   Retweeted

    “If I want to edit my genes and make my skin glow green, whose business is that?” Barbara Evans on paternalism issues in our views of regulating DIYbio

  17.   Retweeted

    Takeaways from Regulating : Hazel: existing DTC genetic privacy policies are all over the place Sharkey: in an era of big data, FDA is poised to pose enhanced role as health information regulator Schweikart: in gene editing, somatic ≠ germline editing

  18.   Retweeted

    I have been waiting so long for this and is finally here!

  19.   Retweeted

    Many of the regulatory issues/possibilities raised by DIYbio will presented by (co-authors and ) “What can we do with what we’ve already got?”

  20.   Retweeted

    Moderators summary: In today’s panel we heard: -Property law won’t work -Anonymity is dead -Data is being commercialized and we don’t realize it -May be need for publicity rights for DNA. But there is hope. Good things are being done with this data.

  21.   Retweeted

    Is ⁦⁩ right, asks Vertinsky ⁦⁩,to be worried about “genetic ” publishing of information derived from your genetic information (especially discarded DNA). Or a presidential candidate ? What role for law?

  22.   Retweeted

    Interesting points by : Because many biohacking materials exchanges may not take place in traditional commercial contexts, attempting to regulate the trade of materials could prove difficult for FDA.

  23.   Retweeted

    We have not seen much FDA involvement in “genetic biohacking” says , but that might be a shame.Don’t need “harsh involvement” but “engagement” such as education — e.g., how long you can leave potato salad out at picnic, does not mean enforcement

  24.   Retweeted

    On genetic ownership and federalism. ⁦⁩ discusses the 5 states that have protected genetic property and skeptical about how well thought out the common law property approach has been. ⁩ ⁦

  25.   Retweeted

    “When you’re doing something that’s really high risk and cutting edge, maybe you SHOULD experiment on yourself–maybe that’s the most ethical way.” Barbara Evans talks up self-experimentation (reffing previous Nobels) @

  26.   Retweeted

    I feel simultanously very overwhelmed and very excited

  27.   Retweeted

    “Whatever the boundaries of FDA’s authority are [re: biohacking]…there are important questions about how it should use that authority.” @

  28.   Retweeted

    One person uploading info to a genetic database illuminates hundreds or thousands of other people–those people’s info isn’t “voluntarily” in datasets. Genetic databases familial searches aren’t voluntary. Natalie Ram @

  29.   Retweeted

    DIY gene therapy, CRISPR, etc. – failures likely to cause more harm (inadvertent) than successes. Speaker at analogizes to regulation of drones, beer, computer hacking many stakeholders with competing interests.

  30.   Retweeted

    Excellent talk by showing that in the face of clinicians can be legally damned if they do use revealed info and also damned if they don’t–potentially liable for patient’s misguided medical decisions

  31.   Retweeted

    “We need to rethink our Informed Consent methods for our secondary research protocols” – given all the confusion arising among Patients, their Doctors and the Researchers working with the data specimens about the use of the data, says – at Wasserstein Hall

  32.   Retweeted

    How do we deal with Publicity Rights in DNA? Thought-provoking talk by Professor Vertinsky of The “Genetic Paparazzi” conundrum – at Wasserstein Hall

  33.   Retweeted

    argues against recognizing Property Rights in personal health data: “A vast amount of ‘orphan Biomedical data’ is useless” – doesn’t help advance research in the field Other protections already available and more suitable

  34.   Retweeted

    Leading up to Friday’s Conference on Consuming Genetics () here’s a post about my topic: why law isn’t a good fit for health data.

  35.   Retweeted

    Professor Kif Augustine-Adams of says that individual privacy settings on Consumer Genetics testing have limited power; total anonymity is a myth. It is only a matter of time before the relational nature of DNA makes all connections identifiable. – at Wasserstein Hall

  36.   Retweeted

    “Wellness Programs” by Employers or Insurance underwriters – how should they deal with collecting genetic data? suggests Employers / Insurers only act as mediators between members and DTC genetic testing companies, and only get aggregate, anonymized data – at Harvard Law School

  37.   Retweeted

    Natalie Ram: there’s an idea of voluntariness re: searching & genetic information. THAT’S FICTION. Genetic relatedness is different–it’s sticky! “I could decline my aunt’s FaceBook request…but [she] can still serve as reliable-as-ever genetic informant on me.”

  38.   Retweeted

    A lot of thought-provoking posts this month from leading scholars in law, ethics, genetics. Get immersed in the issues before Friday’s conference!

  39.   Retweeted

    When employer “wellness programs” incentivize employees to use , consider what goes to , what to or , & what does employee have about any of this.

  40.   Retweeted

    Looking forward to joining this awesome line-up of speakers at ‘s conference & talking about ‘s, ‘s & my work. Thx to , & for organizing!

  41.   Retweeted

    It’s not every day that a serious conference on discusses Brad Pitt in a bath leaving behind sperm that later impregnates a woman and the legal challenges that emerge. Well done – you managed to get everyone’s attention 🙂

  42.   Retweeted

    Anguishing story told with elegance and grace. We are all utterly unprepared for generations of secrets unearthed by 26 million ++ kits sold to date.

  43.   Retweeted

    “Civilized societies are nearby, believe it or not!” explains how when is implemented in Canada, it means the government pays for it. (We are all v jealous about your developed country to the north, Vardit)

  44.   Retweeted

    Jonathan Kahn ⁦⁩ ⁦⁩ discusses the fall and rise of race in genetic medicine, its science and politics.

  45.   Retweeted

    Yes! And we should continue to strive to have racial and ethnic representation to ensure that genomic research and policy doesn’t continue to exacerbate racial disparities

  46.   Retweeted

    Fascinating discussions today at the conference

  47.   Retweeted

    Potential consequences are greater when editing germline compared with somatic cells, because its modification can allow for the generational transmission of altered genes. laying out priciplist bioethical concerns of

  48.   Retweeted

    Health information should not be treated as property to protect individuals, says . Instead, we should continue to enhance existing regulatory and liability rules to safeguard individual privacy and data security.

  49.   Retweeted

    There has been a relunctance by courts to recognize information as property, but that could change drastically when it comes to genetic data.

  50.   Retweeted

    Sir Wm. Blackstone is always a hit on the big screen — from my talk today on why health data isn’t property .

  51.   Retweeted

    FDA involvement with DTC tests hasn’t shut them down. Five have been approved, and FDA has been flexible in its approval pathway (4 de novo, 1 510(k)). – Catherine Sharkey @

  52.   Retweeted

    Emily Qian of is a genetic counselor and is co-author on one of the blog posts in our symposium:

  53.   Retweeted

    At the Ethics Conference on Consuming Genomics. There was a question about why patients decline participating in precision medicine research. Check out our paper on why patients decline genomic sequencing

  54.   Retweeted

    Great turnout at DTC genomics conference today. Tour de force discussion of the issues facing the personal genomics industry and consumers today.

  55.   Retweeted

    “Informed consent is a process” that should include: test’s purpose, possible results of the test, test’s limitations/consequences, confidentiality/privacy, risks of testing and familial implications, and voluntary participation.

  56.   Retweeted

    The amazing ⁦⁩ closes out the conference by discussing the ethics of non-invasive prenatal testing (NIPT), it’s ethical challenges, and how whole genome NIPT may make “the fetus transparent.”

  57.   Retweeted

    .: what about DNA vigilantes who upload information to databases explicitly to help law enforcement? Natalie Ram: BAM I ALREADY WROTE THAT ARTICLE CHECK IT OUT. (forthcoming , mayyyybe here? )

  58.   Retweeted

    23andMe does a pretty good job situating and contextualizing results, but APOE testing may have little benefit

  59.   Retweeted

    Is ⁦⁩ ‘s test for APOE associated with Alzheimer’s different ethically speaking from its other tests? ⁦⁩ ⁦⁩ discuss ⁦

  60.   Retweeted

    Ultrasound technology made the uterus transparent, so parents could see their child before it was born. In the future, could make the fetus itself transparent, so parents can see the whole genome. Many associated ethical challenges, both pre- and post-birth

  61.   Retweeted

    Great talk by one of the authors at on the need for laws and regulations to protect the privacy rights of genetic testing consumers and assuage concerns about information

  62.   Retweeted

    Johnathan on The Fall and Rise of Race in Genomics: – not a thing (2000) – a stepping stone to true targeting (2005) – useful to classify subpopulations (2011) – under-representation of ethnically diverse subpopulations are necessary for good data (2019)

  63.   Retweeted

    When tests allow the breach of anonymity and privacy of relatives who don’t want to be known–including in cases of rape–what should we do? Answers aren’t easy. -Kif Augustine-Adams

  64.   Retweeted

    Listening to the brilliant discuss the concept of non-directiveness in genetic counseling.

  65.   Retweeted

    Grateful for the opportunity to participate in the Annual Conference – thanks Carmel Sachar & Cristine Hutchison-Jones for a great line-up & planning- learned a lot & left with many more ?s to consider

  66.   Retweeted

    & : “The more jurisdictions that adopt a cautionary approach to their own regulations for genome editing (particularly heritable genome editing) the more likely negative world-wide consequences can be mitigated.”

  67.   Retweeted

    There’s no prospect of potentially suing because of the disclaimers and forced arbitration put into agreements by the company ⁦

  68.   Retweeted

    explains the ways employer wellness programs is only a “theoretical win-win.” Minimal results come at the cost at privacy, and all of which can also show up in insurace realms as well. (Ex: Life insurers also implementing wellness policies)

  69.   Retweeted

    Although increasing access to predictive/actionable genetic tests could theoretically be beneficial, we should be cautious about using third-parties, like life insurers, to disseminate these tests to their consumers without greater regulatory protections.

  70.   Retweeted

    . has examined for years whether we should own our genetic info. Three reactions: Lay: yeah, duh Lawyers: no, duh (see Moore v Regents of U of Cal) Clinicians/researchers: Good God No! Disaster! (Not live-tweeting b/c draft here: )

  71.   Retweeted

    Property Conversion in Genetic Property Rights – who owns the rights? “Researchers need to be transparent and use adequate informed consent” – claims for generic conversion should not stifle research or create moral harms, suggests – at Wasserstein Hall

  72.   Retweeted

    We’re so proud of our friend and Academic Fellowship alum ! ✨🕺🏻

  73.   Retweeted

    Why is most insurance typically a state issue? FYI – Congress essentially “blessed” and preserved a state regulatory system of the insurance industry with passage of the McCarran-Ferguson Act of 1945. It makes it politically difficult to push this at federal level

  74.   Retweeted

    DTC genetic testing customers lack legal protections. Genetic conversations might offer them some rights… ?

  75.   Retweeted

    . takeaway: Wellness programs aren’t necessarily bad, but question is what data goes to consumers, what data to employers and insurers, and what can they do with it?

  76.   Retweeted

    . takeaway: w/r/t liability, companies are essentially immune because of disclaimers & arbitration clauses; doctors may be on the hook.

  77.   Retweeted

    Q by : What do we tell GCs/trainees when we get a DTC result that needs to be confirmed but insurance won’t pay for confirmation? Answer: not very clear, but might be liable if we do nothing. Yikes!

  78.   Retweeted

    Major disconnect with the ideas of ways to convert health data into what we have traditionally considered property-like rights.

  79.   Retweeted

    Great point from about how to treat “control group” genetic data, from those without the indicative genetic information, in arguments for genetic ownership/remuneration arguments.

  80.   Retweeted

    The story of a mom who contacts her (donor conceived) five-year-old’s grandmother — then gets threatened by a sperm bank

  81.   Retweeted

    The ethical debate about anonymity is MOOT. There is no anonymity for sperm donors, nor are there any federal laws regarding anonymity of sperm donors. (Some states address medical information/disclosure but not anonymity)

  82.   Retweeted

    Three observations: 1. Biomedical data/samples are governed by method of procurement 2. Contributors care about use 3. Specimens/data procured differently end up being used similarly (lots of mixing between academia & industry). ==>TENSION. – @

  83.   Retweeted

    Rights to privacy or publicity – What will the courts decide? Well, it’s unclear because there are gaps in the existing laws. Liza Vertinsky also looking at the underlying implications of the choices of legal pathways

  84.   Retweeted

    . is an active moderator! Asking excellent questions (including mine–how do we react to patients not ‘getting’ consent info?, and then ‘s on right not to be a genetic parent! Need to think on your feet w/ Nita around!)

  85.   Retweeted

  86.   Retweeted

    Wondering how panelists and fellow attendees feel about this lack of anonymity? and individuals conceived from egg or who want to know about their background never consented to anonymity of donors

  87.   Retweeted

    Yeah that looks simple! Barbara Evans on what the regulatory pathway issupposed to look like and what makes it challenging in the world of genetics using charts from 2017 reports. And an ode to the “pink golden retriever” we all want

  88.   Retweeted

    You’re welcome!

  89.   Retweeted

    Barbara Evans: Peer-review is no longer the threshold for good science it once was – grant review is. But if research is not funded…those protections aren’t there

  90.   Retweeted

    How well are companies doing in complying with the privacy principles they themselves signed on to? James Hazel talks about the work he and Chris Slobogin ⁦⁩ ⁦⁩ have done. ⁦

  91.   Retweeted

    Excellent talk by Barbara Evans expressing skepticism about a top down regulatory approach on biohacking (“If I want to turn my skin bright green who’s the FDA to tell me I can’t?), citing Lisa Ikemoto’s excellent DIY Bio Hacking article

  92.   Retweeted

    Terrific representation of women at ! Speakers: 14F, 6M Moderators: 4F, 2M Nicely done, folks.

  93.   Retweeted

    Panel takeaways: * DTC privacy policies are all over the place, and Best practices are a good way forward. * FDA is poised to take an advanced role as a regulator in the field. * We must differentiate between germline and somatic editing for regulation

  94.   Retweeted

    Catherine Sharkey asks us to consider the FDA may play in managing the conceptual risk and regulatory model for DTC genetic testing especially given the complexities that AI, machine learning, and big data add to this industry

  95.   Retweeted

    You can hear a pin drop in the auditorium as Kif Augustine tells a very personal tale about how reveals a story of rape and a lost half sister. Secrets, lies, ancestry, DNA, and Mormon Orthodoxy in 1959 Utah.

  96.   Retweeted

    And what does diversity mean? What does it do? Among other things, drives $$$$ funding in the research cycle.

  97.   Retweeted

    Health equity is due to structural and systemic racism in the field present from its beginnings. Seeking more diversity in the workforce will not solve this “health equity” issue. As Jonathan Khan notes, these d&i initiatives can be used to elide responsibility

  98.   Retweeted

    Natalie Ram at talks about familial investigations for law enforcement. For a short, recent piece w/ & Amy McGuire: . Longer ago and longer (by far) in :

  99.   Retweeted

    Natalie Ram uses her baby bump as the ultimate scholarly “flex” in showing the involuntary and immutable nature of informational revelation for the children we produce. How do these elements make the forensic use of that information different?

  100.   Retweeted

    Ooh interesting! Natalie Ram argues that the involuntariness of familial info getting into databases means the Third Party Doctrine [which sucks anyway] shouldn’t apply. (here’s her piece, DNA by the Entirety: )

  101.   Retweeted

    providing a range of policy/legal choices about how to address new forms of noninvasive prenatal testing

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Tweets and Retweets by @AVIVA1950 and by @pharma_BI for @USAIC and #USAIC2019 at the 13th Annual BioPharma & Healthcare Summit, Thursday, May 9, 2019, Marriott Hotel, Cambridge, MA

 

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  1.   Retweeted

    Alise Reicin discusses endpoints needed in and effect of cost of in Panel Discussion morning Networking break

  2.   Retweeted

    Alise Reicin Panel Discussion: best done as Basket&Umbrella trial; response rate 30-50% but Phase3 negative

    Translate Tweet

  3.   Retweeted

    Dr. William Chin design challenges with newer in recruiting patients; use Basket&Umbrella Trial design Live

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On risk | benefit: Long term impacts of treatment may be present for the life of the patient

  1.   Retweeted

    Discussion of cyber security at panel moderated by – realization that everything is interconnected: risks to business-critical functions. Much to learn from FinTech & others’ prior experience.

  2.   Retweeted

    Unexpected best thing about – at least three Zimbabweans in the crowd / on the stage.

  3.   Retweeted

    segueing into a discussion of safety, and risk tolerance. Prevention has a higher safety bar than treatment later in the disease process.

  4.   Retweeted

    Most humbling & touching moment: meeting an exec who nodded & teared up as I told him what we do His 9 yo child needs frequent contrast enhanced MRI scans for a rare disease. We felt like the smallest co at yet so important for hope & health

  5.  
  6.   Retweeted

    Great initiatives to bring CAR-T to India an automation to drug manufacturion

    Amazing moderator asking provoking question of best panel in responses by experts made known were different for competing rivals the aim is same best faster largest at lowest keeping maximized

  7.   Retweeted

    Dr. Bruce Chabner Talk: Old Phase 1,2,3 design not needed for & era based . very accommodating in Phase 1 trial design.

  8.   Retweeted

    Dr. Bruce Chabner panel discussion: selection based on new design paradigm; 40 drugs approved by accelerated approval for

  9.   Retweeted

    Dr. Mace Rothenberg talks for approvals vary greatly over multiple countries makes issues of ong-term design and post approval reimbursement

  10.   Retweeted

    Talk : design now depends on systems e.g. organelle delivery. only wants accelerated approval not conditional approval. Surrogate markers critical for new trial design

  11.   Retweeted

    Dr. Rob Scott Panel Talk crisis in not in . Lowest investment in development. Physicians using SAME design for . use in trails increasing

  12.   Retweeted

    Dr. Rob Scott on design @usaic2019: Regulators as partners not barriers but burden of efficacy on . Can use advertising to increase recruitment as 70% willing participants live too far away so use &

  13.   Retweeted

    Dr. Rob Scott discusses recruitment and burdens : prefers to do in house & not use CRO as CRO less effective in monitoring trial

  14.   Retweeted

    “Some drug platforms are mature enough to fall under the practice of medicine” – Tim Yu of

  15.   Retweeted

    Closing R&D strategies panel at is with NIBR’s Janssen’s and Takeda’s Andy Plump. Moderator Martin Mackay (now of newco Rallybio) asks: What are you most excited about?

  16.   Retweeted

    Talk of indexed pricing model in the US may be a challenge for access to other parts of the world, says a speaker on rare disease panel

  17.   Retweeted

    The biggest problem that we have in the industry is the lack of empathy, says Chris Viehbacher

  18.   Retweeted

    Tim Yu’s example left a room full of seasoned biopharma R&D execs wowed. More background here:

  19.   Retweeted

    (May 9, Boston) will feature plenary panel on Emerging R&D Strategies moderated by Dr. Martin Mackay, Co-Founder, Rallybio, with of , Andy Plump of , of Janssen, Michael Ehler of -> register today

  20.   Retweeted

    Check out my latest article: Where is Oncology Drug Development Heading Next? Hear From Top KOLs at 13th BioPharma Summit May 9, Boston via

  21.   Retweeted

    Check out my latest article: One in a Million: Emerging Trends in Rare Diseases at 13th annual BioPharma Summit- May 9, Boston via

  22.   Retweeted

    Check out my latest article: Chris Viehbacher, Gurnet Point Capital joins the USAIC Advisory Board. Please join Chris & other leaders at our annual BioPharma Summit, May 9, Boston via

  23.   Retweeted

    Check out my latest article: R&D Panel: BioPharma KOLs Debate R&D Strategies & Trends at 13th annual BioPharma Summit, May 9, Boston via

  24.   Retweeted

    Check out my latest article: What Does The Future Hold For Drug Development & Clinical Trials? Hear Predictions From Top Drug Developers at the 13th BioPharma Summit May Boston 9 via

  25.   Retweeted
  26.   Retweeted

    Value and Access – The Ongoing Debate.The BioPharma Summit will feature this special session. Join the discussion with BioPharma KOLs via

  27.   Retweeted

    BioPharma Manufacturing in the Future: Hear KOLs Debate the Challenges and Opportunities at the 13th annual BioPharma Summit, May 9, Boston via

  28.   Retweeted

    Our 13th Biopharma & Healthcare Summit has kicked off with introductory remarks from USAIC President Karun Rishi and emcee Dr. Andrew Plump, President of R&D for Takeda.

  29.   Retweeted

    The session is starting as I attend the focused on US-India bio-pharma healthcare summit. The focus is on and to deliver compelling affordable care with key role for technologies.

  30.   Retweeted

    Carl June believes we’re only a few years away from outpatient CAR therapies, with no need for intensive infrastructure with ICU.

  31.   Retweeted

    Dr. Maus ⁩ monitoring data from clinical trial is very important development of new targets multiple drugs multiple mechanism multiple specificities more modification to one cell contamination results

  32.   Retweeted

    “Cancer is a collection of rare diseases” – , Director of Clinical Research, Cancer

  33.   Retweeted

    Sanat Chattopadhyay of US Merck says costs of manufacturing in US/Europe is significantly higher because technology deployed is ancient, both in small molecules and biologics.

  34.   Retweeted

    Rare disease taking center stage as technologies mature, panel moderated by CRISPR Therapeutics CEO Samarth Kulkarni

  35.   Retweeted
    Replying to  

    Enjoyed moderating the panel on manufacturing in the future as bio pharma companies explore ways to deliver drugs at affordable price and address access challenges. Digital innovation in manufacturing and supply chains will be key.

  36.   Retweeted

    Price is part of doing business…if you are not able to define value, you are sunk, says Chris Viehbacher Gurnet Point Capital

  37.   Retweeted

    All diseases are unique Your perspective changes when you or someone you love is diagnosed with a life-altering disease – rare diseases panel

  38.   Retweeted

    Arun Singhal, addl secretary, health ministry speaks about Ayushman Bharat, trade margin rationalisation, clinical trial rules at meeting

  39.   Retweeted

    Clinical trials in India picking up steadily, says Eswara Reddy, DCGI

  40.   Retweeted

    Regulators will “provide complete support” for clinical trials in India provided drug developers meet the new requirements – Drug Controller General of India Eswara Reddy

  41.   Retweeted

    discusses prevention and treatment of early disease e.g. precancer The challenge is to work out the commercial model says organize around prevention Early diagnosis / discovery of disease processes saves lives (’s raison d’etre)

  42. AMAZING EVENT @AVIVA11950 13th Annual & Healthcare Summit, Thursday, May 9, 2019, Marriott Hotel, Cambridge, MA via

  43. Dr. James Bradner, President, Novartis Institutes for BioMedical Research biophysical biochemical protein degradation – rewire disease cells with biomolecules combing propertitie of permiability of small molecules

  44. World PGD Growth of 4% in India 31%

  45.   Retweeted

    Takeda R&D Head Andy Plump asks question from audience to peers on stage: “I’ve been in the industry for 18 years and I can’t understand why a clinical trial costs so much. Why does it?”

  46.   Retweeted

    Manufacturing in the age of individualized medicine? We may need a completely different thinking for that says Paul Mckenzie, Biogen

  47.   Retweeted

    The so-called low-cost manufacturing edge of India will go away in a few years, says Hari Bhartia, Jubilant…being closer to the customer will be important

  48.   Retweeted

    Tricky question: getting patients to cancer centers to participate in clinical trials. Should patients be reimbursed for long travels and other expenses or will it be seen as an inducement?

  49.   Retweeted

    A chance to collaborate with my old colleague & friend ! -> another point from same panel: AbbVie CMO Rob Scott predicts tele-health solutions for clinical trial patients will be scalable soon

  50.   Retweeted

    Carl June: There are no CAR-T clinical trials in India. But says countries like India could eventually leapfrog to next gen (outpatient) cell therapy which will require less infrastructure + lower COG

  51.   Retweeted

    The 13th Annual BioPharma & Healthcare Summit is being kicked off by Andrew Plump. In his opening remarks, he commented that we should feel privileged as attendees because not even or is invited to this meeting.

  52.   Retweeted

    A well-represented panel of scientists, CEOs and entrepreneurs discuss a range of discovery research from CAR-Ts to small molecules…on the same panel is Arjun Surya of Curadev that licensed a preclinical oncology lead to Takeda.

  53. The promise of India is the largest democracy, the educated workforce the size of the market for therapeutics, access and price, reimbursement and regulation. DCGI the analogue of FDA is very active and innovated the challenge of 1.3 Billion a population of patients

  54. Great Leader in immunotherapy, Carl June early inventor and endless commitment to patient a Pro for BioPharma

  55. GREAT Conference of who is who in BioPharma, Boston at the top 500 startats of Biotech in Cambridge, MA ten years afo only a handful, boost by Novartis HQS in Cambridge, MA

  56. Liked the analogy of

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LIVE 13th Annual BioPharma and Healthcare Summit, Thursday, May 9, 2019, Marriott Hotel, Cambridge, MA

 

http://www.usaindiachamber.org

8:40 AM – 9:10 AM Registration and Networking
9:10 AM – 9:20 AM Welcome addressKarun Rishi, President, USAIC

Opening comments: Dr Andrew Plump, President R&D and Director, Takeda Pharmaceuticals

9:20 AM – 9:40 AM Fireside Chat

  • Mark Abdoo, Acting Deputy Commissioner, U.S. Food and Drug Administration
  • Dr Eswara Reddy, Drug Controller General of India, Central Drug Control Organization

Moderator: Sanat Chattopadhyay, President, Merck Manufacturing Division; Merck & Co.

9:40 AM – 10:00 AM Presentation on CAR (chimeric antigen receptor) T-cell Therapies
Dr. Carl June, Director of Translational Research, Abramson Cancer Center University of Pennsylvania Moderator: Dr. Raju Kucherlapati, Professor of Genetics, Harvard Medical School
10:00 AM – 10:50 AM Panel Discussion: Oncology – The Emperor of BioPharma Development

Panelists:

Moderator: Dr. Christiana Bardon, Managing Director, MPM Capital

10:50 AM – 11:20 AM Networking Break
11:20 AM – 12:10 PM Panel Discussion: Future of Clinical Trials and Drug Development

Panelists:

Moderator: Dr. William Chin, Professor of Medicine, Emeritus, Harvard Medical School

12:10 PM – 1:00 PM Panel Discussion: Manufacturing in the Future

Panelists:

  • Hari Bhartia, Founder and Co-Chairman, Jubilant Bhartia Group
  • Mark Abdoo, Acting Deputy Commissioner, U.S. Food and Drug Administration
  • Dr. Paul McKenzie, Executive Vice President, Pharma Operations & Technology, Biogen
  • Sanat Chattopadhyay, President, Merck Manufacturing Division; Merck & Co.
  • Vinay Ranade, Chief Executive Officer, Reliance Life Sciences

Moderator: Professor N. Venkat Venkatraman, Boston University Questrom School of Business

1:00 PM – 1:50 PM Lunch
1:50 PM – 1:55 PM Video message from Suresh Prabhu, Hon’ble Minister of Commerce & Industry, Gov. of India
1:55 PM – 2:45 PM Panel Discussion: One in a million – Emerging trends in Rare Diseases

Panelists:

Moderator: Dr. Samarth Kulkarni, Chief Executive Officer, CRISPR Therapeutics

2:45 PM – 3:20 PM Networking & Tea Break
3:20 PM – 3:50 PM Fireside Chat: Value and Access – The ongoing debate

Moderator: Dr Andrew Plump, President R&D, Takeda Pharmaceuticals

3:50 PM – 4:10 PM India update on Clinical Trial Regulations

  • Arun Singhal, Additional Secretary, Ministry of Health & Family Welfare, India
  • Dr Eswara Reddy, Drug Controller General of India, Central Drug Control Organization
4:10 PM – 5:00 PM Panel Discussion: Research and Development Strategies and Trends

Panelists:

Moderator: Dr. Martin Mackay, Co-Founde, Rallybio

5:00 PM – 5:05 PM Closing Remarks
5:05 PM – 6:15 PM Cocktails & Networking Reception

Aviva Lev-Ari, PhD, RN & Leaders in Pharmaceutical Business Intelligence (LPBI) Group

will cover the event in Real Time

REAL TIME COVERAGE USING SOCIAL MEDIA

 

LIVE Images taken by @AVIVA1950

 

 

 

9:10 AM – 9:20 AM

Welcome addressKarun Rishi, President, USAIC

Opening comments: Dr Andrew Plump, President R&D and Director, Takeda Pharmaceuticals

  • tomorrow announcement @Shire
  • India 1.3Billion in India, each person is a potential patient in the largest democracy in the World
  • China – transformation takes place every day
  • The Patient and the Pricing of Drugs the biggest issue missing the ball dialoguing on Panel today

9:20 AM – 9:40 AM

Fireside Chat

  • Mark Abdoo, Acting Deputy Commissioner, U.S. Food and Drug Administration (FDA)
  • Dr Eswara Reddy, Drug Controller General of India (DCGI), Central Drug Control Organization

Moderator: Sanat Chattopadhyay, President, Merck Manufacturing Division; Merck & Co.

9:40 AM – 10:00 AM Presentation on CAR (chimeric antigen receptor) T-cell Therapies
Dr. Carl June, Director of Translational Research, Abramson Cancer Center University of Pennsylvania Moderator: Dr. Raju Kucherlapati, Professor of Genetics, Harvard Medical School

  • Video on child with recurrent twice of leukhimia
  • T-cell HIV Virus infect

 

10:00 AM – 10:50 AM

Panel Discussion: Oncology – The Emperor of BioPharma Development

Panelists:

  1. solid vs blood tumors
  2. T-Cells amplification microenvironment and biology
  3. PD-1 in combination therapies thousand Trials
  4. Biomarker allows to check response in conjunction with genomics data brings insights
  5. Tumors World, Biomarkers in Immuno oncology respond to PD-1 no response to other drug
  6. stratify patients
  1. Protein experimental data compound design from simulations of VIRTUAL compounds,
  2. how to incentivise to take on new innovations
  1. more that one single administration by injection
  2. response rates different even in one patient let alone among patients
  3. detection gene
  4. CAR-T glioblastoma
  5. pancreatic cancer good responses in combination therapies
  6. immunr repertoire biology so complex that biomarkers are limited

Moderator: Dr. Christiana Bardon, Managing Director, MPM Capital

  • 30% patinets with complete cure

10:50 AM – 11:20 AM Networking Break11:20 AM – 12:10 PM

Panel Discussion: Future of Clinical Trials and Drug Development

Panelists:

  1. endpoints need to be redefined it effect price of drug development
  2. in Oncology – Basket and Umbrellas Trial – two stufies approval for melanoma, biomarker
  3. Is response rate is 30% va 50% and Phase 3 is negative Kertuda when worked at Merck dose ranging last phase when response dropped from 60% to 30% in the case of Study C3
  4. 30% of the cost of the study – 30% was translational
  5. CRO model appropriate oversite vs douplication of tasks
  • Dr. Bruce Chabner, Director of Clinical Research, Mass General Hospital Cancer Center
  1. Old paradigm Phase 1,2,3 – off the board now, New drugs do not need the old paradigm
  2. Phase i1 changed if genomics is involved multiple cohorts at same time
  3. FDA play amazing role
  4. patient selection is key
  5. mutations in rare disease vs mutations in cancer
  6. immunotherapy and endogenic drugs with chemo in RENAL cancer
  7. check-points – lung cancer understood money spent to find responders
  8. HOW to select which cheno therapy — no improvement today vs past
  9. 40 drugs approved by accelerated approval one came back on the market
  10. Financial burden of being in a clinical trial
  11. Foundation gives money to Institutions to reimburse patients for flights, meals, acommodation, Pharma are reluctant to participants due to potential accusation of bias id Pharma pays Patients that participate in Clinical Trials
  1. FDA recognizes approval process – systems involved AFTER approval for reimbursement and monitoring after market
  2. regulatory by countires are different
  3. which factors are sacrifiable in the long tern in clinical trial design
  1. Safety – benefit risk is what physicians work with every day
  2. Drugs paradign of small molecules does not hold is you have a drug that deliver entire organelle – how you dose for half life how you prive the rate of replication in the body
  3. Surrogate markers
  4. Taking a drug off the market ->>  conditional approvals [approval can be taken back or require additional studies] not a favorable view of Pharma in the present to support Conditional approval vs accelerated approval

 

  1. speed
  2. differentiation from competition
  3. drug development in crisis is CVD not cancer, US and the rest of the world – lowest investment in drugs is CVD
  4. Studies designed by Physicians using SAME design
  5. need to create experts to use ML in the course of clinical trial design
  6. regulators as Partners not as Barriers
  7. Proof of efficacy is a burden on the developers of the drug not on the Regulatory
  8. Increase use of advertising to recruit
  9. 70% OF PATIENTS WILLING TO PARTICIPATE  lives to far from site of trials
  10. Telecommunication between administrators of study ans clinical Trials participants
  11. Back when I was at Pfizer, designing study – patients burden relieved more willingness to participate
  12. Preferrs to run studies in house vs use CRO they are not effective in monitoring like study run in house

Moderator: Dr. William Chin, Professor of Medicine, Emeritus, Harvard Medical School

  • Probability of success to clinic has not changed
  • challenge is design and execution in clinical trials
  • changes in drug modalities: RNA, DNA,
  • which combination to use
  • how to find the many patients needed
  • Basket and Umbrellas Trial

12:10 PM – 1:00 PM

Panel Discussion: Manufacturing in the Future

Panelists:

  • Hari Bhartia, Founder and Co-Chairman, Jubilant Bhartia Group
  1. supply change
  2. blockchain
  3. quality by design
  4. CPK
  5. productivity will go up variability will decrease
  6. manufacturng must happen in India
  7. Genetics price selection
  8. Secure system, data quality the data logic and the analytics
  9. infrastructure in manufacturing is not completed yet
  10. Training by augmented reality Turnover high in India
  11. cyber security – digitization and central control
  12. demonstration data offense
  • Mark Abdoo, Acting Deputy Commissioner, U.S. Food and Drug Administration
  1. next 10 years India and China will improve regulatory activities and match better the US requirements
  2. review foreign hosts
  3. skills and location of hosts:
  4. India: Standards and unannounced inspections and
  5. China: same
  6. Blockchain is experienced as experimentation at FDA across each all parts of the Agency
  • Dr. Paul McKenzie, Executive Vice President, Pharma Operations & Technology, Biogen
  1. raw material to patients: Pharma very slow than other industries Reliable needs be very high, relationships
  2. Hurrican in PortoRIco affected supply chain
  3. Reality, every one HAVE to be in China
  4. Platforming for each modality for Scaling out vs Scaling up
  5. diversify vs modality x
  6. build capacity and capabilities customization of ultra filtration different in two plants lowers standardizations
  7. Training on Demand, Virtually, documnetation needs to change to electronic
  8. Continueous manufacturing Academic contribution
  • Vinay Ranade, Chief Executive Officer, Reliance Life Sciences
  1. Pharma was slow in India the manufacturing
  2. infantile diarreha vaccine 70,000 in 4 years needs that drug,
  3. massive intellectual capital in India
  4. How to implement and make best use of data to improve processes
  5. cyber security was not experiences
  1. Phase 1 scaling out vs up – it is different in vaccine field
  2. ML, Block chain, supply chain and manufacturing will be adapted in supply chain
  3. Apply analytics and relationships in manufacturing
  4. obsolescence and upgrades
  5. capture data electronically
  6. cyber security can be a hazard hard to mitigate when all systems are down
  7. significant challenges in manufacturing and data security

Moderator: Professor N. Venkat Venkatraman, Boston University Questrom School of Business

  • How can Pharma become leaner
  • heterogenuious environment for production
  • cyber security

1:00 PM – 1:50 PMLunch1:50 PM – 1:55 PM Video message from Suresh Prabhu, Hon’ble Minister of Commerce & Industry, Gov. of India1:55 PM – 2:45 PM

Panel Discussion: One in a million – Emerging trends in Rare Diseases

Panelists:

  1. worked with Academic community on how to treat rare disease in the future
  1. Show clinical benefit and impact multiplemyeloma
  2. patients becoming activists
  3. access
  4. foundation by patients
  5. Patient to get cloud
  • Dr. Dhaval Patel, Executive Vice President  and Chief Scientific Officer, UCB
  1. if a modality will cure a disease justify innovation Model for payment: Mortgage Model
  2. Access INDEX pricing – US will benchmark the price in other parts of the world
  3. Gene therapy is not only got monognenic diseases but for
  4. decrease work involved in development of drugs
  • Dr. James Wilson, Director – Gene Therapy Program, University of Pennsylvania
  1. tension between physicians and development of the perfect drug.
  2. AV
  3. Protein replacement therapy repeated infusion gene therapy infrastructure develop in China for China, Develop in India for India vs develop in US for India or China
  4. Cost of manufacturing to decrease
  • Dr. Timothy Yu, Assistant Professor in Pediatrics, Harvard Medical School
  1. Scalability beyond the one case: the mechanism for the drug has generability for other aptients iwth same mutation the method has no limit
  2. Molecular type of mutation Spice Switching strategy, just-in-time manufacturing

Moderator: Dr. Samarth Kulkarni, Chief Executive Officer, CRISPR Therapeutics

  1. Rare diseases, potential for cure
  2. Academia, Hospitals, biotech
  3. commercial model of the disease

2:45 PM – 3:20 PMNetworking & Tea Break3:20 PM – 3:50 PM

Fireside Chat: Value and Access – The ongoing debate

  1. since 2003 testify in the House, against Canadian  David Brenner was asked about importation from Canada of breast cancer tamoxiphen at a lower price than in the US.
  2. From importation crisis to Obama Care – stable system Medicare Part D – drug coverage for Olderly
  3. After Obama – Price is part of doing business REBATES $100Billion the valur of REBATES
  4. Co-Insurance
  1. right for innovation will be preserved
  2. price increase
  3. give and take
  4. Co-pay – We need lower co-pay
  5. with current administration, sink finding the Well instead of Well funding the sick
  6. CHange is coming, co-pay will change
  1. Genzyme days vs 2019
  2. changes how drugs are priced?
  3. Flaws of the system:Gevernment induce prices that will change
  4. $800,000 drug is now $80 [ala Regeneron] – R&D was $2Billion
  5. CO-pay for hospital stay is lower than co-pay on drugs – 10% twice a year

Moderator: Dr Andrew Plump, President R&D, Takeda Pharmaceuticals

3:50 PM – 4:10 PM

India update on Clinical Trial Regulations

  • Arun Singhal, Additional Secretary, Ministry of Health & Family Welfare, India
  1. Each patient deserve access to healthcare in India
  2. experimenting
  • Dr Eswara Reddy, Drug Controller General of India, Central Drug Control Organization
  1. Time line for Application approval for drugs, if approved in another country 60 days
  2. Gov’t hospitals can import New drugs which have not been permitted in India

4:10 PM – 5:00 PM

Panel Discussion: Research and Development Strategies and Trends

Panelists:

  1. Neuroscience – Pharma understand biomarkers and now genetics
  2. Vaccines – across species in the animal WORLD
  1. Attempt not to tweak the PIPELINE: CVD, NEUROSCIENCE AND CANCER
  2. 485 Teams doing R&D convluence of interests to develop cure
  3. Modularity – BioMolecule — multimodality biophysical biochemical protein degradation – rewire disease cells with biomolecules combing propertitie of permiability of small molecules
  4. PHARMACOLOGICAL PREVENTION – biotech is inspiring only Pharma can solve
  1. immunooncology – mutation signature – marker protein signature — that group of diseases respond to
  2. colon cancer and multiple myeloma — understanding of the biology was deep

Moderator: Dr. Martin Mackay, Co-Founder, Rallybio

5:00 PM – 5:05 PM Closing Remarks

5:05 PM – 6:15 PM Cocktails & Networking Reception

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Tweets by @pharma_BI and @AVIVA1950 at #GenMed2019 on Translating Genetics into Medicine, April 25, 2019, 8:30 AM – 6:00 PM, The New York Academy of Sciences, 7 World Trade Center, 250 Greenwich St Fl 40, New York

  1. ⁩ CC-220 binds to proteins degraded exposure correlates with B cell depletion normal T cells SLE IS THE NEW INDICATION of a repurpose of thalidomide and another drug for melanoma GENETIC DOSE-response portal: genetics, interrogation pleiotropy data analysis visual

  2. Dr. Pledge ⁦ human genetics and drug discovery drug R&D attrition drug value to patient in decline failure in Phase 2&3 lack of efficacy cause hi drug price human as the model organism longitudinal test therapeutics on human phyno

  3. from genetics to target selection finding genetic evidence new opportunities cross-biobank research other RWD genetic data enabler: biobanks FINGEN (Finland collaboration) 23andme GWAS case control prevention disease trajectories

  4. Dr. Rader UPenn Gain of function mutation increase HDL-C therapeutic relevance LCAT Fig below is on TRL