08 Jun Headlines from PMWC 2019 Silicon Valley

A big ‘Thank You’ to all of our presenters and attendees for celebrating 10 years of precision medicine progress with us! PMWC 2019 Silicon Valley was attended by 2000 participants from 35 countries, which included over 400 speakers in 5 parallel tracks!

PMWC 2019 fostered great dialogue on genetics, genomics, immunotherapy, regulatory, reimbursement, machine learning, data access & data sharing, as well as critically important conversations around trust and transparency.

Select Quotes / Announcements from PMWC 2019 Speakers:

• Francis deSouza (Illumina): “This morning at PMWC19 we are announcing that the FDA has given us breakthrough device designation for Illumina’s pan cancer assay. This is an important product in terms of putting a tool in the hands of oncologists that will allow them to match patients with precision oncology therapy.”
• Harold Paz (Aetna): “For me, most important is moving towards value-based care… Thinking about genetic tests, as we are thinking about any type of diagnostic test that is performed. If there is good clinical evidence and/or a consensus statement from a nationally recognized group of clinicians, then we will cover that.”
• Carl June (UPenn): “I’m optimistic that solid tumors will be problem solved. The time scale how long it will take, I don’t know. It’s not going to be a single bullet, but it will require multiple modalities.”
• Brooke Byers (Kleiner Perkins): “ I’m super enthusiastic about all areas of cell therapy, of which there have been a lot of talks here at the conference. I hope all of you have gone to every one of those sessions.”
• Vijay Pande (Andreessen Horowitz): “The future biologist will be data scientist.”
• Atul Butte (UCSF): “What I usually tell AI startup companies, the academic medical centers, of course, will be great reference accounts. But we are lousy first customer. Talk to small community hospitals that actually get it. Write a white paper with them. Show the world what you can do, and then knock the door of an academic medical center.”
• Randy Scott (Invitae): “If there is anything that I have learned is that [consumer] genetics is massively complex…Frankly I think people will wake up in few years and realize you need an expert if you want to understand this.”
• Sharon Terry (Genetic Alliance): “I challenge the industry to put people at the center to be able to make the best decisions in discovery, medicine, science, intellectual property, business models.”
• Aleksandar Rajkovic (UCSF): “UCSF is moving towards whole genome sequencing in clinical practice.”
• Lisa Alderson (Genome Medical): “The future…where genetic testing and access to genetic services become part of mainstream clinical care…is becoming a reality today.”
• Anil Sethi (Ciitizen): “We should be going through patients instead of around them. Patients are the most underutilized resource in healthcare. Moral of the story: Work WITH patients to make it happen folks!”
• Kaylene Ready (Myriad Women’s Health): “Barriers to access to genetic counseling include: only 5,000 genetic counselors in the US located mostly in urban areas, longer appointments 30-60 min, huge growth in the number and depth of tests, and reimbursement challenges.”
• Seema Verma (CMS): “We’re all about empowering patients. We love this mantra! But let’s make sure we’re co-designing alongside those patients for the best possible outcomes!”
• Daphne Koller (Insitro):  “Data Scientists & Lab Scientists (domain experts) have to be integrated into a single team from Day 1 — we need bilingual teams — the cultural department has much more of an impact than the technical department…!”
• Dawn Barry (LunaDNA): “I love that we’re at such a sophisticated conference and we’re talking about sharing, fairness, and transparency.”
• Sheryl Krevsky Elkin (N-of-One): Early on we learned that we needed to be able to incorporate interpretation that accounted for the effects that different mutations indifferent genes have on each other and also the results on testing from different modalities, like FISH test, cytogenetic test, in combination with NGS test which all affect the diagnosis, prognosis, and sometimes the therapeutic indication for a specific patient.

A Few Key Learnings from the Conference:

• Real-World Evidence (RWE) and Real-World Data (RWD) sessions:
  • Deborah Schrag (Harvard Medical School) suggested that one of the biggest challenges she sees is to track outcomes in the “real world” and use these outcomes to inform clinical-decision making, and to identify denominators in increasingly small patient subsets.
  • Mimi Huizinga (Novartis) believes that RWE will help close the efficacy and effectiveness gap in drug development.  There are three main buckets to consider: 1) Understand the impact of specific mutations its impact on outcome – need to go beyond genomics (epidemiology); 2) Estimate the value of the potential product in the market (value-based care); 3) Close the gap between efficacy in the rural world and randomized control trials
  • George Komatsoulis (ASCO) provided an overview of the ASCO RWD registry, CancerLinQ, that is EHR-agnostic, has curated 107,000 cases from 100 participating organizations.
  • Sean Scott (Qiagen) taught us that:
    • We see a fundamental shift across the industry from an instrumentation technology and secondary assay technology focus to one that really focuses on “Are we building solutions that provide meaningful insights and report clinically relevant findings that support the decision making process?”
    • We need to integrate multi-modality-based testing within the hospital systems which includes standardization, actionability, and reimbursement aspects.
    • We need multi-omics-based approaches versus the current state which is DNA-diagnostic-centric testing.
  • Marty Tenenbaum (Cancer Commons) detailed his company: Cancer Commons tracks all patients that were cases we studied to help other, new patients. This requires the proper software, databases, and networks and challenges associated with RWD are mostly of technical nature which can get expensive. In addition, it is often very challenging to describe the value incentive to the patient to share their data.
  • Raju Pillai (City of Hope National Medical Center) taught us that:
    • A substantial number of patients are not served by the current state of the art of genomic testing.
    • We need to combine current genomic testing with pathway-based analysis, based on gene expression and look at specific therapies that affect those various pathways.
    • Currently, if you send the same tissue to three different labs you get different results – there are very few standards in place besides ACMG, ASCO, and a few others and different gene panels are used to perform the testing.
  • Preston Estep (Veritas Genetics) on the value of genome screening told us: The biggest value is seen in carrier screening, pharmacogenomics, ancestry analysis, and the management of genetic health risks. But there is more and more evidence that healthy people may benefit from genome sequencing, as shown with a number of recent sequencing studies such as BabySeq (WES – ~11% have a childhood disease risk), Rego et al. (WES), MedSeq (WGS), and Human Longevity (WGS)
  • General learnings:
    • There are no standards across RWD for sample/tissue handling.
    • We need to include optimized work processes (e.g. there are lots of errors in EHR systems).
    • We need to support humans in how to enter data
    • We need to standardize protocols – economically and with regulations in place
    • We need good data before we can feed it into an AI system, before we can feed it to an algorithm.

PMWC 2020 Silicon Valley is set to take place January 21-24, 2020. The conference is returning to the Santa Clara Convention Center, but this year we are taking the whole floor.

See details and early bird pricing on our website: 1.pmwcintl.com/2020sv

I hope you can join!