Dr. Ridenour has over two decades of clinical and research experience in etiology, assessment, and clinical research methodologies. One of his foci is developing methods for rigorous analysis of longitudinal, within-person clinical trials using small samples. His recent studies have demonstrated and highlighted the relative strengths and weaknesses of analytic techniques for detecting experimental change within individuals over time, including trajectory analysis and state space modeling. Read his full bio.

Interview with Ty Ridenour of RTI International

Q: What need is RTI International addressing?

A: As an independent research institute, RTI is dedicated to improving the human condition. We answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development.

In the realm of clinical trials, medical and behavioral health care have largely been limited to traditional randomized controlled trial (RCT) designs. RCTs are superb for the acquiring the data for which they were originally designed – efficacy of a treatment in a population. However, for other purposes the utility of RCTs is limited. To illustrate, with greater “precision” in medicine (meaning the application of treatment to more specified types of persons), the RCT requirements for large samples and funding streams generally become less tenable.

Our PersonAlyticsTM idiographic clinical trials (ICTs) approach provides alternatives to RCTs, which are designed to understand within-subject processes that occur in response to a treatment. Under certain conditions (e.g., rare diseases, specific genotypes, early stage drug development, small samples or N=1), ICTs can be used to estimate efficacy. But, perhaps the greatest strength of ICTs is to carefully elucidate how a treatment is affecting individuals as the treatment is delivered and soon thereafter.

Q: What are the products and/or services RTI International offers/develops to address this need? What makes RTI International unique?
A: RTI offers both services and products to help its clients leverage ICT technologies. First, our team has decades of wide-ranging experience in conducting ICTs including drug development for FDA approval, organ transplantation, biosensor-measured outcomes, metabolomics, and psychotherapy (many publications about these studies can be found at: https://personalytics.rti.org/). Second, we provide consultation, collaborative research design, and analytics to support clients’ research and development of treatments and medical devices. Third, we create tailorable software to support patient monitoring and clinical decision-making. One example is Curelator (https://n1-headache.com/), which helps individual patients suffering migraine headaches to identify the triggers/protectors and severity modifiers of his / her migraines; this evidence in turn informs the patient and his / her neurologist of what treatment strategy to pursue in a wholistic and personalized manner. RTI’s software is currently offered as a “white label” product that operates in the background and can be automated for rapid analytics and real-time patient monitoring. RTI is a preeminent non-profit research institution offering expertise across a breadth of health and life sciences, engineering, education and communication sciences, policy, bench science, public health and psychology, environmental sciences, and analytics. Included is RTI Health Solutions, a business unit focused on providing research and advice on clinical, regulatory, market access, and safety programs for pharmaceutical, medical device, and diagnostic companies.
Q: What is your role at RTI International and what excites you about your work?
A: I head the PersonAlytics Team of statisticians and software architects at RTI. As a trained Developmental Behavioral Epidemiologist, I also wear several other hats: NIH-funded researcher, statistician, and developer of medical devices. What gets me out of bed in the morning is the anticipation of making new discoveries that can improve people’s lives. So, by continually improving PersonAlytics services and software, I get to help innovators prepare their treatments and devices to improve people’s health and livelihood.
Q: When thinking about RTI International and the domain RTI International is working in, what are some of the recent breakthroughs that are propelling the field forward and how will they impact healthcare?
A: RTI’s mission is to improve the human condition by turning knowledge into practice, and our researchers apply this mission across a wide breadth of basic and applied sciences. To illustrate the swath of RTI’s research topics, my own first-hand recent collaborations include developing a virtual exercise regimen for patients recovering from heart attack whose health care coverage for physical therapy has run out; identification of marijuana metabolomics that correspond to level of marijuana-induced cognitive dysfunction; validating a biosensor measure of stress based on electrodermal activity levels to test on-the-job stress-reduction interventions; and a clinical trial that is testing a screening, brief intervention and referral to treatment (prevention) for youth at high risk of early-age substance use that can be used during pediatric well-child check-ups. These few examples of RTI’s innovative research are a miniscule sampling of the swath of health care-related work occurring at RTI.
Q: What are the short-term challenges that RTI International and its peers are facing?
A: The most pressing short-term challenge for an organization like RTI is to align with the funding priorities of federal agencies to meet societal needs. For example, within drug abuse research the rise of the opioid epidemic has led to shifts in funding from drug abuse prevention to treatment for heroin addiction and overdose. Another example is that the FDA has recently prioritized speeding up the drug development process to more rapidly get innovative treatments to market. As the research funding landscape evolves, organizations must also evolve to respond with high-quality solutions to the most important scientific and societal challenges we are facing.
Q: Is there anything else you would like to share with the PMWC audience?

A: The RTI International team is looking forward to networking with attendees at PMWC. Precision medicine is at the heart of our PersonAlytics efforts. But, for our methods to move forward and have an impact, we need to collaborate with innovators in health care. We hope to foster those collaborations at PMWC.

Interview with Ken Bloom of Ambry Genetics

Q: Tell us more about your organization/company. What patient population are you serving and which services are you specializing in?

A: Ambry Genetics is a recognized leader in high quality complex genetic testing. We seek to find the genomic cause or contributors to rare diseases, abnormal phenotypes and hereditary disorders.

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Interview with Lee Pierce of Sirius Computer Solutions

Q: What is the state of big data and analytics in healthcare, and how to best use the reams of data available?

A: More than ever, Healthcare organizations are achieving measurable value through use of their data and analytics assets. There is more raw material available than ever to create value. This raw material is the data flowing from internal systems and applications and also from devices and systems external to healthcare organizations.

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Interview with Anita Nelsen of PAREXEL

Q: There are various new, emerging technologies that bring us closer towards a cure for life-threatening disorders such as cancer, HIV, or Huntington’s disease. Prominent examples include the popular gene editing tool CRISPR or new and improved cell and gene therapies. By when can we expect these new technologies being part of routine clinical care?

A: Today’s emerging technologies are making the promise of individualized treatment a reality.

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Interview with Ilan Kirsch of Adaptive Biotechnologies

Q: The Nobel Prize in Medicine was awarded recently to James Allison and Tasuku Honjo for their work on unleashing the body’s immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options. The Nobel committee hailed their accomplishments as establishing “an entirely new principle for cancer therapy.” What is your first-hand experience the impact that those new drugs had on patients?

A: For decades cancer was viewed as solely a cell-autonomous condition.

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BMS buys Celgene | Lilly buys Loxo Oncology – Does this Signal a Return to Strong Deal-Making Activities in 2019?

Bristol-Myers Squibb’s blockbuster $74B deal to buy Celgene creates an oncology powerhouse amid industrywide excitement about the rapidly evolving science and explosive growth of the sector. The agreement could signal a return to deal-making for the pharmaceutical industry in the $133B global oncology therapeutics market.

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Interview with Gini Deshpande of NuMedii

Q: What need is NuMedii addressing?

A: NuMedii, has been pioneering the use of Big Data, artificial intelligence (AI) and systems biology since 2010 to accelerate the discovery of precision therapies to address high unmet medical needs. Artificial Intelligence approaches are a natural fit to harness Big Data as they provide a framework to ‘train’ computers to recognize patterns and sift through vast amounts of new and existing genomic

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Interview with Minnie Sarwal of UCSF

Q: Genomic medicine is entering more hospitals and bringing with it non-invasive technology that can be used to better target and treat diseases. What are some key milestones that contributed to this trend?

A: Completion of complete sequence data from the human genome project, and the advances in proteomic, microRNA and epigenetic assays added a layer of pathway biology to the understanding of human diseases.

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Interview with Shidong Jia of Predicine

Q: Once sequencing has been validated as a clinical solution via trusted workflows, and coinciding with the technological developments driving costs lower, we can expect accelerated human genome profiling for clinical Dx. How soon, do you think, will we see accelerated growth and what can we expect?

A: We will see accelerated human genome profiling for clinical Dx in 2019 and the coming years as more biomarker-based cancer drugs are gaining approval.

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Interview with Iya Khalil of GNS Healthcare

Q: Artificial intelligence (AI) techniques have sent vast waves across healthcare, even fueling an active discussion of whether AI doctors will eventually replace human physicians in the future. Do you believe that human physicians will be replaced by machines in the foreseeable future? What are your thoughts?

A: I think that there’s a lot of speculation and uncertainty around AI, but I don’t foresee a time when we won’t need physicians.

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Interview with Ilya Michael Rachman of Immix Biopharma Inc.

Q: The Nobel Price in Medicine was awarded recently to James Allison and Tasuku for their work on unleashing the body’s immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options. The Nobel committee hailed their accomplishments as establishing “an entirely new principle for cancer therapy.” Besides CAR T-cell therapy what do you think next generation immunotherapies will look like to successfully combat cancer?

A: The next generation of immunotherapies will build on the insights discovered by immunologists like James Allison and Tasuku Honjo and extend them to modify the body’s response to tumors.

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Join me to Kick off PMWC Silicon Valley in the Santa Clara Convention Center, Focusing on Every Element of Precision Medicine

My team worked in collaboration with Bill Dalton, Kim Blackwell, Atul Butte / India Hook Barnard, Nancy Davidson and Sharon Terry to create a program that touches every component of precision medicine while bringing together all of its key stakeholders. Leading participating institutions including Stanford Health Care, UCSF, Duke Health, Duke University, John Hopkins University, University of Michigan and more will share their learnings and experiences and their successes and challenges, as they make precision medicine the new standard of care for all.

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Interview with Dominic Eisinger of Myriad RBM

Q: The Nobel Price in Medicine was awarded recently to James Allison and Tasuku for their work on unleashing the body’s immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options. The Nobel committee hailed their accomplishments as establishing “an entirely new principle for cancer therapy.” Besides CAR T-cell therapy what do you think next generation immunotherapies will look like to successfully combat cancer?

A: Next generation immunotherapies include CAR-Ts, TCRs, cancer vaccines, ADCs, bi-specific antibodies, and checkpoint inhibitors.

Read More

2018 Year in Review Milestones: Stakeholder Partnerships Carving Precision Medicine’s Future

2018 has clearly been a year when significant opportunities intersected with strong partnerships to yield advancements. In particular, the clinical advancements that were realized are a testimony to stakeholders working together to deliver on promises affecting major aspects of precision medicine. 2018 has clearly been a year when significant opportunities intersected with strong partnerships to yield advancements.

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Interview with Lisa Alderson of Genome Medical

Q: Tell us a little bit about Genome Medical. What market need is Genome Medical addressing and how?

A: Genome Medical is a telegenomics company that is bridging the gap between available, genetic expertise and the clinical application of genomics.

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Interview with Nasir Bhanpuri of Virta Health

Q: What need is Virta Health addressing?

A: Virta Health delivers an evidence-based treatment to safely and sustainably reverse type 2 diabetes without the use of medications or surgery. In the U.S. alone, type 2 diabetes and prediabetes affects 115 million people, and the economic burden is well-over $300 billion and growing.

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Johns Hopkins
University Of Michigan

The Precision Medicine World Conference (PMWC), in its 17th installment, will take place in the Santa Clara Convention Center (Silicon Valley) on January 21-24, 2020. The program will traverse innovative technologies, thriving initiatives, and clinical case studies that enable the translation of precision medicine into direct improvements in health care. Conference attendees will have an opportunity to learn first-hand about the latest developments and advancements in precision medicine and cutting-edge new strategies and solutions that are changing how patients are treated.

See 2019 Agenda highlights:

  • Five tracks will showcase sessions on the latest advancements in precision medicine which include, but are not limited to:
    • AI & Data Science Showcase
    • Clinical & Research Tools Showcase
    • Clinical Dx Showcase
    • Creating Clinical Value with Liquid Biopsy ctDNA, etc.
    • Digital Health/Health and Wellness
    • Digital Phenotyping
    • Diversity in Precision Medicine
    • Drug Development (PPPs)
    • Early Days of Life Sequencing
    • Emerging Technologies in PM
    • Emerging Therapeutic Showcase
    • FDA Efforts to Accelerate PM
    • Gene Editing
    • Genomic Profiling Showcase
    • Immunotherapy Sessions & Showcase
    • Implementation into Health Care Delivery
    • Large Scale Bio-data Resources to Support Drug Development (PPPs)
    • Microbial Profiling Showcase
    • Microbiome
    • Neoantigens
    • Next-Gen. Workforce of PM
    • Non-Clinical Services Showcase
    • Pharmacogenomics
    • Point-of Care Dx Platform
    • Precision Public Health
    • Rare Disease Diagnosis
    • Resilience
    • Robust Clinical Decision Support Tools
    • Wellness and Aging Showcase

See 2019 Agenda highlights:

    • Five tracks will showcase sessions on the latest advancements in precision medicine which include, but are not limited to:
      • AI & Data Science Showcase
      • Clinical & Research Tools Showcase
      • Clinical Dx Showcase
      • Creating Clinical Value with Liquid Biopsy ctDNA, etc.
      • Digital Health/Health and Wellness
      • Digital Phenotyping
      • Diversity in Precision Medicine
      • Drug Development (PPPs)
      • Early Days of Life Sequencing
      • Emerging Technologies in PM
      • Emerging Therapeutic Showcase
      • FDA Efforts to Accelerate PM
      • Gene Editing / CRISPR
      • Genomic Profiling Showcase
      • Immunotherapy Sessions & Showcase
      • Implementation into Health Care Delivery
      • Large Scale Bio-data Resources to Support Drug Development (PPPs)
      • Microbial Profiling Showcase
      • Microbiome
      • Neoantigens
      • Next-Gen. Workforce of PM
      • Non-Clinical Services Showcase
      • Pharmacogenomics
      • Point-of Care Dx Platform
      • Precision Public Health
      • Rare Disease Diagnosis
      • Resilience
      • Robust Clinical Decision Support Tools
      • Wellness and Aging Showcase
  • Luminary and Pioneer Awards, honoring individuals who contributed, and continue to contribute, to the field of Precision Medicine
  • 2000+ multidisciplinary attendees, from across the entire spectrum of healthcare, representing different types of companies, technologies, and medical centers with leadership roles in precision medicine
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