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Our Take: New developments ahead for drug development, from genomics to generics

Jan 20, 2020
New developments ahead for drug development, from genomics to generics


With a new year and a new decade underway, we’re seeing a spate of news about innovative alliances and approaches to develop and produce new medical therapies. This week’s special edition of Our Take focuses on recent developments that we believe could have substantial long-term impact.


Mayo Clinic Platform, a strategic initiative launched last year to improve health care through data-derived insights, announced its first venture on Tuesday: the Clinical Data Analytics Platform. Through this venture, Mayo Clinic will partner with a Cambridge, Mass.-based company called nference “to accelerate drug discovery and development across the biopharmaceutical ecosystem.”


As part of this collaboration, Mayo Clinic will deploy a new, “nontraditional” patient privacy model to ensure that all data is de-identified and that Mayo retains control and possession of the data. The de-identified data will be housed in cloud-based containers, and providers, payers, and pharmaceutical companies will be able to access it through application programming interfaces — the data never actually leaves the containers. The platform’s federated architecture will prevent anyone who accesses the data from re-identifying it, a measure designed to further safeguard patients’ privacy.


“The whole point of doing this is [to develop] new therapies faster, and get those therapies targeted to the right people,” Andy Danielsen, chair of Mayo Clinic Ventures, told HealthLeaders Media, noting that the venture should make it possible for drugs to be produced at lower cost by curtailing failures in clinical trials.


Mayo Clinic also announced recently that it is creating a library of genomic sequencing data in collaboration with Helix. The library will include data on 100,000 “consented” participants whose DNA will undergo Exome+ sequencing to screen for genetic variants that can increase the risk for disease. Initially, the participants will receive screening results for three “highly actionable” conditions: familial hypercholesterolemia, hereditary breast and ovarian cancer (BRCA1 and BRCA2), and a type of hereditary colorectal cancer called Lynch syndrome.


Another notable name in gene therapy research, Nationwide Children’s Hospital in Columbus, Ohio, also is stepping up its fight against life-threatening inherited diseases. The hospital’s Abigail Wexner Research Institute (AWRI) already develops gene therapies in a small-scale onsite facility — mainly gene products used in early-stage clinical trials. Last Monday, the hospital announced that it is creating a for-profit subsidiary called Andelyn Biosciences that will manufacture gene therapy products on a commercial scale.


“The goal of Andelyn Biosciences is to support the advancement of novel gene therapies for rare genetic diseases by building commercial manufacturing capacity which is needed as more of these treatments are developed over the coming years,” AWRI’s chief scientific officer, Dr. Dennis Durbin, said in a press statement. “As a for-profit company, revenues generated by Andelyn Biosciences will allow us to reinvest back into the nonprofit research mission at AWRI, supporting its commitment to advance best outcomes for children around the world.”


Andelyn is expected to be operational in 2023.


While we’re on the topic of genetics, 23andMe signed an agreement licensing the first drug it developed entirely in-house to Barcelona-based drugmaker Almirall. The drug is a bispecific monoclonal antibody that blocks the IL-36 cytokine subfamily; it has already been tested in animal studies, and now Almirall will continue its development in clinical trials.


Meanwhile, veteran biotech venture capitalist Alexis Borisy — who has founded or helped launch 15 companies, including Blueprint Medicines, which just had its first drug approved (Ayvakit [avapritinib]), and Foundation Medicine, which Roche paid $2.4 billion for in 2018 — is launching a new startup in Cambridge, Mass., called EQRx.


Borisy’s intent with EQRx is to develop new drugs that are similar to high-priced drugs already on the market, and then sell them at “dramatically lower” prices, according to a news release.


“[T]he pricing of new therapeutic approaches is pushing beyond the limits of common sense, preventing people and society from equally benefiting from innovation,” Borisy said in the press statement. “The time is now for a market-based solution to rising drug costs,” he added.


Borisy’s EQRx co-founders are Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, and Dr. Sandra Horning, former chief medical officer at Genentech/Roche.


In other news, Civica Rx, the nonprofit generic drug company created nearly two years ago by several of the country’s leading health systems, just signed a seven-year agreement with Thermo Fisher Scientific to develop and manufacture its own drugs.


Until now, Civica Rx has collaborated with drugmakers that have manufacturing facilities to produce drugs with the Civica Rx label. This new partnership with Thermo Fisher will allow Civica Rx to build an internal pipeline of drugs, and Civica Rx will own the Abbreviated New Drug Applications for those drugs.


Civica Rx said the collaboration would focus at first on nine critical drugs that either have been in short supply or currently have too few manufacturers, putting the supply at risk.


Last but certainly not least, the venture capital arm of University of Pittsburgh Medical Center, UPMC Enterprises, said in a press release that it will invest $1 billion in the development of new drugs, diagnostics, and devices by 2024. UPMC Enterprises has already formed five companies in the translational sciences sector in the last couple of years. Although the group initially concentrated on immunotherapies for cancer, transplantation, and diseases related to aging, it has expanded its focus into areas such as retinal and respiratory disease, autoimmune diseases, and neuroinflammation.


What else you need to know
Teladoc is buying InTouch Health for $600 million. Santa Barbara-based InTouch Health provides telehealth solutions for more than 450 hospitals and health systems across the country, including powerhouses such as HCA, Providence St. Joseph Health, and Kaiser Permanente. Teladoc will pay approximately $150 million in cash and $450 million in Teladoc Health common stock, according to the company’s news release. The transaction is expected to close in the second quarter, provided customary closing conditions are met.


Partners HealthCare and One Medical will collaborate to better coordinate care and expand access to primary care in Boston. One Medical is a membership-based primary care platform with 77 medical offices nationwide and backing by Google parent company Alphabet. Two of One Medical’s locations are in Boston and will be renamed One Medical with Mass General Brigham, in light of Partners’ recently announced plans to rebrand itself as Mass General Brigham. The organizations said in a press statement that they will become clinically and digitally integrated across primary and specialty care settings.


Dartmouth-Hitchcock Health and GraniteOne filed for approval with New Hampshire’s attorney general’s Charitable Trust Unit to merge, according to a report by Valley News. The health systems, based in Lebanon, N.H., and Manchester, N.H., respectively, announced their plans to merge a year ago and signed a formal agreement in October.


Kaiser Permanente is launching Futuro Health, a $130 million nonprofit, in partnership with Service Employees International Union-United Healthcare Workers West to address California’s shortage of health care workers. Their goal is to graduate 10,000 new licensed, credentialed workers — including nurses, medical coders, health information technicians, radiology technicians, and laboratory staff — in the next four years. Van Ton-Quinlivan will lead the new organization.


CVS Health plans to add 600 new HealthHUBs to its stores by the end of this year and another 900 by the end of 2021, according to a Forbes article citing CVS’ CEO, Larry Merlo, who added that the HealthHUBs will be able to cover 80% of what primary care physicians can treat. The company also intends to begin offering health plans with low or no copays for Aetna members who use HealthHUBs and other CVS services.


What we’re reading

href=”https://www.forbes.com/sites/robertpearl/2020/01/13/boldest-healthcare-prediction/#2ee6437b6187″>The Boldest Healthcare Prediction For 2020: Business As Usual. Forbes, 1.13.20

href=”https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2019.00466″>Spending And Quality After Three Years Of Medicare’s Voluntary Bundled Payment For Joint Replacement Surgery. Health Affairs, Jan. 2020 (subscription required)


One last thing…
We don’t accept advertising in Our Take (and yes, we are frequently asked to do so). But Dr. Kain was generous enough with his time for our podcast that we offered to let readers know about his upcoming conference. This is from the folks at ACPM:


“Come spend this winter in sunny Newport Beach, CA at the largest conference on Value-Based Care in Orthopedics! The 4th Annual Largest Conference on Orthopedic Value Based Care will focus on the Financial/Operational, Clinical, and Real-world tools necessary to successfully implement value-based care models and stay current with changing rules and regulations affecting the orthopedic space! Go to https://acpm.health/ovbc2020/ to check out the world renowned lineup of speakers, incredible conference program and to register before time runs out!”


Contact Darwin Research Group and we will get right back to you.