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2019 in Review – Major Acquisitions, Population Studies, Gigantic Founding Rounds, Technological Advancements, and ….

The year 2019 comes to an end with significant advancements in precision medicine, genetics, genomics, CRISPR technology, liquid biopsy, and immunotherapy. Highlights and notable news included various technological advancements, genetics and genomics moving more and more into the clinic, the launch and recent successes of population studies, artificial intelligence and machine learning investments and AI potential, advancements and learnings in the area of CRISPR technology and the microbiome, immunotherapy further establishing itself as the leading weapon to attack cancer, and major acquisitions that change the landscape of pharma and biotech. The results speak a clear language: improved patient care via better diagnostic and more precise therapeutics.

Here below a few highlights – not an all-inclusive summary – of what made 2019 so exciting. Find a more complete list of 2019 news on the enlightenbio Industry News site.

The therapeutics sector – pharma / drug discovery

Some of the biggest news in this sector in 2019 followed the FDA approval of Novartis’ new gene therapy drug Zolgensma – a treatment for spinal muscular atrophy for children under 2 years of age – and its high drug price of $2.1M per patient/treatment regimen; the recent FDA approval of Vertex Pharmaceutical’s Trikafta, a gene-based therapy for children with cystic fibrosis; Biogen resurrecting the Alzheimer’s drug Aducanumab and submitting it for drug approval to the FDA, creating new hope for Alzheimer’s patients; while Roche scoring its first U.S. approval of immunotherapy for breast cancer with Tecentriq (atezolizumab) for advanced triple-negative breast cancer. All of these examples nicely demonstrate the ever increasing importance of understanding the molecular mechanisms that define a disease and with that enhancing and translating this knowledge into therapeutic approaches that enhance the success rate of targeted, individualized medicine. Also of note in this sector in 2019 is GSK’s formed partnership with CRISPR pioneer Doudna to establish drug discovery operations in new laboratories in search for new drugs in San Francisco and spending up to $67 million over five years.

Numerous acquisitions across the entire sector of health care

Starting with the January 2019 JP Morgan conference – typically a window into what the new year will have to offer – major acquisition took place throughout the entire year and included Eli Lilly buying Loxo Oncology for $8bn, BMS buying Celgene for $74bn, Roche purchasing gene therapy company Spark Therapeutics for approximately $4.8bn (Spark Therapeutic is the maker of Luxturna, a one-time gene therapy for individuals with an inherited retinal disease), Johnson & Johnson buying surgical robotics company Auris Health, Novartis buying cholesterol drug maker Medicine Co. for $9.7bn, Pfizer acquiring Array Biopharma, Merck buying Peloton Therapeutics in a transaction valued at $1.05bn and drug developer ArQule for $2.7bn, QIAGEN acquiring N-of-One (which enables QIAGEN to expand its decision-support solutions), Exact Sciences buying Genomic Health in a $2.8bn deal (expecting to generate $1.6bn in revenue and grow profit of $1.2bn in 2020), Invitae acquiring Singular Bio to help increase access to genetic screening in early pregnancy, all the while Google is buying Fitbit to position itself against Apple and its AppleWatch.

Major population studies and sequencing/genomics initiatives and partnerships are taking shape

Various population studies/initiatives were either launched or took shape this year, as demonstrated with projects such as… :

These various initiatives and partnerships are likely to accelerate advancements in precision medicine via the move of genomics into the clinical setting, thus increasing the diversity of data, and engaging participants to take ownership of their data.

To overcome the diversity issue challenging the healthcare sector and particular genome-based studies, the NIH funds new centers to expand and diversify the human reference genome. This $29.5M grant will enable to generate and maintain a completely new and comprehensive reference sequence of the human genome that represents human genetic diversity.

Genomic medicine with next-generation sequencing and genetic testing reached new milestones

The first month of 2019 already was rich in content and activities as it started out with a series of announcements emerging from the JP Morgan Healthcare Conference: Invitae exceeding the company’s own prior guidance in testing volume and was boasting double testing volume year over year, and Illumina’s deSouza highlighting that ~12M consumer tests were processed in 2018 alone, or more than the cumulative volume in the previous 3 years expecting consumer testing volumes would continue with this trajectory. While these announcements were highly significant for the genomic/genetic testing sector, Illumina later in the year lowered its full-year expectations, citing near term uncertainties in the direct-to-consumer (DTC) genetic testing market due to privacy concerns and the limited long-term value of genetic tests to consumers. In other news, 23andMe announced it is moving beyond consumer DNA tests and building a clinical trial recruitment business directly competing with Apple which also offers as a service the aggregation of this kind of health information.

Large investments in technologies and companies shaping the industry….

Investments were bountiful, especially in the sector of AI and machine learning (Tempus, Freenome, Sophia Genetics, Healx, Insilico, and PathAI), data platforms (DNAnexus), and in the therapeutic sector (BioNTech, Achilles Therapeutics, ArsenalBio, and Verve Therapeutics). Again, the list shown below is not comprehensive, but simply highlights a few select major investment rounds that took place in 2019:

The other side of 2019 included shutdowns and bankruptcies:

As is often the case in times of fast-paced development, there are also challenges and setbacks that need to be mentioned. Unfortunately, 2019 was no exception and delivered its share of not so good news in the area of precision medicine, including two major shutdowns: the wellness company Arivale and Veritas Genetics. uBiome had to declare bankruptcy amid an FBI investigation due to its billing practices, while a failing fundraising round of $1.5bn valuated Proteus Digital Health may now challenge its future. Arivale stated that they may have “simply been too early”, while Veritas’ challenges  were based on a much needed fundraising round that was hampered by a previous Chinese investment [Note: Veritas only ceases operations in the US and continues to be served by Veritas Europe and Latin America services]. Interestingly, the Veritas Genetics shutdown follows a recent data breach announcement of which no further details are available. PatientsLikeMe, another company that faced fundraising challenges, was forced by U.S. to ditch Chinese investors, and was sold to UnitedHealth Group. Furthermore, an interesting potential data privacy precedent may have taken place in Florida which could open up all consumer DNA sites to law enforcement agencies across the country.

Additional noteworthy news to include in this section:

Technological advancements

Some of the recurring technological themes of 2019 included artificial intelligence/machine learning, and scientific innovations such as the CRISPR technology, liquid biopsy, single cell genomics, and spatial transcriptomics.

Scientific research advancements

On the independent and academic research side, several scientific advancements took place that are noteworthy and listed below:

To sum it all up – 2019 was an eventful and exciting year creating a solid foundation for what is to come in 2020.

We should expect larger technological advancements, with AI/machine learning taking the lead and big data applications such as in drug discovery and clinical decision-making benefitting from these; Population initiatives are expected to be increasing its diversity to help explain genomic differences across populations; Whole genome sequencing will continue on its path of slowly but steadily increasing its footprint in the clinical space, ultimately improving our diagnostic capabilities. Furthermore, it is very conceivable that we’ll witness the potential of liquid biopsies to translate into cheap and accurate simple diagnostic tests. We’ll likely see an emerging elucidation of the role of the microbiome in multiple sclerosis, inflammatory bowel disease and even cancer. All these developments will help drive translation of genetic discoveries and expedite clinical applications. The 2020 JP Morgan healthcare conference, scheduled for this coming week, will surely again live up to its reputation of providing a first glimpse of what the new year has in store of us

Brigitte Ganter

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