Genetic Engineering & Biotechnology News

AUG 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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GENengnews.com | Genetic Engineering & Biotechnology News | AUGUST 2018 | 9 days, physicians steer their patients to com- peting trials." Almac's labs run seven days a week, 365 days a year to provide fast turn- around times. "There's also a rapid move to liquid biop- sies for more complex clinical trial designs," says Dr. Harkin. "We're seeing umbrella studies that incorporate multiple biomark- ers and drugs in the same trial." With small quantities of rare samples, researchers are pressed to use as little as possible; preserving as much as they can for future use. Therefore, Almac Diagnostics recently launched novel DNA and RNA panel solu- tions for multi-arm clinical trials. Based on Illumina's NGS technology, they let clients evaluate multiple biomarkers from one sample, thereby saving tissue, time, and costs. Overall, Dr. Harkin says, "We're seeing pharma clients adopt much more aggressive Phase IB to registrational Phase II or Phase III trials." That poses a particular challenge for both pharmas and their CDx developers. It's sometimes difficult for the diagnostics pipeline to mirror an aggressive drug devel- opment pipeline, especially when the drug developers come to a CDx developer just be- fore entering Phase IB/II. Oftentimes, the biomarker has not even been locked into its final format. To respond to this challenge, Almac Di- agnostics developed a single site premarket approval (PMA) strategy. "We validate the PMA process based upon data from a single lab rather than from multiple sites," says Dr. Harkin. That lets the product go into limited production faster than waiting for studies from multiple sites, but limits products to material from that one lab. Later, as more material is validated, production can be mi- grated from that single lab to a kitted for- mat. This option is particularly useful when there is a risk the kitted version won't be available on time. Looking to the Future "We want to continue to grow organically and to broaden our technology platforms and assay offerings. I'm not planning a divergence in our strategy," Dr. Harkin says. Almac Di- agnostics' growth plan includes diversifying into Parkinson's and Alzheimer's diseases, and blood-based biomarkers. To that end, Almac Diagnostics recently partnered with Archer to identify recirculating DNA in the bloodstream. In the coming years, the Almac Group plans to expand its presence in Japan and other Asian countries, bringing its philoso- phy, experience, and zealous research to those growing markets. High Throughput mAb Characterization ® • Maximize epitope diversity • Identify unique epitopes • Build your IP portfolio The LSA™ instrument is a fully integrated antibody characterization instrument that uses Array SPR to analyze up to 384 bind- ing interactions simultaneously, delivering up to 100x the data in 10% of the time with 1% of the sample requirements of other systems. Combined with our application-focused analytical software, the LSA facilitates high throughput: • Kinetics screening • Epitope binning • Epitope mapping • Quantitation Contact us at: www.carterra-bio.com/lsa info@carterra-bio.com Toll free: 844-642-7635 Characterize the epitope landscape of your entire antibody library at the earliest stages of discovery to make smart decisions: On Your Radar Almac Diagnostics Location 19 Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom Phone 44 (0) 28 3833 7575 Website www.almacgroup.com/diagnostics Principal Paul Harkin, Ph.D. President and Managing Director Number of Employees 170 Focus Almac Diagnostics is a stratified medicine company specializing in biomarker-driven clinical trials that are focused around oncology, im- munology, central nervous system disorders, and infectious diseases. Vital Signs

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