Curia | February 15, 2022
Curia, formerly AMRI, a leading contract research, development and manufacturing organization, announced that Integrity Bio and LakePharma, two companies that it acquired last year, have fully transitioned to the Curia brand. This change reflects the accelerated organizational integration of the acquired companies into Curia and its provision of comprehensive biologics discovery, development and manufacturing solutions to customers. Curia completed the acquisition of Integrity Bio in August 2021 and closed the LakePharma transaction in September 2021.
“The addition of LakePharma and Integrity Bio demonstrate our commitment to expanding and deepening our biologics capabilities. We have moved quickly to integrate our expanded organization so we can provide comprehensive technology and scientific solutions that enable customers to advance their biologics candidates from R&D through manufacturing. More than a name change, the combined Curia organization brings a singular focus on creating a distinctive customer experience designed to accelerate projects and navigate complexity, all driven by a shared commitment to the mission of improving patients’ lives."
Curia Chairman and CEO John Ratliff
Curia, formerly AMRI, is a leading contract research, development and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s 3,700 employees at 29 locations across the U.S., Europe and Asia help its customers advance from curiosity to cure.
SurGenTec® | March 03, 2022
SurGenTec®, a privately held spine and orthopedic technology company based in Boca Raton, FL, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for ION™ Screw, its proprietary stand-alone spine fixation implant. This unique device can be used to treat a variety of pathologies throughout the spine from C2-S1. The patented ION implant is the smallest posterior fixation implant cleared for spine surgery – smaller than the size of a dime – and can be placed through a tiny incision with minimal tissue disruption. ION screws are enhanced with Nanotex™ surface technology designed with bony interdigitation in mind. ION provides patients with a treatment option between conservative care and major interbody fusion in the algorithm of care.
“The ION screw technology truly changes the game for spine surgery. Patients are looking for options outside traditional bulky metallic devices such as pedicle screws and interspinous plates. This minimally invasive option provides excellent fixation with zero profile. It’s a non-intimidating solution for patients that need to undergo a spine surgery procedure. We are thrilled to announce the addition of ION to our portfolio. Our team has put years into pre-clinical research and development to create this truly novel spinal fixation option. Our team managed to create a ‘micro’ implant with a unique surface technology that provides fixation without the need for cumbersome implants,” added Greenhalgh.
Travis Greenhalgh, Founder and Chief Executive Officer of SurGenTec
ION can be used in a variety of open or true minimally invasive surgery (MIS) applications including facet fusions, adjunct to decompressive procedures, the treatment of adjacent level disease or to provide added stability with interbody fusions. The ION facet screw system instruments were designed to minimize tissue trauma and incision size while delivering the ION implants to the surgical location. "The ION system is a great fit for the ambulatory surgery center environment by providing a cost-effective solution for physicians looking to minimize trauma while still providing a high level of spinal care to patients. Patients are demanding access to a more efficient operating environment with less risk of illness and disease transmission," said Andrew Shoup, Chief Operating Officer of SurGenTec.
“ION represents a tremendous paradigm shift in the ability to treat my patients suffering from chronic degenerative lumbar conditions more definitively and less invasively,” said Dawood Sayed M.D., Division Chief and Professor of Anesthesiology and Pain Medicine at The University of Kansas Medical Center in reference to the recent FDA cleared ION facet screw system. “Traditionally, our patients with chronic back pain from lumbar degenerative disc disease, spondylosis, and spondylolisthesis are offered temporary relief with injections and ablations or invasive open surgical procedures. ION bridges an important gap for patients and physicians seeking less invasive options for these debilitating conditions. I am very honored to be amongst the first in the world to offer this remarkable treatment at our medical center,” continued Sayed.
Unlike other spinal fixation options, the ION has zero profile above the bone which may prevent soft tissue contact and the potential for irritation. The implants may be packed with bone graft prior to and after insertion to help facilitate fusion while providing an opportunity for bone to bridge over the implant and prevent implant migration.
“Using the ION system was intuitive and safe. It allowed me to provide a less invasive solution than I would have typically provided. The standard of care is changing, and ION offers a simple solution to advanced spinal conditions,” said Dr. Raphael Roybal M.D., orthopedic spine surgeon Coral Gables, FL.
SurGenTec is a privately owned medical device company based in Boca Raton, Florida that is focused on unique technologies for the orthopedic and spine fields. SurGenTec develops and manufactures innovative products with patient and surgeon safety in mind. SurGenTec looks to launch ION immediately, with plans in the future of obtaining CE mark to market overseas. The vast pipeline of unique implants, instruments, biologics and ancillary solutions will continue to develop through a high level of internal research and development. SurGenTec currently has multiple products lines to market which are sold within the US and internationally. In 2018 and 2020, SurGenTec received the Spine Technology Awards for their ALARA™ target needle system and 3D Graftrasp presented at NASS.
Twelve Consulting Group, | February 11, 2022
Twelve Consulting Group, a consultancy firm specializingin designing and delivering cloud-based solutions, has formalized its partnership with Celonis, the global leader in execution management.
This partnership combines Twelve CG’s technology consulting expertise with Celonis’ market leading process mining and execution management capabilities, enabling customers to optimize their business operations, identify inefficiencies and unlock their full execution capacity.
The Celonis Execution Management System (EMS) provides companies with a modern way to understand and execute their business processes, eliminating billions of dollars in inefficiencies. The EMS powers all facets of business execution, including real-time data ingestion, process and task mining, planning and simulation, visualization and daily management, and targeted action flows to course correct in real-time.
“By partnering with Celonis, we’ll be able to help our customers identify broken processes and execution gaps. And in addition, we can use the Celonis platform to fix those process issues and unlock efficiencies and value. This collaboration brings together the strengths of both organizations to deliver exceptional business outcomes and improve performance for our joint customers.”
Jon Howard, Director of Solution Innovation at Twelve CG
“Today’s businesses need to be able to see and understand processes before they can effectively act. Our Execution Management System helps customers identify and fix failing business processes, and addresses every facet of execution management from analytics, to strategy and planning, management, actions and automation,” said Nicole Gallant, VP Partner Management North America at Celonis. “Partnering with Twelve CG will help enterprises close the execution gaps that have been holding them back from achieving full execution capacity.”
About Twelve Consulting Group
Founded in 2013 by Jill King, Twelve Consulting Group leverages leading cloud-based technologies to help customers unlock potential with smarter data. Twelve CG works with 100+ customers across the CPG, Pharmaceutical and Technology industries to solve mission critical business challenges with speed, accuracy and agility.
McQuade | January 06, 2022
The McQuade Center for Strategic Research and Development, LLC, a member of the global Otsuka family of pharmaceutical companies, and Mindset Pharma Inc. announce a collaboration that will support the development of psychedelic medicines. MSRD has made a strategic investment to support the discovery and development of novel chemical entity assets of Mindset, a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs.
“Exploring multiple paths is essential as we work to address the unique needs of individuals living with mental health conditions. We look forward to collaborating with Mindset on these assets and are hopeful that medical psychedelics could be approved to treat mental illness in the future.”
Robert McQuade, Ph.D., president, McQuade Center for Strategic Research and Development, LLC, and chief strategic officer, Otsuka Pharmaceutical Development & Commercialization, Inc
MSRD, which identifies and supports early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders, will financially and operationally support the development of two families of Mindset’s novel medical psychedelic compounds through Phase 1a and Phase 1b clinical trials. MSRD has made an upfront cash payment of $5 million USD to Mindset and under the terms of the agreement, MSRD and Mindset may agree to expand the collaboration to continue to develop the compounds as pharmaceutical products.
In addition, Mindset has granted MSRD a right of first refusal with respect to any asset sale, exclusive licensing or collaboration opportunities pertaining to the drugs and a right of first negotiation with respect to a merger, acquisition or asset sale related to Mindset, both in exchange for the upfront payment, further collaboration, and funding of the development of Mindset’s novel compounds. MSRD also has the ability to potentially receive single-digit percentage royalty payments under certain circumstances when the right of first refusal is not consummated or the agreement is terminated.
“It is our great pleasure to collaborate with MSRD, a member company of Otsuka, to further the development of two of our families of novel psychedelic compounds. We look forward to leveraging their extensive experience in drug development and CNS indications to accelerate and de-risk our development pathway as we prepare to launch clinical trials,” said James Lanthier, chief executive officer of Mindset. “There is a high unmet need for innovative treatments of mental illness. This collaboration further validates our belief that optimized and patentable next-generation psychedelic compounds will be the future of treatments for mental illness.”
Mr. Richard Patricio, chairman of Mindset’s board, added, “This transformational transaction is a validation of what our team has accomplished over the last several years. We are ecstatic that Otsuka has chosen to collaborate with Mindset in the novel psychedelic drug development space and see this as a pivotal moment in Mindset’s maturation. Our team is excited to work closely with MSRD to help meet the unmet needs of millions of people worldwide suffering with a variety of mental disorders. The future is truly exciting.”
About Mindset Pharma
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds. For further information on Mindset,
About the McQuade Center for Strategic Research and Development (MSRD)
Established in 2019, by the Otsuka pharmaceutical business in the U.S., the mission of MSRD is to search for, identify, and fund innovative early-stage research and development programs that have the potential to build the future portfolio of Otsuka products.
Otsuka is dedicated to investing in innovative and creative products in areas of unmet need and MSRD was created as an extension of this commitment to support and identify early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.