PRNewswire | June 29, 2023
WCG, one of the world's leading providers of solutions that measurably improve the quality, efficiency, and safety of clinical research, recently announced a partnership with Mint Medical to leverage its mint Lesion™ radiology platform for oncology trials.
The mint Lesion™ software is used for standardized and computer-assisted review of medical imaging according to defined protocols, guidelines, and workflows. Compliant and highly configurable, mint Lesion™ is a trusted imaging software for oncology clinical trials, offering quick deployment and more than 20 standardized and configurable response criteria templates out of the box.
Through this partnership, WCG will combine its suite of clinical trial management solutions: operational processes, quality systems, imaging solutions, technology, and expansive reviewer network with mint Lesion's™ verified, read-ready platform, structured reporting, and site-specific workflows for a best-in-class solution for oncology trials.
"The combination of WCG and Mint Medical offers a powerful solution to the market. WCG's teams are experts in study management and have a proven record of managing international clinical trials across all therapeutic areas and indications, including oncology," said Terri Moench, president, WCG Clinical Research Solutions. "Our ISO-certified processes ensure the processing of participant images received from sites are meticulously planned, implemented, and monitored for success. Combine that with mint Lesion™, a technology built to keep pace with changing requirements and the demand for new response criteria, and you have a solution that is unmatched in the industry."
"WCG impressed us with their swift and sound implementation of our groundbreaking technology," said Matthew Hayden, executive director of Clinical Research Operations, Mint Medical. "After just one in-person meeting we crafted a fully operational, fully compliant reading platform that was built and ready for live trial use in just one month. Through this collaborative endeavor, we have forged a dynamic partnership that ensures rapid adaptability to our customers' evolving needs and requirements."
About Mint Medical
Mint Medical GmbH located in Heidelberg/Germany was founded in 2010 as a spin-off of German Cancer Research Center. The company commits itself to developing innovative software solutions in the field of medical imaging and combines image assessment and reporting in one system by considering guidelines for each clinical application context. A particular focus is currently being set on the field of oncology where the software platform mint Lesion™ is applied in clinical routine and clinical trials. Customers of Mint Medical are radiological practices, (university) hospitals, cancer centers, (Imaging) CROs, as well as pharmaceutical and biotech companies all over the world. In addition to the headquarters in Germany, the company has a subsidiary, Mint Medical Inc., in New Jersey, USA.
WCG is a global leader of solutions that measurably improve and accelerate clinical research. Biopharmaceutical and medical device companies, contract research organizations (CROs), research institutions, and sites partner with us for our unmatched expertise, data intelligence, and purpose-built technology to make informed decisions and optimize study outcomes, while maintaining the highest standards of human participant protection. WCG raises the bar by pioneering new concepts, reimagining processes, fostering compliance and safety, and empowering those who perform clinical trials to accelerate the delivery of medical therapies and devices that improve lives.
PRNewswire | July 17, 2023
Cleveland Clinic Laboratories and LabConnect have announced a strategic alliance to accelerate clinical trials and connect patients to new medicines for improved patient care.
Through this alliance, LabConnect will utilize Cleveland Clinic Laboratories, the reference laboratory within Cleveland Clinic. LabConnect will leverage the health system's extensive array of testing and assay validation services to support laboratory testing for an increasing number of clinical trials.
"This new collaboration will enable our organizations to leverage our complementary strengths to deliver cutting edge testing to an expanded patient base, furthering the mission of Cleveland Clinic to touch more lives," said Brian Rubin, M.D., PhD., chairman of Pathology and Laboratory Medicine Institute at Cleveland Clinic.
The alliance will also significantly accelerate turnaround times for testing results and help researchers achieve clinical trial milestones sooner, resulting in more efficiently developing therapies for patients.
"With our shared mission to create healthier communities, we are excited about this alliance with Cleveland Clinic Laboratories to further accelerate the development of new medicines for patients around the world," said Dawn Sherman, LabConnect Chief Executive Officer.
LabConnect will also establish a new facility to process samples for testing in Cleveland, which is anticipated to result in potential new job opportunities for Northeast Ohio as part of the Cleveland Innovation District.
Partnering with pharmaceutical and biotechnology companies, contract research organizations (CROs), and foundations/non-governmental organizations (NGOs), LabConnect provides innovative central laboratory support services for clinical trials of all sizes and complexity across the globe. As the requirements for clinical trials and the drug development process have become more complex, LabConnect meets these requirements by offering researchers scientific and technical expertise for all laboratory-related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions tailored to each trial.
Cleveland Clinic performs more than 23 million tests each year in Ohio, providing access to high-quality, cost-effective, and convenient laboratory services. More than 100 board-certified anatomic and clinical pathologists, paired with hundreds of expertly trained medical technologists and laboratory technicians, provide essential services and test development to guide clinical decision making for more than 5,000 clients locally and globally.
LabConnect's Co-founder and Chief Development Officer, Jeff Mayhew stated, "With our combined team bringing an unparalleled breadth and depth of experience and expertise, our clients have access to the top clinicians and scientists in the world to help them develop their lab scientific strategy and optimize their protocol for accelerating the development of new medicines."
"By broadening access to expertise and quality care in pathology and laboratory medicine, we are able to continue evolving our services." said Ziad Peerwani, MD, Medical Director of Cleveland Clinic Laboratories. "Through this teamwork, we will support and elevate our work with local and global communities while creating the care for tomorrow."
About Cleveland Clinic
Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Among Cleveland Clinic's 77,000 employees worldwide are more than 5,658 salaried physicians and researchers, and 19,000 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,665-bed health system that includes a 173-acre main campus near downtown Cleveland, 22 hospitals, more than 275 outpatient facilities, including locations in northeast Ohio; southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2022, there were 12.8 million outpatient encounters, 303,000 hospital admissions and observations, and 270,000 surgeries and procedures throughout Cleveland Clinic's health system. Patients came for treatment from every state and 185 countries.
LabConnect improves lives by partnering with pharmaceutical and biotechnology companies, contract research organizations (CROs), and foundations/non-governmental organizations (NGOs), to accelerate the development of new medicines around the world. LabConnect delivers a unique combination of support services through Central Laboratory Services and Functional Service Provider Solutions that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex clinical trials.
PHARMACY MARKET, PHARMA TECH
Globenewswire | August 22, 2023
Timber Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to be acquired by LEO US Holding, Inc. a wholly-owned subsidiary of LEO Pharma A/S, in a total transaction value of up to $36 million with (i) an initial upfront consideration of $14 million and (ii) up to an additional $22.0 million in contingent value rights (CVRs) payable upon achievement of certain milestones described below. All of the issued and outstanding shares of capital stock and other equity interests of Timber will be converted into the right to receive the initial upfront consideration, less the payments for certain outstanding warrants that contain a Black Scholes cash payout value. For example, based on a current estimate of the Black Scholes value of such warrants of approximately $5.1 million, subject to change based on the assumptions detailed below, Timber expects the initial amount per share to be paid to Timber stockholders to be approximately $2.62 based on approximately 3.4 million shares of Timber common stock and restricted stock issued and outstanding as of August 20, 2023.
The current estimated value to stockholders is based on an implied value assigned to certain outstanding warrants based on Black Scholes option pricing model as of August 18, 2023. This value will not be finalized until the closing of the merger and is subject to increase or decrease based on certain variables, including the actual trading price of Timber at the time of the merger and the trading volatility of Timber common stock prior to the merger.
The CVRs that Timber stockholders will receive provide for the payment of up to an additional $22 million with respect to specific milestones for TMB-001, of which up to $12 million is related to FDA approval of TMB-001 by October 1, 2025 for the treatment of congenital ichthyosis, and up to $10 million of which is related to the first achievement of TMB-001 net sales exceeding $100 million within four consecutive calendar quarters by December 31, 2028. As part of the transaction, LEO Pharma has agreed to provide Timber with a bridge loan of up to $3.0 million, subject to certain conditions. The payments of the CVRs are subject to certain deductions relating to the repayment of 50% of the bridge loan provided by LEO Pharma to Timber in connection with the merger.
John Koconis, Chairman and Chief Executive Officer of Timber, said, “We are very pleased to deliver a transaction that will maximize long term value for Timber’s shareholders. LEO Pharma is a leader in global dermatology with a mission that matches our own - a relentless pursuit to help patients suffering from skin diseases.
“LEO’s expertise and global footprint make it the best choice to advance and achieve the full potential of Timber’s portfolio of product candidates. We believe that LEO has the potential to establish TMB-001 as the standard of care in the treatment of congenital ichthyosis, a devastating, rare disease.
“Finally, I would like to sincerely thank our dedicated team at Timber for their tireless efforts, and the clinical investigators, medical professionals, patients and families whose personal contributions have been instrumental in shaping our understanding of TMB-001.”
The transaction has been unanimously approved by the Boards of Directors of both companies and is expected to close in the fourth quarter of 2023, subject to customary closing conditions, including approval by the holders of a majority of the shares of Timber’s common stock. Following completion of the transaction, Timber will become a privately held company and shares of Timber’s common stock will no longer be listed on any public market.
Timber will file a Current Report on Form 8-K with the Securities and Exchange Commission (“SEC”) that will include a copy of the merger agreement and the CVR agreement and will contain a more detailed description of the merger and the consideration to be received by Timber stockholders.
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,700 people, serving millions of patients across the world. In 2022, LEO Pharma generated net sales of DKK 10.6 billion.
About Timber Pharmaceuticals, Inc.
Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing, and control) and safety profiles. Timber is focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, visit www.timberpharma.com.