PHARMA TECH

LEO Pharma and Veeva Systems Partner for Digital Patient-Centered Trials

LEO Pharma | September 30, 2021

LEO Pharma , a global leader in medical dermatology, and Veeva Systems announced a strategic technology partnership to enable scalable digital trials, paperless and patient-centered.

Building on its success with the Veeva Clinical Operations suite, LEO Pharma will complete its standardization on existing Veeva clinical technology, be an early adopter of future Veeva solutions, and help shape the Veeva digital trials roadmap. By adopting technology and optimized business processes, LEO Pharma plans to achieve the following goals while maintaining the highest standards in data accuracy, regulatory compliance and patient safety:
  • Significant improvement in the patient experience
  • Increased patient diversity through decentralized trials
  • Greater precision of clinical data
  • 25% reduction in the cost of clinical trials
  • 25% reduction in clinical trial time

LEO Pharma will use the integrated suite of Veeva clinical products, including eTMF, CTMS, CDMS, Site Connect, eConsent, ePRO, Virtual Visits and eSource.

We were exploring ways to transform clinical trials, but COVID-19 has accelerated this process. By responding quickly to changing market dynamics, we allowed our testing to continue without delay. The partnership with Veeva supports our 2030 strategy because it will help us deliver innovative treatments to patients faster while supporting a more sustainable business. Veeva's results in terms of product excellence make it the ideal long-term partner to help us achieve this goal, which allows us to help patients better and faster. 

- Jörg Möller, Executive Vice President and Head of R&D at LEO Pharma.

We are excited and honored to extend our long-standing partnership with LEO Pharma to be an early adopter of our comprehensive digital testing platform, We intend to help the industry move forward with a scalable digital trials platform that dramatically improves the clinical trial process for patients, sites and sponsors. 

- Peter Gassner , Founder and CEO of Veeva

About Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence and customer success, Veeva has more than 1,000 customers, from the world's largest pharmaceutical companies to emerging biotechnology companies. As a public benefit company, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.

About LEO Pharma
LEO Pharma helps people achieve healthy skin. The company is a leader in the field of medical dermatology, with a strong R&D portfolio, a wide range of therapies and a pioneering spirit. Founded in 1908 and majority-owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advancing the science of dermatology, setting new standards of care for people with skin diseases. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company achieved net sales of 1,359 million euros.

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Evergreen Theragnostics Increases Alpha Radiopharmaceutical Production Capabilities

Evergreen Theragnostics, Inc. | July 17, 2021

Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) has started a major strategic expansion at its Springfield, NJ manufacturing facility. Evergreen has already started expanding to build a GMP state-of-the-art alpha emitter production center, incorporated into Evergreen's current facility, with the Evergreen Springfield Facility scheduled to open within the next two months. The expansion, which is scheduled to open in the first quarter of 2022, will strengthen Evergreen's capacity to serve alpha-based radiopharmaceutical projects from pre-clinical pharmaceutical research through commercial production and supply. Evergreen's new alpha program will research and manufacture novel radiopharmaceuticals, including Actinium-225 (Ac-225), Astatine-211 (At-211), Lead-212 (Pb-212), and Thorium-227 (Th-227). Targeted Alpha Therapy (TAT), which uses the radionuclides mentioned above, is a growing segment of therapeutic radiopharmaceuticals owing to its unprecedented promise of improving patient clinical outcomes in cancer. This new class of medicines, however, poses significant difficulties in both clinical development and manufacturing. The new facility was created by combining Evergreen's expertise in clinical production of TAT radiopharmaceuticals with a collaboration with Tema Sinergie, a leading supplier of radiopharmaceutical manufacturing equipment. This resulted in developing specifically made production equipment to meet the challenges associated with manufacturing alpha-emitting radiopharmaceuticals in a complete cGMP environment. About Evergreen Theragnostics, Inc. Evergreen Theragnostics, founded in 2019, is a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) headquartered in the United States. Evergreen will offer highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals from early development through commercialization, with a state-of-the-art global GMP facility opening in Q3'21. The company was founded by a team with extensive experience in radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management. About Tema Sinergie Tema Sinergie, founded in 1985, is a pioneer and global leader in the design and manufacture of shielded isolators for the nuclear medicine market, consistently working to extend its proven leadership onto the market of aseptic containment isolator systems to the pharmaceutical, biotech, and ATMP business branches. The company has obtained ISO 9001 and ISO 13485 certifications.

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RESEARCH

Ethypharm to acquire Altan Pharma, allowing it to enter the Spanish market and expand its Critical Care portfolio and R&D pipeline.

Ethypharm | June 19, 2021

Ethypharm reports today that it has entered into a definitive agreement to acquire Altan Pharma, a specialty pharmaceutical company that develops, manufactures and markets injectable medicines for hospital use. On account of the strong presence of Altan Pharma in Spain, Ethypharm will reach full commercial coverage of the main 5 European markets after shutting, which is expected in the second half of 2021. Ethypharm will likewise profit with an enlarged portfolio of great hospital injectable products and a rich pipeline of R&D projects, which fit perfectly with its current Critical Care franchise. "Altan Pharma's product portfolio and geographic coverage are highly complementary to those of Ethypharm. We look forward to welcoming Altan Pharma's teams, as we are convinced that together, our product portfolio, our R&D and our industrial expertise, will put us in a stronger position to fulfil our commitment to the patients we serve", said Bertrand Deluard, CEO of Ethypharm. "The Altan Pharma acquisition is an important milestone in Ethypharm's transformation journey. By entering the Spanish market and reinforcing our Critical Care franchise, Ethypharm proves once again its ability to execute on its long-term growth ambition." "Joining an established European specialty pharmaceutical company, with a strong direct commercial presence in Europe beyond Spain and in major growth territories for injectable medicines, will be a booster for the international expansion of Altan Pharma's product portfolio" said Guillermo Herrera, CEO of Altan Pharma. "Since its inception in 1998, Altan Pharma has been committed to improving patient care by providing specialty medications of superior quality and value for the benefit of patients and caregivers." About Altan Pharma Altan Pharma is a specialty pharmaceutical company that develops, manufactures and markets injectable medications for the hospital and other provider segments. Altan is a premier, global injectable drug company that is committed to improving patient care by providing specialty medications of superior quality and value for the benefit of patients and caregivers. Altan Pharma currently markets a portfolio of over 40 injectable medications used in pain and anaesthesia, epilepsy, oncology, anti-infectives, cardiovascular, and gynecology and is developing an attractive portfolio of additional products in these areas.

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RESEARCH

Algernon Pharmaceuticals Signs Agreement with Charles River Laboratories for DMT Preclinical Studies

Algernon Pharmaceuticals, Charles River Laboratories | February 11, 2021

Algernon Pharmaceuticals Inc. a clinical stage pharmaceutical development company is pleased to announce that is has signed an agreement with Charles River Laboratories for preclinical studies of AP-188 ("N,N-Dimethyltryptamine or DMT") for the Company's stroke clinical research program. Algernon's preclinical study of DMT will be conducted at the Charles River research facility in Finland. Charles River Laboratories, Inc. is an American corporation specializing in a variety of preclinical and clinical laboratory services for the pharmaceutical, medical device and biotechnology industries. It also supplies assorted biomedical products and research and development outsourcing services for use in the pharmaceutical industry. Algernon recently established a clinical research program for the treatment of stroke zeroed in on DMT, a known psychedelic compound that is part of the tryptamine family. The Company plans to be the principal company globally to seek after DMT for stroke in humans and is planning to begin a clinical trial as soon as conceivable in 2021. The Company's decision to investigate DMT, called "The Spirit Molecule," and move it into human trials for stroke, is based on various independent, positive preclinical studies demonstrating that DMT advances neurogenesis as well as structural and functional neural plasticity. These are key factors involved in the brain's ability to form and reorganize synaptic connections, which are needed for healing following a brain injury. Unlike other companies recently researching psychedelic drugs, Algernon will be focusing on a sub-hallucinogenic, or microdose of DMT provided by continuous intravenous administration. By pursuing a continuous active microdose, the goal will be to provide patients with the therapeutic benefits of DMT, without having a psychedelic experience. This is an important element when considering treating a patient who has quite recently endured a stroke, wherein medications that cause a hallucinogenic response would cause unwanted confusion and stress. DMT Background N,N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing impacts similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin. DMT happens naturally in many plant species and animals and has been utilized in strict ceremonies as a traditional spiritual medicine by indigenous individuals in the Amazonian basin. DMT can also be synthesized in a laboratory. At higher portions, DMT has a rapid onset, intense psychedelic impacts, and a relatively short duration of action with an estimated half-existence of under fifteen minutes. Like other hallucinogens in the tryptamine family, DMT binds to serotonin receptors to deliver euphoria and psychedelic impacts. Because the impacts of DMT don't last long, it has been alluded to in certain circles as the "businessman's outing". Named the "Spirit Molecule" by Dr. Rick Strassman, an American clinical associate professor of psychiatry and DMT research pioneer, and Algernon consultant, DMT has been shown to induce neuroplasticity in a number of key preclinical studies DMT is believed to activate pathways involved with forming neuron connections and has been shown in studies to increase the number of dendritic spines on cortical neurons. Dendritic spines form synapses (connections) with other neurons and are a major site of molecular activity in the brain. While Dr. Strassman's Phase 1 bolus intravenous human study identified the sub-hallucinogenic portion of DMT in humans, another preclinical animal study demonstrated this same portion level actually retains the neuroplastic impact seen in higher hallucinogenic dosages. Algernon will be investigating an intravenous sub-hallucinogenic portion of DMT in its research and clinical studies. About Algernon Pharmaceuticals Inc. Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

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