Regis | February 18, 2021
Regis Technologies, Inc. today reported the culmination of a significant extension of their laboratory facilities for the development of dynamic pharmaceutical ingredients (APIs) situated in Morton Grove, Illinois. The extension, which pairs the organization's ability to take on new development projects, is currently completely operational. It expands capacities across Regis' custom pharmaceutical service contributions, including analytical development, process chemistry, solid state chemistry, validation, stability studies, and commercialization.
Regis works in serving the API development and assembling needs of medium sized and arising pharmaceutical and biotechnology organizations. Their blend of top notch, full-service CDMO contributions and individualized client consideration has energized developing demand for their services. The new lab extension activity was dispatched two years prior in light of this demand, empowering Regis to give the new limit something to do during this period of uncommon scarcity for U.S.- based exhaustive, experienced API development and assembling services.
The new 9,000-square-foot development incorporates extra process chemistry and analytical research centers, a committed ICP-MS suite, extra environment controlled capacity, 14 extra smoke hoods, a few new kilo-scale reactors, and process security hardware for reaction calorimetry estimations to guarantee safe control and scale-up. What's more, the new labs have an advanced variable air volume (VAV) air framework for clean energy-efficient operations.
“The boom in biotechnology firms developing novel small molecule drugs has contributed to our robust growth in recent years,” said Joe Miller, PhD, CTO at Regis Technologies. “We provide top quality end-to-end API development and manufacturing services for clinical-stage companies and for commercial-stage firms serving medium-sized, rare disease and other specialty markets. This focus enables us to provide a comprehensive range of services that are tailored to our customers’ individual needs.”
Dr. Miller continued, “Our investment in this new capacity broadens Regis’ capabilities and our flexibility to support the growing need for U.S.-based custom pharma services. The desire to reduce supply chain risk, ensure quality, and maintain intellectual property is driving a surging interest in domestic on-boarding of API development and manufacturing. This timely expansion allows us to meet this demand, enabling our scientists to support additional API projects as our customers advance their novel drugs to market.”
Regis Technologies, Inc. is a U.S.-based CDMO specializing in small molecule APIs. We offer a full range of services to support the development of our clients' lead molecules from preclinical and clinical API through commercialization, including process research and development, solid state chemistry, analytical development, stability services, GMP API manufacturing, and micronization. In addition, Regis also offers an innovative line of proprietary chromatography products sold throughout the world. Regis is privately owned and operated and has been in business in the Chicago area since 1956.
Veeva Systems | October 07, 2021
Veeva Systems (NYSE: VEEV ) announced that Celerion has launched Veeva eConsent , a MyVeeva for Patients solution, to provide electronic consent for its Phase I clinical trials obtain. With Veeva eConsent, Celerion is moving from manual and paper-based consent forms to a fully digital process. The company uses Veeva eConsent for several studies and has already given their consent to more than 200 test subjects.
Covid-19 limited the time we could spend with attendees. So we needed new and digital ways to advance our studies while meeting regulatory requirements for proper consent,
- Staci McDonald , Executive Director, Scientific Clinical Operations at Celerion .
An easy-to-use solution that can keep pace with our fast-paced environment and improves the participants' understanding of the study processes. The implementation of the solution went smoothly, and the feedback from the study teams, on-site staff and participants was positive. "
Celerion, a leading global provider of early clinical research services, uses Veeva SiteVault to digitally create, manage and distribute informed consent (ICF). Patients can then securely access the eConsent document and complete the consent process via a mobile device. This simplifies the comparison of documents and reduces the administrative effort for the locations. Thanks to a seamless flow of information, Celerion has a complete overview of the status of consent and can thus improve study compliance and monitoring.
Celerion is driving industry collaboration by leveraging digital solutions that enable patient-centric, paperless clinical trials, Veeva eConsent improves the process of informed consent for everyone Stakeholders by providing an intuitive and digital experience for patients and easy collaboration with locations and IRBs for sponsors.
- Tim Davis , vice president, MyVeeva for Patients at Veeva Systems.
About Veeva Systems
Veeva is the world's leading provider of cloud software for the life science industry. Veeva is committed to innovation, product quality and customer success, serving more than 1,000 customers from the world's largest pharmaceutical companies to emerging biotech companies. As a not-for-profit, Veeva is committed to aligning the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.
Aspire | September 24, 2021
H.I.G. Capital, LLC, a leading global alternative investment firm with $45 billion of equity capital under management, is pleased to announce that one of its affiliates has acquired Aspire Pharma Limited, a leading UK provider of niche generic and branded specialty pharmaceuticals, alongside its founder Graham Fraser-Pye. The financial terms of the transaction have not been disclosed.
Aspire licenses and develops niche generic and specialty pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets that are often underserved. The business holds leadership positions in urology, ophthalmology, CNS and dermatology, with a highly diversified portfolio of more than 250 products across multiple categories, including branded specialty products and unbranded niche generics. H.I.G., together with the management team, aims to continue Aspire’s strong track record of organic growth and to support new initiatives, such as M&A and international expansion. The existing management team of Aspire Pharma will remain in place, with Graham Fraser-Pye taking the role of Chairman.
I am very pleased to welcome H.I.G. as a key investor in the future of Aspire Pharma. Since our foundation in 2009, we have grown rapidly and consistently through our astute strategic choices and extensive development know-how. H.I.G., with its significant financial and geographic reach, will help us maintain our impressive growth trajectory and take Aspire into another exciting phase for its people and customers. We remain committed to the development and supply of innovative products and medicines that offer value to our customers and make a difference to the lives of patients.
- Graham Fraser-Pye
We are delighted to be supporting Graham and his team to further build upon Aspire’s success. The Company’s track record of identifying, developing and launching niche pharmaceutical products, coupled with H.I.G.’s international presence and history of supporting organic and acquisitive growth in its portfolio companies, underpins an exciting next chapter for Aspire.
- John Harper, Managing Director and Head of the H.I.G. Europe Lower Middle Market LBO team in London
Aspire was founded in 2009. Aspire has an asset-light business model that focuses on R&D, business development and sales and marketing, while outsourcing manufacturing and distribution to specialist third parties.
About H.I.G. Capital
H.I.G. is a leading global private equity and alternative assets investment firm with $45 billion of equity capital under management.* Based in Miami, and with European offices in London, Hamburg, Madrid, Milan, Paris, and U.S. and Latin American offices in New York, Boston, Chicago, Dallas, Los Angeles, San Francisco, Atlanta, Bogotá, Rio de Janeiro and São Paulo, H.I.G. specializes in providing both debt and equity capital to small and mid-sized companies, utilizing a flexible and operationally focused/ value-added approach