In the latest from contract services companies this month, we lead with Enviro's launching of the PATHWAY safety assessment solution. From MedSource comes a new business unit, MedSource Staffing Solutions, which will focus on staffing sourcing and recruitment. And PPD and HLT have co-created a service designed to enhance research capabilities and access to China’s evolving drug development market for the Chinese pharmaceutical industry.
Envigo launches PATHWAY
EAST MILLSTONE, N.J.—Envigo recently debuted PATHWAY, an integrated solution that optimizes non-clinical safety assessment programs to enable first-in-human clinical trials. PATHWAY is designed to manage the complexity of the entire safety assessment process on behalf of Envigo’s pharmaceutical and biotechnology customers by integrating safety assessment study types and bioanalytical support with scientific and regulatory consulting, program design, and project management.
Envigo developed the PATHWAY solution to help its customers navigate the increased scientific and regulatory complexity facing advanced therapies going through safety assessment. The intricacy of design and management of these critical non-clinical programs, and the level of interaction with regulatory bodies required, raises the risk of introducing delays and costs to development programs. PATHWAY has been designed to use Envigo’s capacity, capabilities and experience in the field to optimize safety assessment programs and deliver translational biology insights for first-in-human clinical trials.
“Our deep expertise in the complex fields of biologics and advanced therapies adds particular value to our customers with drug development programs in these growing categories. On our customers’ behalf, we frequently work with regulators to determine the most appropriate interpretation of regulatory guidance as it applies to a specific therapeutic,” said Lee Coney, Envigo’s chief scientific officer.
MedSource creates Staffing Solutions division
HOUSTON—MedSource has expanded with the offering of a new business unit, MedSource Staffing Solutions. The complementary sourcing division of MedSource will continue the dedication to drug development by providing clinical, technical and executive professionals to life-science organizations.
MedSource has recognized the industry’s demand for an innovative clinical staffing provider. The formal launch of MedSource Staffing Solutions allows MedSource to better deliver solutions for the multitude of resource constraints encountered during the life cycle of biotechnology, pharmaceutical and life-science companies.
“Our tagline, ‘Taking Relationships as Seriously as Science,’ is not simply an empty catchphrase, but a standard exemplified by everyone within our organization. With the launch of our staffing solutions division, now more than ever we can continue to focus on identifying passionate people to join our deep network of industry professionals,” mentioned MedSource president and CEO Eric Lund.
MedSource Staffing Solutions is led by MedSource’s current director of Client Services, Billy Howell, who has been MedSource’s head of recruitment for over three years.
“I am excited to apply my previous experience to leading the growth of MedSource Staffing Solutions,” noted Howell. “Over the past 20 years, MedSource has continued to build a strong recruitment engine in addition to our wide experience as a clinical research organization. The skilled team we’ve constructed for this new division has the expertise to deliver staffing solutions from clinical to executive, supporting clients from early clinical development through commercialization.”
HLT and PPD pair up
WILMINGTON, N.C. & BEIJING—Pharmaceutical Product Development LLC (PPD) and Happy Life Tech (HLT) of China have signed an exclusive agreement to develop a distinctive service offering for the China drug development market, delivering data science-driven clinical trials and real-world evidence of drug products’ effectiveness, safety and value.
The strategic collaboration is designed to enhance global pharmaceutical companies’ access to China’s evolving drug development and post-marketing ecosystem to address unmet clinical needs in China, while enhancing research capabilities for the Chinese pharmaceutical industry in the global market. The combined service offerings are powered by HLT’s artificial intelligence and data technology, and PPD’s global expertise in clinical trial management and evidence generation.
“Our collaboration with HLT will provide PPD’s clients with exciting new opportunities in China,” said David Simmons, chairman and CEO of PPD. “Our focus on sites with access to eligible patients is designed to speed patient recruitment at high-performing sites, and to more effectively incorporate Chinese patients into global trials. We will help clients adapt study protocols to the China market, while helping sites enhance quality, drive performance and lead global multicenter trials. In addition, we will intelligently leverage real-world data in China to recruit patients with a high potential for participation in our clients’ studies and to generate real-world insights needed for market access and product uptake.”
“I am very excited about this collaboration. We believe a joint effort between PPD and HLT will empower our clients with unique solutions, significantly increase trial efficiency, reduce costs and ultimately benefit patients in China and around the world,” explained Rujing Gong, founder of HLT. “We’ll also help the Chinese pharma industry be more competitive in the global market through a better registration strategy. China’s research capability has been developing quickly and will play an important role in the global clinical development market in the future. We have strong interest in being involved and in driving the process.”