On January 8, 2016 Moderna Therapeutics, a pioneer in the development of messenger RNA (mRNA) Therapeutics, and Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), reported a strategic collaboration to support Moderna’s evolution as a clinical-stage company (Press release, PPD, JAN 8, 2016, View Source [SID:1234508705]). Covering a broad expanse of drug modalities and therapeutic areas, Moderna’s pipeline has the potential to address the unmet needs of numerous patients worldwide. PPD will be a key partner in advancing Moderna’s proprietary pipeline as it rapidly scales up its clinical efforts in the coming months and years. Schedule your 30 min Free 1stOncology Demo! Under the terms of the agreement, PPD will play a significant role in Moderna’s clinical development efforts, including support for investigational new drug (IND) strategic planning, as well as for clinical trial design and execution. The collaboration is built around a unique risk-sharing model that incentivizes both organizations to achieve shared milestones.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are excited to partner with PPD as we rapidly progress multiple mRNA candidates toward the clinic across our ventures," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are building a high-quality, scalable clinical development capability to match the accelerated output of our mRNA research, which will require the ability to test many mRNA therapeutics in clinical trials in parallel each year. PPD is an ideal partner for Moderna because of its proven track record of quality and delivery at every phase of clinical development. Further, PPD is uniquely positioned to help us achieve our goals because of its ability to be nimble while scaling to our evolving pipeline needs."
Moderna’s pipeline is composed of a series of novel drug modalities, each representing a distinct application of the company’s proprietary core expression mRNA platform to encode proteins that achieve a therapeutic benefit. Moderna’s current modalities include infectious disease vaccines, personalized cancer vaccines, intracellular/transmembrane liver proteins, intratumoral cancer therapy, and secreted antibodies and proteins. Moderna is leveraging these modalities to advance drugs across a broad spectrum of therapeutic areas via its four ventures, including Valera, focused on infectious diseases; Elpidera, focused on rare diseases; Onkaido, focused on oncology; and Caperna, focused on personalized cancer vaccines.
With more than 30 years of CRO industry leadership, PPD offers a comprehensive portfolio of services featuring integrated development consulting, Phase I-IV delivery, and laboratory services. PPD Biotech, the company’s best-in-class, custom-built offering, provides emerging companies with tailored services that are flexible, innovative and nimble. Through PPD Biotech, PPD offers biopharma companies high-quality delivery, broad global scale and top-notch therapeutic and medical development expertise.
"We are pleased that Moderna has selected PPD to be its premier clinical development partner," said David Simmons, Chairman and Chief Executive Officer of PPD. "We recognize the breakthrough nature of Moderna’s novel mRNA platform and its unique business model. We look forward to applying our deep capabilities and expertise in the emerging biopharma space to help Moderna progress its pipeline through the clinic with the ultimate goal of delivering novel drugs to address unmet medical needs."