NEWS

nnounced its latest innovative offering for emerging biotech drug sponsors. CMC.Live is an interactive podcast where DSI’s team of subject matter experts and program managers watch the CMC and regulatory industry trends and discuss current hot topic areas. CMC.Live subscribers can listen to their conversations and ask questions (Ask the Experts).

DSI announced today that it will be actively engaged in partnering meetings during the BIO International Convention. The 2020 BIO International Convention will transition to a virtual event format, BIO Digital. This virtual gathering of the global biotech industry provides access to partners via BIO One-on-One Partnering and educational resources. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, DSI is focused on the critical CMC issues and build programs that enhance development.

Design Space InPharmatics (DSI), a full-service CMC consulting firm focused on providing pharmaceutical attributes, regulatory affairs, and drug discovery and development consulting services, is delighted to announce today the appointment of Thomas Hoy to Head of Project Management. The role of Thomas Hoy will be to oversee sponsors development of new drug and chemical products, assume manufacturing leadership and managerial roles, and superintend regulatory compliance.

While this has opened up many new avenues in sharing information, We want to reassure you of DSI’s service resilience during this time. In fact, as you may be aware, we have been supporting CMC for our clients' programs VIRTUALLY FOR OVER 14 YEARS.

A scientific review of the pertinent development data provides the necessary information to assure that informed decisions are made regarding the potential in-licensing of a development compound. By highlighting perceived risks and resource implications, the examination provides assurance that a given compound meets the requisite technical and quality elements. In advance of Biotech Showcase and the JP Morgan Healthcare Conferences next month, we are providing our complementary Drug Product Due Diligence Checklist. Send us a message if you would like a copy.

Drug Substance Development Expert, Dr. James Mencel, will be presenting “Expedited Filings and their CMC Implications: Considerations toward Better Planning”, sponsored by AMRI, a global contract research and manufacturing organization. Conference sessions will occur at AMRI’s Corporate Headquarters.