Meranda Parascandola - DSI InPharmatics

March 30, 2020

Published by Meranda Parascandola at March 30, 2020

4 CMC Topics to Discuss During Milestone Meetings

e FDA recognizes that CMC-specific discussions, during Pre-IND meetings, are typically unnecessary when projects are “straightforward.” However, unlike more traditional 505(b)(2) products, certain new chemical entities (NCE’s) and biologics are anything but straightforward. These novelties can create unique manufacturing roadblocks that impede the path to clinical development.

April 1, 2020

Published by Meranda Parascandola at April 1, 2020

COVID-19 DSI Operation Update

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.

May 7, 2020

Published by Meranda Parascandola at May 7, 2020

CMC Considerations for Successful CMC Drug Development

With reduced resources accessible (both in personnel and funding), smaller emerging sponsors will seldom have a sizable Chemistry, Manufacturing and Controls (CMC) group, and in many cases may only have one support individual within their organization. It is common for all CMC activities from pre-IND through Phase 2 and even beyond to be coordinated by this one individual, often simultaneously with other responsibilities. Most if not all these sponsors, who in many cases are also virtual, use contract manufacturing organizations (CMOs) for the CMC aspects of their development and manufacturing.

May 12, 2020

Published by Meranda Parascandola at May 12, 2020

DSI APPOINTS NEW HEAD OF PROJECT MANAGEMENT

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.

May 20, 2020

Published by Meranda Parascandola at May 20, 2020

DSI to Conduct Digital Partnering Meetings During BIO International Convention

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.

May 21, 2020

Published by Meranda Parascandola at May 21, 2020

Constructing the CTD Module 3: A Primer…

Module 3 is a well defined component of the Common Technical Document (CTD) containing both drug substance (active ingredient) and drug product sections, each containing required presentations of Chemistry, Manufacturing and Controls (CMC) information, covering processes and key control parameters, and various justifications supported by qualification and validation studies.

June 2, 2020

Published by Meranda Parascandola at June 2, 2020

Quality Overall Summary Reviewers Guide

The value of the QOS should be to point reviewers at the most important information to support the quality of the drug in the most transparent presentation possible.

June 12, 2020

Published by Meranda Parascandola at June 12, 2020

The Odd Couple- Part 1: Characterization – He’s Never Developed a Regulatory Submission and She’s Never Submitted One.

For the purposes of this blog series, it will be necessary to produce an admittedly unbalanced summary that shortchanges some sections of the Quality Module but that includes considerable discussion of other sections that can largely influence the ultimate success or failure of an application. I have therefore focused discussion on selected aspects from a remarkably diverse and technical exercise, which is the production of the CTD Quality Module.

June 23, 2020

Published by Meranda Parascandola at June 23, 2020

The Odd Couple – Part 2: Authoring the Manufacture of Drug Substance and Drug Product Modules (S2, P3)

An overview of the quality assurance aspects of the manufacturers may provide insight into the viability of the process. Although not required to be included in the application, a request for the report of the most recent cGMP manufacturing inspection from the US Food and Drug Administration (FDA) and/or European Union (EU) agencies enable a broad overview of the cGMP compliance aspects of the facilities.

July 2, 2020

Published by Meranda Parascandola at July 2, 2020

The Odd Couple – Part 3: Authoring the Control of Excipients Modules

The acceptance criteria and tests conducted for the excipients should be reviewed relative to the preformulation experimental results. The acceptance criteria for the excipients should consider those qualities critical to the drug product performance and manufacturing operation as described earlier in formulation development.

July 14, 2020

Published by Meranda Parascandola at July 14, 2020

The Odd Couple – Part 4: Authoring the Analytical Control and Analysis and Reference Standards Modules

Perhaps the most consequential specification input is analytical method capability. The attribute of interest must, after all, be assessable. Thus specifications depend on the method’s specificity, sensitivity, variability, and accuracy.

July 23, 2020

Published by Meranda Parascandola at July 23, 2020

The Odd Couple – Part 5: Authoring the Container Closure Systems for Packaging of Drug Substance and Product Modules

Container closure systems refer to the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. The packaging information in the chemistry, manufacturing, and controls section usually includes a description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance and drug product during their use.