Meranda Parascandola - DSI InPharmatics

October 17, 2019

Published by Meranda Parascandola at October 17, 2019

Developing a Phase-Appropriate CMC Matrix

The landscape of chemistry, manufacturing, and controls (CMC) has continued to shift over time. Just a few decades ago, most drugs were developed from beginning to end by large pharma with well-defined systems of control. Today, this has significantly changed; much if not most early development (Pre-IND to Phase II) work is performed by small- to medium-size emerging biotech sponsors, many of which are virtual companies.

October 29, 2019

Published by Meranda Parascandola at October 29, 2019

CMC and Regulatory Affairs – See the forest and the trees

Here’s the problem: drug development managers must translate guidance into clear program objectives, identifying the data and information that needs to be produced, and prioritize resources and expenditures.

December 3, 2019

Published by Meranda Parascandola at December 3, 2019

Phase 2 to Early Phase 3 Regulatory Opportunities: Return on Investment

To ensure scientific and commercial success, it is critical to understand the drug development process and the myriad tasks and milestones that are vital to a comprehensive development plan. Although the primary purpose of a well-designed regulatory strategy is to assure an efficient process for providing new, high quality and effective drugs for patients, it is also essential to effectively maximize the return on investment. Each step along the path to commercialization is important and an effective chemistry, manufacturing and controls (CMC) strategy and ensuing communication plan plays an integral role in the overall success of a product.

December 19, 2019

Published by Meranda Parascandola at December 19, 2019

2020 J.P. Morgan Health Care Investor Conference

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.

January 30, 2020

Published by Meranda Parascandola at January 30, 2020

A Feng Shui CMC Guide to 2020: Will the Year of the Rat bring you Luck?

ncorporation of phase appropriate development strategies is becoming increasingly essential to manage the balance between speed, cost and completeness during development. The possibilities for both Chemistry Manufacturing and Control (CMC) development and filing approaches range from the minimalist style to a continuously supported style.

February 28, 2020

Published by Meranda Parascandola at February 28, 2020

Why Your Program Needs a Biologics CMC Consultant

Looking for answers? Where are you at with your process and controls? Who is managing the operations? What bioassays are necessary for your product? When, where and how to validate your bioassay?