White Papers, Executive Briefs & Slideshares

Gene Therapy CMC ThumbnailGene Therapy CMC Strategies Paving the Way for Commercialization

While significant advancements have been made, gene therapies still present many manufacturing challenges, this paper explores CMC approaches gene therapy developers are applying to increase success rates. Download paper


4 SteBiopharmaceutical Project Management Thumbnailps for Managing the Criticality and Challenges of Biopharmaceutical Projects

Biopharmaceutical project management is exceptionally challenging, requiring unique experience and expertise. This paper explores the demands of the field and insights for managing them. Download paper


 Expedited Approval Drug White Paper ThumbnailProcess Validation and Regulatory Review in the Age of Expedited Approval Drugs

Expedited approval drugs have profoundly changed the thinking and approach to Process Validation and other CMC activities. When working on the development of an expedited approval drug, Chemistry, Manufacturing and Controls (CMC) data needs to be generated in about half the time of the traditional process. Of course, an expedited approval classification does not mean that the drug developer can do less. In order to meet these accelerated timelines, analytical methods creation and product and process characterization needs to start sooner, and the process needs to be handled differently. This paper explores those dynamics and offers some revised approach suggestions. Download paper


Combination Products Paper Thumbnail4 Things You Need to Know About Combination Drug Compliance

Combination products are a fascinating area of the pharmaceutical industry and present great future promise. The segment is projected to reach $115 billion in global sales by the end of 2019. It has grown solidly at a rate of 7.9% CAGR since 2013, and is projected to continue at that rate through 2019.1

Some of the key factors driving this growth include: higher levels of patient compliance, demand for minimally invasive surgeries, opportunities for precise pain relief, quicker healing and governments and non-governmental organizations (NGO) embracing combination drugs for their ease of administration.

However, combination drugs present unique challenges addressed in this paper:

  • What is 21 CFR Part 4?
  • Understanding the Role of the FDA’s Office of Combination Products
  • Bringing Legacy Combination Products into Compliance with 21 CFR Part 4
  • Streamlined Approach for Review and Approval of Some Combination Products

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