Macon Raine provides domain-specific content marketing expertise for
the pharmaceutical and life science sectors.

We help drug, ingredients, packaging, medical technology, contract manufacturing, and development organizations create highly targeted content, increase visibility, and generate more leads.

Below are a few samples of our recent work.

Oligonucleotides: Opportunities, Pipeline and Challenges

At Long Last, Nucleic Acid Therapeutics Are Coming of Age

Although meaningful progress toward the development of oligonucleotide therapeutics began in the 1970s,
nearly a half century later, only six oligonucleotide drugs have been approved by the FDA as of November
2017. However, the field is gaining momentum and the clinical benefits of the dozens of oligonucleotide
therapeutics currently in various stages of clinical trials are extremely promising.

While there are numerous challenges the field is currently grappling with, this paper will focus on four: enabling
technologies, diversity within this class of therapeutics, delivery challenges and regulatory complexity.

4 Things You Need to Know About Combination Drug Compliance

Four essential insights for navigating the complex world of combination drug compliance

While the technologies and innovations driving the combination product market deliver a great deal of value to patients
and to the medical community, the novelty of these products is often challenging for drug developers and regulatory
agencies. The marriage of two different disciplines – drug and medical device – creates a complex regulatory process
that must be well managed. In addition, evolving regulations as the combination product segment matures can present
challenges for older, legacy combination products.

The Evolution of Therapeutic Monoclonal Antibodies (mAbs)

Enabling technologies are tackling development and manufacturing challenges, paving the way for dynamic mAb innovations.

Before diving into the discussion of the benefits, challenges and exciting future of mAbs, it’s worth taking a moment to reflect on merely one aspect of the near magical intricacy of antibodies. Of course, an antibody is a blood protein produced to counteract a specific antigen, or foreign substance such as bacteria, viruses or another foreign substance detected by the body. mAbs bind monospecifically to one antigen, one epitope, or one cell type making them incredibly useful for highly targeted therapeutic administration. Their therapeutic specificity makes them ideally suited for helping to minimize adverse side effects, especially when highly toxic drug substances must be delivered.

4 Steps for Managing the Criticality and Challenges of Biopharmaceutical Projects

Why is biopharmaceutical project management more challenging than project management for small molecule drugs?

The objective of any project management pursuit is to complete the project on time, within budget and within required quality or performance parameters. Whether making an automobile, computer or pharmaceutical, project management is not easy. However, given the complexity and intense regulatory demands of the pharmaceutical industry, project management is more difficult than many other segments. As if pharmaceutical projects weren’t demanding enough, biopharmaceutical project management is exceptionally challenging, requiring unique experience and expertise.

Process Validation and Regulatory Review in the Age of Expedited Approval Drugs

A World Turned on Its Head – Novel Approaches Needed for Accelerated Pharma and Biologics Approvals

To meaningfully discuss the process validation and regulatory approval strategies required for drugs that have been designated for Fast Track, Breakthrough Therapy, Accelerated Approval or Priority Review, we must first clarify these designations and briefly remind ourselves what the Process Validation guidance looks like. Then we will be able to clearly identify challenges and approaches to these barriers when working to bring a drug earmarked for expedited approval to market.