03.07.23 -- FDA On Orphan Drug Statutory Exclusivity

As the number of monoclonal antibody (mAb) drugs entering the market continues to rise, accelerating development to meet demand will require solutions that maximize efficiencies while minimizing risk.

In the U.S. today, Latin Americans account for 18% of our total population but only 1% of enrolled trial participants. At this rate, the industry will make medicines that are only effective for half of our population by 2045. Learn about the problems with diversity in clinical trials and how we can address them.

Robotic aseptic fill/finish equipment offers many benefits to modern facilities, including flexibility to adjust to future growth and the speed to market necessary for today’s changing industry.

Explore the shift from gamma retroviruses to lentiviruses, the impact of this shift on development and manufacturing, and the challenges CDMOs still need to overcome.

We demonstrate a versatile platform for the expansion of T cells that that reduces time and resources needed to produce a therapeutic dose.

Explore some automated scale-up solutions and how you can design and execute your allogeneic cell therapy seed chain from Phase 1 onward.

Opting to take your biotech program global can help save crucial resources, produce high-quality clinical data for your therapy, and leverage unique regional advantages like region-specific indication strategies.

Encapsulated mRNA–LNP creation begins with synthesizing the DNA template. Explore the DNA template, DNA template synthesis, the challenges and strategies of generating a DNA template using PCR, and more.

Creating new manufacturing capacity requires finding the right CDMO with a global footprint, large-scale capacities and resources, and technical expertise in developing and bringing treatments to market.

Learn how qualification and validation requirements apply to the computer systems that support good manufacturing practices (GMP) manufacturing.

Experts discuss several ways in which natural killer (NK) cells can offer a path forward as a delivery platform for engineered cell (and ex vivo gene) therapy. Explore four different aspects of cytotoxic cell therapy.

Designing and conducting a gene therapy trial is a complex undertaking. Learn how understanding, planning for, and overcoming the myriad challenges of operationalizing these studies will help bring safe breakthrough treatments to patients with unmet medical needs.

Many 505(b)(2) development programs have been placed on clinical hold or disrupted because of incorrect or inadequate advice from professionals inexperienced in 505(b)(2) product development.

This webinar presents case studies from the pharma and biotech industry that show the use of digital solutions in asset performance and reliability.