OR WAIT null SECS
After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.
Legendary basketball coach John Wooden advised his players to “be quick, but don’t hurry” to improve their performance on the court. This is sound advice for the bio/pharma industry, also.
This month, our sister publication, BioPharm International marks 30 years of publishing information about scientific, technical, and business advances in biologic-based drug development as science pushes technologies into unexplored areas.
In covering the industry, the editors carefully balanced optimism-or, in some cases, hype-about promising therapies with the reality of challenges that drug developers face. Every day, we receive press releases extolling the potential of a drug in development. These pitches are part of a process to gain attention for the company or therapy, secure investments, or build partnerships. Sometimes, however, these messages build false hope for patients waiting for needed therapies.
For a patient afflicted with a debilitating or terminal disease, a lengthy drug development and approval process can be frustrating-or a death sentence. They seek hope from any possible treatment. The ability of drug companies to serve these patients is tempered by their scientific knowledge, legal and regulatory restrictions, and limited financial support for ongoing research and development. It is a tricky balance that the industry needs to communicate honestly to patients.
As always, politics plays a part. The Right to Try Act, enacted in May 2018, gives terminally ill patients access to therapies that have passed Phase 1 safety trials, but have not been approved by FDA. The legislation has been criticized as being duplicative of similar laws in individual states, potentially causing unknown harm, conflicting with scientific goals of clinical trials, and undermining the regulatory authority of FDA.
At the same time, FDA faces criticism that it is approving drugs too quickly. A recent article (1) argued that while FDA is approving more drugs and at a faster pace, the expedited approach involves more risk for patients because approvals are based on limited information about safety or effectiveness from shorter clinical trials, not survival rates or cures.
At its 2018 annual meeting in Boston on June 5–7, 2018, the Biotechnology Innovation Organization (BIO), also celebrated an anniversary, marking 25 years of promoting the evolution of the biotech and biopharmaceutical industries. At the event, speakers recalled milestones in the industry’s development, including ethical questions raised by scientific efforts such as animal cloning or stem cell research and biotech-fiction fears driven by the movie Jurassic Park.
During a session, Jim Greenwood, BIO president and CEO, recounted his negative reaction when a fertility doctor said in a 2001 television interview that he could-and planned to- clone a human being. Greenwood, then a US Congressman from Pennsylvania, said he called for a hearing with the goal to outlaw human cloning. A visit from BIO CEO Carl Feldbaum, who explained the potential of therapeutic cloning, converted Greenwood into a proponent for biologics industry development, leading to his appointment as head of the organization a few years later.
The past 30 years has seen the biopharma industry witness the emergence of protein-based therapeutics. The next chapter in the biopharma story-cell and gene therapies-brings a new theme, that of providing a cure for disease and conditions. The “cure” word was used multiple times in discussions at the BIO event, presenting a new set of science, business, technical, and ethical challenges for the industry in the years ahead.
In addition to being quick, biopharma companies and the regulatory industry also need to be smart, be honest, and keep patients at the forefront of all of their activities, not just their press releases.
1. C. Chen, “FDA Repays Industry by Rushing Risky Drugs to Market,” ProPublica, June 26, 2018.
Vol. 42, No. 7
When referring to this article, please cite it as R. Peters, “Be Quick, But Don’t Hurry" Pharmaceutical Technology 42 (7) 2018.