Making the Impossible Possible: PIC MC Office Hours with Dr. Gail Wasserman

“What was impossible yesterday is possible today.”

Those were the words Dr. Gail Wasserman, Senior Vice President, Biopharmaceutical Development, R&D at AstraZeneca shared with faculty, staff, and students during this week’s PIC MC “Office Hours with the Experts” program.

“I hope that this program will flourish and contribute to what Montgomery College is already doing to inspire students on their journey of life-long learning.  They are the architects of the future and in their hands (and heads) are the possibilities of what could be.  The college is a tremendous resource for the county and I am happy to support the students,” she said.

Wasserman, who also serves as academic partnership chair for the Pinkney Innovation Complex for Science & Technology, discussed the timeframe it takes for the development of biological products including monoclonal antibodies.

Reflecting on her three decades in the pharmaceutical industry, including the bulk of her career with AstraZeneca, Wasserman touted the changes in technology that have sped up drug development, particularly during the ongoing COVID-19 pandemic. Technological innovations have allowed for the development of two mRNA vaccines that were developed, assessed in clinical trials, and authorized for emergency use in less than a year. Neutralizing monoclonal antibodies developed by the likes of Eli Lilly and Regeneron have also been developed at a rapid speed due to the advances in technology, she said.

“The timeline for approving medicines has broken all kinds of records,” Wasserman said. From first recognizing the threat of COVID-19 in the first weeks of 2020 to having two vaccines authorized by December is the new “Miracle on Ice,” she added, referring to the extremely cold temperatures the mRNA vaccines require for storage.

Rapid development certainly wasn’t always the case. On average, drug development took about 10 years to go from discovery to commercialization, Wasserman said. But those drugs that made it through regulatory approval are few and far between. Typically out of 5,000 preclinical studies, five will make it to clinical studies. Of those, one will make it to market, she said.

“This gives you a sense of how amazing this last year has been with companies coming together for COVID-19,” she noted.

And the increased speed for drug development was possible due to technology and increased use of biologics and monoclonal antibodies. Biologics are molecules created by living cells, not chemical reactions, while monoclonal antibodies are proteins made in a laboratory that mimic the body’s immune system capabilities. 

The use of these kinds of approaches provides companies with more shots on goals in treating diseases, Wasserman said. Monoclonal antibodies are proving to be effective in fighting diseases for which no vaccines exist. Wasserman said it’s possible to find a monoclonal antibody against a specific epitope even when it is difficult to induce an immune response against that epitope.

Monoclonal antibodies provide immediate protection against disease and can be engineered for activities that could not be induced by vaccines, she noted. In the 1980s, Wasserman said there were questions of whether or not antibodies could be a drug. But now, there are dozens of approved antibody treatments due to advances in technology and biological understanding.

“It shows you how far along we’ve come since then,” she said.

Wasserman traced her own timeline in the pharmaceutical industry to her roots in a small New Jersey town. Growing up, Wasserman said she would often stare at the nondescript Hoffman-LaRoche facility and wonder what went on behind those walls. After completing her graduate programs, Wasserman first went to work for GlaxoSmithKline before taking a role with MedImmune, which is now part of AstraZeneca. 

At AstraZeneca, Wasserman was part of the team that developed palivizumab, a monoclonal antibody used to prevent severe disease associated with respiratory syncytial virus infections in high-risk infants. Wasserman said palivizumab was a significant improvement over the common treatment at the time, which required a four-hour infusion. Palivizumab is administered as a monthly intramuscular injection. 

Improvements over palivizumab were due to advances in technology that allowed them to manufacture an anti-RSV treatment that could be administered in a single dose. They also learned to make more of the drug in a cost-effective manner. “Technology will be able to take drug designers and patients to new places,” she said.

The next Office Hours with Experts will be in Spring 2021 with John Compton of GeneDx. Make sure to follow Montgomery College on LinkedIn for upcoming PIC MC “Office Hours with the Experts” event opportunities.