Seeking COVID cure
Woodbridge woman helps in search for vaccine
Working behind the scenes of the scramble to bring a safe and effective vaccine for COVID-19 to market is Lodi native Judy Wudel.
She is the executive director of business development for Worldwide Clinic Trials, a company based in North Carolina. It’s her job to contract with drug companies to provide the services required to take a new drug through phase 3 trials. Depending on how the testing goes, the drug would then be considered by the Food and Drug Administration (FDA) and approved (or not) for market.
Her company provides services that include three phases of human trials, plus research, project and site management — all stepping stones to potential approval. The process can take years and buckets of money to gain approval.
For example, it could take up to 10 years and as much as $600 million dollars to complete the three trial phases. However, in the era of COVID-19 the FDA has tried to expedite the approval process, so “some of the normally strict guidelines for contracting have been ‘relaxed’ … while still maintaining the normal safety parameters for the drug,” says Wudel.
Interestingly, vaccines take a lot less time to test and considerably less money to take through trial, according to Wudel.
“The cost of bringing a vaccine trial to market is significantly less than the cost of other disease related trials due to (their) duration,” she said.
Many drugs being studied
Wudel says worldwide there are currently about 677 drugs in development for COVID-19, some of which are new and some repurposed. About 70% of those are pre-clinical (not in human testing yet). Globally, there are about 1869 trials currently underway, she says. Her company has more than 10 of those trials currently underway, two of them involving Bay Area biotech firms. The names of the firms she works with are confidential.
During the human trials Wudel’s company records all data and lab results, which will be reviewed by the FDA when it considers approving the new medicine.
Her company also recruits the volunteers, who participate in the trials by allowing the experimental medicines to be administered to them, usually intravenously or orally, sometimes in a hospital setting. A volunteer may be paid a modest fee, ranging from $1,800 to $18,000, according to the company website. Before
testing begins, volunteers are told about everything that could possibly go wrong. They also have 24/7 access to a doctor in case there is a problem.
New volunteers are first screened to make sure the study is a good fit for them, then they are given a physical assessment, and then the study begins once they are approved.
“When you participate in a clinical study, you help make medical advances possible, giving hope to countless people all over the world,” the company website says.
Wudel says that many times the volunteers are medical students, whose efforts help pay for their schooling. There are also “professional” volunteers who do it strictly for the money. Some, she says, are repeat volunteers, however, a person is only allowed to volunteer a maximum of five times.
Almost all of the research that is ultimately considered by the FDA and its European counterpart (EMA) is generated by a contract research organization such as Wudel’s employer, without which there would be almost no new medicines coming to market.
Wudel says she deals with the top 10 biotech companies on the West Coast; however, her company deals with most of the major pharma and biotech companies globally. She spends three or four days a week traveling from one end of California to the other seeing clients.
Traveling the world
Her travels have also taken her to such destinations as Rome, London, Athens and the Czech Republic. It is in these locations that Wudel attends “investigator” meetings, where all the trial investigators come together to discuss a project. A clinical investigator is someone who actually conducts the clinical investigation, and under whose immediate direction the drug is dispensed to a subject, according to the FDA.
With “shelter-in-place” orders in effect, Wudel says she has had to conduct business over the phone and through Zoom meetings. She says they’ve found that much of the work can be done remotely. However, she prefers personal, one-on-one contact.
Before she prepares a bid for services, Wudel says she studies the disease in question. What is it? What does it do? What are the symptoms? What are the impacts? She goes in fully read-up and prepared when meeting with the drug companies, knowing that through her efforts and those of her colleagues lives could be changed.
Wudel was born and raised in Lodi. She attended Lodi High School, but went on to graduate from Tokay High when Lodi High split. She went to the University of the Pacific and holds a bachelor of science degree in business administration. She lives in Woodbridge with her husband, Gary Allen.
She has been in the pharmaceutical and research industries for 30 years, seven of which have been with her current employer. She previously worked for drug giant Pfizer and PPD, a global contract research organization.
While her current focus has been diverted to arranging clinical trials for new COVID-19 drugs, she’s normally involved in clinical research for such diseases as Alzheimer’s, Parkinson’s, Multiple Sclerosis, and other neurological disorders, including rare diseases.
Searching for a cure
One area of research that’s close to her heart is for a condition known as Vanishing White Matter Disease (VWM), a genetic disorder that affects the nervous system and causes neurologic symptoms. It is found mainly in young children, Wudel says. Youngsters with the disease may suffer loss of motor skills, episodes of fever, loss of muscle coordination and balance, seizures and spasms, among other symptoms.
The motor difficulties in VWM are progressive, and some episodes result in permanent loss of neurological function and sometimes coma or death. Curing this disease is something Wudel is passionate about.
There is currently no treatment or cure for VWM, but Wudel sees hope in a new drug currently in clinical trials. “It gets exciting when you see the potential to cure or treat” a disease that has such a devastating impact on people, especially children.
She says the drug, if approved, probably won’t be a big money-maker for the company, emphasizing that sometimes it’s not about the money.
Some of her clients, she says, are small companies with “all their marbles in one basket.” That’s to say, the company has all their efforts and resources invested in one drug, and if it fails to gain approval, they’re finished.
Would Wudel ever be a volunteer in a drug trial? An emphatic ”No!”
“You never know what will happen in a drug trial,” she says.
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