Hello valued member,
What a great opening day! We hope you clocked your steps in bridging science and compliance.
Over 25 speakers tackled the leading issues of the industry with innovative thinking, surprising discoveries, and practical tactics. Here’s a quick rundown of some of the highlights.
The Main Stage
There’s nothing better than kicking off a professional conference with an update on our astronauts in outer space from a microbiology perspective. Monserrate C. Román, MA, Program Manager, NASA has a sense of humor to match her expertise, and she gave us all an inside view of what it’s like to exist in a low-orbit space station.
She shared on-site challenges and personal stories. The audience laughed their way to a new understanding of the microbiological perils of doing experiments in the space station and everyday micro situations on Earth that take on larger, more dangerous dimensions in space. The most surprising microbiological challenge for our astronauts? Contending with practical day-to-day events, like skin cell shedding that most of us would never give a second thought to, or CO2 bubbles that challenge the ability to breathe. Who knew?
All the examples she shared offer each one of us a reason to pause and respect our peers working on solving these enormous challenges to protect our astronauts while furthering our society for the future. She was quick to add that research on Mars and the moon, not only furthers our off-Earth goals but will also help advance Earth technology.
The next equally fascinating plenary presented the evolution of microbiome therapies from both academic and industry perspectives. Dr. Alexander Khoruts, Professor of Medicine, Division of Gastroenterology, Hepatology and Nutrition at the University of Minnesota was another expert with a sense of humor. He gave insights on the microbiome journey of fecal transplants, a therapeutic that has now been classified as a drug.
As in many micro advances, the human factor is always a key component of innovation. Dr. Khoruts said that each qualified donor represents a $35,000 investment, and the relationship with the lab team is based on extreme trust. There was interest in the audience of the relationship between the gut-brain axis and the fact that an unhealthy gut could affect the brain, with autism a case in point. The audience was also concerned about how an industrialized diet (as opposed to an ancestral diet) affects the complexity of microbiome therapies.
Sathya Janardhanan, Vice President, Development and Manufacturing, Rise Therapeutics complemented Dr. Khoruts’ presentation with the manufacturing challenges of developing microbial products that precede FDA regulations. Sathya gave a master class on the process, evolution and engineering of innovating new microbiome-based medicines.
Key takeaways: It takes an appetite for ambiguity, acquiescence (without forcing a fit), and creativity as an innovator. Any new way of seeing things challenges the status quo and it requires critical thinking to identify the hypotheses and the right testing procedures.
He said there are risks and rewards in creating a new class of therapeutics, and both need to be grounded in science.
Working Sessions
The breakout sessions covered real-life case studies, research and scenarios that face the industry on a daily basis. Contamination, sanitization, objectionable microorganisms, sterilization, water systems, and control strategies were common themes.
The conversations got down to basics with the challenge of developing strategies to identify sources of contaminations (nozzles and gaskets, for example) and devising biofilm cleaning strategies for different surfaces.
The stakes are high when it may take up to two years to re-engineer a facility and the millions of dollars lost on contaminated batches as well as the delay in ensuring a safe manufacturing facility.
The critical value of discipled research supported by relevant data is the unlock to solving microbial sterile manufacturing.
Heard in the Halls
Today’s poster presentations were jammed with eager and curious attendees. If you didn’t get a personal presentation of the many innovations displayed today, be sure to visit the on-site attendee webpage where all of the conference posters are available for your review.
Today’s selection of posters in the hall will offer you continued opportunity to immerse in new ideas, approaches and research.
Explore all of the posters>
The solution providers in the exhibit hall were also busy sharing their innovations – especially during the opening night reception where the energy was buzzing.
Make sure to collect your Conference Passport stamps to be eligible to win one of the great prizes being offered.
On Deck for Tuesday
Be sure to attend today’s plenary session. High-level micro thought leadership will inspire and no doubt trigger action and new ways of thinking about industry issues.
Stephanie L. Goff, MD, Senior Research Physician, Surgery Branch, CCR, NCI, National Institutes of Health (NIH) will explore the legacy of CAR T cells tracing their origins from Dr. Steven Rosenberg’s pioneering work nearly 50 years ago to their widespread impact today.
The concurrent sessions cover everything from contamination control strategies case studies in the application of advanced rapid technologies for adventitious viral testing, bio-burden monitoring to the application of next-generation sequencing in adventitious virus detection and tactics for using machine learning,
We look forward to offering you more detail on the working sessions in Wednesday morning’s conference daily.
Sport Your New T-shirt
For those lucky few hundred attendees who secured one of PDA’s new limited-edition T-shirts, we hope to see you sporting them during the remaining two days of the conference!
Look out for the PDA staff taking pictures in the halls and session rooms and you may just find yourself spotlighted on social media (hashtag #pdaMicro), in the pre-session attendee spotlight slides and on the onsite attendee webpage.
And remember, the new PDA fleece and limited edition serialization T-shirt remain on sale at the PDA Booth outside of the Exhibit Hall and Poster Hall. Get one (or both) for yourself and your team back at the office.
If you need to download the PDA Technical Report No. 68 (for free), visit the PDA booth for more information!
Afterhours
There is still availability for the tour Washington DC by twilight.
The Monuments by Moonlight Trolley Tour is this evening from 18:45 – 21:00, and you can see Washington, DC’s most popular monuments in a new light!
Stop by the Registration Desk for more information and to purchase your tickets.
Optimize Tuesday as a Breakthrough Day
Carpe diem and take advantage of all the opportunities available to you for expanding your knowledge, honing your expertise, thinking differently – and networking with your peers who are helping to shape the future of the industry.
Today is going to be another exciting learning experience!
Let us know if you have any questions or need help. PDA staff are positioned around the conference to offer you assistance.
Sincerely,
Kurt Jaecques, MA, Conference Co-Chair, GSK, Global Aseptic Technologies Lead Monitoring & Control
Erika Pfeiler, PhD, Conference Co-Chair, U.S. FDA, Supervisory Microbiologist, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER
And a big thank you to our Sponsors!
