Akkeri, Inc.

Akkeri, Inc.'s Kenjie Amemiya, PhD, DABT will be performing tonight at SOT's Regulatory and Safety Evaluation Specialty Section Meeting/Reception! ?? Come join us for an evening of great music and a time to enjoy one another's company! ??? ?? Location: Hyatt Regency Ballroom – open to all in-person Annual Meeting attendees ?? Time: 6:00 – 7:30 PM EST Don't miss out on a fun opportunity to connect and unwind!??? Ric Stanulis, PhD, DABT, Juliana Cave, Ewa Budzynski

We’re happy to announce that Akkeri, Inc. will be attending the Society of Toxicology (SOT) Annual Meeting in Orlando, FL, on March 17, 2024! ?? As a boutique nonclinical drug development consulting firm, Akkeri provides strategic scientific advice and operational support to the pharmaceutical and biotechnology industries. Akkeri’s approach is not only carefully detailed but tailored to your program. Our team of expert consultants—composed of former FDA reviewers, industry professionals, and board-certified toxicologists—brings decades of experience. We are excited to share insights, network with fellow experts, and explore how Akkeri can support your drug development programs. Want to grab a coffee or lunch??Reach out to us at [email protected]. See you at SOT! Ric Stanulis, PhD, DABT, Juliana Cave, Kenjie Amemiya, PhD, DABT & Ewa Budzynski

?? Today is Rare Disease Day! ?? Recently released was The FDA's Accelerating Rare Disease Cures (ARC) Program Year Two Report highlighting key efforts in rare disease drug development. With 25 to 30 million Americans (globally 300 million) living with a rare disease, these treatments are especially needed: ?? START Pilot Program: Enhances communication with the FDA to support rare disease clinical trials. ?? Translational Science Team (TST): Provides expert guidance to drug review teams. ?? LEADER 3D Initiative: Offers educational resources for rare disease drug developers. ?? Enhanced Online Resources: Improves accessibility to FDA information. ?? Patient Engagement: Involves patients and advocacy groups in drug development discussions. These initiatives aim to accelerate rare disease treatments. For more details, see the full report here- https://lnkd.in/gq8viV7K If you have questions, Akkeri’s Senior Consultant, Shawna Weis who has a passion for helping individuals with a rare disease, can provide expert insights given her extensive experience in rare diseases and commitment to guiding drug developers through complex regulatory pathways.

Akkeri, Inc. has loved getting to know Shawna Weis!

Meet Our Newest Senior Consultant: Shawna Weis! At Akkeri, Inc., we believe in a personalized, tailored approach—whether it’s working with our clients, solving complex problems, or getting to know our incredible team. That’s why we’re thrilled to introduce Shawna Weis, our newest Senior Consultant, and give you a glimpse into what makes her tick! ?? Favorite book? Pride and Prejudice—but as an avid reader, there are too many to name! ?? Favorite movie? Babette’s Feast ?? Best vacation? Hiking the Inca Trail to Machu Picchu ?? What inspired her career in toxicology? A background in experimental pathology made toxicology a natural fit. ?? Favorite joke? "What did the Leaning Tower of Pisa say to the Tower of London? If you’ve got the time, I’ve got the inclination." ?? Perfect day? Scuba diving or snorkeling with sea turtles! ?? Favorite holiday? Thanksgiving ?? Weirdest food tried? Guinea pig in Cusco, Peru… verdict? Not a fan. ?? One thing she can’t live without? Dogs! ?? Best part of being a toxicologist? The challenge of solving complex problems, discovering novel products, and uncovering new biochemical pathways & disease mechanisms. We hope you’ve enjoyed to getting to know Shawna like we have, and we are excited with the impact she’s already making with our clients and their program needs! ??

We are thrilled to welcome Dr. Shawna Weis to Akkeri, Inc. as our newest Senior Consultant! With over 20 years of expertise in drug and biologic development, Dr. Weis brings a unique dual perspective as both a pharmaceutical toxicologist and FDA reviewer/supervisor (most recently the Division of Rare Diseases and Medical Genetics, prior CDER Office of Hematology and Oncology Products). Her extensive experience leading toxicology programs for small molecules and biologics across diverse therapeutic areas—spanning Discovery through Phase 4—will be an incredible asset to our team and clients. We look forward to the leadership and insights she brings to Akkeri. Welcome Shawna! #WelcomeToAkkeri #Toxicology #DrugDevelopment

We’re proud to share that our Senior Consultant, David R Compton, PhD, DABT, participated remotely in the ASGCT-FDA workshop on AAV immunogenicity this week. As a member of ASGCT, Dave engaged in two impactful half-days of discussions, reflecting on the strides the gene therapy field is making to deliver even greater patient benefits. We’re thankful to have experts like Dave, who put an immense amount of value into continued education, ensuring Akkeri, Inc. remains at the forefront of scientific innovation. #ASGCTAdvocacy #GeneTherapy #AAVTherapy asgct.org/2025aav

Last night, we celebrated our quarterly Virtual Happy Hour - brews, pizza and good conversation with the best team in the game. Building strong connections isn't just about the work we do but also the moments we share and here at Akkeri, Inc., you never know what you're going to receive when a box shows up at your door! ?? Cheers to teamwork and good vibes! ?? A special shoutout to Caleb at Jester King Brewery for sharing the interesting chemistry of brewing and keeping us laughing throughout the night!?????

?? Happy Holidays from Akkeri! ?? As we close out an incredible year, we want to take a moment to thank all our valued clients and partners for their trust and collaboration. Your support has been instrumental in driving our shared success in nonclinical drug development. At Akkeri, Inc., we are proud to have helped accelerate the development of life-changing therapies by providing innovative and high-quality nonclinical services. Together, we've tackled complex challenges, advanced scientific knowledge, and contributed to the future of healthcare. This year, we celebrated many milestones—successfully advancing drug development programs, optimizing regulatory strategies, and ensuring the safety and efficacy of novel therapies. We are deeply grateful for the opportunity to work alongside such visionary clients who share our commitment to improving lives. As we look ahead, we are excited to continue our partnership and further support your program goals. Wishing you all a joyous holiday season and a prosperous new year! ?? Thank you for an amazing year—here’s to continued success in 2025! ?? #HappyHolidays #Akkeri #DrugDevelopment #NonclinicalServices #ClientAppreciation #HealthcareInnovation #ThankYou

?? The countdown is on until ACT’s 2024 Meeting Symposium! We’re excited to share that Akkeri, Inc.’s very own Ewa Budzynski will be chairing a highly anticipated session on AAV Gene Therapy. This session will cover preclinical strategies and safety considerations for targeting critical organs, including the ear, eye, and spinal cord. It’s going to be a valuable discussion for anyone interested in the cutting-edge advancements of gene therapy. Akkeri’s team will be there and eager to connect, share insights, and discuss the latest trends and innovations in the industry! #ACT2024 #GeneTherapy #AAVGeneTherapy #PreclinicalResearch #Akkeri #BiotechInnovation #Healthcare #MedicalResearch