About Akkeri

Dr. Ric Stanulis is the President and CEO of Akkeri. He is a Board-certified toxicologist with over 25 years of nonclinical drug development experience. Ric has been a nonclinical consultant providing strategic advice for scientific and regulatory issues in drug development since 2017, working with clients of diverse resources and needs from the US, Europe and Asia. Ric received his PhD in Pharmacology and Toxicology from the Medical College of Virginia/Virginia Commonwealth University, and entered industry as a Study Director for a CRO. Thereafter, he worked for several biotech/ small pharma companies with the primary role of establishing and being responsible for the nonclinical safety assessment function; thus Ric understands the needs, complexities, and pitfalls faced by early-stage biotech companies.

Ric provides full nonclinical program support with expertise in toxicology program design and study conduct; regulatory document and meeting preparation; gap analysis and due diligence; and issue resolution for challenges that inevitably arise. Ric has experience with a variety of development programs to include small and large molecules (as well as gene therapy) at all stages of development, across diverse therapeutic areas, and with various routes of administration. Ric routinely interacts with regulatory agencies and has directly contributed to the successful filing of numerous IND/CTA's and NDA/BLA’s. Ric is an active member of the American College of Toxicology, Society of Toxicology, and Safety Pharmacology Society.

Bio coming soon!

Dr. Hilary Sheevers is an established toxicology and regulatory strategy consultant to the pharmaceutical industry. She provides advice on nonclinical safety and strategic planning for drug development, gap analysis, and due diligence for in/out- licensing assets. Hilary received her PhD in Pharm/Tox from the University of Arizona. Hilary was a former regulator at FDA (CDER), founder/president of Aclairo Pharmaceutical Development Group, and Worldwide Director at Janssen Pharmaceuticals.

At Akkeri, Hilary continues to provide nonclinical worldwide safety strategy, study planning recommendations, position papers, and regulatory documentation/interaction support. She is an acknowledged and worldwide expert in regulatory communications with health authorities, including conventional regulatory filings to complex position papers with sophisticated scientific and regulatory discussions. Hilary’s experience includes virtually all therapeutic areas for both biologics and small molecules. Hilary is an active member of the American College of Toxicology (ACT) and Society of Toxicology (SOT); and serves on the National Advisory Board for the College of Pharmacy, University of Arizona.

Dr. Kenjie Amemiya has over 35 years of toxicology experience in addition to extensive experience in regulatory strategy development and hands on GLP compliance as both a study director and head of GLP and nonclinical operations. The span of his career has been spent at both large and startup pharma where he has held various positions related to nonclinical drug safety with part of his career at his last pharma company, Genentech also being focused on clinical safety. In addition, Kenjie has served as both a Discovery and Development project leader where he has for the latter led a team through a successful phase 2 POC study.

With specific regard to nonclinical safety, Kenjie has led the nonclinical safety evaluation of a number of small molecules and biologics for a variety of therapeutic areas, including oncology, neurology, anti-psychotics, anti-infectives, cardiovascular, respiratory, inflammation and metabolic disorders and has been part of several FDA and Global Health interactions and submissions. Additionally, as part of Genentech early clinical safety Kenjie carried out pharmacovigilance and risk management activities, providing clinical drug safety input as a component of clinical development strategies.

As a consultant previously for Aclairo Pharmaceutical Development Group, Inc and currently at Akkeri, Kenjie has successfully advised companies on nonclinical safety evaluations, early clinical drug safety, regulatory strategy and regulatory agency interactions as well as on occupational exposure limits. Kenjie's approach to working with sponsors is to view himself as a team member taking complete ownership of safety aspects of projects as well as being part of the success of the entire program.

Dr. David Compton is a Board certified-toxicologist with over 30 years of combined academic, CRO, and pharmaceutical experience including GLP study directing, safety pharmacology, toxicology, and nonclinical drug development. To start his career, Dave served as Assistant/Associate Professor at MCV (Medical College of Virginia), part of Virginia Commonwealth University (VCU). Subsequently, Dave has over 25 years of experience in industry positions which included Huntingdon Life Sciences (3 years) Schering-Plough Research Institute (6 years), Sanofi (15 years), and PTC Therapeutics (3 years).

While Dave has served as a GLP Study Director and Project Team Toxicologist, he is also recognized Subject Matter Expert in gene therapy and abuse liability. Dave has experience developing and achieving marketing approval for gene therapy programs and has published 4 gene therapy manuscripts (one as first author) during 2020-2023.

Dave has extensive experience in nonclinical abuse liability assessment, including being the corporate subject matter expert for a large pharma, a founding member of the Cross-Company Abuse Liability Council (CCALC), and interacting with FDA Controlled Substance Staff (CSS). He was the editor for a 2015 industry-oriented book Nonclinical Assessment of Abuse Potential for New Pharmaceuticals. As part of service in multiple scientific organizations, Dave is notably a past-President of the American College of Toxicology (ACT).

Dr. Ewa Budzynski is a Board certified-toxicologist with over 15 years of experience in drug development working in toxicology and pharmacology, supporting the development of small molecules, oligonucleotides, and biologics (including antibody drug conjugates, antibodies, cell and gene therapies). Most recently Ewa was a Project Toxicologist at PTC Therapeutics and Regenxbio where she was responsible for toxicology strategy development and execution and support of gene therapy product development ranging from discovery to late stage. She also supported process impurity risk assessment and was a Program Lead, responsible for leading the team towards candidate nomination.

Ewa received her PhD in Biomedical Engineering from Northwestern University in Retinal Metabolism and has since authored over 40 scientific articles published in peer reviewed journals, reviews, and/or conference abstracts. Following a postdoctoral fellowship in mammalian genetics, with concentration on retinal diseases, at Jackson Laboratory, Ewa moved to the drug development industry. She held pharmacology positions developing screening assays and animal disease models at Bausch & Lomb and Acucela.

Ewa transitioned to toxicology over 10 years ago, joining Covance Laboratories (now LabCorp) as Study Director in the Ocular Safety Assessment Group. While at Covance Ewa supported the development of different products including devices, small molecules, oligonucleotides, and biologics (e.g., monoclonal antibodies, gene and cell therapy). Ewa is an active member of the American College of Toxicology (ACT) and Society of Toxicology (SOT).

Dr. Kristin DeSouza is a toxicologist with over 10 years of nonclinical drug development experience, working with both small and large molecule programs. She offers specific expertise with antisense oligonucleotides (ASOs), rare disease and orphan designations in neurology, carcinogenicity studies and unique dosing routes - including intrathecal and nasal administration. Kristin served as a toxicology Study Director for 8 years at CRL (Ashland) and LabCorp (Madison), gaining extensive expertise in design, conduct, interpretation, and reporting of nonclinical toxicology studies. Kristin continued her career as the lead project team nonclinical representative at two biotechnology companies (Praxis Precision Medicines and HotSpot Therapeutics), where she was responsible for executing design and oversight of nonclinical programs as well as strategy and preparation of nonclinical sections for IND/CTA submissions. Kristin further participated in regulatory agency interactions/responses, carcinogenicity waivers, impurity assessments, and target safety assessment profiles. In her current role as a consultant at Akkeri, she provides scientific strategy and operational support for a variety of client drug development programs.

Kristin earned her PhD in Molecular Genetics at Ohio State University, followed by a post-doctoral fellowship at Nationwide Children’s Hospital, Research Institute. In these roles she focused on organ development with emphasis on the role of transcription factor regulation and disruption to normal development processes. Kristin is an active member of the American College of Toxicology (ACT) and the Society of Toxicology (SOT).

Stephene Ford has over 28 years of experience working in the pharmaceutical industry, with specific knowledge in the development of vaccine, infectious disease and biologic programs (including up to BSL 2/3). She spent 17 years as a Study Director at CRL (Reno, NV and Mattawan, MI) and was responsible for the planning and conduct of nonclinical studies in accordance with applicable regulatory guidelines and contemporary scientific practice. Stephene served as the subject matter expert for vaccines at the CRL Mattawan site, building a robust vaccine program and providing advice and study designs to clients for nonclinical IND- enabling programs. She served as chair the Institutional Biosafety Committee and as the Biosafety Officer.

Prior to CRL, she spent 8 years at Covance laboratories (now LabCorp) in Vienna VA. As a consultant previously for Aclairo Pharmaceutical Development Group, Inc and currently at Akkeri, Stephanie provides an expertise on nonclinical assessments for development of vaccines, biologics and small molecules as well as drugs for ocular, oncology, and infectious disease indications. Stephene provides complete toxicology program support to include: study design, study monitoring, and regulatory support (including data interpretation and presentation). Stephene collaborates with several project teams and has experience with the preparation of government grants and regulatory submissions.