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.

Juliana Cave is a results-driven C-Level financial executive with a career spanning over two decades of strategic planning, financial analysis, and corporate accounting management. As the Founder, CFO, and COO of Akkeri, Inc., she plays a pivotal role in providing operational leadership and financial oversight to support the pharmaceutical and biotechnology industries.

With a proven track record in fiscal analysis, accounting systems development, and compliance, she is known for building efficient financial infrastructures and fostering client success across industries. Prior to Akkeri, Juliana held leadership roles, including a seven-year tenure as Controller and Director of Operations at Aclairo Pharmaceutical Development Group, where she managed complex financial projects and streamlined business operations. Additionally, she's provided specialized financial consulting services for over 25 years, showcasing a dedication to excellence and adaptability in dynamic environments.

Juliana is an innovative thought leader and out-of-the-box thinker, she combines deep expertise with exceptional interpersonal and organizational skills. Whether leading diverse teams, managing key projects, or facilitating business expansion, she ensures that all efforts align with strategic goals, consistently delivering value to Akkeri's clients and their programs.

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. 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. Diann Blanset is a Board-certified toxicologist with over 35 years of experience leading nonclinical safety programs for small molecule, biological and viral based products in various therapeutic areas, including oncology, respiratory, inflammation and infectious diseases. She is a recognized expert in viral vector-based products and reproductive toxicology for biologics, having published several manuscripts in these areas. Over her impressive career, she has contributed to the development of numerous new biological entities, including approved biologics for inflammatory diseases and several novel immunomodulators for oncology.

Prior to joining Akkeri, Diann was a Highly Distinguished Research Fellow at Boehringer Ingelheim responsible for the nonclinical development of a variety of programs over approximately 15 years. Previously, she served as the of Senior Director of Preclinical Development at Medarex, and held positions at Enzon, Roberts Pharmaceuticals and Huntingdon Life Sciences. She is an active member of BIO, having served as their representative on the ICH S5(R3) Expert Working Group and the BioSafe Leadership Committee. Diann is also a member of the Society of Toxicology and the American College of Toxicology. She received a B.A. and M.S. from Rutgers University and a Ph.D from the University of Medicine and Dentistry of New Jersey.

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. Shawna Weis is a highly skilled toxicologist with over 20 years of experience in drug and biologic development, blending her expertise as a pharmaceutical toxicologist and regulator. She has successfully led nonclinical and regulatory toxicology programs across small molecules, biologics, and oligonucleotide therapeutics, covering all stages of development from discovery through Phase 4. Dr. Weis's extensive career includes leadership roles at prominent organizations, where she has overseen toxicology studies, regulatory submissions, and strategic program management. With deep expertise in FDA and international regulatory processes, she has guided teams through complex toxicology challenges, contributing to the advancement of innovative therapies across diverse therapeutic areas. A dedicated mentor and recognized expert in her field, Dr. Weis is an active member of professional societies, including the American College of Toxicology and the Society of Toxicology.

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.

Lindsey Madara is an accomplished professional with over a decade of experience in administration, business development, marketing, and recruitment, now supporting operations at Akkeri. Her expertise in managing complex administrative systems, streamlining workflows, and fostering client relationships has positioned her as an invaluable asset to the company's mission.

Lindsey's background includes managing applicant tracking systems, analyzing market trends, and aligning talent with organizational goals. Her ability to develop effective communication strategies and foster team collaboration has been instrumental in driving operational efficiency and achieving business objectives. Additionally, her experience in marketing, branding, and client engagement reflects her multifaceted approach to enhancing organizational growth.

In her current role, Lindsey leverages her foundational experience in proposal creation, administrative management, and organizational optimization to oversee Akkeri's business operations. Her results-driven mindset, personal approach, and enthusiastic commitment to innovation enable her to support the company’s vision while ensuring seamless execution of its objectives.