Transform Your Therapeutic Breakthroughs into Success
with Innovative and Cost-Effective Preclinical Development Solutions from Snow Leopard Consulting
Toxicology | Pharmacology | Drug Metabolism and Pharmacokinetics
How We Serve Our Clients
At the heart of our work is a commitment to collaboration, innovation, and delivering measurable results on time. Together, we navigate the complexities of preclinical drug development to efficiently achieve transformative milestones.
Our Value
How We Create Value for Our Clients
Evaluation of Licensing and Acquisition Opportunities
Evaluation of Licensing and Acquisition Opportunities
Our comprehensive evaluation of preclinical data enables you to make informed decisions about licensing and acquisitions opportunities, pipeline prioritization and strategic business decisions. We work closely with you to align your portfolio with your strategic and financial goals, identifying high-value opportunities while identifying and mitigating risks to maximize your investment potential.
Preclinical Strategy and Regulatory Advocacy
Preclinical Strategy and Regulatory Advocacy
We guide you through complex regulatory pathways with fit-for-purpose preclinical strategies and study designs for IND, NDA, and BLA submissions. Our proactive approach ensures your programs efficiently meet global regulatory requirements, minimizing hurdles while saving time and resources. By representing your best interests during health authority interactions, we also secure study waivers, streamline approvals, and reduce costs without compromising quality or compliance.
Accelerating Development While Managing Costs
Accelerating Development While Managing Costs
We recognize the urgency of delivering impactful therapies on time and within budget. By designing innovative and efficient preclinical strategies, we help you streamline workflows to achieve critical milestones faster and more cost-effectively. We have saved our clients millions of dollars a year. Our solutions empower you to focus on therapeutic innovation while reducing unnecessary expenditures and time.
Expertise in Emerging Modalities
Expertise in Emerging Modalities
Navigating the complexities of emerging modalities requires specialized knowledge, and that’s where we excel. From typical Small Molecules to Bispecific Antibodies, Antibody Drug Conjugates, Radioligands, Targeted Protein Degraders, LYTACs, mRNA Therapeutics, Oligonucleotides and Gene Therapies, our expertise ensures you stay at the forefront of therapeutic innovation. We partner with you to de-risk your programs, implement innovative solutions, and capitalize on new opportunities in cutting-edge science.
Innovative Problem-Solving for Complex Challenges
Innovative Problem-Solving for Complex Challenges
Preclinical development often presents unforeseen challenges, and we’re here to tackle them with creativity and precision. From mechanistic problem-solving to cutting-edge study designs, we collaborate with you to overcome obstacles and advance your programs with confidence. Our adaptive approach ensures meaningful results at every stage of development.
Thought Leadership and Industry Influence
Thought Leadership and Industry Influence
By partnering with us, you gain access to a trusted advisor who can help you position your innovation by representing your company and various scientific meetings. Through speaking engagements, publications, blogs and podcasts we can help position you as a leader in the field.
Delivering Real Business Impact
Delivering Real Business Impact
Our focus is on delivering tangible results that align with your business priorities. We have helped clients save millions of dollars, shorten preclinical timelines, and achieve regulatory approvals with confidence. Whether you’re a startup, venture-backed company, a publicly traded biotech or an established pharmaceutical leader, we integrate seamlessly into your team to ensure success.
Our Services
Client Offerings
Due Diligence, Candidate Selection and Predictive Risk Assessment
We conduct due diligence reviews to inform licensing and acquisition decisions. We author target safety reviews and design in vitro and in vivo triaging studies to optimize candidate selection.
Preclinical Program Design
We design integrated resource- and timeline-sparing preclinical programs, including the selection and management of Contract Research Organizations (CROs) through all phases of development.
Study Outlines, Protocols and Report Reviews
We design fit-for-purpose NGLP and GLP-compliant IND-enabling toxicology, safety pharmacology, pharmacokinetic (ADME) and mechanistic studies to enable INDs, NDAs and BLAs.
IND Documentation and Authoring
We author Pharmacology, Secondary Pharmacology, Safety Pharmacology, Toxicology Written Summaries, Integrated Nonclinical Overviews, Investigator Brochures (IBs), NDAs, and BLAs.
IND Filing Strategy
We develop strategies to minimize resources, and the time required for IND filings.
Regulatory Agency Representation
We prepare briefing documents and represent clients during regulatory agency meetings.
Developmental and Reproductive Toxicology
We have deep expertise in Developmental and Reproductive Toxicity Studies and Juvenile Toxicity Studies.
Health Authority Waivers
We author health authority waivers for carcinogenicity and reproductive toxicology studies.
Academic Collaboration Management
We manage and integrate academic collaborations into the drug development process. We help transform nascent ideas into reality by working hand-in-glove with your academic counterparts.
Why Choose Snow Leopard Consulting?
With over 30 years of experience and a proven track record of enabling countless Health Authority Submissions for numerous therapeutic platforms and indications, Snow Leopard Consulting LLC offers unparalleled expertise across therapeutic areas and modalities.
We pride ourselves on transforming therapeutic breakthroughs into success through practical, efficient, cost-effective strategies.
Let’s work together to turn your vision into reality.
About the Founder and Principal
Stan Spence PhD DABT
Stan offers more than 30 years of experience in Preclinical Drug Development across multiple modalities, including small molecules, targeted protein degraders, molecular glue degraders, antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), cytokine muteins, radioligands, oligonucleotides, mRNA therapeutics, and gene therapies. His expertise spans numerous therapeutic areas, including Oncology, Immuno-Oncology, Immunology & Inflammation, Neuroscience, Cardiovascular, Respiratory, and Infectious Diseases.
First and foremost, Stan is a passionate drug hunter and a recognized expert in Toxicology, Pharmacology, Pharmacokinetics, Developmental and Reproductive, and Juvenile Toxicology. He has held key leadership roles, at Merck, Centocor (now the biologics arm of Johnson & Johnson), and Wyeth (now Pfizer), as well as Executive Director of Nonclinical Development at Generate Biomedicines and Novartis and Vice President of Nonclinical Development at Xencor, Praxis Precision Medicines, and C4 Therapeutics.
In these roles, Stan has collaborated extensively with Medicinal Chemistry, Drug Discovery, Clinical Development, Regulatory Affairs, Business Development, and Academic and Industry partners. He has enabled countless Health Authority submissions, de-risked early drug candidates through screening strategies informed by the pharmacological target, the drug platform and mechanistic interrogation of toxicity. We relentlessly try to solve your problems.
Additionally, Stan has deep expertise working with contract research organizations (CROs), conducting due diligence reviews to support licensing and acquisition decisions, co-develop programs with partner companies, and oversight of academic collaborations.
Stan thrives on partnering with program teams and senior leadership to craft comprehensive, integrated, and innovative drug development strategies that are efficient, cost-effective, and scientifically rigorous. As a seasoned drug developer and team leader, he is dedicated to advancing innovative therapies with a focus on practicality, scientific excellence, and strategic execution.
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