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Nonclinical safety strategy
Develop customized nonclinical safety strategies for novel therapeutics dosed by oral, IV, SC, inhalation routes of administration.
Regulatory toxicology consulting
Regulatory toxicology for drug programs headed to the clinic.
Applying 30 years of regulatory toxicology experience to pharma/biotech companies in all aspects of nonclinical safety in drug discovery and development.
Confidential. No obligation. Every inquiry gets a direct reply.
Ray Liu, PhD, DABTPresident and CEO, Ray Liu Consulting LLC · San Diego
Experience
30 years in pharma and biotech toxicology
Certification
Diplomate, American Board of Toxicology (DABT)
Memberships
Society of Toxicology (SOT), American College of Toxicology (ACT)
Specialties
DART, juvenile toxicology, carcinogenicity
Experience at
SmithKlineDuPontSchering-PloughAmgenSGX PharmaceuticalsHalozymeTakeda CaliforniaGossamer Bio
Services
Nonclinical safety support from due diligence to health authority questions.
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CRO selection and study management
CRO selection, management of timelines, non-GLP and GLP study design, protocol review, study monitoring, interpretation of study data and report review.
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Regulatory writing
Regulatory writing: Investigator Brochures, IND, CTA, white papers.
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Health authority questions
Address questions from global health authorities, including FDA.
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Due diligence
Conduct due diligence on potential licensing assets.
Not sure which you need?
Describe the program on a short call. Ray Liu Consulting will tell you where to start.
By stage
Where Ray Liu Consulting fits in your program.
Nonclinical safety work changes at each stage of development. Each stage below opens to show the support Ray Liu Consulting provides there.
Click any stage, or use the arrows below the card. The tour moves on its own until you pick one.
Identify your best drug candidate
Once your drug candidate has been selected, all attributes of the drug are locked in, eg, PK, efficacy, safety. Make the best selection
Whether your drug assets are generated in-house or in-licensed, do your diligence from a toxicology standpoint. Identify potential concerns, gaps, areas to probe deeper. Better understand your asset before candidate selection.
What you get
- Review of the existing nonclinical data package
- Gaps and risks called out plainly, with what it would take to close them
- A view on the safety story a health authority would expect to see
A safety strategy built for this molecule.
Develop customized nonclinical safety strategies for novel therapeutics dosed by oral, IV, SC, inhalation routes of administration.
Every program needs a plan; what studies, which species, what order, which vendors. At Ray Liu Consulting, that plan is crafted around the molecule, the route, the indication, the regulatory region, and the clinical path you intend to take.
What you get
- A nonclinical safety strategy sized to the program and its timeline
- Species, study, and dose rationale you can defend in front of a regulator
- Coverage for small molecules, large molecules, and novel delivery platforms
For teams moving a candidate toward IND-enabling work.
Excellence in study design, vendor oversight, coordination, data interpretation, and report review
CRO selection, management of timelines, non-GLP and GLP study design, protocol review, study monitoring, interpretation of study data and report review.
Identify the right contract research organization for the work, keeps timelines honest, monitors studies, and deliver what regulatory reviewers want to see.
What you get
- CRO selection and a managed study timeline
- Non-GLP and GLP study design and protocol review
- Study monitoring, data interpretation, and final report review
For programs with IND-enabling studies on the calendar.
Meet the high expectations of global health authorities.
Regulatory writing: Investigator Brochures, IND, CTA, white papers.
A core strength at Ray Liu Consulting is writing. Whether for an Investigator's Brochure, IND, or CTA, the nonclinical safety sections and in particular the integrated nonclinical summary, needs to be clear, transparent, concise, and in context. When appropriate, a dedicated white paper, eg, weight-of-evidence (WoE) document, can be prepared to support a scientific position.
What you get
- Nonclinical sections for Investigator Brochures, INDs, and CTAs
- White papers on specific safety questions
- A submission narrative that matches the data behind it
For teams preparing a first-in-human filing.
When the agency writes back.
Address questions from global health authorities, including FDA.
Reviewers ask questions, and the answers have to be quick, complete, and scientifically sound. Ray Liu Consulting drafts and defends the nonclinical responses, for the FDA and for health authorities outside the United States.
At Ray Liu Consulting, high-quality nonclinical safety sections have yielded no significant questions from global health authorities
What you get
- Responses to nonclinical questions from the FDA and global authorities
- Support for meetings and briefing documents
- A steady hand during the review clock
For sponsors in active review or preparing for a meeting.
The specialty studies later phases depend on.
Specialty areas of toxicology that include developmental and reproductive toxicology, juvenile toxicology, and carcinogenicity studies.
As your clinical program advances, additional toxicology assessments are needed to meet regulatory expectations. These include reproductive and developmental toxicology, juvenile toxicology to support pediatric trials, and carcinogenicity to support your marketing application. These are Ray's specialty areas.
What you get
- Developmental and reproductive toxicology (DART) strategy and studies
- Juvenile toxicology for pediatric programs
- Carcinogenicity study strategy and execution
For programs in Phase 2 and beyond, and pediatric indications.
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Coverage
Modalities, routes, specialties, and therapeutic areas.
Broad experience in IND-enabling nonclinical safety studies, across multiple therapeutic areas.
Modalities
- Small molecules
- Large molecules
- Novel delivery platforms
Routes
- Oral
- Intravenous IV
- Subcutaneous SC
- Inhalation
Specialty areas
- Developmental and reproductive DART
- Juvenile toxicology
- Carcinogenicity
Therapeutic areas
- Auto-immune and inflammatory
- Oncology
- CNS
How Ray Liu Consulting works
Begin with the end in mind
First, define what success looks like and let Ray Liu Consulting build and execute the plan to get there as efficiently as possible.
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Introductory call
This introductory call is to meet Ray, describe your needs and see if this is a good fit.
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The work
Strategies and study designs customized to your program. Single point of contact with vendors to oversee work and timelines, present data, review reports, integrate and author nonclinical sections for regulatory submissions.
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Delivery and follow-through
Final deliverables, and availability when the health authority questions arrive.
Confidentiality first. Ray Liu Consulting signs a non-disclosure agreement before any compound-specific discussion, so you can share the program in full from the first call.
About
Ray Liu, PhD, DABT
Ray’s toxicology experience in the pharmaceutical/biotech industry spans 30 years. Born and raised in the UK, his interest in toxicology started with a 1-year college placement at SmithKline, now GSK, at the historic British Special Ops site, The Frythe, Welwyn. Here he analyzed clinical pathology samples from GLP toxicology studies and from an on-site clinical trial facility. He returned to college for his final year to major in toxicology and pharmacology. On completion of his degree, he re-joined SmithKline, this time in Reproductive Toxicology.
Ever sensing the desire to see beyond generating high-quality data, Ray felt the call of “the bigger picture”, not only to critically review safety data but also to integrate and interpret it. This set him firmly in pursuit of a PhD in reproductive biology at the University of Central Lancashire and Roslin Institute in Edinburgh, of Dolly the Sheep fame. This PhD brought him to the US to postdoc in reproductive toxicology in Delaware. He then became a study director on non-GLP and GLP toxicology studies, and represented the toxicology function on cross-functional teams on drug discovery and development projects.
In this project-team setting, Ray found his calling in toxicology: to help teams develop efficient strategies to bring important new medicines to patients.
While enjoying the resources at larger companies, Ray also found the thrill of the smaller biotech environment particularly addictive! The combination of like-minded people pulling in the same direction towards common goals is an incredibly rewarding experience.
Board-certified in toxicology by the American Board of Toxicology (DABT), Ray brings decades of experience in the discovery and development of small and large molecules, across multiple therapeutic areas, including auto-immune/inflammatory disease, oncology, and CNS.
Diplomate, American Board of ToxicologyBoard-certified in toxicology (DABT)
PhD, Reproductive BiologyUniversity of Central Lancashire and Roslin Institute, Edinburgh
SOT and ACT memberSociety of Toxicology, American College of Toxicology
FAQ
Questions people ask before the first call.
Will you sign an NDA before we talk about the compound?
Yes. Signed before any compound-specific discussion.
How soon can you start?
Discussed on our introductory call. Depends on your needs and timeline and the available bandwidth supporting other clients.
Which compound types and therapeutic areas have you worked on most?
Small molecules, large molecules, and novel delivery platforms, dosed by oral, IV, SC, and inhalation routes. Therapeutic areas include auto-immune and inflammatory disease, oncology, and CNS. Specialty areas are developmental and reproductive toxicology, juvenile toxicology, and carcinogenicity.
Do you work with CROs directly, or only advise?
Both. Ray Liu Consulting selects CROs, manages timelines, designs non-GLP and GLP studies, reviews protocols, monitors studies, and reviews the final reports, end to end or for a single piece of it.
Can I see a resume or CV?
The full resume will be provided before our introductory call.
Contact
Reach Ray Liu Consulting on LinkedIn.