OLIVIERKONSULTING Contact

Drug development consulting · Massachusetts

Nonclinical and regulatory strategy that gets programs into the clinic.

Olivier KOnsulting, LLC is the practice of Kenneth J. Olivier, Jr., Ph.D., who has developed drugs for more than 24 years at Regeneron, Biogen, GSK, Merrimack and five more biotechs. He advises programs from discovery through Phase 1/2 in small molecules, biologics, and cell and gene therapies.

Human creation, AI execution.

Discuss your program See the track record
The Olivier KOnsulting monogram: a gold O and a deep green K joined by a DNA double helix, over a soft background of gold molecular lattices and purple cells.
  • 24+years developing drugs, from candidate selection through approval
  • 9biotech and pharma companies, from Regeneron to Neutrolis
  • 11due diligence and partnering deals supported, 2003–2020
  • 0FDA or EMA comments on the ONIVYDE nonclinical NDA and MAA sections

Services

The nonclinical, regulatory and operational work between a candidate and a first-in-human dose.

Engagements are typically fractional and hands-on: weekly guidance for a founder team, a full IND package for a lead program, or a diligence read on a deal.

  • Nonclinical safety and toxicology

    Study strategy, CRO selection and oversight, dose-level selection and risk assessment for small molecules, biologics, antibody-drug conjugates, nanotherapies, and cell and gene therapies.

  • Regulatory strategy and authoring

    Pre-IND briefing documents, INDs, IMPDs and CTAs, and the nonclinical modules (2.4, 2.5, 2.6 and 4) of NDAs, BLAs and MAAs, plus responses to questions from health authorities.

  • Pharmacokinetics and bioanalysis

    Oversight of assay development, validation and sample analysis across nonclinical and clinical programs, and the PK strategy that ties them to dose selection.

  • Program and project leadership

    Discovery-to-clinic plans, budgets and timelines; IND core teams; and target product and molecule profiles that keep cross-functional teams working toward the same filing.

  • Due diligence and partnering

    Nonclinical and regulatory diligence for in-licensing, acquisitions and pharma partnerships, from a single asset to a company-wide collaboration.

  • Quality and GLP systems

    Outsourced quality systems for young companies, GLP CRO qualification and in-process audits, and readiness for eCTD and SEND submissions.

  • Human creation, AI execution

    AI-enabled regulatory and quality workflows

    Custom AI agents, connections and tools for regulatory, nonclinical, GxP and quality work, including regulatory submissions, built by a drug developer who has written the documents by hand. Paired with the team sites and document infrastructure that keep pipelines and regulatory files in order.

  • Team training and coaching

    Practical drug-development training for CSOs, CEOs, CMOs, project team leaders and functional heads moving a company from discovery into development.

  • Scientific advisory

    Advisory board and expert-consultant work for start-ups, academic spin-outs and translational programs, including a DARPA-funded tissue chip project at MIT.

Modalities
Small molecules Biologics and bispecifics Antibody-drug conjugates Liposomal and antibody-directed nanotherapies Enzymes Gene therapy (AAV, LV) Cell therapy (TAA, TCR) Diagnostics
Therapeutic areas
Oncology Immunology Neurology Cardiology Metabolic disease Neuromuscular disease Rare disease Infectious disease Fibrosis

Track record

Nine companies, from early-stage cell therapy to marketed biologics.

Selected contributions by company, in reverse chronological order. Roles are as held at the time; every program is the work of many teams.

Marketed medicines Dr. Olivier contributed to

  • EYLEAVEGF Trap · Regeneron
  • ARCALYSTIL-1 Trap · Regeneron
  • DUPIXENTIL-4/13 Trap · Regeneron
  • AVONEXJapan approval · Biogen Idec
  • TYSABRIRegistration · Biogen Idec
  • TECFIDERAEarly IND · Biogen Idec
  • PLEGRIDYIND stage · Biogen Idec
  • TYKERB / TYVERBNDA filing · GSK
  • ONIVYDENDA and MAA · Merrimack
  • LuspaterceptBLA support · Acceleron

Neutrolis

Executive Vice President of Development

Dec 2023 – Aug 2026

  • Led three discovery programs into development in high-unmet-need indications, and two European clinical programs into the US.
  • Composed INDs, IMPDs, CTAs and companion-diagnostic plans, with budget and strategy, for three lead programs.
  • Oversaw regulatory, toxicology, PK, pharmacology, GLP quality assurance, bioanalytical and program management.
  • Built AI agents and capability tools for regulatory, nonclinical, GxP and quality work, including submissions.

TScan Therapeutics

Vice President of Development (from Associate VP)

Feb 2020 – Nov 2023

  • Set nonclinical pharmacology/toxicology, regulatory and clinical strategy for two cell-therapy programs through pre-IND and IND.
  • Composed IND plans, budget and strategy for two lead programs, and stood up outsourced quality systems.
  • Supported due diligence behind significant partnerships with large pharma, and the company's path to becoming public.

Morphic Therapeutic

Executive Director of Development

Apr 2018 – Oct 2019

  • Provided toxicology and regulatory strategy for five pre-IND programs.
  • Composed the IND plan, budget and strategy for two lead small-molecule programs.
  • Subject-matter expert on the due diligence teams behind the AbbVie partnership in oral integrins for fibrosis.

Torque Therapeutics

Head of Nonclinical Development

Aug 2017 – Apr 2018

  • Built nonclinical strategy for cell-therapy discovery through development, and contributed to the pre-IND briefing document and meeting.
  • Led a six-person team on a company-wide effort to define decisions, responsibilities and accountabilities at every level.

Acceleron Pharma

Head of Toxicology, Nonclinical PK/DM and Bioanalytical Assay Development

Mar 2017 – Aug 2017

  • Managed three teams supporting toxicology, drug metabolism and bioanalytical functions.
  • Contributed to molecule and target product profiles for three upcoming INDs, primarily ACE-083, and supported BLA efforts for luspatercept with Celgene.

Merrimack Pharmaceuticals

Associate Director to Global Head of Toxicology, Nonclinical PK, Bioanalytical, Discovery Regulatory and Program Management

Aug 2008 – Mar 2017

  • Composed the entire nonclinical section of the ONIVYDE NDA and MAA (with Baxter, Baxalta and Shire on the MAA): no comments or objections from FDA, EMA or several other authorities.
  • Drove project and IND teams for MM-151, MM-141, MM-302 and MM-310, and a submission-ready package for MM-131, across toxicology, PK, bioanalytical, project management and early regulatory roles.
  • Responsible for nonclinical safety and PK on 8 clinical, 4 pre-IND and 3 discovery projects at the peak; led the internal SEND initiative and supported in-house eCTD capabilities.
  • Supported diligence and partnering with Sanofi, Baxter and Ipsen, and two spin-out companies.

GlaxoSmithKline

Project Representative, Safety Assessment

Aug 2007 – Aug 2008

  • Represented Safety Assessment on seven program teams, and contributed to the TYKERB/TYVERB NDA filing.
  • Conducted extensive due diligence on RNAi and oligonucleotide companies (Regulus, Isis/Ionis, Alnylam).

Biogen Idec

Toxicologist, Scientist I and II, Pharmacotoxicology

Apr 2004 – Aug 2007

  • AVONEX Japan: worked with the Genzyme Japan office to resolve more than 400 MHLW questions, including the labeling meetings; approved July 26, 2006.
  • Contributed to TYSABRI registration, including the PML safety signal that nonclinical studies did not predict, and to early IND work on TECFIDERA and PLEGRIDY.
  • Prepared three pre-IND briefing documents and three INDs, two of them cleared by FDA to begin Phase 1 trials in multiple sclerosis and idiopathic pulmonary fibrosis.

Regeneron Pharmaceuticals

Toxicologist; PK/PD Sciences Group Supervisor

Jul 2002 – Apr 2004

  • Contributed to early-stage success (IND through end of Phase 2) of the VEGF, IL-1 and IL-4/13 Traps, through study design, due diligence and collaboration management with Sanofi, Novartis and, later, Bayer.
  • Managed a five-person PK group and oversaw CRO toxicology studies from dose-range finding through carcinogenicity.

Also: President of Olivier KOnsulting since October 2019, and Head of Regulatory Toxicology at Orange Grove Bio (2018–2020), advising academic scholars on spin-out drug programs in oncology and immune disease. Client work is confidential.

Due diligence and deals

Eleven transactions, 2003 to 2020.

Nonclinical and regulatory diligence support for partnering, licensing and merger transactions, with values ranging from roughly $10 million to $1 billion.

  1. 2003Regeneron – NovartisTrap technology, IL-1 Trap
  2. 2003Regeneron – SanofiTrap technology, VEGF Trap
  3. 2003–05Biogen–Idec mergerMS and oncology focus
  4. 2006Biogen Idec – FumapharmOral small-molecule therapy for MS
  5. 2008GSK – RegulusRNAi
  6. 2008GSK – SirtrisSirtuins
  7. 2009Merrimack – SanofiErbB3 receptor
  8. 2014Merrimack – BaxterONIVYDE
  9. 2017Merrimack – IpsenOncology assets acquisition
  10. 2018Morphic – AbbVieOral integrins in fibrosis
  11. 2020TScan – NovartisTCR T-cell targeted therapies
Portrait of Kenneth J. Olivier, Jr., Ph.D.

About

Kenneth J. Olivier, Jr., Ph.D.

President, Olivier KOnsulting, LLC · Instructor, Biotech Primer · Adjunct faculty, Oklahoma State University

Ken trained as a toxicologist and spent two decades inside the companies that build drugs. Most of his work has been safety evaluation, but he has also been the project leader, head of project management, head of regulatory, head of toxicology, head of pharmacokinetics and head of bioanalytical development, on programs supporting INDs, IMPDs, CTAs, NDAs, BLAs, PLEs and IDEs.

He has spent the past 15 years teaching executives and project teams how to move from discovery to development to approval, and has chaired, co-chaired or presented at symposia and courses every year for 18. In 2016 he published a book on the development of antibody-drug conjugates, from discovery through post-market approval.

Most recently he was Executive Vice President of Development at Neutrolis, where he also built AI agents and tools for regulatory and quality work. Olivier KOnsulting is where that combination now goes to work for other teams.

Education

  • Ph.D., Veterinary Biomedical Sciences, Oklahoma State University
  • B.S., Toxicology, University of Louisiana at Monroe
  • Boston University Executive MBA Scholarship, 2015–2017

Service and affiliations

  • Editorial Board, International Journal of Toxicology
  • American College of Toxicology: formerly elected Council Member; Awards Committee
  • Scientific advisory: Tissue Chip Technologies at MIT (DARPA PhysioMimetics), Nova Research Labs

Awards

  • Merrimack Values Leadership Award, 2015
  • ACT Young Professional Award, 2012
  • Oklahoma State University Phoenix Award, 2002

Memberships

  • Society of Toxicology; Society of Toxicologic Pathology
  • Drug Information Association
  • Cardiac Safety Research Consortium

Teaching and speaking

Explaining drug development is part of the job.

Courses and programs

Biotech Primer, instructor since 2016. Customized immersion courses in drug discovery, development and commercialization for biotech and pharma professionals and for academic scholars, including at Dana-Farber Cancer Institute and Harrington Discovery Institute.

Oklahoma State University. Created the graduate course on nonclinical drug development (VBSC 5801), a webinar series of 16 sessions with five guest speakers, attended largely by faculty and by medical and veterinary students.

Harvard, MIT and the American College of Toxicology. Guest lectures and course teaching, and symposium chair or co-chair roles on stem cells, network biology, infections in non-human primates, safety pharmacology, antibody-drug conjugates and statistics.

Toxicology Round Table, 2014. Organizer, chair and host of a three-day meeting with 42 speakers.

Selected talks

  1. 2018Patient-Focused Drug SafetyInvited speaker · Gordon Research Seminar, Stonehill College
  2. 2016The Use and Misuse of Statistics in ToxicologyChair · American College of Toxicology
  3. 2015Nonclinical Development of Antibody-Targeted NanotherapeuticsInvited speaker · GTC Antibody Drug Conjugates Conference
  4. 2015Tasks and Timelines: The TnT of Supporting Clinical Trials in Drug DevelopmentCo-chair and speaker · American College of Toxicology
  5. 2014Antibody-Drug Conjugates: The Next Evolution in the Cure for CancerInvited speaker · Harvard, Principles of Toxicology
  6. 2013The Art of Dose Level Selection: From Bench to the Clinic, Enabling First in Human Studies of Novel Oncology TherapiesCo-chair and speaker · American College of Toxicology
  7. 2012Nonclinical Safety Assessment of Dual Targeting BiotherapeuticsInvited speaker · Society of Toxicology

Publications and patents

Safety science in immunology, oncology and cell therapy.

A selection. The full list, including abstracts and posters, is in the CV.

Selected publications

  • Antibody-Drug Conjugates: Fundamentals, Drug Development, and Clinical Outcomes to Target CancerOlivier & Hurvitz · Wiley, 2016
  • BiomarkersOlivier, Krejsa & Freeman · Information Resources in Toxicology, 5th ed., Elsevier, 2020
  • Unbiased screens show CD8+ T cells of COVID-19 patients recognize shared epitopes in SARS-CoV-2 that largely reside outside the spike proteinFerretti et al. · Immunity, 2020 · doi:10.1016/j.immuni.2020.10.006
  • Antitumour activity and tolerability of an EphA2-targeted nanotherapeutic in multiple mouse modelsKamoun et al. · Nature Biomedical Engineering, 2019 · doi:10.1038/s41551-019-0385-4
  • MM-141, an IGF-IR- and ErbB3-directed bispecific antibody, overcomes network adaptations that limit activity of IGF-IR inhibitorsFitzgerald et al. · Molecular Cancer Therapeutics, 2014
  • HER2-targeted liposomal doxorubicin displays enhanced anti-tumorigenic effects without associated cardiotoxicityReynolds et al. · Toxicology and Applied Pharmacology, 2012
  • In vivo pharmacology and toxicology evaluation of PEGylated interferon beta-1aHu et al. · Journal of Pharmacology and Experimental Therapeutics, 2011

Patents

  • US 9,688,761 · 2017Biomarker profiles for predicting outcomes of cancer therapy with ERBB3 inhibitors and/or chemotherapies
  • AU 2011338487 B2 · 2015Dosage and administration for ErbB3 inhibitors
  • Application familyDosage and administration of ErbB2-targeted immunoliposomes comprising anthracycline chemotherapeutic agents

Contact

Start with the program.

A short note is enough to start: the modality, the stage, and the next regulatory milestone. Conversations are confidential, and an NDA is available on request.

Strategy and submissions Due diligence Training
Email
KO@olivierKOnsulting.com
olivierKOnsulting@outlook.com
Phone
1-617-949-1575
Office
Olivier KOnsulting, LLC
100 Agricultural Ave
Rehoboth, MA 02769