About Chris Crean

Key qualifications & Experience

I am a qualified pharmaceutical professional, with 25 years of experience in large and small molecule integrative early phase drug discovery/translational research, nonclinical pharmacokinetics, drug metabolism, GLP toxicokinetics/toxicology and clinical pharmacology/bioequivalence/pharmacokinetic (study design, operations and pharmacokinetic analysis).

Awards & Recognitions

Career Experience

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Xyzagen has worked with over 40 different clients since its founding in 2018 within the fields of ophthalmology, neurology, anti-infectives, addition, pain and autoimmune diseases; as well as other therapeutic areas.   Xyzagen is a small, focused, contract bioanalytical small molecule LC/MS/MS lab with a rodent vivarium and drug development consultancy expertise, organized to support early stage biotechs in their nonGLP discovery in vivo PK and PK/PD studies.  We are able to support client product development through IND and initial clinical trials with GLP TK support and Nonclinical ADME and Clinical Pharmacology consulting services. Xyzagen offers within one organization the capability to formulate a new chemical entity, dose, collect fluids and tissues for concentration analysis, develop bioanalytical methods to quantitate the drug, and then analyze the concentration data for pharmacokinetic interpretation in a cost effective nonGLP setting.   Xyzagen’s consultants have supported IND and NDA submissions of small molecules, biologics such as mAb and enzymes, and gene therapies.

Clients include large, midsize and small pharmaceutical companies as well as biotechnology, veterinarian companies and CROs. Other clients include private equity groups, investment banks and business consultancies. Activities include strategic and scientific due diligence, formulate and refine product pharmaceutics strategies, safety assessment plans and clinical development programs.   I have specifically supported specific Phase 1/2A clinical operations, pharmacokinetic analysis, medical writing and nonclinical/clinical expert input for regulatory activities associated with IND, ANDA and (s)NDA preparation and review.

  • My experience covers small and large molecule, both antibody and enzyme, nonclinical and clinical noncompartmental and compartmental pharmacokinetics and GLP toxicokinetics.
  • I was the Biopharmaceutics/Clinical lead for >$70M sustained release formulation technology transfer and formulation change and over saw the clinical trials operations.
  • Member of team that successfully negotiated a removal of an FDA REMS ETASU program for Potiga
  • Developed and wrote the pediatric Major Depressive Disorder Phase 4 safety and efficacy and open label extension protocols for a post marketing commitment of Aplenzin.
  • I’ve worked on over 30 INDs/NDAs writing CTD sections 2.4, 2.6.1-7 and 2.7.1-2.7.2 for various clients.
  • As a consultant, I’ve worked with over 30 clients from providing expert review of their asset for a gap analysis to conducting nonGLP and GLP pharmacokinetic/toxicokinetic analyses or in vivo studies at Xyzgen.
  • I’ve been the primary pharmacokinetist analyzing and reporting on over 10 phase 1 and phase 2 pharmacokinetic clinical trials.
  • Broad experience in nonclinical and clinical pharmacology 505(b)(1) and 505(b)(2) small and large molecule drug development.

1st Order Pharmaceuticals (1OP) was a clinical development-stage pharmaceutical company focused on advancing 1OP-2198, an IND-ready small molecule potassium channel opener (KCNQ2/3), for unmet medical, medically important and orphan indications in neurology and pain management. 

  • Responsible for all aspects of the business, scientific and clinical development plans, fund raising and financial management of the organization.
  • Led the asset sale and divestment of 1OP-2198 to Xenon Pharmaceuticals, Inc. April 2017 for up to $48.7 million in milestones plus sales royalties.

Clinical Pharmacology and nonclinical development consultant

Reported directly to Global Head of R&D and member of R&D leadership team from 2010-2011 and member of CMO’s leadership team from 2012-2013.  As department head within a lean organization was also responsible for the Alliance Management lead on multiple projects with numerous companies (GSK, J&J, Lundbeck, Sanofi) thus was responsible for the strategic/scientific direction, financial management and operational success of the projects within my department and at times across the North American organization.

  • Oversaw the clinical trials operations for Phase 1/2A trials
  • Managed a department with minimal internal head count and a multi-million dollar operating budget
  • Valeant member to the GSK international core Medicine Development Team (MDT) and Alliance Management lead for Potiga/Trobalt worldwide development.
  • Clinical PK/Biopharmaceutics lead for ezogabine ER formulation development, Cardizem CD formulation change and technology transfer, Motofen re-approval and Bontril SR formulation change and technology transfer.
  • Project and technical lead for series of 505(b)2 ophthalmology projects; 1) Lacrisert (smaller size), 2) Macugen Extended Release formulation, 3) Timoptic XE preservative free formulation development, and 4) drug loaded daily ophthalmic erodible ocular inserts
  • Clinical PK/Pharmacology lead on successful EMA/FDA joint Good Clinical Practice (GCP) inspection for Potiga/Trobalt
  • Clinical and Nonclinical Safety Assessment project lead for Xenazine® CTD NDA update for Huntington’s Chorea in Emerging Markets and Asian partnered markets
  • Clinical Development and Pharmacology lead on Aplenzin pediatric Phase 4 study design
  • Participated in the integration of Aton, Biovail, Dermik, Ortho Dermatologics and Eyetech at Valeant
  • Clinical Pharmacology/PK and Nonclinical DMPK writer/reviewer for efinaconazole NDA submission in Onychomycosis (JUBLIA®, filed under Dow Pharmaceuticals Sciences, a subsidiary of Valeant)

Received increasing responsibilities within the organization with regard to drug development programs and built out the core laboratory ADME capabilities and Clinical Pharmacokinetics functions. These responsibilities afforded interaction across a fully integrated organization from the bench top scientists through clinical and commercial where I was responsible for internal and external nonclinical ADME/Clinical Pharmacokinetic studies, writing and/or review of all regulatory documents for FDA, EMEA, Health Canada under CTD sections 2.6.4-5 and 2.7.1-2 in the therapeutic areas of Cardiovascular, Pulmonary and Ophthalmology.

  • Built up from the ground the Mass Spectrometry/ DMPK facility, hired in key PhD team members and operated a yearly budget of approximately $1M/year
  • Project leader in the discovery program for Pain Management with co-management responsibilities of external chemistry collaboration with partner Discovery Partners International
  • Key drug metabolism and pharmacokinetics team member that identified two molecules through discovery SAR and advanced them to Phase II (INS50589/CABG, INS117548/Glaucoma)
  • Help advance two additional programs to Phase III (denufosol/Cystic Fibrosis, epinastine intranasal/Allergic Rhinitis)
  • Clinical Pharmacology lead with Inspire/Faes Farma collaboration on Bilastine (Allergic Rhinitis)
  • Member of numerous national and international due diligence processes
  • Technical lead for proof of concept study in CABG surgery conducted in dogs at an academic lab
  • Participated in the launch of Inspire’s first product, AzaSite, and was critical team member of Phase 4 clinical/nonclinical pharmacokinetics program that demonstrated the importance of the DuraSite formulation of AzaSite.


Responsible for writing summaries for CTD module sections 2.6.2 through 2.6.5 (pharmacology and pharmacokinetics) for molecules in therapeutic areas of Sickle Cell Anemia and Epilepsy and conducting nonclinical pharmacology and ADME research in the CNS and pain therapeutic areas.

  • Helped internalize core Mass Spectrometry capabilities that lead to the responsibility for coordinating, conducting and interpreting pharmacokinetic and drug metabolism experiments for internal discovery projects and partnerships with Abbott, Yamanouchi and Bristol Myers Squibb.
  • Core team member of the Project Discovery team with responsibilities for in vivo efficacy validation and early ADME profiling for novel ion channel agonists/antagonists in the therapeutic areas of Epilepsy and Pain Management (Acute, Inflammatory and Neuropathic)

Responsible for new molecular entity research in a variety of therapeutic areas.  The core focus of the group was in vitro and in vivo kinetics, drug metabolism and metabolite ID utilizing analytical technology such LC/MSn, robotics and combinatorial chemistry in the lead optimization process.

Responsible for the conduct of GLP acute, chronic and oncogenic inhalation nonclinical safety studies on a variety of systems of atmosphere generation; vapors, dusts, gases and liquid aerosols. 



Masters of Science in Clinical Research

Campbell University, Buies Creek, NC, USA | 2003

Thesis: Development Plan for Vulvar Vestibulitis Syndrome

Bachelors of Science in Biochemistry

Michigan State University East Lansing, MI, USA | 1995

Ph.D. Pharmaceutics

University of North Carolina-Chapel Hill | 1998-1999

Left program for job opportunity

Master of Science in Chemistry

Western Michigan University | 1996-1997

Left program due to relocation to N.C

Additional Career Training


Regulatory Affairs Certification (R.A.C.) from R.A.P.S. (2000)

Laboratory Animal Technologist (L.A.TG.) from A.A.L.A.S. 1999


Lead technical expert on the international patent families associated with Valeant’s KCNQ potassium channel opener program as well as lead technical expert on patent applications associated with retigabine formulation development.  Provided technical support and consultant and review for Valeant North America’s intellectual property team.

Society Memberships