Gaylen M. Zentner, PhD

Principal Partner and Founder

Core expertise — All technical, manufacturing, and documentation aspects of Chemistry, Manufacturing & Control (CMC) sections of regulatory submissions; drug substance and drug product; sophisticated drug delivery systems, controlled release, solubilization, and bioavailability enhancement; human and veterinary drug  development programs have been advanced through preclinical development and into clinical trials in the US, EU, and Asia; 33 years experience. 

Pertinent Professional Experience & Responsibilities

Vice President, CMC R&D — Myrexis, Inc. (formerly Myriad Pharmaceuticals, Inc.)

  • Directed all internal and vendor-related CMC work in support of 12 successful national and international IND/CTA/IMPD/NDA filings
  • Created and managed budgets of $millions/year
  • Responsible for all CMC technical, IP, legal, and budgeting efforts
  • Oral and parenteral drug delivery systems/dosage forms; design, manufacture, and clinical supply
    • Solubilization and amorphous solid dispersions

Executive VP, Research and Development — MacroMed, Inc.

  • Controlled release drug delivery (supporting US, Asian & EU clinical trials)
    • Parenteral biodegradable polymer systems; design, manufacture, and clinical supply
    • Oral controlled release systems
    • Solubilization technologies; design, manufacture, and clinical supply

Director, Electromechanical Drug Delivery — Sarcos

  • Directed all programmable, electromechanical drug delivery programs

Director, Controlled Release Research — Merck & Co., Inc.

  • Dosage form design and formulation
    • Bioavailability enhancement
      • Solubilization and amorphous solid dispersions
      • Controlled release drug delivery systems
      • Oral and parenteral dosage forms, including long-term parenterals based on biodegradable polymers.
        • Oral technologies have been commercialized
    • Managed budgets of ca. $2 million/yr; responsible for technical, IP, and legal interactions

Academic Appointments

  • Adjunct Professor — University of Utah
  • Adjunct Associate Professor — University of Kansas
  • Assistant Professor — University of Connecticut

Author / Co-author:  86 peer-reviewed publications (articles, abstracts, book chapters)

Inventor / Co-inventor:  43 US and foreign patents on formulations and drug delivery systems

Presentations:  23 invited lectures

Educational qualifications:

Ph.D., Pharmaceutical Chemistry — University of Utah

B.Sc., Pharmacy — University of Utah

Select Awards, Honors and Professional Activities:

Associate Editor, Journal of Pharmaceutical Sciences

Editorial Board, Journal of Pharmaceutical Sciences

Complete Curriculum Vitae available upon request

Kraig M. Yager, PhD

Principal Partner

Core expertise — Medicinal Chemistry, API process development and manufacturing, CMC drug substance sections of regulatory submissions, solubilization technologies; 17 years experience.

Recent Professional Experience & Responsibilities

Head of Chemistry — Myrexis, Inc. (formerly Myriad Pharmaceuticals, Inc.)

  • Responsible for Myrexis’ 25-member chemistry department
  • Advanced six NCEs into development
  • Selection, contract management and scientific leadership of off-shore medicinal chemistry FTEs
  • Technical packages for cGMP API synthesis and manufacturing
  • Technical oversight during process development and c-GMP manufacturing campaigns
  • Regulatory documentation; drug substance CTD Module 3 and FDA pre-IND briefings
  • Due diligence data packages, summaries and reports
  • Identification of appropriate API chemical and physical forms prior to scale-up
  • Solubilization technologies for optimization of bioavailability and dosage forms

Associate Director — Chemistry, Manufacturing and Controls (CMC) - Myriad Pharmaceuticals, Inc.

  • Coordinated API contract manufacturing in support of three development candidates
  • Identified manufacturing contractors; negotiated, executed and managed contracts
  • API Quality standards assurance
  • CMC regulatory submissions including CTD Module 3 for drug substances
  • Participated in drug formulation and drug product teams
  • Review of all CMC Sections of regulatory submissions
  • Technical review of DMF and regulatory documentation for NDA submission
  • API manufacturing technical transfer documentation
  • API Master and Executed batch record review and approval
  • API stability programs
  • Drug substance CMC due diligence reviews
  • US Federal and European Agencies; CFR Title 21, ICH Guidance documents, GMPs and GLPs

Author / Co-author — 35 peer-reviewed publications and presentations

Inventor / Co-inventor — 20 US and foreign patents and patent applications

Educational qualifications

NIH Postdoctoral Fellow — Department of Chemistry, University of Pennsylvania

Ph.D., Synthetic Organic Chemistry — Department of Chemistry, Oregon State University

B.Sc., Chemistry — Department of Chemistry, University of Arizona

Select Awards, Honors and Professional Activities

National Institutes of Health (National Cancer Institute) Postdoctoral Fellowship

Invited lecturer, Medicinal Chemistry Gordon Research Conference, New Hampshire

“Current GMP Concepts:  Preparing for 21st Century FDA and European Agencies Inspections”

“Designing Drugs with Optimal in Vivo Activity after Oral Administration”

American Chemical Society

Complete Curriculum Vitae available upon request 

James C. McRea, PhD

Principal Partner

Core expertise — CMC Virtual Operations Management, Clinical Trials Setup & Materials Logistics,  Controlled Drug Delivery Systems Clinical Development; CMC Regulatory Documentation; Medical Devices Development & Product Launch, 35 Years’ US & International Experience.

Recent Professional Experience & Responsibilities

Director, Chemistry, Manufacturing, Control - Myrexis, Inc. (formerly Myriad Pharmaceuticals, Inc.)

  • Directed virtual CMC activities in support of corporate global drug development
  • Managed budgets, schedules and performance requirements; generated RFPs, and contract reviews
  • Organized drug substance tech-transfer for analytic methods, master/executed batch records, raw material vendors, stability testing, audits, and technical service agreements from primary to secondary vendors
  • Directed and supervised worldwide logistics procedures for initiation and/or re-supply of Phase I -III clinical studies with cold-chain control when required & cGMP compliance storage facilities

Vice President, Product Development & Clinical Affairs – MacroMed, Inc.Designed and directed commissioning of a one-of-a-kind, specialized, cold-clean room, (class 100) for an aseptic filling operation within a contract vendor’s existing facility.
Established and managed human clinical trials in US & Europe of a novel thermopolymer, controlled drug delivery system by direct intratumoral injection of chemotherapeutic agents into malignant tumors.

Vice President, Technical & Scientific Affairs – Baxter International, Inc.

  • Internally merged and/or out-licensed from our Cardiovascular Group all non-aligned product technologies after Baxter acquisition of Research Medical, Inc.
  • Established New Business Initiative Plan for alternate financing of “Break-out Technologies” for product and  technology development outside of  Baxter Cardiovascular Group,
  • Completed internal product technology transfer Homeostasis Catheter Kit from Baxter‘s Cardiovascular Group to its Biopharmaceutical Group

Vice President, Technical & Scientific Affairs – Research Medical, Inc. (RMI)

  • Established first Product Technologies R&D Department, 15 staff and 10,000 sq. ft. facility, within RMI
  • Directed establishment of European contract manufacturing facility & conducted European clinical trials
  • Directed the pre-market launch of three new products: “Biofilter”, “AFD Kit” & “HRD System” for blood salvage & hemostasis requiring preparation of company’s first Investigational Device Exemption (IDE).

Academic Appointments — University of Utah

  • Adjunct Professor — Department of Bioengineering, (1991 – present)
  • Adjunct Assistant Professor — Dept. of Pharmaceutical Sciences (1983-1988)

Author / Co-author – 100 plus peer reviewed publications, book chapters and invited symposia

Inventor / Co-inventor – 12 US & EU patents (drug delivery, blood processing, cardiovascular blood access)

Educational Qualifications

Ph.D., Physical Pharmaceutics — Dept. Pharmaceutics and Pharmaceutical Sciences, University of Utah

B.Sc., Biology — Department of Biology, University of Utah

Selected Awards, Honors and Professional Activities

Invited lecturer, Biomaterial Gordon Research Conference, Chairman of Industrial Advisory Board at U. of Utah; Principal Investigator, Phase I and II NIH Small Business Investigational Research (SBIR) Grants; Member of American Association of Pharmaceutical Scientist & Rho Chi Pharmaceutical Honor Society; Board of Directors Membership: Research Medical Inc. (1985-89), Process Instruments, Inc. (1998-present)

Complete Curriculum Vitae available upon request

Mark S. Williams

Principal Partner

Core expertise — Technical and manufacturing aspects of Chemistry, Manufacturing & Control (CMC) sections of regulatory submissions; drug product manufacturing and characterization for clinical and commercial applications; oral solids (including controlled release) and sterile injectables; 36 years experience.

Pertinent Professional Experiences & Responsibilities

Independent CMC Consultant / Contractor (2010 – present)

  • technical and project manager expertise for the successful and concurrent technical transfer of multiple parenteral and solid dosage products for international clients
  • drug product formulation/process development, clinical supply, tech transfer, validation, manufacturing, documentation, and project management.
  • extensive work and management experience in the development of solid dosage, parenteral, and LCO dosage forms.

Director, Pharmaceutical Manufacturing and Technology (Myriad Pharmaceuticals, Inc.; 2006-2010)

  • managed multiple contracted vendors (USA, Europe, and Australia) to develop, manufacture, and supply cGMP drug products (clinical supplies) to support international clinical studies.
  • Directed all formulation, process, and analytical development efforts.
  • Directed manufacture, scale-up from clinical to commercial scale, and packaging efforts, and analytical/manufacturing transfers.
  • Implemented sophisticated, enabling solubilization technologies for both oral and parenteral dosage forms.
  • Implemented QbD, DOE, and other statistically based manufacturing approaches.

Senior Scientist, Aptuit, LLC/Quintiles, Inc. (formerly Marion Laboratories; 2002-2006)

  • Technical lead at a CRO for multiple clients with contracted development projects.
  • Provided innovation and problem solving skills to manage compressed timelines and challenging  formulations, processes and equipment trains.
  • Technical lead for numerous formulation and process development contracts including consulting arrangements at client facilities.
  • Responsible for drug product clinical and commercial scale-up, and transfers into manufacturing facilities in USA/Europe.

Senior Scientist II/III, Manager/Group Leader, Geneva Pharmaceuticals, Inc. (1997-2002)

  • Managed multiple product optimization projects that achieved formula, process, and sourcing improvements to generic oral solid dosage forms., including technical transfer or commercial products.
  • optimized fluid bed, high shear granulation, compression, roller compaction, and coating processes for large volume commercial products.

Formulator, Marion Laboratories, Inc. (including two subsequent mergers; 1976-1997)

  • Formulated and evaluated processes for new development candidates
  • Performed scale-up, technical transfer, diagnostics, and operations support for multiple products; worked with products utilizing controlled release, transdermal and spray-drying technologies
  • NDA-supporting manufacture and documentation, scale-up, and transfer of processes from development into manufacturing.