James Wachholz, BS, MBA



  • 26 years of experience in new drug development in pharma and biotechnology; 19 years as senior Regulatory Affairs management.

Design / Conduct / Oversight / Monitoring of Clinical Trials Phases 1-3 and GLP Nonclinical Safety Studies; Defining Clinical Indication, Sample Population / Size, Primary and Secondary Endpoints; Regulatory Affairs and Strategic Planning / Analysis; Global GCP Compliance; FDA / EMA Negotiations (special protocol assessment, end of Phase 2 discussions, pre-Phase 3, defense of proposed trial design); Pre-NDA, INDs/CTAs, and IMPD ; Pre-submissions; Safety Reporting; Electronic Submissions Preparation; Scientific Advising; Health Regulatory Authority Meetings; Manufacturing / QA / GCP Compliance; Market Application, Labeling / Promotional Materials Development and Defense (MAA); Therapeutic Areas: CNS, Oncology, Asthma / Allergy, Cardiovascular, and Urology. Successfully managed 2l lNDs and 7 NDAs, including Xopenex, Soltara, and Lunesta.
Principal, A20 Regulatory Partners, Inc.
Provides regulatory strategy consultation for expedited pharma and biotechnology development. Defines and implements global opportunities to achieve optimal development pathway: Orphan Drug, Fast Track, Breakthrough Drug, etc. Plans strategy for regulatory agency interactions (briefing package, submissions, meeting plan, and rehearsals). Designs and compilation consults for investigational phase and market access dossiers: negotiation and resolution of Performs Due Diligence review and report functions, assessing data quality, study design acceptability, and identification of weaknesses and/or strengths. Recommends action forward in support of licensing activities.
Vice President, Drug Development Strategy, ICON Clinical, LLC
Provided drug development guidance and consultation focused on regulatory strategic analysis / planning, including review of overall development plans (preclinical through Phases 2-3), content review and guidance for major submissions, and assistance with global agency interactions. Developed content strategy and authored multiple lNDs, created regulatory affairs strategies, performed in-depth product / portfolio assessments for venture capital and investment banking organizations’ due diligence, and produced multiple Orphan Drug, SPA, and Breakthrough Therapy applications.
Vice President, Regulatory Affairs and Quality Assurance, Molecular Insight Pharmaceuticals
Managed all regulatory affairs and quality assurance functions for developer and manufacturer of targeted molecular radiotherapies, including six regulatory professionals and subject matter experts in CMC, Pharmacy, and Regulatory Operations (electronic publishing). Developed regulatory strategy for interactions with FDA, EMEA, and EU competent authorities, such as BfArM and MHRA, including pre-lND, end of Phase 1, end of Phase 2, pre-Phase 3 (protocol negotiations), and pre-NDA. Developed regulatory strategy for European-wide Compassionate Use Program for a pre-approval oncology therapy. Devised reimbursement strategies, including CMS negotiations to proactively incorporate pricing and reimbursement criteria in IND-stage clinical protocols. Successfully executed Special Protocol Agreement for pivotal oncology clinical trial with EMEA. Obtained four Orphan Drug Designations in US and EU, Fast Track development status for two products, and brought five new lNDs for imaging and oncology therapeutic drugs from the R & D bench to clinical Phase 2. Led successful pre-NDA meeting for an oncology product, developed strategy, and was implementing NDA structure at time of successful company acquisition.

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