IAA Consulting LLC
Excellence in Pharmaceutical Consulting
Screen Shot 2022-06-14 at 4.55.43 PM.png

About

Innovation. Agility. Alliance.

- Our Leadership Team -

 

managing director, head of development

Monil Shah, PharmD, MBA

  • Over 25 years of pharmaceutical and biotechnology industry experience in drug development

  • Oncology Early Development Scientist at Novartis

  • Medical Sciences Director at Amgen

  • Oncology Development and Operations activities at Fibrogen and Novacea

  • Solid tumor development programs and the Clinical Portfolio and Strategic Planning function at Celgene

  • Founder and Head of Clinical Development and Operations at Ventrus Biosciences prior to its merger with Assembly Biosciences

  • Medical Affairs Lead for Immuno-Oncology at Bristol Myers Squibb - Checkpoint inhibitor development programs

  • Chief Operating Officer of IRX Therapeutics /Brooklyn ImmunoTherapeutics - Cytokine drug development

  • Chief Development Officer at WindMIL Therapeutics - Cell therapy platform

  • Chief Business Officer at Imugene – Oncolytic virus and B cell immunotherapy

  • Managing Director and Head of Clinical Development at IAA Consulting

  • Bachelor of Science in Pharmacy and Doctorate of Pharmacy degrees from Rutgers University in New Jersey

 
 

partner, president of r&d and regulatory development

Kip Vought

  • 30 Years of pharmaceutical experience with overall development, regulatory, and CMC (quality) expertise

  • Ivax:

    • Analytical R&D

    • Product development

    • Project management (new and generic drugs)

  • NaPro BioTherapeutics

    • Global regulatory affairs for oncology portfolio

  • Regulus/Clinipace

    • Lead consultant for overall strategy development (from preclinical to market approval)

    • Hosting agency meetings (FDA and ex-US)

    • Lead in preparation and submission of clinical trial applications and market applications

    • Indications: oncology, analgesia, dermatology, gastrointestinal, cardiovascular, anti-infectives, pulmonary/respiratory, ophthalmic, and rheumatology

    • Therapeutics: NCE/NMEs, repurposed drugs (505(b)(2)/10(c) and equivalents), siRNAs, monoclonal antibodies, oligonucleotides, biologics, high-value generics, and over-the-counter (OTC) products (including novel OTC dosage forms).

    • Dosage forms: solid oral (including modified release), topical/transdermal (patches, creams, ointments, gels, etc.), sprays (oral and topical), inhalation, nasal, and parenteral

  • Scilex

    • Development lead ZTlido

    • Pipeline management

  • IAA Consulting

    • Development and regulatory lead for portfolio companies

 
 

partner, regulatory and compliance

Linda McBride, R.Ph., RAC

  • Over 30 years of extensive experience in the science of drug development in the biopharmaceutical industry

  • Implementation of registration strategies for drug candidates in various therapeutic areas at different stages of development through marketing application and at the post-approval phase

  • Significant expertise in preparing teams for successful interactions with health authorities and for delivering approvals for marketing applications for drug candidates, while striving to achieve the corporate vision for success

  • Member of the Regulatory Affairs Professionals Society

  • Sits on the Editorial Advisory Committee

  • Co-led authoring the book on global pediatric development

  • Presenter on pediatric drug development at RAPS events

 
 

Manufacturing

Herb Brinkman

  • Over 30 years of drug development experience in CMC activities ranging from early product development to commercial launch

    • Early-stage formulation development

    • API development

    • Process development

    • Technology transfer

    • Validation activities

    • Intellectual property generation

  • Head of Manufacturing at PharmAust, Ltd.

  • Executive Director, Product Development at Arcutis Biotherapeutics, Inc

  • Vice President, CMC at Brickell Biotech

  • Executive/director-level roles at KVK Tech, Inc., TOLMAR, Inc., Tapestry Pharmaceuticals, Inc., and NaPro BioTherapeutics, Inc

  • Hoffmann-LaRoche in the Pharmaceutical Process Development group, involved in the development and scale-up of 4 NDA products, including Xedola® (Capecitabine) and Rocaltrol® (Calcitriol)

  • BA in Chemistry from Rutgers University and a Ph.D. in Organic Chemistry from Seton Hall University

 
 

commercialization and market access

Mike Sweeting

  • 32 Years of pharmaceutical experience with Commercialization and Market Access expertise

  • Sanofi

    • Oncology, Cardiology, Sleep, Allergy, Osteoporosis, Metabolism, Antibiotics, & more

    • Sales, Market Access, Government Affairs

    • Sr. Leadership and Project Director; Leading teams up to 235 members

  • Questcor / Mallinckrodt

    • Built Market Access Payer Team

    • Developed Value Message, Marketing Tools, Pricing, Contracting, Reimbursement & Medical Policy strategies

  • Scilex

    • Executive Team Member

    • Built Market Access Team in less than 6 months

    • Developed strategies, messages and tools to launch ZTlido

    • Created and published 22 government Policies and Operating Procedures

    • Responsible for all Pricing, Contracting, Reimbursement strategies

  • Sweeting & Associates

    • Enhancing Commercial Success

    • Consulting to more than a dozen companies in 15 Therapeutic areas

    • From Early-Stage Development to Commercial Viability thru Launch Readiness

 
 

project management

Judee Strouss

  • Over 30 years of pharmaceutical development experience with expertise in project management

    • POC through launch for NCE and 505(b)(2) candidates

    • Large and small pharma, biotech, and devices

    • Preclinical and clinical study planning and execution

    • US and non-US regulatory submissions

    • CMC development

    • Virtual team management

    • Vendor management

  • Director of Global Portfolio Management, Pfizer

  • Sr. Director, Program Management, Eloxx Pharmaceuticals

  • Executive Director of Clinical & Commercial Operations, Scilex Pharmaceuticals

  • Head of Program and Project Management, Dohmen Life Sciences

  • Director of Portfolio Management, Array BioPharma

  • BS in Chemistry from University of Michigan and MBA from Eastern Michigan University

  • Certified Project Management Professional (PMP), Project Management Institute

 
 

clinical development & operations

Holli Cherevka

  • Over 15 years of leadership in clinical, chemistry manufacturing and controls (CMC), and quality

  • Experienced project and program manager across therapeutic indications in drug, biologic, and device development supporting US and ex-US regulatory applications

  • Board of Directors, Artyc, focused on decarbonizing cold chain logistics in the pharmaceutical development

  • Chief Operating Officer, Ampio

  • Director of Business Development, American College of Radiology, imaging core lab for drug, biologic, and medical device development

  • MSc Biomedical and Molecular Sciences Research, King’s College, London