About

managing director/head of development

Monil Shah, PharmD, MBA

• Over 20 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

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