David Weyna

Pharmaceutical scientist with a history of results-driven, broad spectrum experience in drug lead creation and optimization of various types of drug delivery systems which includes implementation of analytical chemistry, solid-state chemistry and crystallization development, preformulation/formulation of preclinical and clinical projects, competitive intelligence, and intellectual property strategies including life cycle management. PBPK modeling with Gastroplus to predict animal and FIH exposure with different crystal forms and formulations. 

Crystal Pharmatech, Cranbury, NJ                                                                                                      2020 - 2022

Senior Scientist II – PBPK modeling using Gastroplus, Preformulation/formulation work and solid form screening including crystallization development for preclinical and clinical level projects.

Crystal Pharmatech is a CRO which has an integrated platform collaborating across key solid-state research areas including formulation development, process chemistry, and manufacturing capabilities. The Cranbury site focuses on solid-form selection, preformulation and formulation, and crystallization development for small to large molecules and small peptides. Pharmacokinetic studies are supported with early phase vehicle identification and PBPK modeling using Gastroplus in coordination with formulation development including predictions based on in vitro and in vivo data, animal to animal predictions, and animal to FIH predictions to guide dosing and delivery strategies.

Catalent Pharma Solutions, Pinellas Park, FL                                                                                          2017 - 2018

Senior Scientist – Preformulation/formulation of softgel oral drug delivery systems. Analytical & solid-state chemistry.

Catalent is a CDMO/CRO in which research and development is utilized in order to provide commercially viable drug products. The site based in Pinellas Park, FL focuses on softgel oral drug delivery systems for drugs which exist physically as oils, have specific needs pharmacokinetically speaking, or for other reasons don’t lend themselves to typical oral delivery vehicles such as tablets. Preclinical and clinical stage projects were conducted within the product development group enabling self emulsifying drug delivery systems, solutions, and suspensions. Dissolution, stability, scale up, and CMC activities are governed by cGMP regulatory requirements as well as following other appropriate regulatory guidelines depending on geography. 

Transgenex Nanobiotech, Inc., Tampa, FL                                                                                                          2017

Contract Scientist – Analytical Chemistry and crystal form screening for anticancer compounds.

Grünenthal GmbH, Germany                                                                                                                                2016 - 2017

Consulting scientist supporting non-clinical and clinical development of T121 (oral zoledronic acid) and integration of Thar Pharmaceuticals portfolio into Grünenthal after their acquisition of Thar in fall 2016.

Thar Pharmaceuticals, Inc., Tampa, FL                                                                                                   2007 - 2016 

Head of Chemistry - Part of a small group of people which built the company from the ground up using crystal form screening and formulation to generate IP and change the physicochemical properties of drugs with untapped potential. 

Began working for Thar in 2007 as a research assistant while finishing the doctoral program.          

Clinical stage, specialty pharmaceutical company that reinvented known, safe, on-the-market drugs by transforming IV only drugs into oral formulations for both the drug’s existing and new indications. The company’s lead drug, T121, was an oral version of zoledronic acid targeted at the treatment of Complex Regional Pain Syndrome. As part of the team I was intimately involved in cross-functional tasks and achieved experience in delivering technical results, market analysis and intellectual property. At Thar we enabled T121 to become orally available which included drug delivery optimization, pharmacokinetic and toxicology studies, CMC activities, and Phase I/II clinical trials. Crystal form screening was used to generate intellectual property and enhance chemical and physical properties of drug candidates in order to solve clinical limitations.

• Preformulation and formulation: Obtained patent-protected novel crystal forms of meloxicam, tramadol, tadalafil, and zoledronic acid. Focused on stability, oral absorption enhancement and improving physicochemical properties.
• Competitive Intelligence: Analyzed over 500 drugs and structured market research to include identification of disease areas with unmet needs, competitive landscape, and freedom to operate.
• Project management: Performed and then supervised a team meeting milestones and timelines conducting solid-form screening of molecules, in vitro and in vivo protocols, and lab management. 
• CRO management: Worked with and directed outside partners for PK studies, toxicology studies, analytical chemistry, and formulation development.
• CMC: conducted and implemented crystallization methods, scale up optimization, technology transfer, sourcing materials, and formulation testing. 
• Technical writing: Drafts and revisions for INDs, grants, patents, SOPs, technical reports, and technology transfer. 
• Regulatory compliance: USP, ICH and 505(b)2 FDA regulatory knowledge.

University of South Florida, Department of Chemistry                                                                                    2005 - 2011 Ph.D. in Chemistry Focused on Pharmaceutical Science; Prof. Michael J. Zaworotko, Ph.D., Advisor
Graduate Dissertation, Scholar Commons USF. “Crystal Engineering of Multiple Component Crystal Forms of Active Pharmaceutical Ingredients” Weyna, D. 1424 downloads from Scholar Commons. 
• Significant contributions to bring cocrystallization into pharmaceutical industry use for solid-form screening.
• Crystal engineering including analysis of existing structural data deposited into the CSD (Cambridge Structural Database).
• Analytical Chemistry 
• Solid-state characterization, physicochemical property analysis and property optimization focused on drug delivery. (Dissolution, stability, hygroscopicity, bioavailability...)
• Database and literature mining, PK protocol development, and intellectual property generation/strategies.

University of North Carolina at Wilmington, Department of Chemistry          1997 - 2001
B.S. in Chemistry with a Concentration in Biochemistry
• Undergraduate Research: Synthesis of a succinyl phosphatase inhibitor by replacing a phosphorus—oxygen bond with a non-cleavable phosphorus—carbon bond via an Arbuzov rearrangement.

Teaching Experience________________________________________
• General Chemistry Lab I and II 
• Tutoring in General Chemistry and Organic Chemistry

Technical Capabilities________________________________________
• PBPK Modeling with Gastroplus 
• Crystallization Method Development, Crystal Engineering : Polymorph, Cocrystal, Solvate, Hydrate, and Salt Screening
• Powder X-Ray Diffraction PXRD, Single Crystal X-ray Diffraction
• Particle Size Analysis
• Polarized Light Microscopy 
• Basic Organic Synthesis 
• Chromatography – HPLC/UPLC, Column, GC and Ion Exchange 
• Spectroscopy – Infrared, UV-Vis, Near Infrared, Raman, Multinuclear NMR, Mass Spectrometry
• Differential Scanning Calorimetry (DSC), Thermal Gravimetric Analysis (TGA)
• Software/Databases – Gastroplus, Cambridge Structural Database (CSD), MS Office, SciFinder Scholar, Pub Med, Beilstein (Crossfire), Origin lab, Endnote, Chem Draw, Marvinsketch, Chromeleon, ACD Openlab, Panalytical & Bruker-Eva