At a Glance | Short Bio | Extended Bio
Dr. Paul Luner, Triform Sciences‘ Founder and Principal:
- Background in Pharmaceutics, 30 yrs Pharma Industry and Academic experience; scientifically focused.
- Worked in small molecule R&D for three major pharmaceutical companies spanning areas of preformulation, solid oral formulation development, solid state characterization and material science.
- Knowledgable across CMC technical disciplines and Pharm Dev/CMC project leadership experience with drug substance and drug product.
- Strong scientific track record and successful collaborations to accelerate compound development through innovative value-added methodologies.
- Areas of Experience
- Solid State Characterization including:
- XRPD, DSC, TGA, DVS, NIR, FTIR, Raman, SS-NMR, PLM, Particle Size Analysis and GMP methods
- Polymorph Screening and Crystal Form Identification; Process Induced Phase Transformation assessment
- Material Science and Material Sparing Formulation Approaches; Surface Characterization
- Solid Dosage Form Development, Preformulation, Tox Formulation
- Biopharmaceutics and Physical Chemistry of the GI Tract
- Solid State Characterization including:
Bio
(click here for extended version with additional detail on contributions)
Dr. Paul Luner received a B.S. in Chemistry in 1984 from Syracuse University (Syracuse, NY). He subsequently obtained his M.S (1986) and Ph.D. (1990) in Pharmaceutics from The University of Michigan, College of Pharmacy (Ann Arbor, MI) where he worked with Prof. Gordon Amidon. Dr. Luner joined the Pharmaceutical Research Division of Parke-Davis/Warner Lambert in 1990 and worked at the Morris Plains, NJ site in Product Development and focused on preformulation and physical characterization of APIs. In 1995, he joined the faculty at the University of Iowa, College of Pharmacy, Division of Pharmaceutics as an Assistant Professor. His research at Iowa centered on qualitative and quantitative near-infrared spectroscopy for solid form characterization and the influence of the gastrointestinal environment on APIs and dosage forms including surface energy determination characterization of pharmaceutical materials. In 1996, he received the AACP-AFPE Pharmacy Faculty New Investigator Award.
In 2002, Dr. Luner moved to Pfizer R&D where he oversaw immediate release tablet formulation development for Phase I through commercial image projects including the early clinical formulation development of Xeljanz® (Tofacitinib) and applied material characterization utilizing API sparing techniques for rapid drug product development. In 2006, he joined the Material Science Group where his responsibilities included commercial API form screening and selection and solid-state characterization of early and late-stage compounds and participated on several project teams including Dalbavancin and Inlyta® (Axitinib).
Dr. Luner moved to Boehringer Ingelheim Pharmaceuticals in 2010 where he joined the Physical Pharmaceutics group and supervised preformulation and toxicology formulation development for NCEs transitioning from research to development. His group was also responsible for material property characterization for DS and DP intermediates in support of formulation development and he also was a discipline lead on R&D project teams. In 2015, he joined the newly formed Material and Analytical Sciences (MAS) global department and led technical support for solid form screening and solid state/physical characterization testing. He became group leader for the Particulate Sciences and Solid State Analysis group, directing GMP/GLP analysis for drug substance physical characterization testing.
Dr. Luner founded Triform Sciences LLC in 2019 to provide scientific consulting services to companies and individuals engaged in pharmaceutical development seeking expertise in the CMC related areas of the drug substance/drug product interface.Dr. Luner has presented invited lectures at leading academic institutions, educational and scientific conferences and the FDA (ONDQA), has held Industrial Advisory Board member leadership positions in the Dane O. Kildsig Center for Pharmaceutical Processing Research (CPPR), served as a Scientific Advisor to the Editors of JPharmSci and is a member of the International Steering Committee for the Handbook of Pharmaceutical Excipients. He has published over 30 refereed articles and 40 poster presentations spanning a wide breadth of pharmaceutically relevant subjects, both fundamental and applied, ranging on topics from crystal structure determination to formulation development.
Biography – Extended Version
Dr. Luner received a B.S. in Chemistry in 1984 from Syracuse University (Syracuse, NY) where he worked in the research group of Prof. B.R. Ware conducting experimental work on diffusion measurements in polyelectrolyte solutions during the early development of FRAP (Fluorescence Recovery After Photobleaching) which later became an established technique enabling quantification of protein movement in living cells. He subsequently obtained his M.S (1986) and Ph.D. (1990) in Pharmaceutics from The University of Michigan, College of Pharmacy (Ann Arbor, MI) where he worked with Prof. Gordon Amidon. His thesis work focused on elucidating the discrepancy between the theoretical binding capacity and the in vivo efficiency of bile sequestrants used for reduction of systemic LDL cholesterol. These studies combined in vitro experimental analysis with computational GI modeling. The project and its further continuation influenced regulatory testing strategies for generic ion-exchange based products and provided insights into improved bile sequestrant products.
After completing his Ph.D., Dr. Luner joined the Pharmaceutical Research Division of Parke-Davis/Warner Lambert in 1990 and worked at the Morris Plains, NJ site in Product Development. At Parke-Davis he focused on preformulation and physical characterization of APIs in addition to research on the drug solubilization by intestinal lipids and surfactants and their impact on wetting of drug surfaces. In 1995 he joined the faculty at the University of Iowa, College of Pharmacy, Division of Pharmaceutics as an Assistant Professor. His research at Iowa centered on qualitative and quantitative near-infrared spectroscopy for solid form characterization and revealed the utility of the technique as a complementary tool for fundamental molecular level understanding in the differentiation of the crystalline and amorphous states. Unexpectedly, this work led to his group to solve the crystal structure of (+/-)-tartaric acid which had not been previously reported although Pasteur’s pioneering work on chirality with this historically significant molecule was conducted ~150 years ago. Dr. Luner also investigated the influence of the gastrointestinal environment on APIs and dosage forms including surface energy determination characterization of pharmaceutical materials. In 1996, he was awarded an AACP-AFPE Pharmacy Faculty New Investigator Award. While at Iowa, Dr. Luner also designed and taught a graduate course on solid-state properties and characterization of pharmaceutical materials.
In 2002, Dr. Luner returned to industry, joining Pfizer Global R&D where he oversaw immediate release tablet formulation development for Phase I through commercial image, also serving as a development team member for a wide range of projects, including the early clinical formulation development of the now marketed JAK inhibitor Xeljanz® (Tofacitinib). He applied material characterization methodologies utilizing API sparing techniques for rapid drug product development and clinical manufacturing, investigated low-scale predictive wet granulation methods for high load tablets and established mechanistic understanding of formulation/process interactions impacting content uniformity for dry processed low-dose systems with platform formulations. In addition, Dr. Luner collaborated with Prof. Lynne Taylor at Purdue University to investigate mechanistic aspects of anhydrate to hydrate transitions during wet granulation and develop strategic approaches to predict, evaluate and mitigate transformation during processing.
In 2006, he moved to the newly formed Material Science Group within Pfizer R&D where his responsibilities included commercial API form screening and selection as well as solid-state characterization of early and late-stage compounds. Dr. Luner was a subject matter expert for API form on several project teams including Dalbavancin and Inlyta® (Axitinib), a highly polymorphic, low solubility compound. For Axitinib, Dr. Luner led a cross-disciplinary team to develop the regulatory background strategy documentation for the End-of-Phase 2A (EOP2A) FDA meeting. This work synthesized the experimental and theoretical understanding of solid forms to document a consistent rationale for form integrity from API isolation to drug product and evaluated the impact of impurity/transformation on chemical, physical stability, manufacturability and BA/BE performance. Raman spectroscopy was utilized for low-level determination in drug substance and drug product along with that from orthogonal techniques including X-ray powder diff raction (XRPD), differential scanning calorimetry (DSC) and 13C Cross-Polarized, Magic Angle Spinning (CP-MAS) Solid State Nuclear Magnetic Resonance (ssNMR).
Dr. Luner moved to Boehringer Ingelheim Pharmaceuticals in 2010 where he joined the Physical Pharmaceutics group and supervised preformulation and toxicology formulation development for NCEs transitioning from research to development. His group was also responsible for material property characterization testing methodologies for DS and DP intermediates in support of formulation development. He had further roles as a CMC project leader and Pharm Dev Team member on R&D project teams with responsibility for coordinating formulation development and clinical supply manufacture. As a way to further lead formulation identification for animal and human studies, he led a team which built and implemented the Artificial Stomach Duodenum dissolution model technique for performance assessment of enabled formulations.
In 2015 Boehringer Ingelheim formed the Material and Analytical Sciences (MAS) global department and Dr. Luner supported solid form screening and solid state/physical characterization testing in a matrixed resource environment. In 2016, he became group leader for Particulate Sciences and GMP/GLP Solid State Analysis within the Solid State group, supporting API solid state characterization and physical release testing for intermediates, starting materials and toxicology study test articles with techniques such as KF, IR, XRPD, Raman and Laser Diffraction, SEM, TGA and DSC. His group developed and implemented a variety of validated PSD methods using both wet and dry dispersion methodologies for supporting API release. He had roles as a team representative for MAS projects in the global development stream and additionally served as MAS R&D project team lead on local and global projects.
Leveraging his experience in formulation development and material characterization, he implemented a streamlined and unified approach for drug substance particle size target estimation for early development based on applied bioavailability and content uniformity modeling to serve as a starting point for QbD product development that addressed the often-conflicting technical requirements across the accountable CMC disciplines. This work helped R&D teams better anticipate the need for DS milling early in development to enable appropriate DS production and milling feasibility to be built effectively into project timelines. He aligned rapid turn-around procedures for solid form verification of in-process testing of Kilo lab and Pilot Plant drug substance and implemented technical protocols for screening and determination of Process Induced Transformation of Solid Forms. Recently, Dr. Luner advanced an external technology initiative to support understanding and quantitative analysis of in-situ API agglomerate size in tablets to address a late-stage PhII dissolution issue using X-ray micro-computed tomography imaging.
Based on both his industrial and academic experience in formulation development, solid state and material characterization, Dr. Luner founded Triform Sciences LLC in 2019 to provide scientific consulting services to companies and individuals engaged in pharmaceutical development seeking expertise in the CMC related areas of the drug substance/drug product interface. Triform Sciences was envisioned and formed based on Dr. Luner’s experience integrating the interrelationship among Form (obtaining the desired solid form/polymorph), Formation (the process to make the form and its impact on material properties and quality) and Formulation (how the form, its material properties, its potential variability impact drug product manufacturing, performance and quality) during the development cycle process to achieve QbD.
With Dr. Luner’s expertise and breadth, Triform Sciences is uniquely positioned to specifically emphasize the understanding and details of solid form generation and selection, solid state and material properties, particulate sciences, formulation performance and their interrelationships. The company’s mission is to guide clients that may not have familiarity with large Pharma scientific capabilities to efficiently design technical studies, recommend phase appropriate characterization testing to address scientific regulatory needs for efficient and cost-effective compound progression, assist in data interpretation, and support accessing technically suitable CROs to achieve their science-based clinical product development goals and meet timelines. Dr. Luner has presented invited lectures at leading academic institutions, educational and scientific conferences and the FDA (ONDQA). He has been an Industrial Advisory Board member, vice-chair and chair for the Dane O. Kildsig Center for Pharmaceutical Processing Research (CPPR) an industry/university cooperative research center (NSF I/UCRC). He served as a Scientific Advisor to the Editors of JPharmSci and has been a reviewer for a variety of Pharmaceutical and other journals. He is a member of the International Steering Committee for the Handbook of Pharmaceutical Excipients and a long-time member of AAPS and ACS. He has published over 30 refereed articles and 40 poster presentations spanning a wide breadth of pharmaceutically relevant subjects, both fundamental and applied, ranging on topics from crystal structure determination to formulation development. He lives and works in Waterford, CT, enjoys cycling, photography while on vacation and doesn’t like yard work.