Anubhav Arora, Ph.D. Email and Phone Number

Pharmaceutical development lead for multiple clinical and pre-clinical programs within a matrixed organization, overseeing formulation and device compatibility across different stages of development.»» Directed key pharmaceutical development studies (formulation and device studies) for NDA submissions (including the first for the company). Authored regulatory submission sections, and supported responses to regulatory reviews under tight timelines.»» Managed multiple successful projects via contract labs, including RFP process, contract negotiation, SOW review/approval, and technical leadership. Manage contracts and vendor relationships of $MM+.»» Trained personnel in designing studies and working effectively in a matrixed environment. »» Contributed to developing previously non-existent methods and capabilities by collaborating with selected contract labs.

Lead activities to support development of a combination drug/device product for transdermal drug delivery technology program for smoking cessation; research led to the filing of provisional patent applications (named inventor on 5). Manage technical team of 4 direct reports, consultants and CROs, and administered up to $2 million annual budget. Report directly to CEO.ACHIEVEMENTS:»» Built new team and lab infrastructure focused on smoking cessation product pipeline development. Developed lab-based system to test characteristics of the device and recommend changes to meet desired pharmacokinetic profile in Phase 2 clinical trial. Additionally, prototyped next-generation wearable drug delivery devices, including critical steps such as sensor identification, fluidics design, and formulation development.»» Identified 2 new markets for platform technology and led preclinical studies for adapting platform to new applications:--- Parkinson’s Disease: Catapulted project from preclinical stage to Phase 2 clinical trial. Led team to generate supporting data for showcasing various nicotine delivery profiles with platform technology and supported licensing Phase 2 clinical data that demonstrated effect of nicotine on dyskinesia in Parkinson’s patients.--- Opioid Cessation: Identified opioid drug candidates and addressable markets. Networked with key opinion leaders (KOLs) to identify unmet clinical need and led team of scientists to establish technical feasibility of platform technology (formulations, drug delivery, and abuse studies). Supported business development for market assessment.»» Led R&D strategy discussions by driving technical due diligence for API candidate selection and evaluating scientific relevance of the platform technology. »» Prepared lab for meeting DEA license standards (Schedule II-IV) and wrote SOPs for meeting ISO standards. Represented company in DEA audits.

Hired as Research Scientist in the New Technologies Lab of this fully-integrated specialty pharmaceutical company with industry-leading transdermal expertise. Promoted in 2014 to Senior Research Scientist role with a dotted-line report.Conducted research on novel combination transdermal, oral, and buccal drug delivery systems and successfully expanded organization’s capabilities in combination products for peptides and small molecules. Developed formulations, led preclinical animal studies, analyzed data, and evaluated technologies.ACHIEVEMENTS:»» Directed relocation of R&D facilities from California to Florida. Completed project on time and negotiated 60% cost savings on installation and calibration services. Ensured site readiness for biological samples and coordinated team of FTEs and relocation company in the packaging, loading, shipping, unloading, and storage of lab equipment.»» Handpicked for cross-functional team tasked with identifying API candidates for a new technology platform. Serving as technical expert, participated in defining selection criteria and then compiled user-friendly API database based on selected criteria, which required extensive literature searching, results interpretation, and findings tabulation.»» Avoided millions of dollars in costs by evaluating and benchmarking drug delivery technologies against existing in-house capabilities. Generated feasibility results for executive review demonstrating that external collaboration was unnecessary.»» Filed 2 provisional patents, generated multiple technical reports, and influenced future research priorities.

Developed research projects for life sciences and pharmaceutical companies, focusing on application development. MICRO-INJECTOR DEVELOPMENT (INDUSTRY SPONSOR: STRATAGENT LIFE SCIENCES, INC.)»» Characterized designs of novel piezoelectric-actuated liquid microjet injector for needle-free delivery of insulin; provided critical data for securing series B financing of $16 million. Developed in vitro models for prototype testing; designed and conducted in vivo proof-of-concept studies.»» Results published in peer-reviewed scientific publication and presented in 1 peer-reviewed and 2 invited presentations. Received media coverage on ABC national news and featured as cover story in scientific journal with editorial commentary.DERMAL FILLER INJECTORS (INDUSTRY SPONSOR: ALLERGAN, INC.)»» Quantified dependence of injection parameters (power, fluid viscosity, and volume) on delivery of dermal fillers with liquid jet injectors in collaboration with Allergan, Inc. »» Patent issued as Lead Author and licensed to Allergan, Inc.CHEMICAL ENHANCER-BASED DRUG DELIVERY (INDUSTRY SPONSOR: HISAMITSU PHARMACEUTICAL CO., INC.)»» Designed and executed experimental screenings of formulations by combining high throughput in vitro assays and in vivo validation. Expanded scope of chemical enhancer formulations from transdermal drug delivery to needle-free vaccination and infectious disease prevention. Developed formulations for controlled transdermal drug delivery.»» Results published in 4 peer-reviewed scientific publications, 2 patent applications, and 1 peer-reviewed poster.CONFERENCE PRESENTATIONS:»» “Developing safe microbicides by high throughput screening of chemicals”. Poster presentation at AAPS Annual Meeting, Los Angeles (2009). »» "Needle-Free Transdermal Drug Delivery Using Pulsed Piezoelectric Microjets". Podium presentation at AIChE Annual Meeting, San Francisco (2006)

Concurrent with Graduate Researcher role, served as Teaching Assistant for MCDB course titled "Introduction to Biology for Non-Majors" with more than 150 students. Duties involved conducting discussion sections and grading assignments and exams.

Set up protocols and conducted experiments for quantifying amyloid formation kinetics using spectroscopic techniques. Tested various small stress molecules for possible therapeutic role in inhibiting amyloid formation. Studied kinetics of amyloid formation under stress conditions.ACHIEVEMENTS:»» Incubated and set up a fully functional protein research lab from the ground up.»» Published results in 2 peer-reviewed scientific publications.