Pratima Labroo, Ph.D. Email & Phone Number

Lakewood, Colorado, United States

Greater Salt Lake City Area

Provide overall project and Cell Therapy technical guidance as part of R&D team. Manage tech transfer, process development and establish characterization assays that will be utilized for product release as part of GMP manufacturing.Assist collaborators in the preparation of Pre-RFD, Pre-IND and Investigational New Drug (IND) applications including Pharmacological section and Chemistry, Manufacturing and Controls (CMC) section-Modules 2.4, 2.6, 3.2.S.3, 3.2.S.4, 3.2.S.7, 3.2.P.1, 3.2.P.2, 3.2.P.5, 3.2.P.8 and 4.2 in the eCTD.Work closely across teams to establish and optimize Standard Operating Procedures (SOPs) for the GMP manufacture of prospective cell therapy products. Draft data package including safety and effectiveness data (SED) and substantial equivalence for a 510(k) application.

Greater Salt Lake City Area

Handling R&D and translational aspects of PolarityTE products and designing new biomaterials. Perform material, mechanical, chemical and electronic testing of cellular and tissue engineered products.• Design and develop small molecule therapeutics, bio-material scaffolds and drug delivery products• Design, plan and determine testing protocols to ensure products meet quality and effectiveness criteria. • Collaborate with Manufacturing, TM (Translational medicine) and PD (Product development) to develop product design inputs and outputs. • Participate and lead cross-functional teams across cell biology, material science and biomedical imaging.• Provide technical support on components, material methods, systems and equipment.• Write and approve protocols, reports and data; oversee testing outlined in protocols and test methods.• Coordinate/develop validation studies on equipment and processes.• Interface with inside/outside contacts to complete assignments, resolve complaints, problems, etc.

Greater Salt Lake City Area

I developed, secured funding, and led efforts for projects involving tissue engineering/drug delivery for surgical applications. Worked in start-up environment to collect clinical needs, refine design inputs, propose design outputs, fabricate prototypes (rapid prototyping, injection molding, manufacturing), verify and validate using benchtop, in vitro and in vivo models.• Designed and tested an implantable bioreactor for bone regeneration using a porous biomaterial based scaffold and stem cells resulting in 80% mineralization in the defect.• Designed and tested biomaterial scaffolds and drug delivering setups for application in tissue engineering and regenerative applications.• Lead DOE studies (using Minitab) to optimize in vitro bioassays and improve efficiency by 30%• Optimized the drug delivery system by simulating mass transport through scaffold using COMSOL Multiphysics.• Mentored and lead a team of engineers in product design, prototyping, fabrication, and testing.• Developing technical competitiveness of company's products through publications and conference presentations• Raised funds (Federal, State) to de-risk company's technologies• Published 3 papers and presented at 3 conferences• Submitted two invention disclosures• Extensive experience with animal handling, including cell implantation (xenografts and tumors, minor surgeries and various methods of dosing), mammalian cell culture, stem cell characterization.• Experience with cell culture, and in vitro cell-based assays.• Experience with immunohistochemistry, confocal microscopy and modeling, reconstruction of engineered tissue.

Greater Salt Lake City Area

Lead Engineer on a DOD funded project for designing new technologies for treatment of trauma injuries. • Designed a drug delivering conduit for controlled delivery of growth factors and small molecules for peripheral nerve regeneration resulting in 65% recovery in a rodent sciatic nerve gap model.• Optimized the efficiency of the device by modelling drug diffusion using MATLAB/MS Excel.• Managed the logistics of three concurrent projects and modelled an easy to follow experiment schedule.• Led and trained three interdisciplinary research (Surgery, Bioengineering and Mechanical Engineering) teams, collaborating with four different labs to improve product yield and performance.• Manufactured prototypes with 3D printing, solvent casting and molding and evaluated device performance through bench and animal testing.• Gained practical experience in animal surgery with proficiency in anatomy and physiology.• Fluency in preparation of histological material, cryo- and paraffin-based fixation, sectioning, immunohistochemistry and immunofluorescence.• Experience with Gait and electrophysiology tests and small animal surgical procedures.• Expertise in Tissue culture, stem cell differentiation, organotypic culture and study of cell-biomaterial interactions.• Responsible for experiment design, execution, and data analysis and laboratory management tasks.• Published 3 papers and presented at 3 conferences

Logan

Lead Scientist on a government funded project for designing and testing next-generation, ultra-sensitive biosensors for multi-analyte detection• Designed a wearable graphene nano sensor for lactic acid detection with up to ~1 nM sensitivity• Designed a paper based graphene sensor for detection of aminosalicylic acid• Designed a paper based graphene sensor for multi-detection of metabolites• Designed and modeled PLGA based microspheres for drug delivery• Designed Silk based patterned sheets for bio-mimetic studies• Pivotal in setting up bio-sensing lab and photo lithography procedure area• Experience in material characterization, mechanical testing, biocompatibility testing• Submitted one invention disclosure• Published 4 papers and presented at 1 conference

Dundee, United Kingdom

• Designed testing setup for examining the effects of hyperthermic conditions on cell necrosis • Examined various methods to give controlled hyperthermic treatment to a localized region • Heat treatment using hot plate, ultrasound transducer, soldering iron and plasma pen was analysed with a thermal imaging camera

Doctor Of Philosophy (Phd), Mechanical Engineering, 3.67

Activities and Societies: -Project Management skills to work on several projects in parallel and train Master and PhD students. -Writing.

Doctor Of Philosophy (Phd)-Transfer To University Of Utah, Biological/Biosystems Engineering, 3.7

Activities and Societies: -Training undergraduate students on how to use the lab equipment such as microscopy, potentiostat and other.

Master'S Degree, Biomedical/Medical Engineering, Distinction

Activities and Societies: -Journal Club (Biomaterials, bioreactors and Tissue engineering) -Dundee Indian Student Union -Dundee Anime.

Bachelor'S Degree, Electronics And Communications Engineering, 8.4/10

Activities and Societies: -Cultural festival organizing committee -Engineering fest organiser -Involved in hosting and presenting cultural.