KTI maintains collaborative arrangements with members of both academic and private biomedical research communities for technical expertise and facility/equipment resources, as well as, with biotech analysts and investors with expertise in developing alliances with pharmaceutical companies for transitioning into clinical trial and commercialization. The highly qualified teams of professionals engaged in different aspects are grouped here according to the type of activity to be pursued for SBIR Phase II grant project and beyond.

 

MICROBIOLOGY AND BIOINFORMATICS

 

Kevin W. Garey, PharmD, Professor & Chair University of Houston College of Pharmacy, Houston, Texas. Dr. Garey’s research career has involved clinical and translational research related to infectious diseases in hospitalized patients.  He has the training and expertise to support large-scale, multi-center clinical and translational studies that combine sample collection (blood, stool, urine) and clinical data collection along with laboratory investigations.  As PI on several funded grants, he has coordinated the bioinformatics and sample collection exchange among several laboratories.  His laboratory routinely performs culture and identification of Clostridium difficile and other multidrug resistant organisms and can perform multiple types of strain typing.  These well characterized strains are used to perform pharmacology studies to better understand the biology of C. difficile and changes influenced by pharmacologic interventions. 

Gayatri Vedantam, Ph.D., Professor, School of Animal & Comparative Biomedical Sciences, University of Arizona. Dr Vedantam research interests are broadly focused on pathogenic mechanisms leading to antibiotic-associated diarrhea and include host-pathogen studies of the C. difficile which is currently leading healthcare-acquired disease in the USA. Her laboratory also offers surveillance and typing services and a genetic manipulation program for clostridial pathogens. These efforts have identified attractive interventions aimed at eliminating C. difficile from the gut and are a focus of translational research goals. Dr. Vedanta has offered genetically characterized isolates to study the effect of EK101 on and brings rich resource to our EK101 development project.

 Dr. Raja Mazumder, Associate Professor of Biochemistry and Molecular Medicine at The George Washington University (GW), Director of The McCormick Genomic & Proteomic Center. Dr. Raja Mazumder to collaborate on microbiome studies aspects of this project. He is involved in genomic and bioinformatics research associated with cancer biology, proteomics, glycobiology, and metagenomics through current NCI, NSF, NIGMS, NIAD, pharmaceutical and FDA funding. His ongoing collaboration on gut microbiome studies on healthy individuals makes him the best suited to collaborate on microbiome studies on hamster model to study effect of EK101 as compared to VAN, or MET or FDX. Dr, Mazumder has deep understanding of identifying therapeutic targets using pathway, immunology, sequence and structure data on one hand and sequence variation and its effect on clonal variation and recombination will enrich our project of generating CFM resistant clones if possible and generating data to help explain its mechanism of action.

 

FORMULATION DEVELOPMENT

 

Firouz Asgarzadeh, Ph.D., Director Technical Services, Evonik Degussa Corporation (Pharma Polymers/Health Care), Piscataway, NJ. Evonik is a world leader company in polymer science and pharmaceutical excipients headquartered in Germany. He has been working at Evonik for over 8 years, leading a team of several exceptional scientists focused on developing pharmaceutical products for drug delivery application. He has over 17 years of experience in the development of solid, liquid and injectable pharmaceutical formulations and published several articles and have few patents on polymers and Pharmaceutical formulations. His current research interest at Evonik is the development of innovative formulations and processes for targeted oral drug delivery, injectable extended release, solubility and bioavailability enhancement of poorly soluble actives. Prior to joining Evonik, he was Principal Scientist at Merck (Schering-Plough) and Senior Scientist at Catalent Pharma Solutions (Cardinal Health) where he developed several early and late stage oral solid and lipid products focusing on solubility enhancement technology platforms inducing self (micro) emulsifying drug delivery systems (S(M)EDDS) and pharmaceutical melt extrusion. He is very active in scientific communities (AAPS and CRS) and is past Chair for Contract Research Organization (CRO) focus group and past chair for Excipient Focus Group (EFG) at AAPS.

Simone Raffa Carvalho, Ph.D. Principal Scientist at Evonik since 2015. Currently she is a lead formulator in the development of specialty pharmaceuticals and nutraceuticals for oral delivery. In addition, her interests are: i) Formulation screening, process development, scale-up and tech transfer to customers for the development of oral dosage forms utilizing specialty polymers in applications such as for modified (sustained-, delayed-) release and taste masking; ii) Subject matter expert on applications of specialty polymers (drug layering and matrix) and proficiency on several related unit operations, including hot melt extrusion, wet granulation, spray drying and tablet compression; iii) Technical and scientific consulting for customers to support troubleshooting, coordination, design, execution and data analysis/interpretation of development studies. Her expertise is used to assist the development of the mini-tablet formulation and the functional film coating for KamTek project on new formulation development of EK101 for CDI treatment.

 

PRE-CLINICAL TESTING FOR EFFICACY AND SAFETY

 

 Srujana Cherukuri, Ph.D., Senior Vice President & Chief Scientific Officer at Noble Life Sciences (NLS). Dr. Cherukuri has broad experience of several areas of biological, biochemical and molecular biology research. She has worked with animal research for whole of her academic career. For the last 4 plus years, she has worked at NLS, a contract Research organization supporting in-vivo preclinical studies of different types of projects. Dr. Cherukuri worked directly with Dr. Kersey and Dr. VedBrat for establishing Golden Hamster Model for CDAD and testing of CFM liquid formulations for its efficacy in this model. Dr Srujana Cherukuri works closely with Dr. Sharan VedBrat and Dr. Rossio Kersey to establish SOPs for GLP standard pre-clinical studies and test KTI formulations under those conditions.

 

 Jianjiang Hao, Ph.D. CEO and founder, Poochon Scientific, Frederick, MD. Dr. Hao is experienced Chief Scientific Officer with a demonstrated history of working in the biotechnology industry. He is skilled in bioanalysis, protein biochemistry, biological mass spectrometry, regulation of biological products, and analytical methods for quality assurance of biologics. Since 2013, he led a team to successfully serve hundreds of clients from biotech and pharmaceutical companies including Bristol Myers Squibb Company, Amgen, Eli Lilly and Company, NOVARTIS, and ABL, Inc. and research institutes including NIH, FDA, JHU and UMBC. With extensive experience in the fields of mass spectrometry, bioinformatics, molecular and cellular biology, and protein biochemistry, his team is combining these fields together to maximize the power of biological mass spectrometry technologies providing solutions to meet KamTek requirements to track Clofazimine in body fluids and tissues for PK/PD studies of new formulations of EK101 to treat CDI-CDAD.

 

Joan Wicks, DVM Ph.D., Partner and Director of Investigative Pathology at Alizee Pathology Services. Dr. Wicks is a board certified pathologist and has 30 years of experience in both veterinary clinic, research experience in academic institutions like Ohio State University and NCI, and pharmaceutical and CRO experience at big Pharma such as Pfizer, Inc. and Charles River.  KamTek has a mutual relationship with Alizee pathology as a service provider for cell culture operations to Alizee and as a client of Alizee to provide Histo-Pathology support for both types of animal studies on efficacy studies on Syrian Golden hamsters and pharmacology/toxicology studies on healthy rats and dogs.

CLINICAL TRIAL PROTOCOL DEVELOPMENT

Dr. Shant Ayanian, Assistant Professor of Medicine, George Washington University (GWU). Dr. Ayanian is an internal Medicine Physician highly specialized in CDI with the only mission to reduce the incidence of CDAD in hospitals. At GWU, he has applied different methods for reducing the number of patients who acquire CDI by using distinct isolation protocols as well as strict antibiotic stewardship program. He served as lead clinician part of KamTek team for the Pre-IND meeting and guided and will continue guiding KamTek on clinical aspects of CDI-CDAD management of patients for preparation of draft of clinical trial protocol and synopses of related protocols.

Dr. Mark Mattar, gastroenterologist at MedStar Georgetown University Hospital.  Dr. Mark Mattar brings his professional expertise and interest in the areas of inflammatory bowel disease (IBD), colitis, Crohn’s disease and CDAD to this project. He is serving as a consultant in this preclinical proposed project to ensure that issues that may transfer to human subject clinical trials are being considered in the animal models; as well as to begin addressing the design of human subject clinical trials. Dr. Mattar is collaborating with KTI on the potential for evaluating metabolomics for CDAD management.

Dr. Eric von Rosenvinge, Associate Professor of Medicine, Division of Gastroenterology, School of Medicine, University of Maryland. Dr. von Rosenvinge is an academic gastroenterologist interested in interactions between intestinal microbial pathogens, the host immune system and the gut microbiota. His focus is to study C. difficile infections, principally caused by type IV pili, as well as C. difficile toxemia, compliance with management guidelines, and fecal microbiota transplantation. He has served as the PI on several human studies of CDI and as a member of the Institutional Review Board of the University of Maryland, Baltimore and for two national VA Cooperative studies, obtaining extensive training in human subject research and extensive experience recruiting patients with CDI. Working as a collaborator with Kamtek, he is willing to lead EK101 clinical trials for CDI treatment at the University of Maryland Medical Center, and we also expect to receive well-characterized clinical isolates during his current operation.

Dr. Mark Sarno, President Vision Biotechnology Consulting and Chief Executive Officer, Vision Clinical Research, LLC. Dr. Sarno has 30 plus years of experience research and development, clinical regulatory/biostatistics and project management operations within pharmaceutical industry. He has developed products covering such diverse clinical areas as oncology, cardiovascular disease, diabetes, infectious disease, metabolic bone disease, rheumatology, fetal aneuploidies, newborn screening, thrombophilia, asthma, and gastroenterology.  KamTek  benefits from his experience for evaluating statistical analysis data on pre-clinical studies, providing advice in statistical planning of Phase I clinical studies protocol as a part of IND submission.

INVESTMENT / STRATEGIC RELATIONSHIP ISSUES

 

Mr. Zachary Prensky, LB Pharmaceuticals and Little Bear Investment. Mr. Prensky is an advisory board member of KTI, overseeing strategic relationships and partnerships. Mr. Prensky has overseen numerous collaborations and successful rounds of fund raising for early stage companies in his role as principal of Little Bear Investments, a NYC-based boutique merchant bank. Mr. Prensky has served on the Boards of Directors of 3 publicly-traded companies, including a $15m Pennsylvania-based dermatology and wound care product company.

Dr. Andrew Vaino, MBA, PhD Biotechnology, Independent Expert Consultant, LB Pharmaceuticals and Little Bear Investment. Dr. Vaino has extensive experience in medicinal chemistry, R&D in biotechnology, IND and biotech business analysis. Dr. Vaino was ranked as the #1 US pharmaceutical analyst by Wall Street Journal l, Dr. Andrew Vaino is an inventor of RE-24 (potential treatment for a neurological disorder). Dr. Vaino has hands-on experience working with drug delivery systems and has been working with KTI in the selection of various drug formulations for research purposes. Our preliminary study of drug solubility and stability is based on his expert advice.

LEGAL COUNSEL

 

Ms. Mary Silvia, Patent Attorney has been giving legal advice about IP rights, their protection and any other related issues. She helped KTI ultimately secure patent rights for the company. Pointed out certain holes in the Development agreement between KamTek and ELONA pharmaceutical and prepared ‘First amendment to make it complete with both entities gaining in the process.  She comes from scientific back ground, master’s in organic chemistry and biochemistry and then got her law degree.

Mr. Urminder Aulakh has been corporate lawyer almost since the inception of KamTek Inc. and continues to offer general legal advice.

REGULATORY AFFAIRS

 

Mr. Travis Che Jarrell, Regulatory Affairs Certified (RAC-US). Mr. Jarrell is an independent expert consultant with extensive experience in regulatory affairs as well as Good Clinical Practices (GCP) compliance in the pharmaceutical industry, and Johns Hopkins Health systems. He has submitted numerous new INDS for drug, biologic and combination products and has made several FDA submissions. Having made Pre-IND meeting package submission and managing the meeting with FDA for KTI, he is fully apprised of its work on the therapeutic potential of CFM for CDAD and is fully supportive of collaborating effort on this proposed project, to ensure its follow up submissions to FDA. He provides an independent review of the GLP condition and relevant documentation provided by the contracted animal research facility to ensure that they will fulfill IND/NDA filing requirements in the near future.

OTHER FACILITY RESOURCES

KTI’s current key collaborating facilities in place  include:

• Noble Life Sciences: Animal research facility
• R&D Facility of Evonik in Piscataway, New Jersey
• Poochon Scientific Inc., Frederick, MD
• Montgomery Community College Bioscience Education Center
• The George Washington University, Department of Biochemistry & Molecular Medicine and The McCormick Genomic & Proteomic Center