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
Gayatri Vedantam, Professor, School of Animal & Comparative Biomedical Sciences, University of Arizona. Dr Vedantam’s 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 hamsters 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.
Dr Suchismita Acharya, CEO, AyuVis Research LLC. Dr. Achayra is a highly experienced organic, medicinal and analytical chemist. She is expert in designing and optimizing lead molecules for drug discovery programs at Alcon labs and Novartis with special focus on anti-infective and glaucomatous optic neuropathy. Dr. Acharya serves as Lead organic expert of KamTek team to address CMC and pharmacokinetic issues of EK101.
Dr. Emmanuel Akala, Professor of Pharmaceutics, College of Pharmacy at Howard University. Dr. Akala offers a deep understanding and expertise in areas of drug formulation and dosage form design. KTI seeks his guidance in the CFM pharmacokinetics and bioavailability experiments. Most of his research focuses on dosage forms and drug delivery, especially related to drugs that precipitate and need to be delivered to specific regions of the GI track. Moreover, his expertise lies in the evaluation of degree of synergy in in vivo conditions. KTI expects to receive expert advice from Dr. Akala on packaging of the formulations of CFM for determining its bioavailability in the gut of animals and later for human studies.
Dr. Dennis Dean, President and Principal Consultant, Dean Process Strategies, LLC. Dr. Dean is an organic chemist with more than 30 years of experience in process development, route selection, optimization and process validation of commercial API processes following GMP regulations as well synthesis of small molecules for medicinal uses i.e. steroids, prostaglandins, various heterocycles, peptides and oligonucleotides. Dr. Dean provides guidance towards maintenance of GMP facility and operations for the preparation of formulations for the pre-clinical studies.
PRE-CLINICAL TESTING FOR EFFICACY AND SAFETY
Dr. Srujana Cherukuri, 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.
Dr. Leslie Lemke-Boutcher, Drug Development Leader, COVANCE. Consultant for Preclinical Animal Toxicology study services is responsible for these studies for EK101 project. She serves as a subject matter expert in ophthalmology and biologics and small molecule development for the sales and marketing teams as well as for internal programs. She provides advice and input on the scientific and regulatory aspects of ongoing programs including risk/mitigation plans when needed. She will manage toxicology studies at Covance on behalf of KamTek, Inc.
Dr. Joan Wicks is a Partner and Director of Investigative Pathology at Alizee Pathology Services. She 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.
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.
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: