The Kenox Team is a group of highly motivated professionals committed to bringing superior drug products to patients around the world. Empowered by experience working with drug formulation and delivery, together with our industry savvy, we are fully equipped to deliver results and achieve goals in all our projects and initiatives.
Dr. Velaga is a highly accomplished and internationally recognized pharmaceutical professional with over 18 years of academic and industrial experience in the areas of solid-state chemistry, solubilization technologies, particle engineering, and the development of specialized dosage forms, including oral films and aerosol-based drug products. Dr. Velaga has proven himself a strong leader, having successfully built and led teams of highly skilled and motivated scientists and scholars. He has established strong business and professional relationships with pioneering scientists, universities, and pharmaceutical companies in a number of countries around the world. He brings his years of experience in drug-product development, innovative research, project management, business development, and strategy to Kenox.
Robert is a demonstrated C-level and senior leadership experience in public, private, revenue stage and development stage companies and have played a leading role in 2 start-ups. Experienced in all stages of the business lifecycle with specific knowledge of life sciences and medical device companies and how to articulate complex and/or scientific concepts to a business audience. Expertise in public and private financings, M&A, partnering/licensing transactions, project management and Chapter 11 reorganizations, as well as building organizations and interacting with Boards, VC’s, shareholders and Wall Street. Prior career as an investment banker, mostly at Lehman Brothers, with deal experience split between M&A and capital markets transactions in a variety of industries, including consumer goods, energy and high technology. MBA from The Wharton School and an AB from Princeton University.
Mr. Stadermann is a Chemical Engineer and aerosol-based product-development scientist with over 12 years of experience in the development and manufacturing of pMDIs and DPIs. He has strong technical expertise in the development, submission, and patent litigations of inhalation drug substances and drug products. He has a proven track record in both generic and innovative development at a number of prestigious pharmaceutical companies, including Teva, Solvay, and Merck. Mr. Stadermann has authored CMC sections for various clinical and commercial inhalation products, and has directly engaged with global regulatory authorities (EMEA, US, JP, LATAM, and RoW). Among his key achievements are the successful development and approval of budesonide/formoterol and fluticasone/salmeterol products.
Dr. Igor Gonda is the founder of Respidex LLC – a consulting firm assisting pharmaceutical companies in corporate strategy, including R&D program design, collaborations with patient advocacy groups, regulatory process, intellectual property management, financing and business development. He was previously CEO of the inhalation company Aradigm Corp and transdermal delivery company Acrux Ltd. Prior to that, he conducted aerosol research and product development at Genentech Inc. (USA) and at universities in the UK, USA and Australia. He has over 120 US patents and patent applications and published over a hundred papers and book chapters primarily on inhalation of drugs and biologics. He graduated in Chemistry and received PhD in Physical Chemistry from the University of Leeds, England.
Mr. Hollander has over 30 years of professional experience working in medical devices, capital equipment, and pharmaceuticals. With an intense focus on commercialization and sales growth both domestically and internationally, Scott has had direct responsibility for all functional areas including Sales and Marketing, Business Development, HR, Manufacturing, Finance, Logistics, Research and Development, Quality, Healthcare Economics and Government Affairs.
Mr. Hollander started his career as a sales representative with Mallinckrodt Medical in Jacksonville, FL. Over his 14 year career with Mallinckrodt he held positions of increasing responsibility including Regional Manager, Market Manager, Director of Marketing, Sr. Director of Global Strategy and Commercialization, Sr. Director of Business Development and VP of Sales, Marketing and Commercial Development. During his tenure at Mallinckrodt, Scott grew numerous line of business to a #1 position and completed more than 20 business development transactions.
Mr. Hollander has held positions of COO and CEO at both private and publicly traded companies. Mr. Hollander served as COO/Head of North America for Bracco Diagnostics where he grew company revenue through successfully negotiating and being awarded four major GPO contracts, a focused effort on new customers, and increasing compliance at existing accounts. He led the organization to a #1 position in three key product categories, positions they still hold to this day. Mr. Hollander also lead Bracco’s strategic acquisition and integration of E-Z-EM, a leading manufacturer of contrast agents for gastrointestinal radiology.
In 2008 Mr. Hollander joined Otsuka Pharmaceuticals as the VP of Business Development. Mr. Hollander completed the acquisition of Interpharma in Prague, Czech Republic and was named President and Chief Executive Officer. During the next 5 years Mr. Hollander built and transitioned Interpharma from a post-communist manufacturing entity to a company that developed and gained FDA approval for product invented and developed in Prague. This was the first time in Otsuka’s history that a product was invented, developed, and approved outside of Japan.
Mr. Hollander holds a BS in Political Science from Alfred University and Master Degrees in Business and Health Services Management from the Olin School of Business, Washington University, St. Louis, MO.
Dr. Makarand (Mak) Jawadekar devoted most of his working years at Pfizer, Inc. based in Groton-New London Connecticut for 28 consecutive years. During his career span at Pfizer, he was responsible for Drug Delivery Technology Assessment function involving external ‘Drug Delivery’ technologies. He has extensive experience in creating and cultivating external partnerships and alliances for Drug Delivery Technologies. He began his professional career at Pfizer Central Research in early 1982, after having completed his Ph.D. in Pharmaceutics, at the University of Minnesota.
His 28+ years of experience with Pfizer Global R&D specifically includes Solids R&D, Drug Product formulation/ Dosage Form/ Drug Delivery development, Clinical Trials Supply Manufacturing, Scale-up and Technology Transfer & Research Pharmacy functions. He also worked on several Intranasal & Inhaled Product Development programs at the bench level at Pfizer. He helped create various Pharma R&D Partnerships, JVs, and Collaborations. He was also involved in conducting ‘Due-Diligence’ activities as a subject matter expert on behalf of Pfizer for eventual acquisition of companies or their IP assets. He managed several internal functions/groups within R&D for many years. As a bench Scientist, he got to work on many challenging commercial formulations which became multibillion-dollar products for many years for Pfizer Inc. Some of these R & D / commercial formulations & Product development programs included ZOLOFT & many other “Life Cycle Management “related products for extending life-cycle of Pfizer’s existing products. Mak has presented at many professional meetings and has participated in various Panel Discussions/Round Tables around the globe. He currently serves on several Strategic & Scientific Advisory Boards & Board of Directors of Pharma, Biotech & Technology companies.
Dr. Reed is a pharmacologist, board certified toxicologist, and Fellow of the Academy of Toxicology Sciences. He has over 23+ years of experience investigating nonclinical and translational inhaled aerosol delivery. He is an internationally recognized in nonclinical respiratory development having been exposed to hundreds of pharmaceutical and device mitigation strategies designed to positively impact respiratory, cardiovascular, cancer, metabolic, infectious, and rare-neglected disease states, etc. Dr. Reed is currently Principal, Coelus Bio where he provides consulting services in integrated strategies for respiratory drug development to industry and academia. He was formerly Vice President, Applied Toxicology and Nonclinical Development at Lovelace Biomedical where he focused on applied toxicology questions, early-phase pharmaceutical transitions, pharmaceutical IP development, and pharmaceutical research and development services. As VP and in over 10 years as Director, Preclinical Drug Development, Dr. Reed oversaw and consulted on all aspects of Client’s drug/ toxicant delivery including formulation/device feasibility and development, pharmacokinetics, pharmacology, safety pharmacology, animal models of pulmonary, cardiovascular, and infectious diseases, etc., and pivotal IND and NDA GLP compliant studies covering oral, parenteral, and inhaled delivery modalities. In addition, from 2004-Present, Dr. Reed has been awarded/ managed over $60M in drug development-focused government/ foundation grants and contracts as PI/ or subcontract PI. These include the Cystic Fibrosis Foundation, NIH (National Cancer Institute and National Institute of Allergy and Infectious Disease), BARDA (Biomedical Advanced Research and Development Authority [Homeland Security]), and DOD- awarded SBIR, IDIQ and other preclinical programs designed to develop and achieve proof of concept and regulatory approval for drugs and vaccines indicated for respiratory indications, infectious diseases, bacterial pneumonia (e.g., VAP), combat-based (surviving) blood loss and chemical, biological, radiological, nuclear, and explosive (CBRNE) threats.
Dr Mahmood has more than 25 years of experience in clinical pharmacology at FDA. He worked both in Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). During this period, Dr. Mahmood worked on neurological products, therapeutic proteins (antibodies and non-antibodies), coagulation factors (hemophilia), immunoglobulins, and cell and gene therapy. Dr. Mahmood helped in establishing a robust clinical pharmacology program in the Office of Blood Review and Research and the Office of Tissue & Advanced Therapeutics (OTAT), CBER. In CBER, he led a team of clinical and preclinical pharmacologists for two years. Dr. Mahmood was the member of several working groups in CDER and CBER which wrote the guidance for pharmaceutical industry. He Received three research grants from CDER for conducting research in the area of anti-epilepsy drugs, pediatric clinical pharmacology, and drug-drug interaction. At the FDA, besides his review duties, Dr. Mahmood was involved with clinical pharmacology research (both small and large molecules) and have published more than 130 research papers in peer-reviewed scientific journals. His research mainly focused on allometric scaling, modeling, sparse sampling, and pediatric drug development. Dr. Mahmood also edited and wrote several scientific books. Since 2019, Dr. Mahmood is a clinical pharmacology consultant.
We also consult with industry veterans on various aspects of drug product development.