Novadiol

Innovation. Science. Opportunity.

Our Mission

To improve the lives of people with kidney disease.

Background

Novadiol, Inc. is a Kansas City based biopharmaceutical company developing patent protected drugs. Our late stage candidate is the next generation drug for secondary hyperparathyroidism (SHPT), in stage 3 and 4 chronic kidney disease (CKD) patients and vitamin D deficiency.

According to the National Kidney Foundation (NKF) and the Center for Disease Control (CDC), approximately 30 million Americans suffer from CKD. (This is the same number of Americans with diabetes!) About 20 million of these patients are categorized with stage 3 or 4 CKD and approximately 4-5 million suffer from SHPT.

Due to increased rates of diabetes, obesity and hypertension the incidence of SHPT is expected to grow.

Product Pipeline and Stage of Development

We are developing medicines for people with diseases of the kidney. Our late stage candidate, Dendocrin™, is focused on chronic kidney disease (CKD) patients with secondary hyperparathyroidism (SHPT). Unlike new chemical entities (NCE’s), Dendocrin has relatively low development risk and low development cost.

With a well-known safety and toxicity profile, Dendocrin™ is being re-positioned for the treatment of secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) stage 3 & 4 patients. Novadiol has strong patent protection, in more than 30 countries. In the US, Novadiol will use the 505(b)(2) NDA regulatory pathway, reducing time and expense associated with traditional drug development.

Dendocrin will address the unmet needs of 4-5 million stage 3 and 4 CKD patients with SHPT in the US. Unlike drug delivery based IP, our IP applies to the use of Dendocrin over a broad clinically effective therapeutic range. This will allow Novadiol to deliver patient friendly chronic therapy with cost savings to patients and payers worldwide.

Novadiol is developing additional pipeline products for patients with kidney disease.

Market Opportunities

Typical treatment of SHPT in CKD stages 3 and 4 includes either high doses of vitamin D2 or D3, which are not effective in the majority of CKD patients, or 1,25D analogues (hormonal D), which can cause imbalances in the calcium and phosphorus metabolism and do not treat the underlying vitamin D deficiency. Novadiol’s product, Dendocrin, delivers a reliable, therapeutically effective increase in 25D without the side effects of the 1,25D analogues in SHPT and efficiently and effectively corrects insufficient blood levels of vitamin D.

Investors / Partners

Novadiol’s value proposition is based upon:

  • Strong worldwide patent rights
  • Low development risk; known molecule
  • Experienced management team

Novadiol, Inc. is raising capital and seeking partners to drive our drug development program. To acquire additional information about Novadiol, Inc. please contact us at bd@craigb196.sg-host.com.

About Us

Novadiol, Inc., is a private biopharma company founded in 2012 to develop innovative medicines for people with kidney diseases. The company is led by an experienced team of pharma executives each with 30+ years in the industry.

Our team works with the leading scientists, nephrologists and drug development experts to advance meaningful products for CKD patients.

Management Team

GP Georges

Chief Executive Officer

GP has over 30 years of experience in the pharmaceutical industry and is a serial entrepreneur with three successful ventures from concept to market. For the past 20 years he has successfully created, launched and marketed a number of dialysis products /n through his flagship company, Nephro-Tech Inc. (www.nephrotech.com). His second venture, Nephro-Tech 1, LLC, launched in 2001 has gone through the patent acquisition, clinical development, FDA approval and commercialization process and is currently out-licensed successfully to in the women’s health, Rx market. He founded his third company, Novadiol, Inc., to develop and market a patented, first-in-class treatment to address unmet needs of millions of Chronic Kidney Disease (CKD) patients and patients who suffer from Hypovitaminosis-D. Mr. Georges’ Nephro-Tech Inc. experience in the CKD market will be invaluable as he guides this new company through the FDA process and the CKD-treatment licensing process.

Tom Krol, Pharm.D, CLP

Chief Development Officer

Tom is an investment partner, and previously managing director at the Kansas Bioscience Authority (KBA). He led the human health investment activities. Tom has more than 25 years of pharmaceutical, biotechnology, /n drug delivery and medical device experience spanning multiple roles in R&D, new product planning and development, technology assessment, strategic planning, marketing, licensing and business development.
Before joining the KBA, he led business development activities at Oakwood Laboratories, a drug delivery company based in Cleveland, OH. Before Oakwood, he founded a specialty pharma company, Verenta Pharmaceuticals. Tom led business development for CyDex (now Ligand), a venture backed drug delivery company specialized in solubility technologies. Tom had multiple roles at Pharmacia-Pfizer, Searle, Sanofi-Aventis and predecessor companies, including Marion Laboratories.
Tom serves on the board of directors for Heartland Plant Innovations, Innara Health/KC BioMedix, Flow Forward Medical, Metactive Medical, and as a board observer for IGXBio. He serves on the advisory board of Epic Medical Concepts & Innovations, Likarda, BioResearch Central, on the life sciences selection committee for Invest Midwest, and represents the KBA to MPM Capital – BV5 Fund.
He has a B.S. in pharmacy from Ferris State University and PharmD from the University of Utah. He completed a residency at the University of Utah and a fellowship in clinical drug development at the University of North Carolina and the Burroughs Wellcome Company (now part of GSK). He is a registered pharmacist and certified licensing professional, as designated by the Licensing Executives Society.

Gerard Wood, Ph.D.

President

Gerard Wood was most recently founder and President of Effexus Pharmaceuticals. He is a proven performer in a variety of business environments, including leading pharmaceutical corporations and privately-held specialty pharmaceutical companies in all segments of the industry. /n He has over twenty-five years experience in the areas of marketing, commercial development, business development, competitive intelligence and corporate strategy. His strong scientific background and deep business experience provides insight into a variety of business situations across all therapeutic categories.

At Effexus, Gerard licensed a drug delivery technology from a major university, developed and successfully executed an IP strategy, filed and granted orphan drug status, and was responsible for business development, strategic business planning and regulatory activities. Prior to Effexus Gerard managed Norwood Consulting company to provide consulting services to small pharmaceutical concerns and start-ups in the area of new products, strategic planning and business development. He assisted a start-up to raise over $200 million.

Gerard was founder and President of Verenta Pharmaceutical which licensed ophthalmic antiviral technology from a major university. He developed company strategy, regulatory strategy, initiated operations and fund raising efforts, and filed and granted orphan drug status for the lead compound. Prior to Verenta he formed OcuQuest Pharmaceutical which later sold to RxElite in the ophthalmic therapeutic space.

In addition to entrepreneurial activities, Gerard worked Hoechst Marion Roussel and other predecessor companies including Marion Labs as a Senior Manager in Global Commercial Development and Senior Strategic Business Analyst.

Gerard has BS in Pharmacy from St Louis College of Pharmacy and PhD in Pharmacy Administration from UMKC School of Pharmacy.

Advisory Board

Robert Hootkins, Ph.D., MD

President and CEO at ESRD Consulting, PLLC

Dr. Hootkins has 30 years of experience as a practicing Nephrologist, including 25 years consulting for Fresenius Medical Care. He also does work in quality improvement, facility protocols, legal review work in Nephrology and specializes in End Stage Renal Disease.

Dave Hobson, PhD

CSO Level Executive

Dr. Hobson has 30 years of experience in pharmaceutical and medical device discovery and development. He has held positions ranging from Principal Scientist to Corporate Vice President in various aspects of toxicology and pharmacology research and development.

Michael Day, PhD

Cardinal Health Regulatory Sciences - CMC Expert

Dr. Day is a Director with the Regulatory Sciences business unit within Cardinal Health Specialty Solutions. He is responsible for the managerial, business and technical aspects of the CMC group. He also directs the preparation of investigational and marketing applications.

Merribeth Adams, Ph.D.

Vice President, Regulatory Affairs

Cato Research

Dr. Adams has more than 30 years’ experience in clinical research and regulatory/governmental affairs in academic and private sectors as well as nonprofit organizations. Her experience includes medical device and pharmaceutical development activities with numerous large pharmaceutical companies and start-ups. Most recently, Dr. Adams was the director of research for the National Council on Alcoholism and Drug Dependence in New Jersey. /n She is the past COO/VP of Regulatory and Clinical Research for Advanced ImmuniT and Peptide T Holdings, and she has served as chief regulatory officer for numerous medical device and pharmaceutical companies. Dr. Adams is currently consulting with multiple pharmaceutical and medical companies in pharmaceutical, medical device, and biologics development and in the areas of healthcare information and virtual assisted care. Her past positions include the acting chief regulatory officer for RAPID Pharmaceuticals, vice president of Regulatory Strategy and Agency Relations for PULSER, and chief regulatory officer for AdviseClinical.

She is co-inventor of global patents for the treatment of cytokine-mediated inflammatory diseases, immediate early gene expression, and potential therapies to treat allostatic stress. Dr. Adams has been able to apply the allostatic stress and inflammatory cytokine work to multiple indications in the central nervous system therapeutic area. She holds undergraduate degrees and licenses in laboratory and nuclear medicine, as well as graduate degrees in healthcare administration. She has numerous publications in research, regulatory/clinical trials.

Raj Riswadkar, MS, MBA

Mr. Riswadkar has 15 plus years of experience in growing biotech, pharma and healthcare businesses for Fortune 50 companies through start-ups in the US and across the globe. His experience includes extensive management consulting, leading corporate and business development, strategy, P&L ownership, strategic marketing and talent management He has worked for Express Scripts, Price Waterhouse, Accenture, KV Pharmaceutical Company, and numerous other companies. He has a MBA from Cornell University and a Master’s degree in Engineering from the University of Toledo.