Mr. Lange was one of the Co-founders of Reven pharmaceuticals and helped build the management team that currently drives the company. He has over 35 years of Executive Management experience, 18 of which have been in the biotech/pharmaceutical industry.
Before Reven, Mr. Lange founded and/or was a director of several private and public companies including establishment of a Corporate finance division of one of the fastest growing broker dealer firms in the U.S. Mr. Lange has years of experience in public and private markets and understands value and market perceived value. Mr. Lange directed IPO’s on several exchanges understands and excels in building companies and returning solid profits to investors. He is able to attract partners who share his belief in management trust and product value.
As a result of living in Europe and building business relationships internationally for decades Mr. Lange also speaks German, French, English and Spanish. Mr. Lange has repeatedly shown investors that failure has never been an option and that he and the Reven team have a commitment to change the landscape of how patients will be treated in the future.
Mr. Denomme is a Co-Founder of Reven Pharmaceuticals with 30 years of International Executive Management experience, over half of which have been in the biotech/pharmaceutical industry.Mr. Denomme’s communication skills, coupled with his ability to work with international standards and regulations, make him uniquely qualified to lead Reven’s global operations. He leverages his background to oversee the company’s manufacturing and operations with direct oversight of Reven’s strategic direction and legal projects.
Prior to Reven, Mr. Denomme started a number of successful businesses in both the thermal processing and food safety industries. During this time, he was the first to apply Electro Activated Water technology to the food processing space for safety and pathogen control. In 2006, he was awarded a U.S. patent for these innovations. In addition to driving ingenuity in food safety, Mr. Denomme, engineered, built, and implemented some of the largest and most efficient thermal processing equipment for meat and food facilities in the US and around the world.
Chief Financial Officer
Mr. Volk is known as a creator. He has consulted with or started over 200 companies including Reven. He has 24 years of International Executive Management experience, 20 of which have been in Healthcare, Pharmaceuticals, and Biotech. His specific areas of expertise are in operations and finance. He has taken companies public and been involved in several complex financial transactions to help companies create a sound capital structure.
Mr. Volk’s career includes several highlights but the most rewarding were the ventures in healthcare that positively impact the quality of life for others.
Prior to helping found Reven, Mr. Volk worked with regulators in starting and licensing a multi-million-dollar specialty hospital and achieved JCAHO accreditation within first year of operation. The company achieved profitability within first 6 months of operation.
Mr. Handley joined Reven in 2016 to cap off a brilliantly successful career in the pharmaceutical industry. Mike is responsible for providing and implementing the development and commercialization strategies for Reven’s products and is the lead for the clinical trials.
Mr Handley’s career started in research and his passion for discovery has been crucial to leading the companies he has been associated with through the regulatory process. He has successfully stewarded 17 regulatory milestones and product approvals for pharmaceutical and medical device products in his career and will be the key to Reven’s continuing product development.
Mike is a successful life sciences executive with cross-functional experience in strategy, operations, finance, product development and product commercialization. He leads a team that is responsible for engaging and executing strategic relationships and licensing agreements with other large multi-national companies in a myriad of markets.
Dr. James Ervin,
Chief Technology Officer
Dr. Ervin was born to analyze systems: to understand the pieces of a system, how they fit and work together, how to measure them, and how to control and optimize them.
Jim brings 25 years of Professional Engineering experience to Reven that includes research, system design, test design, prototyping, development, manufacturing, and patent / contract / commercialization of innovative products for the automotive, aerospace, and software industries He holds a Ph.D. in mechanical engineering (mechanical systems and design focus) from the University of Michigan, Ann Arbor.
Jim additionally has worked in various capacities to manage IP strategy, map IP / patent landscapes and has personally been issued 39 patents from the USPTO for innovative designs in fields of engine airpath control, powertrain controls, actuation systems, compliant wing systems, and wind energy systems.
His past employers / affiliations include Ford, FlexSys, NASA, University of Michigan, Balanced Dynamics, Holley Automotive, Kelsey Hayes, LocoLingo, SAE, US First Robotics, and MForesight.
To augment his engineering and business mindset, Jim has applied much of his effort at Reven to scour the medical literature in fields of cardiovascular disease, metabolic disease, CNS disease, tissue modeling, antioxidant function and ROS damage mechanisms, mitochondrial function and metabolic pathway mapping, electrolytic system functions, acid / base system chemistry, and cellular signaling. This context has allowed him to lead the Reven team in defining mode of action for current drug product and also to define target variants for future product. In addition, he manages the Reven team to progress drug products through specification of non-clinical and clinical test protocols, analysis of lab / non-clinical / clinical and manufacturing data, refinement of manufacturing and product certification methods, definition of next-gen product + IP / patent strategy, while supporting future business strategy through market analysis / profit modeling.
Henk van Wyk,
Mr Van Wyk brings over 40 years of experience in the pharmaceutical industry to the Reven team, including research, development, drug design and formulation.
Originally from South Africa, he directly oversaw the development of the first automated manufacturing facility for sterile intravenous fluids in South Africa which was ultimately awarded a “Technology Top 100” award by the Engineering Association of SA for innovation in the Medical/Pharmaceutical field. Mr. van Wyk was also a founding member of the South African Academy of Pharmaceutical Sciences. His groundbreaking research for new therapies in the treatment of PAD, Endothelial Dysfunction, CLI, Raynaud’s Disease, Buerger’s Disease and Coronary Arterial Disease are the foundation of the Reven product line.
Global Clinical Affairs
Ms. Cabala’s 35 year career in the pharmaceutical industry has been highlighted by success after success in clinical trials and bringing ground breaking treatments to market. She has a strong record of achievement in big pharma at local, regional and international level in management, leadership, clinical research, strategic alliances and business development.Her specialty is ensuring high quality, timely and cost effective conduct of Phase l, ll, lll and lV clinical research programs in accordance with prevailing ICH/GCP and industry standards.
While building and leading Pfizer Australia’s clinical research effort, Ms Cabala successfully merged the early phase and late phase research efforts to create a more streamlined research environment and ensure that new treatments reached the clinical trial stage faster and with better results than ever before. Her efforts led to Pfizer team becoming the largest and most successful research team in the Southern Hemisphere. It also led to her department becoming the “Research Partner of Choice” throughout the world.
Kristina will use her collaborative experience with government and regulatory bodies, medical researchers and institutions to support and further develop Reven’s clinical research environment.
Director of Operations
Mr. Pacult has 16 years of operations experience across multiple disciplines. Having held leadership roles in pharmaceuticals, finance, sales, marketing, and film, Mr. Pacult has always focused on streamlining day-to-day operations across all departments. With a diverse background, he understands the universal importance of bridging big picture goals and translating those down to daily action plans that utilize every team member's strengths.
Mr. Pacult was project lead for the RJX Non-Clinical Program, which lead to Reven's most recent Investigational New Drug application with the FDA. He continues to support the growing operational needs of Reven, across Research and Development, Manufacturing, Non-Clinical, Clinical, Regulatory, and Intellectual Property.
Mr. Pacult holds a BA from Northwestern University.
Ms. Lopez is the go to Clinical Trials director in the pharmaceutical industry. She has participated in or supervised over 100 clinical trials in many specialties. Her 20 years of experience, industry knowledge and professional network make her the key to Reven's navigation of the clinical trial process.
Ms. Lopez controls the clinical trial process, development, research site recruitment and will oversee the progress of all trials to ensure each study's data is of the highest integrity.
Ms. Lopez will coordinate SOP development, legal reviews, quality reviews, co-monitoring, drug supplies and logistics, audit support, standardisation and resource allocation.
Senior Project Manager -
Analytical / Bioanalytical
Ms. Powell has years of project management and principal investigation experience in the Bioanalytical Clinical Research Organization (CRO) sector. She specializes in bioanalytics and has worked with global companies on a variety of bioanalytical study types from small rapid turnaround GLP studies, Phase I clinical studies requiring dose escalation data, and large ongoing late phase clinical studies.
Ms. Powell holds a BA in chemistry from the University of Nebraska that allows her to provide oversight to the scientific team to troubleshoot and resolve any unexpected events or method specific difficulties as needed. Joy will the execute and validate sample analysis studies to ensure timeline and quality goals are met.
Kevin McGovern is the Chairman and CEO of McGovern Capital. Through McGovern Capital and its affiliates, he has co-founded over twenty-five (25) companies, six of which have become world/category leaders, and he has been lead negotiator/principal in over fifteen (15) global joint ventures. McGovern Capital serves as an investment, strategy and licensing participant and advisor to global businesses. He owns McGovern & Associates which provided legal counsel to certain of the largest acquisition funds in the world.
McGovern was a founder of SoBe Beverages, the fastest growing beverage company ever in the US (sold to Pepsi), and McGovern Capital was one of three owners of KX Industries, L.P., the largest manufacturer and worldwide source of carbon water purification filters, having invented and supplied PUR to P&G, the first end-of-tap filter to Brita, and the first refrigerator water filter to Electrolux. He also created the program, supervised and negotiated all licensing of Tristrata’s alpha hydroxy acid (AHA) patents, which technology was incorporated in approximately 40% of all global skin care products, and is/was sold in approximately 84 countries. Mr. McGovern has spent well over the last decade working to provide clean drinking water to people with the worst water contamination issues (including bacteria, viruses, arsenic and lead). He serves/served on many public and private boards including The Sports Authority (Exec. Committee – NYSE).
McGovern Capital is also currently involved in several consumer technologies including innovative foods and beverages; several teams/organizations in e-Sports; and building wellness facilities for Native Indians.
McGovern is actively involved in the medical cannabis industry with numerous companies across the globe. He is Co-Chairman of Israel Plant Sciences which has numerous subsidiaries working on uniform seed breeding for all agricultural purposes and cutting edge drug solutions for intestinal bowel disease (IBD), addictions, and colon cancer. Kanativa and Intiva BioPharma develop cannabisrelated drug and medical solutions and Intiva BioPharma (Stock: NTVA) is a leader of orphan cannabis drug development. He is a member of the Board of WeedMD, a licensed Canadian medical marijuana producer and dispenser, which has one of its specialties to provide cannabis related healthcare to the elderly.
Mr. McGovern is also known for his nanotechnology involvement, serving as co-chairman of Angstrom Publishing LLC, which together with Forbes publishes a global monthly Nanotechnology newsletter currently entitled The Forbes/Wolfe Emerging Tech Report. He is a member of the National Board of the Smithsonian (the world’s largest research and museum institution) and is a Trustee Emeritus and a Presidential Councilor (highest honor to alumnus) of Cornell University (having served as the Co-Chairman of the Technology Transfer Committee and Co- Chairman of the Sports Task Force). He was recently (April 2018) appointed to the Cornell University-wide Committee on Research and Innovation. He also teaches a course on “Global Innovation and Commercialization” at the graduate business school at Cornell University and is a guest lecturer at Cornell NY Tech, Stanford (business lecturer and executive programs), MIT, ESCP Europe, NTU in Singapore, and KAUST in Saudi Arabia. He also served as Chairman of Entrepreneurship@Cornell for over seven years. The McGovern Family Center for Venture Development in Life Sciences at Cornell University was recently acclaimed as one of the Top 10 Venture Development Centers in North America. In addition, he established the McGovern Fields at Cornell.
Mr. McGovern served on the Board of the US Pavilion at the World Expo in Shanghai and was appointed (only foreigner) to the Expo’s Post-Development Committee. He is also Vice Chairman of the Silver Shield Foundation, providing assistance to families of policemen and firemen who die in the line of duty in New York, Connecticut and New Jersey. He also serves on the Board of Point Hope providing global assistance to orphans and is an Advisor to the Child Center of New York which strengthens the skills/opportunities and provides emotional support for 26,000 low income children in New York City.
Mr. McGovern has received numerous awards including the Cornell "Entrepreneur of the Year", St. John's University School of Law’s "Distinguished Alumni Award" and The East West Institute's "Global Game Changer Award". In addition, he received the 2013 Pioneer Award from the United Nation’s International Council for Caring Communities, the Luce Foundation honored him as its 2015 Humanitarian of the Year, and he received the 2016 Gold Medal Award from the American Irish Historical Society.