picture essay great depression essay on discretion descriptive essay about a boyfriend essay writing editing software

We are Thinkers.

We are Innovators.

We are Velius.

The Velius Team

Our team has vast and varied industry experience.  Successful in his or her own field, each member’s pursuit of and reputation for excellence results in a whole that is greater than its parts.

Joel R. Studin, MD, FACS

CEO
Dr. Studin is a plastic and reconstructive surgeon credited with medical device and pharmaceutical patents, both domestically and around the world. Prior to Velius, Dr. Studin founded, built and and sold two technology related regional and global companies.

Daniel Easton

EVP – Marketing
Prior to Velius, Mr. Easton was a senior marketing executive responsible for creating major campaigns for such brands as Pepsi, Lipitor and Reach Toothbrush.

John Nicoletti

EVP – Sales
Prior to Velius, Mr. Nicoletti was a senior sales executive for Rubbermaid, and before that, Hartz Mountain.

Steve Levinson

VP – Operations and Purchasing
Prior to Velius, Mr. Levinson was  a purchasing agent for Nestle, and subsequently VP of purchasing and operations for  ET Brown Drug Company and then Adrienne Arpel.

Bob Giuliano, RPh

EVP – Research and Development

Mr. Giuliano served as director of pharmacy for two New York City hospitals. He has extensive experience in drug formulation and custom drug compounding as the founding principal of a drug compounding company.

Dudley Harris - Consulting

Regulatory and Quality Control
Mr. Harris served as Director of Compliance for an FDA field office before becoming a Regional Director for the FDA. He is an expert in pharmaceutical cGMP and functions as a consultant.

Kathy Shoob, MBA, CPA

Controller
Ms. Shoob has over 20 years experience conducting and overseeing audits and reviews of public and private companies in senior corporate and accounting firm positions.

Mason Diamond, DDS

EVP Regulatory Affairs
Dr. Diamond has over 20 years experience guiding regulatory compliance and approvals in the following capacities.
Director, US Regulatory Affairs, Ferring Pharmaceuticals Inc., Parsippany, NJ    - Medical Device and Combination Product development.

President, Texel Fortis, LLC, Wayne, NJ  Provide Clinical, Regulatory, Quality, and Project Management services to US and European companies .

Director, Regulatory Affairs, Integra LifeSciences Corp.  Plainsboro, NJ Lead regulatory efforts for dermal regeneration, nerve regeneration and orthopedics.

Board of Directors

Joel R. Studin, MD, FACS

Dr. Studin is a plastic and reconstructive surgeon and past hospital Chief of Plastic Surgery. He is credited with several pharmaceutical and medical device patents. Prior to Velius, Dr. Studin founded, built and and sold two technology related regional and global companies. His business background combined with his clinical experience provide valuable insight in guiding Velius. Dr. Studin received his Bachelor’s Degree from The University of Rochester, his M.D. Degree from The Mount Sinai School of Medicine in New York, his Fellowship training in Reconstructive Microsurgery at St. John’s Medical Center and his Laser Surgery training at Harvard Medical School. He is Board Certified by the American Board of Plastic Surgery.

William A. Landman

Since 1987, Bill Landman has served as a Senior Managing Director for CMS Companies. He is one of the managing partners for this 40-year-old boutique investment firm, overseeing $2 billion of investments in the areas of private equity and real estate. From 1977 to 1987, Mr. Landman was a partner in Reich & Landman, with expertise in transactional corporate practices and the representation of professional athletes. Mr. Landman currently serves as a Member and Board Chairman of Thomas Jefferson University Hospital and Chairman of the Audit Committee and Board Member of Jefferson Health System. He is a board member of Cetero, Inc., Biltmore Capital Group, Liberty Restaurant Group and Caivis Acquisition Corp. Mr. Landman previously served as a Director and Chairman of the Compensation Committee and member of Audit Committee of Russ Berrie & Company, Inc. (NYSE) and as a Managing Director of KRG Capital Partners, a $705M private equity firm in Denver. He also was the President of the Philadelphia Israel Chamber of Commerce; Vice President & Treasurer, Philadelphia Jewish Community Center; and Member of Federation of Young Leadership Cabinet. Mr. Landman is the author of “The Alternative Edge? Boosting Returns and Reducing Risk with Private Fund Investing”, a user friendly guide to maximize returns on alternative investments. Mr. Landman holds a B.A. from  the University of Pittsburgh and a J.D. from the University of Pittsburgh School of Law.

Tom Jennings

Mr. Jennings has a 25 year career as an independent Labor consultant to nationwide fortune 500 companies such as Anheuser Busch N.A., Albertsons Inc., Supervalue Inc., Praxair, Stop and Shop Companies and H&M Container. Tom served as the Chairman of STS Inc. which was a supplier of specialized labor forces throughout 48 states. He was also the Founder and Chairman of the Board of The Westchester Hawks, a non-profit youth organization based in New York; Principal of TJJ Capital Funding; Founder and Board member of Greater Northern New Jersey Development Corp. and Managing Member Of STS Southern, LLC, which was heavily involved in the Hurricane Katrina Relief Effort.

Andy Oxenhorn

After an early successful career marketing home electronics, Mr. Oxenhorn went on to become President of MB Quart International, a global electronics company headquartered in Germany. In 1996, he was recruited to become president and a partner at JL Audio, Inc, a privately held company headquartered in Miramar, Florida. JL Audio is a leading brand for premium car, home and marine audio equipment worldwide. Under Mr. Oxenhorn’s guidance, JL Audio expanded its product offerings and quadrupled sales to over $63 million annually. JL Audio is the only brand in the audio industry that has remained committed to manufacturing the majority of its products in their US factory. Mr. Oxenhorn is a hands-on manager whose duties for the company include Marketing and Sales, along with Logistics and Finance. Due in large part to Mr. Oxenhorn’s guidance, JL Audio’s products are now sold in 74 different countries throughout the world. Mr. Oxenhorn is a graduate of the University of Vermont and did his postgraduate studies in the MBA program at Babson College.

FDA Advisory Team

Dr. Mason Diamond

Dr. Diamond is a biotech Executive with extensive industry, academic and clinical practice experience encompassing Medical Device, Pharmaceutical, and Biologics development. Developed and managed clinical and regulatory programs across many therapeutic areas, including, stem cell therapy, plastic and reconstructive surgery, regenerative medicine, in vitro diagnostics, orthopaedics, cardiovascular, oncology, etc. Served as Industry representative on the FDA Device Advisory Panel for Dental Products. Served on several ADVAMED committees relating to new legislation (involving Congressional interaction), new regulations, clinical study design, and safety reporting. Served as Director, US Regulatory Affairs for Ferring Pharmaceuticals LLC, Texel Fortis, Integra LifeSciences Corp., and Isolagen Corp.

Peter R. Mathers, J.D.

Peter R. Mathers, J.D.
Kleinfeld, Kaplan and Becker, LLP

Since joining the firm in 1979, Peter Mathers has had the privilege of helping clients understand and negotiate their way through regulatory issues from the routine to the unprecedented. He believes that regulatory practice ideally involves the balancing of opportunities and risks in light of applicable legal standards as well as the policies and practicalities, both industrial and bureaucratic, that underlie those standards. Peter has been recognized since 2013 in The Best Lawyers in
America for FDA Law, and has been listed on the Super Lawyers list since 2013. Peter received a Client Choice award in the Healthcare & Life Sciences category in 2014.
Peter was involved in litigation with FDA over the development of generic drug approval procedures even before the Hatch-Waxman Amendments, and has continued to be involved in the ongoing interpretation, application, negotiation and litigation of the critical issues arising under those Amendments. He has extensive experience helping clients through the development and approval process and all aspects of the subsequent manufacturing and marketing activities for their products. Peter has defended numerous firms and individuals facing substantial legal jeopardy arising from civil, criminal and administrative enforcement actions arising out of alleged good manufacturing practice violations, marketing violations and/or “integrity” issues. Peter also hasunparalleled experience in advising and defending clients manufacturing and distributing prescription drug products traditionally marketed without FDA approval. In all of these areas, Peter’s advice reflects the critical need for pro-active strategies to minimize and to defend against foreseeable, yet unpredictable risks of regulatory action, competitive disputes, and product liability claims. In addition to his extensive work with manufacturers of drugs, medical devices, APIs and other FDA-regulated products and components, Peter has also had broad experience with all areas of DEA regulation. This experience includes registration proceedings for importers, manufacturers and distributors of controlled substances (including bulk manufacturers), regulation of listed chemicals, related security, recordkeeping and reporting requirements, drug scheduling proceedings, and quota allocations. Mr. Mather graduated from Yale Law School in 1979 and Rensselaer Polytechnic Institute, B.S., cum laude, 1976. He is a member of the Thomas Swan Barristers Union, Omicron Delta Epsilon, Economics honor society and is admitted to the District of Columbia Court of Appeals, U.S. District Court for the District of Columbia, U. S. Court of Appeals, D.C. Circuit and other Federal Circuits and the United States Supreme Court.

Suzan Onel, J.D.

Suzan Onel
Kleinfeld, Kaplan and Becker, LLP

With almost 30 years of experience, Ms. Onel advises FDA-regulated companies on regulatory, compliance, and enforcement issues involving medical devices, foods, dietary supplements, over- the-counter drugs, cosmetics and consumer products. She regularly advises international and domestic manufacturers, distributors, and researchers on market entry strategies, labeling and promotional activities, regulatory compliance, recalls and field corrections, and enforcement defense. Ms. Onel assists clients with the preparation of FDA submissions, including 510(k) premarket notifications, premarket approval applications (PMAs), food additive petitions, GRAS self-affirmations and notifications, food contact notifications, new dietary ingredient notifications, and adverse event reports. Ms. Onel’s experience includes representing clients before the U.S. Food and Drug Administration, the Federal Trade Commission, the U.S. Department of Agriculture, the Bureau of Alcohol, Tobacco, and Firearms, the National Advertising Division of the Better

Business Bureaus, and similar international and state bodies. Ms. Onel’s practice also includes FDA due diligence investigations and advising companies and private equity/venture capital investors on transactional matters involving life science company acquisition, divestment and capital growth as well as supplier contracts and clinical research agreements.

Professional Background:

Ms. Onel regularly speaks and writes on FDA issues including medical device software, food regulation and dietary supplement/functional food. She has written articles and chapters in compilations published by the Food and Drug Law Institute, the Regulatory Affairs Professionals Society, the Medical Device & Diagnostic Industry, and others. Ms. Onel is also co-editor of the PLI treatise, “Medical Devices Law and Regulation Answer Book” (5th edition).

Prior to joining KKB, Ms. Onel was Chair of the FDA Practice at a global law firm.

Professional/Civic Activities:

Former Chair, Food, Cosmetics and Nutraceuticals Committee, ABA Section of Sciences & Technology Law (2012-2015)
Former Co-Chair, FDLI Medical Devices Committee (2012-2015)
Former FDA Counsel, Neurotechnology Industry Organization (NIO) (2008-2015)

UVA Law Class Manager, Annual Giving Program, 2005-2009
Former Chair, FDLI Update Editorial Advisory Board
Member, Food and Drug Law Institute (FDLI) and Regulatory Affairs Professionals Society (RAPS) Ms. Onel hold a J.D. from the University of Virginia School of Law, 1990 (Notes Editor, Virginia Environmental Law Journal) and a B.A. from the University of Pennsylvania, 1986 (Neurobiology and European Intellectual History, Honors)

Jonathan Wilkin, MD, FAAD - Consulting

Dr. Wilkin is the founding director of the Division of Dermatology and Dental Products at the US Food and Drug Administration. Dr. Wilkin remains active in regulatory matters, of American Academy of Dermatology’s Ad Hoc Task Force on Academy’s Efforts with the FDA. Prior to FDA, he served as Director, Dermatology Division and Professor of Medicine and Pharmacology Departments, of The Ohio State University. Prior to Ohio State University, he served as Chief of Dermatology section, Hunter Holmes McGuire Veterans Administration Medical Center in Richmond, Virginia. Dr. Wilkin served as the Chairman of medical advisory board for the National Rosacea Society from 1998 to 2012. Dr. Wilkin is a fellow of both the American College of Physicians and American Academy of Dermatology. He is a diplomate of both the American Board of Clinical Pharmacology and the American Board of Dermatology. He has over 130 publications in dermatology and clinical pharmacology.

Mark Kramer - Consulting

Mr. Kramer established and led FDA’s Office of Combination Products from its inception in 2002 until 2007, when he left the Agency to become Regulatory Affairs Executive at GE Healthcare, a position he held through July 2010.  Since that time he has consulted for many companies. Mark’s experience both as a regulator and as a regulatory affairs leader at a $17B global medical products company, gives him a comprehensive understanding of the complex laws, regulations, regulators, and review processes, as well as the practical experience that can only be gained in the “real world.” Mark currently serves on the Board of Directors of the Regulatory Affairs Professional Society (RAPS).

Scientific Advisory Team

Joel R. Studin, MD, FACS

Dr. Studin is a plastic and reconstructive surgeon and past hospital Chief of Plastic Surgery. He is credited with several pharmaceutical and medical device patents. Prior to Velius, Dr. Studin founded, built and and sold two technology related regional and global companies. His business background combined with his clinical experience provide valuable insight in guiding Velius. Dr. Studin received his Bachelor’s Degree from The University of Rochester, his M.D. Degree from The Mount Sinai School of Medicine in New York, his Fellowship training in Reconstructive Microsurgery at St. John’s Medical Center and his Laser Surgery training at Harvard Medical School. He is Board Certified by the American Board of Plastic Surgery.

Dr. Mason Diamond

Dr. Diamond is a biotech Executive with extensive industry, academic and clinical practice experience encompassing Medical Device, Pharmaceutical, and Biologics development. Developed and managed clinical and regulatory programs across many therapeutic areas, including, stem cell therapy, plastic and reconstructive surgery, regenerative medicine, in vitro diagnostics, orthopaedics, cardiovascular, oncology, etc. Served as Industry representative on the FDA Device Advisory Panel for Dental Products. Served on several ADVAMED committees relating to new legislation (involving Congressional interaction), new regulations, clinical study design, and safety reporting. Served as Director, US Regulatory Affairs for Ferring Pharmaceuticals LLC, Texel Fortis, Integra LifeSciences Corp., and Isolagen Corp.

Bob Giuliano, RPh

Mr. Giuliano served as director of pharmacy for two New York City hospitals. He has extensive experience in drug formulation and custom drug compounding as the founding principal of a drug compounding company.

Daniel C. Baker, MD, FACS

Dr. Daniel Baker is one of the most exclusive and renowned plastic surgeons in the world. He is a Professor of Surgery at New York University Medical School and The Institute for Reconstructive Plastic Surgery. He has been teaching plastic surgeons for over 30 years, and has been invited to lecture and perform surgical demonstrations for plastic surgeons in over 30 countries around the world. Every year he lectures and teaches at numerous National Meetings in the United States and International Meetings around the world. He is a recognized figure in the field of surgical facial rejuvenation, and was the first to popularize the short-scar facelift procedure. He received his medical degree from Columbia University College of Physicians and Surgeons, his plastic surgery training at NYU Medical Center and then completed a fellowship in Head and Neck Cancer and Reconstructive Surgery at Columbia University.

Sherrell J. Aston, MD, FACS

Dr. Sherrell J. Aston is a board-certified plastic surgeon and is considered one of the foremost international experts in aesthetic plastic surgery. He is a past President of the American Society for Aesthetic Plastic Surgery. He is currently the Surgeon Director and Chairman of the Department of Plastic Surgery at the Manhattan Eye, Ear and Throat Hospital in New York. He also serves as a Professor of Plastic Surgery at the New York University School of Medicine and Institute of Reconstructive Plastic Surgery. Dr. Aston received his Medical Degree from the University of Virginia, in Charlottesville, Virginia. His post-doctoral training included a surgical internship and residency at the University California, Los Angeles (UCLA) Medical Center. Prior to being Chief Resident at UCLA, he was a Halsted Fellow in Surgery at John Hopkins Hospital. Dr. Aston continued his training as a Plastic Surgery Resident and Chief Resident at the Institute of Reconstructive Plastic Surgery, New York University Medical Center. Dr. Aston has been recognized with numerous awards and honors.

Think we make a good match?