Joseph V. Gulfo, MD, MBA most recently served as President & CEO at MELA Sciences from 2004 - June 2013, where he was Chairman of the Board since November 2011. While at MELA Sciences, he was responsible for (1) effecting an IPO in 2005 and consummating 11 public financings totaling ~$160 MM: (2) obtaining FDA approval of MelaFind, a breakthrough PMA smart diagnostic device for early melanoma detection through which he gained national attention for the process that included the issuing an illegal not approvable letter by FDA, a Citizen Petition filing requesting that the FDA enforce the company's Binding Protocol Agreement, and a Congressional Hearing at which the FDA admitted the error; and (3) launching MelaFind in US and Europe, and placing MelaFind systems within 75 miles of 63% of the US population in the first 12 months on the market.
He was responsible for the 1998 NDA approval of Valstar (as President & COO of Anthra Pharmaceuticals and Chairman of its UK Subsidiary), a drug for superficial bladder cancer. He was also responsible for the development of ProstaScint (Cytogen Corporation), a BLA-approved monoclonal antibody for prostate cancer. He is currently on the board of directors and audit committee of Procertus Biopharma, a company developing palliative care products for radiation dermatitis and oral mucositis. Dr. Gulfo was CEO and Chairman of Antigen Express, an immunotherapy company in the field of vaccines for cancer therapy, antiviral therapy, and asthma, responsible for its merger.
He received his MD from University of Medicine and Dentistry of New Jersey, and MBA from Seton Hall University. Dr. Gulfo is a leader in medtech / biopharma innovation, a skilled entrepreneur, manager, and product/market development executive. He has been awarded the Ernst & Young Entrepreneur of the Year Finalist and American Business Awards Maverick of the Year for his work and leadership with MelaFind.
Dr. Gulfo is an adjunct professor and teaches graduate Cancer Biology, maintains an educational cancer biology blog (http://blogs.shu.edu/cancer), and teaches classes and seminars in biopharma/medtech entrepreneurship and the nexus of science, business, and law. He is author of Innovation Breakdown: How the FDA and Wall Street Cripple Medical Innovation.
Diana is a diverse market development professional with over 10 years of experience in the development and execution of strategic business plans and market positioning in the medical technology and consumer goods industries. Most recently, Diana was the General Manager for the European markets and Director of International Marketing at MELA Sciences, Inc. (now Strata Sciences) where she was responsible for building the business from the ground up, contributing the highest global sales of their flagship product. While there, she worked on global-to-regional market strategies with a strong focus on business partnerships, KOL relationship development/management, patient engagement/experience, and practice flow and product integration. As a member of the Corporate Finance Committee, she worked closely with the CEO on developing and pitching capital raising strategies to the investment community, as well as in effectively communicating the Company’s strategy and results to all stakeholders.
Previous to this, Diana worked on developing and executing product launch strategies within the consumer goods market, driving sales through the management of over 500 sku’s, and conducting over 25 product launches annually in the retail, B2B and wholesale markets. Additionally, Diana worked at a New York City hedge fund where she focused on communicating and marketing the fund’s portfolio to existing and potential investors, as well as on developing, sustaining and deepening the fund’s relationships with its investors.
Her role at BMI is to develop new markets and/or improve performance in existing markets. She provides thought leadership, marketplace assessment, and market insights and expert opinion, that helps drive sales and execute business strategies. She is entrepreneurial, a creative and strategic thinker, and able to implement changes through influence and negotiation skills.
Diana has received a master’s degree from Columbia University with a focus on international media and communications, as well as business and finance. A former classical ballerina trained in the Balanchine technique, she attended the prestigious School of American Ballet and danced professionally for the New York City Ballet (at Lincoln Center).
John M. Burger, MS most recently served as SVP, Business Development at GfK Custom Research LLC, in the health industry vertical. While at GfK, John was responsible for: (1) designing and directing over 300 business critical, primary market research programs for pharma, biotech, medical device, and consumer health (collectively, life science) companies, utilizing qualitative, quantitative, online, and mobile techniques, (2) providing brand teams at life sciences companies with strategic therapeutic area and market insight, and (3) developing business with life science companies in excess of $50MM. John earned numerous business development awards at GfK and in 2011 received a Knowledge Exchange Company Award.
Prior to GfK, John executed marketing strategy and closed-book due diligence as part of a leading consulting firm, and prior to that was a risk manager for three pharmaceutical raw materials manufacturing facilities at BASF.
John received his MS in Management from New York University's Polytechnic Institute, and BS in Chemical Engineering from Bucknell University. Most recently, he completed coursework in biostatistics and epidemiology through Harvard University's School of Public Health's edX online program.
Jeffrey Wallace is an Executive Management Professional that comes from a background of over 18 years in the medical industry. Most recently, Jeff served as Senior Vice President of Product Development and Innovation at MELA Sciences, Inc. While at MELA Sciences, he was a key leader in the organization, reporting directly to the Chief Executive Officer. During his tenure, he was responsible for all aspects of the research, development and quality measures that led to the commercial execution of MelaFind, a first of its kind, PMA approved medical device. Key areas of focus included; 1) engineering, product development and operational activities, 2) leading various teams through the process from conceptualization to deliverable, 3) management of simultaneous projects, 4) delivering manufacturable designs to marketing specifications, fostering innovative solutions to customer needs, and adhering to all time, compliance, and budget constraints.
Before joining MELA Sciences, he was a Partner and Lead Consultant at SoftwareCPR, a consulting firm that specialized in partnering with medical device companies to ensure compliance with FDA and international regulations. Companies in his portfolio varied in size and specialty, ranging from chronic care hemodialysis systems and spinal modulation implantable devices to computer system validations.
Jeff has multi-faceted experience in project management, design and manufacturing, development planning, software quality assurance, 62304 compliance, 13485 compliance, verification/validation and test planning, requirements development, traceability analysis, design and development of standard operating procedures (SOP), work instructions, and technical documentation.
Jeff began his career in the medical industry as a Quality Assurance Test Engineer at Baxter Healthcare where he worked for over nine years, focusing on the design and development of hardware, software, and user interfaces for medical devices and automated test equipment.
Prior to his career in healthcare, Jeff served in the United States Navy as an Aviation Electricians Mate for four years as an Aircraft Electrical Technician on Lockheed P-3 Orion’s, and served as an Aircraft Handler/Director and night shift supervisor. He holds his Bachelor of Science Degree in Electronic Engineering Technology from ITT Technical Institute.
Claudia V. Beqaj is a biopharma commercialization professional with 12 years of hands on experience and management including marketing, sales, training, PR and supply chain in both the US and abroad (Europe, Asia Pacific and Latin America). Most recently, Claudia was the Director of Commercialization at MELA Sciences, a medical device company with a first in class product for melanoma detection. While at MELA Sciences, Claudia was responsible for; (1) the development and execution of the global commercialization strategy; (2) building and leading a team of 30 individuals in various departments which include: sales and all sales functions, marketing, technical service, and customer support; (3) Leading the marketing team through strategic pre-launch activities including execution of market research and the development of a novel pricing strategy; (4) the creation of advertising campaigns, digital/social marketing and media, and the strategic/tactical planning via public relations; and (5) assisting the CEO in fund-raising and financing activities with analysts, bankers, and private equity firms.
Prior to joining MELA Sciences, Claudia was the Global Marketing Lead for the Diversified Products portfolio at Merck, primarily focusing on the Emerging Markets (Asia Pacific and Latin America) in the execution of the global strategies. She was instrumental in the creation of the Asian Atopic Dermatitis (AD) Consensus Treatment Guideline which was approved for publication in the Journal of Dermatology in October 2012.
Claudia also has developed and evaluated pricing strategies and guidelines for key brands during her time at Schering Plough in the US Managed Markets and Payer Strategy business unit. She has also driven business development initiatives such as product acquisitions and third party partnerships in order to expand portfolios and increase share of voice.
Throughout her career, Claudia has managed staffs of up to 30 people, portfolios of $2.3B and marketing budgets up to $4 MM. She has developed and executed successful strategies for launches, new market entry, mature product penetration, and loss of exclusivity. She also has extensive experience in primary care disease states (cardiovascular, respiratory, infectious disease and pain) as well as specialty markets (dermatology and oncology).
Claudia received her bachelor's degree from Rutgers University focusing on marketing and communications in 2000. She has been recognized by various trade publications for marketing programs, and received PM360 Trailblazer's Innovation Award in Healthcare Marketing.
Gene Timmons is a veteran creative/art director with more than 18 years of experience in cutting-edge visual communications and the development and promotion of consumer and business-to-business brands. With expertise in all aspects of corporate branding and identity, print, interactive, web, mobile and application design, he has successfully designed and directed a wide range of engaging projects for companies such as America Online, Canon, Citibank, Dell, Disney, Ford Motor Company, General Motors, HP/Compaq, MTV, Nike, Samsung, Schering-Plough, and Watson Pharmaceuticals.
Gene also has vast experience in print production and publishing where he began his career, and has designed and art directed numerous in-flight publications for such global firms as Air France, American Airlines, British Airways, Delta, Lufthansa, and United Airlines.
Most recently, Gene was the Creative Director for iBoard Inc., where he helped guide the creative development of the company's desktop and mobile software products including the Family iBoard, the V-Album, and the Lexus NAAB iBoard.
He is a graduate of the prestigious Cooper Union School of Art of New York City, where he earned a BFA degree with a concentration in Graphic Design.