Mathias Romacker Email & Phone Number

Ventura, California, United States

Use industry knowledge and expertise to guide Kymanox team members and assist clients with bringing their Combination Products, Biologics, and Medical Devices to market. Provide expert strategic guidance to maximize success for business start-up, scale-up and organizational growth, operations and commercialization, connected and digital health, drug/device combination product development, and intellectual property development.

Bethesda, Maryland, United States

New York

Led device strategy across the organization and owns front end of novel device technology assessment across organization.• Identified gaps in existing device portfolio and categorize novel device technologies according to value to Pfizer, maturity etc.• Orchestrated outreach efforts and conducted market surveillance.• Guided product teams through early stages and LCM device options selection process; ideation and feasibility phases• Created and implemented device governance process for Pfizer. • Furnished process that addresses objectives, resourcing, accountabilities, responsibilities, and decision-making authority.

Analyzes market trends and new technologies in the areas of invasive drug delivery. Liaises with other company functions – especially global marketing – to develop and implement device strategies for launched and pipeline drugs.Leads the cross-functional Device Surveillance Team. This team develops tools and databases designed to track new technologies, monitor the market and, if applicable, prepare device business cases. Represents Amgen as a frequently-invited speaker at drug delivery conferences. Reviews industry peers’ worldwide device activities and integrates findings into overall drug-device strategies. Initiates interaction with device and package vendors; manages relationships with all third parties/device vendors that are potential Amgen suppliers.

Lead introduction of pre-sterilized RTF syringes into the US market. Defined and implemented strategy for penetrating competitor’s accounts. Developed targeting system to identify potentials. Be responsible and manage US staff. Organized and initiated events like the PDA 'Universe of Prefilled Syringes and Injection Devices' conference in Hanover in October 2004 in order to promote prefilled syringes and devices to a broader audience. Participated as speaker and chairman. Delivered additional presentations at Management Forum conferences in London, U.K.Furnished business and marketing plans to define strategy for the company’s drug delivery products. Positioned Gerresheimer Buende GmbH from packaging supplier to player in area of ‘drug delivery’Managed key accounts including J&J Pharma and Schering AGSuccessfully filled company’s pipeline for future business in all markets.

Lead marketing efforts for new self-injection product lines offered by this major supplier of parenteral drug delivery systems including autoinjectors; injection pens and nasal spray systems. Held responsibility for advising sales team, supporting projects, creating promotional materials, performing competitive and market analysis and monitoring budgets. Maintained contact with BD Europe and other regional offices to support marketing efforts and sales to worldwide pharmaceutical clients.Positioned company and market leader in self-injection products, including the disposable pen and auto-injector, by championing development and redefining the business strategy to capitalize on new product platforms and achieved double-digit sales growth.Instrumental in obtaining commitments from one contract filler and two major pharmaceutical companies to utilize new products.Conducted market research to prove product viability as well as the advantages to pharmaceutical customers’ marketing efforts, providing sales force with a structured approach and resources to help close complex sales.

Johannesburg Area, South Africa

Selected to grow company market share in Southern Africa by driving sales performance and profitability to a territory consisting of distribution, retail and hospital customers. Managed six dedicated representatives selling a mixture of injection, anesthesia and infusion therapy products. Served as office legal representative overseeing one accountant and two assistants. Boosted sales five fold from 1996 to 2000 by effectively developing sales team, securing long-term contracts, building strategic partnerships and determining appropriate marketing mix.Successfully integrated Ohmeda product line, which contributed an additional sales in territory.Produced additional sales by securing partnership with major competitor, Sekunjalo Healthcare, enabling Becton Dickinson to focus on manufacturing hypodermic needles and two-piece syringes while letting Sekunjalo handle sterilization and packaging.Protected company interests during the liquidation of a major distributor by collecting over $1 million in outstanding invoices just days before the announcement, securing all remaining inventory and securing an arrangement to continue supplying the market.

Heidelberg Area, Germany

Headed sales efforts focused on pharmaceutical companies with responsibility for managing three personnel, devising an effective targeting system and generating interest in new therapeutic classes.Overcame fierce competition to secure contract with Cilag, a Johnson & Johnson company, to use Hypak glass syringe system for its Biotech drug Eprex, a deal that converted a new therapeutic class to prefilled syringes.Realized double-digit growth each year by building strong relationships with major contract fillers of prefilled syringes and other accounts in the territory.

Works for this Japanese pharmaceuticals company to communicate with scientific opinion leaders, create promotional tools, coordinate sales team efforts and lead marketing of a drug called Enantone-Gyn to position Takeda as the market leader in treatments for Endometriosis, uterine fibroids and breast cancer. Instilled confidence in sales team by increasing product knowledge through special events and promotional materials, which led to significant competitive edge.Maximized product awareness and credibility by managing opinion leaders to deliver presentations at conferences, contribute publications and conduct clinical trials.

Sold prefilled glass syringes throughout Northern Germany and the Netherlands by cultivating new business and growing existing accounts.Expanded client base from 4 or 5 to more than 10 within only 3 years by effectively identifying prospects and proactively managing accounts.Secured business with Germany’s leading vaccine manufacturer, who demonstrated intense initial resistance, to triple overall sales from 1989 to 1992.