We partner with the world’s premier healthcare corporations to achieve more new product approvals. Capstone advances our corporate partners' goals of bringing more new healthcare products to market, quickly and efficiently. We lead product development, manage regulatory services and achieve timely approval of new healthcare products on our clients' behalf. Our unique partnership model enables our clients to expand their product development portfolio without increasing their operating expenses.Capstone is the parent company of Celerity Pharmaceuticals, Gage Development, and Balmoral Medical which support the development work that we conduct on behalf of our clients. In addition, Capstone is the parent of Long Grove Pharmaceuticals, which independently identifies and develops pharmaceutical products. Capstone is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the healthcare industry.

• Coordinate global injectable R&D at three R&D centers – Galway (Ireland), Hyderabad (India), and Morgantown (USA) including regulatory submission activity to support Mylan’s global institutional (hospital) strategy.• Work closely with the VP of global commercial strategy (Mylan Institutional) on portfolio optimization• Assisted the technical and regulatory review of all injectable acquisition, licensing, and co-development opportunities with business development.• Managed an expense budget of $20 million (direct); $50 million (indirect); worked with corporate manufacturing on a sterile facility expansion capital plan in excess of $100 million• Direct Reports – Heads of Injectable R&D at two sites, R&D Project Sr. Manager, and Director of External R&D Project Management and Technology Transfer• Indirect Reports – Head of Global Regulatory Affairs, Director of Quality, Sr. Director of 3P Injectable Contract Manufacturing, Head of Global Sourcing (API), and two VP and GM of sterile manufacturing sites – Galway (Ireland) and Napa (USA)

• Responsible for global R&D including the development of generic sterile injectable products, proprietary injectable products, medical devices, and lifecycle management. Project total was 47.• Built a greenfield R&D organization including the design of new 10,000 square foot facility in Galway, Ireland and fully staffing a leading injectable development group.• Integrated the acquisition and licensing of 25 injectable projects including Ultiva® (Remifentanil for Injection), Mefoxin® (Cefoxitin Injection), and Duraclon® (Clonidine HCl Injection).• Managed 18 external development programs expanding development capabilities into oncology, lyophilization, pre-mix bags, controlled-substances. • Assisted with the sale of Bioniche Pharma to Mylan , Inc. for $550 million (9.4x increase in equity value)

• Responsible for the development of over 60 generic sterile injectable products and proprietary nanotechnology drug products (Phase 1 through Phase IV)• Worked closely with Regulatory Affairs to earn approval of 5 ANDAs in 2005.• Accelerated ANDA approvals with 8 in the first quarter (1Q06) including APP’s first Paragraph IV victory, Azithromycin for Injection, USP.• Managed a $12 million R&D budget; oversaw a $23 million R&D facility renovation.• Direct Reports – Sr. Director of Biopharmaceutical Technology Development, Head of Analytical Development, Sr. Manager of Formulation Development, Manager of Biotechnology, Managers of Project Planning, Principal Compliance Auditor• Indirect Reports – Over 60 scientists including formulators, analytical chemists, and biochemists

• Facility general manager of Plainsboro Research Center and the Northvale, NJ, pilot and commercial manufacturing plant. Each site is approximately 28,000 square feet. Both sites are focused on the development and manufacture of the transvaginal ring drug delivery system.• Responsible for the development of seven transvaginal ring NDA projects. Four INDs filed in 2004. Three projects are expected to be in Phase II clinical trials by early 2005.• Managed a $12 million budget including Formulation R&D, Analytical R&D, Process Development, Facilities and Engineering, and General and Administrative departments.• Oversaw a $6.5 million capital renovation project for Northvale transvaginal rings manufacturing.• Direct Reports – Director of Facility and Engineering, Associate Director of Process Development, three Analytical R&D Group Leaders, and Laboratory Auditors.• Indirect Reports – 35 representing Analytical R&D, Bioanalytical R&D (vaccine development), Process Development, and Administrative.

• Managed two research groups comprising 23 scientists, including QA auditors, department IT manager, and laboratory coordinator. Over three years, doubled the team’s size and maintained low turnover.• Responsible for laboratory automation capabilities targeted to reduce formulation development timelines and optimize critical manufacturing parameters.• Coordinated a $2 million R&D laboratory renovation in collaboration with Engineering Department.• Directly responsible for the development and submission of ANDAs, including patent challenges.• Responsible for several approved products including Isotretinoin Capsules (liquid-filled hard gelatin capsules), Fexofenadine Tablets (tentative approval), Fexofenadine and Pseudoephedrine Tablets (tentative approval), Ethambutol HCl Tablets, Mefloquine HCl Tablets, and Pyridostigmine Br Tablets.• Worked directly with FDA on Pre-Approval Inspections, deficiency letter responses, and other regulatory communication.

• Managed a group of 5 scientists who were responsible for analytical method development and validation in support of animal health drug substances and drug products.• Responsible for dissolution testing (Apparatus 1, 2, and 3) of proprietary controlled-release delivery systems, and establishing in vivo in vitro correlation (IVIVC).• Responsible for establishing stability-indicating analytical methods for pharmaceutical products.• Evaluated novel drug substances for licensing opportunities.• Supported preformulation activities and released drug substance for GLP animal toxicology studies.• Served as GLP study director and supervisor for investigations submitted to global regulatory agencies.• Responsible for analytical method transfers to manufacturing sites including final method validation.• Corporate Y2K team member.

• Responsible for implementing Good Manufacturing Practices (cGMP) regulations in QC/QA laboratory of this start-up pharmaceutical company.• Duties included outfitting laboratory and capital budget planning.• Developed and validated HPLC, GC, dissolution (Apparatus 2), and UV-visible test methods in support of several Phase I and II clinical drug products.• Experienced with preparing and submitting Investigational New Drug (IND) and orphan drug applications.• Designed and delivered presentations to major pharmaceutical firms in an effort to out-license a new male sexual dysfunction drug therapy. Abbott Laboratories and TAP Holdings, Inc., entered into an agreement with Pentech Pharmaceuticals for Apomorphine HCl (Uprima®). New Drug Application (NDA) filed with FDA in 1999 and approved in Europe.• Computer network manager for company