Global Life Science Consultant and Expert Witness in the Pharmaceutical and IP Industries

Expertise

• Commercial leadership in the global life sciences industries, with extensive experience guiding both large and small life-science companies.
• Life science commercial strategy development.
• Product development (commercial): Clinical study design, labeling development, and KOL networks.
• Product launch in various disease states and platforms including diagnostics, vaccines and nutriceuticals.
• Market access strategy development: expert recommendation, Key Opinion Leader (KOL) in support, pricing, policy, coverage and reimbursement.
• Disease awareness strategy and program development.
• Positioning of products or companies in competitive markets.
• Overall pharmaceutical support in business strategy, tactical development, new product launches, profit and loss management, and sales and marketing.
• Cross cultural team leader and collaborator with experience in Europe, North America, Latin America, the Middle East, and Asia.
• Competitive Assessment and brand and company differentiation.

Expert Witness Experience

• Grand Jury Testimony - Pharmaceutical in several cases: Medical education, marketing, and pricing practices for the U.S. District Court, Boston, MA.
• Department of Justice Inquiry - Pharmaceutical pricing and contracting for the U.S. District Court, Boston, MA
• Deposition - Pharmaceutical patent infringement and penalty phase infringement, Philadelphia, PA.
• Legal Strategy Development - Pricing practices civil case, Collegeville, PA.

Experience

Undisclosed Company, Owner, 2011 - Present

• Advised senior leaders on launch and commercialization strategy for biotechnology products.
• Monitor, communicate and consult on vaccine industry trends.
• Developed comprehensive global launch plan for 2nd generation TB vaccine.
• Developed and presented (venture capital) business plan for new medical supply company.

Clients and Projects - Biotechnology Consulting

Undisclosed Company, Dietary Supplement and Launch

• Develop commercial plan.
• Obtain investor funding.
• Secure partnership agreements.

Silagene, Inc., Hillsboro NJ

• Support request for funding grant.
• Provide commercial assessment.

Institutes for Pharmaceutical Discovery, Branford, CT

• Developing and launching unique business opportunities for medical markets.
• Secured funding and acquired rights to market a unique dietary supplement to medical specialties.
• Developed business plan, branding etc. for the launch of a unique supplement.
• Launched a uniquely positioned dietary supplement through urology specialists' medical practices.
• Hired and managed a team of 5 employees to conduct the launch and marketing of the new product.

Emergent Biosolutions, Rockville, MD

• Developed global business plan for a new tuberculosis vaccine.
• Developed a global partnering and sales model for a new vaccine business unit.

Employment

Pfizer Pharmaceuticals, Vaccines, Collegeville, PA, Vice President, 2009 - 2010

• Supported the launches of Prevenar 13 for both infant and adult indications
• Co-led the team to refine the global vaccines business strategy for Pfizer and provided recommendations on internal and external assets in pursuit of portfolio strategy.
• Evaluated and met with vaccine companies to discuss a variety of vaccine technology acquisitions.
• Evaluated and provided commercial recommendations on new vaccine technologies.
• Developed business governance structure for the global network of vaccines businesses.
• Member of the Vaccines Leadership and Infectious Disease Area Leadership Teams.
• Advised commercial groups on global vaccine policy issues.

Wyeth Pharmaceuticals, Vaccines, Collegeville, PA, 1991 - 2010

• Serving the positions of Vice President and Global Business Manager of adult vaccines.
• For a new commercial vaccine group built, launched the next blockbuster vaccine and first adult pneumococcal conjugate vaccine with expected growth of over $2 billion.
• Created vision and strategy for building a marketing department to launch first of a kind adult vaccine, and recruited a new team of 14 marketing specialists.
• Developed global launch strategy, branding, and positioning for a new pneumococcal vaccine.
• Secured over $40 million in global funds and expanded the global team to 25 professionals.
• Global profit and loss responsibility; U.S. P&L responsibility and direct management.
• Designed and supported implementation of the U.S. adult vaccine sales force, (recruits and deploy).
• Led the process to train and target adult vaccine sales force.
• Led the process for supporting policy and positive recommendation (ACIP) for PCV13 in U.S. and to support similar recommendations within the EU, Latin America and Asia.
• Built alliances with infectious disease organizations (NFID, ESCMID, ASM, FIDEC and IDSA).
• Established strong relationships with GMs, marketing directors, meeting in various locations, Europe, Latin America and Asia.
• Networked and strengthened relationships with, global government and NGO infectious disease organizations relating to adult vaccine policy, (e.g., CDC, WHO, ECDC).

Assistant Vice President, Vaccines New Business - Prevenar 13, 2006 - 2008

• Responsible for developing and executing the global launch strategy and plan for Prevenar 13 pediatric and adult indications.
• Developed global launch strategy for launching PCV13 in the competitive pediatric market and the new adult indication.
• Communicated these strategies effectively to all affiliate General Managers and marketing teams.
• As Chairman of the Global Launch Committee, partnered with General Managers of major European, Latin American and Asian affiliates to structure launch investment and approach.
• Designed structure and recruited marketing personnel for both pediatric and adult global teams.
• Co-developed lifecycle strategy for pneumococcal vaccine franchise.
• Created a new marketing department to prepare for the launch of Wyeth's largest vaccine.
• Provided input for clinical and regulatory strategy.

Assistant Vice President, Cardiovascular Business, Altace Marketing, 2005 - 2006

• Appointed by and reported to Executive VP and GM of Pharma Business Unit.
• Led U.S marketing group.
• Differentiated Altace in highly genericized ACE Inhibitor market through unique indication.
• U.S. profit and loss responsibility $105 million marketing and sales spend annually.
• Increased profit by 25% ($20 million) through increased sales and eliminating unnecessary spending.
• Optimized asset by restructuring licensing deal which retained annual revenue of over $225 million.
• Boosted profit by eliminating unproductive promotional activity.
• Directly negotiated divestiture of asset as well as terms of new partnership.
• Commercial representative on cross functional licensing and acquisitions team for CV/GI and other non-core technology areas.
• Managed co-marketing and sales alliance with King Pharmaceuticals.

Area Business Director, Sales Management, NE Business Unit, 2003 - 2004

• Led and managed the regional sales force in two states (PA & WV). The team consisted of 10 sales directors, 10 specialty and 105 primary care sales representatives.
• Position included sales goal attainment as well as leadership and human resource management responsibilities.
• Improved area ranking from 15 to 5 (out of 23) areas in U.S.
• Generated over $50 million growth in PA and WV off of a base of $400 million.
• Restructured Psychiatry Specialty group to enhance performance in key product.
• Introduced a new management advancement program based on sales results and management skills.
• Subsequently promoted 18 representatives or managers in two years.
• Selected as member of Senior Sales Council.

Group Product Director, Gastrointestinal Marketing, PPI, Protonix®, 2001 - 2003

• Marketing: Reported to VP of GI/CV Marketing.
• Developed highly successful launch strategies for the Hospital, Specialty and Primary Care markets.
• U.S. profit and loss responsibility; over $200 million marketing and sales budget annually.
• Fastest product in corporate history to reach $1 billion in annual sales (peak over $2 billion).
• Product attained #1 status in hospital and MCO formularies for PPI class (audited).
• Successfully managed a variety of supply chain issues and prevented lost sales.
• Launched first intravenous proton pump inhibitor.
• Directed launch of Protonix; categorized in the top 10-best pharmaceutical launches in the U.S.
• Provided commercial recommendation for the Wyeth to acquire the license of pantoprazole.
• Managed business alliance with Byk Gulden / Altana Pharmaceuticals (Germany).
• Renegotiated product agreement with Byk to extend marketing reach and improve P&L.
• Managed U.S. lifecycle strategy for pantoprazole based compounds.
• Evaluated, proposed and pursued new business opportunities in GI area including proton pump inhibitors, prokinetics and combination therapies.
• Transferred site of manufacture to save an additional $10 million in COGs.

Product Director, Gastrointestinal Marketing, PPI - Protonix, 1998 - 2001

• Position established to brand, position, price, messaging, and launch new GI product.

Senior Product Manager, Musculoskeletal, Anti-Arthritics (NSAID), Lodine®, 1995 - 1998

• Marketing and Business Development accountability.

International Product Manager, Diabetes, Alredase®, 1991 - 1995

• Responsible for helping marketing director construct a business model and launch the first aldose reductase inhibitor for preventing diabetic complications.
• Focused on markets in Europe, Asia and Latin America.

Honors & Publications

Credentials

• Executive Education Course Work
• Harvard Business / Harvard Law Schools-Vantage Negotiating Skills
• University of Pennsylvania, Wharton Business School - Value Creation; Global Positioning
• Wyeth Global Executive Leadership Program

Languages

• Spanish

Awards

• President's Golden Circle (Top 2% of company)
• President's Excellence and Recognition Awards (Protonix Team)
• Project Team Achievement Award, (pantoprazole)
• Brand Team Award - Bronze, Product Management Today, Protonix
• Reader's Choice - Bronze, Product Management Today, "Gerdie" campaign
• Toth Award - Best of Show, Public Relations Society (National) "Protonix"

Education

• B.S. Biology, Ursinus College, Collegeville, PA