Life Science Product Commercialization-Marketing Consultant and Litigation Expert

Expertise

• Biopharmaceutical product commercialization, diagnostic and medical device markets with over 30 years of success.
• Over 20 years operational leadership in mid-size to large biopharmaceutical companies and established medical device firms.
• Marketing, market research, pricing and reimbursement, business planning, and sales, contributing to ten new product launches in the life science industry with consulting engagements and industry experience spanning thirteen therapeutic classes.
• Advisor and Consultant to life science companies, healthcare data providers, private equity, venture capital and top tier law firms.
• Provide consulting to numerous clients in the United States and served as an advisor and expert witness on commercial litigation matters related to marketing and promotion, product valuations, pricing and reimbursement issues.
• Identify market opportunities, providing market assessments, product valuations and forecasting, new product planning and launch planning, brand strategy and tactics, product lifecycle management, pricing, reimbursement/market access and licensing due diligence.
• Led and or contribute to the launch of new products (i.e., Prozac (Eli Lilly) and Abilify (OAPI) two of the most successful brands ever introduced).

Expert Witness Experience

• Expert and advisor on 19 litigation matters. Experience includes trial, arbitration and deposition testimony.
• Patent Infringement and ANDA Litigation: Expert reports on commercial success and irreparable harm.
• Patent Infringement and Damages Claim: Advised counsel on market dynamics and shares of drug eluting stents.
• Patent False Marking: Expert report for defendant, a major biopharmaceutical company.

Contracts

• Breach of Contract Damages: NPV analysis and expert report on a fentanyl-based pain management system in development.
• Breach of Contract-Commercially Reasonable Efforts: Expert report on a company's launch planning and marketing of a technology to detect circulating tumor cells.

False Advertising

• Provided expert reports on false and misleading claims, causation and harm.

Vacated Temporary Restraining Order and Damages

• Expert report on lost sales revenue and market shares of a gout therapy.

Bankruptcy-valuation of debtors secured claim

• Assessment of allergy therapy marketing strategy, forecasts and the fair market and liquidation value of patents.

False Claims Act

• Advised counsel on off-labeling marketing programs in the biopharmaceutical industry.
• Other Cases: Securities Fraud, Antitrust, and Misappropriation of Trade Secrets.

Experience

Undisclosed Company, Principal and Managing Partner, 2003 - Present

• Grew revenues from $450,000 to $4.3 million in 5 years with the efforts of the Founder and Staff.
• Expanded services offerings to include analytics, market access, pricing and competitive intelligence.
• Clients include 4 of the top 20 global biopharmaceutical companies, numerous emerging biotech, 5 of the top U.S. business litigation law firms and major private equity, venture capital organizations.
• Completed over 80 engagements spanning 25 pharmacologic therapy areas and 4 medical device categories.

Selected Projects

• Developed an oncology network market access strategy for a top 5 biopharmaceutical company resulting in 18% annual sales increase for an oncology therapeutic.
• Modeled the launch pricing of oral/ fixed dose combination regimens of protease and polymerase inhibitors to treat Hepatitis C for a major investment firm. Pricing within 4-10% of actual launch prices.
• Due diligence and valuation of a company with a portfolio of diagnostic imaging agents led private equity firm to decline making a $12 million investment.
• For an Asian biopharmaceutical company helped define U.S. subsidiary's life cycle management strategy for a cardiovascular agent resulting in an additional 6 months market exclusivity and $160 million in sales.
• In a patent infringement dispute testified at trial on the origin of commercial success for an innovator brand with sales exceeding $1 billion.

Otsuka America Pharmaceutical Inc., Rockville, MD, Vice President, 1996 - 2002

• Subsidiary of Otsuka Ltd of Japan that develops and commercializes pharmaceuticals and diagnostics. U.S. sales that exceeded $6 billion.
• Part of a senior management team that grew company sales from $15-$600 million. Member of the Otsuka Japan Global Licensing and Evaluation team and the Management Committee.

Vice President Business Planning and Market Research

• Managed commercial assessment and business analytics and forecasting for Otsuka pipeline and marketed products, and in-licensing candidates.
• Part of a team that completed valuations on eleven potential in-licensing candidates.
• Responsible for all data acquisition within the commercial function.
• Executive Committee adopted key recommendations to adjust marketing spend on certain customer segments saving $6 million.
• Co-chaired the analytics group in co-marketing arrangement with BMS.

Vice President Managed Markets

• Built and staffed the managed markets and trade relations function within the commercial group.
• Co-chair of team that developed the global launch pricing and reimbursement strategy for the anti-psychotic Abilify (peak U.S. sales exceeded $7 billion).
• Developed pricing, reimbursement and access strategy for the novel anti-platelet Pletal, gaining acceptance on 80% of targeted health plan formularies within 10 months.

Vice President of Sales

• Managed 5 district managers, 2 managed care directors, 40 medical representatives and contracting and sales operations function.
• Increased sales of ophthalmic product from $15 to $20.5 million in 21 months in declining market while reducing budget $2.5 million.
• Established formal contract operations department including staffing and evaluating vendor chargebacks and rebate systems.
• Created initial field sales expansion plan (30 to 135 personnel)

Independent Consultant, Raleigh, NC, 1995 - 1996

• Completed market assessment and developed marketing plan for blood glucose monitoring system (Polymer Technology Inc., Issaquah, WA).
• Strategic advice to a disposable manufacturer on an acquisition.

IVAC Corporation, (Eli Lilly & CO), San Diego, CA Chicago, IL, Raleigh, NC, 1985 - 1995

• A market leader in the development and manufacture of drug infusion instruments and disposables. Eli Lilly sold IVAC and the company is now known as CareFusion.

Division Vice President, Eastern Area

• Managed 7 regional managers, 55 sales consultants, and 8 clinical nurses. Yearly sales responsibility of over $75 million.
• Designed and instituted a formal business planning program for all levels of the sales force.
• Six-fold increase (2 to 13) hospital conversions in 12 months, displacing 3000 competitive hospital infusion instruments ($8.0 million value).
• Presided over two largest sales in company history: University of Maryland Medical Center ($2.73 million) and Columbia Presbyterian ($2.25 million).

Director of Marketing

• Increased revenue by $12 million (10%) and grew placements of drug infusion instruments from 13,000 to an average of 17,500.
• Launched two new products: One captured 33% of the tympanic thermometer market in first year against four competitors; the other exceeded unit forecast by 14% (4,100 vs. 3,600).
• Simplified marketing and sales strategy and improved manufacturing efficiencies by eliminating 5 of 10 infusion device product lines.
• Expanded disposable line to include high margin customized disposables and initiated new program for needle free technology.

Other Positions

• Marketing Manager, Drug Infusion Systems; Regional Sales Manager; Product Manager of Special Projects

Eli Lilly & Co., Indianapolis, IN, New Orleans, LA, Washington, DC, 1973 - 1985

• Positions held for this Fortune 200 biopharmaceutical company: Corporate Pharmaceutical Pricing Associate; Prozac Marketing Associate; Medical/Marketing Liaison; Hospital and office-based sales representative.

Honors & Publications

Credentials

• Executive Education Program, Kellogg-Northwestern Chicago, IL
• Executive Program, UCLA, Anderson School of Management, Los Angeles, CA

Education

• M.S. Microbiology, Fairleigh Dickinson University, Rutherford, NJ
• B.S. Biological Sciences, Fairleigh Dickinson University, Madison, NJ