Black Mountain Consulting Group. Not just Knowledge..Know-How

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1 Black Mountain Consulting Group Not just Knowledge..Know-How

2 BMCG in a Nutshell. A collaborative of more than 45 Pharmaceutical Industry experts, each with more than 10 years of success in their well defined area of expertise working with clients like yourself..who put you and your company first by doing the work themselves. No junior partner assignments. Extensive experience with start-up, small & medium-sized pharma companies. BMCG differentiates itself from other consulting companies by not only offering strategic guidance but also by rolling up their sleeves and performing the tasks as directed by you. BMCG offers different experts as your needs change, insuring you always have expertise central to your business.

3 Black Mountain Consulting Group We serve clients exclusively in the Pharma, Biotech and Medical Device Industries. Individual narrowly defined subject experts experienced across a wide range of therapeutic areas. Across broad geographic areas including: U.S. & Canada Europe As a result of our experience, our experts are keenly aware of the practical solutions that are likely to work for you within your budget.

4 Serving Client Company needs BMCG assists client companies in solving problems like these.. Where can I find pharma-exclusive experts who are organized like a pharmaceutical company? a collaborative group with a history of working together for my benefit? that make me and my company their top priority? that know when to take on a project, as well as when to refer me to someone else that understand the important issues of a small company

5 How is it we know what it is like to sit in your chair? Because we ve done it. Paul F. Duffy, Managing Principal Mr. Duffy brings Black Mountain Consulting Group extensive experience at both big pharma and start-up organizations. He acquired more than 30 years of big pharma experience at Novartis Pharmaceuticals (formerly Sandoz Pharmaceuticals), having held sales and marketing positions of increasing responsibility from 1972 to 2003, when he served as U.S. National Sales Director-Neuroscience. Mr. Duffy then left Novartis to co-found CNS start-up Alamo Pharmaceuticals, where he served as Executive Vice President. At Alamo, he created a fully integrated commercial pharmaceutical company to market Fazaclo, a patented reformulation of Novartis' anti-psychotic drug, Clozaril. Duffy left Alamo in July 2006, after completing its sale to Avanir Pharmaceuticals. He then became founding CEO of Validus Pharmaceuticals, creating an entirely new type of private-equity backed pharmaceutical company. Most recently, Duffy served as President -US Commercial Operations for the UK-based multinational, Amarin Pharmaceuticals. Josh Weinstein, Principal For the past 12 years Weinstein has served as President of jweinstein Strategic Messaging, Inc., an advertising, PR, and advocacy development company specialized in helping young pharma and device companies. Mr. Weinstein s career began at Sandoz Pharmaceuticals (now Novartis) where he developed the launch campaigns for Tavist and Visken. Weinstein then joined Schering-Plough where, as Director of Marketing, he launched Normodyne and Intron-A (alfainterferon)--now a multi-billion dollar product. After moving to Schering International, to manage their cardiovascular market development, he was recruited by Squibb to be Vice President of Marketing, USA and to manage the development of Pravachol (one of the nation s first statins ). Weinstein was later recruited to run the New York Healthcare practice of the prestigious public relations firm, Hill & Knowlton, and went on to become Executive Vice President in PR giant, Burson-Marstellar s Washington, DC and New York healthcare operations. Subsequently, Mr. Weinstein was recruited by McCann-Erickson s Torre-Lazur and Weber divisions where he became Founding President of Torre Lazur/Weber, and the Torre-Lazur/McCann Global Advocacy Group. Mike Leone, Principal Mike Leone is recognized as an accomplished pharmaceutical executive with broad therapeutic expertise. His over 25 years of experience and leadership includes positions of increasing senior level responsibility at Bristol-Myers Squibb, First Horizon Pharmaceuticals, Eyetech Pharmaceuticals and Takeda Pharmaceuticals North America. Mike is currently President of Strategic HealthCare Resources, LLC, and is consulting for a number of venture capital, pharmaceutical, biotech and device companies. He has helped companies create sales force deployment models, developed compensation models, served as a direct customer liaison with state Medicaid and federal government customers on formulary and pharmacoeconomic issues, consulted on clinical trial focus areas, conducted focused leadership training programs, and counseled a growing sales organization on how to enhance the structure of its organization and improve the capabilities of its leaders. Having spent the majority of his career at Bristol-Myers Squibb, Mr. Leone held numerous positions of increasing responsibility. These positions included National Director, Federal & Institutional Sales, a position in which he rebuilt the Hospital Sales Team and strengthened BMS role and commitment to VA and military customers. In that role, Mike spearheaded the institutional launches of Maxipime and Plavix. Mike s National Accounts experience, and focused, field-based hospital sales leadership expertise have made him an especially valuable asset to Specialty Pharma clients.

6 Four Key Business Components Strategic Consulting Tactical Implementation Pharma Services Subject Experts

7 Four Key Business Components Strategic Consulting: We provide business strategy development for addressing key challenges across the organization and brand life cycle. Capabilities include corporate business and brand strategy, from early stage clinical and regulatory development through successful commercialization. Tactical Implementation: We bring your strategy to life by doing the work that you may not be staffed to do. Our collaborative strength is in all phases of Clinical, Commercial and Corporate/Operational projects, designed to place a carefully matched professional to your needs.

8 Four Key Business Components Ask Our Experts: As a BMCG client, you can quickly access subject area experts via a brief teleconference, in situations where you may only need some quick advice or a second opinion. Choose the expert from our team who most closely matches your issue or opportunity and dial-in to a solution. BMCG Pharma Services: are pharma dedicated and proven service experts in their field. We know because we worked shoulder to shoulder with them. BMCG invites only those proven to deliver results. They have proven their mettle to us; let us show you how they can deliver for you!

9 BMCG s Seven Service Groups We organize like a Pharma company, focusing on critical company functions: Corporate Operations Pharma Services Business Development Sales Medical, Legal and Regulatory Marketing Strategy, Services & Support Distribution & Trade

10 Corporate Operations Corporate Infrastructure I.T. Systems & Services, including design, creation, development and validation. I.T. Help Desk support. Data Management and Storage / Disaster Recovery Drug Product / CMC Development and Manufacturing Services Technical & outsourcing support; Quality-By-Design program development Personnel Key employee recruitment, compensation analysis & contracts Interim short term senior management Executives CEO, CFO, COO, CMO, HR, Sales, Marketing, for start-up companies, short term projects Permanent Staff Recruitment, vetting and placement

11 Business Development Capabilities Business development strategy and execution Target identification Product portfolio development Commercial and technical due diligence services Focus Brand & corporate acquisitions, licensing Co-promotion and joint ventures Pharmaceutical, biotech, and medical devices

12 Medical, Legal and Regulatory Clinical Development Bench/Toxicology assessment & analysis Clinical strategy & protocol development Investigator recruitment Patient recruitment Contract budget negotiations Project management & site monitoring Orphan Drug market analysis & research Regulatory FDA Submissions: Rx, OTC, Bio-Generics Dossier preparation FDA /EU /CPSC / DEA representation Project management Medical due diligence

13 Distribution & Trade Complete New Product Launch Service Distribution Trade Complete Third Party Logistics including: Warehousing your product(s) Pick, pack, ship and invoice with EDI support Sales rep sample and literature services Wholesaler Fee for Service negotiations Wholesaler strategies, negotiation & placement Stocking negotiations & placement

14 Distribution & Trade Market Access Managed Care representation & formulary placement (Commercial, Medicare, GPO s) Medicare Part D formulary placement Government contracting program (FSS, PHS, VA, DoD, etc.) CMS / State Medicaid drug lists placement Market Advocacy & Profitability Medicaid rebate calculations & review Reimbursement dispute resolution State Government representation

15 Marketing Strategy, Services & Support Marketing strategy Pricing research and strategy New product planning Launch strategy Marketing Services & Support Communications Plans Advertising, Brochures, Package & Label Design Public Relations, Press Releases, Advocacy Groups Artistic / Printing / Production Materials Services Non-personal marketing support

16 Sales Force Management & Support Sales Force Leadership Development, Management & Productivity Field force design & deployment Interim Senior Field Force Executives, Directors & Managers Complete Contract Sales Force (CSO) recruitment & deployment Compensation & commission program development Initial, continuing & new product sales training Sales Management skills programs / workshops Development / Assessment Centers Sales Support Services Sample / literature / and sales rep services Sales Force Automation

17 Pharma Services & Special Teams Medical convention planning & staffing services Medical investigator meetings Media: Electronic/ Film / Digital A-V programs specific to Pharma industry (product, corporate, meetings, PR, patient education, clinical trial patient recruitment, sales & marketing, training) Customer Loyalty programs TEAMS Tele - Reach inbound and outbound services team FDA-DDMAC medical/ legal review team Government compliance teams / SOP development

18 Summary: BMCG Supports Clients BMCG Capabilities Experienced senior level experts prepared to support client companies across a wide range of business needs. Skills to develop creative, practical strategies and the resources necessary to successfully implement them. Provide our clients with access to BMCG s industry -wide relationships and resources. Our Pledge: To listen to fully understand our client needs and goals. To be professional, respectful, and practical. To be committed to the success of our clients.

19 To continue the discussion, please contact: Paul Duffy, Managing Principal Black Mountain Consulting Group P : [email protected] This Presentation is Confidential and is not Authorized for Reproduction,Electronic Transmission,in whole or in part, without the Prior written Permission of a Principal of the Black Mountain Consulting Group.