Black Mountain Consulting Group

Not just Knowledge..Know-How

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.

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.

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”

How is it we know what it is like to sit in your chair?

Paul F. Duffy, Managing PrincipalMr. 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, PrincipalFor 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 (alfa-interferon)--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.

Because we’ve done it.

Mike Leone, PrincipalMike 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.

Four Key Business Components

Strategic Strategic ConsultingConsulting

Tactical Tactical ImplementationImplementation

Pharma ServicesPharma Services Subject Subject ExpertsExperts

• Strategic Consulting: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: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.

Four Key Business Components

• Ask Our Experts: Ask Our Experts: As a BMCG client , you can quickly access As a BMCG client , you can quickly access subject area experts via a brief teleconference, in situations where subject area experts via a brief teleconference, in situations where you may only need some quick advice or a second opinion. Choose you may only need some quick advice or a second opinion. Choose the expert from our team who most closely matches your issue or the expert from our team who most closely matches your issue or opportunity and dial-in to a solution.opportunity and dial-in to a solution.

• BMCG Pharma Services: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!

Four Key Business Components

BMCG’s Seven Service Groups…

Pharma Services

CorporateOperations

Medical,Legal and

Regulatory

Distribution&

Trade

MarketingStrategy,

Services &Support

Sales

We organize like a Pharma company, focusing on critical company functions:

Business Development

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

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

Medical, Legal and Regulatory Clinical Development

Bench/Toxicology assessment & analysisClinical strategy & protocol developmentInvestigator recruitmentPatient recruitmentContract budget negotiationsProject management & site monitoringOrphan Drug market analysis & research

Regulatory

FDA Submissions: Rx , OTC , Bio-GenericsDossier preparationFDA /EU /CPSC / DEA representationProject managementMedical due diligence

Distribution & TradeComplete New Product Launch Service

Distribution

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

Trade

Wholesaler strategies, negotiation & placement

Stocking negotiations & placement

Distribution & TradeMarket Access

Managed Care representation & formulary placement (Commercial, Medicare, GPO’s)

Medicare Part D formulary placement

Government contracting program (FSS, PHS, VA, etc.)

CMS / State Medicaid drug lists placement

Market Advocacy & Profitability

Medicaid rebate calculations & review

Reimbursement dispute resolution

State Government representation

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

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

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

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.

To continue the discussion, please contact:

Paul Duffy, Managing Principal

Black Mountain Consulting Group

P : 973.534.0507

E-mail: pduffy@bmcgRx.com

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.