New Products Strategy: Driving the Bottom Line Through Strategic Project Management
9:15am – 10:45am

Hear business development and project management veterans from established and emerging Bay Area companies share best practices for bringing successful products to commercialization. From initial project selection criteria to launch, learn how these experts drive the complex, lengthy new product development process towards a successful outcome.

Panel Moderator:

Dr. Phyllis Gardner
Associate Professor of Medicine, Stanford University School of Medicine

Panel Speakers:

Stephen Dilly
Chief Medical Officer, Chiron Corporation

Mark A. Goldsmith, MD, PhD
Senior Vice President, Health Care, Genencor International, Inc.

Peter Hirth, Ph.D.
Founder & Chief Executive Officer, Plexxikon, Inc.

Integrated New Product Strategies from R&D to Launch to Marketing & Sales
11:00am – 12:30pm

As companies grow, they often develop silo-mentalities with ruptures at the transitional interfaces from research to clinical development, and from clinical development to commercialization. Not only does this corporate evolution disrupt the collaborative culture but it also leads to a sub-optimal overall development process and consequently deficient product launches falling short of achieving full commercial potential. Although this realization came about in the early 90s in Big Pharma, biotech companies still have to address the challenge as they mature and expand their development portfolio.

In order to address this challenge, firms need to change their approach to the business of drug development. Those that really focus on commercialization understand the importance of developing a product profile and place this at the core of their overall development. This will optimize product potential and set the precedence for future new product successes.

Successful new product strategies require integrated project and Team formation as early as the preclinical development phase. Teams involving Commercial, R&D, Regulatory and Clinical development should develop product profiles, along with clear check-lists and timelines for a successful launch. Recently approaches to reintegrate all key functional groups have emerged and those companies are demonstrating “lean and mean” product development. Key functions involved in driving the success of these Teams are New Product Development and Project Management.

This session will explore and answer the following questions: When and how do silo’s get established, how are silo-mentalities successfully broken down? Why aren’t firms further along in embracing the concept? What can be done differently to ensure success? Best practice of integrated product development Teams: What should the governance be for the Team? Who leads the Team? Who should function as a Core Member? Skill sets? What people are needed for Sub-teams? Skill sets? How is a budget build for the Team? Maintaining know-how from step to step: Timed and targeted communication between functional areas, partners. How does product “development” work in organizations that embrace this concept? What to avoid, Check-lists.

Panel Moderator:

Michael R. Schuppenhauer, Ph.D.
Vice President Life Sciences, Fleishman-Hillard Inc.

Panel Speakers:

Debra K. Bowes
Director, New Product Development, MedImmune Oncology

James R. Bradburn
Principal Consultant, Pharma Practice, IBM Business Consulting Services

Chris Garabedian
Vice President of Corporate Development, Gilead

Building Pricing and Reimbursement into Valuation and Decision-making
1:45pm – 3:15pm

Accurate product and pipeline valuation is a critical input to securing financial investment and commercial success and therefore must consider both the costs of bringing products to market as well as expected revenues. Since patient population size and price are two key drivers of revenue - and profitability - maximizing profitability in the wake of significant consumer, physician, payor, and regulatory scrutiny is a considerable challenge. Added to this are a dynamic market, lengthy discovery process, evolving label development, and an uncertain approval timeline, all of which make pricing and reimbursement determinations even more difficult to establish and synchronize in time for launch. Finally, firms of any size, whether industry start-ups or biotech veterans, need to maximize value in order to be financially viable and attractive for investors.

This panel will layout from experience and case studies: How to use valuation and option thinking to drive company decision making; How does pricing enter into the various valuation models and forecasting tools and when is it established; Identify and differentiated the targeted customer segments in order to establish successful pricing and reimbursement strategies; Understand and accurately apply pricing drivers and benchmarks as a function of therapy area and product value; Refine pricing and reimbursement scenarios over the course of the entire product lifecycle, from discovery through launch and product maturation; Deploying pricing differences for similar NCEs based upon formulation and mode of delivery; Determine the optimal balance between patient access and profitability; Drivers to affect lift at – and after – launch; Assess pricing and reimbursement requirements around the world.

Panel Moderator:

Mike McCully
Recombinant Capital

Panel Speakers:

C. Lee Blansett
Partner, DaVinci’s Oncology Marketing Strategies

Karl Handelsman
General Partner, CMEA Ventures

Ted Sweeney
Managing Director, Emerging Biopharma, IMS Health

Building a Sales Force – Acquire, Build or Partner
3:30pm – 5:00pm

This panel includes three contrasting approaches to the sales channel as told by the executives who made key decisions on the road to success. Panelists will feature management contrasts in acquisition of a sales force, building an in-house sales force and out-licensing to a third party with sales.

Panel Moderator:

Matthew Le Merle
Partner, Monitor Group

Panel Speakers:

David McCaleb
Senior Vice President of Commercial Operations, CV Therapeutics, Inc.

Glen Sato
Chief Financial Officer, Protein Design Labs

Tom Wiggans
Chief Executive Officer, Connetics Corp.