2012 Overview

You have a great target or a novel technology or perhaps both. Now you want to build a company around it? What’s next? This hands on practical workshop takes you through the journey of how to build a biotech company as well as how to assess the decisions to do an IPO.

This workshop is offered as a stand-alone event or as a pre-conference Entrepreneurship Boot Camp workshop to the New Paradigms conference.

Schedule - Tuesday, January 10, 2012

8:15 am

Registration and Coffee/Tea

9:00 am

Program Begins

10:30 - 11:00 am

Networking Break

12:30 - 1:45 pm

Lunch Break

3:30 pm

20 Minute Break

5:00 pm

Program Concludes

Agenda

9:00 am

Part I Building your IP Position & Establishment

1. •Understanding the value of your IP
   

2. •The critical components on creating and building your IP
   

3. •Once established in the US, where do you go from there?
   

4. •Expanding your IP position? If and when?
   

5. •Financial considerations
   

10:00 am

Part II - IP Strategy

1. •Do you establish your IP and then the corporation or do you establish the corporation and then your IP?
   

2. •Establishing the company. What makes sense for you: A Corporation, an LLC, C Corp?
   

3. •What are the tax ramifications?
   

4. •What are the practical and legal reporting requirements?
   

11:00 am

Part III - What are the Absolute Basic Building Blocks to Get the Company Off the Ground?

1. •Building your company up: from founders in the lab to a functioning company
   

2. •The basic elements
   

3. •What is the necessary infrastructure?
   

4. •Staffing
   

5. •Going virtual
   

6. •The pros and cons of going virtual
   

7. •What can be in house or outsourced?
   

11:30 am

Part IV - Formulating Goals, Strategy, Plans

1. •Differences between leading discovery/laboratory, clinical and commercial organizations
   

2. •Driving plans and adapting to changing circumstances
   

3. •Attracting, retaining and inspiring the key people/Elements of a great team
   

4. •Mapping out and refining your work process – using process to make your plan work
   

5. •Thinking through your enabling technologies
   

6. •Managing your key enablers: BOD, SAB, Consultants, Regulators, VCs
   

7. •Executive skills: How to manage meetings, how to make presentations, persuasion, how to manage your time?
   

8. •What do you need to know to be an effective CEO?
   

9. •What can a good CFO do for you?
   

12:00 noon

Part V - What is the Money Game in the Biotech Start Up World and How it’s Played?

1. •How do you set up budgets?
   

2. •Planning your money
   

3. •What are the key financial measurement metrics you want to track?
   

4. •How understanding exits will drive your plan
   

5. •Financing a biotech at the angel stage, the initial VC stage, secondary financings and IPOs
   

2:00 pm

Part VI -  Strategy

1. •How do you devise a strategy?
   

2. •What are the mechanics of preparing for an inquisition? An advisory meeting?
   

3. •What are the key strategic targets: Target product profile, the eight dimensions of a partnerable product
   

4. •Hurdles: REGULATORY:
   

5. •What does it take to register a pharmaceutical product: US, EU, Japan, Asian Markets?
   

6. •When do you outsource a regulatory strategy?
   

7. •When do you bring regulatory strategy in-house?
   

8. •Strategies for the registration and commercialization of devices in the US, EU, Japan and ROW
   

2:30 pm

Part VII - Essential Enablers

1. •People: How do you structure and compensate your staff? What roles should be internal? External and why?
   

2. •Process: How do you organize your workflow, project management, tracking
   

3. •Technology: How do you use technology to be more productive and cost efficient? (Document management systems, databases, data analytic tools, project planning tools, time and financial management tools)
   

4. •When do you stay in charge and when do you pass the reins to someone else?
   

3:00 pm

Part VIII - Boards & Building Investor Base

1. •Boards of Directors: How to recruit and manage them? The evolution of BODs as the Company progresses.  Pitfalls and Opportunities
   

2. •How to build your investor base
   

3. •When should I start? What sort of shareholder’s do I want?  How do I target the right shareholders?
   

4. •Understanding the different types of investors and investment vehicles
   

5. •Methodically build image without hype
   

6. •Communicating to the investment community; the what, when, where and how
   

3:50 pm

Part IX - Exit Strategies

1. •What do you need to have to IPO?
   

2. •What does it take to be acquired?
   

3. •How to approach M&A Exit Strategies
   

4. •Strategies for Partnerships and Deals?
   

5. •Why do companies fail?
   

6. •What happens if the enterprise fails? Bankruptcy? Liquidation? Restructuring? Is there life after bankruptcy?
   

7. •How does success look?
   

8. •Tax and organizational structures to maximize retained value in successful enterprises
   

9. •Creating an enterprise in the US, EU, Japan, India, China: Similarities and Differences
   

4:35 pm

Part X - Adapting to Success: What the Challenges are and How to Overcome Them

1. •What are the things that make people fail?
   

2. •Rising regulatory burdens
   

3. •Increasing payor pressures
   

4. •What if the drug does not work?
   

5. •The rate of failure by therapeutic areas
   

6. •Understanding the macro environment and financial environment
   

7. •Where are the opportunities?
   

8. •Being the Outlier
   

5:00 pm

Program concludes

Audience intended for:

The workshop is designed for entrepreneurs and young biotechs. This workshop is primarily intended for people who have not been through the entire business cycle of building a biotech or would like an intense review to gain further insights. This workshop may also benefit investors and potential partners.

Workshop Leader

Christopher Gallen, MD, PhD
Executive Vice President, R&D and CMO
Zalicus Inc

Workshop Speakers

Solomon Babani, MBA
Vice President, Alliance Management
Celtic Therapeutics Development

Rhonda Chiger
Co-President
Rx Communications Group, LLC

Stephanie K. Marrus
Founder & CEO
Portfolio Strategies

Matthew S. Rossiter
Partner, Corporate and Intellectual Property Groups
Fenwick & West LLP

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