Within the biopharmaceutical industry there is a growing emphasis on alliances and collaboration with external organizations driven by the need to access innovation and leverage strategic partnerships to gain market access. Yet, despite the impetus to forge strategic partnerships, stakeholders are often confronted with the increasing complexities of systematically and effectively managing partnerships throughout their lifecycle. What practical solutions exist to overcome innate partnership challenges while effectively executing an Alliance Management (AM) function? How do partnering companies create shared culture, develop trust, and alleviate perturbations? How can organizations develop a robust and durable AM capability to continuously create and drive value? The ever-evolving discipline of alliance management meets these challenges, and has become a critical component for the success of biopharma partnerships.

Cambridge Healthtech Institute’s 13th Annual Strategic Alliance Management Congress, May 16-18, brings together senior alliance management, business development, technology transfer and licensing professionals, to network, share experiences, discuss case studies, and to share the components that cultivate successful partnerships. Delegates will gain strategic insights, proven tools, methods, and perspectives from a variety of leaders advancing the art of alliance management.

Final Agenda

Day 1: Monday, May 16, 2016

12:00 pm Conference Registration

1:25 Chairperson’s Opening Remarks and Welcome

Kip Harry, Director, Conferences, Cambridge Healthtech Institute

BUILDING TRUE ALLIANCE CAPABILITY –
WHAT IS IT REALLY WORTH?

2:15 Alliance Capability – How to Develop a Corporate Capability and Explore the Upsides for the Organization

Michael Kennedy, Ph.D., MBA, Director, Alliance Management, Business Development & Licensing, Bayer HealthCare

Developing a true alliance capability takes time and goes through many stages, from establishing the role of alliance management through delivering a function-level capability to realizing a true corporate capability. A collaboration-savvy organization has upsides – empowered teams, increased capability to problem solve, ability to innovate and manage organizational change.

2:45 Networking Refreshment Break with Exhibit Viewing

PARTNERS OF CHOICE: A LOOK INTO ALLIANCE MANAGEMENT AT GSK, SANOFI, PFIZER, AND CELGENE

3:25 Chairperson’s Remarks

Kip Harry, Director, Conferences, Cambridge Healthtech Institute

3:30 Insights into Alliance Management at GSK

Steven L. Pessagno, Alliance Director and Head of CoE Operations, Alliance Management, Worldwide Business Development, GlaxoSmithKline

Across the life sciences industry we spend billions each year on collaborations of all sizes and shapes with the hope that by working together we will deliver more innovative medicines, devices, and diagnostics for patients, and in turn, generate greater value for our shareholders. We all have our own stories to tell on these collaborations and our approaches to working with alliance partners. The GSK approach may be unique. We focus on the evolution of alliance management to address the needs of the diverse types of collaborations we enter into.

4:00 Co-Presentation and Case Study: The Sanofi – Evotec Strategic Partnership

Dominique Sonneville, Alliance Manager, R&D, Sanofi

David Hallett, Ph.D., Executive Vice President & Global Head, Alliance Management, Evotec

4:30 Co-Presentation and Case Study: Avelumab: Combining to Win

Dana Hughes, Vice President & Global Head, Integration and Alliance Management, Worldwide Business Development Group, Pfizer

Harm-Jan Borgeld, Head, Alliance Management, Merck KGaA  

At Pfizer, we strongly differentiate between the alliance function, a very small core of professionals at the center, and alliance capability, which we aim to strengthen at multiple levels throughout the company. Our priority is to build on the existing alliance capability within our businesses, while maintaining a highly leveraged corporate alliance team to ensure success of our most important deals. Pfizer BD sees this balance as critical to the success of our deals, a match to expectations in our potential partner set and an appropriate match to Pfizer’s strengths.

5:45 Welcome Reception with Exhibit Viewing (Sponsorship Opportunity Available)

7:00 Close of Day

Day 2: Tuesday, May 17, 2016

8:00 Interactive Breakout Discussion Groups and Speed Networking

Grab a cup of coffee and delve deeper into some of the overarching concerns facing alliances today. These are moderated roundtables with brainstorming and interactive problem solving, allowing conference participants from diverse backgrounds to have frank discussion while exchanging ideas, experiences, and developing future collaborations around a focused topic.

Table 1: Alliance Management at the Forefront of Deal Making

One of the principal roles of an alliance manager is to manage the collaboration based on an agreed upon contract. Ahead of the contract signing, during the negotiation process, alliance managers are in a unique position to provide input based on the management of past deals. This group will explore ways in which Alliance Management can get involved earlier in the deal making process, transferring the knowledge and experience of managing other partnerships.

• At what point should Alliance Management get involved in the deal making process?
• What contributions can an alliance manager make to the negotiation process?
• How would a partner perceive Alliance Management at the table? What message would that deliver about your company's approach to partnership?
• What steps are required to gain alignment in your own organization about the role of Alliance Management in the deal making process?

Table 2: Alliance Launch

Organizations commit significant resources to alliance deals that are central components of the organization’s long term strategy. Too often, however, such deals get “thrown over the fence” from those who identify the asset, to those responsible for negotiating and closing the deal, to those finally responsible for managing the working relationship with the partner organization. This group will explore some of the challenges and some best practices for launching an alliance for success.

• How, if at all, does your organization employ a systematic approach to launch alliances?
• What are the initial challenges, necessities and opportunities during an alliance launch?

Table 3: Alliance Management & Project Management – Managing the Divide

Alliance Management (AM) and Project/Program Management (PM) can be similar enough that many companies struggle to manage the divide between the functions, or debate if the two functions need to be separate. This roundtable will tackle the issues of whether alliance management and project management should be treated separately or as a combined function, including the following topics:

• Benefits of separate functions versus single function
• Assigning roles and responsibilities
• Ensuring responsibilities of both functions are managed adequately

Table 4: Introducing Alliance Management to a Growing Biotech Company

A larger percentage of alliance deals in the life sciences space involve a Big Pharma – Biotech partnership. This group will discuss the key aspects to consider before introducing alliance management to biotech companies.

• What types of alliances should innovative enterprises form?
• Which alliance management skills and tools do companies need to possess?
• How can organizations develop a culture of open innovation?
• What are the ways to create value and share it among stakeholders involved?
• How do you get CEO & senior management engagement?
• What questions should senior management ask as they implement policies, processes, and SOPs that will apply to (and possibly conflict with) partners

Table 5: A Review of Best Practices for Collaborations between Pharmaceutical Companies and Companion Diagnostic Providers

At some point most pharmaceutical companies look for a diagnostic partner. This group will discuss issues surrounding selecting a partner and avoiding challenges in managing these types of partnerships.

• What factors do you consider in selection of a companion diagnostics partner?
• What are the key milestones and associated decision points moving forward in diagnostic development?
• Is your CoDx agreement implemented in stages, i.e., first for IDE, then for validation, then for assay development and finally for PMA? Or are all facets of the process implemented together?
• How long does it take to complete an agreement with a CoDx partner?
• Is it a fee for service, pay as you go or broader alliance?

THE BIGGER PICTURE: THE ALLIANCE LIFECYCLE – MANAGING TRANSITION, CHANGE AND TERMINATION

9:25 Chairperson’s Remarks

Mark Coflin, Senior Director, Alliance Management, Global Business Development & Licensing, Baxalta

9:30 Co-Presentation: Transitioning from Licensing to Alliance

MaryAnne McCarthy, Executive Director, Alliance Management, Incyte Corporation

Jennifer Gallagher, Director, Global Strategic Alliances, Oncology, Novartis Pharmaceuticals Corporation

These innovative partners will provide an overview of how to streamline the transition from the licensing deal to interacting as a high-performing alliance team. The discussion will highlight key activities during the due diligence and deal negotiation, kickoff best practices, and the identification of joint objectives for a 120-day plan in order to successfully create a long-term alliance strategy. They will highlight challenges and how they can be managed utilizing the alliance strategy. They will also touch upon the value of alliance surveys and making adjustments on the fly.

10:00 Case Study: Central Components for the Successful Restructuring and Transition of a Collaboration

Lena Frank, Executive Director, Program and Alliance Management, Eisai

How many of you have, or expect to face a major restructuring of an alliance? The following presentation will take a look at a recent restructuring of an alliance and transition of the activities from one party to the other. In this presentation, the activities that took place prior to the change to enable a much smoother transition and how well this planning worked when the transition was executed will be discussed. What worked, what did not and what surprised the participants will also be presented.

10:30 Networking Coffee Break with Exhibit Viewing

11:15 Co-Presentation and Case Study: Importance of Alliance Joint-Team Membership Longevity

Dana M. Hammill, Director, Business Development and Alliances, Center for Cellular Immunotherapies, University of Pennsylvania

Simon Bateman, Ph.D., Executive Director, Global Strategic Alliance Management, Novartis Oncology

During the pre-launch and launch phases of an alliance, the key team players come together and learn how to best work together for mutual achievement of goals. Charters and joint team meetings are established, as well as best practices for meeting execution and communication. As months and years go by, programs, projects, and individuals come and go. This presentation will discuss examples of alliance turnover, how turnover can positively or negatively impact an alliance, and measures that can be taken to ensure that turnover has little impact on the alliance relationships, goals, and achievements.

11:45 Preserving Value and Relationship at the End of the Alliance Lifecycle

Mark Coflin, Senior Director, Alliance Management, Global Business Development & Licensing, Baxalta

All alliances have a lifecycle of key events and activities which can shape the future in many ways. Sometimes, an Alliance Leader may be faced with the end or termination of a partner collaboration, planned or unplanned. This presentation will share the Do’s & Don’ts of Alliance best practices when termination or product transition is likely to occur: how to plan, communicate and successfully manage the end of the lifecycle while preserving the value and relationship.

12:15 pm Luncheon Workshop: Why and How to Enhance Strategic Collaboration between Sponsors and CROs - Podcast Preview Available! Listen Now

Jonathan Hughes, Partner, Outsourcing & Supply Chain Management Practice Leader, Vantage Partners

Alliances and strategic partnerships (between large pharma companies, small bio-techs, and academic institutions) are increasingly pervasive. But what about alliances between bio-pharma companies and CROs? Are true partnerships with CROs (and other suppliers) really possible? What are the risks and benefits of moving beyond a traditional customer-vendor paradigm? In this interactive luncheon workshop, we will explore these and other issues using a number of case studies, and will also discuss how to adapt best practices for strategic outsourcing from other industries to the clinical development context.

AN ALLIANCE MANAGER’S TOOLBOX: ENSURING HEALTHY PARTNERSHIPS

1:25 Chairperson’s Remarks

Colette Goderstad, Program Director, Alliances, Integrations, and Divestitures, Medtronic Neuromodulation

1:30 Co-Presentation: Survey Results: Internal Perceptions, External Realities

Michael Sumpter, Head, Alliance Management, Business Development & Licensing, SERVIER

Catherine Rochat, Head, Alliance Management, Research & Development, Institut de Recherches Internationales Servier (IRIS)

We present the results of a very recent survey, performed by Servier internally and externally with its partners. We discuss methodology (hypothesis basis), results and lessons learned for the benefit of the alliances.

2:15 Case Study: Expected and Unexpected Benefits of an Alliance Health Check

Brandon Drew, Senior Director, Bone Patient Value Unit, UCB

Steven G. Rossi, Director, Alliance Management, Amgen

We took an established partnership through its first Alliance Health Check 12 years into the partnership. Conducted jointly by the newly assigned Alliance Management team members, the process highlighted specific areas that needed attention within the Alliance, but also established the platform for ongoing improvement in the relationship between the teams. A comprehensive action plan was put in place and executed by Alliance Management and Project Management on both teams.

2:45 Using Alliance Management Tools to Ensure a Successful Integration

Colette Goderstad, Program Director, Alliances, Integrations, and Divestitures, Medtronic Neuromodulation

Successful alliances and successful integrations lead to greater revenues and lower costs, but the majority of both fail to meet expectations. In both cases, the primary reason is not related to strategy, but is related to human elements: communication, decision making, and culture. Many of the processes and tools used to ensure a successful alliance can also be used to ensure a successful integration. Attendees will gain insight into:

• The reasons why alliances and integrations fail
• The processes used for creating alliances and completing integrations
• The role of Alliance Management in alliances and integrations
• How to use Alliance Management tools to ensure a successful integration
• Key learnings for creating successful alliances and integrations

3:15 Networking Refreshment Break with Exhibit Viewing

Integration and Divestment Management: Emerging Roles for Alliance Managers

3:45 Going with the Feeding Frenzy: Alliance Management from Both Sides of the Mergers and Acquisitions Boom

Harry Atkins, Senior Director, Global Corporate Development, Proprietary Products, Dr. Reddy’s Laboratories, Inc.

When a small biotech or pharma company receives an offer to be acquired or merged into another company, Alliance Management at that company can step up and make its mark in the response. How should Alliance Management respond? What information will be required? Conversely, on the side as the larger acquirer, what does Alliance Management need to know and what questions should be asked to be sure that the target is the right fit? How can Alliance Management play a key role in the post-merger integration?

4:15 Case Study: Shire’s Journey and Approach to Alliance Management

Prashant Rao, Director, Alliance Management and Project Operations, Shire Pharmaceuticals

This presentation will highlight Shire’s journey in establishing its Alliance Management Center of Excellence to support discovery, development and commercial partnerships and a network of globally dispersed Alliance Managers with diverse backgrounds and varied exposure to alliances.

5:30 Close of Day

Day 3: Wednesday, May 18, 2016

8:00 am Morning Coffee

LOADING THE DISCOVERY PIPELINE: APPROACHES FOR MANAGING EARLY, INNOVATION-DRIVEN PARTNERSHIPS

8:25 Chairperson’s Opening Remarks

Dana M. Hammill, Director, Business Development and Alliances, Center for Cellular Immunotherapies, University of Pennsylvania

8:30 Co-Presentation and Case Study: Avoiding the Pain - Best Practices from the Bayer-Evotec Strategic Endometriosis Alliance

Christoph Huwe, Ph.D., Alliance Manager, External Innovation Therapeutics & Global External Innovation & Alliances, Global Drug Discovery, Bayer Pharma AG

Steve Courtney, Ph.D., Senior Vice President, Drug Discovery & Chemistry Operations, Evotec

In October 2012, Bayer Pharmaceuticals and Evotec entered into a five-year multi-target strategic alliance with the goal of identifying three clinical candidates for the treatment of endometriosis. Bayer and Evotec share the responsibility for early research and preclinical characterization of potential clinical candidates, while Bayer is responsible for clinical development and commercialization. To date, three preclinical candidates have already been delivered. In this presentation, we will highlight the long-term vision of the alliance, focus on the alliance execution and outcome, discuss challenges and issue resolution approaches, and illustrate the transfer of the alliance model to new areas.

9:15 CRT-DL’s Themed Oncology Alliances: Shortening the Path to Patient Benefit

Tim Hammonds, Ph.D., Deputy Director of Discovery, Discovery Laboratory, Cancer Research Technology Discovery Laboratories

At CRT-DL we bring together the best minds in basic and clinical cancer research. We combine the rigor and drive of pharmaceutical and biotech companies, key academic knowhow and our in-house drug discovery and alliance management capabilities to deliver breakthrough medicines for cancer patients. In recent years, we have established and run early discovery pipeline alliances involving multiple PIs with AstraZeneca, Teva Pharmaceuticals and FORMA Therapeutics. This talk will describe this unique model and the collaborative opportunities it brings to academia and industry alike.

9:45 Networking Coffee Break with Exhibit Viewing

NEW MODELS FOR NON-PROFIT- AND ACADEMIC-INDUSTRY COLLABORATIONS

10:30 Standardized Identity Trust: Key Security Component In Managing Drug Development Collaborations

Mollie Shields Uehling, President and CEO, SAFE-BioPharma Association

Globalization and digitization of the drug development process relies on the Web to share information and raises issues specific to managing diverse partnerships. It's a matter of time before patient and other data is hacked, exposing the process to HIPAA violations and important scientific intellectual property to competitors. This presentation will provide an overview of cyber security issues associated with Web-enabled collaboration and the importance of standardized identity trust in addressing those issues. I will include discussion of ongoing successful alliances (e.g. within Merck, GSK and Pfizer) and how their use of standardized identity trust allows the secure free flow of information across firewalls among collaborating parties.

11:00 Alternative Ways of Working with Academics

Christine Jost, Ph.D., Director, Alliance Management, R&D Strategy and External Innovation, Sanofi

Sanofi has embarked on a new collaborative program, the Sanofi iAwards. This collaboration involves seven academic partners. The goal is to increase connectivity with academics and bring more innovation to pharma. Attendees will learn more about the Sanofi iAwards and the lessons learned from managing a large multi-party academic alliance.

11:30 Interim Results of a New Model for Academic-Biotech Collaboration

Jake Reder, Ph.D., CEO, Celdara Medical, LLC

For the last seven years we’ve been executing on a new model for the identification and development of therapeutic innovation. The model is highly collaborative, including key roles for the inventor, the preclinical development specialist, and often - either early or at the clinic - large pharma or biotech companies. We have codified “open innovation” practices into the foundation of our business model, and the results have been encouraging.

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

IMPROVING SERVICE- AND SUPPLY-BASED PARTNERSHIPS

1:25 Chairperson’s Remarks

Kip Harry, Director, Conferences, Cambridge Healthtech Institute

1:30 You Can Take a Horse to Water but You Can’t Make It Drink: Using the Alliance Management Capability and Principles in an Early Clinical Development Clinical Outsourcing Environment

Charles O’Donnell, Director, Alliance Management; Director, Early Clinical Development, AstraZeneca

AstraZeneca Early Clinical Development (ECD) has a desire to leverage as much value from its interactions with CRO partners as possible. To do this, the ECD has undertaken the building and application of the Alliance Management capability and principles to clinical outsourcing. This presentation will describe examples of tactics used to achieve this, to what degree they have been successful and reflections on how to do it better next time.

2:00 Enabling Innovation and Value Creation in Sponsor/CRO Collaborations

Andrew S. Eibling, CSAP, Vice President, Alliance Management, Covance, Inc.

2:30 Alliance Management Partnerships that Create Value in the Healthcare Continuum

Colette Goderstad, Program Director, Alliances, Integrations, and Divestitures, Medtronic Neuromodulation

Medical devices and healthcare systems are undergoing a sea change given the world’s aging population, limited government and private pay resources, and increased scrutiny from insurance companies. This presentation addresses the opportunity medical devices and the healthcare system present if partnerships are carefully selected and well managed. The challenge is to promote wellness and support patients as they move through the healthcare continuum using the best technologies and therapies that can be identified and developed in an alliance environment.

3:00 Close of Conference