Conference Sessions

Session 301
Non-traditional Partnerships: The Changing BioPharma Alliance Landscape and the Implications for the Alliance Professional and Alliance Management Community

Speakers:
Stuart Kliman, CA-AM
Partner
Vantage Partners

Ben Siddall
Partner
Vantage Partners

The partnering landscape for biopharma firms is evolving to include a variety of non-traditional partners that collaborate for a set of purposes different from those of classical business development and licensing (BD&L) type alliances. These new kinds of alliances can create significant value, but this shifting landscape also brings with it a variety of challenges due to the very different business models and operating styles of biopharma and these new entrants. Biopharma companies need new company-wide alliance management capabilities and additional skills for alliance managers to be able to effectively manage the relationship and execute with these new partners.

To be successful in this changing landscape, it is important to understand how and why these alliances are different from more traditional partnerships and the implications of these differences—both on the structure, governance, and operations of these alliances and on the internal organizational structures that need to be in place to manage this new partner portfolio. In this session, the speakers will discuss the unique challenges faced in these partnerships as well as:

• What is takes to effectively navigate this changing alliance landscape and enter into new alliances with non-traditional partners
• The different types of alliance management capabilities that need to be in place internally
• The kinds of new and evolved skills needed for alliance managers

Session 302
Tech Start-Up Meets Pharma: Building a 'New Normal'

Speakers:
Craig McDonald
Director, Alliance Management
Otsuka America Pharmaceutical, Inc.

Tom Richards
Director, Alliance Management
Otsuka America Pharmaceutical, Inc.

As pharmaceutical companies look to expand their portfolios beyond traditional medicines, alliance management professionals are eager to help navigate the waters of new types of collaborations. This session will introduce participants to two real-world tech-pharma collaborations, presented by the alliance managers who stepped into this brave new world and emerged with a new appreciation for the opportunities afforded by this new space.

Attendees of this session will have the opportunity to ask questions and will walk away with:

• The important lessons learned during the development and management of these unique alliances, including insights, tips, and key areas of focus
• The confidence to use these opportunities to lay the groundwork for building a "new normal" within their own companies

Session 303
To Tango or Slow Dance: The Question in Companion Diagnostic Development

Speakers:
Ellen Locker
Executive Director, MRL Strategic Alliance
Merck & Co.

Trevor Page
Chief Business Officer, Companion Diagnostics
Agilent Technologies

Discovery and development collaborations between biopharma companies can be challenging, but the world of companion diagnostics increases complexity dramatically. Complexity increases further in the immune-oncology field where clinical development and regulatory approvals are accelerated and patient selection is critical to getting the drug to the right patient. Aside from cultural differences between biopharma and diagnostic companies, working together in close lockstep from development through registration and commercialization is a dance requiring agility and close coordination to not step on toes.

After the initial research collaboration, Merck and Dako (subsidiary of Agilent) executed a definitive development and commercialization agreement announced May 30, 2014 associated with PD-L1 IHC testing supporting Merck’s pembrolizumab program. Both parties underestimated the breadth of the diagnostic program and the clinical benefit of diagnostic testing for immuno-oncology therapy. Early clinical success confirmed the value of these treatments to the right patients. With clinical value came the need to massively expand diagnostic development, as well as adapt the collaboration model.

This session will focus on innovative approaches to alliance management and lessons learned in this fast-paced environment leading to critically important achievements for patient benefit. Key takeaways from this session include:

• How alliance management contributed to identification and creation of collaboration models to accommodate growth
• How solutions were developed, aligned, and deployed to stay in lockstep together
• Key lessons learned from this experience

Session 304
Taming the Octopus: Managing the Web of Clinical Collaborations

Speakers:
Jan Twombly, CSAP
President
The Rhythm of Business, Inc.

Judy Baselice
Director, Alliance Management
Pfizer Inc.

Ellen Locker
Executive Director, Alliance Management
Merck & Co.

Biopharma companies are engaging in multiple collaborations to create combination therapies. Sometimes, simple clinical supply agreements are all that are needed. Oftentimes, a single drug is partnered with multiple drugs from a number of companies and tested for numerous indications in a plethora of trials. This is resulting in a complex web of agreements, restrictions, obligations, and headaches for alliance managers.

To stay ahead of the curve, alliance managers are getting creative in contracting, governance, and operational management. As combinations are making their way through the regulatory/pricing/reimbursement maze, often forging new pathways, implications for the standalone drugs' regulatory and pricing strategies are causing alliance professionals to take a second look at potential business and legal risks.

This interactive panel discussion features research conducted by The Rhythm of Business, as well as practical insights from alliance professionals who are adapting and iterating "best practices" every day to realize value and manage the risks of the explosion of clinical collaborations. Join the conversation and help develop leading practices for:

• Scaling the management of the many contractual obligations and restrictions these collaborations present
• Surfacing the implications for global regulatory and market access strategies of the underlying standalone drugs
• Proactively identifying and acting on the emerging governance priorities and structures for combination clinical collaborations
• Building firewalls and other safeguards against intellectual property (IP) contamination or dilution

Session 305
Innovating an Alliance: Opportunities and Complexities in Facilitating a Restructure

Speakers:
Cathy Connelly, CA-AM
VP & Head of Alliance Management
Sanofi Genzyme

Vin Sharma
Senior Director & Head, Alliance Management
Alnylam Pharmaceuticals

Alliances often experience change during their lifecycles. When such changes are significant enough to one or both parties, it may be the right time to reevaluate the construct of the alliance. Such was the case between Sanofi Genzyme and Alnylam Pharmaceuticals. Based on some key program and organizational changes, a team worked together to understand and enhance the collaborative approach, an effort which ultimately culminated in an alliance restructure.

Alliance management is uniquely positioned to conduct reassessments of the current and potential future state, and to drive valuable change within and across organizations. This session will examine some key elements of the Sanofi Genzyme and Alnylam alliance restructuring from early 2018 and discuss effective practices, processes, and potential challenges, which may be applied to any alliance assessment and reformation.

This interactive session addresses the alliance manager's role in:

• Facilitating alliance assessments in the face of program and/or organizational changes in joint and company-specific goals, interests, and capabilities
• Ensuring that communications and processes enable rapid assessment and adaptation
• Implementing agreed changes with minimal disruption to ongoing, time-sensitive activities

Session 306
Grappling with 'Wicked Problems' in Alliance Management

Speaker:
Jeremy Ahouse, CSAP, PhD
Vice President Alliances
Merus

"Wicked problems" are difficult to address because of incomplete, contradictory, and changing requirements. They are often difficult to recognize. And they can be difficult to discuss. We struggle to share our experiences with difficult problems involving complexity, uncertainty and conflict, especially when we were not able to resolve the issues. Surfacing the hard problems can teach our community the most.

These challenges arise throughout the alliance lifecycle and range from structural problems that come from company size, details in the contract, competing roles, portfolio versus individual program, organizational culture, and the many different assumptions that companies make about process and role. Add the dynamics that bedevil us, including team churn, joint steering committee roles, and meeting and decision making behavior.

To the extent that we are better able to discuss difficulties (even failures) when stripped of identifying details, this session is based on a series of confidential interviews with senior leaders in alliance management who grapple with these problems and illustrate how seasoned alliance practitioners have approached them.

Bring your questions and be prepared to share your own reactions and suggestions. Leave with:

• A heightened awareness of what makes some challenges especially difficult
• A framework for thinking about wicked problems, how to engage them, and what resources you may need
• Specific next steps that you can try when facing your own wicked problems

Session 401
Essential Role of Alliance Management in Expanding an Existing Collaboration

Speakers:
Angela Bylancik, CA-AM
Executive Director, BD&L, Global Alliance Management
Novartis

Stacie Wild, PhD
Business Development Director, Alliance Management
Amgen

In 2015 Amgen and Novartis entered into a neuroscience collaboration covering migraine and Alzheimer’s disease. The first migraine product in development was a CGRP receptor antagonist for the preventive treatment of migraine in adults, Aimovig™. As the innovator, Amgen led the development. Initially Amgen had commercialization rights in the US, Canada, and Japan, and Novartis to commercialize in the European Union and the Rest of the World. The collaboration got off to a very swift start with the product in Phase 3 and filing expected less than two years later. Alliance governance launched quickly and both companies worked hard for a smoothly operating collaboration.

In 2016 the two companies decided to expand the collaboration to include co-commercialization of Aimovig in the US and to add Canada to the Novartis territory, which required an additional agreement. As alliance managers, the presenters were brought onto the negotiating team to provide operating principles guidance, governance design for the new collaboration (including links to the existing collaboration), and to ensure that the deal could be effectively operationalized.

Following the signing of the US agreement in 2017 the presenters are reflecting on the value of the alliance managers’ contributions. Join the session to hear their thoughts and learnings into the negotiation process and subsequent implementation based on their knowledge of key negotiated issues and agreement terms, not to mention their judgment on when and how to flex as necessary to resolve any differences that arise. Bring your experiences for input on:

• The role of alliance managers in deal negotiation
• Effective tools to structure the collaboration
• A year later, what has been learned

Session 402
Let's Make a Deal: Driving Better Contracts to Win in Clinical Genomics

Speakers:
Katherine Ellison, CA-AM
Associate Director, Alliances
Illumina, Inc.

Ragen Lester
Manager, Alliances
Illumina, Inc.

How involved should alliances be in negotiating and creating the contract with a new partner? Our business development colleagues may see alliances as an impediment to getting a speedy deal done, or perhaps an unnecessary input. However, the partnership's success depends on having all the right information when writing the contract.

The field of clinical genomics is a particularly dynamic space where the fortunes of companies can be won or lost on critical partnering decisions. Illumina, like many of its industry peers, increasingly relies upon partnering to meet key strategic goals in the dynamic field of clinical genomics. Yet partnerships do not always yield the desired results. Through company case studies, attendees of this session will uncover key areas where an alliance team can work collaboratively with business development throughout the deal negotiation process to identify and mitigate risks, provide greater transparency, inform better decisions, and ultimately drive increased partnership value.

Bring your own case studies to discuss with your peers to consider:

• Methods to transform working relationships
• Shared process models and governance structures to facilitate collaboration
• Fit-for-purpose tools that drive internal and external information sharing
• The merits of centralized and decentralized alliance and business development models

Session 403
When 1+1 = More than 2: Harnessing the Power of the Technical Expert

Speakers:
Soo Bang, CA-AM
VP Business, Strategy & Integration
Celgene

Jason M. Urban, PhD
Senior Director Business Strategy & Process Excellence
Celgene

The past several years have seen a flurry of deals across the biopharmaceutical space. Celgene alone launched more than fifty collaborations during the past five years. With the focus on providing the next breakthrough therapy for the patient, these deals require new, innovative approaches and technology platforms. With an eye towards the future, the complexity of the molecules mirrors the innovation. Early deals are particularly prone to the necessity of understanding the more scientific complexity and translating what this means to the long-term success of the partnership and delivery to the market.

With changes in approaches to biopharmaceutical portfolios and the rise of advanced manufacturing technologies, a new way in which to partner with our scientific experts is needed. This session will open a conversation around:

• Internal stakeholder management: building the relationships with technical experts
• Risk identification and mitigation in issues and escalation: learning the most from the vantage point of the scientific expert
• Collaborative approach: walking the line between the science and the business
• What an alliance professional can do to expedite technical collaborative relationships

Session 404
Why Alliance Management Is So Critical to Divestments

Speakers:
Emma Barton, PhD
Director, Alliance and Integration Management
AstraZeneca

Elena Cavalli, CSAP
Director, Alliance Management and Corporate Development
Astellas Pharma Europe

Rapidly changing external pressures in the pharmaceutical world makes business development one of the key activities that drives rapid change to the shape and composition of a company's portfolio. Businesses that are equipped with the capability to transact a diverse deal portfolio and that can deliver on those contractual obligations are ideally placed to maximize value for their organizations.

This presentation will take a practical look at the value that the alliance management professional can bring to post-deal divestment management. Particular focus will address the role of alliance management throughout the divestment management lifecycle and how some of the key challenges and risks might be mitigated in the post-deal environment. There will also be an opportunity to share your own experiences.

The main takeaways include:

• Understanding of how the alliance management professional can significantly impact the output of a divestment through a successful transitional period
• Practical steps to delivering a successful divestment transition
• The value to the alliance management professional by expanding experiences beyond traditional alliance management activities

Session 405
Due Diligence: Building Value into Strategic Partnerships

Speakers:
Brent Harvey, CA-AM
Director Alliance Management
Eli Lilly and Company

Kristi Huntington, CA-AM
Director Project Management
Eli Lilly and Company

Have you ever been asked to start up a strategic partnership that you first became aware of when the ink was barely dry? This interactive session will focus on how alliance professionals can get involved earlier in the deal flow and how they can influence the due diligence process to build value into strategic partnerships.

The session will include a presentation and interactive discussions where participants can engage in candid dialogue with subject matter experts and alliance professional colleagues, sharing solutions that are grounded in real alliance-based experiences.

Bring your questions and experiences to the session. Gain practical insights on principles for:

• Incorporating a partnering tone into due diligence
• Engaging alliance management early in the process
• Adding value during the pre-deal to contracting stages

Session 406
The Part-time Alliance Manager: Creating Collaboration Capability

Moderator:
Brenda Schultz, CSAP
President and Principal Advisor
Strategic Partners, LLC

Panelists:
Frederic Bonfils, CSAP
Vice President, Corporate Alliance Management
Pierre Fabre

Lynnelle Pittet, CA-AM, PhD
Director, Alliance and Program Management
WAVE Life Sciences

Petra Sansom, CA-AM, PhD
Senior Director, Alliance Management
Vertex

What are your experiences working with part-time alliance managers? Wonderful, or not so great? This panel discussion takes attendees on a journey of panelists’ experiences working with alliance managers who are thrust into their new roles. The panel will share strategic insights and practical information on how to support part-time alliance managers in their role transition, including advocacy, emotional quotient, training on core roles/responsibilities, mentoring, etc. This session will discuss candid solutions and resources that are grounded in real alliance experiences.

Bring questions and be prepared to share your own experiences while listening and interacting with the panelists during this session intended to provide plentiful takeaways:

• Identify and manage unique challenges when working with part-time alliance managers that, if not addressed, may slow or halt a partnership’s progress
• Gain insight into strategies and practices that support the success of part-time alliance managers and ultimately the partnership
• Understand aspects of partnering with part-time alliance managers in the dynamic environments of start-ups, midsize to large pharma companies, and biotechs

Session 501
Harnessing Alliance Inflection Points (and Associated Conflict)

Speakers:
Gary Butkus, CA-AM
Director of Alliance Management
Eli Lilly and Company

Lena Frank, CSAP
Exec. Director Alliance & Program Management
Eisai Inc.

Kevin Little, CSAP, PhD
Senior Partnership Director
Novo Nordisk

Conflict, when managed appropriately, can be an advantage in alliances. During the 2017 ASAP BioPharma Conference, a workshop explored how to recognize conflict in alliance management. The participants identified trigger points or events in the biopharmaceutical partnering lifecycle that most commonly brings unproductive conflict and recorded the discussions in a workbook. In this 2018 BioPharma follow-on workshop, results and analysis will be shared and then participants will have the opportunity to take a deeper dive into the most crucial trigger points. Through guided roundtable discussions, participants will engage with practitioners to discuss scenarios that have worked to prevent these trigger points from being unproductive or counter-productive. Learn how to anticipate key conflict events, understand better the underlying issues represented that may have adverse impacts, and identify the tools for optimization.

This interactive workshop will include review of the key data from the 2017 "Conflict as an Advantage" workshop. In Roundtable discussions assess each of the following trigger (pain) points common to biopharmaceutical alliances:

• Generating and protecting IP (discovery, non-clinical, biomarker, clinical studies, associated publications)
• Getting to market/commercialization (regulatory submissions, pricing and reimbursement, marketing, sales, life cycle management)
• Manufacturing/supply (formulation work, scale up, technical transfer, contract manufacturing (CMO) strategy, commercial forecasting)

This group work will continue to inform the toolkit development to manage conflict and to harness added value from critical inflection points in the alliance lifecycle.

Session 502
Building Alliance Lifecycle Value: Overlapping Business Development and Alliance Management Best Practices

Speaker:
Anthony Hoerning, CSAP
Founder
Strategic Transactions Advisory AG

Published earlier this year under an initiative of the Swiss Healthcare Licensing Group (SHLG), the Good Partnering Practices (GPPs) are a new instrument in the business development and alliance management toolbox. How do alliance management leaders envision the use and impact of GPPs for their organizations? Are there business model or cultural differences? How will the trend for non-traditional partnerships fit? What's your organization's approach?

Join in an interactive workshop to discuss collaboration among business development and alliance management as well as other partnering-related functions. This output oriented session will be led and hosted by senior alliance management executives who will engage the participants in a lively, active discussion format. It is highly recommended and valuable that attendees familiarize themselves with the GPPs (click here to download) prior to participating.

In this workshop, explore:

• What are the collaboration models in your organization, and how can you leverage the GPPs in your company and in your environment?
• How can you use the new tool to integrate an "implementation matters" alliance mindset with colleagues taking a role in business development?
• With the advent of more non-traditional partnerships and business models, what is the use of GPPs?
• What further externalization steps would be useful for the widespread adoption of GPPs?