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How Contract White Space Becomes the Gray Area of a Deal (Part Three)

Posted By Genevieve Fraser, Tuesday, October 31, 2017
Updated: Saturday, October 28, 2017

Panelists were discussing the very different worlds of deal making vs. alliance management when ASAP Media left off in Part Two of our coverage of “Reading Between the Lines: Living in Contract White Space” explored the “gray area” between contract signing and actual implementation on day two of the 2017 ASAP BioPharma Conference September 13-15 in Cambridge, Mass. USA. The presenters were Christine Carberry, CSAP, chief operating officer at Keryx Biopharmaceuticals, Andy Eibling, CSAP, vice president of alliance management at Covance, the drug development business of LabCorp, and Brian O'Shaughnessy, a partner at Dinsmore & Shohl and president and chair of the board of LES, the Licensing Executives Society (USA and Canada), which focuses on licensing and commercial transactions involving intellectual property (IP) rights. Now the panel is discussing the handoff from deal to alliance management implementation of the partnership.

 

How does effective handoff happen?

  •  Knowledge transfer.
  •  Art meets science.
  •  The deal leader needs to have significant EI, emotional intelligence.
  •  Sometimes working through difficulty can be bonding.
  •  You don’t want everybody involved in every step, but you need an effective handoff. Bring in the alliance early on and as things wrap up, so the knowledge transfer occurs. Make a note of potential problem areas.

O'Shaughnessy: “There are problems with getting a person to read the contract. He tells me ‘he trusts me,’ but this is HIS business. He needs to bear down and read the terms. Too often a client signs off on details but has never read the contract. That’s when you need to document the visits and confirm the statements he made. Granted, this is difficult to do diplomatically. Frankly, if the boss isn’t going to read the contract, the boss isn’t going to read the contract.”

 

Carberry: “The executive sponsor, whoever that person is, needs to take ownership of it. What will this mean in a year’s portfolio? Is this a big deal or small? If this is a primary revenue driver, you will pay greater attention.”

 

“In terms of anticipating problems, a lot has to do with how you get started. Building a relationship in the beginning is helpful when things get contentious. Everyone should state what they consider to be successful and what concerns them, so everyone has an understanding. Whatever the ‘noise is in your head,’ get it out on the table. Think about having everyone come up with an evaluation of the project, then share it. In the end, the value may be the same, but they used totally different assumptions to get there. Also, set up an easy achievement to drive momentum.”

 

“Remember, people who created the deal are not the ones who implement it. It’s important to reset it with the people involved with the process. You need to get the teams together to discuss process and reinterpret the contract based on what each believes is the deal.”

 

O'Shaughnessy: “The third phase is when the respective implementers and deal makers get together to see if there are fundamental differences. Deal maker drafters will hear the implementers out. Feedback is critical. Don’t drag the last contract out as a basis to begin; instead, examine hot buttons. Sometimes you discover ‘the last time we did this we got burned,’ so seek to avoid it again.”

 

Takeaways:

  •  Success means: parties up-front agree on a set of values.
  • Nothing was agreed to ‘til everything was agreed.
  • Look at everything in development, then made sure it sticks—is held together.
  •  Put details into a ledger.
  •  Teams work through areas as they come up and acknowledge that processes happen within companies so they can move on with negotiated details working in parallel.
  •  Autonomy is a good thing. If lawyers create a massive structure, the results may be too bureaucratic. Flexibility is needed to reflect variables that crop up.

How can we apply previous experiences to future deal negotiations?

According to the audience, there’s a need for “common learning,” sharing it back. You need to discuss what could have been done differently and, in the end, retain some collective understanding, such as capturing what is of value and problem areas.

Tags:  ”First patient  alliance management  alliances  Andy Eibling  Brian O'Shaughnessy  change agent  Christine Carberry  compromise  contract  Covance  Dinsmore & Shohl  due diligence  emotional intelligence  first visit”  governance  Implementation  Keryx Biopharmaceuticals  Licensing Executives Society 

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How Contract White Space Becomes the Gray Area of a Deal (Part Two)

Posted By Genevieve Fraser, Monday, October 30, 2017
Updated: Saturday, October 28, 2017

This picks up where ASAP Media left off in Part One of our coverage of “Reading Between the Lines: Living in Contract White Space” explored the “gray area” between contract signing and actual implementation on day two of the 2017 ASAP BioPharma Conference September 13-15 in Cambridge, Mass. USA. The presenters were Christine Carberry, CSAP, chief operating officer at Keryx Biopharmaceuticals, Andy Eibling, CSAP, vice president of alliance management at Covance, the drug development business of LabCorp, and Brian O'Shaughnessy, a partner at Dinsmore & Shohl and president and chair of the board of LES, the Licensing Executives Society (USA and Canada), which focuses on licensing and commercial transactions involving intellectual property (IP) rights.

All presenters agreed that in general no one talks about when things go wrong. People focus on success. But change agents happen. People need to think more about likely situations that arise, about what can change. According to Carberry, biopharma negotiations offer special problems when teams spend 80 percent on work related issues and 20 percent on the exit. The exit can be what’s tricky.

“How should you run an alliance?” Eibling asked, shifting the focus of the discussion. “There’s a boilerplate we’d like to follow vs. figuring out what happens when everything blows up. Think of audit provisions; once you pull the trigger, everyone shifts into distrust mode.”

He reminded them that governments impose transparency and accounting, a carefully defined system of disclosures so the process is established. But it’s your responsibility to address issues early on, before they become an issue. 

“Trust is everything in an alliance. Trust is key,” Eibling stated. “Some think controls run in the face of trust, but it’s the opposite. The process helps establish trust building. If you have trust, you can more easily get to benchmarks. My motto is ‘no deal without a meal.’ Sit down over lunch with your counterpart to build trust.”

 

Shifting focus once again, Eibling questioned what’s missing from agreements. “External communications need to be on-going. ‘What’s material and what’s missing’ is what’s needed when everything blows up. The question is, what can be done during the deal making process to improve success?”

O'Shaughnessy: “Licensing is a full contact sport and needs the full team—lawyers, tax experts, scientists, business folks. Speaking from a LES prospective, they don’t appreciate the growing field of alliance management, so there’s not an effort to bring alliance into the deal process. They need to understand that an alliance team can analyze the details to see problem areas.”

“I had no idea what went on after the deal was signed.”

“Too often, LES views alliance management as a hindrance, as the folks who throw up roadblocks. Alliance management needs to stay in the background and define simple defining principles: This is how we work—from cultural differences to operating principles. When in the grey space, the alliance team will make it work, will look to principles to get through the grey area.”

Eibling: The alliance will shepherd the process, but the alliance needs to remain in the background and let others negotiate. The alliance folks tell them to finish the deal and then we’ll focus on governance, commitments etc. Meanwhile, they need to remain vigilant to see what was contentious, to remain alert to problem areas.

This interaction continues in Part Three of ASAP Media’s coverage of the 2017 ASAP BioPharma Conference session, Reading between the Lines: Living in Contract White Space.”

Tags:  ”First patient  alliance management  alliances  Andy Eibling  Brian O'Shaughnessy  change agent  Christine Carberry  compromise  contract  Covance  Dinsmore & Shohl  due diligence  first visit”  governance  Implementation  Keryx Biopharmaceuticals  Licensing Executives Society 

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How Contract White Space Becomes the Gray Area of a Deal (Part One)

Posted By Genevieve Fraser, Friday, October 27, 2017
Updated: Thursday, October 26, 2017

There’s a place—a twilight zone— that exists between the high “expectations of a deal well struck and the hard reality of implementation. “Reading Between the Lines: Living in Contract White Space” explored that “gray area” on day two of the 2017 ASAP BioPharma Conference September 13-15 in Cambridge, Mass. USA. The presenters were Christine Carberry, CSAP, chief operating officer at Keryx Biopharmaceuticals, Andy Eibling, CSAP, vice president of alliance management at Covance, the drug development business of LabCorp, and Brian O'Shaughnessy, a partner at Dinsmore & Shohl and president and chair of the board of LES, the Licensing Executives Society (USA and Canada), which focuses on licensing and commercial transactions involving intellectual property (IP) rights.

O'Shaughnessy cut right to the chase. “Typically, the problem is that people negotiating the deal are talking the same lingo. You need to look at common deal terms that cause collaborations to falter. Too often short shrift is given to definitions, to defining terms. Spelling out definitions doesn’t seem important because you and the others know what you mean. But contracts need to be written so non-experts understand. Spend time writing definitions in plain, simple terms. For example, technology patent and patent applications are two different things.”

 

“Three months from the signing of the contract, you will not be living in the world you had envisioned,” Christine Carberry added. “When you are caught up in the excitement of creating the deal, it’s natural to avoid looking at inherent risks. The likelihood is that X drug may not move to blockbuster status. Then, how do you navigate? How do you avoid having the reality of the situation, the reality you must deal with, keep from pulling people apart?”

 

“There areas often missing that are not even gray space—with nothing there to give guidance,” Andy Eibling began, throwing it out to the audience. “Name some areas in a contract that cause issues. What are your pet peeves?” Responses included:

  • Milestones based on study initiation (When does a study really start?)
  • “First patient, first visit” doesn’t mean what most thinks it means.
  • Every single compromise is going to come back—because the people who work on the contract were not part of the compromise.
  • Implementation time is not realistic. The contract states six months, but WE KNOW it takes nine months.
  • There are definitions within definitions. Check to see if the contract is still in alignment.
  • Due diligence—Best efforts—Clear process is needed for dispute resolution. The idea that you will just specify “arbitration” doesn’t cut it. You need to set up a process.

 Carberry rattled off a few scenarios: You couldn’t come to agreement, so you punted. Even worse, you know going into a contract, tension exists, so you opt not to deal with it. And, it’s contentious because you know it’s likely to happen!

 

“You can come up with complicated solutions that sound great—but how to execute it is the issue. It’s important that alliance people are brought in early to assist with ironing out conflicts,” she emphasized.

 

Let LES, the Licensing Executives Society draft the front end and the company draft how it will work, O'Shaughnessy suggested. “How do we prevent this and that from becoming a problem—such as scheduling meetings? And there’s always a risk of shifting provisions. Business people like to say, ‘that’s all legal stuff. Let the lawyers figure it out.’ But what they figure out might not align with the business model. If I absorb more risk, I need more attention.”

Tags:  ”First patient  alliance management  alliances  Andy Eibling  Brian O'Shaughnessy  Christine Carberry  compromise  contract  Covance  Dinsmore & Shohl  due diligence  first visit”  Implementation  Keryx Biopharmaceuticals  Licensing Executives Society 

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Competencies versus Characteristics in Driving Partner Performance

Posted By Genevieve Fraser, Monday, March 20, 2017
Updated: Friday, March 17, 2017

The use of competencies as a hiring tool has evolved into a gold standard for many professions, including alliance management.  But can competencies as a stand-alone tool effectively identify those who will be successful in the role? 
 

The question was front and center at the sessionTraits and Attributes of Successful Alliance Managers” as Andy Eibling, CSAP, vice president of alliance management at Covance, and Kerri Lampard, CSAP, director of the global services center of excellence in the global partner organization at Cisco Systems, reviewed how and why competencies alone should not be used to hire alliance managers. The session was part of theDriving Partner Performance” offerings at the 2017 ASAP Global Alliance Summit “Profit, Innovation, and Value for the Partnering Enterprise,” which took place at the San Diego Marriott Mission Valley, San Diego, California. 
 

“So, how do you locate, develop, and hire alliance managers? Why do some excel and others struggle? What are the traits that help people to succeed?” Lampard asked as she posed a string of key questions at the opening of the session.

 

Lampard’s overall answer? Competencies can be taught, she explained. However, characteristics are more locked in. Companies need to align the candidate with the organization and look at overarching characteristics, she said. “For, example, Big Pharma can be change adverse. There’s a natural trepidation built into the culture due to the length of time it takes between the inception of a project, the roll out, and the cost.”

Andy Eibling focused on traits that help people succeed such as vision - the ability to see the big picture possibilities. “When a person has vision, they have the natural curiosity and desire to learn and balance change, to decide the appropriate time and place to take risk, to pivot and think about where they're going.  Their role is to strategize and then get people to buy in.”

Advocacy is also important, Eibling stated. “It’s important for an alliance manager to be able to see both sides and understand why someone is acting the way they do.  Folks who can step back and fit into someone else's shoes, advocate for them and articulate issues, can take conflict and make it productive. They move the process forward.”

“One of the most important characteristics is the ability to engender trust,” he added. “Employ the Vegas rules. What is said in a conversation stays in the conversation. The ability to engender trust is crucial. People within an organization and partners need to know they can have a candid conversation before it becomes a big issue,” he also noted. “It’s important to understand, as [Henry] Kissinger once said, that ‘Competing pressures tempt one to believe that anissue deferred isa problem avoided; more often, it is acrisis invited.’”

Tags:  alliance manager  alliances  Andy Eibling  Cisco Systems  Competencies  Covance  engender trust  hiring tool  Kerry Lampard  partner performance 

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The Benefits of Sponsor and CRO Collaboration—from Leveraging Innovation to Sharing Patient Information

Posted By Cynthia B. Hanson, Saturday, October 17, 2015

For many years, Contract Research Organizations (CROs) have sought to move beyond their role as fee-for-service providers and branch out into strategic alliances with pharmaceutical companies. These emerging services alliances pattern to some degree the partnerships that pharmaceutical companies form with biotech firms and with each other—but there are differences too. This CRO/Sponsor evolution became a talking point on Thursday, Sept. 10 at the 2015 ASAP BioPharma Conference in the session “Enabling Innovation and Value Creation in Sponsor/CRO Collaborations.” Moderated by Doug Williams, business development consultant at BioDigital, the discussion addressed the benefits in two partnering mini-presentations: Covance/Eli Lilly and Company and EMD Serono/Quintiles.

 

In 2008, Lilly and Covance created a groundbreaking 10-year strategic agreement that spans the drug development process, explained Andrew Eibling, CSAP, global vice president and alliance manager at Covance, about the history of the partnership.  “It involved working across the spectrum and various silos of drug development.”

 

Today, Covance has a highly successful cardio vascular partnership with Lilly. At the beginning, it required lots of fine-tuning, because in the rush to get started, they missed out on some crucial steps, recalls Jay Turpen, senior director of clinical laboratory operations at Lilly.

 

“First, we got the right people together to frame out how we were going to work together. It’s so crucial to invest in defining the process: how to communicate, what hand-offs look like, handling escalation. There were skeptics from both companies, so we took time and invested in kaizan events to determine the likely areas where there was the most friction in the program, and invested proactively in those areas,” he added. “Creating a culture of one team with one approach and applying alliance management was successful, and we were able to enroll the study in less than … the scheduled 24 months, and it was 98-99 percent clean through the process.”

 

Then there was a second added valuepartnering on laboratory research. “What’s in the best interest of both Lilly and Covance as we build this new lab system? What information is in our mutual interest?” they asked. “We got literally thousands of people working on these alliances. There needed to be common linkages across those silos,” Turpen added. The central labs group started a unique rewards recognition program. And they reached the point where they now pass patient information back and forth.

 

The final results? “Lilly’s CEO said that it was the best study the company has ever done. It was a high five, a best practice, a solid metric for what a great job that team did,” said Eibling.

 

In the case of EMD Serono/Quintiles, Quintiles’ clinical development division wanted a CRO who got involved early in clinical stages sitting at the development table. The companies also were looking for processing standards, high benchmarks, and most of all, innovative minds at the boardroom table. They signed a partnership with EMD Serono in 2013, and the CRO became a partner in drug/biosimilar development.

 

“Clinical development is challenging because how do you persuade patients and physicians to join a trial? Or are you going to fall back on biosimilar drug development?” Those were some of the key questions raised by Raymond Huml, DVM, executive director of strategic drug development and head of global biosimilars strategic planning at Quintiles Biosimilars Center of Excellence, and Louk Pechtold, CA-AM, directoralliance management biosimilars, in the biosimilars unit at Merck Serono SA. 

 

Biosimilars are follow-on copies of originator medicines made from living tissues (e.g., monoclonal antibodies). The question of biosimilar drug development is increasingly important because by 2020, some $100 billion of original biological medicines will lose intellectual property protection.

 

They also addressed the question of how alliance managers factor into drug/biosimilar development. “We have upper management, middle level, and closer-to-the-ground alliance management. There are alliance managers that look over entire portfolios, but at the end of the day, you need someone who understands the differences or subtleties. And there are differences with biosimilars,” explained Pechtold.

 

“The main value in collaboration is leveraging innovation from one partner to another,” Huml added. Regulatory experience is a plus, and having a global reach can be an advantage. “Those with experience working with multiple companies also have an advantage over one-on-one,” he concluded.

Tags:  Alliance Management  Alliance Managers  alliances  biotech  Collaboration  Contract Research Organizations  Covance  CRO  drug/biosim  Eli Lilly and Company  intellectual property  Louk Pechtold  Merck Serono SA  pharmaceutical companies  Quintiles Biosimilars Center of Excellence  Raymond Huml  strategic alliances 

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