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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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ASAP Announces Theme and Program for Sept. 9-11, 2015 ASAP BioPharma Conference Focused on Evolution of Partnering in the Rapidly Evolving Ecosystem

Posted By Cynthia Hanson, Friday, July 31, 2015

This week, ASAP issued a press release announcing the theme and program for the 2015 ASAP BioPharma Conference, the organization’s annual event attended by partnering executives from around the world who work in life sciences and healthcare. “Alliance Expertise at the Forefront: Leadership for the Ecosystem” is the theme of the three-day conference at the Revere Hotel, Boston Common.

 

“The healthcare and life sciences industries are going through a profound metamorphosis and alliance executives need to prepare for significant adaptation,” said Michael Leonetti, president and CEO, ASAP, in the release. “This year once again will be the pivotal event for partnering executives in biopharma and its ecosystem, as our conference will discuss drivers in the ecosystem that are causing fundamental shifts, such as new technologies, demographic and lifestyle changes, shortages in resources, and scientific, regulatory, and market forces. We’ll explore the questions of why alliance managers need to get ahead of this shift, why these ecosystems are beginning to emerge now, how they differ from traditional markets, what new incentives will emerge, and the best ways for individual organizations to respond.”

 

Registration for the 2015 ASAP BioPharma Conference begins at 7 a.m. Wednesday, Sept. 9. For an additional fee, attendees attend one of three pre-conference professional development workshops taking place from 10 a.m. to 4 p.m., including a CA-AM Certification Exam Prep Workshop facilitated by Ben Gomes-Casseres, CSAP, author, alliance strategy consultant, and Brandeis University professor.

 

Opening remarks will kick off the main conference at 4:45 p.m., followed by a late afternoon conference keynote, “Taking on a Silent Killer through Partnership and big Data” by Niven R. Narain, co-founder, president, and chief technology officer at Berg Health.

 

Thursday morning’s plenary session kicks off with “ASAP Quick Takes,” designed after the renowned “TED Talks.” Heather Fraser, global life sciences & healthcare lead at IBM’s Institute for Business Values, will talk about “Redefining Partnering in the Healthcare and Life Sciences Ecosystem.”  Cindy Warren, vice president of alliance management at Janssen Pharmaceutical Companies of Johnson & Johnson, will explore “Alliance Leadership for the Healthcare Ecosystem.”

 

The second half of the morning is devoted to “Deeper Dive” sessions with more in-depth speaker presentations and peer exchanges in solution-focused roundtable discussions. Fifteen educational sessions, starting that afternoon and ending the following day at noon, include interactive presentations, mini-workshops, and expert panels discussing essentials and current skills for the alliance professional.

 

You can read the full announcement issued July 30 via the PR Web newswire. 

 

ASAP’s annual BioPharma Conference attracts partnering executives, academics, innovators, managers, patient advocates, service organizations, and other life sciences and healthcare representatives from countries around the world. For more information regarding session offerings and registration for this conference, visit www.asapweb.org/biopharma.

Tags:  alliance managers  Ben Gomes-Casseres  Berg Health  Brandeis University  Cindy Warren  healthcare  Heather Fraser  IBM’s Institute for Business Values  Janssen Pharmaceutical Companies  life sciences  Niven R. Narain  professional development workshops 

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Collaborations Can Work Together To Find the Holy Grail in Health Care Problems: Dr. Mark Rosenberg Addresses a Rapt Audience at the ASAP Summit on How to Discover the Gold

Posted By John W. DeWitt, Tuesday, March 31, 2015

The “Holy Grail” in health care is the golden promise of being able to eradicate a disease, pronounced Dr. Mark Rosenberg, president and CEO of The Task Force For Global Heath, based in Decatur, Georgia. As the director of the Task Force’s Center for Global Health Collaboration, he described one effort after another where collaboration served as a key component in successful global health-related achievements during his talk at the 2015 ASAP Global Alliance Summit held at the Hyatt Regency in Orlando, Florida, USA. Drawing on his co-authored work Real Collaboration: What Global Health Needs to Succeed” (University of California Press, 2010) and its “Partnership Pathway,” he outlined the necessary steps to developing large-scale, effective global health projects. 

The Task Force’s collaborations are particularly instructive for alliance managers because they involve multiple partners working on massive projects – global and regional agencies, businesses, non-governmental organizations, and other nonprofits. In his talk “Fostering Real Collaboration: Lessons from Solving Global Health Problems,” he covered a range of circumstances where large coalitions tackled major health issues – from smallpox and river blindness to pedestrian accidents. The room was still as he described how his own personal experience with a tragic accident in his neighborhood impacted his career a number of years ago. 

“A young woman runner had just been hit by a car. She had a tremendous head injury, so I started doing CPR,” he explained. “An ambulance came … [but] she died in my hands there on the street – she had two children waiting for her at home. It turned out she was the most famous runner in Atlanta – she had run 17 marathons.” 

Rosenberg sent pictures of the accident scene to a European colleague, who responded, “Your street is designed to kill people.” Rosenberg recounted the conversation with his friend: “There are no speed bumps at intersections. You can’t see those white lines. You also have red lights—red lights kill people. The only collisions that are fatal are high-speed collisions and when the light turns yellow, what do people do? They speed up—and in Atlanta, they speed up when it turns red,” Rosenberg added, cutting the tension of his powerful story. His colleague continued, “That’s what creates fatal crashes. In Sweden, we got rid of all red light intersections and reduced fatalities by 90 percent in road traffic injuries.” 

“More than 1.5 million people are killed on roads every year, but we can reduce crashes to zero,” Rosenberg colleague believes. The goal in Sweden today is to eliminate them altogether, and that required a coalition. They recognized it was a multi-faceted problem involving transportation, road building and construction, education, police, and almost every area of the public sector. So they started by involving Volvo, which declared in a campaign that by 2020, no one will be killed by road crashes. The effort grew to such a degree that the European Union adopted a standard to eliminate all traffic deaths by 2050. 

The experience led to Rosenberg’s involvement in establishing the Centers for Disease Control and Prevention’s National Center for Injury Prevention and Control. He became its first permanent director in 1994 and also worked with Costa Rica’s President Oscar Arias to organize a coalition to address road traffic injuries throughout Latin America and the Caribbean. 

All coalitions undergo a series of steps to become successful, he pointed out. “The most important part of the journey is how you manage the alliance. Make your meetings productive and manage in a way so that there is trust.” The biggest obstacle to success is the failure to do these five things: Define your goal, define your strategy, clarify your structure, your membership, your management, he concluded. 

Tags:  “Real Collaboration: What Global Health Needs to S  2015 ASAP Global Alliance Summit  alliance managers  Center for Global Health Collaboration  collaboration  Dr. Mark Rosenberg  high-speed collisions  large coalitions  manage the alliance  The Task Force For Global Heath  Volvo 

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Keeping Pace with the Internet of Things: Walking the Post-Disruption Walk While Transforming Partnerships

Posted By Cynthia Hanson, Monday, March 23, 2015

Like Mickey’s brooms in the film “Fantasia,” the Internet of Things has multiplied into a labyrinth of complexity accompanied by its companion—disruption. “As disruptive technology takes hold, companies not used to partnering together are forced to do so, and it’s up to alliance managers to forge these alliances as leaders and define the swim lanes between companies,” said Tony DeSpirito, vice president of global alliances at Schneider Electric during the session on “Transforming Partnering Post Disruption” at the 2015 ASAP Global Alliance Summit held at the Hyatt Regency in Orlando, Florida, USA. 

 

“The greatest challenge we are facing right now as we look forward strategically is issues around the Internet of Things—I’m talking about control systems that operate in the infrastructure. It’s forcing Schneider to partner with different companies we’re not used to. We are being forced to partner with folks that own the digital world. For us, every day, it’s how do we connect the physical world with the digital world? How do we connect Schneider Electric with IBM?” he concluded.

 

For the company worth $30 billion (US) and its 15-person global alliance team, it’s a major puzzle. “Alliance is not core to the strategy of Schneider,” he admits, but digital disruption has forced the company to add an alliance manager to the corporate executive committee.

 

Schneider’s challenge points out a critical alliance question: How do we lead with a velocity of change that is happening at such a rate that is not business as usual? asks  Lorin Coles, CSAP and CEO of the consulting and training company Alliancesphere. “Not doing anything is not acceptable. Companies like IBM are reorganizing from top to bottom. Other companies are trying to change customer buying behavior. If we can solve this customer problem, then the ecosystems and partners support that.”

 

Don’t be afraid. Embrace the change,” chimed in Laura Voglino, general manager of IBM’s ecosystems and social business, who has experienced major disruption and transition at IBM. “It will take you to great things on a personal level because it keeps you vital and great for your companies and in the market.”

 

IBM changed the whole cloud structure with a huge focus and substantial team, she explains. “What really caught us by surprise was the velocity of the transformation and adoption.”

 

More than 90 percent of budgets in data centers are being put into cloud, she adds. The buying behavior of clients is changing, and there is a much greater focus on developers. “We needed to change our view of partnership to catch those cloud developers. We needed to open the scope to have venture capitalists. We needed to work with startups. These guys are bringing a lot of innovation that our clients are very thirsty for. Every time we think of alliances we think of Apple and IBM. But there’s a different level, a different dynamic. We just announced Citibank and IBM partnering, going to the market to activate developers to serve Citibank. This is a different system.”

 

We needed to get people enthusiastic about the start-up guys, ask what the vision is, and ask how to break the inertia of the immediate results. “Inertia is the worst enemy. When you have disruption, the worse you do during disruption time, the better it is to change,” she concludes.

 

With the Internet of Things, if you don’t get revenue, look at the activity or pipeline. And if you don’t have that, then look at lighthouse accounts—those accounts that will bring you revenue in 2016-2018.  “It’s incumbent upon us to stand up and show true leadership. As alliance managers, to be leaders you need to say 100 times to the same people, you will see revenue!” says DeSpirito.  “We don’t need to be the fastest bear. The winner of the Internet of Things is a group of kids in China that developed a remote control way to control forest fires. All of the innovation we are talking about is API [Application Programming Interface].”

Tags:  alliance managers  Alliancesphere  API  Apple  Citibank  cloud  disruption  IBM  Internet of things  Laura Voglino  Lorin Coles  Schneider Electric  start-ups  Tony DeSpirito 

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