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New Interactive Summit Session Allows Participants to “Spin the Globe” for Intensive Study of Regional Cultures Around the World

Posted By Cynthia B. Hanson, Friday, April 15, 2016

ASAP introduced a thought-provoking session at the March 2016 Global Alliance Summit that allowed attendees to “spin the globe” and finger regions of interest for cultural exploration. Designed to help alliance managers glimpse the importance of understanding cultural nuances, “Alliances Around the World: Cultural Roundtables” provided insights and tips on doing your homework before stepping into a partnering venture that’s sometimes halfway around the globe. 

Deftly moderated by Philip Sack, CSAP, president of ASAP’s Asia Collaborative Business Community, the two-hour session that took place at “Partnering Everywhere: Expert Leadership for the Ecosystem,” held at the Gaylord National Resort & Convention Center, National Harbor, Maryland, was co-presented by three knowledgeable alliance managers: China was covered by Andrew Yeomans, CSAP, director of alliance management, biopharma business, Merck KGaA, Darmstadt, Germany; India was covered by Subhojit Roye, CSAP of Tradeshift; Latin America was covered by Guarino Gentil Jr., CA-AM of Serono, a healthcare division of Merck.

The next issue of Strategic Alliance Magazine will feature the first of several articles written about the roundtables—a virtual collective deep dive led by Yeomans and his Chinese partner, Jin Wu, who works for Serono (a healthcare division of Merck KGaA, Darmstadt, Germany) in China. The article takes readers into the nuances, taboos, and norms of doing business in China, via a roundtable discussion, with the roundtables for India and Latin America following in a subsequent issue.

“What’s needed for success, in general, has to do with people and relationships,” summarized Sack when introducing the session. After describing the need for partnering with cultural sensitivity in our fast-merging world, he provided a very basic list applicable to anyone doing business in any country:

  • Be an active listener
  • Communicate well—be a good speaker
  • Be patient

Attendees then selected a region, and eventually rotated throughout the room engaging in regional exchanges led by the remaining two co-presenters. The animated discussions included multiple questions and answers from the co-presenters and participants on topics ranging from traditional values, social networks, and product approval processes to contracts, copyright, inflation, and state-by-state legal variances.

The co-presenters emphasized the value of developing appropriate soft skills, such as understanding what is important in a particular culture: holidays, seniority, punctuality—or in some cultures a laid-back approach to time.

In China, for example, knowing how to socially negotiate the system of guanxi (the concept of drawing on connections in personal or business relations) is critical for access to Chinese markets. The guanxi business network is a web that interlinks thousands of social and business connections.

In India, it’s key to understand the lines of delineation and codes of conduct: a partner can become a competitor; a prospective acquisition target can end up assuming your company. In Latin America, effective communication requires easing into relationships with chitchat on personal issues because direct communication can be viewed as impolite.

Becoming attuned to legal, political, and structural differences in a country, region, or district is also advantageous. For example, taxes in Latin America can be very complicated. Several layers of tax fees exist, and Brazil can be especially complicated with different VAT taxes, each with its own rules. The taxes may vary product-to-product and state-to-state, explained Gentil.

In India, where software development has matured considerably, doing business in village areas requires sensitivity and insight into the caste system. “The caste of an individual could play an important part in success. It’s best to have the local country representative guide you,” advised Roye. “This needs to be done with extreme sensitivity as India is a democracy, and equality of opportunity is important.”

In China, it’s especially important to pay careful attention to the contract. One needs to consider the spirit as well as the letter of the contract and differing approaches to interpretation, said Yeomans. A lot of partnering is done with the Chinese government, and your goals for doing business need to be seen as adding value, "a kind of Robin Hood philosophy where the company is distributing for the human good, for humankind,” he added. “They would see that approach as an added value concept.” Negotiating the nuances of China “requires a huge amount of depth and understanding, and the key is to harness [the skills necessary for entering] the Chinese market.” 

Tags:  Alliance managers  Andrew Yeomans  China  cultural nuances  cultural sensitivity  guanxi business network  Guarino Gentil Jr.  India  Latin America  Merck KGaA  Merck Serono SA  negogiating  Philip Sack  Subhojit Roye  Tradeshift 

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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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