The biopharmaceutical industry has experienced dramatic changes within the last few years as a result of economic challenges. Small companies have faced a difficult capital formation environment, while many of the larger pharmaceutical companies have downsized.

The trend toward globalization continues as countries around the world strive to build and strengthen their biotech hubs to attract more business development and investment within their borders. This globalization has had a significant impact on the contract services sector. 

“In the last year, there has been a considerable increase in the amount of work we’re doing in U.S., Europe and, to some degree, Japan,” said Marco Oomen, senior director of Global Sales and Marketing at DSM BioSolutions. “We expect that the trend toward globalization will continue and will have a major impact on the future of the industry.” 

How Do You Size Up A Potential Partner?    Partnering remains one of the most important activities within the biotech industries. Finding a good partner does not have to be an arduous process if you take the right steps upfront.  Keep your eyes and ears open. Always be on the lookout for potential partners. Talk to your colleagues and read industry trade publications. Networking also plays a vital role in uncovering potential opportunities that await you and your company. Conduct appropriate due diligence. Your best asset is knowledge; appropriate due diligence may prevent either party from experiencing unnecessary harm. Examples of areas of due diligence include financial, legal, labor, tax, IP, labor and the market or commercial position of the company. Assess the potential. Conduct a risk/reward analysis to determine the potential of a proposed partnership. Analyze every angle of a potential partnership, as well as the investment and/or contributions your company will need to make in order for the partnership to be effective. Look for opportunities to interact. Ensure that all the relevant players have an opportunity to meet and discuss the potential partnership. Remember that asking the right questions and listening closely to the answers is critical. Check your assumptions at the door and keep an open mind. Multiple meetings will be necessary to assess whether or not the partnership is a fit. Monitor the company closely. Track news coverage of the company and its spokespeople. Find out if the company or its spokespeople are active in social media groups and monitor their activities.  Trust your instincts. Intuition plays a significant role in helping us make the right decisions at the right time. Regardless of how much time and energy has been invested in exploring the potential partnership, making the right decision to pursue the opportunity is paramount for success. Remember that it is never too late to cut your losses and move on.   —TC

In the last two years, many companies have been forced to cut costs, particularly in the area of R&D. “This trend opens up opportunities for companies that focus on R&D, and enables companies to focus on what they do best,” said Donato DiBiase, business director for Drug Delivery at DSM Biomedical.

Mr. DiBiase added that if you can accelerate progress in R&D and achieve regulatory results through faster approvals, you can speed up the time to market and become ‘invaluable to a company’ by helping it secure earlier revenues. CMOs can also prove to be invaluable by providing higher productivity processes, which leads to shorter campaigns and increases the potency of customer products. 

“This double impact requires us to be more flexible and presents us with a fresh challenge — to switch between products more quickly and cost effectively,” said Dr. Stephen Taylor, commercial director, Fujifilm Diosynth Biotechnologies (formerly Merck Biomanufacturing Network) in the UK.

There is a strong desire for flexibility, balanced with a close collaboration that is focused on streamlining processes and conducting rigorous testing. “As biopharmaceutical companies cut preclinical development and outsource earlier stage assets, companies offering CRO/CMO services can become ever more crucial in product development,” said Mr. DiBiase. 

As a result of layoffs at big pharmaceutical companies, many high quality employees were picked up by CROs. Drug developers can use CROs and CMOs to address shortfalls in capacity or expertise. Mr. DiBiase recommends building a network of potential clients through partnering conferences and events.

Mr. Oomen refers to the BIO International Convention as the ‘most important event in the industry’ because it allows him to make new contacts and connect with previous contacts. “Instead of flying all over the world, the people I want to meet with are in the same place for a few short days, it’s an effective use of my time,” he remarked.

Partnering conferences can help put new companies on your radar screen and provide interesting leads from new companies. Building and managing the team is a key consideration when identifying, selecting and setting the rules of engagement for new partnerships. 

The use of CROs and CMOs presents a significant opportunity to build a strong team with vendors and internal and external stakeholders who have expertise across the drug development spectrum. 

“It is important to have a true collaboration with companies that will lead to success,” said Mr. Oomen. “They have to trust you and you have to trust them.” He recommends communicating with contractors early and often to instill a sense of teamwork and transparency.  

Mr. DiBiase offers companies a trial phase to work together on a small project and build up trust. Once the trial phase is successful, then they start discussing a co-development agreement. 

BIO: The Global Event for Biotechnology The annual BIO International Convention, held June 27-30, 2011 in Washington, D.C., is the largest global event for the biotechnology industry and attracts the biggest names in biotech, offers key networking and partnering opportunities, and provides insights on major trends affecting the industry. The event features keynotes and sessions from leading policymakers, scientists, CEOs, and celebrities. Past speakers include Presidents George W. Bush and Bill Clinton, Michael J. Fox, Her Majesty Queen Noor of Jordan and General Colin Powell, among many others. BIO also includes hundreds of sessions covering biotech trends, policy issues and technological innovations, and the world’s largest biotechnology exhibition. BIO performs many services for members, but none of them is more visible than the BIO International Convention. The BIO International Convention helps BIO fulfill its mission to help grow the global biotech industry. Profits from the BIO International Convention are returned to the biotechnology industry by supporting BIO programs and initiatives. BIO works throughout the year to create a policy environment that enables the industry to continue to fulfill its vision of bettering the world through biotechnology innovation. The event dates back to 1987, when the Association of Biotechnology Companies hosted an international conference in Washington, D.C., that exceeded expectations by attracting 155 attendees; the goal had been 100. Some of the session topics would become perennial themes: raising capital in the venture and public markets, FDA, USDA and EPA regulation, and patenting trends. Since then, growth has been steady — attendance hit 1,400 in 1993, the year BIO was formed, and more than 22,000 in 2007, with representatives from 68 countries. Growth of the meeting, and BIO overall, has paralleled that of the young, dynamic industry BIO represents.  The 2011 BIO International Convention will be held June 27-30 in Washington, DC. For more information, visit convention.bio.org.

“We try to develop phased programs and help customers focus on priority issues, and save other issues for later,” said Dr. Taylor. “Building in process validatablity at the start also helps.” 

Contracting organizations should keep in mind that there is a big difference between small and more established companies. “Small companies are focused on a niche, while big pharma companies have a much broader focus,” Mr. DiBiase noted. “Small companies also are more aware of the risk and reward, drug development is a huge venture that is highly dependent on investor’s capital.” 

Regulatory challenges have made businesses more competitive and forced companies to develop their own approach to the regulatory process. The U.S. regulatory system continues to set the global “gold standard” for regulatory science and consumer protection while facing an ever-increasing array of issues and revolutionary food and medical advancements with tightening resources.

The development of new therapies is best facilitated through a regulatory environment that is science-based, collaborative, transparent, and accountable, as well as predictable and consistent. By definition, prescription drugs carry both benefits and risks that must be carefully evaluated in the context of the product’s benefit/risk profile, and in the context of the disease severity. 

These inherent risks must be mitigated and communicated to patients, their caregivers, and medical providers, which necessitates early and regular coordination between FDA and the Sponsor during drug development, review, and marketing, particularly if a Risk Evaluation and Mitigation Strategy (REMS) is potentially involved. “There has been a much stronger focus on understanding and navigating the regulatory process over the last few years,” said Mr. Oomen.

It is important that the FDA meet and communicate with companies early in the development and approval process through both formal meetings and ongoing dialogue. This is particularly important for smaller, emerging companies.

Each company must develop its own approach to navigating and achieving regulatory approval. CROs can provide a significant advantage based on their experience working with multiple companies on the approval process. 

The outlook for biotech is that the trend toward outsourcing will continue to grow. With the growth of the sector, partnering activity with CROs and CMOs is expected to increase. Many academic and research institutes are exploring potential partnerships as well. Partnerships between academic research centers and companies can be critical for sustaining U.S. invention and innovation. Transfer of government-funded research for commercialization can improve state and regional economic prosperity, and states and regions are increasingly focusing attention on tech transfer as a mechanism to boost private sector R&D activities within their locales.

BIO-Outsourcing News   The number of self-identified service (CRO/CMO) companies in the BIO Business Forum increased 20% from 2009 to 2010. The Number of meetings involving a service provider and a pharma/biopharma company has remained consistent (2009-2010) at 38% of all one-on-one meetings in the BIO Business Forum, which represented more than 6,500 meetings in 2010. The Contract Services Summit at the BIO International Convention will be held Tuesday, June 28, 1:00pm-4:30pm

Once university or federal lab research yields a new discovery, there is still a great deal of work to be done before the technology can be incorporated into the marketplace. Universities increasingly focus their efforts on assisting faculty, entrepreneurs and companies through the commercialization process. 

As the industry addresses streamlining the drug development process, and alleviating challenges within the regulatory system, contract service organizations can play a pivotal role in guiding companies through product development to commercialization.

Tracy Cooley, APR is director, Events Communications for Biotechnology Industry Organization (BIO). She can be reached at tcooley@bio.org.