Blog Article on Future of Biopharmaceutical Outsourcing

January 16, 2015 in Blog by jmeyer

As posted on BioStorage Technologies’ Blog:

The biopharmaceutical industry faces a unique challenge in its quest to develop new and innovative therapies. Unlike any other industry, Biopharma research is dependent upon the human body and its genome. In a sense, it is working to drive continual innovation within a highly complex, but closed environment. Not surprisingly, Biopharma is finding it more and more difficult and costly to discover, develop and commercialize new therapies. Just this November, the Tufts Center for the Study of Drug Development reported the cost to develop and win marketing approval for a new therapy has reached nearly $2.6 Billion – a far cry from the $802 Million estimate Tufts published just 11 years ago. To offset this increasing challenge Biopharma has and continues to actively pursue strategies to do things better, faster and cheaper. One of the key strategies used by Biopharma is outsourcing R&D activities to contract research organizations (CROs).

Recently, Life Science Strategy Group (LSSG) conducted research with 100 biopharmaceutical R&D professionals globally that have responsibility and visibility into R&D strategies, budgets and outsourcing practices to better understand trends driving change in R&D innovation, efficiency and outsourcing strategies. Top outsourcing trends uncovered by LSSG are below.

Top Factors Driving Biopharma R&D Outsourcing Strategies

Pic 1Source: The Future of Pharma Outsourcing, Life Science Strategy Group, LLC, 2014

The key takeaway from our trend analysis is that over the past year and in the future, Biopharma companies will place an even greater emphasis on outsourcing.   Specifically, the majority of R&D effort will stay focused on late stage (Phase 2-4) opportunities, which are closer to market dollars – Biopharma needs to ensure revenue streams to drive its programs. However, Biopharma companies depending on their size have different ideas on who they will turn to for support. Respondents from large Biopharma companies indicate they will increasingly turn to large full-service CROs, while small/mid-size Biopharma will turn to mid-size CROs.

Trends in CRO Utilization

Pic 2Source: The Future of Pharma Outsourcing, Life Science Strategy Group, LLC, 2014

Large Biopharma will look to bigger CROs because of their global footprint, breadth of capabilities and ability to reach, access and monitor trials in an increasing array of countries in Eastern Europe, Asia (China, India) and Latin America (BRIC countries). As large Biopharma expands its R&D efforts into more, specialized therapeutic areas, access to patients will become more difficult. Large CROs are well suited to address this challenge both with their internal capabilities and geographic reach. In order to expand their breadth of core service offerings even further, large CROs will seek collaborations with other niche CROs and specialty service organizations, which are critical to their success as “soup-to-nuts” providers.

Just as biopharmaceutical companies are outsourcing to CROs so that they can focus on their core expertise, CROs are finding the need to build collaborations with niche specialty service organizations who provide best-in-class solutions in areas that are not the core expertise of the CRO. The types of niche specialty service providers who are indirectly benefiting from this trend include global sample storage and management companies, clinical trial technology companies, as well as esoteric, diagnostic and genomic testing laboratories. In addition, the growing number of academic-based strategic research institutions will provide large CROs with a collaborative avenue for research capability expansion.

Small and Mid-size Biopharma are shifting their outsourcing efforts towards mid-size CRO companies due to their ability to provide them with more personalized attention to their larger trials, while maintaining a high level of customer service – something small to mid-size Biopharma may perceive is missing when working with a larger CRO. Again, niche CROs and specialty service providers will play a critical role in supporting mid-size CROs’ in their ability to deliver a deeper breadth of service capabilities with their Biopharma customers often indirectly through partnerships and alliances.

A second outsourcing strategy to be used by Biopharma over the next few years will be to shift from transactional to more strategic relationship models with CROs. In its research, LSSG found that both large and small/mid-size Biopharma will decrease its use of fee-for-service (transactional) types of CRO relationships while increasing its use of preferred-provider and strategic partnerships. Specifically, large Biopharma respondents expect use of fee-for-service relationships to decrease from 24% to 19% of trials while use of strategic partnerships will increase from 23% to 28% of trials. Small/mid-size Biopharma respondents indicate a similar trend with fee-for-service relationships decreasing from 40% to 32% of trials while strategic partnerships should increase from 15% to 21% of trials.

A third outsourcing strategy Biopharma will utilize to drive further efficiency with CROs is service bundling. In particular, large Biopharma expects to increase bundling of routine study conduct activities with upstream study feasibility support, among other areas. Small/mid-size Biopharma respondents anticipate further service bundling across trial planning, conduct, technology and reporting services.

Clinical Trial Services Bundling

Pic 3 Source: The Future of Pharma Outsourcing, Life Science Strategy Group, LLC, 2014

Considering the current pressures facing the Biopharma industry and the need to drive innovation under increasing complexity, it is clear CROs will play an increasing role as an enabler of success in the future. As such, Biopharma will continue to evaluate its relationships with CROs and how it can maximize its return on its investment. Over the next 2-3 years and (likely) beyond, it is clear that Biopharma companies will look to further streamline and improve relationships with CROs. Strategies including greater use of preferred and strategic partnerships, more careful CRO selection and further service bundling are but a few of the strategies Biopharma will utilize with the goal of reducing administrative time, FTEs and spend. The goal of these strategies will be to ensure resources are more efficiently allocated to Biopharma’s core competencies such as the science and execution of R&D with the goal of doing more with less and improving drug development success.

The Fight Against Ebola – Potential New Therapies

November 10, 2014 in Blog by jmeyer

By Dr. Joanne Elliott

According to the World Health Organization, almost 2300 people have died as a result of the current Ebola virus outbreak in West Africa, including 79 health workers. Moreover, it is estimated that approximately 4000 are infected in Guinea, Sierra Leone, Nigeria, Senegal and Libera. Although severe, Ebola hemorrhagic Fever is a relatively rare infection that can affect primates and humans. The incubation period of the virus can range form 2-21 days and symptoms of infection include high fever, bleeding and CNS damage.

Understanding the spread of Ebola is essential to curtail further transmission. Although bats are the natural virus host, it is thought humans become infected through contact with infected blood, meat or bodily fluids. The index case for the current Ebola outbreak has been linked to a woman in the Congo who ate an infected bush animal. Proven methods of infection control, protective clothing and new treatment centers are the current methods used to halt the spread of the virus while researchers are striving to develop a proven, effective treatment that can combat the Ebola epidemic.

Promising research by Stanley et al., published in Nature Medicine on September 7th, suggests a Ebola vaccine may be attainable. Using a Chimpanzee derived, replication deficient adenovirus modified to contain 2 Ebola virus gene segments, they could protect 4 out of 4 macaque monkeys exposed to Ebola 5 weeks after vaccination. However, only 2 out of the 4 monkeys where protected after subsequent challenge 10 months after vaccination. Rates of long-term protection where improved when a separate group of macaques were given a booster vaccine consisting of a recombinant poxvirus containing Ebola gene sequences. Currently, this vaccine has been fast-tracked for safety testing in healthy volunteers at the NIH in Bethesda and if positive, may become available for use in November.

ZMapp, developed by Mapp Biopharmaceutical based in San Diego, has also been proven to be effective in treating two US aid workers who contracted Ebola while caring for patients in Liberia. ZMapp is a combination of three mouse monoclonal antibodies that is thought to stop the virus from gaining entry into host cells. However, ZMapp has yet to be subjected to a randomized clinical trial and its limited supplies have been exhausted. An upsurge in Zmapp manufacturing has become and hopefully supplies will be become available over the next two months. Another potential therapeutic vaccine against Ebola, has been developed in collaboration with the Public Health Agency in Canada. The vaccine based on Vesicular Stomatitis Virus is a live virus containing Ebola proteins, which can stimulate the host immune response to offer protection. New Link Genetics, which has licensing rights for this vaccine, has given permission for the FDA to start trials in healthy volunteers this Fall.

Although, an effective Ebola vaccine is on the horizon, an immediate solution to the current epidemic suggested by the World Heath organization is to use blood therapies. Although controversial, individuals that have survived infection will have antibodies present in their serum to fight Ebola virus. With the current Ebola, outbreak having a mortality rate of 50%, there are a large number of survivors whose blood may be used to treat others. During the 1995 Ebola epidemic in the Congo, 7 out of 8 people who were given blood therapy survived. However, large-scale data is lacking and those who survived received better than average care and may have recovered without medical intervention. Using blood of patients who recover form Ebola to treat others may be both cost effective and potentially useful in the short term to limit the spread of the current Ebola outbreak. However, in the long-term it is hoped that a safe, effective and easily administered vaccine may become available to combat the current Ebola epidemic.

OutsourcePharma Advisory Board Featured in New Report – Biopharma RFP Flow

October 27, 2014 in Publications and Posters, Resources by jmeyer

The OutsourcePharma Advisory Board members’ contributions are featured in a new report published by Life Science Strategy Group.  The story can be found on’s website.

Genes Are Not Patentable, But cDNA Is

September 3, 2014 in Blog by jmeyer

By Dr. Joanne Elliott

US authorities have been granting gene patents to researchers in both Academia and Industry for almost 30 years. By isolating genes relevant to disease, scientists hoped that these discoveries could be applied to genetic screening and potential gene related therapies. It is estimated that current gene patents cover approximately 40% of the human genome. A biological patent provides the patent holder with the exclusive right to use or sell the protected invention for a limited time (usually 20 years) and to exclude others from doing so.

Gene patents might be considered essential to allow companies time to research genes without competition while simultaneously encouraging investment in research and development. However, on June 13, the US Supreme Court made a ruling that as a product of nature, human genes cannot be patented. This decision is a culmination of efforts by the American Civil Liberties Union and the Public Patent Foundation, who originally filed a lawsuit in 2009 to challenge gene patents.
They filed a lawsuit claiming that gene patents were unconstitutional and hindered cancer research. Specifically, the lawsuit was aimed at Myriad Genetics, a Utah based company, who had the monopoly to perform diagnostic tests on BRCA1 and BRCA2. Myriad was granted these patents in 1994 and 1995. Mutations in these human tumor suppressor genes are associated with hereditary breast and ovarian cancer. As patent holders, Myriad had the exclusive right to screen patient samples for these genes. Samples of hundreds of patients had to be shipped to Myriad in Salt Lake City for screening at a cost of over $3,000 each. Moreover, other companies were forced to exclude BRCA1 and BRAC2 in their genetic screens in order to prevent patent infringement.

While Myriad argued that BRAC1 and BRAC2 were both isolated by the company as a result of human ingenuity and were therefore patentable, the Justice’s final decision that isolated genes are non-patentable, will have repercussions throughout the biotech industry. For example, companies may now expand their clinical care and research focus. More companies can offer multi-gene testing, leading to greater competition and competitive pricing. Likewise, more open research on these previously patented genes may advance our understanding of disease and aid the development of relevant therapies. Current and future plans for whole genome sequencing projects such as those aimed at sequencing DNA of cancer patients and those with rare genetic diseases can also proceed without the fear of infringing gene patents.

Finally, although the US Supreme Court concluded that naturally occurring genes can not be patented, they agreed that artificially copied DNA can. These include complementary DNA (cDNA) or synthetic DNA. The Justice ruled these can be patented as it involves making something that does not naturally occur. However, cDNA is nothing more than an edited copy of the same information that already exists within a gene. Is it necessary to introduce deletions, insertions or other modifications into the cDNA sequence to make it patent eligible? In addition, some viruses make their own cDNA from mRNA suggesting that cDNA can be a natural product. Likewise, is a synthetic gene product patentable if a single base change is incorporated into the sequence? Although certain doubts and questions remain regarding the US Supreme Court decision, the ruling will obviously alter the road map for biotech companies. It is envisaged that cDNA patents may become more valuable to allow exclusive research protection for pharmaceutical companies.