Amy Ritter was Scientific Editor, BioPharm International.

Amy Ritter, PhD

 the formation of a nonprofit organization called TransCelerate BioPharma, the mission of which is to accelerate the development of new medicines by identifying and solving common drug development challenges. The ten founding companies include Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi.

	The ten founding companies will pool resources and personnel to solve industry-wide problems. Initially, TransCelerate will focus on best practices for clinical trial execution. Five projects have been selected for funding and development, including: development of a shared user interface for investigator site portals, mutual recognition of study site qualification and training, development of risk-based site monitoring approach and standards, development of clinical data standards, and establishment of a comparator drug supply model.

	A senior R&D member from each of the founding companies will sit on TransCelerate’s board, but membership is open to any biopharmaceutical company that can contribute to and benefit from the solutions being pursued by the company.

	In years past, drug development was a secretive process. However, the rising cost and diminished success rate of bringing new drugs to market has forced the realization that going it alone is not always the most effective or efficient way of developing drugs. This realization has resulted in greater willingness of pharmaceutical companies to collaborate-with academics, with government agencies, and now, with each other.

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Ten biopharmaceutical companies announced the formation of a nonprofit organization called TransCelerate BioPharma, the mission of which is to accelerate the development of new medicines by identifying and solving common drug development challenges.

Members of Big Pharma Collaborate to Define Best Practices

	As the saying goes, an ounce of prevention is worth a pound of cure. The US Department of Health and Human Services (HHS) has taken that advice to heart, according to an 

 from HHS’s Office of the Assistant Secretary of Preparedness and Response. According to the announcement, HHS has awarded three-year contracts to all five US-licensed influenza vaccine manufacturers to produce master vaccine seed stocks for viruses with pandemic potential before a pandemic occurs. HHS will choose the vaccine strains to be stockpiled, and expects that with vaccine seed stock already in hand, the government will be able to respond to a flu pandemic more quickly.

	The contracts also allow HHS to purchase cell-based vaccine in addition to conventional egg-based vaccine in a pandemic, which is a new initiative in the government’s pandemic response efforts. Because cells can be frozen and stored in advance of an epidemic, or developed rapidly in response to an epidemic, scale-up and production of vaccine using this method can be performed more rapidly and can more easily meet surge capacity requirements than egg-based vaccines.

	According to the announcement, some of the funding will go towards clinical trials and stockpiling of vaccine and adjuvants. Current licensed seasonal flu vaccines do not contain adjuvants. However, use of adjuvants in flu vaccine would be expected to lower the amount of the antigen required per dose, and result in more doses of vaccine being available during a pandemic.

	Contracts were awarded to Sanofi Pasteur, Novartis, GlaxoSmithKline, CSL Biotherapies, and MedImmune, and will overseen by the HHS Biomedical Advanced Research and Development Authority (BARDA). Initially, HHS will commit a total of $4.4 million for the companies to produce master vaccine seed stocks and $7.3 million for the companies to store prepandemic vaccines.

	“These contracts build on the lessons learned from the 2009 H1N1 pandemic and nearly a decade of stockpiling avian flu vaccines,” stated BARDA Director Robin Robinson in the announcement. “The increased national manufacturing capacity for pandemic influenza vaccines afforded by this effort is derived from successful public-private partnerships resulting in more U.S.-based vaccine manufacturing facilities and innovative vaccine technologies.”

As the saying goes, an ounce of prevention is worth a pound of cure. The US Department of Health and Human Services (HHS) has taken that advice to heart.

Be Prepared

 that the National Institutes of Health (NIH) can continue to fund embryonic stem cell research, upholding a July 2011 ruling that found that such research does not violate the Dickey-Wicker Amendment prohibiting federal funding for research in which a human embryo is destroyed.

		To recap, in 2009, President Obama signed an Executive Order removing restrictions on funding for research using embryonic stem cells put in place in 2001 by the Bush administration. President Obama also asked the NIH to update their guidelines for the responsible use of embryonic stem cells, which were originally drafted in 2000. Shortly after the restrictions were lifted, two scientists opposed to embryonic stem cell research filed a lawsuit against the NIH (read more 

). The scientists asked that the court find the NIH guidelines invalid, citing a 1996 federal law called the Dickey-Wicker Amendment that prohibits funding for “research in which a human embryo or embryos are destroyed.”

		The NIH, in turn, took the position that an embryonic stem cell is not an embryo. The NIH stated that the Guidelines “recognize the distinction, accepted by Congress, between the derivation of stem cells from an embryo that results in the embryo’s destruction, for which Federal funding is prohibited, and research involving [human embryonic stem cells] that does not involve an embryo nor result in an embryo’s destruction, for which Federal funding is permitted” (Fed. Reg. 74 (128), 22107, 2009). In July 2011, US District Court for the District of Columbia Chief Judge Royce Lamberth dismissed the suit, agreeing with NIH’s distinction that research using embryonic stem cells is different from research on embryos.

		When the suit was dismissed, it was predicted that the plaintiffs would appeal. The three-judge appeals court upheld the District Court ruling, but the judges arrived at their decisions by different pathways, and with some soul-searching over the original ruling. Circuit Judge Janice Rogers Brown wrote in her decision, “The challenging-and constantly evolving-issues presented by bioethics are critical and complex. Striking the right balance is not easy and not, in the first instance, a task for judges.” She concludes, “Given the weighty interests at stake in this encounter between science and ethics, relying on an increasingly Delphic, decade-old single paragraph rider on an appropriations bill hardly seems adequate.”

A federal appeals court has ruled that the National Institutes of Health (NIH) can continue to fund embryonic stem cell research, upholding a July 2011 ruling that found that such research does not violate the Dickey-Wicker Amendment prohibiting federal funding for research in which a human embryo is destroyed.

Funding for Embryonic Stem Cell Research Gets Green Light

 an agreement to establish an exclusive long-term collaboration to develop, manufacture, distribute, and market generic drugs in Japan. Under the agreement, Pfizer's responsibilities would consist of the commercialization of the combined generics portfolio, including sales and marketing while Mylan would manage operations, including R&D and manufacturing. The collaboration between Pfizer and Mylan will include a portfolio of more than 350 marketed products across a broad range of therapeutic categories, as well as more than 125 additional products in development. Products included in the collaboration are expected to be sold under the Pfizer brand with joint labeling.

“We are very excited to have the opportunity to be partnering with Pfizer to build upon our existing assets and drive an even stronger, more sustainable generics business in Japan, which will be well-positioned to take advantage of anticipated growth in generic utilization in this market and other significant growth opportunities,” said Mylan's CEO, Heather Bresch in the release. “As a leading global biopharmaceutical company and a leader in the Japanese market, we expect Pfizer will bring significant benefits to the collaboration, particularly in the commercialization of products, and will complement the strengths of our existing Mylan business. With contributions from both companies, we believe the collaboration will result in a powerful generics platform that we believe will be a leader in Japan in terms of scale, scope, and quality.”

Under the agreement, Pfizer and Mylan will each continue to operate independent entities in Japan, but will collaborate on current and future generic products, and share the costs and profits resulting from the collaboration. The transaction remains subject to the satisfaction of certain closing conditions. Transaction terms remain confidential.

Pfizer and Mylan have agreed to establish an exclusive long-term collaboration to develop, manufacture, distribute, and market generic drugs in Japan. The products included in the collaboration are expected to be sold under the Pfizer brand with joint labeling.

Pfizer and Mylan Partner to Develop Generic Drugs in Japan

Chips for drug discovery are not new-gene chips, which are microchips containing snippets of DNA, have been in use for a number of years as diagnostic tools or tools to study gene expression. But a few recent initiatives suggest that the combination of silicon and biology can be expanded even further.

 in the Aug. 19, 2012 online issue of Nature Medicine highlights a collaboration between researchers at the Stanford University School of Medicine and Intel Corp. to create a peptide chip. In an interesting marriage of wafer fabrication and biochemistry, the researchers were able to synthesize short polypeptide chains directly on the chip, rather than synthesizing the peptides separately and then affixing them to the chip.

	In this instance, the chip was designed to detect antibodies recognizing amino acid sequences from a DNA-packaging protein called histone 2B. The chip included every possible overlapping sequence of every length from the last 21 amino acids of the histone 2B protein, and was used successfully to identify lupus patients with high levels of antibodies against histone 2B. In an accompanying 

, the researchers indicate potential uses for the technology in addition to that as a diagnostic tool for lupus. The chip technology could be used to better understand protein-protein interactions or to help design influenza vaccines that elicit a strong immune response.

	On a larger scale, the National Institutes of Health (NIH) and the Defense Advanced Research Projects Agency (DARPA) are investing heavily in tissue chips to more accurately detect drug safety signals. Tissue chips are microchips ranging from the size of a quarter to the size of a house key lined with living tissue. The goal is to accurately model the three-dimensional structure and function of human organs, reproducing the complex interactions, both chemical and biomechanical, that occur among different cell types within an organ system. The chips could then be used to predict drug toxicity and efficacy more accurately and at lower cost than current methods.

	NIH is providing more than $70 million in funding over 5 years to develop this technology, with part of the funding coming from the recently established National Center for Advancing Translational Science. DARPA is conducting a separate but parallel program. It has awarded two grants, one to the Wyss Institute at Harvard University and the other to MIT, both of which also are NIH tissue chip grant recipients, to develop engineering platforms capable of integrating 10 or more organ systems.

In the September PharmTech issue, researchers from MIT’s Center for Biomedical Innovation (CBI) describe the interim results from recent research into 34 commercial-scale biopharmaceutical products at 11 international sites.

Silicon Meets Biology

South Carolina-based Altec Medical pleaded guilty to one count of conspiring to defraud FDA and to commit federal offenses in connection with a drug-diversion scheme that lasted from 2007 to 2009. Altec was ordered to pay a $2 million fine and to forfeit a further $1 million and has also been placed on probation for a year, according to a US Justice Department 

According to the release, the government charged that Altec paid its supplier and co-conspirator William D. Rodriguez approximately $55 million for prescription drugs that it knew had been diverted from lawful channels of drug wholesale distribution. The government alleged that Rodriguez first sent the diverted drugs to companies he controlled in South Carolina. His companies, in turn, resold the drugs to Altec, which, in turn, resold the drugs to various purchasers throughout the US, including drug distributors with valid drug distribution licenses. Eventually, the diverted drugs were bought by retail pharmacies, which dispensed the drugs by filling prescriptions for individual consumers. Altec admitted to falsifying pedigrees for the drugs to make it appear that they had come through legal distribution channels.

In June 2012, in US District Court in Miami, Rodriguez pleaded guilty to conspiracy and money laundering in a separate case charging him with, among other things, his role in this drug diversion scheme. He has not yet been sentenced, according to the release.

“Drug diversion undermines the safety and effectiveness of our prescription drug system,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division, in the release. He added, “When individuals divert drugs from lawful channels, we cannot be sure that the drugs are properly handled and stored.  As a result, diverted drugs could be expired, become contaminated, or have their mechanisms of action altered. Diversion is a serious crime that puts consumers at risk; we will continue to prosecute those who engage in it aggressively.”

South Carolina-based Altec Medical pleaded guilty to one count of conspiring to defraud FDA and to commit federal offenses in connection with a drug-diversion scheme that lasted from 2007 to 2009.