Archive for the 'Industry conferences' Category

Big Pharma Leverages Early-Stage Risk with Innovative Options

In recent years, large pharmaceutical companies have launched a variety of initiatives to restock ailing pipelines and boost business performance including mergers and acquisitions, diversifying business portfolios to non-pharmaceutical products, downsizing, spinoffs, and entering the biopharmaceutical arena.

Whatever the approach, pharmaceutical companies want balanced portfolios with programs at various stages and risk profiles, says Melinda Richter, founder and CEO of San Francisco-based Prescience International in a BioPharm International podcast.

To date, most Big Pharma companies have partnered or acquired assets of biopharmaceutical companies with products in late-stage development, says Richter. However, as the availability of late-stage development opportunities shrink and the landscape becomes more competitive, Big Pharma is turning to more early-stage partnerships with academia and early-stage companies.

It is attractive to for the pharmas to go after early-stage companies because “by nature, they are smaller, they are nimbler, and they are willing to take the risks that the large pharmas just can’t. These small companies have to swing for the fences and they have to win. Pharmas have a lot to protect. They have to be more conservative,“ says Richter.

More scalable innovation opportunities are another part of the story, says Richter.

For example, last year, Merck announced a $90 million, seven-year commitment for the California Institute for Biomedical Research (Calibr), an independent, not-for-profit organization established to accelerate the translation of basic biomedical research to innovative new medicines.

However, for hands-on research, startup companies need laboratory and office space, as well as specialized equipment. Janssen Labs, located on the West Coast Research Center of Janssen Research & Development in La Jolla, Calif., offers short-term leases on wet laboratory and office space.  Tenants also have access to core research facilities and instruments.

The facility, operated by Prescience International, has a “no strings attached” policy. Janssen R&D does not take an equity stake or first right of refusal in the work of tenants, protecting the entrepreneurial rights of startup companies that choose independence.

Janssen Labs and Calibr are two options offered by Big Pharma that will be explored in the session “And Now for Something Completely Different: How Will Pharma Access External Early-Stage Innovation?” at the 2013 BIO International convention on April 23, 2013.

Opportunities and Challenges in the Development of Stem-Cell Therapies

Stem cells are being developed to treat a diverse set of conditions, including spinal cord injury, amyotrophic lateral sclerosis, macular degeneration, Parkinsons disease, and Type I diabetes. But the challenges in moving from the laboratory to the clinic are formidable.  The California-based biotech company, Geron, pioneered clinical trials using embryonic stem cells, with a Phase I trial using oligodendrocyte precursors derived from embryonic stem cells to treat spinal cord injury approved in 2009. In November 2011, however, Geron announced it would be discontinuing all of its stem-cell development work, citing cost and regulatory complexity as factors in that decision.

At the BIO International Convention, a panel will convene to discuss the current landscape for developing stem cell therapies in a breakout session titled Opportunities and Challenges in Developing Innovative Stem Cell Therapies. BioPharm International spoke with one of the session’s presenters, Dr. Armand Keating, Epstein Chair in Cell Therapy and Transplantation, University of Toronto about the challenges facing developers.  According to Keating, funding remains the biggest challenge in moving from laboratory to clinic.  He points out that unlike small-molecule development, stem-cell development is still very much rooted in academia. The traditional sources of funding available to academics are ill-suited or inadequate to fund preclinical validation studies, manufacturing scale-up studies, or the clinical trials themselves. While an organization such as the California Institute for Regenerative Medicine is able to provide some funding   for early-stage clinical trials, later-stage trials will be far too expensive to be carried out at academic research centers, he says.

Clarification of statement in podcast: There have been approximately one million bone marrow transplants performed worldwide since 1959.

Experts at Symposium Promote Quality by Design for Analytical Methods

Representatives from Merck, Pfizer, and Novartis shared their recent efforts in applying quality-by-design (QbD) concepts to analytical methods, and Todd Cecil from USP explained the related new draft USP chapter in a symposium at Pittcon on Monday, March 18, 2013. The session, “Understanding Analytical Method Variance and the Impact for QbD Filing for Pharmaceutical Products,” was sponsored by the American Chemical Society’s Division of Analytical Chemistry (ACS ANYL) and the American Association of Pharmaceutical Scientist’s  Analysis and Pharmaceutical Quality Section (AAPS APQ). Read more »

The Next Horizon: Single-Use Technologies for Finished Drug Product Manufacturing

Patricia Van Arnum PharmTech editor Biopharmaceutical production is an often discussed application for single-use technologies, but single-use technologies also have application for small-scale finished drug-product manufacturing for producing clinical-trial materials. An educational webcast by Pharmaceutical Technology, “Accelerate Sterile and Non-Sterile Clinical Trial Manufacturing with Single-Use Technologies,” on Wednesday Mar. 6th examines this application. Read more »

Implementing FDA’s New Process Validation Guidance

Amy RitterIn January, 2011, FDA released its guidance, Process Validation, General Principles and Practices, describing process validation practices based on quality-by-design principles. At the IBC Biopharmaceutical Development and Production conference held this week in Huntington Beach, California, scientists described how their companies have been working toward implementing the guidance for the production of biopharmaceuticals.
Vijay Chiruvolu, director of corporate validation at Amgen discussed his company’s current process validation practices. Amgen, he explained, was somewhat ahead of the game, having worked toward implementing a data-driven and risk-based approach to process validation before the guidance was finalized. For the past 10 years, Amgen has taken a lifecycle approach to process validation, by beginning to plan process validation strategies during the early phases of process design and by continuing to update the plan throughout the lifecycle of the product. Process validation, he explained, is not a once-and-done activity, but should be adjusted as process understanding improves over time, or as expected or unexpected process changes require additional validation.
Peter Calcott, president of Calcott Consulting, weighed in with what the guidance means for small companies. Big biotechs like Amgen can devote a lot of resources towards risk assessment, process understanding, and developing a risk-based process validation plan, but smaller entities that outsource some or all of their process development and manufacturing activities will likely not have the staff or knowledge necessary to implement the guidance on their own. Calcott said he is commonly asked how much effort a company should spend in implementing the new guidance, and his advice, he says, depends on what the company’s business model is and where in the development cycle they are. For example, companies in early stages of development that expect to sell the compound to a larger entity for development need not concern themselves with the guidance, with the expectation that process validation will fall to someone else. A company that expects to manufacture and perhaps market the compound itself, however, should invest the time and resources to develop a compliant process validation plan.

Informex Perspectives: Still a Small-Molecule World

Patricia Van Arnum PharmTech editor As fine-chemical producers, custom manufacturers, and pharmaceutical companies gathered this week for Informex in Anaheim, California, one observation stands out: for all the inroads that biologic-based drugs have made, the pharmaceutical industry remains a small-molecule marketplace. Read more »

From Raw Materials to Lifecycle Management: IBC’s Biopharmaceutical Development and Production Week

Amy RitterAt the end of February, sunny southern California will be the site for a week-long conference devoted to the development and production of biopharmaceuticals. Read more »

Roche on Continuous Manufacturing at the PDA/EMA Joint Conference

VLUU L110  / Samsung L110Continuous manufacturing is now becoming a trend as its advantages are being increasingly recognized. At the PDA/EMA joint conference, which took place earlier this month, Martin Wunderlich from F. Hoffmann-La Roche presented an industry case study on solid drug product manufacturing based on this concept. He explained how a continuous wet granulation process for one of the company’s product (referred to as ‘product X’ hereafter) was developed using a quality-by-design (QbD) approach and a control strategy based on process analytical technology (PAT), as well as the technical challenges involved in the development of the process. Read more »

PDA/EMA Joint Conference on Process & Validation

VLUU L110  / Samsung L110On the second day of the PDA/EMA joint conference, we had a choice of three different topics, all running simultaneously: GMP inspection practice, process and validation, and challenges for EU harmonisation. I somehow found myself listening to Lina Ertle from the French national agency for medicines and health products (ANSM), who gave an update on process validation guidelines. Read more »

Real-time Data Aids Continuous Manufacturing

How to optimize continuous processing and make it work in pharmaceutical manufacturing is a crucial issue. Real-time devices for continuous feeding processes, among many other topics, were discussed at a seminar I attended last week. The seminar, “Advances in Pharmaceutical Processing”, was sponsored by K-Tron, which supplies material handling and feeding systems. Read more »

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