Thursday, July 24, 2014

New Tool to Help Analyze Immunogenicity

The FDA suspended a clinical trial for a Factor IX protein in 2012 but a new web-based tool may help avoid that very issue in the future.  In a collaboration between Dartmouth, University of Rhode Island and EpiVax Inc., researchers have developed a tool that will help manufacturers of protein-based therapeutics improve the safety of their manufacturing process.  The tool, known as CHOPPI (CHO Protein Predicted Immunogenicity), predicts the product associated impurities will trigger an adverse response in patients.

Protein therapeutics are frequently produced in host cells such as CHO cells. These hot cell proteins have been known to contaminate and ultimately damage the final product.  The immunogenicity of a CHO protein is generally low based on the fact that it’s very similar to a human protein. However, some believe that “any protein is potentially immunogenic”.  The tool is expected to help predict these immune responses of these host cell proteins and ultimately aid protein engineers in accurately assessing the purity of the final product.

Immunogenicity Responses Analyze Predict Tool
Said Greg Paquette, Director of the Biotechnology and Medical Laboratory Science Programs, at URI, "The purity of these complex genetically-engineered therapeutic agents continues to be one of the biggest challenges for the biotechnology industry.”

More details can be found on this new tool in this Biotechnology and Bioengineering report.

Want more on the latest in immunogenicity?  Join us at Immunogenicity for Biotherapeutics conference this October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

SAVE $100. Register here and use code XP1969BLOG.

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Biosimilars: The (Brand) Name Game

What’s in a name?  A lot if you’re talking about biosimilars.  The FDA recently received a letter from a 32 member coalition consisting of major pharmacies, health insurers and unions asking that they not require biosimilars to be given different names than biologics.  The group claimed that with distinct names for biologics and biosimilars, there’s an increased risk for medication errors as well the potential to slow the adoption of cost-saving drugs. 

The letter states, “Requiring different INNs (International Nonproprietary Names) for biologics and biosimilars could lead to patient and prescriber confusion, increasing the possibility of medication errors, and would also effectively separate the biosimilar from existing safety information about the underlying molecule.”

This request comes less than a year after the US Senate made a similar request to the FDA.  The letter from the senate states that “There is already a precedent for shared names (e.g., erythropoietins, somatropin, interferon), which has not resulted in any known issues.”  The more recent letter reiterated that argument and while also pointing to the fact that shared INNs have been successfully applied in the EU, Canada, Australia and Japan. 

There is also a concern that unique names could confuse both patients and prescribers and potentially hinder the adoption of these biosimilars and the cost savings associated with them.  The letter states there is anywhere between $42 billion and $108 billion in savings at stake over the first ten years of the biosimilar market. 

One group not on board with utilizing the same INNs?  Brand name drug manufacturers.  A distinct marketing advantage lies within these names and drug manufacturers are not willing to share them.  They claim that having unique names would make it easier to track adverse events in patient records—A claim refuted by generic drug makers who say these events can be identified through national drug codes.

While they’ve yet to institute a naming policy, indications are they may be waiting for a cue from the World Health Organization.  The INN System is overseen by the WHO, however its recommendations are not mandatory.

We’ll have more on latest in the biosimilars industry at the Business of Biosimilars  conference. Join us October 20-22 in Boston, MA. Download the agenda here to see what’s on tap.

SAVE $100Register here and use code XP1986BLOG.

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Wednesday, July 23, 2014

Vaccine Development Advancing Due to New Technologies

Vaccine development may significantly improve as technology on the fields of antigens, genomics and immunological monitoring advances. The report published in Nature Immunology stated that a focus on the human immune system will overcome the challenges posed by the animal immune system. The team that wrote this report stated that a leveraging of this technology will provide a better
understanding of specific antigens need for protective immunity.

According to WRAL Tech Wire, North Carolina has emerged as the world leader in vaccine development. It is home to two of the world’s most advanced vaccine manufacturing factories, built by the federal government to be the first responders when diseases are spread. North Carolina has a total of 28 vaccine companies that are employing a total of 13,000 in development or manufacturing

Accelerating HIV vaccine discovery and development may require paradigm shift according to twelve national and international experts in HIV and non-HIV vaccine discovery and development. These experts exchanged information from the perspectives of basic science, regulatory affairs and industry at the Canadian HIV Vaccine Initiative (CHVI) Research and Development Alliance Coordinating Office (ACO) Annual Meeting held in St. John's, Newfoundland on May 1, 2014. "HIV vaccine research and development requires a collaborative, global effort where researchers, funders and industry work together towards a common goal," says ACO Director Greg Hammond according to CNW. "HIV vaccine research and development may further benefit from closer ties to the research and development communities of non-HIV vaccines, where there is much in common and mutual benefits may be expected."

This October at BioProcess International, we'll have a variety of sessions looking at the biopharmaceutical manufacturing and drug discovery of vaccines including the sessions "Biomanufacturing Strategies to Prepare for the Pipeline of the Future" presented by Philippe-Alexandre Gilbert, Ph.D., Head of Upstream Development, Novartis Vaccines & Diagnostics, Inc, "Innovative Characterization Methods to Identify an Optimal Vaccine Drug Product Formulation" presented by Merck Research Labs and more. For more information on these sessions and the rest of the program, download the agenda.  If you'd like to join us, as a reader of this blog, when you register to join us and mention code BPI14BLOG, you'll save 20% off the standard rate.

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Tuesday, July 22, 2014

Top Ten List of Analytical Inadequacies in IND and BLA Submissions

Today, we feature a presentation from the 2013 Well Characterized Biologicals event. Last year, Alfred Del Grosso, Team Leader, Analytical Chemistry at FDA/CBERTop presented Ten List of Analytical Inadequacies in IND and BLA Submissions.

So what are the Top Ten List of Analytical Inadequacies in IND and BLA Submissions?
1) Procedural Details
2) System Suitability Tests
3) Representative Instrumental Outputs
4) Types of Validation Characteristics / Test Categorization
5) Linearity in Matrix
6) Verification of “Compendial” Procedures
7) Robustness of Critical Assay Parameters
8) Accuracy Calculations
9) Evaluation of Range
10) Choice of Factors in Intermediate Precision

Why?  Download Del Grossso's full presentation here.

This year's perspectives from the FDA come from Lokesh Bhattacharyya, Ph.D., Lab Chief, Laboratory of Analytical Chemistry and Blood Related Products, Division of Biological Standards and Quality Control, CBER, U.S. FDA in the presentation New FDA Draft Guidance on Analytical Procedures and Analytical Method Validation for Drugs and Biologics.  For more information on this session, download the agenda.  If you'd like to join us November 3-4 in Washington, DC for the Well Characterized Biologicals event, as a reader of this blog when you register to join us and mention code XD14193BLOG, you can save 20% off the standard rate.

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Friday, July 18, 2014

Full Program Now Available for Antibody Engineering & Therapeutics 2014 Meeting

The final agenda is now available for IBC's 25th Annual Antibody Engineering & Therapeutics meeting, taking place on December 7-11, 2014 in Huntington Beach, CA.

Accelerate your antibody research, discovery efforts and clinical programs by joining 750 of your colleagues at the #1 forum for academia and industry to connect for scientific exchange and networking in antibody engineering & therapeutics, immunobiology and next-generation binders.

Watch a 3-minute YouTube highlight video of last year’s meeting:

Why Do Attendees Return Year After Year?
  • - Find new antibody targets beyond the low-hanging fruit - strategies for targeting difficult antigens
  • - Learn about development strategies for ADCs, bispecifics, fusions, antibody combinations and other complex molecules/next-generation antibodies
  • - Exploit immune checkpoints for target discovery, new agent design and preclinical/clinical development
  • - Engineer improved antibody developability - expression, solubility and polyreactivity
  • - Develop antibody therapeutics for multiple non-cancer indications including diabesity, autoimmune disease and multiple sclerosis
  • - Get the latest data and lessons learned from numerous preclinical and clinical antibody therapeutic projects
As a reader of this blog, when you register to join us in Huntington Beach and mention code XD14172BLOG, you'll save 20% off the standard rate.  Have any questions or want to get involved?  Reach out to Jennifer Pereira.

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Thursday, July 17, 2014

The history of bioprocess manufacturing

Recently, BioProcess International Sponsors Thermo Fisher Scientific published a video that looks at the timeline of bioprocess manufacturing. Highlights include when the first cell was discovered in 1663, the discovery of genetics in 1865, penicillin's discovery from fungus in 1928, the discovery of the double helix structure in 1953 and more.

Watch the video:

Thermo Fisher Scientific will participate in the BioProcess International Event this October in a variety of ways including the presentation Single-Use Systems – Expanding Platforms from Daniel Nelson, Integrated Solutions Product Manager, CaptureSelect™ Technology: Introducing One-Step Selectivity in the Purification of Biological Products from Frank Detmers, Ph.D., Director Ligand Application, Bioproduction, and more. Find out more about these presentations and the rest of the program by downloading the agenda. Would you like to join ThermoFisher Scientific this October 20-23 in Boston? As a reader of this blog, when you register to join us and mention code BPI14BLOG, you'll save 20% off the standard rate!

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Wednesday, July 16, 2014

Biosimilars Challenges Facing US Companies

Estimates for biosimilar approval in the United States range anywhere from two to five years, but that may only be the start of some considerable challenges for US drug makers. 

The global market for oncology biosimilars is expected to boom over the next few years and predictions have that market alone generating between $6 and $12 billion by 2020.  A recent IMS report predicts the US will have a direct impact on the global reach of these products and this potentially lucrative business.  Explains the author of the report, “The US is the largest biologic market by size, and is pivotal to the success of the overall biosimilar market.”

Biosimilars Challenges Facing US Companies
But if the U.S. is to become the factor everyone expects, it will not be without overcoming their share of obstacles.  The report found the US to be trailing the rest of the world in biosimilar development primarily due to a complex regulatory process.

Said Javier Coindreau, MD, vice president of global medical affairs for Pfizer Biosimilars Business Unit, in a recent interview with Specialty Pharma Times:
“One of the most important roadblocks is clarity in the regulatory pathways. The pathways are evolving all the time, and this is especially true in the biosimilar world. The current regulation doesn’t provide the needed clarity for specific molecules. One of the most challenging parts is when we submit drug submission packages with the best analysis finding the best chance for being approved, sometimes we struggle in identifying what exactly are going to be the demands of the regulatory agencies because the current regulations have many grey areas that need to be clarified case by case.”

Among other obstacles are the struggle in proving a biosimilar is the same product as the name brand.  Not only is it difficult to prove that a biosimilar is the same product as a name brand, but the process of proving that similarity is not well defined. 

Coindreau cited another reason that’s overlooked by many.  Difficulty in recruiting patients for clinical trials is an obstacle not just for US drug makers, but for global companies as well.  He discussed the idea that patients would be more apt to enter a trial for a new treatment as opposed to one that is supposedly the same.  “They think if I’m going to enter a trial, I’m going to do it for a new molecule not something that’s the same as the previous one,” he said. 

Whether the approval for biosimilars in the US is two years from now or five years, there’ll be a host of challenges for drug companies.  We’ll have more on those challenges at the Business of Biosimilars conference.  Join us October 20-22 in Boston, MA.  Download the agenda here to see what’s on tap.

SAVE $100. Register here and use code XP1986BLOG.

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STEM Chat: Dr. Uma G. Gupta, Founder and Executive Director of

Today,we continue or highlight on the Women of STEM. Dr. Uma G. Gupta, founder and executive director of is today's guest.  She'll be joining us this October in Waltham, MA for our Women in STEM event.

Here’s what Dr. Gupta had to say:

IIR: What’s your favorite part about your job in STEM?
Dr. Gupta: It gives me an opportunity to help people solve complex problems. I have to continuously learn from others in order for me to improve my own thinking and problem-solving skills. Every day opens up a world of possibilities.

IIR: How and why did you decide to go into STEM as a career?
Dr. Gupta: At one point in my life, it seemed like the best path forward to economic security. However, once I got into it, I loved it. There were not too many women in the field and I had an opportunity to work with thinkers and those who had very different academic and life experiences than I did. I stayed in the field because I loved it and saw the possibilities for making a difference in the world.

IIR: Why is it so important today to broaden the diversity of the STEM workforce?
Dr. Gupta: What does any organization want? They want to achieve their mission and win in the marketplace whether it be a profit or not-for-profit organization. In order to do this, one has to be creative and innovative in order to survive and to achieve a competitive edge. At the heart of creativity is diversity. The more we are exposed to different ideas and experiences and perspectives, the more creative we become. This is backed by compelling and irrefutable evidence that diverse teams and organizations are more productive, generate more profits, and weather market storms much better than organizations that are not committed to diversity. STEM workforce, or for that matter any workforce, benefit from the influx of creative ideas and experiences that a diverse team brings to problem-solving and critical thinking.

IIR: Where do you see the Women in STEM industry in 10 years?
Dr. Gupta: I see the next generation as being creative. They easily and readily disrupt traditional models of business. They have the potential to make gender a non-issue. This is my fond hope and dream that the discussion will shift from gender to talent.

IIR: What do you see as the biggest obstacle for Women who work in STEM? How can it be overcome?
Dr. Gupta: The biggest obstacle I see is that women tend to under-estimate themselves. Women must build and expand their confidence levels. They must be go-getters. They must step forward and take on challenging assignments, even if they don’t have all the skills, experiences, and talents that the job may demand. They must lead with grace and power.

IIR: What can we expect from your session at the event, “Broadening the Breadth of the STEM Workforce through Racial and Ethnic Diversity”?
Dr. Gupta: Everyone knows and agrees that diversity is important. I will focus on three things that organizations can do to break through this barrier. My recommendations will be based on research findings from the world of neuroscience and it will show how we can make better decisions and follow through on these decisions to effect change.

The Women in STEM Exchange Summit in Boston will bring together women in STEM professions this fall. For companies, the summit provides the opportunity to make one-to-one connections with potential employees, feed mentoring and internship pipelines, maximize ROI of K-12 STEM investments, increase STEM retention rates, and promote initiatives in support of women in the workplace. For college students, the summit provides an opportunity to learn about corporate internships, mentoring programs and the many rewarding career paths that are open to STEM educated young women.  Find out more about Dr. Gupta's session by downloading the agenda.  Head to our webpage to find out more about the event and register to join us.

This post is co-posted with the Women in STEM blog.

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Tuesday, July 15, 2014

Cell Line Development: MicroRNAs in a Commercial Process

A few weeks ago, we wrote about an interview with Dr. Niall Barron, who’ll be speaking at this year’s Cell Line Development & Engineering conference, in which he explained why researchers should be paying attention to MicroRNAs.  Given that an estimated 50% to 70% of all protein encoding genes are under the control of MircoRNAs themselves, it’s clear that these molecules should be peaking the interest of researchers.  But how can they be leveraged in the commercial sense?  We go back to Dr. Barron for the answer.

How might they be implemented by industry in a commercial process?

Dr. Barron: So, as I mentioned previously, there are two main approaches. Ideally, an industry would use this technology before going through regulatory submission. So, with a new cell line making a particular product of interest, a cell line would be manipulated stably by using something like the technology I just described. For instance, over expression sponge that would target the microRNA of interest, or indeed, over expressing a short hairpin that will mimic the microRNA of interest if over expression is desired. So, that forms a stable cell line that can act as the parent, into which the product gene or the transgene is placed and that would go through the normal regulatory process.

The alternative in existing process where full regulatory submission is not desirable would be to add either mimics or inhibitors, which are short molecules that are typically complexed with some kind of transfection reagent and that can be fed directly into the culture medium where it is transported across the outer cell membrane to mediate its effect directly in the process.

You can hear the complete interview with Dr. Barron here, or you can download the transcript included in our brochure here.

Get the latest from Dr. Barron and other industry experts at this year’s Cell Line Development and Engineering conference, September 8-10, Berkeley, CA.  Now, SAVE 20% off the standard rate*.  Register here and use code XB14189BLOG.

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Top Three Biobanking Challenges Today

The Memorial Sloan Kettering Center is known as the premier cancer research institute in the world.  Needless to say, their research team is well acquainted with some of the challenges the biobanking industry currently faces today.  Who better to provide the latest on the challenges in the field than Vinagolu Rajasekhar, a Senior Research Scientist working on live tissue banking with the Memorial Sloan Kettering Cancer Center and a speaker at this year’s Biorepositories and Sample Management Conference.  He filled us in on what he sees as the three biggest hurdles in the industry today as well as a couple of other minor obstacles. 

What are some of the challenges that you’re experiencing in your industry today?

Raj: I am glad that you brought up this very important point of the present context regarding functional biospecimens and biorepositories. In fact, this is not only the challenge that we face but it is also a challenge for all those striving to succeed in clinical translation studies all over the world.  Particularly as a team member of the Memorial Sloan-Kettering Cancer Center, which you all know as the world premier cancer research institute and also the cancer clinic, my perspective to this query is different from what one may normally expect from industries.

Developing durable and functional therapies against human cancers is the prime challenge for all of us. This is very difficult task to accomplish unless we have set up faithful pre-clinical experimental models that closely mimic that of real time patients’ situations.

Human tumors are generally composed of heterogeneous tissues, I mean multiple cell types within a single tumor mass.  So, it becomes important to comprehend well with the science behind the biospecimens we obtain. Present cancer cell line models and also genetically engineered mouse tumor models would never recapitulate the original patient tumor heterogeneity that we all have to deal with during the real time treatment situations. Particularly, as a Working Group Member of Biospecimen Science in the International Society for Biological and Environmental Repositories (ISBER), and also collaborating with Dr. Fay Betsou at the Integrated Biobank of Luxembourg (IBBL), I must also bring to the light that the most cancer therapeutics developed to date all over the world have also relied on the data obtained from conventional bio-repositories of flash frozen bulk tumor specimens, which might not represent the real time clinical situations.

First, human tumors are also dynamic organs.  Thus, they manifest variability in their tissue heterogeneity during cancer development within an organ. These also add up to inter- and intra- tumor heterogeneities among different foci of the same cancer within the same organ and within the same tumor lesion across the radius or from the center to the margins of the tumor. Therefore, flash frozen tissues are not harmonized specimens.  Studies based on these biospecimens would not reflect the real time patient situation. We are increasingly convinced of the significance of patient specific treatments for cancers from our personal experience with the laboratory bench and at the patient bedside.
Second, the conventional biorepositories are exhaustible and cannot be replenished. So now the prime challenge is to aim at developing live tumor banks that are continuously available, which is a sort of renewable or replenishable as harmonized biospecimens.
Towards this goal, I and Dr. John Healey, the Chief of Orthopedic Surgical Oncology are together developing various live banks of human tumors as viable biorepositories. These live bio-repositories are nothing but patient derived xenograft (PDX) models of human cancers. Here upon our internal review board approved consenting of the cancer patients, we utilize their surgically resected tumor specimens. We transplant the fresh tumor specimens into immunocompromised rodents (mice for example) and follow the development of tumor growth.
Essentially, here patient tumor tissues are transplanted into the mice whose immune system is genetically shut down to facilitate the tumor take-in, and the growth of PDX as clinically relevant experimental models. This approach will facilitate us conveniently harvest sufficient tumor volumes and functionally characterize these tumors at different developmental stages in vivo and in the laboratories. These PDX models would, on the other hand, generate the original patient tumor-specific heterogeneity in real time comparable to that of patient situation. Thus, these models form clinically relevant experimental models for carrying out functional pre-clinical studies. For example, any drugs we identify by screening for the sensitive compounds that affect the growth of the at least early PDX models are expected to be functional in the real patient tumor microenvironment.
Finally, this live biobanking approach can be also utilized in co-clinical trials in terminally ill patients as well as for sharing among different clinical research groups worldwide for facilitating simultaneous global collaborations with relevant tumor types.

In this process, we also encounter some minor technical challenges as well.

For example:  
1. Isolating cells from human tumors present more complex hurdles than that of from the so far relied mouse tumors.  
2. Each organ human tumor type is different from the other organ tumors within the same patient. For instance, the tissue of human brain tumor cannot be the same as another human breast tumor or a liver tumor. So, even to disassociate and extract these cells in functional from, we need to have sound experimental skills and intellectual expertise and a few others of minor importance that we can deal another time.

You can download the full interview with Vinagolu here.

You can hear more from Vinagolu as well as other leaders in the biobanking at the Biorepositories and Sample Management ConferenceDownload the agenda here to see what’s on tap.

SAVE $100. Register here and use code XP1998BLOG.
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Monday, July 14, 2014

IIR's 15th Annual Business of Biosimilars Brochure is Ready for Download!

The biosimilars industry is projected to grow $200 billion by 2015.  Are you ready to capitalize on it?  IIR’s industry-leading 15th Annual Business of Biosimilars is back this October 20-22, 2014 in Boston and we’ll show you how to capture that growth through:
  • •  Identifying business opportunities by analyzing the commercial realities of the market
  • •  Increasing market access by expanding your global footprint in the US, EU and emerging markets
  • •  Gaining clarity by understanding regulatory & legal considerations
  • •  Driving commercial success through proactive clinical development
Download the brochure for full details.

You can personalize your agenda here.

Save $400 when you register by July 25th.  Plus, you can save an extra $100 as a reader of this blog.  Register here and use code XP1986BLOG.

Questions? Reach out to me at

See you in October,

Mike Madarasz

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BioProcess International Podcast Series: Michael Keenan and Barry Walsh, Conference Producers

BioProcess International Magazine is releasing a series of podcasts over the summer to prepare for the BPI Conference and Exhibition taking place this October in Boston.  To kick things off, we're going to start by highlighting the interview with conference producers Michael Keenan and Barry Walsh.

In their interview, they discuss the new additions to the BioProcess International Conference Conference and Exhibition 2014 including cell therapy commercialization, raw materials, BPI Theater, early stage molecules, BPOG, the standardization of the single use industry and more. Other new topics that Michael and Barry are excited about includethe new focus on cell therapies and antibody drug conjugates, quality risk management strategy, and knowledge management.

They also share details on the new networking opportunities at this year's event including a visit to Pall Lifesciences, the Poster Hall and opportunities to meet the top bioprocessing companies in our Exhibit Hall.

Would you like to join us this October 20-23 in Boston at the BioProcess International Conference and Exhibition?  As a reader of this blog, when you register to join us and mention code BPI14BLOG, you can save 20% off the standard rate.

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Friday, July 11, 2014

STEM Chat: Courtney Tanenbaum, American Institutes for Research (AIR)

Today, we start our series which looks at the women that are making an impact in STEM in preparation for our first Women in STEM event this fall. Our first interview features an interview with Courtney Tanenbaum, Senior Researcher, STEM Marketing & Research Lead, American Institutes for Research (AIR).

The person who inspired me the most when I was growing up was my grandfather. He was kind, funny, always ready with a hug, and always inventing things—both in the kitchen and in his garage! As I got older, he also listened to all of my ideas with such thoughtfulness and interest; he truly made me believe I could accomplish anything I wanted.

To me, the greatest mathematician/technologist/scientist/engineer is Amelia Earhart. A woman who broke the mold, and inspired the adventurer in all of us!

If I could tell a young woman pursuing STEM one thing, it would be "persist".

If I could meet one person it would be Eleanor Roosevelt.

My favorite non-fiction book is "The Chosen: The Hidden History of Admission and Exclusion at Harvard, Yale, and Princeton" by Jerome Karabel.

My favorite fiction book is Jane Eyre. Although I was recently introduced to a different kind of love story, "The Dot and the Line: A Romance in Lower Mathematics." For anyone who loves STEM and appreciates the creativity and artfulness of science, this is a love story for you!

My favorite source of industry news is Science. The most recent edition is a special issue on the science of equity. I love how they bring to light how integral science and technology are for solving the world's biggest challenges.

To me a successful woman is a woman who is confident in herself, is meaningful in her work, and always willing to listen and learn more.

My favorite technological innovation is Facetime/Skype. Being able to interact with loved ones myself, and to share my son's growth, laughter, and playfulness, with those who are far away with more than just voice, is truly a gift.

In high school, I wish I knew that I actually was good at math and science.

When I first started to work in my field I never realized the issues of equity and opportunity in STEM, and how critically important exposure to STEM is early in one's life in ensuring the widest array of choices to all individuals. My dream project is visiting the schools and institutions that have successfully fostered STEM talent in neighborhoods and within communities that are too often overlooked or underserved in these fields; and then sharing their strategies and successes to motivate change in behavior, practices, and perceptions among others.

The best advice I ever received was if you don't understand something, ask!

In my free time I...Yikes?! What free time…when I do find some, I curl up with a big book (and not a kindle, but an old fashioned hardback or paperback)!

The best way to unwind after a long day is a nice long walk with loved ones or friends.

The smartest person I've ever worked with...There are too many to name just one! But, I recently attended the Advancing Equity in STEM Symposium in Washington, DC and the physics teacher from a STEM-focused charter school served on one of the panels. A fantastically smart woman when it comes to engaging youth in STEM, and someone anyone would be lucky to work with, I imagine.

My favorite city in the world is Seattle. Perhaps not as exciting as it sounds, but it reminds me of home and I love the water, the mountains, the food, and the coffee!

If I had a one year sabbatical, I would travel and read lots and lots of books.

The biggest misconception about women in STEM is that they are different than other women.

My tools of the trade are in broadening participation in STEM research, I find the most useful "tools" are attending events on the issue, reading diverse perspectives and ideas, and asking questions!

The biggest thing that has changed since I started in the industry is the emerging focus on changing STEM cultures and environments (rather than "fixing" individuals) to successfully engage a wider array of diverse individuals in the STEM community.

I'm happiest when I'm with family and friends.

I lead by sharing my passion and interest for the work with my team. I'm proud that I push myself to accomplish what is important to me in all aspect of my life—career, family, friends, and health.

The first STEM Summit will take place October 21, 2014 at the Center for Women and Business at Bentley University, in Waltham, MA. Find out more about the program by downloading the agenda.  Want to join us?  Register today.

This post is co-posted with the STEAM Accelerator blog.

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Thursday, July 10, 2014

Researchers Regenerate Cornea, Successfully Grow Tissue from Stem Cells

A team of Boston researchers has identified a way to leverage limbal stem cells in order to regenerate human corneal tissue—One of the first examples of developing tissue from an adult-derived human stem cell.  The research, a collaboration between Massachusetts Eye and Ear, Boston Children’s Hospital, the VA Boston Healthcare System and Brigham Women’s Hospital, provides hope for those with eye-damaging injuries or diseases. 

The loss of limbal stem cells, which help maintain and restore corneal tissue, is one of the leading causes of blindness. 

It’s long been known that limbal stem cells have powerful regenerative potential, but the issue has been locating these stem cells.  The breakthrough came when Markus Frank, M.D. and Natasha Frank, M.D., co-senior investigators on the study, discovered the existence of ABCB5 molecules in limbal stem cells as well as their role in the maintenance and survival of the cell.  Scientists were then able to leverage the ABCB5 molecule as a marker for these cells and more easily identify them.  

Stem Cell Therapy Research Tissue Grow
The Frank team then put this theory to the test on two groups of mice--A group with fully functioning limbal cells and those without.  Using the presence of the ABCB5 molecule, researchers were able to locate and then extract these cells from donor tissue and transplant them into the corneal tissue of one of the groups.  They found that this group of mice was able to re-generate fully functioning corneas.  

The control group was divided in two with half the mice being given limbal cells that were ABCB5 negative and half receiving no limbal cells.  Both of these groups failed to repair the damaged tissue.  This helped to confirm ABCB5 molecule status as being responsible for the regenerative properties of these stem cells.  

“ABCB5 allows limbal cells to survive, protecting them from apoptosis [programmed cell death],” said Markus Frank.  “The mouse model allowed us for the first time to understand the role of ABCB5 in normal development, and should be very important to the field in general,” added Natash Frank. 

What’s next for the team?  Said Frank in a Fox News interview, “For the first step, we’re really working towards an autologous graft in patients who are blind in one eye.  And then the second step, we’d really work towards using donor derived cells to transplant in a similar manner that may require immune suppression – but it may not.” 

What else is new in the field of cell therapy?  Join us for the Cell Therapy Bioprocessing conference, September 15-16, Boston, MA.  Download the agenda to see what’s on tap.

SAVE 20%* off the standard rate as a reader of this blog. Register here and use code XB14188BLOG.

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Wednesday, July 9, 2014

Delivering Safe, Effective Therapeutics: IIR’s Immunogenicity and Bioassays Conferences

Two events, one goal.

Bring safe and effective therapeutics to the patient faster with IIR’s Immunogenicity and Bioassays conferences. 

The complexity of developing effective biologic therapeutics require adequate analytical methodology to characterize both their physicochemical properties and biological activity. Reducing the risk of triggering unwanted immune responses must be considered early on in drug development. The events focus on the current practice of comprehensive characterization of biotherapeutics from their discovery through all stages of their development.

IIR invites you to join us October 20-22, 2014 in Boston, MA for two co-located events: 15th Annual Immunogenicity for Biotherapeutics and 10th Annual Bioassays and Bioanalytical Method Development.

Download the brochure to find out how to register for one or both events and see for yourself why these are two can't miss events.

Now, you can save $100 on the current rate for each event. Register here with code XP1938BLOG for the Immunogenicity for Biotherapeutics conference.  Register here with code XP1969BLOG for the Bioassays and Bioanalytical Method Development conference. 

Questions? Comments? Reach out at

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Distinguished Leaders in Biologics Development to Give Keynotes at BioProcess International 2014

IBC Life Sciences, the organizer of market leading events in drug discovery, diagnostics, biologics development, production and delivery today unveiled the headline keynotes for BioProcess International conference and exhibition, October 20-23 at the Hynes Convention Center in Boston, MA. This year’s keynote presentations feature several of the leading scientific leaders in the business of developing next-generation biologics. BPI is the largest annual event where all segments involved in the development and manufacture of biologics gathers to network, collaborate and learn about the most advanced bioprocessing methods.

Commenting on the drive for continual biological innovation, Ralph Lambalot, Ph.D., Vice President, Biologics Development, AbbVie said, “Bioprocess innovation plays a key role in responding to the economic and regulatory pressures on the BioPharma industry. Advances in our speed to market, product compliance, patient access and the patient experience all depend on continued innovation in our processes and capabilities.”

BPI 2014 keynote presentations feature:
  • - Understanding Complexity in Biological Systems through Big Data Analytics- Applications to Biosimilars and Novel Biologics presented by Ganesh V. Kaundinya, Ph.D., Co-Founder and Chief Scientific Officer, Momenta Pharmaceuticals.
  • - Delivering Innovation in Biotherapeutic Manufacturing: From Continuous Improvement to Disruptive Innovation, What Can Current Industry Trends Tell Us About the Next 10 Years? presented by Ralph Lambalot, Ph.D., Vice President, Biologics Development, AbbVie.
  • - Delivering on a Global Biopharmaceutical Portfolio: Biogen Idec's Strategy for Success through Innovations in R&D, Protein Development and Manufacturing presented by John G. Cox, Executive Vice President, Pharmaceutical Operations & Technology, Biogen Idec.
  • - Keeping the Patient's and Caregiver's Experience in Mind presented by Robert Mattaliano, Ph.D., Group Vice President and Head of Biologics, Sanofi-Genzyme R&D Center
  • - Biologically-derived Medicines on Demand for Battlefield Medicine presented by Geoffrey Ling, M.D., Ph.D., Director, Biological Technologies Office, DARPA.

BPI is the leading event covering the full bioprocessing spectrum including, cell culture, recovery and purification, formulation and delivery, manufacturing strategy, analytical and quality and new sessions for early-stage companies on moving quickly from IND to the clinic.

A major new attraction launched at BPI 2014 is the BPI Theater, specially designed to showcase the latest products and innovations from the industry’s leading companies and scientific pioneers.

Enhancing the productivity of BPI delegates is access to partnering360®, the largest online network of life science dealmakers. BPI delegates gain exclusive access to a BPI specific partnering360® networking tool enabling them to identify and schedule meetings with potential partners, and foster deeper engagement before, during and following the event. Significant partnering opportunities exist for biopharmaceutical firms developing new and improved biologics including mAbs, vaccines, ADCs, recombinant proteins, bispecifics, enzymes, biosimilars and cell therapies.

BioProcess International conference programming is held on October 20-23, 2-day training courses on October 21-22 and the exhibition is October 21-23. Complete details on this event can be found at or to receive a press pass or arrange an interview with a speaker, email Dawn O’Connor at

About IBC Life Sciences
IBC Life Sciences, a division of Informa, is your connection to the life sciences industry. Through conferences, webinars, podcasts and its suite of integrated marketing solutions, IBC Life Sciences delivers expert knowledge, valuable connections and customized offerings so customers can meet their goals.

IBC Life Sciences hosts the annual BioProcess International™ (BPI) Conference and Exhibition. The BioProcess International Conference & Exhibition is where the biologics value chain meets to do business. Each year BPI attracts over 1500 biologics industry leaders for four days of power networking and learning. No other industry event delivers the high-level connections and insight needed to accelerate your business. Use this preeminent industry platform to showcase your company, products and thought leadership. To get involved, visit

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Friday, July 4, 2014

BioProcess International Spotlight: Manufacturing Strategy

Learn how to maximize your efficiencies and cost savings across your manufacturing network through the implementation of disruptive technologies, operational excellence and new facility concepts, while remaining flexible to the production needs of a diverse pipeline of novel molecules in a multiproduct environment.
  • ● New Concepts in Biomanufacturing
  • ● BPOG Strategic Workstreams
  • ● Tech Transfer & Scale-up/Scale-down
  • ● Continuous Manufacturing
  • ● Single-use Applications & Town Hall Forum
  • ● Relaxing Environmental Controls in Facilities

The Evolving Landscape of Biomanufacturing
  • • Transforming Biopharmaceutical Manufacturing
    • >Randy J. Maddux, Vice President and Site Director, GlaxoSmithKline
  • • Biomanufacturing Strategies to Prepare for the Pipeline of the Future
    • >Philippe-Alexandre Gilbert, Ph.D., Head of Upstream Development, Novartis Vaccines & Diagnostics, Inc.
  • • Operational Excellence & Six Sigma Efficiency in Biomanufacturing
    • >Jonathan Blackie, Senior Director of Business Process Integration, BioMarin Pharmaceutical, Inc.
BPOG Strategic Workstreams: Progress and Industry Updates
  • • Capacity, Technology and Innovation Trends in a High Variety Product Portfolio World
    • >Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom
BPOG Strategic Workstream Updates
  • • Reflecting cGMP Requirements down the SUS Supply Chain
    • >Tony White, Director, BioPhorum Operations Group (BPOG), United Kingdom
  • • Continued Process Verification: A Model Plan Based on Cross-Industry Knowledge
    • >Brett Frohlich, Ph.D., Director of Bioengineering, Shire
BPOG Strategic Workstreams: Progress and Industry Updates (continued)
  • • Microbiological Monitoring for Biological Drug Substance Manufacturing - An Industry Perspective
    • >David Bain, Ph.D., Facilitator, BioPhorum Operations Group (BPOG), United Kingdom
  • • Raw Materials Variability: The Need for Supply Chain Collaboration, Transparency and Mutually Beneficial Relationships
    • >Matthew Muldoon, Sourcing Manager, Strategic Sourcing Raw Materials & Medical Devices, Bayer HealthCare LLC
Case Studies of Technology Transfer and Scale-up/Scale-down
  • • New Data: Revamping a Technology Transfer Process to Maximize the Efficiency of a Multi-product
  • Facility: Accommodating Transfer of Phase 1 Clinical to Commercial Process
    • >Jim McColgan, Director, Site Technical Services, Pfizer Global Supply
  • • Case Study * New Data: Overcoming Technical Challenges while Transferring a Bacterial Production Process into Manufacturing
    • >Rick St. John, Ph.D., Senior Group Leader, Purification Development, Genentech, Inc.
  • • New Data: Challenges during Scale Down and Up of E.coli Processes
    • >Britta Krampe, Ph.D., Process Engineering Manager, Roche, Germany
Continuous Processing for Manufacturing Sponsored By: Novasep
  • • Case Study * New Data: Progress towards Efficient Implementation of Continuous Upstream Processes in Early Development
    • >Daryl Powers, Ph.D., Senior Scientist, Early Cell Culture Development, Sanofi Global Biotherapeutics
  • • Case Study * New Data: mAbs for the Multitude by Automated Continuous Processing Enabled by Single Use
    • >David Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co Inc.
  • • New Data: Design and Optimization of Countercurrent Tangential Chromatography for Monoclonal Antibody Purification
    • >Andrew Zydney, Professor and Department Head, Chemical Engineering, The Pennsylvania State University
  • • Case Study * New Data: Using Continuous Precipitation for the Purification of High Titer
  • Monoclonal Antibodies
    • >Robert S. Gronke, Ph.D., Senior Principal Scientist, Biogen Idec
  • • Continuous Chromatography, A Multi-Angle Solution to Drive mAb Capture Step Costs Down
    • >Fabien Rousset, Ph.D., Deputy Director, Head of Biopharma Technologies, R&D, Novasep, France
  • • Case Study * New Data: ASAP: Toward a Fully Disposable Continuous Process
    • >Benoit Mothes, Pharm.D., Senior Scientist, DSP Process Development, BioProcess Science and Technologies, Sanofi
The Next Wave of Single Use Manufacturing: Closed Systems, New Technology and Cost Comparisons
Sponsored by: Life Technologies & Thermo Scientific
  • • Case Study * New Data: Biomanufacturing Using Solely SU Technologies - Case Study and Cost Comparisons with a SS Facility
    • >Venkatesh Natarajan, Ph.D., Senior Process Engineer III, Global Engineering Sciences, Biogen Idec
  • • UNICAN: Dual Capability in Single Use Bioreactor
    • >Edward Chan, Technical Specialist, Cell Culture Pilot Plant, Genentech
  • • Case Study: Disposables and Closed Systems Operation as Tools to Support the "Facility of the Future" Concept
    • >Berthold Boedeker, Chief Scientist, Bayer Healthcare AG, Germany
  • • Single-Use Systems - Expanding Platforms
    • >Daniel Nelson, Integrated Solutions Product Manager, Thermo Fisher Scientific
An Interactive Town Hall Forum on Standardization of Single-Use Systems: What is the Next Step for the Industry?
  • • Featuring updates from ASME BPE, ASTM, BPOG, BPSA, PDA, USP and ELSIE
  • Speakers and Panelists:
    • >Jay Ankers, Director of Technology, M+W Group
    • >Robert Steininger, Senior Vice President, Manufacturing, Acceleron Pharmaceuticals, Inc.
    • >Tony White, Director, BioPhorum Operations Group (BPOG), United Kingdom
    • >Jerold Martin, Senior Vice President, Global Scientific Affairs, Pall Life Sciences
    • >Bob Repetto, Senior Director, External Affairs, Pfizer
    • >Dennis Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corporation
    • >Douglas J. Ball, Research Fellow, Pfizer
  • Point-Counterpoint Session
  • • Challenges and Considerations around Relaxing Environmental Controls in Biopharmaceutical Facilities
    • >Kristin Murray, Director, GCMC Regulatory Affairs, Pfizer
    • >Stephen Reich, Director, Quality Systems & Compliance, Pfizer
  • • Point-Counterpoint Session: Challenges and Considerations around Relaxing Environmental Controls in Biopharmaceutical Facilities
  • Speakers and Panelists:
    • >Jeffrey Skene, Acting Chief, Monoclonal Antibodies Division, Health Canada
    • >Marc Pelletier, Ph.D., Director of Biotechnology, CRB Consulting Engineers
    • >Joel Gates, Director of Quality Assurance, Shire
    • >Alex Tschumakow, Director, Manufacturing, Shire
    • >Anastasia Lolas, Owner & President, Visionary Pharma Consulting LLC
    • >Smock, Biotechnology Quality and Technical Consultant
Find out more the sessions in this year's Manufacturing track along with the rest of the agenda by downloading the brochure. BioProcess International will take place October 20-23, 2014 in Boston, MA. As a reader of this blog, you are eligable to save 20% off the standard rate when you register to join us and mention code BPI14BLOG.

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2014 BioProcess International Awards: Nomination Deadline Extended

Important Bioprocess International Awards Announcement: Deadline extended: July 18, 2014

The nomination deadline has been extended by request from our readers and partners to better accommodate the upcoming holiday.

The 2014 BioProcess International Awards celebrate and recognize the outstanding people, organizations and technologies that have significantly changed, impacted, and advanced the efficiency of biotherapeutic development and manufacturing process ultimately allowing the industry to deliver better, more effective treatments to a global patient base.

Help us recognize the leaders in the bioprocessing industry, and nominate your company, colleague, mentor, customer or supplier today!
We will recognize the finalists, and the twelve winners will be announced on October 22, 2014, during the gala award dinner and ceremony at the BioProcess International Conference in Boston, MA.

If you have any questions or need assistance on the submission process please contact, Elizabeth Gormley at or 508-614-1475.

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Thursday, July 3, 2014

Vaccine production expanding in developing countries

BioProcess International recently took a look at the growing manufacturing demand in developing countries of vaccines. The big four Pharma companies are in control of the majority of the production of vaccines: Sanofi, Merck, GlaxoSmithKline and Pfizer.  With the world wide market valued at $30 billion a year, vaccines are in demand and widely considered a right and often create a healthier public.  As many governments are the only suppliers of healthcare in growing countries, they find the need to be able to produce these products within their borders so that they can reach their citizens.  New technologies are expanding the capabilities making vaccines affordable, quick and feasible in may of these countries.

Why is production in so many countries possible?  According to BioProcess International:
The great majority of those vaccines in the pipeline involve recombinant technologies, with bioprocessing and equipment much the same as for conventional recombinant proteins and antibodies. Vaccines in development include next-generation, follow-on versions of current products as well as new vaccines for diseases without curret available vaccines. Such diseases primarily affect populations in developing countries (e.g., dengue and malaria).

The technologies making this production possible are:
> Single-use/disposable bioprocessing systems, providing easier operation
> Modular/transportable bioprocessing facilities
> Novel expression systems/improved cell lines
> New purification technologies.

Read the full BioProcess International Article here.

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Celebrate America and Bioassays! Register Thursday & Friday and save 30% off the standard rate!

Let freedom ring! Celebrate America’s freedom and YOUR freedom to register for IIR’s 10th annual Bioassays and Bioanalyitcal Method Development with a 30% discount off the standard rate!*

Register here to join us and mention code XP1969JULY4 to take advantage of this discount.

The Bioassays event will take place October 20-22, 2014 in Boston, MA,
visit the website for full details. Don’t forget this event is co-located with IIR’s 15th Annual Immunogenicity for Biotherapeutics event—find out more here.

Have any questions? 
Email Jennifer Pereira.

*This promotion is only valid July 3 & 4, 2014.

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