NEWSLETTER
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April 2008, Volume XVIII, No. 2
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ISPE Boston Area Chapter Members Make More Money and are Happier - Here’s Proof
Newsletter Archive
Hello ISPE Boston Area Chapter Members,
It's finally been proven beyond a doubt.
Members of the ISPE Boston Area Chapter
make more money, like their jobs better, and are
even happier people on average than their
nonmember peers. I'm not kidding.
A January ‘08 study out of Syracuse University
by Arthur C. Brooks, PhD, titled "Where the
Winners Meet" reviewed national surveys of
30,000 households to determine that, on
average, members of professional associations
make $10,000 more per year, are 47% more
likely to say they are "very satisfied" with their
jobs (72% versus 49% for nonmembers), and
are 25% more likely to say they are "very happy"
with their life (45% versus 36% for
nonmembers). These numbers were determined
after using regression analysis to hold constant
differences in job categories, disparities in
education, and all other relevant personal
characteristics. I have the 20-page study and
would be glad to send it to anyone who's interested.
Chapter President Rick Pierro
presenting at the March ISPE Conference in Tampa.
Now before you hit your boss up for a $10,000 raise because you're an ISPE Boston Area Chapter member, consider
this. The study further concludes that these significant differences are most likely based on reverse causation:
Prosperity, success and happiness at work encourage professional association membership because that's where
the "winners" meet in many professions. It doesn't conclude that membership necessarily causes these benefits but
rather that very successful professionals gravitate towards societies like the Boston Area Chapter to access
educational programs, identify themselves, network with their peers, and form mutually beneficial communities.
And there's more. The data also show conclusively that societies like the ISPE Boston Area Chapter can create value
for employers. Exposing high-value employees to the positive "winning" atmosphere of our seminars, tours and social
functions encourages higher morale which lowers attrition. The study concludes, "Thus it is in the interest of
employers to encourage high-value employees to participate in their professional associations."
So let me tell you about what the "winners" of the Boston area biotech and medical device industry are up to these
days. First I'd like to welcome Kevin Lynch, Director of Manufacturing at Shire Pharmaceuticals, to our Board of
Directors. Kevin has 16 years of direct experience in manufacturing proteins at Shire, TKT, and Genzyme and will
also participate in our Student Activities Committee. We look forward to Kevin's advice and guidance about how we
can best serve our membership.
In other news, several winning members of your Board of Directors, Vice President Doyle Johnson, Past President
Mike Denault, Dave Novak and your President, attended the National ISPE conference in Tampa, Florida this past
February along with 500 members from across the nation. In addition, the Board is working with National ISPE to
provide an in-depth, Boston-based educational program next year. Stay tuned.
Boston Area Chapter Officers join a winning team of NASAAC Members in Tampa.
March was a busy month. Along with 65 other ISPE winners, you might have participated in the festive, March 7th sell
out, ski outing to Sunapee where snow conditions were absolutely perfect. Or you might have attended the March
11th sell out, Millipore tour and program with 50 of your fellow ISPE winners. Or you might have attended the
fascinating "Everything You Always Wanted to Know About an FDA Audit But Were Afraid to Ask" presentation at
Biogen Idec on March 18th with a packed crowd of ISPE winners. The INTERPHEX show this year in Philadelphia on
March 25-27th was another major draw for local area ISPE winners.
Coming up on April 16th we have "S88 in Parallel Industries" at the Cambridge Sonesta, where experts will compare
batch control to that in non-FDA regulated industries. "Quality versus Engineering" will be the hot topic at the Talking
Shop (debate?) program at Genzyme, Framingham on April 22nd. And finally, on May 13th at the Spring Hill Marriot in
Devens, a Bristol-Myers Squibb presentation will discuss the largest ongoing biotech expansion in New England.
Be sure to sign up early for these programs because there are approximately 1250 ISPE Boston Area Chapter
Members ...winners...who may also want to attend. And if you're not yet an ISPE Member but feel that you're, on
average, more intelligent, appropriately better paid, and happier than your peers, then you probably belong in ISPE.
You'll feel at home here.
Sincerely,
Rick Pierro
President, ISPE Boston Area Chapter
With a special thank you to Doyle Johnson for his winning photos.
Upcoming Chapter Events - Mark Your Calendar
Tuesday, April 22, 2008
Talking Shop: The Love-Hate Relationship Between Quality and Engineering
Genzyme Corporation
Framingham, Massachusetts
Please join us for this unique roundtable discussion....
"Talking Shop" is an experienced based program and significantly more interactive than our traditional lecture type
formats. The goal of this program is to provide technical professionals the opportunity to discuss new technologies;
and share experiences, concerns, and problems with their peers. All who attend are encouraged to bring "lessons
from the field" and/or pesky challenges they currently face. Space is limited to 50 attendees to foster a comfortable
venue for open discussion and sharing.
MODERATED TALKING-SHOP TOPIC:
There are many factors involved in drug product and substance production. There are interdependent relationships
which impact operating philosophies, equipment and instrument maintenance, and the overall quality of the product.
This program will examine the everyday issues that Engineering, Validation, Operations and Quality professionals
experience in the pharmaceutical/biotech industry. Three panelists will lead this program and discuss several topics
which include:
z 1) System and Equipment Commissioning/Qualification Approach
z 2) The Impact of Shifting Philosophies for New and Existing Facilities
z 3) Interpretation of Good Engineering Practices
Click here for full information and registration form!
http://www.ispe.org/galleries/boston-files/ISPE-April-22-2008-Talking-Shop.pdf
Thursday, May 15, 2008
Putting Together a Project Team for World-Scale Bio Facility
Spring Hill Marriott
Devens, Massachusetts
Tuesday, May 20, 2008
Water Seminar
Royal Sonesta
Cambridge, MA
June 17, 2008
Facility Monitoring System Validation
Royal Sonesta
Cambridge, MA
August 18, 2008
Annual Golf Outing
Ferncroft Country Club
Middleton, Massachusetts
Wednesday, October 8, 2008
Annual Product Show
Gillette Stadium Clubhouse
Foxborough, Massachusetts
February's Joint Program with MIT's Professional Institute: Continuous Improvement
in Biologicals Manufacturing and Process Analytical Technology (PAT)
text and photos by Wes Hyman
In February, the ISPE Boston Area Chapter was very fortunate to have MIT Professor Charles Cooney address our
Members as part of a joint educational program with MIT's Professional Institute. Professor Cooney is a professor of
Chemical and Biochemical Engineering in the Department of Chemical Engineering at MIT. In addition to his
academic credentials, his extensive background in biotech includes consulting for a number of biotech and
pharmaceutical companies, serving on Genzyme's Board of Directors and chairing the FDA Advisory Committee for
Pharmaceutical Science from 2004-06.
Though it is impossible for me to capture the level of sophistication and technical detail Professor Cooney brought to
his topic, I will attempt an overview of the broad themes he conveyed during his presentation. His introduction to the
topic provides a good place to start:
A major challenge in biological manufacturing is continuing to improve the process while operating to maintain
regulatory compliance. There is a normal variation in biological performance; however, in the drive to assure
regulatory compliance and replicate the standard batch, we create a tension between learning from the variance and
seeking to eliminate it. Analytical technologies provide us with multiple lenses on the process to probe the
relationship between operating variables and process performance. The FDA's PAT initiative creates an atmosphere
in which multiple analytical tools can be leveraged for continuous improvement.
He then went on to highlight current trends in biologics manufacturing. From the clinical perspective, these include
ever-increasing molecular complexity, larger pipelines, increasing late-stage rejections of candidate drugs and
evidence of a more personalized medicine defining the smaller markets. On the regulatory side, there is an increased
focus on risk, heightened interest in understanding process science and a heavier regulatory burden from new
products and amended applications. Lastly, on the marketing side of the spectrum, he described an increasing
number of dosage forms, greater diversity of package inserts in global markets and pressure to reduce prices while
increasing access to the latest products.
While discussing the major challenges of process design and operation, Professor Cooney pointed out that metrics
and goals are very important. "We need to know where we want to go and have the analytics to measure where we
are (relative to our product specifications) and understand how the process affects the important properties of the
product." There is also uncertainty. He said we need to assess and reduce this uncertainty to an acceptable level to
manage risk across the value chain.
Professor Cooney described PAT as a system for designing, analyzing, and controlling manufacturing through timely
measurements (i.e. during processing) of critical quality and performance attributes of raw and in-process materials
and processes with the goal of ensuring final product quality.
Chapter Program Manager Mike Denault and Professor Charles Cooney
touch base prior to the presentation.
Attendee and Chapter Vice President Doyle Johnson was struck by the evolution of PAT "from simple measurements
of pH and cell density to more complex analyses of genetic information" as described during the presentation. With
this more advanced type of PAT, it should be possible to better ensure bioequivalency and lead to a greater pace of
innovation in biopharmaceuticals, according to Johnson.
When I spoke with Professor Cooney prior to his presentation, I asked him about the industry's acceptance for the
use of PAT. He indicated that while there has been slow acceptance of PAT, it is something the people can embrace
and should feel comfortable with while translating it into actual practice. He said PAT is being more rapidly accepted
by the larger companies, but could help the small firms even more. Biologic process development demands good
understanding and requires that you are able to measure what is going on in order to use PAT successfully, he
continued, and said he sees it as being an integral part of the future of biologics manufacturing.
In summary, the program was extremely timely and informative, and benefited greatly from Professor Cooney's
academic credentials and real world experience. Audience members paid rapt attention during the formal
presentation and followed up with a series of detailed questions that demonstrated the depth of their expertise and
intense interest in the topic.
Equally important, the event allowed attendees to trade information about PAT, its use within their own companies
and its evolution as a universally accepted continuous improvement methodology. And, as always, the networking
reception was well received (especially the lobster thermidor, chicken pot pie, and mac and cheese appetizers) and
provided a great way for people to interact with their peers and gain valuable industry insight.
Mt. Sunapee Welcomes Boston Area Chapter Annual Ski Trip
by Doyle Johnson with photos by Rick Pierro and the author
This year the (sold-out) ISPE Boston Area Chapter Ski Trip went to a new venue,
Mt. Sunapee in New Hampshire. Another difference was a new bus driver, Jack.
Jack went to Cornell University (alma mater of your humble author for this article)
and had no sense of direction, a characteristic we found curious for a bus driver.
Still, he was a pleasant enough chap and as long as we told him (repeatedly) how
to get there, it was no problem.
Well, almost. As we entered the Sunapee State Park, Jack told us that the bus
transmission had a problem and was refusing to shift. He planned to stop the bus,
shut it off, count to 10, and then pray that the transmission reset itself. As luck
would have it, Jack's prayers were answered and we did not end up having to walk
up the hill with all of our ski gear.
Jack, our intrepid bus driver,
went to Cornell
but had no sense of direction.
The Boston Area Chapter "ski team" atop Mt. Sunapee.
We arrived at the mountain in time to make the first tracks of the day and the conditions were super thanks to the
excellent job of grooming the runs the folks at Sunapee had done, plus the fact that it being Friday there were no lift
lines at all. The sun warmed the back side of the mountain first and softened things up just enough to create excellent
skiing conditions. We all stopped for lunch on the deck outside to enjoy the sun and the spicy chili.
(left to right) John Magyar (Parsons) and
Dan Rufo, Patrick Walsh and Paul Bergonzi (all MassBioLogics)
In the afternoon the front of the mountain was softer and we all made multiple runs up and down the Express Quad
and it's assortment of blue and black diamond runs. It was during this time that your author made a valiant attempt to
keep up with Mssrs. Crowley and Grunwald but to no avail! By 4pm we were all skied out and enjoying some
refreshments in the Horsefeathers bar, and by 6pm we piled back into the bus for our ride home (still telling Jack
which way to go: "No, Jack, 93 South!").
When you consider we had a great day of skiing, the company of some 56 fine people, lunch and after-ski drinks
plus a bus ride made only slightly longer by a few wrong turns, the $50 cost seemed an incredible bargain.
Relaxation, refreshment and camaraderie
followed a great day of skiing.
We hope that next year even more people take advantage of this ISPE Boston Area Chapter March tradition!
Let’s Get Together and Spread Out: Millipore R&D Center
by Joseph A. Naughton, AIA, LEED® AP with photos by Warren Patterson
The new Millipore BioProcess R&D Center in Bedford shows us how smart space design and equipment
management results in better work space and more of it. According to the company's Web site, the 110,000 square
foot building contains 47,000 square feet of lab space, consolidates multiple functions and fosters "an even more
collaborative approach for the up to 500 professionals who will work
there." About 50 ISPE Members from the
Boston Area Chapter gathered at the newly expanded campus on March
11, 2008 to learn more about the design process that created the new
facility and to view the results for ourselves during a comprehensive plant
tour. Our hosts included some very proud and gracious scientists from
Millipore and an equally proud contingent from ARC/Architectural
Resources Cambridge, the designers for the new facility. We began the
evening with some light hors d'oeuvres and good conversation in the new
dining/presentation room, which, even at dusk, was filled with an
abundance of natural light and views out to a carefully manicured natural
landscape.
Following a brief introduction by Educational Program Committee member
Dave Truex, ARC's Thomas Loring opened the evening with an overview
of the primary drivers behind the project, the internal team Millipore
mobilized to guide the decision-making process, and the external team
Millipore engaged to implement the plan. He then described the process
Millipore and ARC utilized to bring vision to reality in the relatively short
time frame of 22 months. The basic components of the planning process
A redesigned reception area welcomes
included: Master Planning in which goals and opportunities were
visitors to Millipore's new R&D Center.
identified, Program Development in which needs and consolidation
possibilities were investigated, and Schematic Design in which a number
of options were reviewed and converted into the optimal solution for Millipore.
The physical design concept at Millipore is essentially open labs versus closed, open offices versus closed.
According to Robin de la Parra, Millipore Director of Core Research Support and our host for the evening, the culture
prior to the expansion project was based on a closed lab and closed office solution so some skepticism surrounding
the effectiveness of the open concept was apparent. At the time the concept was first unveiled, she estimated that
only about 20 percent of the population was convinced of its benefits; today that figure is in the 80 percent range and
climbing.
Even our Millipore tour guide admitted that
she could count herself as part of the
original 20 percent club and was initially
tentative about the functionality of the open
configuration. While there are certain
advantages associated with the closed
office configuration, after approximately 8
months of working in the new facility, she
believes that the benefits of communication
and collaboration that are now evident
every day have moved her firmly into the 80
percent club.
The "parti," or the basic relationship of the
various spaces to one another, arranges the
office spaces in banks with a proportionate
number of one-on-one meeting rooms
opposite the lab zone with breakout areas in
centralized areas accessible to each
individual lab. These shared break-out areas
are marked by a double height
interconnecting lounge type area with open
stair connecting the floors and surrounded by
small, medium, and large conference and
presentation rooms. The color palette
throughout the building was rich with light
warm tones and subtle accents and an
interesting assemblage of bamboo, tile and
carpet for aesthetic interest and sound
control.
The
labs
were
Shared spaces replace individual bench labs in the bright new facility. grouped
into
bench lab pods adjacent to process lab pods, each linked by shared
instrumentation and equipment zones in central locations. In addition to
the shared instrumentation and equipment rooms, the building includes
a secured central store with inventory that is bar code stocked and
tracked. Scientists access the store with a security card and obtain
materials needed from the store by simply keying in the bar code on the
items needed; the system maintains a fully automated and up-to-date
inventory with automated purchasing support and a charge account to
each lab for materials consumed.
The beauty of both the shared instrumentation/equipment zones and
the automated central store is, that by centralizing these functions and
automating the scheduling and inventory of each respectively, Millipore
scientists have been able to move equipment and materials that used to
take up space inside the labs, out of the labs to free up valuable bench
and floor space that can be better utilized by people and their work. The
Millipore team proved that smart design, lean equipment management
and automated inventory and charge accounting has resulted in a better
working environment, allowing the many talented individuals who work
there to be even more efficient and productive than before.
In terms of real dollar impacts, because Millipore is working at higher
equipment utilization than before, their equipment purchasing needs
Process labs combine large, open shared
have declined from previous levels, improving their equipment budgets.
spaces and adjacent specialty, support
And the higher usable space that resulted in the labs meant that the 10and equipment rooms.
foot lab module is effectively more generous than in the previous model.
Translation: this building is bigger on the inside and smaller on the
outside which means the building cost less money for what is effectively more usable space.
We left the Millipore facility with many good impressions and we would like to thank our friends at Millipore for their
hospitality. The people who run the facility have shown how a careful planning and design process will yield impressive
results and an optimal facility solution. They were really able to get together and spread out.
Help Wanted: Boston Area Chapter Seeking Event Photographer
The Boston Area Chapter is seeking a local ISPE Member willing to attend Chapter educational and social events
and take photos for use in this newsletter, the Chapter website and other ISPE-related materials. Free attendance at
events will be provided. For more information, contact Chapter Manager Amy Poole at 781.647.4773 or
ispe@camihq.com.
Nanotechnology: A Key Trend in the Pharmaceutical and Biotech Industries
[Editor's Note: The following article has been reprinted from the Summer 2007 issue of the Carolina-South Atlantic
(CASA) Chapter Newsletter. Our thanks to CASA for sharing their expertise with Boston Area Chapter members.]
Nanotechnology: A Key Trend in the Pharmaceutical and Biotech Industries
by Martin E. Rock, P.E., J.D.
Substances with dimensions less that 100 nm often act quite differently from larger materials with the same chemical
or elemental composition. (For reference, a nanometer is one billionth of a meter; a human hair is about 80,000 nm
wide.) Nanomaterials are, by definition, designed and produced to have at least one dimension that is 100 nm or less
and include an array of engineered materials already in commercial applications as more than 350 nanoproducts are
already on the market. Such products range from deodorant to dishwashing liquid and from toothpaste to tanning
lotion.
The application of nanotechnology to the life sciences has been termed nanobiotechnology (Mazzola 2005). The very
small size and high surface-to-volume ratio of several types of nanomaterials make them ideal candidates for drug
delivery (Bianco et al. 2005; Colvin 2003; Hardman 2006; LaVan et al. 2003). The transition from calculating the size
of very small objects to manipulating them as needed defines the emerging field of nanotechnology. The things that
can be seen and done with nanometer-size objects are the subjects of nanotechnology research and development,
and a growing community of researchers is beginning to call themselves nanotechnologists.
By using nanotechnology, fundamental changes in drug production and delivery are expected to affect about half of
the $380 billion worldwide drug production in the next decade. Some examples of nanotech applications within the
life sciences and pharmaceutical industries include the following:
z Targeting of tumors with nanoparticles in the 50 to 100 nm size range: larger particles cannot enter the tumor
pores while nanoparticles can move easily into the tumor. (Currently, organic solvents are used to deliver
larger molecules and these solvents often make people sick.)
z Nanosized markers facilitating cancer detection in the incipient phase when only a few cancer cells are
present.
z Nanosizing enabling the use of low solubility substances as drugs, approximately doubling the number of
chemical substances available for pharmaceuticals (where particle size ranges from 100 to 200 nm).
z Increasing the degree of localized drug retention by increasing the adhesion of finer particles on tissues.
In addition, nanotechnology is rapidly emerging as an innovative answer to pharmaceutical industry formulation
challenges, including:
z solubility enhancements,
z reduction of R&D and manufacturing costs,
z quicker time-to-market (TTM) for new drug candidates,
z better targeting ability,
z potential lessening of side effects, and
z increased user-friendliness and convenience.
All of this is good news for cancer therapy. According to Dr. M.C. Roco, head of the National Nanotechnology
Initiative, "it's conceivable that by 2015, our ability to detect and treat tumors in their first year of occurrence might
totally eliminate suffering and death from cancer."
Others claim that nanotechnology will account for over $1 trillion in economic activity with employment for over a
million people by the year 2010. While not all of this investment would occur in the life sciences sector, the
importance of nanotechnology to the pharma and biotech industries is expected to be an important driver of growth.
The Role of the FDA
The following are issues anticipated by FDA pertaining to nanotechnology development:
z The likelihood that many of the nanotechnology products that the agency regulates will be combination
products (i.e., drug-device, drug-biologic, or device-biologic products).
z Because FDA regulates products based on their statutory classification rather than the technology they
employ, FDA's regulatory consideration of an application involving a nanotechnology product may not occur
until well after the initial development of that nanotechnology.
z Because FDA has limited regulatory authority over certain categories of products, the agency may have
limited authority over the use of nanotechnology related to those products. For example, there is no premarket approval of cosmetic products or their ingredients, with the exception of color additives, whether or
not they employ nanotechnology.
FDA has also formed an internal Nanotechnology Task Force. The new task force is charged with determining
regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated
products that use nanotechnology materials. The task force will identify and recommend ways to address any
knowledge or policy gaps that exist so as to better enable the agency to evaluate possible adverse health effects
from FDA-regulated products that use nanotechnology materials. According to FDA Commissioner Andrew von
Eschenbach:
As this exciting new area of science develops, FDA must be positioned to address both health
promotion and protection challenges that it may present. Through this task force, we are leveraging
our expertise and resources to guide the science and technology in the development of
nanotechnology-based applications.
Nanotechnology has been included under FDA's Critical Path Initiative designed to facilitate review of innovative
science and technologies (Sadrieh 2006). The FDA has previously reviewed products containing nanoscale
materials, such as sunscreens and cosmetics. Whether a new NM submission is categorized as a drug-device, drugbiologic or device-biologic product will determine which FDA Center will have jurisdiction regarding regulation.
General considerations for NM product approval include characterization, safety issues related to specific delivery
route (ie. inhalation, dermal, ingestion, injection), and environmental impact.
Environmental Health & Safety Issues
Investigators know relatively little about the hazards people may face if they eat food, breathe air, touch objects, or
drink fluids containing nanoparticles. A number of universities are researching these issues. Regulatory agencies
such as the Environmental Protection Agency, the Food and Drug Administration and the Occupational Health and
Safety Administration are closely examining whether new regulations are needed to guard against "potentially
harmful but currently unknown" effects, said Kevin Powers, associate director of the University of Florida, National
Science Foundation Particle Engineering Research Center.
The Toxic Substances Control Act (TSCA) is the federal statute presently receiving the most attention by EPA as it
considers how best to regulate engineered nanoscale materials. TSCA governs the manufacture of new chemical
substances and regulates uses of existing chemical substances that EPA has determined to be "significant new"
uses. A "significant new" use of a chemical substance that is already listed on the
TSCA Inventory is treated much like a new chemical substance and the new use is subject to EPA review in much
the same way EPA reviews a new chemical.
Nick Katov, associate professor of chemical engineering at the University of Michigan has stated that stable
nanocolloids and titanium dioxide "do exist currently in nature. However, we don't know what their circulation path is
and how it is affected by the influx of new materials." A key question is, "Can they become concentrated in humans or
animals?"
The total amount of research on nanotechnology issues is growing very quickly (see figure below) as the torch is
being passed from government-sponsored research to corporate and privately funded research for commercial
purposes.
Trends in the growth of nanotechnology research at the
National Science Foundation (NSF), 1991-2005.
According to the National Nanotechnology Initiative (NNI), the "understanding and control of matter at dimensions of
roughly 1 to 100 nanometers, where unique phenomena enable novel applications," is expanding rapidly. During the
next 5-10 years, the challenges of nanotechnology will increase in new directions. While expectations of
nanotechnology may be overestimated in the short term, the long-term implications on healthcare, productivity, and
environment appear to be underestimated.
The potential for nanobiotechnology and innovative nanoparticle/drug combinations as medical treatments is certainly
exciting. Clearly, those who work in this emerging field should have up-to-date information about related toxicology
issues, potential health and safety risks, and the regulatory environment that will impact patient use. Understanding
both the benefits and the risks of these new nanotech applications will be essential to good decision-making for drug
developers, regulators, and ultimately the consumers and patients who will use this new drug delivery technology.
Martin E. Rock, P.E., J.D., is a registered professional engineer (PE) with an M.S. in Environmental Engineering; he
is also a licensed attorney with a Juris Doctor in law. He is a graduate of the University of Michigan (Ann Arbor),
College of Engineering and of the Lumpkin School of Law at the University of Georgia (Athens). Rock serves as
President & Senior Principal with OMNI Professional Environmental, based in Research Triangle Park, North
Carolina. He served as President and Board Chairman of the ISPE Carolina-South Atlantic Chapter during 2006-07,
and he has been a member of ISPE for over 10 years.
Industry News In Brief
by Patti Charek
Shire Promises 680 Jobs with Expansion in Lexington
After months of playing coy, the British drug maker Shire PLC says it plans to go forward with a $394 million
expansion in Lexington that is expected to create 680 jobs over the next eight years, one of the largest economic
development projects in the state. The decision is a coup for Governor Deval Patrick, who has been aggressively
trying to encourage Shire and other life sciences companies to expand or move to Massachusetts. And it comes as
Patrick is pressing legislators to approve the $1 billion life sciences initiative he proposed last year.
Shire executives said they were already committed to going forward with a portion of their project in Lexington.
Shire's Human Genetic Therapies unit is based in Cambridge, but needs additional office and lab space nearby to
accommodate its rapid growth. Shire, however, threatened to build the centerpiece of the expansion project, a
pharmaceuticals manufacturing plant, in another state if Massachusetts didn't come up with an attractive enough
incentive package.
Shire plans to renovate several buildings (some of which were formerly used as Raytheon headquarters before the
defense contractor moved to Waltham four years ago) and build a manufacturing plant on Patriot Way in Lexington.
The company currently has about 675 employees in Massachusetts and expects to have 1,350 - mostly in Lexington
- by 2016. (Source: Todd Wallack, The Boston Globe, 14 February 2008)
New Stem Cell Bank at UMass Medical to Open in April
An effort by the UMass to establish a leading repository of human embryonic stem cells is slated to be completed by
April, according to UMass President Jack Wilson. The stem cell bank, to be housed within UMass Medical School, is
expected to store hundreds of embryonic stem cell types to aid in research and development of new treatments. "It's
really to establish Massachusetts as a global leader in stem cell research," Wilson said during a meeting at the
Statehouse. "It's also important because it will help us to attract talent to Massachusetts."
The Massachusetts Life Sciences Center, a state agency created in 2006, has approved $8.2 million for the stem cell
bank, and Kofi Jones, a spokeswoman for the state, said the agency and UMass are expected to finalize a contract
soon.
In 2001, President Bush placed strict limits on federal funding for stem cell research. He limited funded research to
already-existing stem cell lines derived from embryos created for reproductive purposes and no longer needed, citing
ethical reasons for his decision. In a recent development, researchers at the University of Wisconsin published
studies showing the ability to program the genes of human skin cells to produce cells in an embryonic-like state.
While the discovery has the potential to answer the ethical debate, many scientists remain committed to developing
treatments from stem cells taken from embryos. (Source: Ryan McBride, Mass High Tech, 1-7 February 2008)
Isis Licenses Cholesterol Drug Rights to Genzyme
Genzyme said it will license a promising new type of cholesterol drug from California-based Isis Pharmaceuticals and
could eventually pay Isis more than $1.5 billion in milestone payments and half the profit from its sales. The deal for
mipomersen, now in late-stage trials, is a validation of Isis' long quest to perfect a technology called antisense and
employ it in potential blockbuster medicines.
The deal for the product, which Genzyme first hopes to introduce for patients with a genetic tendency toward high
cholesterol, would entitle Isis to an initial 30 percent share of profits. Its profit share would rise to 50 percent once
global annual sales reach $2 billion or more. "We believe it could prove to be the most effective lipid-lowering agent
for high risk patients for whom conventional therapies are not sufficient," said Henri Termeer, Genzyme's chief
executive. (Source: Reuters, The Boston Globe 8 January 2008)
Drug Firms say Vytorin Same as Generic in Limited Study
Merck and Schering-Plough said their cholesterol pill Vytorin worked no better than an older, cheaper drug, in a study
that looked at a rare population of patients with extremely high artery-clogging LDL cholesterol. The companies have
three additional studies on Vytorin underway, involving more than 20,000 patients, that may resolve those issues. To
get US marketing approval, the companies needed only to show that Vytorin lowered LDL, a standard measure for
cholesterol drugs.
Schering-Plough spokesman Lee Davies said the Vytorin study wasn't definitive about whether the drug improves
outcomes because it was looking at a rare population of patients with extremely high artery-clogging LDL cholesterol.
"It was never intended to be a definitive study on outcomes," Davies said. "They both started at incredibly high LDL
levels, so the patients were not brought to goal. If they were brought to goal, they might have had different
outcomes."
(Source: Bloomberg News, The Boston Globe, 15 January 2008)
Study Says Schering Drug Subdues AIDS Virus
A research study sponsored by Schering-Plough shows that the company's new AIDS drug, designed to block the
virus from entering human cells, suppressed infections in patients who did not respond to older medicines. A
combination of drugs, including Schering-Plough's vicriviroc, held back the virus better than the combination of older
medicines alone, the study found. The findings were presented at the Conference on Retroviruses and Opportunistic
Infections in Boston.
Vicriviroc may become the second medicine, after Pfizer's Selzentry, in a new family of drugs that work by blocking
the CCR5 receptor, a chemical doorway the virus uses to enter human cells. The drugs promise to give doctors a
new weapon against resistant forms of the human immunodeficiency virus that causes AIDS. Vicriviroc, like Pfizer's
drug, works by altering the shape of a protein on the surface of healthy human cells, making it impossible for HIV to
get a good enough grip to enter. Before Selzentry won US approval in August 2007, the only so-called entry inhibitor
available was Fuzeon. Fuzeon, made by Roche and Trimeris, is an injectable therapy while both Vicriviroc and
Selzentry are pills.
HIV has proven to be a formidable foe for drug designers because of its ability to mutate, develop new strains, and
change its shape to force its way into human cells. The virus's attack begins when it attaches itself to a cell surface
molecule, called a receptor, and uses one of its proteins to force its way into the cell. (Source: Bloomberg News, The
Boston Globe, 4 February 2008)
Wyeth Plans Generic Protonix; Litigation With Teva to Continue
Wyeth has said it is introducing a generic version of its blockbuster drug Protonix, signaling that the company has
been unable reach a settlement with Israeli firm Teva Pharmaceutical Industries that would protect the heartburn
drug's exclusivity. Teva, a big generic-drug maker, is embroiled in a lawsuit filed by Wyeth claiming a violation of
Protonix's patent, which is set to expire in 2010. Teva introduced a generic version of the drug in December 2007,
eating into Protonix's sales, but then agreed to temporarily halt selling its product, known as pantoprazole, while the
companies engaged in settlement talks.
Protonix, one of Wyeth's top sellers, posted sales of $1.45 billion in the first nine months of 2007. Wyeth yesterday
said its generic version would be distributed by Prasco Laboratories, a closely held Cincinnati company. Wyeth
spokesman Doug Petkus said the company would continue its litigation with Teva and noted that Wyeth's move gives
Teva the option to resume selling its version of Protonix.
A steep drop in Protonix sales, which would be expected in the face of generic competition, would deliver another
blow to Wyeth, which has tried, unsuccessfully, to win approval of some new drugs, including Pristiq for menopause
symptoms and bazedoxifene for osteoporosis. Wyeth has said it is considering reducing its work force by about 10
percent in the next three years, as it grapples with generic competition as well as the drug-pipeline setbacks.
(Source: Sarah Rubenstein, The Wall Street Journal, 29 January 2008)
Inverness Set to Buy Matria for $900 Million
Inverness Medical Innovations, a Waltham-based maker of home pregnancy tests and fertility monitoring kits, said it
would buy Matria Healthcare for $900 million to expand its disease management business and focus on bringing
diagnostics into the home.
The acquisition of Matria would bolster Inverness' presence in disease management, where its focus is on women's
health, oncology, and cardiology. Matria offers specialized oncology services and is a leading provider of programs
for managing high-risk pregnancies. "What we're doing is improving the health and the life of the individual, while
simultaneously helping to reduce healthcare costs by getting the patient more involved in their own treatment plan,"
said Inverness' chief executive, Ron Zwanziger.
The deal is the latest in a series of acquisitions for Inverness which includes disease management company Alere
Medical, purchased in November for $302 million, and diagnostic tools provider Cholestech, purchased in September
for $326 million. Also in November, the company announced plans to buy Paradigm Health for $230 million.
Zwanziger told investors the company expects significant cost and revenue synergies as it combines Matria, Alere,
and Paradigm Health into a new health management division. (Source: Reuters, The Boston Globe, 29 January
2008)
NitroMed Halts Marketing of Drug
Lexington-based NitroMed is shutting down its effort to market and sell BiDil, the first drug approved for use in a
single racial group. BiDil entered the market in 2005 to great fanfare after it was cleared as a congestive heart failure
treatment for African-Americans. But the rollout of BiDil was stalled by insurers concerned about its price and doctors
who were skeptical that the drug, a branded combination of two generic drugs, was an improvement. Others
complained the lackluster sales of BiDil were evidence of continuing racial gaps in the health-care system.
NitroMed said it was discontinuing sales and promotional activities and eliminating 70 of the 90 jobs at the company.
The company will continue to make BiDil available for patients. It also has retained investment-banking firm Cowen &
Co. to advise it on strategic alternatives. NitroMed is still trying to develop a new version of BiDil, one that is taken
once a day rather than three times. It said it has received positive reaction to the new formulation from the FDA.
However, approval of a new formulation is still years away. (Source: David Armstrong, The Wall Street Journal, 16
January 2008)
Novartis Planning Four New Cancer Drugs
David Epstein, president of Novartis Oncology, said he hopes the drug maker will be able to start selling four new
cancer treatments by the year 2011. In an interview published in The Wall Street Journal, Epstein said he believes at
least one of four Novartis pipeline cancer drugs could eventually achieve blockbuster status, with sales of $1 billion or
more annually, if they are approved by the FDA.
The first new cancer drug Novartis aims to market is RAD001, Epstein said. The drug is being tested against
endocrine tumors and renal-cell cancer and has shown recent success in treating lymphoma. Other Novartis
oncology drug hopefuls include ASA404 for non-small-cell lung cancer, SOM230 for a rare group of neuroendocrine
tumors and LBH589 for cutaneous T-cell lymphoma. Novartis and its UK biotech partner Antisoma PLC hit a snag in
July when ASA404 failed in human tests against ovarian cancer.
Novartis' Gleevec, a treatment for chronic myeloid leukemia (CML), is the drugmaker's top-selling cancer drug and
second-best selling product overall with sales of $2.55 billion in 2006.
Novartis's focus on oncology products could eventually help the company recover from some of the hits suffered by
key products in 2007. (Source: Stephen McGuire, Medical Marketing & Media, 5 December 2007)
Dyax Signs Potential $500 Million License Deals for Sanofi-Aventis
Cambridge-based biotech Dyax Corp. has entered into a license agreement with Paris-based Sanofi-Aventis that
gives an exclusive worldwide license to them for Dyax's tumor-fighting monoclonal antibody DX-2240. The two firms
have also penned a second, nonexclusive license to Dyax's proprietary antibody phage-display technology.
The two agreements make Dyax eligible to receive up to $500 million in license fees and milestone payments if the
first five antibody candidates, including DX-2240, become commercial successes. Dyax is set to receive $25 million
in 2008. In addition, Dyax is eligible to receive royalties from commercial sales of DX-2240 and other antibodies
developed by Sanofi-Aventis. (Source: Mass High Tech, 15-21 February 2008)
Curis, Genentech to Move Cancer Drug into Phase 2
Cambridge-based Curis reported that its partner Genentech plans to move a drug candidate the two firms are
collaborating on into midstage development during the first half of 2008. The company said the drug candidate would
be aimed at targeting one or more types of solid tumor. The collaboration focuses on developing cancer treatments
based on Curis' technology. Curis will be eligible for a milestone payment when San Francisco-based Genentech
starts its Phase 2 clinical trial and is also eligible for future payments. (Source: Mass High Tech, 14-20 December
2007)
Acceleron's Celgene Deal Worth Almost $2Billion
Cambridge biotech Acceleron Pharma has struck a pair of deals with pharmaceutical firm Celgene that could bring
nearly $1.9 billion in payments to Acceleron. The two firms have agreed to jointly develop and market Acceleron's
lead bone-forming protein, called ACE-011, now in Phase 1 clinical trials. And Celgene has optioned three of
Acceleron's discovery-stage programs in a separate agreement.
In the deal related to ACE-011, Celgene has agreed to pay an initial fee of $50 million to Acceleron and to make a $5
million equity investment in the privately held Cambridge biotech. Both companies would share costs to develop
Acceleron's bone-forming agents, and Acceleron is eligible for $510 million in milestone payments as well as royalties
on potential sales of the proteins. Celgene, based in Summit, NJ, would also buy at least $7 million in Acceleron
common stock if the biotech has an initial public offering. The deal is subject to standard closing conditions.
Acceleron could also receive up to $1.3 billion in payments from Celgene in connection with the development of the
three discovery-stage programs focused on cancer and cancer-related bone loss. The biotech would also receive
royalties from Celgene on potential sales of the drugs. (Source: Mass High Tech, 22-28 February 2008)
RXi Pharmaceuticals Signs Lease at WPI Life Sciences and Bioengineering Center
RXi Pharmaceuticals has signed a 20-month lease at the Worcester Polytechnic Institute Life Sciences and
Bioengineering Center, with the option to become the lead tenant of a future 100,000-square-foot building in the
construction planning stages at Gateway Park in Worcester. The company, founded by Nobel Laureate Craig Mello of
UMass Medical, is one of several firms that have signed on as potential future tenants of the rapidly expanding
Gateway Park.
RXi Pharmaceuticals was created to develop therapeutics for the treatment of human disease employing the RNA
interference (RNAi) technology co-discovered by Dr. Mello. RNAi technology can help determine the function of
particular genes in the body and also potentially lead to the development of new RNAi-based drugs. Using RNAi to
turn off defective genes opens the door for an entirely new class of drugs to potentially treat cancer, diabetes,
Alzheimer's, ALS, and many other diseases. (Source: Mass High Tech, 2-8 November 2007)
Teva Agrees to Buy CoGenesys, Gaining Foothold in Biologics
Israeli generic-drug giant Teva Pharmaceutical Industries has agreed to acquire CoGenesys Inc. for $400 million in
cash. The deal is likely to stoke the debate about the role generic-drug makers should play in the emerging market
for biological therapies.
CoGenesys, a closely-held spinoff of Human Genome Sciences, would give Jerusalem-based Teva a foothold in the
market for biologic therapies. Unlike "small-molecule" drugs, which typically are made through well-proven steps in
the form of pills, biologics are proteins manufactured in living cells. CoGenesys' pipeline of biologic drugs includes
treatments for cardiovascular disease, cancer and autoimmune disorders.
Biologic drugs have become a source of deep tension between biotech companies and generic-drug makers such as
Teva. The companies that develop the drugs argue that biologics are far harder to manufacture, and that it is very
difficult to show whether copycat versions are as effective. But that hasn't stopped generic-drug companies from
devoting significant resources to the development of generic biologics, which industry experts expect to enter the US
market in about five years.
To get there, the generic-drug makers will have to convince regulators and Congress that they are capable of
manufacturing the treatments with the same standards of quality and reliability as mainstream biotechs. Currently,
there is no legislative pathway for generic biologics to gain approval, though congressional efforts in this direction are
under way. (Source: Matthew Karnitschnig and Heather Won Tesoriero, The Wall Street Journal, 22 January 2008)
Genzyme's Framingham Drug Plant Set After Sewer Problem Resolved
Genzyme said it has resolved a problem with Framingham's sewage system, allowing the Cambridge company to go
ahead with plans to build a $260 million drug manufacturing plant there. The biotech warned late last year that it
might be forced to build the plant in another town or state, because Framingham's aging sewage and water system
would not be able to handle the added load from Genzyme's facility without a $12.9 million upgrade.
Though Framingham and Massachusetts officials both promised to work to secure state funding for the project,
company executives said they couldn't afford to wait much longer for the state to make a commitment. And even if
the funding eventually came through, Genzyme managers worried the sewage project wouldn't be finished by the
time the manufacturing plant was ready to open in 2010, prompting them to begin considering alternative sites.
But Genzyme executives said they believe they have found a solution - upgrading a small portion of the system first,
taking less time and for a fraction of the cost. Genzyme estimated the partial work - enough to support the plant would cost roughly $1 to $2 million. In addition, Genzyme officials said they have received a verbal commitment from
the Massachusetts Office of Business Development to provide $250,000 in interim funding to the town to immediately
begin design work on the sewage project, while state and local officials have pledged to keep working to secure the
rest of funding as part of Governor Patrick's $1 billion life sciences bill.
"We have arrived at a point where we are confident we can move forward with the project," said Henry Fitzgerald,
vice president of facility operations. He said the company is no longer considering building elsewhere.
Genzyme said the Framingham project would create 300 jobs and include 300,000 square feet of office, laboratory,
manufacturing and purification space. It would be similar in size to the plant Genzyme built in Allston 12 years ago,
before that plant was expanded. Genzyme already has 4,500 employees in Massachusetts, making it the state's
largest biotech employer. (Source: Todd Wallack, The Boston Globe, 19 January 2008)
Biogen Idec's Tysabri OK'd for Crohn's Disease
The FDA has given Biogen Idec good news about one of its key drugs: Tysabri, a treatment for multiple sclerosis,
won approval for use against Crohn's disease, another debilitating illness.
The move comes six months after an FDA advisory panel voted 12 to 3 to recommend the drug's approval to treat
some forms of Crohn's, a chronic inflammatory disease of the intestinal tract.
Biogen Idec temporarily shelved the drug three years ago after it was linked to a rare brain disease. The company
says there have not been any additional cases of the disease since sales resumed in 2006, with new guidance on
how it should be used. But some doctors remain wary of the treatment, even though it has been shown to be highly
effective in some patients.
The FDA decision does carry some caveats. Specifically, the agency approved the drug to treat patients with
moderate to serious cases of the disease who can't be treated effectively with other drugs, such as steroids. The
label will also carry safety warnings to reduce the risk that patients will contract the brain disease or other infections.
Despite the safety concerns, Biogen Idec has predicted Tysabri will eventually become a major source of revenue.
This month, the company reaffirmed predictions it will be used by 100,000 patients by the end of 2010, up from more
than 21,000 at the end of 2007.
About 500,000 people in the US suffer from Crohn's, but it is unclear how many of them will qualify to use Tysabri.
The disease frequently causes diarrhea and abdominal cramps; symptoms can also include fever, bleeding, and
weight loss and there is no cure. The drug should be available for Crohn's patients by the end of February 2008.
(Source: Todd Wallack, The Boston Globe, 15 January 2008)
Alkermes to Cut 150 Jobs as Partner Eli Lilly Cancels AIR Insulin Development
Alkermes announced it plans to cut about 150 jobs, or 18 percent of its workforce, and shut down its Chelsea
manufacturing plant, two weeks after Eli Lilly canceled trials of AIR, an inhaled insulin system the two companies had
been developing in partnership. Both companies said the decision to halt development of the product was not based
on safety issues. According to Alkermes spokesperson Rebecca Peterson, Alkermes will try to use the technology to
develop inhalable treatments for other diseases such as chronic obstructive pulmonary disease (COPD).
Lilly's action followed similar decisions by two other major players in the inhaled insulin field. In October 2007, Pfizer
shelved Exubera, despite spending close to $3 billion developing and marketing the product; and Novo Nordisk of
Denmark followed suit by halting development of its own version of inhalable insulin after studying the Exubera
failure. "Pfizer's and Novo's decisions caused us to re-evaluate the marketplace," said an Eli Lilly spokesperson, who
added the company was also concerned about its prospects with US regulators.
California biotech Mannkind Corp. is still actively developing an insulin inhaler which is in Phase III studies and which
the company expects to submit for FDA approval by the end of the year. If successful, new diabetes drugs have the
potential to generate billions of dollars in sales. In the US alone, about 21 million people are thought to have diabetes
and many of them take insulin regularly to help control their blood-sugar levels. (Source: Avery Johnson, The Wall
Street Journal, 8-9 March 2008 and Todd Wallack, The Boston Globe, 18 January and 20 March 2008)
Regulatory & Legislative Highlights
By Deepen Joshi
FDA Takes Action Against Pharmacies Compounding Hormone Therapy Drugs
The FDA has sent letters warning seven pharmacy operations that the claims they make about the safety and
effectiveness of their compounded "bio-identical hormone replacement therapy" or "BHRT" products are unsupported
by medical evidence and are considered false and misleading by the agency, thus violating federal law. Compounded
drugs are not reviewed by the FDA for safety and effectiveness. The agency encourages patients to use FDAapproved drugs whenever possible and is concerned that unfounded claims like these mislead both patients and
health care professionals.
The pharmacy operations targeted improperly claim that their drugs, which contain hormones such as estrogen,
progesterone and estriol (which is not a component of an FDA-approved drug and has not been proven safe and
effective for any use), are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious
diseases, including Alzheimer's, stroke, and various forms of cancer. The pharmacy operations receiving warning
letters use the terms "bio-identical hormone replacement therapy" and "BHRT" to imply that their drugs are natural or
identical to the hormones made by the body.
FDA's action does not target pharmacists who practice traditional pharmacy compounding and who do not make
false or misleading claims about compounded products. All patients who use compounded hormone therapy drugs
should discuss menopausal hormone therapy options with their health care provider to determine if compounded
drugs are the best option for their specific medical needs. (Source: FDA Website, 29 January 2008)
FDA Approves Medtronic's Drug-Eluting Cardiac Stent
The FDA approved the Endeavor Zotarolimus-Eluting Coronary Stent, manufactured by Medtronic of Minneapolis, for
use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart.
Like all drug-coated stents, the new device is a tiny metal mesh tube coated with a drug. In this case the drug is a
new compound called zotarolimus, developed specifically for use on a stent. The stent is crimped around a balloon
and delivered to the narrowed section of the coronary artery via a long thin catheter during a procedure known as an
angioplasty. Once the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in
place, acting as a mechanical scaffold to keep the artery open. Slow release of zotarolimus over time prevents the
artery from re-narrowing when new tissue begins to form. This process, known as restenosis, can eventually require
a repeat angioplasty.
The Endeavor drug-eluting stent is the first to hit the US market since safety concerns plagued the market two years
ago. Use of drug-coated stents compared with their bare-metal predecessors declined after evidence emerged that
the drug coatings may increase dangerous clots. Endeavor is one of a new generation of stents the industry hopes
can recapture US demand for the drug-eluting devices, sales of which sank to $2 billion last year, down from a peak
of $3.1 billion in 2005. (Source: FDA Website, 1 February 2008 and Associated Press, The Boston Globe, 2
February, 2008)
FDA Licenses Wyeth's New Hemophilia Treatment
The FDA has licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects
approximately 15,000 individuals, almost exclusively males, in the United States. The new treatment, called Xyntha
Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is licensed for the control and prevention of bleeding,
which can occur spontaneously or after an accident or injury in patients diagnosed with hemophilia A and to help
prevent surgical bleeding in this patient population.
Manufactured by Wyeth Pharmaceuticals, Xyntha is a genetically-engineered version of factor VIII, a protein essential
for the clotting of blood. Factor VIII, known as an anti-hemophilic factor, is missing or decreased in patients with
hemophilia A. To make Xyntha, genes from Chinese Hamster Ovary cells (CHO) are modified to produce factor VIII.
These CHO cells are free from known infectious agents, and Xyntha undergoes an additional process of viral
inactivation. Also, the culture in which the cells are grown is free of any human or animal material. (Source: FDA
Website, 21 February 2008)
Governor's $1b Life Sciences Plan gets a Makeover in House
House Speaker Salvatore DiMasi unveiled a plan that would give $1 billion over 10 years to Massachusetts' lifesciences industry. While DiMasi's proposal differs in some key respects from the one Governor Patrick proposed last
year, it does incorporate the major elements of the governor's initiative, designating $500 million in bonds for capital
projects, $250 million in research grants and $250 million in targeted tax credits to Massachusetts-based companies.
However, DiMasi is also seeking to put his own imprint on the life sciences plan with an array of narrowly targeted,
regional spending initiatives that would benefit individual companies, communities, and University of Massachusetts
campuses. These include $12.6 million to build an interchange on Interstate 93 near Andover, where the state wants
to spur development of science-related companies; $12.9 million to improve sewage treatment in Framingham, which
would benefit an expansion planned by Genzyme; and $30 million for vocational and technical high schools to
improve life sciences courses. The bill also calls for $95 million to build a life science center at the University of
Massachusetts at Amherst; $90 million for a center for genetic research and genetic therapy on the UMass Medical
School campus in Worcester and establishes five regional offices throughout the state that would help businesses
decide whether to locate in Massachusetts. (Source: Matt Viser, The Boston Globe, 15 February 2008)
House Life Sciences Bill Restricts Some Benefits to Companies with Headquarters in Massachusetts
When House lawmakers unveiled the latest version of the state's $1 billion life-sciences bill, a new wrinkle caught
some Patrick administration and industry officials by surprise. A provision in the bill would restrict some benefits to
companies with a corporate or US headquarters in Massachusetts - apparently shutting out some of the state's
largest life-sciences employers, including drug makers Wyeth and Novartis AG. But after reading the bill closely,
some observers say the impact could be muted. It turns out the restriction doesn't apply to the $250 million in tax
benefits set aside to encourage companies to expand in Massachusetts over the next decade, but only to a narrower
set of benefits.
Specifically, the restriction in the House bill applies to $45 million in "bridge loans" and assistance from the
Massachusetts Life Sciences Center in setting up clinical trials. It also gives preference to companies with a local
headquarters for research partnerships with state universities, job training programs, and access to pre-permitted
industrial land - but doesn't preclude non-local companies from receiving those benefits as well. (Source: Todd
Wallack, The Boston Globe, 21 February 2008)
State Backs Medical Device Center at UMass Lowell
The state will spend $4 million to help UMass Lowell build an "innovation center" to assist entrepreneurs in
developing, testing, and commercializing medical devices. The center will bring together the engineering expertise of
UMass Lowell and the medical know-how of the UMass Medical School in Worcester, with about 40 faculty members
from the two schools contributing to the goal of turning ideas for medical devices into products. With construction
already underway, the center could be open within a year, according to Stephen McCarthy, a UMass Lowell plastics
engineering professor and codirector of the center.
To succeed, medical device start-ups must get through a period known as the "valley of death" in which the product
is under development, but not far enough along to attract venture capital. The center aims to help young, promising
companies survive that period by giving them access to needed equipment and expertise.
Massachusetts has one of the nation's biggest medical-device industries, led by Boston Scientific, the Natick maker
of stents, defibrillators, and other devices that employs more than 28,000 people worldwide. The Merrimack Valley,
which includes Lowell, has a particularly large medical device cluster, including firms such as Philips Medical
Systems and Straumann AG in Andover, and Zoll Medical of Chelmsford. (Source: Robert Gavin, The Boston Globe,
13 February 2008)
Opening of Boston University Biolab to be Delayed
BU administrators overseeing the Biosafety Level-4 lab, the centerpiece of a larger federally sponsored project, had
predicted that the facility would be operating by the fall. In a clear setback for BU, which first began pursuing federal
grants to build the lab on its South End medical campus five years ago, the NIH has said in a court filing that it now
anticipates an ongoing environmental review of the lab will take longer than expected and won't be completed until
"on or before April 30, 2009."
The revised NIH schedule also appears to acknowledge blistering criticism of the agency's conclusion that the lab
posed no danger to the surrounding neighborhood. In November, an independent panel of scientists concluded that
the federal review "was not sound and credible" and failed to adequately address the consequences of highly lethal
germs escaping from the lab.
In a federal lawsuit, US District Judge Patti Saris had refused to immediately block construction of the project. But
Saris said she would retain oversight of the Biosafety Level-4 lab, leaving open the possibility that she could prevent
research with the deadliest germs, including Ebola, plague, and Marburg virus. Once the environmental review is
completed, representatives of BU, NIH, and the lab's opponents must appear before Saris again, adding still further
time to the lab's opening date. (Source: Stephen Smith, The Boston Globe, 1 February 2008)
Synta Wins Orphan Drug Status for Cancer Drug
Synta Pharmaceuticals of Lexington and its British partner, GlaxoSmithKline PLC, said the FDA has granted orphan
drug status to their experimental drug, elesclomol, for metastatic melanoma, a skin cancer. Such status is designed
to encourage companies to develop drugs for rare diseases by letting them have seven years of market exclusivity
for the products they develop. In November 2006, elesclomol received "fast track" designation from the FDA; the
companies can submit clinical data to the FDA as it becomes available rather than wait to submit it all at once for
review. (The Boston Globe, 29 January 2008)
Baxter Halts Production of Heparin
Baxter International temporarily suspended production of the widely used blood-thinner heparin because of about 350
possible allergic reactions, including four deaths, primarily in patients undergoing kidney dialysis and heart surgery.
Because heparin, a generic drug available for decades, is widely used in hospitals and dialysis centers, Baxter said it
isn't suspending sales of the heparin already produced. Officials of the FDA made that decision along with executives
of Baxter to avoid shortages.
Baxter supplies about 50 percent of the heparin used in the US, so the possibility of a shortage arising is a real one.
Although the company first said it had concluded the reactions were confined to nine lots of heparin, it later said the
adverse reactions have spread beyond those lots and to a wider range of dosages. Baxter began recalling the
original nine lots January 17th. The FDA decided not to extend the recall beyond those lots.
Leaving a possibly tainted product on the market required an agonizing balancing act by the FDA, and will mean
more balancing by kidney specialists, heart doctors and others who use the product. The agency advised doctors to
use small amounts of the drug infused over a longer period of time whenever possible. (Source: Thomas M. Burton
and Jon Kamp, The Wall Street Journal, 12 February 2008)
White House Wants to Widen FDA Authority Over Imports
Health and Human Services Secretary Mike Leavitt said the Bush administration supports legislation giving the FDA
explicit authority over unsafe food or drugs made overseas with the intent of shipping them to the US.
The FDA has been hobbled in its enforcement of imports even as the number of products entering the U.S. has
skyrocketed. Recently, some have questioned how the FDA failed to inspect a Chinese plant that supplies much of
the active ingredient for Baxter's blood thinner, heparin, which has been linked to hundreds of bad reactions and four
deaths.
The letter marked the first time HHS, the FDA's parent agency, supported the effort to give the agency such authority.
Earlier, the administrations cabinet-level import-safety panel, which Mr. Leavitt heads, had proposed increasing
penalties and other enforcement power over imports and importers, and the Justice Department has supported the
amendment for a number of years. (Soure: Jane Zhang, The Wall Street Journal, 23 February 2008)
Vytorin, Avandia Rekindle Debate Over FDA Drug-Approval Process
Controversies about cholesterol drug Vytorin and diabetes drug Avandia are reigniting debate over what evidence the
FDA requires to approve drugs - and may generate pressure on the agency to raise its bar. The FDA's system for
approving drugs has been criticized as scrutiny grows about Vytorin, co-marketed by Schering-Plough and Merck, in
the wake of a study that raised questions about whether the widely advertised blockbuster drug worked better than a
cheaper generic.
A shift by the FDA toward tougher scrutiny of new drugs could add hundreds of millions of dollars to the cost of
developing a drug at a time when some big drug makers are struggling to replenish product pipelines. In addition, any
pre-approval holdup eats into the manufacturer's crucial time to sell the drug before protective patents expire and
generic competition leaps in.
The lawmakers' interest is the latest sign that the flap over Vytorin, in addition to a recent controversy about the
safety of GlaxoSmithKline PLC's Avandia, is adding new fuel to a long-running debate over FDA approval standards and, specifically, a mechanism known as "surrogate markers." Vytorin and Avandia went on the market based largely
on evidence that they helped control patients' cholesterol and blood sugar, respectively. Sometimes a drug works on
a surrogate marker but doesn't deliver the promised benefit for the primary health problem. Or a drug can have side
effects that don't surface during initial surrogate marker studies but end up outweighing its benefit. (Source: Anna
Wilde Mathews and Ron Winslow, The Wall Street Journal, 25 January 2008)
FDA Clears Abbott's Combination Heart Drug Simcor
The FDA granted Abbott Laboratories approval for Simcor, a drug that raises "good" cholesterol and lowers both
"bad" cholesterol and triglycerides. Simcor is a combination of two existing, approved treatments: simvastatin, a
statin, and Abbott's Niaspan, an extended-release version of niacin, a B vitamin. Statin treatments lower LDL, or bad
cholesterol; but they don't treat HDL - good cholesterol - or triglycerides, two other types of lipids associated with
cardiac problems if found at abnormal levels.
Simcor's approval is the first for a cholesterol drug since questions cropped up about the effectiveness of another
treatment, Merck and Schering-Plough's Vytorin, and could augur well for FDA approval of Merck's Cordaptive
cholesterol-lowering drug, which is also based on niacin. The question with Simcor is whether the treatment will be
any better at preventing heart attacks or death than the components of the medication alone, the same question that
Merck and Schering-Plough face with Vytorin. The two components of Simcor have separately demonstrated an
ability to reduce heart attacks and death. It also remains to be seen how many patients will actually make the switch
to a combination treatment. (Source: Shirley S. Wang, The Wall Street Journal, 16 February 2008)
Genentech Clears Hurdle On Cancer Drug Avastin
The FDA granted accelerated market approval for Genentech's Avastin, a drug to treat advanced breast cancer, in a
cliffhanger decision that split the breast-cancer community. Avastin is a biotech drug made from cells that are
genetically engineered to replicate the body's own weapons - in this case, an antibody that blocks proliferation of
blood vessels that feed tumors. The agency's decision means Genentech can market and sell the drug to oncologists
for their breast-cancer patients, pending two other studies.
European Union regulators approved Avastin for breast cancer a year ago. American doctors and activists had been
split over whether Avastin's benefit - an extra 5½ months of "progression-free survival" - offers patients tangible
benefits or a better quality of life when balanced against severe drug side effects. The FDA's decision fuels ongoing
debate over the agency's approval standards for cancer drugs. Traditionally, the "gold standard" has been to show
that a drug is able to help patients live longer, rather than simply arrest tumor growth. (Source: Marilyn Chase and
Anna Wilde Mathews, The Wall Street Journal, 23 February 2008)
FDA Faulted for Scrutiny of Medical-Device Makers
The FDA can't keep up with requirements to inspect domestic makers of medical devices to assure manufacturing
quality, and the agency rarely examines foreign facilities, according to congressional investigators. In testimony
scheduled to be delivered before a House Energy and Commerce subcommittee, the Government Accountability
Office will tell lawmakers that it found "weaknesses" in the agency's oversight of an industry that makes products
ranging from contact lenses to defibrillators. According to FDA officials' own estimates, overseas makers of the
riskiest products, such as pacemakers, were examined only every six years, and moderate-risk device manufacturers
on average went an estimated 27 years between FDA inspections.
The GAO testimony on medical devices will be a part of the hearing's broader effort to highlight an issue that has
turned up in reports and critiques over the past few years: concerns that the FDA's resources and technology aren't
enough to meet its regulatory responsibilities to oversee drugs, food and other products. The medical device
testimony will say that FDA officials estimated US makers of the highest-risk products are examined, on average,
every three years. Domestic manufacturers of moderate-risk devices get inspected every five years. Both are
supposed to be looked at every two years. (Source: Anna Wilde Mathews, The Wall Street Journal, 29 January 2008)
New Members
Adaze O. Aimua, University of Massachusetts Amherst
Mr. Luke T. Almeida, New England Electropolishing
Mr. Peter M. Antoniuk, Antoniuk Consulting Services
Miss Katherine A. Barkley, University of Massachusetts Amherst
Kiel L. Boutelle, University of Massachusetts Amherst
Mr. Kenneth J. Brennan, Controlled Contamination Services LLC
Evan J. Burns, University of Massachusetts Amherst
Ms. Monica J. Cahilly, GMQA, LLC
Julia L. Carn, Tufts University
Liam M. Casey, University of Massachusetts Amherst
Ms. Virginia Corbin, Waters Corporation
Stefano G. Creatini, University of Massachusetts Amherst
Neil Desai, University of Massachusetts Amherst
Jack C. Dietz, Genzyme Corp
Ms. Laura M. Dinn, Tufts University
Mrs. Jayna Dinsmore, Dakota Systems Inc.
Mr. Nick Dowd, Mettler-Toledo Thornton
Jennifer M. Duffy, University of Massachusetts Amherst
Ms. Caroline L Dugopolski, Genzyme Corp
Ms. Brenda A. Dukeshire, Millipore
Nikola A. Finneran, University of Massachusetts Amherst
Mr. Ray E. Fraley, Parsons
Mr. Todd Griffith, CRB Consulting Engineers
Mr. Bryan Gubbins, William Berry & Son
Ms. Chris Heleter, Wyeth Biopharma
Mr. Simon M. Huang, University of New Hampshire
Mr. Shardool Jain, Northeastern University
Ms. Deborah Jamieson, AstraZeneca
Benjamin M. Johnson, University of Massachusetts Amherst
Mr. Douglas Jones, Boston Scientific
Christopher W. Kalinowski, University of Massachusetts Amherst
Patrick Kelley, Shire HGT
Ms. Clara Kelly, Wyeth
Mr. Jason W. Kuc, Wyeth Biopharma
WheYong Lo, Tedor Pharma
Thomas W. Long, University of Massachusetts Amherst
Mr. Mead F. Lotz, Commissioning Agents, Inc
Blaine F. Maddalo, University of Massachusetts Amherst
Mr. Padmadhar R. Madupu, Bristol Myers Squibb
Dr. Valerie Maier-Speredelozzi, URI
Samuel T. Martin, University of Massachusetts Amherst
John T. McNamara, University of Massachusetts Amherst
Mr. Gary J. Mills, UMass Med School MassBioLogics
Ms. Michelle Mitchell, Lymtech Scientific
Olga A Morozova, University of Massachusetts Amherst
Kelley A. Munnelly, University of Massachusetts Amherst
Megan E. Murphy, University of Massachusetts Amherst
Lawrence D. Mutty, University of Massachusetts Amherst
Mr. John Neroth, IN USA Inc
Mr. Daniel F. Neville, Shire HGT
Quan A. Nguyen, University of Massachusetts Amherst
Chris Nielsen, Acambis Inc.
Mr. Mark A. Omobono, University of Massachusetts Amherst
Mr. Mark J. Palma, Alkermes
Mr. Kenneth H. Park, Abbott Bioresearch Center
Mr. Stephen Perreault, Dakota Systems Inc
Ms. Sarah B. Peters, University of Massachusetts Amherst
Mr. Eric L. Peterson, Wyeth
Ms. Cheryl A. Plummer, Wyeth BioPharma
Mr. Joseph P. Polin, University of Massachusetts Amherst
Mr. Krishnan Ramanathan, Sales Manager, Enerquip, Inc.
Ms. Kimberly Riley, PhD, Shire HGT
Mr. Jeff Rome, New England Controls
Mr. Scott F. Ryan, Biovest International
Mr. Bruce P. Ryerson, Sr., Pharmasys, Inc
John P. Seffernick, Cascade Controls, Inc.
Mr. Brad G. Sepp, Lonza
Amit Shavit, University of Massachusetts Amherst
Mr. Kevin J. Shield, DECCO Inc
Robert Siegler, BMS Medical Imaging
Catherine Simard, Shire HGT
Mr. Frederick Simard, Bristol-Myers Squibb
Mr. Michael J. Sommers, Trane
Ms. Christine Southall, Millipore Corporation
Ms. Kerry Spielberger, Acceleron Pharma
Ms. Melissa M. St. Amand, Genzyme Corporation
Brody J. Stara, University of Massachusetts Amherst
Leah K. Stidsen, Alkermes, Inc
Mr. Robert Swenson, Lonza Biologics Inc
Mr. Michel R. Thenin, Spraying Systems Co
Aubrey R. Tiernan, University of Massachusetts Amherst
Mrs. Debra E. Tracy, National Process Systems
Mr. Richard L. Travers, Siemens Healthcare
Dr. Thomas H. Treutler, Berkshire International Ltd
Michael Veksler, MBL
Christopher M. Vercollone, University of Massachusetts Amherst
Brendan G. Walker, University of Massachusetts Amherst
Mr. Clive S. Wan, University of Massachusetts Amherst
Mr. Brian K. Warne, American Automation Inc.
Mr. David W. West, Genzyme Corp
Kenneth R. White, Richard White Sons, Inc
Donald Wuchterl, Shire, Human Genetic Therapies
Mr. Frank Yeschanin, Jr., Medical Imaging Company
Alan Yim, Microfluidics
Mr. Hossein Zarrin, MKS Instruments, Inc.
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Chapter Manager: Amy Poole, CAMI - Tel: 1.781.647.4773 and E-mail: ispe@camihq.com
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