Thursday, December 18, 2014

Striving to find new development methods for chemically defined media

In a recent article at European Business Review, Francesc Gòdia took an in-depth look at how to scale up the production of cell culture media in a safe way.  Reliability of supply, variability in performance and risk of viral infection has caused manufacturers to find new ways to develop these cell cultures.  The race is on and three alternatives to traditional methods are insulin, trasferrin, and albumin.  To examine the opportunities, Gòdia designed an experiment that screened for optimal compounds and another that optimized their concentration.  Read the results on page 36 of the European Biopharmaceutical Review.

This March, Gaurav Chauhan, M.S., Associate Scientist II, Cell Culture and Fermentation Sciences, MedImmune, will be on hand to share the presentation A Mathematical Model: Predict How HTST Impacts Media Treatment and Resolve Scale-Up Issues at Biopharmaceutical Development and Production Week.  For more information on this session and the rest of the program, download the agenda.  If you'd like to join us March 30-April 2, 2015 in Huntington Beach, California, as a reader of this blog when you register to join us and mention code BDP15JPLA2, you can receive the current lowest rate available to the event!


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Thursday, December 11, 2014

Announcing Your 2015 TIDES Keynote Lineup

IBC's 17th Annual TIDES meeting is coming to San Diego, CA on May 3-6, 2015.This is the leading forum for CMC, clinical and discovery scientists in the oligonucleotide and peptide industry to share best practices and new technologies to help you:
  • • Accelerate your promising therapeutic to market
  • • Ensure accurate CMC submissions
  • • Comply with emerging regulatory expectations
  • • Apply best practices from leading preclinical/clinical projects
  • • Improve process development timelines

This year, we move coasts and provide you visionary keynotes sharing key success factors for drug development and manufacturing highlighting these areas:
  • >Antisense Technology: Stanley T. Crooke, Ph.D., Chief Executive Officer, Isis Pharmaceuticals, Inc.
  • >RNAi Therapeutics: John Maraganore, Ph.D., Chief Executive Officer, Alnylam Pharmaceuticals
  • >Peptide Therapeutics: Torsten Hoffmann, Ph.D., Executive VP and CSO, Zealand Pharma A/S
  • >Oral Peptide: Kunwar Shailubhai, Ph.D., Co-Founder & CSO, Synergy Pharmaceuticals, Inc.
And don't forget - as a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off the standard rate!


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Thursday, December 4, 2014

What is next for immunotherapy?

We recently had a chance to sit down with a few of the Antibody Engineering and Therapeutics speakers to get an inside look into what they're working on and insights into their work.  We continue our interview series off with Omid Hamid, MD, Chief of Research, Immuno-Oncology at The Angeles Clinic and Research Institute.

As we wrap up our interview series with our Antibody Engineering speakers, Dr. Hamid answers this final question:
What is next for immunotherapy?
Dr. Hamid: The future for immunotherapy in solid tumors is bright. There are many avenues to take. We are looking at bispecific antibodies that are antibodies that bring two things together, like a T cell close to the tumor and then initiating an immune response. We are looking at adoptive T cell therapy where you take the T cells out of the tumor and grow them and then re-infuse them into patients. That is also referred to as “TIL Therapy” as is done at NCI and other major academic centers. We are looking at trying to bring that to community cancer centers and all patients. Again, combinatorial therapies with other immune therapies, including IL-2, anti CTL 4 therapy coming forward. And this will move quickly now that the field of oncology has understood these benefits. 
Now, as we talk about combination, we talk about where the field is going. Let’s not forget that immuno-oncology can be paired with many different modalities. We are looking at the ability to initiate or improve immune response through radiation – so called “Abscopal Effect”. We are looking at the role of chemotherapy within oncology or target therapies, which is something that I haven’t spoken about. But, the first checkpoint inhibitor to be approved was Ipilimumab and it was approved at the same time that BRAF targeted therapy was approved in metastatic melanoma. Today we have multiple trials looking at combinations of BRAF targeted therapy and immunotherapy with PD-1, PDL-1 and anti CTLA 4.

So, what’s next is happening now. I would support patients looking into options with any one of these modalities. What we have seen is that even heavily pre-treated patients and patients with rare tumors may have the possibility of benefiting from these modalities.

Dr. Hamid will be presenting The Promise of PD1 Checkpoint Inhibition for Multiple Solid Tumors on  next Wednesday, December 10 at the Antibody Engineering and Therapeutics event. For more information on his session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code XD14172BLOGJP, you can save 20% off the standard rate.


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Thursday, November 27, 2014

Who is the right patient for this immune therapies?

We recently had a chance to sit down with a few of the Antibody Engineering and Therapeutics speakers to get an inside look into what they're working on and insights into their work.  We continue our interview series off with Omid Hamid, MD, Chief of Research, Immuno-Oncology at theThe Angeles Clinic and Research Institute.

Today's question for Dr. Hamid is:
Who is the right patient for this therapy? Are there any predictive and prognostic markers?
Dr. Hamid: Great question. That’s like the “Holy Grail” now. Can we find out who can benefit prior to treating them? Immune therapies take time to show response. Immune therapies are not 100% for everyone. We are seeing better response rates than historically with immunological therapies with PD-1 inhibition and PDL-1 inhibition, but can we improve that?

What I say is that we are not there yet, but we’ve taken the right steps. Initially, PDL-1 staining of tumor was thought to be a great biomarker; a great predictive marker. We thought if you were negative you didn’t respond and if you were positive you had
great chance of responding. Now early data has shown that PDL-1 negative and PDL-1 positive response, possibly the negative has a lower response rate, but still a significant response rate where this would not be a gatekeeper for whether patients get therapy or not.

What we’ve also found is that PDL-1 expression changes during therapy. So, there are groups looking at whether we can predict response by looking at changes at tumor PDL-1 expression. John Powerly presented at ASCO 2013 looking at circulating biomarkers of T cell activation and response. So, still a very early undertaking, but we are moving forward.

The Pembrolizumab Study Keynote 001 had an interesting poster at ASCO that looked at initial tumor burdens. That is, how much tumor does a patient have and whether that predicts full response. Interestingly – in a small sub-set – it was the strongestpredictive marker for response (Joseph et al).

So, we’re moving forward and the good news is that almost every clinical trial that is being put together for PD-1 and PDL-1 inhibition and for combination is doing biomarker correlates, whether it’s blood, tumor or archival tissue, etc. So, we are getting closer to that answer.

Dr. Hamid will be presenting The Promise of PD1 Checkpoint Inhibition for Multiple Solid Tumors on Wednesday, December 10 at the Antibody Engineering and Therapeutics event. For more information on his session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code XD14172BLOGJP, you can save 20% off the standard rate.


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Wednesday, November 26, 2014

Cyber Monday starts early! See details on how you can save on all IIR and IBC Events!

 


To get a head start on the holiday season, as a member of our online community, we’re giving you an extended chance to take advantage of our Cyber Monday sale. Register for the following event and receive 30% off the standard rates. Mention code CYBER2014 when registering for the following:

IBC’s Vaccine Development & Production Summit
December 8-9, 2014 in Boston, MA
Disease and Pandemic Vaccine Research, Discovery and Innovation
More about the event:
Register here.

IBC’s Antibody Engineering & Therapeutics 
December 7-11, 2014 in Huntington Beach, CA
The #1 Forum for Academia and industry to Connect for Scientific Exchange and Networking in Antibody Engineering & Therapeutics, lmmunobiology and Next-Generation Binders
More about the event.
Register here.

IBC’s Commercialization of Cell, Gene & Immunotherapies
December 11-12, 2014 in San Diego, CA
Accelerating the Translation of Commercially Viable Cell, Gene and Immunotherapies Through bioprocess Tools and Technologies
More about the event:
Register here:

IIR’s FDA/CMS Summit for Biopharma Executives
December 11-12, 2014 in Washington, D.C.
Hear about the commercial outlook for biopharma under the new health care exchanges.
More about the event.
Register here.

 IIR’s 19th Annual Drug Delivery Partnerships 
January 29-30, 2015 in Boca Raton, FL.
Accelerating the path to market by leveraging new partnerships, breakthrough innovation and unique business models. Visit the website for full details.
More about the event.
Register here.

IIR’s 12th Annual Medicare Congress
February 3-5, 2015 in New Orleans, LA
Survive the toughest rate environment to date with lessons from top-notch healthcare executives
Visit the website for full details.
Register here.

ePharma **
February 24-26, 2015 in New York, NY
Charge up your marketing campaign with ROI-infused initiatives and embody the newest technologies that bleed success
More about the event.
Register here.

IBC’s Genome Editing Applications
March 18-19, 2015 in Boston, MA
Don't miss out on the only event in the industry focusing on applications of genome editing technologies in research, drug discovery and therapeutic development.
More about the event.
Register here.

IBC’s Biopharmaceutical Development & Production Week (BDP)
IBC’s Single-Use Applications for Biopharmaceutical Manufacturing
IBC’s Flexible Facilities Conference
March 30 – April 1 in Huntington Beach, CA
Create Unique End-to-End Bioprocessing Solutions that Guarantee Reproducible Results and Commercial Manufacturing Success
More about the event.
Register here.

IIR’s 24th Annual Partnerships in Clinical Trials
April 22-24, 2015 in Boston, MA visit the website for full details.
Accelerate speed to market by leveraging new partners, new technologies, and new business models at the must-attend clinical event of the year
More about the event.
Register here.


TIDES
May 3-6, 2015 in San Diego, CA visit the website for full details.
The #1 Industry Forum for CMC, Clinical and Discovery Professionals to Accelerate Oligonucleotide and Peptide Product Development
More about the event.
Register here.

Have any questions? Email Jennifer Pereira.

*This promotion is only valid Wednesday, November 26th 2014 through Monday, December 1st  2014. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IIR approval.
**Cyber Weekend offer only applicable to registrants not utilizing the Buy One Get One offer. Only pharma/biotech/med device companies are eligible for The Buy One Get Offer


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Friday, November 21, 2014

Novartis invests in gene editing technology

Announced earlier this week, Novartis will be joining in forces with Atlas Venture, a partnership created to back start up Intellia Therapeutics which will focus on gene editing technology in the oncology field. One of the key players in the start- up team is the former chief scientific officer of AbbVie, John Leonard and they will be based in Camebridge, Massachusetts.  The key technology CRISPR Cas9, which according to Fierce Biotech, works by developing  host bacterial cells incorporate short bursts of DNA sequences from invaders that can trigger disease which has the potential to create huge shifts in oncology treatment.  They are in-licensing this technology from Caribu Biosciences.

Plans for the initial work include:
Initially Intellia plans to focus on ex vivo work, where cells are collected from patients and then modified for therapeutic purposes before being injected back into patients--with applications relevant to CAR-T and checkpoint inhibitors. An in vivo approach can later be used to correct genes found inside cells, with applications in ophthalmic, central nervous system, muscle, liver, anti-infective and other disease.

This March at the Genome Editing Applications event, Caribou Biosciences will be joining us at the event to share more about this technology in the presentation Crisper Designs for Cas9-mediated Genome Engineering.  For more information on this session and the rest of the program, download the agenda.  If you'd like to join Caribou Biosciences in Boston March 18-19, as a reader of this blog, when you register to join us and mention code D15223BLG to save 20% off the standard rate. Have any questions or want to get involved? Reach out to Jennifer Pereira.


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Thursday, November 20, 2014

Where do you see the immune checkpoints and immune therapies field going?

We recently had a chance to sit down with a few of the Antibody Engineering and Therapeutics speakers to get an inside look into what they're working on and insights into their work.  We continue our interview series off with Omid Hamid, MD, Chief of Research, Immuno-Oncology at theThe Angeles Clinic and Research Institute.

Today's question for Dr. Hamid is:
Where do you see the immune checkpoints and immune therapies field going?

Dr. Hamid: Well, the future of this field is bright. To begin with, this field will expandto multiple solid tumors and multiple indications as I’ve just alluded to. As we moveforward, immune checkpoints and immune therapies will start to proceed in the normal fashion that traditional chemotherapy did. That is, if we could get good response and good benefit as a single agent, can we have combinatorial therapy showing even better benefits for our patients while being able to mitigate toxicity? 
At ASCO 2014, Mario Sznol updated the recent data of Ipilimumab and Nivolumab in combination for malignant metastatic melanoma. This was data initially presented by Dr. Jedd Wolchuck in The New England Journal of Medicine in 2013. The updates are just as promising. Although there was a bump in toxicity, response rates may have been greater. There is an indication that possibly there can be improvement in duration of response. Now, this has to be born out in randomized studies. But, as we speak today, a major Phase III randomized trial – double blinded – looking at the combination vs. each single agent alone, and blinded, has accrued and we’re awaiting that data. 
But it’s not just for melanoma anymore. It’s for multiple solid tumors. Combinatorial trials of immune check inhibitions are now accruing for lung cancer, head and neck cancer and other solid tumors. In addition, it’s not just checkpoint inhibition alone. Clinical trials are looking at PD-1 inhibition with other forms of immune manipulation. Most importantly, IDO inhibitors and oncolytic therapies. By themselves, these therapies are promising and, hopefully, in combination the promise can be improved and we can move forward in that way.

Dr. Hamid will be presenting The Promise of PD1 Checkpoint Inhibition for Multiple Solid Tumors on Wednesday, December 10 at the Antibody Engineering and Therapeutics event. For more information on his session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code XD14172BLOGJP, you can save 20% off the standard rate.


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Wednesday, November 19, 2014

Creating A New FDA/Capitol Hill Legend

Via RPM Report, an FDA/CMS Summit for Biopharma Executives event supporter. The RPM Report provides actionable insight on regulation, policy, FDA and CMS to apply directly to your decision-making.

When FDA managers reflect on their experiences on Capitol Hill, the stories often involve unfair, inflammatory or downright abusive sessions. But Center for Drug Evaluation & Research Director Janet Woodcock has built a different legend this year during the 21st Century Cures initiative of the House Energy & Commerce Committee.

CDER Director, Janet Woodcock has pulled off a Capitol Hill miracle during the 21st Century Cures review of the issues affecting drug and medical device development and commercialization, being the regulator embraced by both sides of the aisle.

From start to finish, Woodcock has basked in praise from Republicans and Democrats. But those notes of praise rose to a crescendo during the final, pre-election session hosted by the E&C/Health Subcommittee on Friday, Sept. 19. During a hearing focused on antibiotic development incentives, Woodcock engaged in a cordial farewell dialogue with the soon-to-retire Rep. Waxman (one of Democrats who traditionally has not been among her supporters), diplomatically handled more calls for FDA-based incentives for the development of antimicrobials and other drugs, and then received congratulations from Rep. John Shimkus (R-Ill.) who applauded Woodcock for staying to listen to the second panel of the hearing.

Incentives Entail Congressional Art, Not Opinions of FDA Scientist/Doctor

Based on her performances, Woodcock has earned the ability to defer opinions on flashpoint issues without looking like she was dodging the issue.

On the topic of incentives for drug developers based on FDA or by conferring exclusivity to a target category or to another drug chosen by the sponsor, Woodcock was able to avoid staking out a stance one way or the other, and instead referred to the criticisms of incentives raised by Waxman and noted that striking that type of balance falls in the realm of Congress and politics and to a physician and scientist.

She had few failures over the five-month period and none that seem to do damage to the agency’s improving reception on Capitol Hill.

Woodcock has so far been unable to see her idea of pushing improvement in drug quality and manufacturing as a jobs issue and a way to stimulate the US economy. That’s a big issue to Woodcock but a small down-note in an otherwise harmonious legislative season for the agency.

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Do you want the chance to hear from Janet Woodcock, other key regulators from the FDA and CMS, and industry game changers? Join them at the 10th Annual FDA/CMS Summit for Biopharma Executives this December 11-12, in Washington D.C.

At the event, Janet Woodcock will be addressing what the midterm congressional elections mean for the biopharma industry. Do not miss this!

Register here.


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Friday, November 14, 2014

Ask the Expert: A New Incompressible Protein A Resin to Improve Downstream Productivity in Single Use Applications

Date:  Tuesday, November 18, 2014
Time: 11:00 AM EST
Duration: 15 minutes
Focus: A New Incompressible Protein A Resin to Improve Downstream Productivity in Single Use Applications
Presenter: Dr. Kiran Chodavarapu, Bioprocessing Business Development Manager, W.R. Grace

Register to join us!

About the session:
Implementation of single use technologies and higher antibody titers upstream have put increasing pressure on downstream processes to improve efficiencies and keep pace with upstream advancements.

There continues to be a lag in the development and adoption of single-use technologies in downstream — particularly in the area of chromatography.

To help achieve the vision of a fully disposable and flexible manufacturing platform that addresses the current bottleneck in downstream processing, a new high-capacity, incompressible Protein A resin has been developed that comes pre-packed in disposable columns. The high capacity silica and bonding chemistry maximize dynamic binding capacity while controlling non-specific protein binding.

About the presenter:
Dr. Kiran Chodavarapu is the Bioprocessing Business Development Manager at W.R. Grace. He leads the commercial and technical development of Grace's bioprocessing products including ProVance® biopurification columns for single campaign use.

Dr. Chodavarapu has a Ph.D. in Chemical Engineering from the University of Massachusetts, Amherst. He joined Grace in 2001 and has extensive R&D experience with zeolite, alumina and silica technologies. During his tenure at Grace, he has led plant start-ups and operational excellence initiatives to drive global manufacturing productivity efforts. He has served in various Engineering, TCS, R&D & Marketing leadership roles within Grace.


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Thursday, November 13, 2014

Update on PD-1 therapy with melanoma and other solid tumors

We recently had a chance to sit down with a few of the Antibody Engineering and Therapeutics speakers to get an inside look into what they're working on and insights into their work.  We continue our interview series off with Omid Hamid, MD, Chief of Research, Immuno-Oncology at The Angeles Clinic and Research Institute.

Today's question for Dr. Hamid is:
What is the recent data with PD-1 therapy with melanoma and other solid tumors?

Dr. Hamid: That’s a wonderful question. Recently, if you picked up a paper or logged into your favorite website and found that there has recently been an approval of a PD-1 checkpoint inhibitor named “Pembrolizumab” for patients with metastatic melanoma.
This was based on benefits seen in a Phase I/II study showing a significant response rate and a durability of response. This is the first checkpoint inhibitor approved in the United States, but not the first checkpoint inhibitor approved worldwide. Nivolumab made by Bristol-Myers was approved in Japan recently.

These checkpoint inhibitors – these PD-1 and PDL-1 inhibitor therapies – are starting to show response in multiple solid tumors. If you look in on ASCO 2014, you recognize that the FDA has clearly indicated that the MPDL3280 – the PDL-1 antibody made by Genentech – is a breakthrough therapy and is being evaluated for patients with metastatic bladder cancer in the second line. This is an indication that has had no clear cancers and our recent Phase I data has shown a 50% response rate in these patients.

Also, if you checked in at ASCO 2014 you realize that the Bristol drug has been indicated as breakthrough for lymphoma. There was amazing data presented in multiple solid tumors, including head and neck cancer, lung cancer, ovarian and renal cell carcinoma. These data are starting to mature and they are randomized. Phase III trials are either accrued or near completion of accrual. So, I expect the next year to two to be a tour de force presentation of these data and hopefully options for patients with multiple solid tumors to benefit. 
In our clinic today – at The Angeles Clinic and Research Institute – we are accruing to trials for patients with cervical cancer, merkel cell carcinoma, HPV positive tumors, nasopharyngeal carcinomas, even glioblastama multiforme, and prostate cancer. Now, what’s come of this is the understanding that the immune system is integral in our eradication of multiple solid tumors. Data presented in world lung and ESMO Conference have shown significant response rates in heavily pre-treated lung cancers with good durability of response. This is all being born out in major Phase II and Phase III trials. 
So, we have had some inroads of data that will be presented at future meetings, including our upcoming meeting at Antibody Engineering and Therapeutics. It will hopefully elucidate the future role of checkpoint inhibitors and PD-1s in the future.

Dr. Hamid will be presenting The Promise of PD1 Checkpoint Inhibition for Multiple Solid Tumors on Wednesday, December 10 at the Antibody Engineering and Therapeutics event. For more information on his session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code XD14172BLOGJP, you can save 20% off the standard rate.


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Wednesday, November 12, 2014

Sovaldi: Shooting Star Instead of Blockbuster

Via RPM Report, an FDA/CMS Summit for Biopharma Executives event supporter. The RPM Report provides actionable insight on regulation, policy, FDA and CMS to apply directly to your decision-making.
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Gilead’s Sovaldi HCV treatment has earned a special place in pharma lore with its rapid rise to about $10 billion in sales (bringing with it lots of controversy about the sustainability of specialty drug pricing). Now the product appears poised to make a new reputation: fastest to fall from blockbuster status.
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The debate over what qualifies as a “blockbuster” drug is one of those inside-industry debates that has gone on—and will continue—for decades. There was a period when $100 million in annual sales earned a product “blockbuster” status, but that is long ago. The new thresholds are about ten times that level.   

No matter what sales trigger defines “blockbuster,” Gilead’s hepatitis C product Sovaldi is far above it. The brand should be remembered for decades as one of the fastest out-of-the-blocks blockbusters -- approaching $8 billion in sales in its first nine months of marketing.

However, Sovaldi may be gone just as fast – more like a flashing comet in the pharma firmament than a lasting blockbuster. The active ingredient, sofosbuvir, will not go away, but the single-ingredient brand is likely to become quickly irrelevant.

Gilead is preparing for FDA approval of the next-generation two-ingredient fixed dose oral combination product to supplant Sovaldi on October 10. That product will have treatment success rates, pricing, convenience and patient-experience qualities that should mean that Sovaldi will recede from the market with something approaching a mirror image of its meteoric rise.

After remaining relatively quiet in public during the months of shock and push back from the payer community about the pricing of Sovaldi at $84,000 for a typical course of therapy, Gilead has begun to speak out in advance of the upcoming launch of the ledipasvir/sofosbuvir combo (called Harvoni in Europe).

Gilead President John Milligan explained the pricing for the new product to the DC policy world at an Oct. 1 Brookings/Engelberg Center half-day session on the “Cost and Value of Biomedical Innovation.” That discussion complemented other conversations with the financial community and presumably with payers who should be more prepared for the follow-on product than for Sovaldi.   

Milligan said the new product will priced in line with the total drug current treatment costs for existing 12-week Sovaldi /PEGinterferon/ribavirin treatment, or roughly $94,500.

That means the new combo will cost about $10,000 more than Sovaldi as a single ingredient per treatment course but the added cost will reflect a shift of PEGinterferon/ribavirin costs to the combo drug and not added costs for the drug regimen part of the HCV treatment. With the new ingredient, Gilead will capture the part of drug costs going to other manufacturers for PEGinterferon and ribavirin.   

Milligan, in fact, argued that pricing to the total cost of current standard of care is the foundation of Gilead’s pricing decisions – and, he suggested, the industry‘s standard practice.

“At the end of the day,” Milligan said, “the pricing analysis [for the original launch of Sovaldi] was  relatively simple – current cost of other therapies.” Responding indirectly to the months of outside speculation on the factors considered in Sovaldi pricing, he said that Gilead “didn’t look at return on investment; we don’t look at sunk costs. None of that goes into our pricing.” Generalizing to the industry, Milligan said, “in fact, I don’t know a single firm that uses that as a metric for how to determine [price].”

So, with the combo removing the tough PEGinterferon and ribavirin pieces of treatments, the need for Sovaldi as a single ingredient should quickly diminish.

Milligan described Sovaldi numerous times (at least three times) in his short Brookings presentation as a “stop-gap” therapy that Gilead developed to get to the market first to meet demand for a higher efficacy HCV treatment -- beyond the big improvements previously offered by Vertex’s Incivek and Merck’s Victrelis.   

“We worked very hard,” Milligan said, “to bring in Sovaldi as a stop gap between where we were with very difficult interferon-containing regimens to the future which will be all-oral regimens.”

So, the blockbuster was really a “stop-gap” to the sponsor.

Maybe looked at in retrospect, it was also a stalking horse – to acclimate the market to the single-ingredient  price and then make the two-ingredient fixed combination look more attractive. That may explain Gilead’s reticence for fighting back on the response to Sovaldi pricing: not only was the product doubling the size of the company, it was creating a better milieu for the more important next product.

Starting the fixed dose combo at the same price as current 12-week Sovaldi plus injections therapy has three other important benefits to Gilead.

1. It sets up the potential of a reduced treatment price for the fixed dose combo when used in a shorter, 8-week treatment regimen for less severely ill patients – thus making it harder for payers to try to limit use to only the sickest patients. The less sick patients will be expensive to treat but enough less expensive than the 12-week therapies that the payers should feel pressure.

2. It creates less room for pricing decisions by the next-comers (like Abbvie’s four-ingredient ABT-450 product which appears on track for an end of 2014 approval decision form FDA).  There is obviously room for price strategies under $94,500 for twelve weeks and $63,000 for eight-week therapy. But by keeping the price close to current costs, Gilead is leaving next competitors less options.

3. Finally, and this is another reason that Sovaldi as a brand may be remembered as a comet rather than a blockbuster, sofosbuvir as a single agent quickly was gaining an important place in an unapproved two-product combination in clinical practice, paired for treatment of about 40% of people getting HCV treatment with the Janssen product Olysio (simeprevir). Together, the two products cost about $150,000 at wholesale acquisition cost, Milligan told Brookings. He described that as “a very expensive regimen,” implying that Gilead could have considered that as the benchmark for its combo, but didn’t.

By pricing a third lower than that existing oral combo, Gilead will look more responsible with its new product. And Sovaldi will be the bright comet that was.

___________________________________________________

Come to the 10th annual FDA/CMS Summit for Biopharma Executives to find out more about these issues and many more plaguing the industry. Our keynote speakers and panels will take a deep dive into each of these topics, and more. You'll leave better able to make strategic decisions on issues such as:

• The commercial outlook for biopharma under the new health care exchanges

• Updates on the latest drug review statistics from the Office of New Drugs and industry's experience under the new review "Program"

• The future of drug safety at FDA — both for the increasingly popular rare disease drugs as well as new treatments for large primary care markets like obesity and diabetes

• What's in store for the reauthorization of PDUVA VI, and a preview of what's to come as industry and FDA take a second look at BsUFA and GDUFA.

• Coming changes to Medicare Part D and what CMS has in store for the prescription drug benefit

• What the mid-term Congressional elections will mean for the biopharma industry.

Register now and join us at the Fairmont Washington DC, December 11-12, 2014 for this can’t-miss event.



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Monday, November 10, 2014

What is the least amount of validation work that can be done to maintain an accuracy in antibody-based studies?

We recently had a chance to sit down with a few of the Antibody Engineering and Therapeutics speakers to get an inside look into what they're working on and insights into their work.  We start this interview series off with Dr. David Rimm, a Professor of Pathology and Director, Yale Pathology Tissue Services and Yale University School of Medicine.

Today, he starts of by answering the question:
What is the least work I can get away with but still have accuracy in antibody-based studies?
Dr. Rimm: In general, that depends on the application. Sometimes you can minimize your work by carefully scrutinizing the spec sheets that come with the antibodies. If the antibodies are validated in a very rigorous way, the spec sheets that come with the antibodies will share that information, including examples of progressively increased cell lines for either Western blots or immunohistochemistry or immunofluorescence or flow cytometry, whichever application you are looking to use the antibody in. So, the least work, I guess, is when the company does the most. You have to be the judge of that as you review their products, often in advance of purchase.
To follow up, we asked:
Is there any hope that I can get someone else to do this work?
Dr. Rimm: There is hope that someone can do it for you and that is the vendors. The vendors may do it for you if they are interested in having high-quality antibodies and if they are concerned about antibody validation. Again, some vendors are more
concerned about this than others.

The other way is to hope for some sort of certification. There is a group called: “The Global Biological Standards Initiative” – GBSI. They have convened a committee of interested scientists from biotech, pharma and academia to try to set up standards by which antibodies should be validated in an application-specific manner. The hope is that ultimately this organization – or some other related organizations – might be able to certify antibodies. You could perhaps envision a day where you could buy only certified antibodies and when you purchase a certified antibody that was properly stored, you wouldn’t need to do any validation at all.

Those events are still in the future. It’s not clear when that will happen, but I think there is hope that at some point we may be able to have less burden of antibody validation on the laboratory and more burden of laboratory validation on the vendor.

Dr. Rimm will be presenting Use and Abuse of Antibodies in Research and the Clinic on Tuesday, December 9.  For more information on this session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us December 8-12, 2014, in Huntington Beach, California and mention code XD14172BLOGJP, you can save 20% off the standard rates.


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Thursday, November 6, 2014

Where is the PD-1 therapy field going?

We recently had a chance to sit down with a few of the Antibody Engineering and Therapeutics speakers to get an inside look into what they're working on and insights into their work.  We continue our interview series off with Omid Hamid, MD, Chief of Research, Immuno-Oncology at theThe Angeles Clinic and Research Institute.

Today, he answers this question:
What is the recent data with PD-1 therapy with melanoma and other solid tumors?
Dr. Hamid: That’s a wonderful question. Recently, if you picked up a paper or logged into your favorite website and found that there has recently been an approval of a PD-1 checkpoint inhibitor named “Pembrolizumab” for patients with metastatic melanoma. This was based on benefits seen in a Phase I/II study showing a significant response rate and a durability of response. This is the first checkpoint inhibitor approved in the United States, but not the first checkpoint inhibitor approved worldwide. Nivolumab made by Bristol-Myers was approved in Japan recently.

These checkpoint inhibitors – these PD-1 and PDL-1 inhibitor therapies – are starting to show response in multiple solid tumors. If you look in on ASCO 2014, you recognize that the FDA has clearly indicated that the MPDL3280 – the PDL-1 antibody made by Genentech – is a breakthrough therapy and is being evaluated for patients with metastatic bladder cancer in the second line. This is an indication that has had no clear cancers and our recent Phase I data has shown a 50% response rate in these patients.

Also, if you checked in at ASCO 2014 you realize that the Bristol drug has been indicated as breakthrough for lymphoma. There was amazing data presented in multiple solid tumors, including head and neck cancer, lung cancer, ovarian and renal cell carcinoma. These data are starting to mature and they are randomized. Phase III trials are either accrued or near completion of accrual. So, I expect the next year to two to be a tour de force presentation of these data and hopefully options for patients with multiple solid tumors to benefit. 
In our clinic today – at The Angeles Clinic and Research Institute – we are accruing to trials for patients with cervical cancer, merkel cell carcinoma, HPV positive tumors, nasopharyngeal carcinomas, even glioblastama multiforme, and prostate cancer. Now, what’s come of this is the understanding that the immune system is integral in our eradication of multiple solid tumors. Data presented in world lung and ESMO Conference have shown significant response rates in heavily pre-treated lung cancers with good durability of response. This is all being born out in major Phase II and Phase III trials. 
So, we have had some inroads of data that will be presented at future meetings, including our upcoming meeting at Antibody Engineering and Therapeutics. It will hopefully elucidate the future role of checkpoint inhibitors and PD-1s in the future.

Dr. Hamid will be presenting The Promise of PD1 Checkpoint Inhibition for Multiple Solid Tumors on Wednesday, December 10 at the Antibody Engineering and Therapeutics event. For more information on his session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code XD14172BLOGJP, you can save 20% off the standard rate.


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Wednesday, November 5, 2014

Last Chance to Save $200 for FDA/CMS Summit for BioPharma Executives | Early Bird Rate Ends Friday


What do payors want when it comes to biopharma policy? Come to the FDA/CMS Summit for BioPharma Executives, December 11-12, 2014 in Washington, DC to hear payor perspectives on biosimilars, drug pricing, FDA reforms and drug coverage under Medicare, Medicaid and in the new Affordable Care Act Exchanges.

Take advantage of our Early Bird Rate, a savings of $200 off the standard registration rate. Register now.


Our keynote speakers and panels will take a deep dive into each of these topics, and more. You'll leave better able to make strategic decisions on issues such as:

• The commercial outlook for biopharma under the new health care exchanges

• Updates on the latest drug review statistics from the Office of New Drugs and industry's experience under the new review "Program"

• The future of drug safety at FDA - both for the increasingly popular rare disease drugs as well as new treatments for large primary care markets like obesity and diabetes

• What's in store for the reauthorization of PDUVA VI, and a preview of what's to come as industry and FDA take a second look at BsUFA and GDUFA.

• Coming changes to Medicare Part D and what CMS has in store for the prescription drug benefit

• What the mid-term Congressional elections will mean for the biopharma industry.


P.S. Maximize your investment by also attending the co-located FDA/CMS Summit for Payers. If you purchase the All Access Pass you will be able to not only collaborate with biopharm exeuctives, but rub elbows with C-Level health plans executives as well. Register now so you can double the speakers, double the content, and double the value for only an additional $800! Use the code XP1917BLOG when getting your All Access Pass to save $100, making it only an additional $700!

Register Here.

If you have any questions about the event, please reach out to Ryan Geswell at rgeswell@iirusa.com


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Tuesday, November 4, 2014

Bruker Announces Industry Leading Quadrupole Time-of-Flight Mass Spectrometry for Life Science Research Analysis

WASHINGTON, DC – November 3, 2014 – Bruker Corporation (NASDAQ: BRKR) announced today, the evolution of their maXis™ line of ultrahigh-resolution quadrupole time-of-flight (UHR-qTOF) mass spectrometers, bringing industry-leading resolution and mass accuracy to the liquid chromatography, time-of-flight MS market space.  The system, announced at IBC’s 18th annual Well Characterized Biologicals Conference, is designed to deliver outstanding resolution and mass accuracy which allows for unambiguous identification of the mono-isotopic mass peak of both the light and heavy chains of monoclonal antibodies for example. In addition, this level of performance also provides scientists confident detection and identification of modifications hard to detect at the protein level, such as deamidation.

 “The maXis II system delivers the fastest time-to-success for life science researchers and across a broad range of applications from the in-depth identification and characterization of biopharmaceuticals and small molecule pharmaceuticals, to bottom-up proteomics and proteoform screening.” said Dr. Bob Galvin, Vice President of Bruker’s Biopharmaceutical Business Unit.  “Additionally, the system is well suited to research in the metabolomics, food safety, and forensic and toxicology screening markets as well.”

The maXis II™ – UHR-qTOF Mass Spectrometer

The new maXis II system is the latest flagship instrument in Bruker’s unique TOF mass spectrometry product line, allowing the simultaneous analysis of small molecules and megadalton proteins on one analytical platform.  The system delivers:

• Industry-leading (>80,000) Full-Sensitivity Resolution (FSR) at UPLC acquisition speeds thus enabling Bruker’s unique and  industry acknowledged True Isotopic Pattern spectral acquisition.  This allows for the  identification of the mono-isotopic mass peak of both the light and heavy chains of monoclonal antibodies or, when linked to Smart Formula 3D provides unambiguous elemental formula determination for the pharmaceutical and related  industries

• A High Mass Option (HMO) yieldingnative spray MS capabilities  provides enhanced analytical performance levels, particularly suited for biopharmaceutical and pharmaceutical challenges, like the analysis of megadalton protein complexes and  determination of antibody drug conjugates (ADCs). 

• The Electron Transfer Dissociation (ETD) option provides a powerful additional MS/MS fragmentation technique for the sequence analysis of intact proteins including monoclonal antibody subunits.  The  ETD MS/MS fragmentation technique is complimentary to collision induced dissociation (CID) MS/MS, yielding greater sequence coverage for proteins and providing additional capabilities to the new system.


Ordering Information
   
The maXis II mass spectrometer is available immediately. Please contact your local Bruker Sales Representative for a quote.

About Bruker Corporation

Bruker Corporation is a leading provider of high-performance scientific instruments and solutions for molecular and materials research, as well as for industrial and applied analysis. For more information about Bruker Corporation (NASDAQ: BRKR), please visit www.bruker.com.



Media Contact:
Tony Lewtas               
Bruker Corporation           
T: +1 978 663 3660  ext.1212 
E: tony.lewtas@bruker.com          

Investor Contact:
Joshua Young
Vice President of Investor Relations, Bruker Corporation
T: +1 978 663 3660  ext.1479
E: joshua.young@bruker.com


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Monday, November 3, 2014

TIDES 2015 Speaker Deadline + Early Registration Offer

Few speaking slots remain at IBC's 17th Annual TIDES meeting, held on May 3-6, 2015 in San Diego, CA. If you are working in any of the following scientific areas below, we encourage you to submit a speaker proposal by Wednesday, November 5, 2014 for a podium presentation:
  • -Oligonucleotide Manufacturing Technology, Analysis, CMC & Regulatory
  • -Peptide Manufacturing Technology, Analysis, CMC & Regulatory
  • -Oligonucleotide Discovery & Clinical Development
  • -Peptide Discovery & Clinical Development
To see an in-depth look of what we’re looking for in each of these categories and submit a presentation proposal here,

Your abstract and presentation must describe scientific results and must not contain marketing or business development content. If you are interested in speaking but cannot make the November 5 deadline, please email Michael Keenan as soon as possible.

How else can you participate in TIDES 2015?

  • - Early Registration Offer Ends January 23, 2015. Save up to $400 when you register.
  • - Sponsorship/Exhibition Opportunities: Highlight your company's expertise to this global audience of oligonucleotide and peptide decision makers by becoming an event sponsor or exhibitor. Email Sherry Johnson at  reach her at 508-614-1451 for pricing and package options.

Have any other questions on this year’s event? Feel free to reach out to me at jpereira@iirusa.com.


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Should vendors validate antibodies before they are sold?

We recently had a chance to sit down with a few of the Antibody Engineering and Therapeutics speakers to get an inside look into what they're working on and insights into their work.  We start this interview series off with Dr. David Rimm, a Professor of Pathology and Director, Yale Pathology Tissue Services and Yale University School of Medicine.

Today, he starts of by answering the question:
What do we need to validate antibodies? Shouldn’t the vendors do this before they sell them?
Dr. Rimm: Well, in the best of all possible worlds perhaps they would. In fact, some vendors do very rigorous validation while other vendors validate almost not at all. So, if all vendors did very rigorous validation, we would not need to validate antibodies. We could just trust that what it said on the label and the spec sheet is actually what was going to happen in our research laboratories or in the clinical setting. But, unfortunately, that’s not the case. Since the vendor’s responsibility is really to their shareholders or their owners to generate revenue – not necessarily to make a biologically good product – some vendors pay a lot more attention to making the product good, whereas other vendors pay a lot more attention to making money.

And to follow, we asked:
Is validation the same for all applications?
No. This is a very important point. Validation is application specific. That is, validation for a Western blot or for an ELISA assay is very different than validation for immunohistochemistry or immunofluorescence. While validation may work across different applications, each application – because of the epitope or because of the antigen – may be in a different state in that application and requires its own methods and its own protocols for validation.

Dr. Rimm will be presenting Use and Abuse of Antibodies in Research and the Clinic on Tuesday, December 9.  For more information on this session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us December 8-12, 2014, in Huntington Beach, California and mention code XD14172BLOGJP, you can save 20% off the standard rates.


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Friday, October 31, 2014

Biopharmaceutical Development & Production Week 2015 > Call for Speakers

Biopharmaceutical Development and Production Week 2015 will be the most in-depth and comprehensive concept-to-commercialization experience for professionals dedicated to the advancement of next-generation biologics via manufacturing facilities of the future. And for the first time, BPD Week will also incorporate IBC’s Single-Use Applications and Flexible Facilities conferences into the event. Take a greater role in this community, add to your professional accomplishments, and help shape the future of the field by presenting a talk at BDP Week.

BioPharmaceutical Development and Production Week will take place March 30-April 2, 2015 in Huntington Beach, California.

Speaker proposals are being accepted now through October 27, 2014.
>> Submit your speaking proposal here.

If you are working in any of the following scientific/business topic areas, we encourage you to submit a proposal for a podium presentation. We are especially looking for case studies with unpublished data on the following:
  • • Manufacturing Efficiencies: Strategy & Technology
  • • Upstream Processing
  • • Downstream Processing
  • • Antibody Drug Conjugate Development & Production
  • • Engineering (Single-Use and Flexible Facilities)
  • • Analytical
  • • Process Validation
  • • Viral Safety
  • • Raw Materials and Supply Chain
To go in-depth on what we’re looking for in each of these categories, visit our webpage.
    How else can you get involved in BDP Week?
    • • We’re also accepting abstracts for posters. Showcase your research by submitting your poster.
    • • We’re also currently recruiting sponsors and exhibitors. Each year, BDP Week debuts as the first must attend event for biopharmaceutical professionals from around the globe. Now is the time, to work with IBC to develop a customized, integrated marketing program that features pre-, post- and on-site solutions that help increase your market reach and influence – before, during and after the event. Request more information. 
    • • You can also join us as an attendee.  Registration is currently open and you can save up to $450 off the current rate.  
    Have any questions? Feel free to reach out Jennifer Pereira.


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    Thursday, October 30, 2014

    Checkpoint inhibitors: What are they and how do they work?

    We recently had a chance to sit down with a few of the Antibody Engineering and Therapeutics speakers to get an inside look into what they're working on and insights into their work.  We continue our interview series off with Omid Hamid, MD, Chief of Research, Immuno-Oncology at The Angeles Clinic and Research Institute.

    Our first question for Dr. Hamid is:
    Tell us about checkpoint inhibitors – what they are and how they work?
    Dr. Hamid: Sure. Checkpoint inhibitors are the body’s way of activating or inactivating the immune system. Checkpoint proteins tell the immune system what to do. So, the signals can up-regulate an immune response so that they are activating checkpoints or down-regulate an immune response. Those are inhibiting checkpoints. So, checkpoint inhibitors are also known as “immune checkpoint modulators”. They are designed to lessen the effectiveness of these checkpoint proteins that are on immune cells or tumor cells. 
    As we have recognized, these interactions between these checkpoint proteins located on tumors and on immune cells down-regulate or dampen our immune systems. By making these checkpoint inhibitors, we can block the interactions and release the suppression of the immune system. 
    Our bodies should be able to eliminate cancer. Unfortunately, the complex relationships with the body’s immune system and the body’s immune response is not always the best at eliminating cancer cells. The key reason is that these tumors can create an immunosuppressive environment. When normal cells change into cancer cells they can up-regulate these checkpoint proteins and evade the body’s surveillance.

    Dr. Hamid will be presenting The Promise of PD1 Checkpoint Inhibition for Multiple Solid Tumors on Wednesday, December 10 at the Antibody Engineering and Therapeutics event. For more information on his session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code XD14172BLOGJP, you can save 20% off the standard rate.


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    Wednesday, October 29, 2014

    IBC’s Spooktacular Savings - Save on some of our largest events!


    Visit the IBC website from October 29-31 and use priority code DEC14FS and you will receive your Halloween treat of 30% off the standard industry rate to attend the following events:



    Vaccine Development & Production Summit
    December 08-09, 2014
    Hilton Boston Back Bay, Boston, MA
    View the Agenda | Register Now

    Environmental Monitoring & Contamination Control
    December 10, 2014
    Hilton Boston Back Bay, Boston, MA
    View the Agenda | Register Now

    Antibody Engineering & Therapeutics
    December 07-11, 2014
    Hyatt Regency Huntington Beach Resort & Spa, Huntington Beach, CA
    View the Agenda | Register Now

    Commercialization of Cell, Gene & Immunotherapies Accelerating the Translation of Commercially Viable Cell, Gene and Immunotherapies Through bioprocess Tools and Technologies
    December 11-12, 2014
    Andaz San Diego, San Diego, CA
    View the Agenda | Register Now

    Questions? Email Jennifer Pereira.

    *This promotion is only valid October 29-31 only. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IBC approval.


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