Archive for the 'Trends' Category

Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications

Guest blog by Richard Freeman, sales manager at MeetingZone

Rich FreemanIn Part 1 of this blog, Richard Freeman looked at some of the challenges faced by pharma firms today as a result of growing competition, regulation and globalization, and argued that more effective communication and collaboration was key to their continued success. Part 2 outlines how unified communications (UC) can help overcome some of these challenges.

Any UC deployment is about connecting people with one another (and with data) in a faster, richer, simpler way. Of course, no technology is a silver bullet, and a firm will only realize the full benefits if it is a truly collaborative organization, or making serious efforts to become one.

As well as the right type of culture, companies also need to have appropriate infrastructure in place to support such a solution. For example, getting different modes of communication such as voice, video, and text working together seamlessly requires the right underlying network and hardware. While that could be an in-house system, for smaller and mid-market firms, a hosted, cloud-based offering that allows you to avoid hefty set-up costs is often a more cost-effective and hassle-free option. Read more »

Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Guest blog by Richard Freeman, sales manager at MeetingZone

Rich FreemanFor an industry that saves millions of lives, pharma is sometimes unfairly perceived by the public as being aloof, unresponsive, or occasionally worse. People outside the sector rarely appreciate the difficulty and cost of bringing new drugs to market, particularly when it comes to rolling them out in emerging global markets such as China, India and Africa.

Although globalization offers the prospect of vastly expanding the market for pharmaceuticals, grasping that opportunity is easier said than done. For a start, firms must ensure they understand and comply with a plethora of ever-changing regulation that varies from country to country. They generally need to liaise with hospitals and other medical and regulatory bodies to conduct country-specific clinical trials, even where a drug has been tested and approved elsewhere. And they may also have to contend with differing cultural attitudes to Western medicine that require them to tailor their marketing efforts accordingly. Read more »

Clusters set to benefit from improved funding climate but IP rights are even more critical

Guest blog written by John Dean, partner and patent attorney at Withers & Rogers LLP.

Life sciences and biotech research clusters across the UK, including those linked to university research departments are benefiting from an improved funding climate and ongoing consolidation in the pharmaceutical sector. However, as big pharma companies increasingly vie for the best spin-out investment opportunities, those with strategic intellectual property plans are likely to find favour. Read more »

FDA, Drug Companies Struggle with Compassionate Use Requests

A national publicity campaign recently succeeded in obtaining early access to an experimental treatment for a seriously ill child, touching off a broader discussion of compassionate use policies and their impact on drug development and approval. As 7-year-old cancer patient Josh Hardy gained relief from a

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life-threatening infection following a bone marrow transplant thanks to Chimerix’ promising new antiviral drug brincidofovir, hundreds of patients turned to the Internet and social media to intensify pressure for similar compassionate access. The trend demonstrates the need for sponsors, health professionals and government regulators to find new ways to handle these difficult requests, while also supporting clinical research and biomedical R&D.

Biopharmaceutical companies receive dozens of requests for early access to promising therapies, but often turn them down. Clinical supplies usually are very limited, often just enough to conduct a study. Production costs for biologics are high, particularly for small firms struggling to finance complex research programs.

Moreover, sponsors fear that adverse events with patient populations outside a clinical trial could delay development and approval. And expanded access can interfere with clinical trial accrual; if patients can obtain treatment outside a regulated study, they won’t want to enroll in a trial where they risk getting a placebo or a less effective comparator drug.

The social media phenomena raises serious ethical issues about whether hard decisions about who gets access to scarce therapies should be made on the basis of catchy publicity campaigns and political pressure, as opposed to who is most seriously ill and who is most likely to respond to treatment. Some consider lotteries or independent third parties as fairer ways to decide how to distribute a scarce, highly valuable resource. The prime ethical obligation of biotech companies, says the Biotechnology Industry Organization (BIO), is to develop safe and effective drugs as quickly as possible so that broad patient populations can benefit. Diversion of resources to deal with

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individual access requests can delay development and stymie efforts to achieve equitable distribution of limited supplies.

Regulatory challenges
FDA’s process for facilitating expanded access requests is a prime focus of reformers. The agency permits clinical trial sponsors to amend an investigational new drug application (IND) to grant patients access to experimental drugs for treatment purposes. Patients can’t apply for such access; the request has to come from the sponsor, physician investigator, or a qualified treating physician, either for a single patient or a small group (up to 100 patients). The expanded access IND requires evidence that the individual(s) have serious or life-threatening conditions, do not qualify to participate in a clinical trial, have no other treatment options available, and that potential benefits are likely to outweigh possible risks.

Details on the process are provided on FDA’s website and in a May 2013 Q&A guidance on expanded access to investigational drugs for treatment use. Jim

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Robinson, president of Astellas US, would like to see additional guidance on criteria for vetting requests for compassionate use, noting that demands for early access will only increase with some 3000 drugs in development for cancer and other serious conditions.

FDA’s Office of Health and Constituent Affairs, which provides information to health professionals and patients on expanded access policies and procedures, reports that the agency receives about 1000 expanded access INDs and access protocols each year and approves virtually all of them. The vetting process includes review by an Institutional Review Board to ensure adequate informed consent, and by the relevant new drug review division.

FDA officials sometimes convey patient requests to pharmaceutical companies and offer assistance to willing firms and physicians in filing necessary information and navigating the application process, explains Patient Liaison Program director Richard Klein. Because the purpose of these programs is treatment, and not research, sponsors don’t have to submit efficacy data from an expanded access study, but must report serious adverse events.

While FDA permits sponsors to charge patients for the cost of drugs provided under compassionate use, this provision is seldom used. Companies usually prefer to keep confidential information on production processes and costs, and limited supply is a larger concern than gaining revenue.

FDA’s desire for flexibility can be seen in its handling of the Chimerix case. Amidst the public demand for access to brincidofovir for Josh Hardy, FDA worked with Chimerix to approve a 20-patient open-label clinical trial for treatment of adenovirus infection in immunocompromised pediatric patients. The company thus avoided a massive open access program, and gained a strategy that it hopes will lead to a Phase 3 trial for this indication. Meanwhile, Chimerix is continuing its main development program (under new company leadership), which seeks accelerated approval of the drug for prevention of the more common cytomegalovirus (CMV) infection in adult bone marrow transplant patients. Chimerix launched its Phase 3 SUPPRESS trial last year at 40 transplant centers, with an eye to enrolling 450 patients, 150 receiving placebo; initial results are expected by mid-2015.

Although FDA and the sponsor addressed this compassionate use case successfully, there’s continued pressure for new approaches. A bill before Congress would permit the manufacture, importation, and distribution of unapproved investigational products to terminally ill patients. State legislatures are considering “right to try” bills, as seen in an Arizona measure that permits physicians to prescribe investigational drugs for certain terminally ill patients. Such proposals raise constitutional questions about the right of states to challenge federal drug approval policies, an issue central to past lawsuits challenging FDA interference in patient treatment.

Faster approval of important new medicines could address some early access concerns, a goal for regulators and sponsors alike. FDA held a public hearing in February 2013 on strategies for improving the accelerated approval process and whether FDA needs additional tools and authority to move promising therapies through the regulatory process, issues that will

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Report: Pfizer Makes $101 Billion Offer to AstraZeneca

Britain’s Sunday Times has reported that Pfizer approached AstraZeneca with a $101 billion purchase offer,

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which AstraZeneca has resisted. Unnamed investment bank and industry representatives were cited as the sources of the report.

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If the sale were to go through, it would be the largest-ever foreign takeover of a UK business, the Times reports. An AstraZeneca deal also

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According to Reuters, Pfizer could use cash it has accumulated through overseas subsidiaries for the acquisition; if repatriated to the United States, the funds would be heavily taxed.


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Innovation on the Rise among Indian Pharmaceutical Companies

India has a name when it comes to generic drug development. According to a recent research on patent applications carried out by Withers & Rogers, innovation by Indian pharmaceutical companies has increased over the past few years; however, the quality did not match the standard seen in Europe. Read more »

Preparing for Regulatory Inspections

Patricia Van Arnum PharmTech editorRegulatory compliance is of paramount importance to pharmaceutical and biopharmaceutical companies, which must be continually prepared for inspections by FDA, EMA, and other health authorities to meet requirements for good clinical practices (GCP) and good manufacturing practices (GMP). Pharmaceutical Technology will present an educational webcast on Thursday Nov. 7th from 1:00 to 2:00 PM EST, “Ensuring Preparedness for Regulatory Inspections,” which will provide insight on inspection trends and practical advice on how to best prepare for GCP/GMP inspections, examine the key information/documentation sought by regulators, and ways to achieve operational efficiency for providing access to that information. Read more »

Pharma Moves Towards Continuous Manufacturing and Low-Cost Products

VLUU L110  / Samsung L110It’s Day 2 at CPhI and the remaining findings of the annual expert industry report were released today during the show. As continuous processing continues to revolutionize manufacturing, Emil Ciurczak, principal at Doramax Consulting, believes that large batch production will one day be a thing of the past.

“We’ve had improved measurement systems, including light-induced fluorescent spectroscopy (LIFS), near infrared (NIR) and Raman, for years, and have used them to guarantee mixing,” noted Ciurczak, “but now there are automated systems that operate continuously that will allow us to speed up pre-pilot-scale work in design of experiments (DOE), technology transfer and the determination of the design space.” He pointed out that these systems eliminate some of the problems observed with conventional methods when moving from laboratory scale to small manufacturing scale. DOE can now be done in a matter of days with the newer systems instead of weeks or months. Such improved tools lower the costs of manufacturing and enable branded players to get more value out of their products while still under patent. According to Ciurczak, there will be less complains in the future about DOE and quality by design (QbD) costing too much or tying up equipment. Read more »

From Blockbusters to Niche Medicines

VLUU L110  / Samsung L110CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, today released Part II of the CPhI annual industry report, in which expert industry panel members share their views on trends that will drive growth and innovation across the pharmaceutical industry over the coming years and beyond.

The pharmaceutical industry is shifting away from the blockbuster model towards the development of personalized medicines and niche, individualized therapies and associated companion diagnostics, noted Sam Venugopal, director, healthcare, PricewaterhouseCoopers. These drugs target specific populations and genomic makeups and are known to have greater efficacy. William Botha, Sensei at Interlean, added that there will also be companies moving towards commodity-based, low-margin products. As a result, one can expect to see increased specialization, particularly amongst small and medium companies. Read more »

Budget Showdown Leads to Partial FDA Shutdown

US government agencies, including FDA, faced the first shutdown in 17 years when the House of Representatives and Senate failed to reach agreement on a budget. While national parks and landmarks, including the Statue of Liberty were closed on October 1 and thousands of government workers were idled, FDA expects to retain approximately 55% of its staff during the current partial government shutdown.

According to a Department of Health and Human Services statement, FDA will continue limited activities related to its user fee-funded programs. The agency will also continue “select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.”

The agency reports that it will not support the majority of its food safety, nutrition, and cosmetics activities and may have to cease safety activities such as “routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making.

Reviews of pending approvals for several drugs, originally scheduled for early October, were uncertain as of Oct. 1.

A provision by House Republicans to delay the implementation of the Affordable Care Act appears to be the major sticking point to an agreement. If elected officials get past this roadblock, the next big debate, over increasing the debt ceiling, is just two weeks away.

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