Pennside Partners Welcomes New European Director

Posted by Tom Penrice on Mon,Feb 20, 2017 @ 06:34 PM

Tom Perkins joins Pennside Partners, a pharma and biotech consulting firim, as European Director.Pennside Partners extends a warm welcome to Tom Perkins, who has been hired as a Director based out of our Zurich office. Tom brings 14 years of pharmaceutical consulting experience to Pennside. Tom is joining Pennside after more than a decade with leading market research firm, GfK. He began his pharma career first as an intern at V2 (acquired by GfK) during his studies at St. Joseph’s University (Philadelphia, PA, United States). He then quickly advanced through the organization to become a Division Manager of GfK’s Swiss arm based in Basel, Switzerland where he was the key account manager for one of GfK’s top clients.


Tom brings vast expertise in respiratory conditions (COPD, PAH, Cystic Fibrosis) and previous experience in oncology and hematology. In his last 3 years with GfK, Tom was running launch tracking for a major respiratory player. Previously, he was the project leader for the largest primary market research program ever conducted in Type 2 Diabetes where over 6,000 physicians and 10,000 patients from 26 countries gave insights on physician communication and marketing. Publications regarding this Diabetes project are forthcoming in 2017.


“We are excited to have Tom join our team. He will be an integral part of our plans to expand our European presence while continuing to provide excellent service to our existing client base. Our recent staff additions as well as the opening of our Manchester, UK area office in May of 2016 demonstrate our commitment to delivering the highest quality business development support, strategy, and competitive intelligence services to the pharmaceutical and biotech industries on a global scale,” said Tom Penrice, VP and Co-Founder of Pennside Partners.

For more information, including how Pennside can help you with your business development and competitive intelligence needs, contact Pennside Partners at 610-372-7000 or consult@pennside.com.

Pennside Partners EU Headquaters in Zurich, Switzerland, from which Pennside's new European Director will serve Pennside's pharmaceutical and biotech clients.Pennside’s Zurich office is located at Balsberg, Balz Zimmermann Strasse 7, CH-8058 Zurich-Flughafen, Switzerland and can be reached at +41 79 372 7070. You may also visit the company website: www.pennside.com.


About Pennside Partners

Pennside Partners is a leading business development consulting firm that has been serving the global pharmaceutical, biotechnology, and medical device sectors for more than 25 years. We earn our clients’ trust by consistently delivering high quality, actionable business insights and competitive intelligence. Our clients gain significant competitive advantages, including knowledge we acquire from mining the industry's deepest analog repository containing unmatched data insights into major launches. We offer an expert worldwide team of industry professionals who support our clients by formulating best-in-class tactical and strategic analysis. 


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Pharma Consulting, Biotech Consulting

7 Top Pharma Trends for 2017

Posted by Tom Penrice on Tue,Feb 07, 2017 @ 09:00 AM

Seven pharmaceutical industry trends for 2017 by pharma consulting firm Pennside PartnersFrom the effects of Donald Trump’s election as US president to pioneering therapies for Alzheimer’s, some trends are set to continue and others to emerge as the global pharmaceutical industry pushes into 2017.

Analyzing the top seven pharma trends forecast for the new year, Pennside Partners offers some key insights into the essentials.

 

Pharma Trend #1: High-tech pharma

With inhalers that track doses and products that monitor patient compliance, high-tech in medication is becoming increasingly important. “The big thing that strikes me is how pharma is becoming more and more dependent on medtech,” commented Dr. Munna Choudhury of AlacraMed in an interview with Life Science Investing News. These technological additions give a product its competitive edge, according to Choudhury. The article highlights that as a result, we could see more collaborations between pharmaceutical companies and unlikely players, such as telecoms companies and mobile device manufacturers. With support from these tech firms, pharmaceutical manufacturers can develop holistic products to support applications including diagnostics, monitoring, and compliance.

Similarly, PharmaPro expects companies to unlock the potential of AI, Big Data, and Cloud technologies to support their supply chains, predict outcomes, and prescribe actions autonomously – offering significant promise for return on investment. PharmaPro said: “In 2017 these advancements will continue to evolve to make the entire supply chain autonomous.”

 

Pharma Trend #2: New treatments for Alzheimer’s

As the baby boomer generation grows older, the Alzheimer’s Association predicts Alzheimer’s Disease (AD) to account for almost 25% of Medicare spending by 2040 – a huge increase over the predicted 2.1% of Medicare spending in 2020. So far, the pharmaceutical industry has not discovered an optimal response to the disease. According to Forbes.com, although billions of dollars have been invested in targeted antibody drugs, the trend is likely to shift towards alternative scientific approaches in 2017.

One theory is that Alzheimer’s can be fought by preventing the immune system from removing synapses required for neuronal functioning. The article also highlights that an anti-inflammatory drug reportedly improved memory in a small set of patients with mild cases of AD.

 

Pharma Trend #3: Political uncertainty in the UK

A significant carry-over trend from 2016 is the political uncertainty following Brexit. According to Pharmafocus, significant consequences of the UK leaving the EU on the pharmaceutical industry could be regulatory. The article explains that for a drug to be placed on the EU market it must have a marketing authorization (MA), which may be granted by the European Medicines Agency’s recommendation to the European Commission.

Alternatively, applications may be considered by a ‘reference member state’ (RMS) residing in the EU. Once approved by that country, the other EU RMS should grant national approvals. It is not yet clear whether the UK could continue to be the RMS for authorized products after it leaves the EU. For more analyses of the possible consequences of Brexit, click here.

 

Pharma Trend #4: The Trump Effect

In addition to UK and EU market uncertainties, the US is anticipating its own economic policy uncertainty with the election of Donald Trump as president. Trump’s plans appear to be a mixed bag for consumers and Big Pharma alike because it is nearly impossible to gauge their potential impact. Trump’s health plan states: “Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products.” According to The Washington Post, this represents a hint that the drug and medical device industries may soon have an easier time getting products to market. Robert Weissman, president of Public Citizen, countered, “…the general deregulatory rhetoric…is a worry for us, but as applied to FDA, it would be very troubling,” meaning that deregulation may compromise safety standards.

Trump has also pledged to cut corporation tax for American companies, with The Telegraph reporting that this move could trigger significant pharma mega-mergers. Furthermore, Trump has suggested he would allow businesses to repatriate money earned overseas into the US without facing hefty fines.

Yet, Trump has intimated that he would allow the importation of high-price medications from abroad, where they are cheaper, notes The Telegraph. This would result in parallel markets entering into direct competition with the US market. While it is impossible to foresee where these proposed reforms will take the economic and regulatory aspects of the pharmaceutical industry, it will be vital to have a finger on the pulse.

 

Pharma Trend #5: Drug prices

The end of 2016 saw several major pharma companies sued for allegedly fixing drug prices, and public outcry in the face of pricing is likely to continue into 2017. Pharmaceutical consultant Carole Bruckler told Pharmaceutical Investment News: “In the US, there is clear political will forming against annual or quarterly drug price increases to fuel sales growth.”

Although the election of Trump is likely to prove more favorable to drug prices than a Clinton victory would have – under Trump, we could see reduced regulation on drug price inflation – pharma companies may have to reconsider their business models, warns the article. Bruckler added, “For pharma revenues to be sustainable in the future there needs to be an increased focus on volume growth … so investors need to really understand the substance behind their investments.”

 

Pharma Trend #6: Biosimilar profitability

Biosimilar drugs present a more affordable option for the consumer and are also potentially lucrative for manufacturing companies. Importantly in 2017, these biological products are set to continue to increase in popularity. Since the first biosimilar drug was approved for use in America in 2015, there are now more than 700 biosimilars approved or in the pipeline. Sales could be boosted by 11 key biologics that face loss of exclusivity over the next seven years, with biosimilar sales expected to generate 27 per cent of the total pharma market by 2020.  

 

Pharma Trend #7: The microbiome

DNA sequencing tools that have boosted understanding of how we exist with the bacteria in our guts has brought the microbiome to significant prominence in biology over recent years. Research suggesting that the bacterial composition of the gut affects mood opens up new avenues for the treatment of depression and other mental illness or disorders of the central nervous system. However, according to Forbes.com, how biotech and pharma companies can develop drugs based on this science is an open question – despite development in that direction.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Pharma Consulting, Pharma Trends

British Pharma Industry Faces Challenges Post-Brexit

Posted by Tom Penrice on Mon,Dec 12, 2016 @ 09:00 AM
The British pharmaceutical industry is facing new challenges following the UK’s decision to leave the European Union, a white paper has revealed. Published by Global Data, it warned of wide-reaching impacts.

The British pharmaceutical industry faces important challenges since the Brexit, with implications for drug development, grant funding, workforce movement.51% of Britain’s medicinal and pharmaceutical products are exported to the European Union (EU). But in June, a referendum indicated the UK should leave the EU – the so-called “Brexit”.

While Big Pharma companies emerged from the vote largely unscathed – some even enjoyed a small but immediate increase in their share prices – the result is likely to create challenges industry-wide, as a new white paper published by Global Data has forecast.

Question mark over drug regulation

Drug manufacturers will face an “immediate impact in the area of drug and medical device regulation,” explained Global Data in its paper.

The European Medicines Agency (EMA), which is responsible for the evaluation and monitoring of all drugs marketed in the EU, is currently headquartered in the UK. If it relocates to the EU when Brexit commences, companies may need to file for approval separately between the UK and the EU.

Then there is the EU Clinical Trials Directive. Although it is fully implemented into UK law, a new directive is expected to take effect in October 2018. Participation is necessary in order to gain drug approval within the EU.

Global Data warned that if the UK does not adopt the upcoming legislation, then the number of multi-center clinical trials in both the UK and EU is likely to be reduced, since “it will be very difficult and costly to integrate national trial authorization procedures with the new EU centralized trial authorizations”.

The issue of grant funding

Another big post-Brexit issue is funding and investment, as Britain’s The Telegraph reported. It explained that UK institutions and researchers receive a significant amount of European funding through grants, including Horizon 2020 and the European Investment Fund.

Up to £8.5 billion of funding and investment in UK science could be lost over the next four years, potentially isolating UK research and development and reducing its influence within the global scientific community.

In order to keep the money from these grants flowing, Britain needs to show why it is an attractive place to invest in life sciences, including pharmaceuticals and medical devices – a sector that accounts for more than 180,000 jobs and generates revenue of over $80 billion in the UK, according to UK Trade and Investment.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, told The Telegraph: “We have a fantastic asset, which is the NHS, and a fantastic science base. We need to connect those two together so the industry can see that as well as investing in our science base at the early stage of research, we have the potential for those medications to flow through the system [into commercialisation].”

Restrictions limit pharma workforce

Meanwhile, there is uncertainty surrounding the pharmaceutical workforce. If restrictions are placed on freedom of movement within EU countries, this could limit the UK’s reach across Europe’s skilled workers.

A PWC blog explained that around 7% of the pharmaceutical and life sciences industries’ employees are non-British EU citizens, warning that many academics and senior pharmaceutical staff who frequently move around Europe could be affected.

Swiss pharma industry sets example

It is not yet known whether Britain will opt for a “hard Brexit” or “soft Brexit”, with the latter being less of a threat to biotech and science, according to Forbes. It is however expected that the EU will make the terms of Brexit as harsh as possible, the site reported, “with little protection for biotech or science”.

Luckily, it is not all doom and gloom. Global Data cited Switzerland as the leading example of successful pharma and medical devices industries outside of the EU.

The country boasts low effective corporate tax rates and flexible labor laws, allowing for more liberal contracts, longer working hours, and reduced union involvement. Perhaps following in Switzerland’s footsteps, British Prime Minister, Theresa May, recently pledged to deliver the lowest corporation tax rate in the G20.

Global Data concluded: “The solution might lie in creating a uniquely British solution. The European Economic Area (EEA) has already been cited by commentators as an alternative approach for the UK to maintain access to the Single Market, albeit at the cost of accepting freedom of movement between the EEA and EU.”

Pennside Partners has also expanded its European presence with a new UK office located south of Manchester. Find out more here.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Development, Big Pharma, British Pharma Industry, Pharma UK, Pharma Europe, British Pharma

Medical 3D Printing Breakthroughs Keep on Coming

Posted by Tom Penrice on Thu,Aug 04, 2016 @ 09:00 AM

Medical 3D printing looks very promising based on recent progress. Organ transplants using 3D "living" body parts may be coming in the next few years.Medical 3D printing is making quick leaps and bounds and could soon be such a key integrated part of the medical world that we will wonder how we ever lived without it.

Doctors are now able to print 3D “living” body parts – which will be a significant advancement for regenerative medicine. A positive breakthrough has already been made, with the successful implantation of bone, muscle and cartilage into animals.

Previously, the field had hit a wall: keeping the cells alive was difficult, as they became starved of oxygen and nutrients. This problem led to a very promising solution by the team at Wake Forest Baptist Medical Centre.


The Sponge

It is exactly what it sounds like. The Wake Forest team developed the idea of printing the tissue with channels interwoven throughout to allow key ntrients to pass through it.

How can a “living” body part be printed with these channels? Through the Integrated Tissue and Organ Printing System (ITOP), which utilizes a bio-degradable plastic to give the tissue its structure, as well as a water-based gel that contains the cells and encourages growth.

These channels allow blood vessels and nerves to grow into the printed tissue. Before the ITOP 3D printer, the largest structure to be kept alive without blood cells was 0.007 inches thick. With the ITOP size isn’t an issue, as the microscopic pores are interwoven into the printed structure allowing the i
plant to be kept alive indefinitely.

Are 3D Organ Transplants Next?

This development gives 3D organ printing a promising outlook. Within the next few years we could be expecting success stories on artificial heart, liver, kidney, and other major organ transplants, giving many on the transplant list hope. Pennside will continue to follow the development of 3D printing in the healthcare industry.

If you aren’t familiar with how 3D printing is impacting the pharma and biotech industry check out Pennside’s earlier blog postings to learn more.

The above post is a condensed and edited summary of NBC News: Wake Forest University Scientists Print Living Body Parts, BBC News: Doctors 3D-print 'living' body parts and Popular Mechanics: Incredible 3D Printer Can Make Bone, Cartilage, and Muscle


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: 3D Body Parts, 3D Organ Printing, Medical 3D Printing

Prescription Drugs: To Import or Not to Import?

Posted by Tom Penrice on Tue,Jul 12, 2016 @ 06:00 PM

Do cheaper, imported drugs really save money – or just compromise safety?

Considerations regarding benefits and costs of importing prescription drugs into the US. Contact Pennside Partners, a pharma and biotech consulting firm, for more information.50 million Americans did not fill a prescription in 2012 because of its cost, a Commonwealth Fund report revealed.[1] Now, prescription costs are under the political spotlight again, with US presidential candidates Donald Trump, Hillary Clinton and Bernie Sanders all commenting on the issue.  

Speaking out against current Food and Drug Administration (FDA) laws that state it is illegal to import drugs into the USA except in rare cases, the presidential candidates all voiced support for the enhanced importation of prescription drugs to address the issue of cost.

Clinton believes America needs “to promote competition and leverage our nation’s bargaining power to lower drug costs on behalf of Americans”.[2] Sanders wants to allow individuals, pharmacists, and wholesalers to import prescription drugs from licensed Canadian pharmacies.[3] And Trump has proposed removing “barriers to entry into free markets for drug providers that offer safe, reliable and cheaper products”.[4]

But do cheaper, imported drugs really save money – or just compromise safety?

The cost of the FDA

Among the reasons drugs sold in America cost more than in places like Canada or Europe are the approval processes laid out by the FDA. The agency states on its website that it is “illegal for individuals to import drugs into the United States for personal use, because the FDA cannot ensure the safety and effectiveness of these drugs.”[5]

The FDA’s Center for Drug Evaluation and Research (CDER) has the job of evaluating new drugs before they are sold to ensure that brand name and generic drugs work correctly and that the health benefits of the drug outweigh the known risks.

It states on its website: “A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research…”[6]

However, the FDA’s regulatory processes have driven up the cost of prescription drugs to sometimes unaffordable levels – for both consumers and pharmaceutical companies. According to the Tufts Center for the Study of Drug Development, the cost of developing drugs has increased phenomenally since 1975.[7]

Its research shows that in 1975, the pharmaceutical industry spent the equivalent of $100 million researching and developing the average drug approved by the FDA. By 2005, that figure had risen to $1.3 billion. At the same time, the high rate of drug failure (only one in 12 drugs that enter human clinical trials secure FDA approval) means that pharmaceutical companies spend about $5 billion per new drug.

Driving this increase has been the FDA’s regulatory process for Phase III clinical trials. These trials typically represent 90% or more of the cost of developing an individual drug from laboratory to pharmacy, highlights commentator Avik Roy in an article on Forbes.com.

The consequence is higher health spending, he explains, as pharmaceutical companies have to charge more to recoup their costly investments. [8]

The dangers of importation

Some believe that the cost of these regulatory processes is a necessary one. The Philadelphia Inquirer’s Robert Blancato argues that any money-saving notions are too good to be true. In his article he comments: “Drug importation is a terrible idea that would put Americans at risk of harm from impure, unsafe, and counterfeit copies of prescription drugs[9].”

Existing cases support his argument. During the drug importation debate in 2003, the FDA examined mail shipments and found that 88% of the imported drugs they tested did not meet FDA standards, with some packages containing unapproved or counterfeit drugs.[10]

In a speech at that time, former FDA Commissioner Mark McClellan commented: “In addition to allowing in some drugs that might be safe, [drug importation] would also create wide and poorly-regulated channels through which a lot of potentially unsafe drugs will also be able to enter the country more easily.”[11] The FDA website explains that these drugs may be contaminated or contain the wrong or no active ingredient. On the other hand, they could have the right active ingredient, but at the wrong dose. [12] 

Campaign rhetoric or a real solution to pricing problems?

Could loosening the reins on drug importation provide American’s some financial relief? If Americans were able to import from select pharmacies in other countries drug costs would decrease and the FDA could still keep a hand in regulating.

Are the presidential candidates right? Does the question of price outweigh these issues of safety?

In 2013, a group from Maine, consisting of state employees, Portland employees, and one large company, claimed to have saved approximately $10 million over several years by purchasing their drugs through a Canadian mail-order pharmacy. [13]

The same year, the National Health Interview Survey revealed worrying statistics about the affordability of prescription drugs: to save money, almost 8% of U.S. adults did not take their medication as prescribed, and just over 15% asked a doctor for a lower-cost medication.[14]

Based on these statistics, if lack of affordability forces people to avoid taking medication as prescribed, is importation really a dangerous idea? After all, in Canada there are drug checks similar to those carried out by the FDA: Health Canada (HC) regulates drug approvals, claiming that “the safety and wellbeing of Canadians is the paramount concern.”

Cost vs. speed

In Europe, where drugs are also cheaper than in America, there is the European Medicines Agency (EMA), which is responsible for the “protection and promotion of public and animal health, through the evaluation and supervision of medicines.”[15]

There are differences between the bodies, though, providing possible reasons for the discrepancies in cost. Let’s take the question of time: the FDA trumps both the Canadian and European agencies for speed. Research conducted by Yale University’s Joseph Ross revealed that the FDA approved drugs almost two months faster than its counterparts, getting products to market first in the majority of cases.[16]

It took the FDA an average of 322 days to approve a drug product, compared to 366 days for the EMA and 409 days for Health Canada (HC). Perhaps then, America is paying the price of efficiency.

Perhaps it also paying the price of a more concise approvals process. According to an article published in Oncology Journal in 2013, the FDA both scientifically evaluates new agents and issues marketing approval decisions for therapeutics. Meanwhile, the scope of the EMA’s Committee for Medicinal Products for Human Use is limited to the scientific evaluation of therapeutics. The EMA then makes recommendations to the European Commission for marketing approval of the drug.

The article adds that additional differences between the agencies arise because each EU member state has a different system for therapeutics approvals. For example, in Britain, licences can be acquired through the Medicines and Healthcare Products Regulatory Agency (MRHA) or the EMA. The National Institute for Health and Care Excellence (NICE) must then evaluate efficacy and any cost concerns.

In the EU, national authorities are free to set the prices of medicinal products and to designate the treatments they wish to reimburse under their social security systems. At the same time, pricing and reimbursement systems are closely linked to the realization of European policy objectives such as the internal market, pharmaceutical competitiveness, sustainable research and development, and the protection of human health. The variety of healthcare and social security systems in the EU has an impact on the pharmaceutical industry, wholesalers, pharmacists, doctors, health insurers, and patients.[17]

Looking past the election 

For now, cost concerns are still a part of life for many American patients. But as the election campaign heats up, we’ll have to wait and see what lies in store post-November for the future of prescriptions.

 

[1] Collins, Sara R., Ruth Robertson, Tracy Garber, and Michelle Doty. "Insuring the Future: Current Trends in Health Coverage and the Effects of Implementing the Affordable Care Act." The Commonwealth Fund, April 2013. Accessed April 25, 2016.

[2] "Hillary Clinton's Plan for Lowering Prescription Drug Costs." Hillary Clinton's Plan for Lowering Prescription Drug Costs. Accessed April 25, 2016. https://www.hillaryclinton.com/briefing/factsheets/2015/09/21/hillary-clinton-plan-for-lowering-prescription-drug-costs/.

[3] "On the Issues: Fighting to Lower Prescription Drug Prices." Bernie Sanders RSS. Accessed April 25, 2016. https://berniesanders.com/issues/fighting-to-lower-prescription-drug-prices/.

[4] "Healthcare Reform." Make America Great Again! Accessed April 25, 2016. https://www.donaldjtrump.com/positions/healthcare-reform.

[5] "U.S. Food and Drug Administration." Personal Importation. Accessed April 25, 2016. http://www.fda.gov/ForIndustry/ImportProgram/ImportBasics/ucm432661.htm.

[6] "Development & Approval Process (Drugs)." U.S. Food and Drug Administration. Accessed June 09, 2016. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/.

[7] Roy, Avik. "How the FDA Stifles New Cures, Part I: The Rising Cost of Clinical Trials." Forbes. April 24, 2012. Accessed April 29, 2016. http://www.forbes.com/sites/aroy/2012/04/24/how-the-fda-stifles-new-cures-part-i-the-rising-cost-of-clinical-trials/#2d2a18bf5bc6.

[8] Roy, Avik. "How the FDA Stifles New Cures, Part I: The Rising Cost of Clinical Trials." Forbes. April 24, 2012. Accessed May 02, 2016. http://www.forbes.com/sites/aroy/2012/04/24/how-the-fda-stifles-new-cures-part-i-the-rising-cost-of-clinical-trials/#2d2a18bf5bc6.

[9] Blancato, Robert. "Commentary: Drug-import Proposal Would Compromise Safety." Philly-archives. April 07, 2016. Accessed April 25, 2016. http://articles.philly.com/2016-04-07/news/72105577_1_drugs-online-prescription-drugs-fda-associate-commissioner.

[10] Turner, Grace-Marie. "Drug Importation Equals Unsafe Drugs, Mr. Trump." Forbes. March 16, 2016. Accessed April 25, 2016. http://www.forbes.com/sites/gracemarieturner/2016/03/16/drug-importation-equals-unsafe-drugs-mr-trump/#799fd87bd3d3.

[11] McClellan, Mark B. "Speech before Fifth Annual David A. Winston Lecture." FDA U.S. Food and Drug Administration. October 20, 2003. Accessed April 25, 2016. http://www.fda.gov/NewsEvents/Speeches/ucm053609.htm.

[12] "U.S. Food and Drug Administration." Counterfeit Medicine. Accessed April 26, 2016. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/.

[13] Space, Judi. "Is Maine Right About Importing Prescription Drugs?" Is Maine Right About Importing Prescription Drugs? November 23, 2013. Accessed May 02, 2016. http://www.pennside.com/blog-pharma-biotech/bid/326207/Is-Maine-Right-About-Importing-Prescription-Drugs.

[14] Cohen, Robin A., and Maria A. Villarroel. "Strategies Used by Adults to Reduce Their Prescription Drug Costs: United States, 2013." Centers for Disease Control and Prevention. January 29, 2015. Accessed May 02, 2016. http://www.cdc.gov/nchs/products/databriefs/db184.htm

[15] "European Medicines Agency." EUROPA. Accessed June 13, 2016. http://europa.eu/about-eu/agencies/regulatory_agencies_bodies/policy_agencies/ema/index_en.htm.

[16] Gaffney, Alexander. "Researchers: FDA Beats EMA, Health Canada in Drug Approval Times | RAPS." RAPS: Regulatory Affairs Professional Society. June 20, 2012. Accessed May 09, 2016. http://www.raps.org/focus-online/news/news-article-view/article/1798/.

[17] "Pricing and Reimbursement of Medicinal Products." European Commission. Accessed May 19, 2016. http://ec.europa.eu/growth/sectors/healthcare/competitiveness/products-pricing-reimbursement/index_en.htm.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Prescription Drug Costs, Prescription Drug Importing

NHS England Overhauls Access to Cancer Treatments

Posted by Tom Penrice on Thu,Jun 30, 2016 @ 06:00 PM

Faster cancer treatment access may result from England's reincarnated Cancer Drugs Fund.Patients in England could have faster access to effective cancer treatments through the reincarnated Cancer Drugs Fund (CDF), the National Institute for Health and Care Excellence (NICE) has announced.

The new fund will replace the existing – and greatly overspent – service, which provides access to cancer drugs that are not routinely available at the National Health Service (NHS) in England. Its costs rose to £340 million between 2015 and 2016, following an annual budget of £200 million when it was set up in 2011.

Devised to counter this overspending, the new system will launch in July, fixing the fund's annual budget at £340 million.

Old CDF Versus New CDF

While the existing CDF can choose to pay for innovative drugs that NICE has rejected for widespread use on the NHS, under the new system the health watchdog will make all the decisions.

In a European first, NICE will issue draft guidance on new cancer drugs or significant new license indications before they have received marketing approval in the UK.

Any drug that receives a positive draft recommendation will be funded from the point of license, with NICE normally issuing final guidance within 90 days of the license. Drugs given a “maybe” rating will be considered for the CDF.

The aim is to bring clarity to decisions about which new cancer drugs will receive NHS funding, as well as to allow the NHS to offer conditional funding for those with uncertain evidence for use.

Sir Andrew Dillon, NICE chief executive, commented in a press release: “Patients in this country will now have access to clinically and cost effective, innovative new cancer drugs faster than ever before.”

He added: “In a first of its kind approach, NICE will issue draft recommendations on the use of cancer medicines before they receive their license, with funding from NHS England available if approved. No other country in Europe does this.”

Impact on the pharma industry

If the case for routine use of a drug is not clear cut and more evidence is needed to prove its cost effectiveness, NICE can recommend the drug for temporary, conditional use in the new CDF.

The drug will remain available in the CDF for up to two years while the manufacturer gathers evidence to show that the medicine works and is fairly priced.

After two years, NICE will conduct a review to consider the drug for routine commissioning on NHS England, with the medicine moving out of the CDF and into routine budgets, or being made available on an exception only basis. 

Dillon argued: “The new CDF will be fair. Companies will be given the opportunity to demonstrate their drugs will benefit patients and bring value to the NHS.”

However, concerns about the new fund have been raised, with claims that NICE’s appraisal process could block access to drugs. The Pharma Times reported that the Association of the British Pharmaceutical Industry was disappointed by NHS England’s decision to push ahead with proposals that carry a “very real risk of significantly setting back patient access to cancer medicines, now and for the foreseeable future”.

Paul Catchpole, value and access director of the Association, told the journal: “If cancer medicines go through more or less exactly the same NICE appraisal process that was in place five years ago - which necessitated the setting up of the CDF in the first place - we will largely get the same answers as before - the majority of medicines will be turned down”.

He warned that under the proposals, two thirds of existing CDF medicines would be likely to no longer be available to NHS patients by the end of the year.

Cancer charities agree. In a letter to the British prime minister published in newspaper The Daily Telegraph, 15 charities wrote that many drugs available the western world would "now struggle to gain approval" in England due to NICE’s “last-century methodology”.

The letter stated: "Unfortunately the new system does not update the methodology used by NICE, introduced back in 1999, and many clinically-effective treatments will now struggle to gain approval.”

The charities highlighted that since 2011, when it was launched, the CDF has paid for 84,000 cancer treatments that NICE turned down. Speaking to the BBC, Baroness Delyth Morgan, chief executive of charity Breast Cancer Now, commented: "Not a single breast cancer drug has been considered cost-effective by NICE in the last seven years and this simply cannot continue." Among the breast cancer drugs NICE has rejected is Kadcyla, a treatment which can prolong a dying patient’s life by six months on average.

Cancer Research UK explains on its website that NICE’s approval process is based on whether a drug works, whether it is cost effective and contributions from patient organizations, health professionals and experts.

Important Dates

The current CDF closed on 1 April 2016. Drugs transferring from the old CDF will be appraised by NICE over the next 18 months. Entirely new drugs will be able to enter the CDF from July 2016.

All drugs on the existing CDF list will continue to receive funding until the point that NICE has completed a new appraisal of them, and any patients currently receiving them will finish their treatment.

The CDF was established in 2011 and covers England.

This article is a synopsis of: Faster access to effective cancer treatments through new Cancer Drugs Fund, Cancer Drugs Fund changes deeply concerning, say charities, and What is NICE and how does it work?

Pennside Partners Expands European Presence through new UK office located South of Manchester

UK-Headquarters-Pharma-Biotech-Consulting-Firm-B650.jpgThe Pennside team is excited to announce their new office in Alderley Edge in the UK, 25 KM south of Manchester. This ideal location will help us better serve our European client base due to its proximity to local pharma and biotech companies. Thomas Penrice, Vice President and Partner will be the EU Managing Director. Learn more


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Cancer Drug Development, Cancer

Pennside Partners Announces Expansion into UK

Posted by Tom Penrice on Sat,May 07, 2016 @ 07:38 PM

Pennside Partners announces the opening of their UK locationAlderley Edge, United Kingdom – As a result of expanding business and a desire to better serve its European client base, Pennside Partners today announced the opening of a new office in Alderley Edge, UK, 25 KM south of Manchester. The office is located within the BioHub at Alderley Park, Alderley Edge, W1U 7EU, United Kingdom (http://www.biocity.co.uk/biocity/alderley-park).

“Our new UK location, combined with our Zurich, Switzerland site, will enable us to expand our delivery of high-quality, actionable business insights and competitive intelligence services to our pharmaceutical, biotechnology, and medical device clients throughout the EU,” said Michael Rhoads, President and Partner of Pennside Partners.

He added: “Alderley Park is an ideal area for our new UK office given its proximity to local pharma and biotech companies, as well as access to an exceptional talent pool of potential employees.”

Thomas Penrice, Vice President, Partner, and EU Managing Director will oversee the new UK office.

For more information, including how Pennside can help with your business development and competitive intelligence needs, contact Pennside Partners at +44 (0) 20 3695 7639 or consult@pennside.com. You can also visit the company website: www.pennside.com.

About Pennside Partners  

Pennside Partners is a leading business development consulting firm that has been serving the global pharmaceutical, biotechnology, and medical device sectors or more than 25 years. We earn our clients’ trust by consistently delivering high-quality, actionable business insights and competitive intelligence. Our clients gain significant competitive advantages, including knowledge we acquire from mining the industry's deepest analog repository containing unmatched data insights into major launches. We offer an expert worldwide team of industry professionals who support our clients by formulating best-in-class tactical and strategic analysis. Pennside has offices In Wyomissing, PA, USA, Alderley Edge, UK, and Zurich, Switzerland.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Press Releases

T-Cell Immunotherapy Market Predicted To Grow

Posted by Tom Penrice on Thu,Apr 21, 2016 @ 06:00 PM

Immunotherapeuticsis projected to be a $30 billion USD market by 2030.Nearly one million people are diagnosed with cancer in the United States per year, according to The American Cancer Society, and although cancer therapeutics are among the most active areas in drug development, treatment still falls short of meeting patients’ needs.

However, experts believe that immunotherapeutics – in particular T-cell immunotherapy – could help fill a vital gap, with Roots Analysis’ "T-Cell Immunotherapy Market, 2015-2030" report predicting the market will be worth $30 billion USD by 2030. 

Robust products in T-cell immunotherapy

Shannon Flynn, a consultant at Pennside with 3 years’ experience in gene therapy, explains that T-cell immunotherapy is an emerging therapeutic modality in which tumor-targeting T-cells are administered to the patient as a sort of “living drug.”

The therapy involves collecting T-cells, either from the patient (autologous) or a donor (allogeneic), as the active ingredient for treatment.  The cells are then modified to enhance their anti-tumor potential, before being expanded to increase total cell numbers for an optimized final product which can be administered to the patient.

Separated into three segments – CAR-T, TCR, and TIL therapies, the market is characterized by a robust pipeline of products targeting hematological cancers and solid tumours.

Researchers identified more than 180 T-cell therapies across various phases of development: at 56%, CAR-T therapies are the most common – and likely to gain the most attention – followed by TCR (25%) and TIL (19%) therapies. Engineered CAR-Ts with switch technologies are among the latest additions to the T-cell immunotherapy pipeline.

Pennside’s analysts note that some of the most recent developments in the field involve engineering CAR-T cells with sophisticated switch technologies which serve to modulate the activity of the cells in vivo. These technologies are primarily aimed at improving safety of the cells by migrating on-target/off-tumor toxicities.

For example, cells can be designated to turn “on” or “off” in the presence of a small molecule drug, while others might be engineered to activate only in response to stimuli from the tumor itself. Novel technologies such as these afford the CAR-T cells with mechanisms to enhance their tumor targeting potential and avoid damaging healthy tissues.

Driving factors behind T-cell developments

As for progress, the numbers speak for themselves: the report identified investments in T-cell research nearing USD 3 billion across start-ups and small firms. Big industry players are also driving research in the field.

Further helping push the T-cell market forward are lucrative rounds of VC funding, the discovery of novel targets, encouraging clinical trial results, and developments in immunotherapy products.

Meanwhile, various providers have pioneered improved efficacy and safety in developing platforms for engineering T-cells. The market has also attracted interest from technology providers with capabilities in genome editing, and viral and non-viral gene transfer. Other providers are developing innovative safety switches to manage side effects, such as cytokine release syndrome and B-cell aplasia.

The report, published by Roots Analysis, provides a comprehensive view of the market, which is still in its infancy.

This blog is based on the press release: http://www.prnewswire.com/news-releases/t-cell-immunotherapy-market-2015-2030-300234571.html and report http://www.rootsanalysis.com/reports/view_document/t-cell-immunotherapy-market-2015-2030/108.html


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: T-Cell Immunotherapy, Cancer Therapeutics, Cancer, Immunotherapy, Immunotherapeutics

Is 3D Printing The Next Big Thing In Pharma?

Posted by Tom Penrice on Wed,Feb 10, 2016 @ 06:00 PM

A Brief History of 3D Printing in the Medical Industry

Are 3D printed drugs the next big thing for the pharmaceutical industry? 3D printing has been making waves since 1984 when its inventor, Charles Hull, used the technology to make a 3D model from a picture, demonstrating that this technology would be a revolutionary way to test a product design before sinking big money into a large manufacturing program. The power of 3D printing limited innovators only to their imagination and took the world by storm in the intervening years- everything from fashion to firearms was transformed.

The medical industry is just one of the industries revolutionized by 3D printing. In 1999, 3D printing allowed scientist to implant a lab grown organ into patients undergoing urinary bladder augmentation. In the early 2000’s, researchers engineered a functioning kidney, giving scientists the ability to “print” organs and tissues. In 2009, a 3D printer was used to “print” the first blood vessel.

3D-Printing, the FDA, and the Pharma Industry

A few years later, headway is still being made in the medical industry. In early August 2015, the U.S. Food and Drug Administration (FDA) approved the first 3D- printed pill. SPRITAM LEVETIRACETAM, manufactured by the pharmaceutical company Aprecia, is used for reducing seizures in epileptics. The manufacturing of SPRITAM LEVETIRACETAM is done through the 3D printing process of layering the active and inactive ingredients layer by layer. The unique process of 3D printing is beneficial to its patients, as it can make each pill more potent than the traditional tableting machine can produce.

The FDA’s approval of SPRITAM LEVETIRACETAM means that Aprecia is the first major pharmaceutical company to “print” drugs, and they now own the rights to their successful technique. Aprecia’s ZipDoseâ Technology is a combination of science and 3D printing, protected by numerous patents through 2033.

The Future of 3D Printing in the Pharma Industry

No one is certain of how the concept of 3D printing will continue to change the pharmaceutical/ medical industry. But the concept of 3D pill printing brings the process closer to patients in need and may allow for hospitals to adjust doses to individual patients. In addition, the effective layer by layer printing concept in SPRITAM LEVETIRACETAM could be beneficial to other similar drugs where potency and precise dose release are important.

The FDA approval of SPRITAM LEVETIRACETAM is likely to lead to more novel 3D-printed therapies. So what’s next? Pharma companies in the UK are already experimenting with everything from pyramid to donut shaped pills, and many other companies are taking a look at the best way to structure pills for the patients who need them.

The above post is a condensed and edited summary of a Brief History of 3D printing , the Business Insider article: 3-D printing is revolutionizing the pharmaceutical industry and TheGuardians: The first 3D-printed pill opens up a world of downloaded medicine


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: FDA, Drug Development, 3D Printing Pharmaceuticals, 3D Printed Drugs

Pennside Partners, Ltd. Celebrates 25th Anniversary

Posted by Tom Penrice on Mon,Nov 30, 2015 @ 09:00 AM

Pennside Partners, Ltd. is a leading business development consulting firm serving the pharmaceutical, biotechnology, and medical device sectors worldwide.

This year Pennside Partners celebrates over 25 years of being a trusted partner within the pharma and biotech industries.

At Pennside, we have gained our client’s trust by consistently delivering high-quality, actionable business insight and competitive intelligence. Our mission is to help our pharma and biotech clients rapidly formulate winning strategies and tactics by providing the industry’s most accurate business intelligence and market insight. With headquarters in both the United States and Switzerland, we are able to quickly and thoroughly respond to the unique needs of each client worldwide.

What Pennside Partners, Ltd. Offers

Pennside Partners, Ltd. provides of the following services:

  • Competitive benchmarking
  • Therapeutic category monitoring
  • Developmental pipeline analysis
  • Brand strategy support
  • New commercial models
  • Pricing & reimbursement
  • Technology due diligence
  • War games and strategy
  • Manufacturing cost analysis
  • Clinical/ regulatory strategy
  • OTC drugs and Rx switch
  • Orphan / rare drug launch
  • Business Development

Pennside Partners, Ltd. can provide insight to these therapeutic categories of interest:

  • Oncology
  • Orphan / rare disease
  • Cardiovascular
  • CNS
  • Endocrinology/ Diabetes
  • Respiratory
  • Anti-infective
  • Dermatology
  • Gastro-intestinal
  • Nephrology
  • Neurology
  • Ophthalmology
  • Rheumatology & bone health
  • Urology
  • Vaccines
  • Women’s health



What is in store for Pennside Partners, Ltd.

In the weeks and months ahead we plan to devote considerable energy to addressing key biotechnology and pharmaceutical industry topics of interest, including:

  • Prelaunch and launch planning
  • Launch analogs
  • Business development
  • Brand strategy
  • Benchmarking
  • Competitive intelligence (CI) and monitoring
  • Pipeline analysis
  • Disease landscape
  • Licensing and acquisition


 

Meet Pennside’s Team

Michael A. Rhoads, President and Co- founder

Mike has 25 years of experience as a consultant to the global pharmaceutical industry. He has managed over 300 competitive clinical benchmarking assignments since 1990. Under his supervision, the Pennside medical staff has completed a variety of strategic and tactical assessments covering all major therapeutic categories. As Director of the Clinical Strategies Group within Pennside, he personally directed multiple clinical CI programs in various therapeutic categories. Mike is one of the earliest participants in the Society of Competitive Intelligence Professionals (SCIP), and an acknowledged expert in the field of competitive clinical intelligence. He has delivered numerous keynote addresses at SCIP annual meetings and was selected to conduct two specific educational workshops for the drug industry in recent years.

Mike earned his MBA from the Wharton School of Business at the University of Pennsylvania and a B.A. from Colgate University.

Thomas J. Penrice, Vice President and Co- founder of Pennside Partners, Ltd.

Tom has over 25 years of experience in the pharmaceutical industry. As a pharmaceutical industry consultant since 1986, he has conducted and managed hundreds of projects in most major disease states and numerous drug delivery technologies.

Tom earned his MBA from the Advanced Management Program at Michigan State University and a B.S. in chemistry from Marquette University.

Anthony Arleth, Managing Director US

Tony has over 20 years of experience in the pharmaceutical industry. He spent 21 years at GlaxoSmithKline, with extensive experience in business opportunity analysis. He began his career as a bench scientist and is a trained biochemist / molecular pharmacologist. He brings a wide range of industry knowledge to Pennside, with specialization in the Cardiovascular, Oncology, and Pharmacogenetic areas.

Tony earned his undergraduate degree from Villanova University and conducted graduate work at the University of Pennsylvania and Villanova University

Eric Vaichunas, M.D., MHSA, Medical Director

Eric has over four years of clinical experience in general medicine. Over the course of his experience, he was involved in various aspects of the internal medicine field with several key opinion leaders at Michael Reese Hospital, Chicago, IL, St. Vincent’s Hospital, New York, NY; and Mount Sinai School of Medicine, New York, NY.

Eric earned his M.D. from St. Matthew’s School of Medicine, his M.S. in Health Service Administration from St. Joseph’s College of Maine, and his B.S. in Biomedical Science from Hahnemann University. Eric completed a year of graduate work in Biomedical Science at the Philadelphia College of Osteopathic Medicine.


 

Contact Us!

Contact Pennside Partners, a leading pharma and biotech consulting firm, at our US or EU headquarters.

To learn more about the advantages of our leading strategic consulting services contact our US or EU offices:

US: +1 610 372 7000

UK: +44 20 3695 7639

Switzerland: +41 79 372 7070

Contact Pennside Partners for all your pharma and biotech consulting needs


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Pharma Consulting, Biotech Consulting, Press Releases

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Learn more about Pennside's pharma launch analog services, including pharma business development, pharma benchmarking, pharma best practices, pharma business analytics, business intelligence, ci, competitive intelligence, pharma launch planning, and other strategic consulting services for the pharmaceutical industry. 

Learn more about Pennside's  pharmaceutical and biotechnology consulting services spanning the following areas: competitive intelligence and monitoring, pipeline analysis and disease landscape consulting, marketing/sales/reimbursement support benchmarking, launch support and best practices benchmarking, customer facing and new commercial models, licensing and support consulting, strategy workshops, and outsourced business intelligence and fixed term contractors consulting for the pharma and biotech industries. 

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Learn more about our Oncology Drug Development Support Services: oncology launch analog service, oncology congress coverage service, post-launch intelligence and market monitoring, oncology business development and licensing and M&A support, and tumor/MOA clinical pipeline analysis services. Oncology launch adoption and market strategy services include: launch planning support, primary field intelligence and market insights, oncology competitive pipeline analysis, inlicensing reviews, oncology biomarker analysis, and benchmarking of oncology organizations. Oncology Congress Coverage services include: preparing a targeted congress schedule, attending and capturing key oncology conference information, and presenting oncology conference findings.

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