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Oct
13
Sandeep Singh Dhillon
NIH And 11 Pharmaceutical Companies Announce $215 Million Collaboration – Forbes
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By Ellie Kincaid , FORBES STAFF

The U.S. National Institutes of Health and 11 pharmaceutical companies today announced the launch of a five-year cancer immunotherapy research collaboration as part of the Cancer Moonshot. In total the partners will contribute $215 million to what they are calling the Partnership for Accelerating Cancer Therapies (PACT).

PACT’s fundamental question, NIH director Francis Collins told reporters in a press conference, is, “why doesn’t immunotherapy work for all patients in all types of cancer, and what can we do about that?”

Top priority in answering that question is testing immune- and cancer-related biomarkers in clinical trials to understand the mechanisms of how cancers respond to or resist immunotherapy. With standardized biomarkers to look at and harmonized assays to test them across many different trials, data from different studies will be more easily compared, Collins said.

Developing standardized biomarkers for immuno-oncology will be “extremely enabling,” like standardizing IP addresses in the early days of the web, Thomas Hudson, vice president for oncology discovery and early development at AbbVie, said at the press conference.

He expects having standard biomarkers and sharing data will help provide a scientific basis for deciding which cancer drugs to try in combination. Given the sheer number of potential combinations, that’s “one of the key reasons we got involved in PACT,” he said. “We don’t think random combinations are the way to go.”

The data for researching biomarkers will come from four National Cancer Institute-funded Cancer Immune Monitoring and Analysis Centers at Dana-Farber Cancer Institute, Stanford Cancer Institute, Precision Immunology Institute and the Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai and University of Texas MD Anderson Cancer Center. The centers will support adult and pediatric immunotherapy trials with tumor and immune profiling.

Getting access to data from clinical trials NCI supports was “very attractive,” Hudson said.

Which biomarkers the collaboration will focus on first is still to be discussed at a meeting the companies will likely have next month, said Douglas Lowy, NCI’s acting director.

The 11 pharmaceutical companies participating are AbbVie, Amgen, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb, Celgene Corporation, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceutical Companies of Johnson & Johnson, Novartis Institutes for Biomedical Research and Pfizer. Each will contribute up to $1 million per year for the five-year partnership, totaling $55 million.

The NCI will make up the rest with $160 million in funding mostly from the Cancer Moonshot, with some coming from regular appropriations, Lowy said.

Read the full article at https://www.forbes.com/sites/elliekincaid/2017/10/12/nih-and-11-pharmaceutical-companies-announce-215-million-collaboration/#287c1aef7b54

Sep
26
Sandeep Singh Dhillon
Pfizer spends billions to develop new drugs. It’s not satisfied. So it’s launching a startup – Statnews.com
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By DAMIAN GARDE @damiangarde SEPTEMBER 25, 2017

There’s a popular theory about the limitations of global pharma companies: For all their skyscrapers and strategy reviews and private jets, they’re simply too knotted up in bureaucracy to realize how many great drugs are gathering dust in their vaults.

Now, the biggest of Big Pharma is out to do something about that. Pfizer, home to nearly 100,000 employees, on Monday announced the launch of a six-person startup to develop new drugs.

This may seem odd in that Pfizer spends literally billions of dollars a year advancing treatments of its own. But the company’s executives say they simply don’t have the resources to advance all the promising compounds that catch their eye — and they believe an independent company with the scrappy ethos of a startup will be in a better position to take on that task.

“The problem is very simple: There’s too much good science and not enough resources to advance it,” said Dr. Lara Sullivan, a former Pfizer vice president who is now leading the startup.

“If you want to see grown men cry, stop a program for budget reasons, not based on science,” Sullivan said.

The new spinoff, SpringWorks Therapeutics, is getting started with $103 million from investors including Pfizer and Bain. It will focus at first on four Pfizer-invented therapies, for conditions including post-traumatic stress disorder and rare forms of cancer. All are already in clinical trials. The two most advanced therapies, targeting tumors found on connective tissue and nerves, will advance to the final stage of development in the coming year.

SpringWorks, which will be based in New York, also plans to scour the pipelines of other pharma companies for compounds that have been set aside for lack of resources, hoping to license some of them for further testing.

It’s a business idea that has been gaining steam of late.

Roivant Sciences, founded by an ex-hedge fund manager in 2014, has built a cottage industry on the same principle, licensing unwanted therapies from the likes of GlaxoSmithKline and Takeda and then launching small startups to test them.

BridgeBio Pharma, established in 2015, takes a similar approach, searching academia and pharma alike for early-stage projects in the field of inherited disease. “We have what we call a better-owner model,” CEO Neil Kumar said. “We try to advance things as far as possible until we’re clearly not the best owner for the asset.”

The concept of scavenging for waylaid gems is considered so promising that Roivant has raised more than $1 billion to widen its search. Its 32-year-old founder, Vivek Ramaswamy, landed on the cover of Forbes, and two Roivant spinoffs pulled off a pair of biotech’s largest-ever Wall Street debuts.

Neither Roivant nor BridgeBio, however, has yet brought a drug to market.

And they’re dogged by the same questions that will follow SpringWorks: If these discarded compounds are so promising, why were they discarded in the first place? And how can a startup push them along better than a multinational heavyweight?

“What I’d say is that from the ground up we’re different,” said Saqib Islam, SpringWorks’ chief financial officer and chief business officer.

The company doesn’t intend to push for quick-turnaround returns on investment, he said. And it plans to work alongside the companies that originally invented or discovered each compound — such as Pfizer — to take advantage of in-house expertise.

“We think that’s the distinction that will draw some attention from those looking to partner their assets going forward,” Islam said.

Pfizer’s decision to wade into the space follows years of navel-gazing at major pharma companies, which have long envied the agility and nothing-to-lose gusto of biotech startups.

Conscious of how the comforts of corporate largess can be counterproductive, companies including GlaxoSmithKline and AstraZeneca in the past sought to create mini startups within their own walls. But though they tried to replicate the feverish immediacy of startup culture, that proved almost impossible when the employees knew they were operating above the multibillion-dollar safety net of a huge pharma company.

Pfizer’s move to create an independent company — deliberately safety net-free — suggests the biggest wheels of the drug industry have learned an important lesson, said Bernard Munos, a former R&D executive at Eli Lilly who now consults for pharma companies.

“I think the industry has realized that they have not really been true to their words in terms of embracing innovation,” Munos said. “So this is very encouraging, frankly, especially coming from Pfizer.”

Read the original post here https://www.statnews.com/2017/09/25/pfizer-startup-new-drugs/

Aug
23
Sandeep Singh Dhillon
MMA urges MOH to clarify process for prescribing branded medicines to patients, especially pensioners – MIMS Malaysia
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The Malaysian Medical Association (MMA) urged on 18 August, for a more efficient and transparent process for prescribing branded medicines to patients, amid the Ministry of Health’s (MOH) “generic first” policy.

MMA president Dr Ravindran R. Naidu said approval for giving patients drugs outside the ministry’s formulary – at public clinics or hospitals – should not rest solely with the Health director-general.

“It’s important to have a transparent process, so everyone knows exactly what is needed for approval,” asserted Dr Ravindran.

“If a safe and effective generic is available in MOH formulary, every public-sector patient should receive the same drug, except where the patient cannot tolerate the generic (e.g. due to allergy). In case of intolerance of generic, the government should supply original drugs ― it’s not the patient’s fault,” he added.

Dr Ravindran said that MOH should instead bring in original drugs with good cost-to-benefit ratio should generics be unavailable, pointing out that “many” drugs do not have generic versions as well.

“Generic first” policy applies to all now

This comes after Health deputy director-general Datuk Dr S. Jeyaindran confirmed, that as part of the “generic first” policy, approximately 700,000 retired government servants will now no longer be reimbursed if they buy brand-name medications that are unavailable at public hospitals – unless they fulfil certain conditions.

Instead, they will receive generic medicines, like other patients, he added.

The policy is part of MOH’s management of medical treatment of federal government retirees and pensioned military veterans, together with the Ministry of Higher Education (MOHE) and the Defence Ministry (MOD), which took effect on 1 June this year.

The change occurred after the contract for the supply of medicines with Oratis Rx Sdn Bhd ended early this year. Pensioners are now told to pay for their purchases first and submit claims subsequently – a process which takes an average of three to six months.

“The process has been made difficult, so people opt for the cheaper generics,” said a doctor who requested anonymity.

Dr Jeyaindran assured that the standard operating procedure (SOP) has been fine-tuned and put into place in the last six weeks, with the Public Service Department (PSD) transferring funds to MOH for pensioners’ healthcare and the Retirement Fund (Inc) (KWAP), handling all dialysis and dialysis-related claims.

Change in SOP causes confusion
However, pensioners lamented that with the change, hospitals needed to approve of the prescriptions first. If approval is declined, pensioners would have to directly pay out-of-pocket for medicines that were previously dispensed for free through Oratis Rx Sdn Bhd.

According to a circular published on 30 June, approval was also needed from the Health director-general to get drugs outside the MOH formulary. This was based on three conditions: drugs in the formulary were ineffective in treating the patient; the patient suffered adverse effects from drugs in the formulary; and the application was not intended to continue medical treatment that had been started at a private hospital or a hospital from another ministry.

This has generated confusion and unnecessary backlog as the rule took effect on 1 June, but only notified relevant parties on 30 June.

The MOH however, remained firm and Dr Jeyaindran cautioned, “If doctors want to use a drug outside the Blue Book, they must justify why the patients need it.”

Efficiency compromised with change

MMA past president Dr Milton Lum said generics are sometimes ineffective in cases of dialysis, high blood pressure and arthritis. There is also an increased resistance to generic antibiotics and common drugs, and there are also no generics for many cancer drugs.

“The Blue Book is based on essential medicines,” explained Dr Lum, referring to the MOH formulary. “They cover the majority of common illnesses, but not everything.”

However, local generics pharmaceutical manufacturers have asked Dr Lum to back up his statement that generics are ineffective in certain cases on 21 August.
In addition, Dr Lum also questioned how long patients and doctors must wait for approval of applications to use branded medicines.

“Is there a process to fast-track it, particularly when it’s needed urgently? What happens if the DG is not in the country? Who approves it then?” he asked.

“It has to be an efficient process with certain timelines for decision to be made, for approval to be given. If you give approval, there is a time lag before you obtain the medicine. So, there has to be efficiency in the process and timelines to be complied with,” he added. MIMS

The full article first appeared at https://today.mims.com/topic/mma-urges-moh-clarify-process-for-prescribing-branded-medicines-to-patients-especially-pensioners?country=Malaysia&channel=GN-Local-News-MY&elq_mid=18726&elq_cid=24884

Aug
22
Sandeep Singh Dhillon
Samsung Wants to Become a Drug Company – Investopedia.com
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Samsung Electronics, the South Korean consumer electronics company is expanding efforts to diversify into the pharmaceutical business, landing its first deal to develop drugs for diseases that are hard to treat.

While the company is best known for churning out mobile phones, semiconductors and other consumer electronics, it recently started to move into the drug market. In late July, The Wall Street Journal reported the company was gearing up to launch a generic version of Johnson & Johnson’s rheumatoid arthritis drug Remicade. The newspaper is now reporting that Samsung is forming a partnership with Japan’s Takeda Pharmaceutical Co. to fund and develop several drugs over the next few years with the first effort focused on a treatment for severe acute pancreatitis. Terms of the deal were not disclosed.

The Path Less Risky
According to the report, the company’s move to get into novel treatments of hard-to-treat drugs is a big enhancement of its drug efforts, but one that is also risky. Only one in 10 drugs that end up with human trials gets approval while companies could spend hundreds of millions of dollars and years working on formulations at the experimental level. Developing a generic version of a popular drug, as with Remicade, has proved to be a less risky strategy for many drug companies. According to the Journal, citing data from EvaluatePharma, the biologic market is on track to have $214 billion in sales in 2017 alone and sales are projected to hit $276 billion by 2020.

With saturation in the smartphone market, and Samsung seeing increased competition from U.S. and Chinese technology firms, the company is seeking ways to diversify beyond consumer electronics, and the pharmaceutical industry is one area it has set its sights on. The generic version of Remicade is expected to sell for 35% less than the current list price for the popular drug.

Samsung got approval from the Food and Drug Administration for the generic version in April, and the launch marked the company’s first push into the pharmaceutical market under its new Samsung Bioepis Co. unit. The biotech arm is going after generic versions of branded drugs that are made from living cells and will address complex diseases like arthritis and cancer, reported the Journal. The brand-name treatments can often cost as much as tens of thousands of dollars a year, presenting a big opportunity for lower-cost players to grab market share. And it is now adding novel drug therapies to its focus, which has always been a goal of the Bioepis unit. “At this stage of our company’s development, we believe this is the next logical step,” said Mingi Hyun, a Samsung spokesman, to the Journal, noting that the unit has held talks with other pharmaceutical and biotech companies to pursue similar deals to its partnership with Takeda.

Read more: Samsung Wants to Become a Drug Company | Investopedia http://www.investopedia.com/news/samsung-wants-become-drug-company/#ixzz4qUjBsxLc
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Aug
17
Sandeep Singh Dhillon
Goldman Sachs breaks down how Amazon can jump into health care – CNBC
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By Christina Farr, CNBC

Amazon is speeding its efforts to crack the health care market, hiring a number of high-profile executives, testing Echo technology in top hospitals and creating a secret “1492” team dedicated to health-technology opportunities like telemedicine and electronic medical records.

Goldman Sachs is now out with a 30-page report from five research analysts on Amazon’s likely ambitions in the $560 billion prescription drug market. The note cites CNBC’s reporting on the 1492 group and Amazon’s hiring of a general manager to lead its pharmacy unit.

Here are some of the key insights from the report:

  • Rather than replacing pharmacies right away, Amazon might start by partnering with a pharmacy benefits manager (PBM), which acts as an intermediary between payers, like health insurers, and the rest of the health system. That would provide “access to patient data and the potential to cross-sell related products.”
  • Amazon could ultimately improve price transparency for the consumer and reduce out-of-pocket drug costs. But it would likely start by speeding up the drug delivery process and facilitating at-home delivery.
  • Amazon could also become an online pharmacy, retail and online pharmacy, integrated PBM and online pharmacy, or handle drug distribution to pharmacies.
  • One potential — and overlooked — challenge for Amazon might be the so-called “age gap.” Amazon’s customers tend to be younger and healthier than people who typically take prescription drugs.
  • Amazon could move into digital health by using the Echo in clinical settings and developing tools for telemedicine and remote patient monitoring. “Imagine seeing a virtual doctor on your Amazon app, having it prescribe you a certain medication, and then tapping a ‘buy now’ button — all without leaving your home.”

Jul
5
Sandeep Singh Dhillon
US Pharma Looks at Blockchain Tech to Track Prescription Drugs – Cryptocoinsnews.com
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U.S. Pharmaceutical companies and the Food and Drug Administration (FDA) could soon track prescription drugs over an interoperable blockchain as a means to detect and put an end to counterfeit medicines in the market.

The solution comes from San Francisco-based blockchain startup Chronicled and its partnership with LInkLab, a life sciences supply chain. The two companies have launched a blockchain “track and trace” pilot at a recent one-day event in San Francisco. Developed for the pharmaceutical industry, the solution could prove a viable means to curbing counterfeit drug distribution and sales in the United States and beyond.

Attended by representatives from global pharma manufacturers, wholesalers and hospitals, the blockchain pilot event also saw participation from enterprise IT giants and blockchain tech companies. The event, according to Chronicled, marks the first phase of a pilot to develop an interoperable blockchain platform for the pharmaceutical industry.

Chronicled co-founder and chief performance officer Samantha Radocchia stated in a release:
We will be working closely with teams at leading enterprise blockchain projects over the coming months to identify the most suitable enterprise blockchain to serve as a data utility for the pharmaceutical industry.

The blockchain platform will adhere and satisfy the FDA’s Drug Supply Chain Security Act, signed into effect by former US President Obama in November 2013. The act was and signed to ‘develop an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.’

With this in mind, the blockchain solution will developed to support and comply with DSCSA protocols. Further, the pilot solution will focus on data privacy while adhering to GS1 standards, a global standardized system for traceability that can be implemented by all participants in a supply chain across borders globally.

Altogether, the blockchain tech solution aims to standardize a less expensive, less cumbersome and more efficient and secure approach to facilitate prescription drug distribution.

“The first phase of this project is to prove that one global pharmaceutical manufacturer can comply with their DSCSA regulatory obligations and meet the 2017 and 2023 requirements,” stated Susanne Somerville, co-founder of the LinkLab. “We are excited to be partnering with a major pharmaceutical player in this first phase.”

Future phases will foster the involvement of other participants in a typical pharma supply chain process, straight from the manufacturer to the pharmacy and hospitals.

One of blockchain technology’s core offerings that make it a no-brainer for supply chains across industries is its immutable, time-stamped, tamper-proof ledger, accessible by its all or pre-approved participants. Last week, Australia Post, the country’s postal service operator announced a partnership with Alibaba to curb the rise of counterfeit food exports from Australia to China, using blockchain technology to improve traceability.

Jul
4
Sandeep Singh Dhillon
Did You Grow Up Thinking You’re Allergic To Penicillin? Guess Again – Forbes
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By Rita Rubin

For years, whenever a health-care provider asked whether you were allergic to any medications, you might have dutifully noted yes, penicillin, which happens to be the most common drug allergy of all. You might not remember ever having an allergic reaction to penicillin, but that’s what your parents always told you, and they wouldn’t steer you wrong.

Well, a couple of new studies suggest that unless your symptoms were pretty dramatic, you might not be allergic to penicillin after all. Researchers tested children and adults who’d been labelled as allergic to penicillin but whose symptoms were relatively mild and found that most tolerated the drug just fine.

Why should you care whether you or your children are allergic to penicillin?

While penicillin is the oldest antibiotic, it and other members of the penicillin family, such as amoxicillin, are still effective, first-choice treatments for a wide range of bacterial infections. But once people are labelled as allergic to penicillin–previous studies suggest that 5% to 20% of the population has been deemed allergic to the drug– doctors instead prescribe second-choice, broader-spectrum antibiotics, which, in the case of garden-variety bacterial ear infections, is kind of like swatting a fly with a sledgehammer.

Broad-spectrum antibiotics kill beneficial bacteria as well as the bad actors, increasing the risk of side effects such as diarrhoea and the possibility that some microbes will develop antibiotic resistance. On top of that, those broad-spectrum antibiotics cost a lot more than generic penicillin or amoxicillin.

In a study published online Monday by the journal Pediatrics, researchers enlisted the help of parents of children ages 4 to 18 who were seen in the emergency department at Children’s Hospital of Wisconsin. The scientists asked 605 parents who reported that their children were allergic to penicillin if they would complete an allergy questionnaire.

Questions included the age of the child when diagnosed with a penicillin allergy, why the drug was prescribed, symptoms of an allergic reaction, how long after the first dose it occurred and whether a parent, doctor or both diagnosed the allergy. The questionnaire also listed 17 symptoms, ranging from a rash to throat swelling and asked the parents to check the ones that occurred in their child after taking penicillin.

Before administering the questionnaire, the researchers consulted with a pediatric allergist about which symptoms were “high risk,” or likely the result of an allergic reaction, or “low risk,” or likely not due to an allergic reaction. High risk symptoms included facial, lip or throat swelling, while low risk symptoms included a rash, itching or hives.

Of the 597 children whose parents completed the questionnaire, nearly three-fourths had low-risk symptoms. The researchers had enough funding to offer testing for penicillin allergy to the parents of 100 low-risk children whose symptoms had been confirmed by their primary physician. The testing consisted of the standard three-tier process: administering penicillin first by a skin prick (also called scratch) test, then by injection and then orally.

“We are prepared to handle serious reactions if one were to occur,” lead author Dr. David Vyles explained to me.

But it turned out that none of the 100 children tested were found to be allergic. In other words, the questionnaire did a good job of identifying the children who really weren’t allergic to penicillin. But, Vyles said, much bigger studies are needed before the questionnaire alone could be used to identify patients labeled as allergic who could safely take penicillin.

In a related study published in April in the journal Emergency Medicine Australasia, researchers in Sydney performed the three-tier allergy test on 100 adult emergency department patients who reported a penicillin allergy. The Australian scientists did not first screen the patients to determine whether their allergy symptoms were high risk or low risk, but they did exclude those who had previously experienced anaphylaxis, a severe, life-threatening allergic reaction, after taking penicillin. Of the 100 patients tested, the researchers found that 81 weren’t actually allergic to penicillin.

“It would be great to examine whether a combination of risk assessment and oral challenge alone could ‘de-label’ the majority of reported penicillin allergies in children.” emergency department physician Dr. Joseph Marwood, lead author of the Australian study, told me in an email. “If this could be demonstrated as safe, without labor-intensive and uncomfortable skin prick testing, it could quickly become practice in the pediatric ER and help children receive the most appropriate antibiotic for their initial illness and beyond.”

Why would people think they’re allergic to penicillin when they’re not?

Vyles thinks parents and even physicians are sometimes too eager to blame penicillin for symptoms that actually are related to the underlying illness. In his study, the children’s primary care doctors had witnessed the supposed allergic reaction in only 14 of the 100 who were tested. In the majority of cases, the primary care doctors diagnosed a penicillin allergy based on what the parents told them.

Personal experience spurred Vyles, an assistant professor of pediatrics at the Medical College of Wisconsin in Milwaukee, to investigate the question.

When his now 9-year-old son was 2, he developed a rash after taking amoxicillin. Because of the rash, the boy’s pediatrician concluded he was allergic to penicillin.

The next time Vyles’ son had an ear infection, his doctor prescribed a broad-spectrum antibiotic instead of amoxicillin. Vyles says he would have had to pay more than $100 more out-of-pocket for the brand-name broad-spectrum antibiotic than for generic amoxicillin.

So he did what only a physician parent could do: He got amoxicillin instead and “challenged” his son with a dose to see if he had any kind of a reaction. Nada. Same thing happened with his daughter, now three. She developed a rash four days after she began taking amoxicillin, so her pediatrician labeled her as allergic to penicillin drugs. Vyles, by then highly skeptical, gave her a dose of amoxicillin, and she did fine.

Again, do not try this at home, but you might want to see an allergist. Says Vyles, “Anybody who has penicillin allergy and questions it should go through the testing.”

Jun
29
Sandeep Singh Dhillon
FDA Pilot to Sign Off on Low-Risk Digital Health Products Without Pre market Review – raps.org
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By Zachary Brennan

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review.

The pilot, part of a new approach to regulating digital health tools, would help to certify, according to Gottlieb, whether a company “consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its software products. Employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies.”

FDA also will provide guidance clarifying its stance on products that contain multiple software functions and which currently fall outside FDA regulations.

“In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements,” Gottlieb wrote in FDA’s Voice Blog.

The push into digital health comes as Bakul Patel, ‎associate center director for digital health at FDA, recently told conference attendees that guidance related to software as a medical device, and a new dedicated unit to digital health are coming to FDA’s Center for Devices and Radiological Health (CDRH).

Gottlieb also noted that the postmarket collection of real-world data might be able to be used to support new and evolving product functions.

“For example, product developers could leverage real-world data gathered through the National Evaluation System for health Technology (NEST) to expedite market entry and subsequent expansion of indications more efficiently … The Medical Device Innovation Consortium (MDIC), a 501(c)(3) public-private partnership, is serving as an independent coordinating center that operates NEST. In the coming weeks, MDIC will announce the establishment of a Governing Committee for the NEST Coordinating Center comprised of stakeholder representatives of the ecosystem, such as patients, health care professionals, health care organizations, payers, industry, and government,” Gottlieb wrote.

NEST’s fully operational system is expected to come by the end of 2019.

Full article at http://www.raps.org/Regulatory-Focus/News/2017/06/15/27917/FDA-Pilot-to-Sign-Off-on-Low-Risk-Digital-Health-Products-Without-Premarket-Review/

Jun
27
Sandeep Singh Dhillon
What Would Steve Jobs Tell The Pharma/Biotech Industry? – Bioprocess Online
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By Martin Lush, Global VP, NSF Health Sciences

Whether you’re a fan of Steve Jobs and his products or not, two things are undeniable: He was very successful and very different. Now you can relax; this short article will not provide a blow-by-blow account of the man and his methods. “What would Steve Jobs tell the pharma/biotech industry?” is just a metaphor to encourage our industry to radically change — not by reinventing the wheel, but by copying the success of others.

Why Maintaining The Status Quo Is No Longer Good Enough

Please take a look at my last article, “Brexit, Trump, What Next? 6 Rules to Succeed in an Era of ‘Brutal Disruption”, for a reminder of the challenges and opportunities facing the pharma/biotech industry. This article reaffirms the sentiments of the great Albert Einstein:
“The definition of insanity is doing the same thing over and over again, but expecting different results.”
We live in an era of “new” everything — new science, new regulations, new presidents, new governments, and new challenges. To prosper in this era of brutal disruption, we have to think differently.
Like some of you, I have read a lot about Jobs and his methods, and what made Apple so successful.1-4 In writing this article, I simply imagined asking Jobs the question: “Based on your experience, successes, and failures, what would you tell the pharma/biotech industry?” Since he was a man who liked to get straight to the point, I’ve kept my imagined list of his recommendations to just five.
Steve’s Top Five Recommendations
1. Simplification Is Survival
Jobs was a complex man driven by a simple belief: Simplification is survival. For the pharma/biotech industry, this means drastically simplifying everything. Let’s start with the simple stuff first.
Your call to action:
Simplify documentation systems, particularly SOPs. For many companies, SOPs are out of control. They have become overly complex and impossible to follow. Instead of improving consistency, they increase the risk of errors and mistakes. Instead of being written for the user, they have been written for the auditor or regulator. This must stop. If you want guidance on how to write a good SOP, just look at a recipe book! You’ll see lots of pictures and simple diagrams! So, the answer to better documentation systems is in your kitchen.
Simplify batch manufacturing records (BMRs). Excessively detailed instructions, poorly designed documents, and excessive check signatures (most of which are not required) all contribute to user overload, stress, and mistakes. The purpose of the BMR is to provide essential guidance to the user, and provide an accurate and reliable history of events — the who, what, when, and how. Unnecessary complexity slows everything down, dilutes essential accountability, and increases risk. Here’s a helpful white paper on batch record simplification: Improving Human Reliability – Batch Record Simplification.
2. No, No, No, And No: Less Is More
Jobs believed success is determined by what you STOP doing. He would be telling us, “Just focus on doing the basics exceptionally well, and forget the rest. If you try to do everything [which translates to initiative overload], you will fail.”
Your call to action:
Tune up your change control system. If your change control system approves everything, it’s dangerous. A good change control systems works on the tried and tested principles of Pareto. A good system only approves the 20% of changes that provide 80% of benefit — those vital few. For more on change management, check out the free webinar Change Management – Best Industry Practices.
Hone your risk management skills. “Less is more” requires good judgment. Whether your change control system approves or rejects planned changes, one thing remains constant: RISK. To make the right decisions, you must have excellent risk management skills and competencies. Take a look at this short video for guidance: Risk Based Decision Making.
3. Hire People Who Break The Rules
Steve Jobs liked to challenge convention — and, on occasion, break the rules. This recommendation will have many industry veterans running for the hills. Employing rule-breakers in an industry that prides itself on “compliance”? Are you kidding? Think about it another way: Rule-breakers are simply those who keep pushing the boundaries. They keep challenging. They keep asking “why”… and they never give up. History proves Jobs was right.
Your call to action:
Rethink your recruiting practices. If companies recruit the same types of employees, they get just that: the “same” in everything. The same decisions and the same outcomes; and, ultimately, maintenance of the status quo. But, in an era of “brutal disruption,” the status quo is no longer good enough. The pharma/biotech industry desperately needs people who think differently — more “why?” people
Allow rule-breakers to do what they do. Progress, in every walk of life, is usually made by rule-breakers; those who are always looking for a different way.
Don’t just recruit people from the traditional sources, such as the pharma/biotech company next door — unless you want more of the same. Try attracting candidates from the automobile and microelectronics sectors. They have been practicing “total quality management (TQM)” for over 50 years!
If you want a lesson in how to manage quality, keep things simple and be laser focused on the end user. Hire people with backgrounds in fast-moving consumable goods. Instead of taking on graduates with “traditional” science degrees, take a walk on the wild side. Recruit a few with degrees in philosophy — people who think differently.
Hire people who know how to think. My Dad, who came from very humble beginnings, used to say, “We don’t have much money, so we have to really think.” The upside of falling prices for our medicines and rising manufacturing costs is that we all have to think differently. So, remember to hire based on two things: character and creative thinking ability.
4. Become Obsessed With …
… finishing and following up! Jobs was a “details person.” A recent survey conducted by Harvard Business Review found that a large percentage of changes and new initiatives fail because of poor implementation and follow-up.5 At NSF, we’ve found the same. For example, most deviation and CAPA (corrective and preventive action) systems have no “effectiveness checks” to make sure the corrective and preventive actions have been implemented correctly and are working. The same goes for many audit and self-inspection programs.
Your call to action:
Become obsessed with disciplined execution, implementation, and follow-up! The pharma industry is populated with very bright people who come up with lots of very bright ideas … that usually fail. The root cause? Poor (ill-disciplined) implementation. This is compounded by no follow-up to see what has worked and what hasn’t. We just need to apply Deming’s PDCA (Plan – Do – Check [measure and follow up] – Adjust).
5. Keep The Main Thing, The Main Thing … Or Die
Jobs was obsessed with satisfying his customers, the end users of his products and services. If you’ve ever been in an Apple Store for repairs or service to your Apple device, you know what I mean. From the minute you enter the store, you are “the main thing.”
Whenever I visit companies, I always ask the people I meet — from the warehouse supervisor to the CEO — about their products and patients. Do they really understand how their products work? Do they really understand every one of their products’ key quality attributes? Crucially, do they really understand how their products improve patients’ quality of life?
Over the last 37 years working in the pharma/biotech industry, I’ve consistently observed one thing: Those who put more focus on the monthly “P&L” (profit and loss) spreadsheet and forget patients’ struggles falter, and, in extreme cases, go out of business. In contrast, companies who keep their patients at the center of everything they do flourish, going from strength to strength.
Your call to action:
Simply conduct the “patient test.” Ask everyone you meet about the products you make and the impact they have on your patients. Ensure that everyone is emotionally connected to the patient. If not, you really are in trouble. Many companies put the “patient first,” using posters and slogans that, in time, become meaningless words; invisible and soon forgotten. One of the most important jobs of leaders at the ground level is to keep people motivated by giving them a reason to care about what they do. This means constant reminders that the patient is at the center of every decision — and this must be communicated not by using flashy posters or slogans, but through the actions of leadership
Don’t allow stress to eat away at your motivation. I am continually amazed by the quality, integrity, and commitment of the people I meet in the pharma/biotech industry. However, the “routine” of working in a highly pressurized, 24/7 world can be dangerous. The hours consumed by emails and meetings; the obsession with measuring things that don’t really matter; the pressure to hit manufacturing, testing, and product release deadlines can cause our patients, “the main thing,” to be forgotten.
Should Pharma Become More Like Apple?
Well, that’s a yes and a no. One thing is for sure: The pharma/biotech industry must get better at “stealing with pride,” rather than reinventing the wheel. Many of the challenges and problems we face are not new. In fact, the answers are already out there. The solutions are waiting to be stolen. Want to know about human error reduction? Study the solutions generated by the aviation industry. Want to know how to write user-friendly, error-free SOPs? Take a look at the IKEA process for designing instructions for furniture assembly. Want best-in-class practices for problem solving, deviation, and CAPA? Take a look at a Toyota car assembly line. Want to know how to use “Big Data”? Look no further than Amazon. So, whether it’s from Apple, Amazon, or anyone else, start stealing with pride!

Jun
12
Sandeep Singh Dhillon
Former Pharma Rep Now Helps Doctors Save Money on Drugs – NBCnews.com
Pharma Extra, Pharma Notables
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As a drug salesman, Mike Courtney worked hard to make health care expensive. He wined and dined doctors, golfed with them and bought lunch for their entire staffs — all to promote pills often costing thousands of dollars a year.

Now he’s on a different mission. When Courtney calls on doctors these days, he champions generic drugs that frequently cost pennies and work just as well as the kinds of pricey brands he used to push.

Instead of big pharma, he works for Capital District Physicians’ Health Plan (CDPHP), an Albany, N.Y., insurer. Instead of maximizing pill profits, his job is to save millions of dollars by educating doctors about expensive prescriptions and the stratagems used to sell them.

“Having come from big pharma, I do really feel my soul has been cleansed,” laughs Courtney, who formerly worked for Pfizer and Johnson & Johnson. “I do feel like I’m more in touch with the physicians” and plan members, he added.

As a drug salesman, Mike Courtney worked hard to make health care expensive. He wined and dined doctors, golfed with them and bought lunch for their entire staffs — all to promote pills often costing thousands of dollars a year.

Now he’s on a different mission. When Courtney calls on doctors these days, he champions generic drugs that frequently cost pennies and work just as well as the kinds of pricey brands he used to push.

A pharmacist works at a pharmacy in Toronto
REUTERS
Instead of big pharma, he works for Capital District Physicians’ Health Plan (CDPHP), an Albany, N.Y., insurer. Instead of maximizing pill profits, his job is to save millions of dollars by educating doctors about expensive prescriptions and the stratagems used to sell them.

“Having come from big pharma, I do really feel my soul has been cleansed,” laughs Courtney, who formerly worked for Pfizer and Johnson & Johnson. “I do feel like I’m more in touch with the physicians” and plan members, he added.

Costs for prescription drugs have been rising faster than those for any other health segment, marked by high-profile cases such as the reported 400 percent increase for Mylan’s EpiPen and 5,000 percent spike for Turing Pharmaceuticals’ Daraprim.

Health plans and others paying those costs are fighting back. Many have tried to give doctors academic research on pill effectiveness or simply removed high-cost drugs from coverage lists.

Consumer groups and medical societies have tried to spread the word about expensive drugs. Startup GoodRx lets patients compare retail prices online.

CDPHP is one of the few insurers to have taken the battle against pricey pills a step further. It is recruiting across enemy lines, hiring former pharma representatives and staffing what may be a new job category: a sales force for cost-effective medicine.

“Insurers are taking matters into their own hands,” said Lea Prevel Katsanis, a marketing professor at Canada’s Concordia University who specializes in the pharmaceutical industry. “They’re saying, ‘We can’t really rely on drug companies to talk to doctors about what’s cost-efficient.’”

If insurance companies can curb drug costs, premiums paid by employers, taxpayers and consumers need not rise as fast.

Two years ago, when one company increased the cost of a common diabetes medicine to 20 times what it had been a few years earlier, Courtney and five other former pharma and medical-device reps working for CDPHP knew what to do.

Valeant Pharmaceuticals had cranked up the price of one common dosage of its Glumetza medicine for lowering blood sugar to an astonishing $81,270 a year, according to Truven Health Analytics, a data firm. Meanwhile a similar, generic version can be bought for as little as a penny a pill.

Because Glumetza was on CDPHP’s list of approved drugs, the insurer and its members had to pay for it when doctors prescribed it, resulting in millions in extra costs and stinging copayments for patients.

Dr. Eric Schnakenberg, an upstate New York family medicine doctor, was shocked when patients began complaining about what he assumed was an inexpensive prescription. Doctors are famously unaware about the cost of the care they order, a situation exploited by drug sellers and other vendors.

While physicians’ electronic prescribing programs and even pharmaceutical guides like the Physicians’ Desk Reference contain prescribing information — some are even peppered with ads — they contain no specific information about prices. Drug sales reps who visit their offices don’t highlight high prices as they drop off free samples, and drugmakers can quietly, but substantially, hike the price of a drug from one year to the next.

“As physicians, we’re blindsided by that,” Schnakenberg said. “We get patient complaints saying, ‘Hey, I can’t afford this,’ and we say: ‘It’s cheap!’”

After Courtney and his colleagues alerted doctors to what Valeant was up to, all but a handful of the 60 plan members who were taking Glumetza switched to metformin, the generic alternative. That saved about $5 million in a year.

Following an outcry over its practices, Valeant agreed last year to raise annual prices by no more than single-digit percentages, the company said through a spokesman. But such hikes could still outpace the inflation rate.

Cardiologist John Bennett got the idea to hire pharma reps a few years ago, after he became CDPHP’s chief executive. He knew reps are smart, genial and motivated. Overhiring by pharma had put many back on the job market.

His sales pitch to them, he says half-jokingly, was: “You know everything they taught you in big pharma? How would you like to use those powers for good?”

Pharma companies spend billions on TV ads, doctor blandishments and expensive salespeople to keep prescriptions flowing.

Pfizer, Johnson & Johnson and other sellers responded to critics a few years ago by restricting gifts of entertainment, coffee mugs and some meals. But the industry’s ethics code still allows lavish consulting contracts for doctors and sponsorship of physician conferences as well as meals for doctors and their staffs who listen to an “informational presentation” from sales reps touting expensive pills.

“When those products go generic, nobody’s promoting them anymore,” Courtney said. Generics makers lack big marketing budgets. CDPHP’s remedy: The insurer promotes generics with its own reps.

“It’s a great idea,” said Alan Sorensen, an economist at the University of Wisconsin who has studied drug prices. “Even a small moving of the needle on their [doctors’] prescribing behavior can have a pretty big impact on costs.”

At first the team concentrated on educating doctors about cheaper alternatives to Lipitor, a widely prescribed cholesterol-lowering medicine, and Nexium, for stomach problems. That saved around $10 million the first year, much in the form of copayments that would have been owed by plan members.

Recently the plan has focused on Seroquel, a branded antipsychotic that costs far more than a similar generic. Switching to the generic saves $600 to $1,000 a month, estimates Eileen Wood, the insurer’s vice president of pharmacy and health quality.

CDPHP’s repurposed reps have helped keep the insurer’s annual drug-cost increases to single-digit percentages, whereas without them and other measures “we would certainly be well into double-digit” increases, she said.

Educating doctors about drug costs is part of a larger push for “transparency” in an industry where Princeton economist Uwe Reinhardt says consumers face the same experience as somebody shopping in Macy’s blindfolded.

Current research by the University of Wisconsin’s Sorensen finds physicians with access to data about drug prices and insurance coverage are more likely to prescribe generics.

That gives Courtney and his colleagues a fighting chance, even if, he said, “we don’t have the freewheeling, unlimited green Amex card like I did back in the day.”