Adaptimmune up 24% premarket on T-cell therapy development deal

Adaptimmune Therapeutics (NASDAQ:ADAP) inks an agreement with Astellas Pharma (OTCPK:ALPMF) aimed at co-developing and co-commercializing up to three T-cell therapies in cancer.

The partnership will leverage Adaptimmune’s target identification and validation capabilities for generating target-specific T-cell Receptors (TCRs), chimeric antigen receptors (CARs), and HLA-independent TCRs that recognize surface epitopes independently of the HLA profile of the tumor cell with Astellas’ Universal Donor Cell and Gene Editing Platform it obtained via its acquisition of Seattle-based Universal Cells.

Astellas will fund research through Phase 1 for each candidate. Afterward, the companies will decide whether to advance development and commercialization together or independently.

Under the terms of the agreement, ADAP will receive $50M upfront, up to $73.75M in milestones per candidate if co-developed/co-commercialized, up to $147.5M in development milestones and up to $110M in sales milestones per candidate in Astellas develops/commercializes alone, up to $7.5M per year in research funding and tiered mid-single-digit-to-mid-teens royalties on net sales.

https://seekingalpha.com/news/3531579-adaptimmune-up-24-premarket-on-t-cell-therapy-development-deal

Insurance startup Bright Health eyes California with 1st payer acquisition

• Health insurance startup Bright Health is expanding into California, announcing Wednesday plans to acquire a small health plan in the state as the payer doubles down on the Medicare and complex condition markets.
• Financial terms of the snap-up of Universal Care, which does business under the moniker Brand New Day, were not disclosed. The deal is Bright Health’s first acquisition of a payer and is expected to close this year subject to regulatory approval by California’s insurance department.
• The buy, when finalized, will bring five-year-old Bright Health’s national footprint to 34 markets in 13 states, covering about 200,000 members.

Since its founding in 2015, Bright Health has raked in more than $1 billion over four rounds of financing, allowing it to grow organically from selling plans in its pilot Colorado market to its current footprint spanning roughly a fourth of the nation.

Bright Health plans to jump into 13 new markets for 2020 in major cities in Florida, Illinois, North Carolina, Ohio, Oklahoma and South Carolina, along with rural and urban counties in Nebraska. The payer wants to triple its product offerings this year compared to 2019.

The acquisition of Brand New Day would add 12 markets and the Golden State as Bright Health continues to scale quickly.

Mike Mikan, Bright Health’s president and vice chairman, in a statement called Brand New Day “a philosophically aligned partner,” adding that the union would allow it to expand its “integrated clinical model of care to all our members across product lines and geographies.”

Bright Health’s plans include individual, family, Medicare Advantage and supplemental plans. The payer touts its care coordination model it says lowers out-of-pocket costs and readmissions for its members by narrowing networks.

Medicare Advantage plans, where a private payer contracts with the government to provide additional services to Medicare members, are en vogue. A number of payers have increased their MA offerings for 2020 and beyond, spurred by a 2019 rule change from the federal government bolstering reimbursement rates for supplemental benefits like at-home grocery delivery or non-emergency medical transportation.

Wednesday’s deal is a bit like a small fish snapping up a bigger one, at least when it comes to Medicare: Brand New Day had more than 41,000 enrollees in 2019, according to the California Department of Managed Health Care. It reported more than $250 million in revenue in 2018 off its members, the large majority of which were in Medicare and Medi-Cal plans.

By comparison, Bright Health had about 4,000 MA enrollees at the end of the third quarter of last year, according to a Star Tribune review of regulatory filings, though the payer does cover roughly 60,000 people overall, mostly through its individual health plans. It has an estimated annual revenue of $36 million, according to Owler.

Bright Health was launched by a number of executives from UnitedHealth, owner of the nation’s largest private payer, UnitedHealthcare. On Monday, the startup announced a new chief financial officer, Cathy Smith, who previously worked at pharmacy benefit management giant Express Scripts.

​It’s the first major acquisition for the privately held company, but its second overall: Bright Health quietly bought a marketing agency called Spyder Trap in 2017 for an undisclosed sum.

Brand New Day has operated in Southern California for more than 35 years, in Medicare, dual eligibles and those with complex or chronic conditions or living in long-term care facilities in 12 countries through a provider network of more than 7,300 primary care physicians and roughly triple that number of specialists.

Brand New Day’s leadership will continue to lead local market operations in the Bright Health Plan leadership team.

https://www.healthcaredive.com/news/insurance-startup-bright-health-eyes-california-with-1st-payer-acquisition/570109/

BioMarin sets gene therapy sights beyond hemophilia

On the cusp of having a marketed gene therapy for hemophilia, BioMarin is readying itself for the commercial challenges that lie ahead. The California biotech’s CEO says he’s assured patients and doctors will go for the therapy, despite a price tag that, at least in the U.S., is likely to fall in the range of $1 million to $3 million.

“There is definitely some significant interest,” Jean-Jacques Bienaime told BioPharma Dive in a Sunday interview.

Bienaime’s comments previewed the first full day of the biopharma industry’s bellwether event, the J.P. Morgan Healthcare Conference. There, BioMarin delivered two announcements that affirm its gene therapy ambitions.

The first was that U.S. and U.K. regulators cleared the company to begin human testing of an experimental gene therapy for phenylketonuria, a rare metabolic disorder also known as PKU. BioMarin plans to inject the first patient before the end of March — a timeline which would put its treatment in competition with gene and cell therapies being tested by Homology Medicines and Rubius Therapeutics, respectively.

BioMarin also unveiled it had more than doubled capacity at a California manufacturing site responsible for making both the PKU gene therapy as well as another, called valrox, for hemophilia A. The company says it can now produce up to 10,000 doses of PKU or hemophilia A gene therapy each year.

Combined, company executives say these developments put BioMarin in a leading position among gene therapy developers. A valrox approval, for instance, would usher the treatment to market possibly years ahead of rival hemophilia gene therapies from Roche and partners Pfizer and Sangamo Therapeutics. And with its new manufacturing capacity, Bienaime says his company could treat all hemophilia A patients in the U.S. within two years.

“I hear the first-mover advantage is pretty dramatic,” in gene therapy, Bienaime said, “because every time you treat a patient, the patient is then off the market.”

Others have made similar arguments. Mani Faroohar, an analyst at SVB Leerink, told BioPharma Dive last year that it’s “very difficult to be the second curative product for a rare disease,” because patients will have little incentive to try out an experimental gene therapy if there’s already another that’s proven safe and effective enough to gain approval.

Being first to market comes with uncertainties, though, namely whether hemophilia doctors and patients will gravitate toward a gene therapy when there are already highly effective options available, such as Roche’s drug Hemlibra.

BioMarin executives are confident they will, citing results from a recent Citi Research survey of 60 U.S. hematologists who collectively expect to switch almost half of their hemophilia A patients from infusions of other drugs to gene therapy within five years of valrox’s launch. The company highlighted, too, that the doctors said they would switch close to 40% of their Hemlibra-treated patients to a gene therapy within three years of valrox’s launch.

“The data that’s been generated for valrox to date shows that we can achieve a sufficient degree of correction of the genetic problem, and you’re actually going to be bleed less frequently than you did when you were taking the infusions,” Robert Baffi, BioMarin’s head of technical operations, said in an interview.

How long such a benefit will last is a key question facing BioMarin. Recent three-year follow-up results from an early study of valrox showed efficacy appeared to wane over time, albeit to levels well above what’s considered mild hemophilia.

BioMarin filed valrox for approval in the U.S. last month. The company has yet to hear whether regulators have accepted the application, according to a spokesperson, but expects to hear back by the end of February.

https://www.biopharmadive.com/news/biomarin-big-day-gene-therapy-pku-valrox/570286/

Roche aims to ‘underwhelm’ on SMA drug price to challenge rivals

Swiss drugmaker Roche plans to price its oral spinal muscular atrophy drug (SMA) risdiplam aggressively to challenge two of the world’s most expensive medicines, Biogen’s Spinraza and Novartis’s gene therapy Zolgensma.

Spinraza’s list price is $750,000 in the first year, and $375,000 thereafter, while Novartis’s gene therapy for the genetic muscle wasting disease lists at $2.1 million, making it the drug industry’s most expensive one-time treatment.

Third-to-market risdiplam is due for a U.S. Food and Drug Administration decision by May 24.

While Roche has not released risdiplam’s price, drug chief Bill Anderson said the Basel-based company will price the drug much as it did its hemophilia A medicine Hemlibra in 2017, when it undercut traditional therapies made by rivals NovoNordisk and Takeda to help win patients.

“With Hemlibra, we priced at about half of bypassing agent,” Anderson said in an interview on Monday at the JP Morgan Healthcare Conference in San Francisco. “We aim to underwhelm with our price” with risdiplam, he added.

Hemlibra costs around $500,000 a year. Treatment that includes bypassing agents given to stop bleeding in hemophilia patients with resistance to traditional clotting factor treatments can top $1 million.

Experts see Zolgensma becoming the treatment of choice for newborn patients who test positive for SMA, because gene therapy may offer infants yet to exhibit symptoms hope for normal development.

Risdiplam, seen by analysts as topping $1 billion in annual sales, and Spinraza, already a roughly $2 billion per year seller, are seen competing for older patients. Oral, daily risdiplam may be less complicated, given Spinraza is given every four months via an infusion in the spine.

Zolgensma is also being tested in older patients with a spinal infusion, though the trial has been halted due to safety concerns. Novartis is awaiting the FDA’s go-ahead to restart.

Novartis also is developing an oral drug, branaplam, though its chief researcher, Jay Bradner, in December indicated the company had cooled to the medicine, saying he did not “see a big opportunity for oral therapy there, or we would develop this molecule further”.

Novartis has since clarified its stance, saying its trial of branaplam would continue, with a decision to be made after the study produces data later this year.

https://www.reuters.com/article/us-roche-sma/roche-aims-to-underwhelm-on-sma-drug-price-to-challenge-rivals-idUSKBN1ZD12F

JPM kickoff: Gilead’s deal ideal, Novartis’ image-polishing, Teva’s shutdown tally

It’s January, which means one thing: The annual J.P. Morgan Healthcare Conference in San Francisco is back on, and drugmakers of all shapes and sizes are doing their best to woo investors.

As in years past, the industry whetted appetites with pre-conference deal announcements, even if those unveilings weren’t nearly as dramatic as last year’s Bristol Myers-Celgene merger. Biotech companies trotted out some smaller tie-ups, including Incyte and Biogen’s announcing deals Monday valued at $750 million and $75 million, respectively.

Meanwhile, we got some developments from last year’s megamerger as Bristol-Myers CEO Giovanni Caforio took the stage—and some news from Novartis from its November MedCo deal that could shake up the PCSK9 market. Several other big players jumped out to a fast start on-site Monday, with J&J, Gilead, Regeneron, Teva and more onstage.

UPDATED Monday 10:20 p.m. Pacific Time

It’s a question investors have asked Merck again and again: Does the company have enough in its pipeline to supplement Keytruda when the drug’s mammoth sales one day slow down? But the way company R&D chief Roger Perlmutter sees it, it’s a fair one. “Everyone recognizes that Keytruda is no ordinary drug,” he said, pointing to the way it’s changing practice and growing “enormously.” That said, he and CEO Ken Frazier agree that the pharma giant’s pipeline has never been “more deserving of investment,” with other oncology assets and vaccines coming in hot.

With Reshma Kewalramani preparing to take the reins as Vertex CEO, the company is eyeing a number of disease areas beyond cystic fibrosis. And moving from one disease area to many is “something we’ve been thinking about and working on diligently” over a number of years, she said Monday, adding that “I cannot underestimate” that challenge. But the disease areas Vertex is targeting with its pipeline candidates all have some things in common. For starters, they’re all programs with efficient development pathways and they’re all served by specialty markets, Kewalramani said.

UPDATED Monday 3:44 p.m. Pacific Time

Johnson & Johnson has posted market-beating pharma growth for years, and it doesn’t expect that to change anytime soon. How will it keep the sales churning? Drugs it’s already fielding. About 75% of J&J’s growth through 2023 will come from existing drugs, whether through market share gains, new indications, or approvals in earlier lines of treatment, said Jennifer Taubert, the drugmaker’s worldwide pharma chairman. Asked during the Q&A session about the tough pricing environment across the industry, she said she doesn’t see things getting any easier. But J&J’s already counting on volume-based growth, she said, and its diverse set of businesses offer ballast in any one sector’s storm.

UPDATED Monday, 2:05 p.m. Pacific Time

With an FDA approval for its second RNAi therapy in hand, Alnylam is calling its shot in 2020, predicting a “catalyst-rich” year ahead with at least four late-stage candidates on the way to launch in the next 12 to 24 months. The promising results for newly minted Givlaari, an RNA therapy for acute hepatic porphyria approved in November, could put Alnylam on the path to becoming a “top five” biopharma, CEO John Maraganore told investors Monday at JPM, though we weren’t sure which five he meant. The drugmaker is aiming for launches of homegrown late-stage candidates lumisiran and vutrisiran as well as partner meds, including highly touted PCSK9 candidate inclisiran and hemophilia hopeful fitusiran.

UPDATED Monday, 1:29 p.m. Pacific Time

Want to know what Gilead Sciences is plotting next in terms of business development? Take a good, long look at the company’s $5.1 billion Galapagos partnership from last July. “We want to find complementary arrangements like we had with Galapagos,” CEO Daniel O’Day said during Gilead’s presentation.

Of course, every deal can’t be as wide-reaching as the 10-year Galapagos pact. “You can’t do a lot of these, but we would like to find a way to do at least one more” over the next few years, CFO Andy Dickinson said during a breakout session afterward. Beyond that, investors should expect a “regular cadence of partnerships,” Dickinson said, including small and medium deals. And O’Day assured investors Gilead would still do some straight M&A, too. “I think we need to think about multiple approaches here,” he said. In terms of what stage transactions Gilead is thinking about, the “vast majority of deals” will be earlier-stage, but “rest assured we are looking at supplementing our late-stage portfolio,” too.

Novartis is no stranger to scandal, but the company is intent on rehabbing its reputation, CEO Vas Narasimhan said at JPM on Monday. To demonstrate that, Novartis is rolling out official goals on ethics, pricing, global health and corporate citizenship, and has a new executive team to keep track of its progress. The kicker? Performance against the goals will be linked to exec pay. Story

Aside from Narasimhan’s trust pledge, the CEO highlighted its digital ambitions; it now employs 1,500 data scientists, he said. And to keep its full range of goals on track, the company has to be a “launch machine,” with 15 ongoing or near-term launches in the works. And like other big pharmas, Novartis has growth plans in China, with 50 expected approvals there in the next 5 years.

UPDATED Monday, 12:58 p.m. Pacific Time

It’s only been about a month since Sanofi and Regeneron split up rights to Praluent and Kevzara and doubled down on Dupixent, but so far the change has “really been great,” Regeneron CEO Len Schleifer said Monday at JPM. The new arrangement is better because there won’t be two companies focusing on “products that are not nearly as important as Dupixent,” Schleifer said. Instead, both companies can focus on that runaway immunology med, which is generating about $2.4 billion per year based on third-quarter 2019 results. Of Sanofi’s new CEO Paul Hudson, Schleifer said he’s “quite capable” and “focused” on turning Dupixent into a megablockbuster.

Two years ago, when Teva CEO Kåre Schultz took the stage at J.P. Morgan, “we had a pretty dramatic situation,” as he put it Monday. Between major debt, competition to star drug Copaxone and a “dramatic decline” in U.S. generics pricing, things were looking dire. But this year, Schultz was ready to offer a progress report.

Teva has closed or sold off 13 manufacturing sites and is in the process of winding down or selling 10 more. It’s closed 40 labs and offices. And perhaps most importantly to Schultz, who proclaimed “I don’t like debt,” Teva has taken its tab down by more than $8 billion over two years. So what’s the next phase for Teva? Optimizing manufacturing in a more “sophisticated” way, leveraging its generics expertise for biosimilar launches, growing in China and expanding Austedo and Ajovy, two meds Schultz said will soon offset revenue losses from still-declining Copaxone.

Last year, Bristol-Myers stole the show with its $74 billion deal agreement for Celgene. But one year later, with the deal just recently closed, CEO Giovanni Caforio says BMS has made “great progress” with integration: Its leadership teams are in place, it’s designed the new company’s operating model, and things are coming together smoothly on the commercial and R&D sides. But in other ways, it’s just getting started. Story

While 2020 hasn’t started in similar style, a report from EY’s experts suggests M&A the rest of the year should be just as strong as last—but this time around, biotech and medtech could play a bigger part. And with $1.4 trillion in dealmaking firepower at hand, the healthcare industry can certainly afford it. Story

Case in point: Incyte, fresh off a trial flop early this month, agreed to pay $750 million for licensing rights to MorphoSys‘ anti-CD19 antibody tafasitamab, which is facing an FDA approval decision in combo with Bristol-Myers Squibb’s Revlimid in diffuse large B-cell lymphoma. Incyte will pony up the $750 million to license the drug, buy $150 million in MorphoSys shares and shell out up to $1.1 billion if future milestones go the right way. Story

Biogen, diving even further into Alzheimer’s R&D, will pick up Pfizer’s early-stage candidate PF-05251749 for a tidy $75 million. The drug is a CK1 inhibitor that moved into the clinic on the strength of evidence it can cross the blood-brain barrier and regulate circadian rhythms, thereby improving behavioral and neurological symptoms in patients with diseases including Alzheimer’s. On top of its $75 million check, Biogen will shell out up to $635 million in milestone payments if development and commercialization targets are met. Story

Roche inked a 15-year, non-exclusive partnership with Illumina that will see the two companies work together to develop the DNA sequencing giant’s pan-cancer assay as a companion diagnostic for different cancer drugs, including with expertise from Roche’s Foundation Medicine division. Additionally, Roche will opt to develop and manufacture its genomic test kits for tumor tissue and blood samples for use on Illumina’s current and upcoming lines of sequencing hardware. Story

After netting a 510(k) clearance from the FDA last year, Ivenix brought on a new CEO to help guide the market launch of its digital infusion pump designed to help reduce medication errors. Jorgen Hansen, formerly president and CEO of Cantel Medical, has also held global strategy and operations positions at ConvaTec and Coloplast, and serves on the board of AdvaMed. According to Ivenix, infusion-related medication errors make up about half of the adverse safety events reported to the FDA. Story

As Regeneron prepared for its JPM presentation Monday afternoon, the drugmaker highlighted booming sales of its eye med Eylea, which hit $4.14 billion in 2019––a 14% increase over the previous year––in a filing with the Securities and Exchange Commission. In the fourth quarter, Eylea nabbed an estimated $1.22 billion in global sales, a 13% jump, the drugmaker said. Eylea nabbed an FDA nod in May to treat all stages of diabetic neuropathy, a condition that affects about 8 million people worldwide, the company said.

Looking for a game-changer in biotech, EQRx and its CEO, Alexis Borisy, has raised $200 million in funding for a new kind of company—one with a mission to create “equally good or better drugs” and sell them at cheaper prices. The new company will focus on equivalars, essentially new medicines designed after existing meds or soon-to-debut therapies. But according to Borisy, EQRx meds will not infringe other companies’ intellectual property and will be protected by their own patents. Story

As all biotech watchers know, the San Francisco Bay Area isn’t just the home of JPM. But soon, in addition to HQs for some of the biggest names in the business, SFO will house a state-of-the-art R&D facility for Johnson & Johnson’s Janssen unit. The biotech unit penned a deal for space in The Shore at Sierra Point in Brisbane, California––a region the drugmaker deems to be a “critical innovation hotbed.” Janssen said the expansion will help it bridge “key interdisciplinary capabilities” such as biology and data science to “fuel a step-change in how it creates medicines.” It didn’t say whether it would be employing new staffers nor how many. Story

https://www.fiercepharma.com/pharma/jpm-kickoff-regeneron-incyte-and-case-missing-mattresses

Tax breaks for college tuition, medical expenses just came back from the dead

On December 20, President Donald Trump signed into law the Taxpayer Certainty and Disaster Tax Relief Act of 2019 (the Act). The new legislation retroactively resurrects and/or extends a bunch of individual and business federal income tax breaks, which we will call the extenders. The extensions generally go through 2020. This column covers what you need to know about the extenders that are most likely to help individual taxpayers.

As its name indicates, the Act also includes a bevy of federal tax relief provisions for disaster victims. See below for more information on that.

More-favorable itemized medical expense deduction threshold extended through 2020

The Tax Cuts and Jobs Act (TCJA) set the threshold for itemized medical expense deductions at 7.5% of adjusted gross income (AGI) for 2017 and 2018. The threshold was scheduled to increase to a daunting 10% of AGI for 2019 and beyond. The Act extends the more-taxpayer-friendly 7.5%-of-AGI threshold through 2020.

College tuition write-off resurrected for 2018 and extended through 2020

This deduction can be up to $4,000 annually at lower income levels or up to $2,000 at middle income levels. It expired at the end of 2017. The Act retroactively resurrects the deduction to cover qualified college expenses incurred in 2018 and extends the write-off to cover costs incurred in 2019 and 2020. If you qualify for the deduction based on your income, you can claim it whether you itemize or not.

* Taxpayers with modified adjusted gross income (MAGI) up to $65,000, or up to $130,000 if you’re a married joint-filer, can deduct qualified expenses up to $4,000.

* Taxpayers with MAGI between $65,001 and $80,000, or between $130,001 and $160,000 if you’re a married joint-filer, can deduct up to $2,000.

* The allowable deduction goes to zero if your MAGI is more than $80,000, or $160,000 if you’re a married joint-filer.

Break for forgiven principal residence mortgage debt resurrected for 2018 and extended through 2020

For federal income tax purposes, a forgiven debt generally counts as taxable cancellation of debt (COD) income. However, a temporary exception applied to COD income from cancelled mortgage debt that was used to acquire a principal residence. Under the temporary rule, up to $2 million of COD income from principal residence acquisition debt that was cancelled in 2007-2017 was treated as a tax-free item ($1 million for married individuals who file separately). The Act retroactively resurrects this break to cover eligible debt cancellations that occurred in 2018 and extends the break to cover eligible debt cancellations that occur in 2019 and 2020.

Key Point: The Act allows the exclusion for eligible debt cancellations that occur after 2020 under a binding written agreement that was entered into before 1/1/21.

Mortgage insurance premium write-off resurrected for 2018 and extended through 2020

Premiums for qualified mortgage insurance on debt to acquire, construct, or improve a first or second residence can potentially be treated as deductible qualified residence interest. Before the Act, the deduction was only available for premiums paid through 2017. The Act retroactively resurrects this break to cover eligible premiums paid in 2018 and extends it to cover premiums paid in 2019 and 2020. However, the deduction is only available for premiums for qualifying policies issued after 12/31/06 and premium amounts allocable to periods before 2021. Note that the deduction is phased out for higher-income individuals.

$500 credit for energy-efficient home improvements resurrected for 2018 and extended through 2020

Through 2017, you could claim a federal income tax credit of up to $500 for the installation of certain energy-saving improvements to a principal residence. This break expired at the end of 2017, but the Act retroactively resurrects it for 2018 and extends it for 2019 and 2010.

Key Point: The $500 maximum allowance must be reduced by any credits claimed in earlier years. In other words, the $500 amount is a lifetime limitation. So, if you claimed the credit before 2018, you may be ineligible for any further credit.

Credit for fuel cell vehicles resurrected for 2018 and extended through 2020

You can claim a federal income tax credit for vehicles propelled by chemically combining oxygen with hydrogen to create electricity. The base credit is $4,000 for vehicles weighing 8,500 pounds or less. Heavier vehicles can qualify for credits of up to $40,000. An additional $1,000 to $4,000 credit is available to cars and light trucks to the extent their fuel economy meets federal standards. This credit expired at the end of 2017, but the Act retroactively resurrects it to cover qualified vehicles purchased in 2018 and extends the break to cover qualified vehicles purchased in 2019 and 2020.

Credit for plug-in electric motorcycles resurrected for 2018 and extended through 2020

The 10% federal income tax credit for the purchase of qualifying electric-powered 2-wheeled vehicles manufactured primarily for use on public thoroughfares and capable of at least 45 miles per hour (i.e., electric-powered motorcycles) can be worth up to $2,500. The credit expired at the end of 2017, but the Act retroactively resurrects it for 2018 and extends it for 2019 and 2020. Don’t forget to wear your helmet.

Credit for alternative fuel vehicle refueling equipment resurrected for 2018 and extended through 2020

The Act retroactively resurrects the personal and business federal income tax credit for up to 30% of the cost of installing non-hydrogen alternative fuel vehicle refueling equipment placed in service in 2018 and extends the credit for 2019 and 2020. You can claim the credit for a personal recharging station in your garage — that means you, Tesla TSLA, +9.77%   owners.

Credit for health insurance costs extended through 2020 for the few who qualify

The health coverage tax credit (HCTC) equals 72.5% of the premiums paid by certain very-narrowly-defined individuals for qualified health insurance coverage. The HCTC was scheduled to expire at the end of 2019, but the Act extends it through 2020 for those few folks who qualify. You know who you are.

You may want to file an amended 2018 return

Unless you’ve not yet filed your 2018 return, you’ll need to file an amended return for that year to take advantage of the breaks that were retroactively resurrected for 2018. Ask your tax adviser if it’s worth the trouble.

The bottom line

The extenders legislation is important good news for the individuals who can benefit from it. If you are in that category, you may also want to file an amended 2018 return to take advantage of breaks that were retroactively resurrected for 2018.

One more thing: Best wishes for a happy and prosperous 2020.

More info: Disaster relief provisions

In addition to all the extenders provisions, the Act also includes a bevy of federal tax relief measures for individuals and businesses in areas affected by federally-declared disasters occurring between 1/1/18 and 30 days after the 12/20/19 date of enactment of the new law. Relief measures include the following:

* Exceptions to the 10% early withdrawal penalty for pre-age-59½ withdrawals from retirement plans and IRAs are provided for qualified disaster relief distributions, as defined.

* IRA withdrawals for home purchases that were cancelled due to eligible disasters can be recontributed to the IRAs they came from.

* Flexible rules are provided for retirement plan loans in qualified hurricane relief situations.

* An employee retention tax credit is available to employers affected by qualified disasters. The credit equals 40% of qualified wages, up to $6,000 of wages per eligible employee.

* Limitations on charitable contribution deductions are temporarily suspended for charitable donations related to qualified disaster relief efforts.

* Liberalized rules apply to deductions for qualified disaster-related personal casualty losses.

* And more. Consult your tax adviser for full details.

https://www.marketwatch.com/story/tax-breaks-for-college-tuition-and-medical-expenses-just-came-back-from-the-dead-heres-what-you-need-to-know-2020-01-08

Pharmacovigilance and Regulatory Trends: IQVIA’s Joe Rymsza

Pharmacovigilance (PV) is basically drug safety. It is, at its core, the collection, detection, evaluation, monitoring and prevention of adverse effects of pharmaceutical products. And it’s an increasingly important—and increasingly complex and expensive—component of biopharmaceutical drug discovery, development, manufacturing and commercialization.

Joe Rymsza, vice president of Pharmacovigilance and Regulatory Technology Solutions for IQVIA, took time out to discuss trends in PV and regulation in the biopharma industry in the coming year as well as to talk about the company’s software-as-a-service (SaaS)-based safety platform.

Rymsza notes that volumes of adverse events have been increasing by more than 20% year-over-year across the biopharmaceutical industry. “It’s the number one challenge the industry is facing and there’s no end in sight. It’s being driven by obvious and non-obvious things, like the introduction of new productions, expansion and marketing of products into new geographies, and requirements to start to mine third-party social media sources for adverse events.”

In fact, biopharma companies spend around 70% to 80% of their operational budget on meeting regulatory requirements, what Rymsza called an “inverted pyramid.”

“They probably spend about 80% of their financial resources on getting data into the system and doing rote reporting to the health authorities and various agencies,” Rymsza said, “and various obligations in countries in which they market, and less than 20% on things that give discernible value to patient safety or that feeds insight back into the drug discovery processes.”

And this is something that most biopharma executives would like to flip.

Although PV is separate from regulation, it is both overlapping and synergistic. Rymsza says that on the regulatory side, “you see the parallel regulatory burden in the companies, particularly companies that market products at scale in 150-plus geographies. They’re dealing with a massive number of country regulations. Once a product is approved, which is in and of itself an amazing and time-consuming process, you have to maintain the labels and do goofy things like paying an application fee in all the countries it’s marketed. If there’s a change, like a change in the supply chain in the ingredients, that also creates a cascading regulatory modification.”

In terms of trends for PV and to a similar extent, regulation, Rymsza believes that automation, with a fair amount of nuance, will be the biggest umbrella trend. He stratifies the market into three layers, essentially large, middle and small/emerging biotechs. Although the trends will undoubtedly affect all three types, in this context Rymsza is primarily focusing on the large biopharma companies with international markets.

“You’re going to see 90% of the top 100 to 200 pharma companies engage in automation-driven projects and pilots and proof-of-concept programs,” he said. “There is absolutely no question it’s started to occur. It began with a trickle in 2017 and now you see it across the board. The industry is just recognizing that their current aged and inflexible technology isn’t able to meet the growing needs of the business.”

This is automation in terms of PV, in particular. Companies, Rymsza said, “are looking to reimagine the end-to-end solutions that need to be on a SaaS platform that’s being built from the ground up with the tenets of automation in mind.”

Part of this need for automation comes from the growing number of resources companies need to keep up with PV activities. “Ultimately,” Rymsza said, “there are not enough people around the world to hire to process this information with the increased number of adverse events and increasing burden of regulations. It’s becoming a really important inflection point from the standpoint of how the industry has to look at their end-to-end processes and systems through the lens of automation.”

Rymsza also cautions about focusing just on the clichés of machine learning and artificial intelligence (AI). “The technology itself is less important than the basic question of how do we make the most value-added processes for the organization without compromising quality and compliance.”

In a related theme, companies are implementing a regulatory information management system to have a single source of information about their product portfolio. Rymsza says, “If you go into a top 40 company and ask for a list of products marketed in which country and which doses, it’s a mess. And it’s an unsustainable way to operate.”

To assist in dealing with this trend, IQVIA has developed Vigilance, a SaaS-based PV system that the company and Rymsza hope will help biopharma companies “flip the pyramid.”

“It’s essentially the cornerstone of our strategy to reimagine PV. We built it from the ground up on Salesforce.com. If you look at the trend, our industry is so far behind the rest of the industry in terms of running their businesses on classic SaaS structure, shackled with expensive upgrade projects, unlike the SaaS arena.”

Vigilance is about looking at the full end-to-end process from the viewpoint of adverse event identification through assessment, signal management and reporting, and, Rymsza said, “how we can intelligently use automation, natural language processing and bits of pieces of machine language and AI where appropriate, to automate every aspect of that process. And to do things with real-world data beneath it so when you get adverse events, you can conduct inline comparison automatically against massive multi-million-dollar assets to determine the probability that an adverse event may be important.”

The company also provides E2B(R3) operational PV services, biostatistics, management on top of the Vigilance, if companies want to purchase them. “We think there’s a lot of advantages to combining the technology and services, but we are also offering the technology as a standalone technology SaaS platform,” Rymsza said.

E2B(R3) doesn’t have a direct translation, but it relates to the efficient transfer of PV safety data electronically. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Ministry of Health, Labour and Welfare (MHLW) have all adopted E2B(Re) as their standard submission formation. All companies that report safety data to these agencies using E2B will be required to adopt E2B(R3) format.

Digital transformation, Rymsza noted, is a buzzword across life science companies, but usually, that has revolved around commercial and clinical activities. “But now they are turning their attention to safety and regulations, and asking, Why aren’t we using commonly accepted processes like natural language processes and automatic ingestion of documents from regulatory affairs, move them in, prep them to learn basic ingestion into the system and begin to automate some of the analysis?”

Only three years ago there wasn’t much interest, but now everyone in the life sciences is interested and wants to find algorithms that can actually perform causality analysis on significant parts of their product portfolios.

“There isn’t an organization in the top 50 that isn’t interested, and in certain cases, have already started running pilot projects with the intention of going live in the latter part of 2020 or in 2021,” Rymsza said.

https://www.biospace.com/article/pharmacovigilance-and-regulatory-trends-an-interview-with-iqvia-s-joe-rymsza/