How to build great products

Adam Waxman

 

Build at the intersection

The best products are created at the intersection of product, design, and engineering. Successful teams start, build, and finish together. Fewer handoffs, and more multidisciplinary debates and considerations.

Decide at the intersection

The best product decisions are made at the intersection of data, empathy, and instincts. Using a variety of inputs helps balance the strengths and weaknesses of these approaches.

Embrace healthy tension

There should be healthy tension between product, engineering, and design. Each team brings unique perspectives and will create a checks and balance system that ensures the end result is viable, desirable, and feasible.

Be data-informed, not driven

Measure what you can, but recognize the limitations of data and that many important things cannot be measured. If you’re interested in this topic check out my related post.

Make time horizon appropriate goals

Orient short-term goals around inputs, medium-term goals around outputs, and long-term goals around outcomes. Make sure they all connect. Deciding appropriate goals and time horizons depends on the maturity of the product (new vs existing), the type of behavior you’re hoping to drive near term (engagement, transactions), and the type of behavior you’re hoping to drive long term (loyalty, retention). The devil is in the details.

Zoom out to recognize true tradeoffs

Short term vs long term business value is a more appropriate and useful framing for many business vs user tradeoff discussions. Focusing on consistently delivering value will create more long term value than using dark patterns to boost near term conversion rates.

Think big, start small

Break down large ideas into iterative experiments that stand on their own but build towards a long term goal. Learn more from the guy who popularized this here.

What heuristics do you use to build great products?

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Five 'Big Idea' Biotech Trends To Watch In 2017

Luke Timmerman , CONTRIBUTOR

Different types of stories cross my radar as a biotech journalist every day.

There are partnerships between established drugmakers that need new products and the little aspiring companies that need cash to develop their thing. Stories about clinical trial results that move markets. Regulatory actions that make or break companies and investors.

But for me, there’s something especially fun about talking with scientific entrepreneurs who raised their first big wad of investment cash. They’re latching onto some kernel of insight from a discovery. Or maybe they have a vision for stitching together a set of technologies. Either way, they are venturing into a great unknown to see if they can make a big step ahead in medicine. They often have insights that put them years ahead of the lumbering drug giants.

The odds are stacked against the creators. But even in failure, startups can sometimes offer clues on where medicine is heading. Sometimes outside groups will see what's wrong and fix it. And yes, sometimes the startups will succeed, going public or getting acquired.

Here were a few trends I observed from covering startups that will remain relevant in the year ahead.

New Ideas For The Treatment Of Alzheimer’s

Alzheimer’s disease is a demographic iceberg. As the baby boomers get older, the national healthcare bills for dealing with it are astronomical—with one analysis estimating Alzheimer’s will gobble up one-fourth of Medicare spending in 2040. The pharmaceutical industry has had no effective response yet. Billions of dollars have been invested in targeted antibody drugs that are supposed to help clear out the buildup of amyloid-beta protein plaques that are thought to gum up memory and cognition as we age. But we’re beginning to see some signs of support for alternative scientific approaches. Cambridge, Mass.-based Yumanity Therapeutics raised $45 million to create a new drug discovery engine for Alzheimer’s and other neurodegenerative diseases. South San Francisco-based Annexon Biosciences, a Stanford University spinout, raised $44 million to build on research that suggests you can fight Alzheimer’s by stopping the immune system from from removing synapses we need for neuronal functioning. And earlier this month, a bootstrap startup I wrote about in Timmerman Report, EIP Pharma, showed that an old anti-inflammatory drug improved cognition and memory in a small set of patients with mild Alzheimer’s. Given the urgent need, the enormous market, and the string of failures with anti-amyloid antibodies like Eli Lilly’s solanezumab, I suspect we’ll see pharma spread its eggs around into multiple baskets.

Scientists At The Movies

Much of drug discovery is based on static images of a molecular target. Chemists want to make compounds that can bind with the specific target. But many of these targets are fluid in real life, and their shape-shifting dynamics make them especially hard targets. What if instead of looking at a still photograph, you could watch a series of images, a “movie” to see how the protein targets folds in different configurations? Could you gather deeper insight into the particular toeholds that a drug could bind with? Two companies in the Boston area, Relay Therapeutics and Morphic Therapeutic, each raised more than $50 million in their Series A venture financings to see if they can better capture the fluidity of protein targets and use that knowledge to discover drugs. This is a big idea that big organizations are watching closely–Morphic is backed by Pfizer, GSK and AbbVie, while Relay Therapeutics was started by Third Rock Ventures and D.E. Shaw Research.

Solving the Problem, Not Just Pushing Drugs

One reason so many people hate the drug companies is not only because of the high prices. It’s because while they get rich off selling their products, many people aren’t getting their health problems solved. Smoking is one good example. A doctor can prescribe a smoking-cessation product like Pfizer’s varenicline tartrate (Chantix) or GlaxoSmithKline's bupropion hydrochloride (Zyban). Clinical trials will tell you that only goes so far for most smokers. While the big companies bring single-minded focus to pushing their products, researchers and health insurers know that an integrated combination of drug therapy and behavioral therapy is more effective at helping people kick the habit. One San Francisco Bay Area startup, Chrono Therapeutics, told me about a clever way of stitching together drugs, digital sensors and human coaching into an integrated approach. If they can put the puzzle pieces together, Chrono should do a better job of helping a person quit than just writing them a prescription, sending them home and hoping for the best.

Drugs For Us (and Our Bugs)

The science of the microbiome has taken biology by storm the past few years. This is thanks in large part to DNA sequencing tools that are yielding an increasingly vivid understanding of how we as humans coexist with the trillions of bacteria in our guts, and on our skin. When we get along well with the bugs, we’re usually what people would consider healthy. But when something goes off-kilter with a certain kind of bug or bugs, our immune systems can go haywire, attacking healthy tissue, causing autoimmune disease. Some research suggests gut bacterial composition affects our mood, opening up interesting new ideas for treatment of depression and other forms of central nervous system disorders and mental illnesses. Exactly how biotech and pharma companies can wrestle this science to the ground and figure out how make elegant drugs based on it, is very much an open question. Cambridge, Mass.-based Seres Therapeutics, a first-mover in the field, crashed this year with a microbiome-based treatment for C. difficileinfections. But money continued to flow toward a variety of microbiome-based drug discovery efforts that are quite different. A few examples I wrote about in FORBES are Vendanta Biosciences, Synlogic, and Second Genome. Timmerman Report subscribers may also see this recent story on Axial Biotherapeutics, a Caltech spinout that seeks to exploit “the gut-brain axis” for the treatment of autism and Parkinson’s.

Shifting Power Dynamics At The Nexus Of Academia And Industry

We as taxpayers invest in basic biomedical research, largely through the National Institutes of Health. When a discovery gets made, universities sometimes get a patent, and businesses sometimes license these inventions for further development. Traditionally, these raw discoveries need an enormous amount of investment and labor before they can be made into a practical product, like a pill in a bottle. Knowing this, businesses have often obtained intellectual property from universities as if it’s roughly on the 10-yard-line and needs a successfully sustained 90-yard drive from industry to reach the end zone with a marketable product. Businesses have usually paid peanuts to obtain these licenses. But as universities have gotten more skilled at some of the basic blocking and tackling that industry does well (things like basic manufacturing of biologic drugs, viral delivery vectors for gene therapy and more), the universities have been able to drive their assets further downfield. No surprise, that has allowed academics to drive a harder bargain with industry.

Harvard notably extracted a $20 million upfront payment from Merck in March for the right to develop a set of small molecule drugs for acute myeloid leukemia that fit this bill. Juno Therapeutics and Spark Therapeutics, prominent cancer immunotherapy and gene therapy players, respectively, had to pay through the nose to get ahold of foundational intellectual property for their companies (subscribers may read my previous coverage at Timmerman Report). The potential for conflicts of interest, and abuse of taxpayer resources, is always here in such deals. It’s also common to see oversimplified critiques of any and all academic-industry deals in the mass media. But I’d argue that universities have gotten more savvy at the tricky balance of technology transfer since the Bayh-Dole Act of 1980 encouraged them to quit letting inventions sit on the shelf. Academia will continue to strike more financially advantageous deals for themselves in the year ahead, and it will cause continued teeth-gnashing in industry and in the press.

Luke Timmerman is the founder of Timmerman Reportand the author of "Hood: Trailblazer of the Genomics Age."

Best Selling Oncology Drugs 2016

THE TOP-TEN ONCOLOGY DRUGS ARE IDENTIFIED ON THE BASIS OF REVENUES IN 2015 AND ACCOUNTED FOR 36% OF THE TOTAL ONCOLOGY DRUGS MARKET.

The list is headed by Avastin, an oncology product manufactured by the Swiss giant Roche. The market is consolidated by six companies including Roche, Celgene, Novartis, Eli Lilly, Johnson & Johnson and Novartis. In terms of revenues the list is topped by Roche with 47% (including three products) in the top-ten list. This is followed by Novartis with four products and 25% share in the list.

Top-ten oncology products:

Avastin:

Used for the treatment of advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, and relapsed glioblastoma. Demand for Avastin was strong, with sales growth in all regions. US sales grew (+8%), Europe sales grew (+4%) due to increasing treatment of ovarian, colorectal, lung and cervical cancer. The US is the largest market for the drug, accounting for approximately 47% of its global sales. The International region growth of 15% was driven mainly by phasing of deliveries to the public sector and approval of new indications.

Herceptin:

Herceptin sales grew 10% with continued strong growth in the US (+15%) resulting in treatment for both early and advanced breast cancer along with gastric cancer. In U.S. Herceptin displayed a positive growth of 15%. In Asia-Pacific, the main drivers of growth of 21% resulted from significant activities to ensure patient access to the medicine in China.

Revlimid:

Sales increased by 16% in 2015 compared to 2014, primarily due to the result of its indication being expanded to newly diagnosed multiple myeloma in the U.S. and Europe. Increases in market penetration, volume increases, primarily driven by increased duration of use and market share gains also contributed to the growth.

MabThera/Rituxan:

It is used for treating non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), follicular lymphoma (FL) and rheumatoid arthritis (RA) as well as certain types of ANCA-associated vasculitis. The product sales were 5% higher, driven primarily by growth in the U.S. (+7%) and accounts for more than half of the drug’s global sales followed by Europe. The International region grew 4%, driven by growth in the Eastern Europe, Middle East and Africa sub-region and public sector sales in Latin America.

Gleevec/Glivec:

It is one of the largest selling oncology drug manufactured by Novartis. It is approved for treatment of chronic myeloid leukaemia, a rare form of cancer, and gastrointestinal stromal tumours (GIST). Gleevac accounts for approximately 24% of the company’s oncology portfolio, and 15% of its pharmaceutical offering. Generic competition in Japan and some EU countries has resulted in declined growth. The company licensed to a subsidiary of Sun Pharmaceutical Industries the right to market a generic version of Gleevec in the U.S. in 2016.

Alimta:

Used in the treatment of advanced non-small cell lung cancer (NSCLC) for patients with non-squamous cell histology. The decrease in revenues has resulted from decreased demand with lower realized prices, unfavourable impact of foreign exchange rates and partially offset by increased volume. Its patent expired in Japan and major European countries in December 2015, while the US patent will expire in January 2017. Furthermore the sales are likely to be hampered by the generics from competitors in Europe and Japan.

Zytiga:

The J&J manufactured product is an oral medicine used for treating metastatic, castration-resistant prostate cancer in men in combination with prednisone. It is also deployed for treating prostate cancer, the second most common male cancer type in the U.S. Zytiga’s sales grew in the U.S. due to market growth and strong growth in Asia and Latin America but was offset by lower sales in Europe due to competition and share decline.

Tasigna:

It is another product for Novartis portfolio used for treatment for chronic myeloid leukaemia (CML). The drug is approved in more than 110 countries for treatment of chronic and accelerated phase CML in adult patients resistant or intolerant to at least other older therapies. The drug grew 16% in annual sales in 2015.

Sandostatin:

Sandostatin is used for treating acromegaly, carcinoid tumours and other types of gastrointestinal and pancreatic neuroendocrine tumours. It has been approved in 50+ countries for treating patients suffering from advanced neuroendocrine tumours of the mid-gut or unknown primary location.

Afinitor/Votubia:

It is the last drug in the top-ten oncology drug segment list due to lowest revenues. The drug is accounted for 10% annual growth rate. It is used to treat multiple conditions including kidney cancers, pancreatic cancer, rare childhood brain tumors, and benign tumors caused by tuberous sclerosis.

Jan Zachnik

Pharma’s Productivity Problem: Finding More Blockbuster Drugs

Standish Fleming

A recent Wall Street Journal article that raised the possibility of Biogen as the target of another huge pharma buyout cited the lack of productivity as a major driver of M&A in the pharmaceutical industry.  The authors made the point that, given the size of companies today, a single garden-variety blockbuster hardly moves the needle.

The increasing need for new drugs is intense.  The industry can only go so far with growth through hyper-inflated pricing and mega-M&As.  At some point pharma has to figure out how to make more drugs more efficiently, or face major dislocations like business-destroying price controls.  It is the hope of new blockbuster drugs that keeps government regulators at bay.

An obvious place to look for help is the venture community—Bruce Booth of Atlas Ventures pointed out in a recent blog that venture capital is doing well, and is positioned to do even better in the future.  Yet despite relative plenty in the bio-venture community, pharma suffers from a shortage of drug candidates.

A recent Silicon Valley Bank report noted that large corporations have dramatically increased pre-clinical acquisitions in the last three years under the pressure of limited supply and competition from IPOs.  Early acquisitions force pharma to take more risk and spend more of their operating budgets on development over a longer time than buying post-phase II, where they can more efficiently deploy large-scale resources.

What Booth didn’t say explicitly is that providing only a limited supply of drug candidates in the face of increasing demand is a key element in the venture investment model.  The quickest way to kill industry profits is to try to put too much money to work.  Losses in over-capitalized “vintage years” over the last two decades have left institutional investors (e.g. pension funds) with little appetite for experimentation with new managers and more funds.

With a limited supply of new firms coming into the business, venture’s ability to expand to meet demand is inherently constrained.  A 2011 white paper by Kevin Lalande of Santé Ventures explains why the size of early-stage funds is not likely to grow substantially in the near term, despite attractive returns:  Life sciences venture does not scale.

Fund size is restricted by exit valuations for portfolio companies; Lalande estimates that, given the high attrition rate of drug development projects, a life-sciences fund should be no larger than 1.0 to 1.5X the average exit value.  In bio-pharma, exit valuations are limited by the stage of development.  No matter how good the phase II data, a product-candidate is not going to command Facebook returns.  So successful early-stage venture firms are not likely to greatly expand the size of their funds or portfolios.

In his blog, Booth pointed out, “There are only a handful of firms that do early stage biotech.”  Yet in the era of precision medicine, pharma needs vastly more drugs. Pharma has not been able to profitably expand their own R&D—in fact, many have cut back budgets—and venture has limited capacity or incentive to scale its R&D. Hence the blockbuster problem.

Pharma understands it must expand its early pipeline of prospective drug candidates, as reflected in the growth of incubators like JLabs and Lab-Central and pre-competitive research consortiums (here, here, and here). But large corporations must do more than simply sow seeds.  While products will emerge from incubators, expanding the number of startups without increasing the supply of capital and drug developers needed to shepherd them through phase II will leave a lot of good technology short of clinical proof-of-concept needed to qualify for commercial development.

To have a meaningful impact on the supply of new drugs, pharma needs more outside managers, funds, proof-of-concept companies, and products in the industry pipeline—in short, a more robust entrepreneurial community.  Pharma has to work with external developers in ways that preserve their independence, initiative, creativity, and energy, while substantially expanding the scale and scope of the sector.

Incubators like J&J’s JLabs do this for research teams that can operate on a shoestring.  However, early clinical costs are an order-of-magnitude greater than pre-clinical studies and don’t lend themselves to bootstrapping.  Start-ups require infrastructure (i.e. labs); proof-of-concept companies require capital and management.

Large corporations have to find ways to fill gaps in the external development pipeline.  Programs like JLabs encourage startup teams to take risks, and to explore new territory with the opportunity, but not the obligation, to partner with the sponsor.  Pharma needs similar business models to help entrepreneurs attract more resources, and to complete proof-of-concept opportunities.

As explained earlier, new venture managers are unlikely to attract institutional backing on their own. By sponsoring new early-stage funds and partnering with portfolio companies, pharma can provide access to the experience and resources of a large corporation—intellectual infrastructure, if you will.  Arrangements like buyout options can enable start-ups to forge close working ties with a potential acquirer over time as products and technologies progress in the clinic.  The support of a large partner enhances the prospect of timely exits and strengthens a team’s ability to attract capital and resources.  Like with incubators, the goal should be to enhance creative energy without co-opting the independence or initiative of the entrepreneurs.

Though organic growth through innovation is not likely to improve the next quarter’s earnings (or executive bonuses), it must become a first-tier priority if pharma as we know it is to survive.  The entire organization has to focus on sustainable development.  More than simply “working closely” with entrepreneurs, large corporations have to integrate R&D seamlessly with the external community over the entire spectrum of development. To expand the industry pipeline on sufficient scale, pharma has to embrace the entrepreneurial business community as a partner in innovation.

Tree Maps

Tree maps are a way to visualize data that has a hierarchical structure, using rectangles where the size of the surface represents the importance of the respective data element. In some ways, tree maps are similar to a pie chart: If your revenue is broken down into five core product categories, you can use either a pie chart or a tree map to visually show the composition of the various elements. The beauty of tree maps is that you can actually show multiple layers: Let’s say product category A represents the biggest share of your revenue with 31%. Drawing a rectangle of that size shows the overall importance of product category A. But you can then actually break that rectangle down to the next level, and introduce sub-rectangles (to show, for example, the countries where product A is sold). This is something you can’t do in a pie chart.

Tree maps apparently were invented by a University of Maryland professor in the early 90s, who wanted to show visually how the hard disk on the university’s computer was being used (back in the days when hard disk capacity was always limited).


The translation into neatly arranged tiles is actually not trivial. There are various algorithms to optimize the lay-out. A number of software applications exist, allowing users to take data and translate them into a graph. A quick Google and Wikipedia search will give you a good overview of those tools. I have found that for most business applications, a hand drawn set of PowerPoint boxes will actually do the trick.


A great example of a tree map chart is the overview of the S&P 500 “map of the market” on SmartMoney (link). The app shows the overall market cap, by sector, by individual stock within sectors, as well as additional information and recent gains/losses as you scroll over the various tiles. Quite impressive!

BCG Matrix

One of the best know frameworks – probably on everybody’s top ten list: the BCG growth / market share matrix. The tool was developed by the Boston Consulting Group in the 70s. The objective is to identify priorities of specific products within a business unit, or priorities of different business unit in a larger corporate setting. The fundamental assumption is that an enterprise should have a portfolio of products that contains both high-growth products in need of cash and low-growth products that generate cash. The BCG matrix has two dimensions: market share and market growth.




The matrix results in four quadrants:
Stars (high growth, high market share): Stars are leaders in the business. They are frequently roughly in balance on net cash flow. The goal is to hold or expand market share.
Cash Cows (low growth, high market share): Cows are often the stars of yesterday and they are the foundation of a company. Because of the low growth, investments needed should be low.
Dogs (low growth, low market share): Avoid and minimize the number of Dogs in a company. Watch out for expensive ‘rescue plans’. Dogs must deliver cash, otherwise they should be liquidated.
Question Marks (high growth, low market share): Question Marks have the worst cash characteristics of all, because they have high cash demands and generate low returns, because of their low market share. Either invest heavily, or sell off, or invest nothing and generate any cash that you can.

The BCG matrix has a number of advantages. It highlight, for example, that generic targets (in terms of growth, or return on capital), can be very misleading in a portfolio of business units. The matrix was developed in the context of an overall understanding of product life cycles: A new business may start as a small star, will grow over time, becomes one of the cash cows of the company, and may end up as a dog towards the end of its life cycle. But the concept also has a number of limitations:
It neglects the effects of synergy between business units.
High market share is not the only success factor, and doesn’t necessarily always lead to high profitability.
Market growth is not the only indicator for attractiveness of a market.
Sometimes Dogs can earn even more cash as Cash Cows.
There are also basic problems in terms of defining what is a “market,” getting the right data on market share and growth, etc.

But overall, it’s definitely a good model to know and keep in the back of your mind.

FirstWord Lists: The drugs that will shape 2016

The recent launches

Opdivo – Bristol-Myers Squibb

A recent analysis of Big Pharma growth rates over the next decade by analysts at Bernstein highlights the importance of Opdivo to Bristol-Myers Squibb's long-term performance. The PD-1 inhibitor is already approved for melanoma and second-line non-small-cell lung cancer. Pivotal data in the much larger first-line NSCLC market is due to be unveiled later this year. Merck & Co. hopes to present similar data for its competing therapy Keytruda by the end of 2016.

Entresto – Novartis

A 2015 approval, Novartis' heart failure treatment Entresto will be one of the most scrutinised in terms of uptake over the course of the next 12 months. Management has sought to lower expectation, particularly in the US market, but a stronger trajectory will be expected in the second half of 2016 as reimbursement hurdles are overcome. With a lack of competition on the horizon, peak annual sales could exceed $10 billion, suggest analysts.

Darzalex – Johnson & Johnson

When Johnson & Johnson releases its 2015 full-year results next week, a familiar narrative will likely emerge; which pipeline therapies will replicate the considerable success enjoyed in terms of new product launches over the past 6 years? The answer is possibly already on the market: Darzalex, approved in late 2015 for the treatment of late-stage multiple myeloma, has key opinion leaders very excited (ViewPoints: Johnson & Johnson's Darzalex tops ASH winners list). Genmab – which discovered the antibody – has likened Johnson & Johnson's study programme to a military campaign in its breath of coverage. Commercial uptake and progress on line extensions will be watched closely by investors.

Repatha/Praluent – Amgen/Regeneron & Sanofi

Approved by the FDA last year for the treatment of primary hyperlipidaemia and homozygous familial hypercholesterolaemia, uptake of the PCSK9 inhibitors Repatha (Amgen) and Praluent (Regeneron Pharmaceuticals/Sanofi) will be watched with much interest over the coming months. More significant will be cardiovascular outcomes data, which Amgen expects to publish later this year. If the results are positive, the sales trajectory of both products is likely to improve considerably (Physician Views Poll Results: Taking an early look at the competing anti-PCSK9 mAb launches). Will Pfizer file its competing PCSK-9 inhibitor bococizumab this year? Their outcomes data is due to be announced in 2018.

The new approvals

Ocrelizumab – Roche

Due to be filed with regulators imminently, analysts are confident that Roche's ocrelizumab will be approved – by the FDA at least – by the end of 2016. Critically, the drug looks odds on to secure approval for both relapsing remitting and primary progressive forms of multiple sclerosis; in the case of the latter indication, it will be the first therapy to do so. (Physician Views Poll Results – Roche's ocrelizumab will compete with oral multiple sclerosis therapies, say neurologists). Biogen will present Phase II data this year for anti-Lingo; expectations have fallen, but the remyelination therapy could be transformative; both for Biogen and in how MS is treated.

Venetoclax – AbbVie/Roche
Earlier this month, AbbVie and Roche confirmed the FDA has granted priority review status to venetoclax as a secondary therapy for lymphocytic leukaemia, which suggests US approval will occur this year. For AbbVie in particular, venetoclax appears key to the company's commercial aspirations in the leukaemia market, primarily through combination usage with Imbruvica. Key opinion leaders think the drug can be a game changer.

grazoprevir/elbasvir – Merck & Co.

Despite dominance of the hepatitis C market by Gilead Sciences' Sovaldi and Harvoni mega-brands, key opinion leaders and analysts are enthused about the opportunity for Merck & Co.'s combination of grazoprevir and elbasvir, in terms of impressive efficacy in niche populations such as patients with chronic kidney disease, those co-infected with HIV and intravenous drug users. Physicians also view launch of this combination – which is expected to gain FDA approval by the end of January – as potentially improving access and reducing the cost of therapy, if Merck chooses to price at a sufficient enough discount versus AbbVie's Viekira Pak franchise (JP Morgan 2016: Gilead exudes confidence on the eve of Merck & Co.'s HCV landfall).

Baricitinib – Eli Lilly & Incyte

Can Eli Lilly's revival continue and what role will the JAK inhibitor baricitinib play? The oral therapy was submitted to the FDA last week for the treatment of moderately to severely active rheumatoid arthritis, which should see approval secured by late 2016. Baricitinib enters the regulatory arena backed with a comprehensive Phase III data set; most significantly it has bettered current standard of care Humira (AbbVie) in head to-head studies (Physician Views: Now filed with the FDA, how do rheumatologists assess the opportunity for baricitinib?)

The pipeline candidates

atezolizumab - Roche

Can Roche successfully deliver the third PD-(L)1 inhibitor to market (after Merck's Keytruda and Bristol-Myers Squibb's Opdivo). Regulatory filings in second-line bladder cancer and second-line non-small cell lung cancer in early 2016. Analysts remain confident that Phase II data will be sufficient to secure approval in the lung cancer setting, but it remains to be seen if atezolizumab can gain share at the expense of the two earlier launches. Roche's combination studies with chemotherapy in first-line patients continue to intrigue.

Dupilumab – Regeneron & Sanofi

Phase III data for Sanofi and Regeneron's dupilumab in atopic dermatitis is expected in the very near future. Speaking at the JP Morgan Healthcare conference earlier this month, Regeneron CEO Leonard Schleifer has high hopes for dupilumab across a range of allergic conditions, where he believes the antibody could be "transformative." (JP Morgan 2016: Regeneron putting its money where its mouth is on dupilumab).

Solanezumab – Eli Lilly

Can Eli Lilly's experimental Alzheimer's disease treatment solanezumab deliver a definitively positive outcome in Phase III studies at the second time of asking? Many are doubtful, but investors are hopeful; approvable-data would be transformational for the company. In the Alzheimer's disease development space, also watch for progress with the BACE inhibitors; Merck & Co. is leading the race with AstraZeneca/Eli Lilly not far behind.

CAR-T therapies – Novartis, Juno Therapeutics, Kite Pharmaceuticals
Focus around CAR-T therapies will shift in part this year from the clinical to regulatory arena. Novartis is awaiting pivotal data in paediatric relapsing, remitting acute lymphoblastic leukaemia with a US filing anticipated in late 2016. Juno Therapeutics is on track to submit its CAR-T treatment JCAR15 for adult ALL by year end, with Kite hopeful of filing KTE-C19 in diffuse large B-cell lymphoma in 2016 also.

ITCA-650 – Intarcia

Speaking to FirstWord earlier this month, Intarcia CEO Kurt Graves confirmed the company's diabetes treatment ITCA-650 will be filed in mid-2016. ITCA-650 is a small implantable device which delivers regular dosing of the GLP-1 agonist exenatide over a six or 12 month period. Graves outlined Intarcia's commercial strategy to FirstWord last year; understandably it will be built around the theme of improved compliance

The biosimilars battleground

Benepali – Samsung Bioepis

Approved in the EU last week, Biogen expects to launch Benepali – a biosimilar version of Amgen and Pfizer's Enbrel – over the coming weeks. Benepali represents the second complex biosimilar to be approved in Europe and a first for both Biogen and partner Samsung in this segment. The Korean technology player has delivered on bullish promises; Benepali has moved from non-clinical development to approval in four years (Physician Views: How will rheumatologists use Biogen and Samsung's biosimilar Enbrel product?).

Remsima – Celltrion & Pfizer

Will Celltrion's Remsima – a version of Johnson & Johnson/Merck & Co.'s Remicade – become the first biosimilar monoclonal antibody to gain US approval later this year? A re-scheduled AdCom meeting on February 9 (a March 2015 meeting was postponed for undisclosed reason) will provide a clearer indication. Pfizer will market Remsima in the US, having acquired Celltrion's existing partner Hospira last year.

Humira – AbbVie

The TNF inhibitor is the world's best-selling drug, with 2015 sales forecast to reach around $14 billion. AbbVie believes that patent exclusivity will hold until 2022, but is yet to fully convince Wall Street. Focus in 2016 will remain sharpened on this narrative as the biosimilar market continues to evolve and AbbVie's patent estate comes under further scrutiny. Recent events are in the company's favour.