Healthcare)Industry)Partners) · PDF fileJoseph)Jimenez,)CEO)Novar5s)(March)2015,)Nikkei)Asian)Review)) Q:$The) ... paent,while$simultaneouslypulling$uptheir$medicalhistory usingGoogle)

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Healthcare Industry Partners HGP Asia Knowledge Day 2015

Past and Future of Informa5on Management within the Healthcare Industry 27th November 2015 Thomas Halfmann

Building Castles in the Air

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Healthcare Industry Partners

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How informa5on in pharmaceu5cal companies was managed formerly

How informa5on in manufacturing is managed today

How digi5zing medicine will change the pharma industry

What does the industry need to prepare for “digital medicine”?

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How informa5on in pharmaceu5cal companies was managed formerly

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Manufacturing OperaCons Management History

•  Before 1980… -  PLC were developed in the 1960s, however they have been seen very rarely in pharmaceu5cal manufacturing before the 1980s

-  Analogue data acquisi5on and display was standard at the 5me

-  Data was recorded by operators (handwriWen) or assisted by data logger

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•  The 1980… -  Introducing Process Control Systems (PCS), mainly in API produc5on

-  Process automa5on with pre-‐configured recipes

-  Stand-‐alone systems

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•  The 1990… -  Digital processing and storage of process data -  Increasing foot print of PLCs and PCSs in manufacturing

- MRP systems are developing into ERP systems

-  Introduc5on of first MES, LIMS, …

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How informa5on in manufacturing is managed today

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Manufacturing OperaCons Management

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IM in the PharmaceuCcal Industry Today

•  Fully integrated informa5on management architecture

-  Focused on research, development, manufacturing, distribu5on, marke5ng of medicine

•  Data integra5on with business partners, mainly supply chain and clinical data

•  Limited system integra5on with pa5ents

•  Smart medical devices, however mostly stand-‐alone systems

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How digi5zing medicine will change the pharmaceu5cal industry

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DigiCzing Medicine… The Pharmaceu5cal Industry

Joseph Jimenez, CEO Novar5s (March 2015, Nikkei Asian Review)

Q: The Internet of Things is quite a hot topic across industries. How will it affect the pharmaceu5cal or health care industries?

A: I think it will have a huge effect. The reason for that is, you are already star5ng to see the digi5za5on of medicine. And I believe very strongly that there will be a 5me when technology comes together with biology to solve some of the biggest areas of medical need.

… The next area is around the shiding from a transac5onal approach to an outcomes-‐based approach. Transac5onal means, for example, just selling a pill. An outcome approach focuses on delivering a posiCve paCent outcome, of which that pill is one piece. A perfect example is what we would poten5ally do with our new heart-‐failure drug. By partnering with companies that could monitor some paCents remotely, we look for vital signs that would tell us whether they should go to the hospital. This is something that is star5ng already.

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DigiCzing Medicine… The Pharmaceu5cal Industry

Severin Schwan, CEO Roche (October 2015, Nikkei Asian Review) Q: Let's talk about how the Internet is affecCng the pharma industry.

A: I think it will get very important as we go forward. If you go today to your doctor for a medical checkup, the doctor pulls out a physical file out of the drawer. He takes notes, asks you some ques5ons, makes perhaps a blood-‐test, makes the diagnosis, gives you treatment, if necessary, and then the file goes back into the drawer. … Even though all the tools are available -‐ the Internet, clouds -‐ medical informaCon today is stored 99% in handwriPen notes which are in physical files. I have no doubt whatsoever that in the future the informaCon will be on a digital plaRorm. When it's digi5zed, you can do something with it. In par5cular, you can correlate that with certain treatment opCons. If you see that medicine is being used in clinical rou5ne very broadly, you can see in which groups the medicine works really well, for which pa5ents it doesn't work as well. Maybe [for some] pa5ent groups, [it will] have side effects which you didn't see in the clinical trials, and that informa5on is incredibly important for R&D because it can give you new hints...

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DigiCzing Medicine… The Technology Industry

Tim Cook, CEO Apple (10 November 2015, The Telegraph):

Cook hints that Apple may have more plans for the health sphere, in a revela5on which will intrigue Wall Street, but he doesn’t want the watch itself to become a regulated, government-‐licensed health product. “We don’t want to put the watch through the Food and Drug Administra5on (FDA) process. I wouldn’t mind puSng something adjacent to the watch through it, but not the watch, because it would hold us back from innova5ng too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it -‐-‐ maybe an app, maybe something else.”

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Real Life Examples Wearable Technology (like Google Glass)

Wearable technology is s5ll in its infancy but has already started to have widespread influence across many industries. Dr. Rafael Grossmann was the very first surgeon to use Google Glass or wearable technology in general while performing a surgery.

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He sees this new technology as allowing a doctor to someday interact with a paCent, while simultaneously pulling up their medical history using Google Glass. The surgery performed using Google Glass could serve as an example of real-‐5me educa5on for medical students and other professionals alike.

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Real Life Examples Electronic Aspirin

Electronic Aspirin is a medical technology that helps pa5ents relieve pain, such as chronic headaches, migraines or facial pain. In many cases, common aspirin tablets are ineffec5ve in trea5ng this pain, as there is no treatment found to be working against SPG (sphenopala)ne neural structure). Therefore an innova5ve technology known as Electronic Aspirin has been made to relieve pain.

The system involves the permanent implant of a nerve sCmulaCng technology. The pointed 5p of the implant connects with the SPG bundle and during the onset of a headache, the pa5ent is able to place the hand-‐held remote on the cheek of the implant. In this way the SPG nerve causing pain will become s5mulated by the signals emiWed by the device and block the pain-‐causing neurotransmiWers.

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Real Life Examples Google Lens

Time, March 2015

Google has been granted a patent for a contact lens with an embedded chip. The patent features a sensor in the lens. Google has previously said that it is partnering with the pharmaceuCcal company NovarCs to create a smart contact lens that could monitor blood sugar for people with diabetes.

Diabe5cs must currently prick their fingers throughout the day to measure blood sugar levels, but Google believes the contact lenses would be less invasive and allow people with diabetes to check glucose more oden and more easily.

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Real Life Examples Diges5ble Sensors

A diges5ble sensor is a sensor that transmits informaCon about a paCent to medical professionals.

Diges5ble sensors will monitor your bodily systems and wirelessly transmit what’s happening in your body to another device like your smartphone or computer for your own review or the review of your doctor. Latest innova5ons with diges5ble sensors don’t even require a baWery source since they solely rely on the human body as an energy.

Approved in 2011, diges5ble sensors will con5nue to provide healthcare professionals with more informaCon about the human body and how various treatment solu5ons affect each system of organs.

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Real Life Examples Diges5ble Sensors

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What does the industry need to prepare for “digital medicine”?

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Conclusions

•  For the next few years (or decades) we will experience the transformaCon of an enCre industry with huge impact on how we manage informa5on

•  We will face an overall increase of complexity in all areas of the pharmaceu5cal value chain

-  New business models due to personalized medicine

-  A new doctor-‐pa5ent rela5onship •  Digitally enabled healthcare is already available – however most pharmaceu5cal companies, but also regulators are not ready yet

•  Pharmaceu5cal companies transform into technology providers and technology providers enter the healthcare market with own products

•  Currently the opportuni5es that digi5zing medicine present, outweigh the risks – however we need to prepare ourselves

•  In future, pa5ent safety is not just a maWer of GXP compliance, but also of cyber security

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Contact

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Halfmann Goetsch Partner AG St. Alban-‐Vorstadt 94 CH-‐4052 Basel Switzerland +41 61 544 0000

[email protected] ww.hgp.ag

Thomas Halfmann – Partner E [email protected] T +41 61 544 00 01

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Documents

Healthcare)Industry)Partners) · PDF fileJoseph)Jimenez,)CEO)Novar5s)(March)2015,)Nikkei)Asian)Review)) Q:$The) ... paent,while$simultaneouslypulling$uptheir$medicalhistory usingGoogle)