Pharma consulting | 医療用医薬品コンサルティング・市場調査 | インフォーマ・ファーマインテリジェンス

Pharma consulting(ファーマコンサルティング)では、経験豊富なコンサルタントが弊社のデータベース群をフル活用し、かつ、外部の情報ソースも利用してお客様のニーズに合わせた個別の市場調査・分析を行います。

コンサルティングで下記のニーズにお応えします：

自社パイプラインの確率調整済みNPVはどれくらいか？
市場参入時の競合状況はどうなるか？
競争が激しい分野の情報をタイムリーに追跡＆視覚化するためにどうすればよい？
承認を受けるための最良の臨床開発経路はどのようなものか？
より高い償還価格を実現するには、どのような治験のエンドポイントが役立つか？
ある製品にとって最良の臨床試験実施機関をどのように選ぶべきか？
臨床試験のための被験者募集に関する実現可能性とタイムラインはどの程度か？
開発中製品の上市までの時間、成功確率、商業的価値のバランスをどうとるか？

Pharma consultingご利用のメリットを1分間の動画にまとめました。ぜひご覧下さい。

インフォーマセミナー講演動画
Pharma consultingのシニアディレクター・Timothy Pangが、Pharma consultingサービスのケーススタディを交えて講演を行いました。
1. Bringing data alive: Consulting Case Studies(2018年2月／東京)
2. New horizons, fresh opportunities: Tech, Big Data, and the next pharma wave(2017年11月／東京)

Consulting enquiry

Medtech Insight: 世界の医療機器・医療技術の最新情報

Start Up Spotlight on New Kidney Technology

07 Oct 2019

On the heels of the July 2019 US presidential executive order to advance kidney health, companies like Paragonix have unveiled new technologies aimed at doing just that. Medtech Insight takes you inside what the company has in store.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Hemodialysis Home Care; Review of the Presidential Executive Order

07 Oct 2019

Since a presidential executive order to advance kidney health was signed in July of 2019, Medtech Insight has been tracking the subsequent developments in US kidney healthcare, noting an uptick in hemodialysis interest and new payment models around renal disease.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Compliance Corner: 2 FDA Compliance Branch Heads Talk Regulatory Meetings – And What You Can Expect

23 Aug 2019

US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Updates On The European Commission’s Medtech Agenda And Deadlines For The Rest Of 2019

23 Aug 2019

The European Commission updates its rolling plan on progress with key document and structures toward implementation of the new medtech regulations every few months. What is new and what is still to come this year?

Medtech Insight: 世界の医療機器・医療技術の最新情報

Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities

By Shawn M. Schmitt 14 Aug 2019

Phil Pontikos, who is also the US agency's national device expert, explains how device-makers can avoid running afoul of the FDA's rules and expectations for sterilization activities.

Medtech Insight: 世界の医療機器・医療技術の最新情報

CMS Weighs Merits Of New Pass-Through Payments For Aquabeam System, Eluvia Stents In OPPS Proposal

14 Aug 2019

The US Medicare agency has been scrutinizing two new devices that have generated some buzz within the industry for pass-through payment status under its proposed 2020 Outpatient Prospective Payment System (OPPS) rules. The devices are Procept BioRobotic’s AquaBeam System for removal of prostate tissue in men with urinary tract symptoms, and Boston Scientific’s Eluvia drug-eluting stent for treatment of peripheral artery disease.

Medtech Insight: 世界の医療機器・医療技術の最新情報

US and EU Guidance Report

06 Aug 2019

US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Exact Sciences Buys Genomic Health In $2.8Bn Expansion Deal

06 Aug 2019

Cancer diagnostics company Exact Sciences is combining with Genomic Health in a major merger valued at $2.8bn. The combined company will offer two of the fastest growing brands in cancer diagnostics, Cologuard and Oncotype DX.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Siemens Cybersecurity Expert Says Medtech Industry Has 'Perverse Incentive' To Not Disclose Vulnerabilities – Might A New Law Be The Fix?

26 Jul 2019

The fear of losing business by being transparent about cybersecurity vulnerabilities means there's "a perverse incentive in some parts of the market that encourages a lack of disclosure," Siemens' Harrison Wadsworth says. But the US FDA's Suzanne Schwartz believes coordinated vulnerability disclosure legislation could "level the playing field."

Medtech Insight: 世界の医療機器・医療技術の最新情報

One Small Step For US FDA, But Maybe A Giant Leap For SaMDs

By ferdous-al-faruque 26 Jul 2019

In a midyear update from the FDA, regulators say a retrospective review of companies in its pre-cert pilot program has concluded that evaluating a company for excellence markers could be sufficient to let Software as a Medical Device (SaMD) onto the market. However, at least one critic says the update doesn’t answer some of the most critical questions about whether the program meets the agency's own requirements and if it creates unfair advantages for certain companies.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Innovator Spotlight: Innovation Through Partnerships Is In Omron Healthcare's Blood

12 Jul 2019

This year, Omron Healthcare launched its new HeartGuide smartwatch and the first FDA-cleared blood pressure monitor with EKG capability. Medtech Insight sat down with Omron's CEO Ranndy Kellogg to learn about upcoming plans.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Catching Fire: FDA's Manufacturing Maturity Program For Devices Spreading Internationally – And To Drug Facilities

12 Jul 2019

The US agency's Case for Quality Voluntary Improvement Program – used to measure a device-maker's manufacturing maturity and quality – has surprisingly been used to assess some pharmaceutical facilities. Meanwhile, regulators from other countries have been reaching out informally to the FDA to learn more about CFQ VIP.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Spanish Medtech Gets Ad Approval Stamp Looks To Rekindle Purchasing

By Bernard Murphy 05 Jul 2019

Enhancing trust in medical devices and medtech companies is the aim of a new agreement between the Spanish medtech industry and an organization specializing in helping businesses meet and maintain high legal and ethical standards.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Two More Notified Bodies About To Be Designated And Surge In Publications Of New Documents

By Amanda Maxwell 05 Jul 2019

The European Commission came under a great deal of pressure in June to deliver the fundamental structures and documents needed for implementing the EU’s new medtech regulations. It has hit the ground running so far this month.

Medtech Insight: 世界の医療機器・医療技術の最新情報

UK To Demand 'Responsible Person' Be Physically Located In Country Under No-Deal Brexit

03 Jul 2019

The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.

Pharma consulting: 医療用医薬品のコンサルティング

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Timothy Pang

Consultant, Senior Director- Pharma consulting

Richard Veal

Practice Lead, Global Director, Head of Pharma Consulting

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