It’s the industry disruptors, the unusual partnerships, and the cross-border and cross-sector relationships that are driving Collaborative Transformation in the health care and life sciences organizations. But a Collaborative Transformation takes more than signing paperwork and shaking hands. A successful Collaborative Transformation takes cultural integration between non-traditional partners, incorporating new technologies into health care regulatory compliance structures, and so much more. At McDermott, we’ve recently had the opportunity to help our clients pursue their own Collaborative Transformations, and are proud to showcase their achievements.

Innate Pharma Expands its Collaboration with AstraZeneca

McDermott Will & Emery advised Innate Pharma, a French oncology-focused biotech company, in signing a multi-term agreement with AstraZeneca and MedImmune – AstraZeneca’s global biologics research and development arm. This agreement broadens the existing collaboration, aimed at accelerating the development of an oncology portfolio of each of the parties and to provide patients with more rapid access to new therapeutic options. This extended collaboration will permit Innate Pharma to develop and commercially strengthen its investment ability to develop its immuno-oncology portfolio (IO) and its R&D platform. For its part, AstraZeneca will enrich its IO portfolio with new clinical and preclinical programs. For more information on this collaboration, click here.

CVS + Aetna

McDermott is one of the firms that has advised CVS Health in connection with its $69 billion purchase of Aetna. The transaction, one of this year’s largest M&A deals, is expected to transform the US health care sector. For more information on this collaboration, click here.

Continue Reading Pursuing Progress: Collaborative Transformation in Action

As the health care and life sciences fields experience ever-increasing levels of disruption, diverse entities across the industry are teaming up to embrace and foster innovation. These new pairings are shaping the future of health care, as organizations come together to tackle the industry’s most pressing issues with redoubled agility and pooled resources.

In an environment of change and uncertainty, this trend of Collaborative Transformation is yielding improved financial outcomes, increased operational efficiencies, and a fresh infusion of diverse talent and perspectives—all of which result in enhanced quality of care.

This is where the McDermott Health and Life Sciences team comes in. As a top-ranked US health law practice and a leader in life sciences with decades of experience advising the leading players in US and cross-border health and life sciences, we have the skill, market insight and ingenuity to partner with you wherever your innovation takes you. Whether you are forming innovative alliances across borders and industries, creating or implementing groundbreaking technologies and services, or restructuring investments to position your organization at the cutting edge of the market, our team can work alongside yours to achieve excellence.

Click here to learn more about McDermott Health, our recent work executing collaborative transformations on behalf of our clients and how we can help your organization form innovative business relationships.

It has now been one month since the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) sent its proposed information blocking rule to the Office of Management and Budget (OMB) for required review.

We expect OMB to approve the much-anticipated proposed rule and ONC to release it soon with the usual opportunity for public comment. While we wait, there are some things that health information technology developers, health information exchanges, health information networks and health care providers who may be subject to the information blocking prohibition and enforcement actions can do to prepare for the upcoming comment period. But before we get to comments, let’s remind ourselves about how we got to this point.

By way of background, Congress asked ONC to produce a report describing the extent of information blocking and a strategy to address it. ONC submitted that report to Congress in 2015 (the 2015 Report) noting, among other things, enforcement authority gaps and indicating that successful information blocking prevention strategies would likely require congressional intervention. In the 21st Century Cures Act, which became law in 2016, Congress granted the HHS Office of Inspector General investigative and enforcement authorities for prohibited information blocking conduct. The Cures Act defined information blocking as a practice that “except as required by law or specified by the Secretary…, is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information [(EHI)].” As part of the law, Congress tasked the Secretary of HHS with issuing rules that identify “reasonable and necessary activities” that will not be considered prohibited information blocking. This is one purpose of ONC’s proposed rule.

At this point, we do not know precisely what kinds of activities ONC will propose to permit by carving them out of the broad information blocking prohibition. However, from the Cures Act we do know the types of practices Congress believed “may” be information blocking, namely:

  • restricting authorized access, exchange and use of EHI for treatment and other permitted purposes, and
  • implementing technology in ways that are:
    • nonstandard and likely to substantially increase the burden or complexity of access, exchange and use of EHI;
    • likely to impede EHI with respect to exporting complete information sets and in transitioning between health IT systems; or
    • likely to lead to fraud, waste and abuse, or impede innovation and advancements in health information access, exchange or use.

These track closely to the types of practices ONC identified as raising information blocking concerns in the 2015 Report, which also provided a few illustrative examples, including: Continue Reading ONC Expected to Release Proposed Information Blocking Rule Soon

McDermott is gearing up for an exciting week of programming during the 2018 BIO International Convention. A number of McDermott partners will on the ground as panelists and moderators across a range of programs during BIO and we hope to see you there!

Thursday, May 31 | Al Sokol will moderate a panel discussion on “Getting and Leveraging Funding” at Mass Life Sciences Innovation Day.

Friday, June 1 | Dale Van Demark will co-moderate the panel “Digital Health – Hospital of the Future” during the IBA 6th Annual World Life Sciences Conference.

Saturday, June 2 | Emmanuelle Trombe will moderate the panel, “Biopharmaceutical Market: Collaboration vs. M&A,” and Al Sokol will be a speaker on the panel “Hot Topics in Venture Capital Investments,” during the IBA 6th Annual World Life Sciences Conference.

Sunday, June 3 | Emmanuel Trombe will moderate, and Veleka Peeples-Dyer will be on the panel, “What is Your Regulatory Strategy?” during the Boston-Paris Biotechnology Summit.

Monday, June 4 | Byron Kalogerou and Jennifer Bock will speak to business investors about the legal issues involved with establishing or expanding an operation in the United States during the SelectUSA FDI Seminar at BIO 2018.

Roger Kuan and Kristina Bieker-Brady will present “Operation Valuation: Maximizing the Value of your Asset Portfolio” during the Redefining Early Stage Investments (RESI) Conference.

Tuesday, June 5 | Sarah Hogan will moderate “Paths to Success in Life Sciences: A Conversation with Women Leaders,” a panel discussion with women executives from across the Life Sciences industry. The Women’s Executive Breakfast will be held at McDermott’s Boston office.

Wednesday, June 6 | Join us for “Connecting the Dots: A Cross-Border Mergers and Acquisitions Case Study, Linking Life Sciences Hubs in Europe, Asia and North America.” Our panel, led by Al Sokol, will connect the dots between the structuring and closing of a cross-border life sciences transaction, focusing on a hypothetical case study involving the auction of a US biotech company with platform technology. The panel will discuss the context, cross-border dynamics, practicalities, opportunities and challenges, underlying the growing volume of international life sciences transactions. Register here.

Immediately following, we hope you’ll join us for an evening of live music by Men In Black, fun in the sun, and networking with life sciences executives during the McDermott Beach Bash. RSVP here.

#BIO2018