Pharmaceutical outsourcing has emerged as a robust—and rapidly growing—subsector of the life sciences industry. As the push for efficiency continues, more pharmaceutical, biotech and medtech companies are turning to contract research organizations (CROs), contract development organizations, medical affairs outsourcing and other service providers for help bringing products to market, manufacturing and distributing products, and improving quality. This trend is creating exciting new opportunities for investors in this burgeoning space.

Several factors are driving this growth in pharmaceutical services outsourcing:

  • Pharma companies are becoming more comfortable with outsourcing. Of outsourced service providers, CROs have the highest penetration, with approximately 50 percent of clinical trials outsourced. Other areas of outsourcing are far less penetrated, however, offering ample opportunity for investment. Consider researching opportunities in health economics or outcomes research market access, for example.
  • The current health care/pharma environment is rich for pharma outsourcing. Biotech is thriving: capital is readily available, and the US Food and Drug Administration regulatory environment for approval of new products is favorable. On the pharmaceutical front, ongoing consolidation has fostered an efficiency mindset. And across the health care and life sciences space, big data is being harnessed in new ways that make outsourcing easier and more efficient than ever.
  • We are in a period of great market fragmentation. The market is starting to skew toward earlier stage rather than big pharma companies. Trials also are increasingly designed with an emphasis on subpopulations and advanced analytics (such as specialty drugs targeted to specific genotypes). Traditional pharma often lacks the specialized skillset to design trials with this level of specificity and therefore can greatly benefit from an outsourcing partner.
  • The number of small pharma and biotech companies has surged over the last decade. Many of these companies have limited resources and staffing, and therefore must outsource tasks such as clinical trials, production of clinical lots and, ultimately, commercial services. In turn, outsourcing companies have developed and expanded their range of service offerings to cater to the specific needs of these smaller pharma/biotech companies.
  • Specialty drugs and personalized medicine have proliferated, and they require extra messaging to encourage patient compliance. For a specialty drug that is very personal to the patient, and very expensive to develop, there is a huge incentive for drug companies to motivate that patient to continue taking the drug as instructed. Outsourcing companies can fill the communications gap by offering payment services, adherence messaging and coaching. Biotechs—which are leading innovation in the area of personalized medicine more than big pharma—also need to run lean and efficiently, since the cost of these drugs is so high. Outsourcing companies can tackle real world data analytics to demonstrate effectiveness and help secure reimbursement.

When evaluating a potential investment in a pharmaceutical outsourcing company, investors should consider the following key points:

  • The company’s team and executive leadership. The CRO space in particular features unique staffing prerequisites: a combination of deep knowledge of the science (to be able to engage with biotech and pharma executives) and keen operations sensibilities (to ensure processes run smoothly and margin is maximized). There is a limited candidate pool with this particular skillset, so it is important that the target organization have adequate measures in place to incentivize and retain key talent in a competitive labor market.
  • Regulatory diligence. How does the outsourcing company manage regulatory oversight and compliance? Do they collect and manage data properly? How do they remediate adverse events?
  • Underlying customer base and pipeline. Look for organizations that have a solid portfolio of existing customers and pipeline of new potential customers or products to work with. The underlying customer base of an outsourcing provider impacts its ability to collect on high-margin products and build value, Successful outsourcing organizations are forward-thinking and have a thorough understanding of their market and their customer’s products, and therefore make attractive targets for investment.

Save the Date! McDermott’s 2019 Life Sciences Dealmaking Symposium & Venture Capital Investing Bootcamp will be held October 15-16 in Cambridge, MA. Click here for details.

Kate McDonald
Partner
Office: Washington, DC
Years at Firm: 6

What is your favorite part about practicing health care law at McDermott? 

The health care regulatory work we do is cutting edge. From the largest health care companies to the smallest start-ups, our clients tend to be highly sophisticated and they come to us with high stakes questions that have no easy answers. We help clients navigate a complex web of health care regulations to implement innovative business models or bend the cost curve. The work I do is intellectually challenging and I love partnering with my crazy smart colleagues to solve problems. This is what keeps me coming back to work day after day.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today? 

There is so much innovation occurring in the health care market today, and in particular in the managed care industry. Health insurers are partnering with an increasingly diverse set of business partners in an effort to provide higher quality care more efficiently, while actually keeping people healthier and improving their experience in the health care system – both of which inure to the benefit of both health insurers and consumers. While health care payors are at a critical intersection and have a unique opportunity to influence changes in the system, figuring out the best way to do that is also the greatest challenge for these companies. Health care is really complex – there is no magic bullet or easy solution, but I am optimistic that some of the innovations that shake out of this transformative time will have lasting and beneficial impacts.

Continue Reading Five Questions with a Health Lawyer: Kate McDonald

Mara McDermott
Vice President, McDermott+Consulting
Focus Area: Policy, Lobbying and Advocacy Strategies
Years at McDermott+Consulting: 1

What is your favorite part about your health policy work at McDermott+Consulting? 

My favorite part about working at McDermott+Consulting is the entrepreneurial spirit of the firm. Since arriving at the firm a year ago we have tested and implemented so many new ideas to better serve our clients at an incredibly fast pace. We have established a weekly Check Up article series to provide health policy updates from Washington, DC, started our Policy Breakfast Series for clients and built a new advocacy coalition to influence policy in Washington, DC, just to name a few. The firm is constantly encouraging and embracing innovation to improve client service.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today? 

I help clients engage with Congress and the Administration on health care policy issues pertaining to provider payment. Right now, we see a lot of opportunity in the physician payment space, working with this Administration to define the next steps in the movement from volume to value. This includes opportunities around new delivery models, such as Direct Contracting and Primary Care First, recently announced Administrative initiatives.

The greatest challenge has been the pace of significant changes in the regulatory and policy space. The Administration and Congress have both been busy on a host of proposals that have the potential to significantly disrupt the health care industry. From surprise billing proposals on Capitol Hill to the Medicare Part D rebate rule, keeping up with those changes and engaging to influence their future has been a challenge we have eagerly embraced on behalf of our clients.

Continue Reading Five Questions with a Health Policy Specialist: Mara McDermott of McDermott+Consulting

The life sciences marketplace has been ripe for collaboration for the past decade, but new players, new technologies and new regulations are changing the space. Traditional life sciences companies are working together in new and exciting ways, bringing a variety of deal structures and new complexities into the landscape. Our Collaborative Transformation podcast episode “Driving the Deal: Life Sciences Partnership Opportunities, Pitfalls and Impact” with Emmanuelle Trombe and Gary Howes explores these issues in depth. Below are key takeaways from the episode, which you can listen to in full here.

It’s not just new players changing the space—it’s new approaches by traditional players. “It’s not only about pharma and biotech,” Trombe said. “We are seeing collaboration with health care players such as payers, insurers and providers.” Technology companies are also entering the space, bringing financial and philanthropic investments to the table. “People are still trying to do the same things, but they’re getting there in slightly different ways,” Howes said. Collaborations are also shifting from exclusive collaborations to more open collaborations, where partners are more closely involved in the product lifecycle, co-developing products and sharing technology, data and profits.

Bridging the gap between different industry cultures is crucial to building a successful collaboration. Product lifecycles and regulatory regimes vary across industries, but the gap between technology and health care/life sciences is particularly broad. “Life sciences health care companies looking at a lifecycle for their product is something like 20-odd years. That’s not the model that pure tech companies are used to,” Howes said. “There has to be some sort of realignment, so that both parties on either side of the collaboration understand each other’s business enough to make them a success.”

Data drives efficiency and efficacy in treatments, but the regulatory environment continues to present challenges to using it. Data collection is restricted in most countries, particularly for pharmaceutical companies and insurers, which makes it challenging to structure deals around data. Data regulations such as GDPR “could be a hurdle for the development of digital therapeutics, because they limit the ability to use the data collected in a meaningful fashion,” Trombe said. Overcoming these hurdles will be crucial to unlocking the potential solutions in medical data. Continue Reading Collaborative Transformation: Life Sciences Partnerships – Delivering Deals that Work

Megan Rooney
Partner
Office: Chicago
Years at Firm: 13

What is your favorite part about practicing health care law at McDermott? 

The team, the team, the team! It’s a pleasure to work with colleagues who have deep substantive expertise, prioritize client service, and are good human beings. As a healthcare M&A attorney, I am responsible for leading large teams of attorneys, including a variety of subspecialists, to drive efficient and effective outcomes and achieve business goals. I love knowing that, in nearly every instance, when an issue arises we have the specific expertise to handle it and there is no need to reinvent the wheel.

What is the biggest opportunity facing clients in your area of focus today? 

Our hospital and health system clients have a tremendous opportunity to improve the delivery of patient care, expand services provided to their communities and defend against the challenge of declining reimbursement through strategic partnerships. In addition to traditional hospital and health system M&A, our hospital and health system clients are increasingly pursuing Collaborative Transformations – that is, partnerships with non-traditional health care players. A successful Collaborative Transformation takes cultural integration between non-traditional partners, incorporating new technologies into health care regulatory compliance structures, and so much more.

Continue Reading Five Questions with a Health Lawyer: Megan Rooney

We are pleased to share that Chambers USA has once again named McDermott Health the only firm to receive a Band 1 national ranking in health care. This year’s Band 1 placement marks 10 consecutive years of securing a top national ranking in this prestigious law firm directory, and the ninth year that we have held this position exclusively. The Health team also garnered Band 1 state-level rankings in California, Florida, Illinois, Massachusetts and Washington, DC—cities and states where we have substantial health law teams—and 29 McDermott health lawyers were ranked individually.

Click here to view the full announcement. 

Don’t miss out! Register today for the 2019 Physician Practice Management & ASC Symposium, May 7-8, Nashville, TN

Private equity continues to fuel robust activity in the physician practice management (PPM) sector. Within the last five to seven years, not only have PPMs within traditional areas of medicine proliferated, but new specialties also have been joining the fray at a rapid clip.

While today’s PPM activity is vigorous, it is markedly more deliberate than the first iteration of these partnerships, which featured a rush of M&A activity but little income repair or ongoing integration, and ended with the dramatic collapse of the single-specialty PPM bubble in the late 1990s.

To ensure that a PPM is viable in today’s environment, consider the following strategies:

  • Pick the right investment targets. Hallmarks of a sustainable health care business include improved outcomes over time and enhanced patient experiences (e.g., access to clinicians, ease of scheduling appointments).
  • Focus on compliance. Take a close look at compliance and utilization early in the deal process. While a compliance audit adds up-front cost, it is a fraction of the price of litigation.
  • Integrate. The 1990s PPM model left physician practices largely independent, with only a loose affiliation under a management agreement. Thorough and carefully planned integration will help you avoid repeating the mistakes of the past.
  • Align your interests. Make sure that compensation and equity are calibrated to incentivize buy-in and a culture of ownership. Strong physician leadership is far more effective in driving care improvement than direction from non-MD executives.
  • Add value. The partnership should be laser-focused on making clinicians’ lives easier. Human capital is the most valuable element of a PPM, so keeping physicians satisfied and energized is a key factor for success.

Today’s PPM sector offers ample opportunities for fruitful investments. With a strategic plan in place, you can set your PPM on the right track for long-term success.

At the 2019 Physician Practice Management & ASC Symposium, taking place in Nashville, TN, on May 7–8, we’ll be convening PPM and ASC leaders from around the country to address the changing environments and strategic and legal imperatives for growth and investment success in 2019.

2019 Physician Practice Management & ASC Symposium
May 7-8, 2019
Nashville, TN
REGISTER NOW

 

Amanda Enyeart
Partner
Office: Chicago
Years at Firm: 4

What is your favorite part about practicing health care law at McDermott? 

Definitely our people. I love the depth and breadth of expertise among my colleagues. We have highly experienced lawyers in just about every health care niche you can think of and this allows us to take on client work with confidence. On top of that, we have lawyers who are gifted strategists who can take a holistic and critical look at an issue from a broad perspective. I am constantly learning from my colleagues.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today? 

Our clients have the potential to transform health care delivery and improve quality of care.  We see forces aligning such as changes in payment models to reward value rather than volume and the integration of advanced technology in health care settings to support health care diagnosis and decision making that could actually result in improved health outcomes for many people.  Sometimes it seems like all you hear is a lot of hype and speculation – but we get to see through our interactions with clients that some things are really changing.

The flip side is that biggest challenge to this innovation is regulatory compliance that has not kept pace with the changes in health care. There is a real struggle for resources in health care and setting up systems to minimize regulatory risk can consume resources in a way that can be perceived as stifling to innovation or disproportionate to the benefit.

What kind of client work gets you most excited when it comes across your desk?

I love getting a project that requires hunkering down and understanding a complex set of facts or concepts and then translating that understanding so that it can be understood by others.  This can occur in different contexts, such as drafting health care technology contracts or conducting and documenting regulatory analyses.  I also like working directly with clients to help them understand available options when trying to reach a goal. Whether it is conducting diligence on a potential investment or acquisition to assess regulatory risk or assisting an organization preparing to undertake a new project or technology, the real pleasure of this job is in helping the client come to the best decision with the facts and laws at hand.

What is the proudest moment of your career to date? 

My proudest moment was successfully helping a pro bono client convince a health care technology vendor to grant a concession in a contract that the client was terminating.  The monetary value of the concession was not very significant to the vendor, but it made a huge difference in the client’s small budget.

When working on a client matter, what does your ideal team look like?

The ideal composition of a team changes depending upon the nature of the work. Sometimes, a project needs several attorneys to work through a hefty set of diligence documents while other times, a project needs only a pair of specialists in different areas to talk through a client question.  Regardless of the composition of a team, the ability for members to communicate freely among themselves and to be consistently communicative with the client can make any team an ideal team to me.

Click here to learn more about Amanda’s practice.

McDermott Will & Emery continues to strengthen its position in Europe, securing an excellent set of results in the Chambers Europe rankings for 2019, which included 13 practice area rankings and a total of 25 individual lawyer recognitions across all of its offices.

Health care and life sciences-specific practice rankings include:

  • Germany: Healthcare (Band 1)
  • France: Pharma/Life Sciences (Band 3)
  • Germany: Life Sciences (Band 4)

Health care and life sciences-specific individual rankings include:

The announcement comes on the heels of an incredibly successful 2018, during which the Firm surpassed the $1 billion revenue mark for the first time in its 85-year history and delivered strong growth across Europe. McDermott doubled down on its commitment to exceptional client service with a number of key lateral hires and strategic growth in new markets and emerging industries.

McDermott received high praise across the board in Chambers Europe, with commentators stating that the Firm “[has] outstanding, profound knowledge of the law” with a “very commercial and solution-oriented” approach. The guide goes on describe McDermott’s lawyers as “highly responsive and insightful,” adding “the depth and breadth of the team is impressive and [they] consistently deliver the highest quality results.”

Click here to learn more about the Firm’s full list of Chambers Europe 2019 rankings.

Matt Friendly
Associate
Office: Miami
Years at Firm: 5

What is your favorite part about practicing health care law?

I appreciate that health care is constantly evolving and changing. While the vastness of the field can be intimidating for some, it provides career-making opportunities to gain experience in a sub-specialty and build a reputation within that space. I am also grateful for the heavy volume of deal activity in health care – with no signs of slowing down – which presents constant opportunities to learn, grow and support clients who are shaping the health care landscape.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today? 

The greatest opportunity for many of our clients is selling their business or portfolio company at a time when the market is ripe for health care acquisitions, with valuations trending upwards and buyers with tremendous amounts of capital to deploy. This dealmaking climate presents a challenge for our clients who must determine how to make smart health care investments and navigate a complex regulatory framework once they own the company. That’s where McDermott comes in – our team is experienced in getting deals done and providing creative, business-focused solutions at every stage of the transaction process.

Who is your favorite health care leader or influencer to read, watch or follow and why?

Physical health and mental health are key components of health care. There is currently a lot of attention on physical and mental wellbeing in law firms and I try to prioritize both to perform at my best in both law and life. On the physical health side is David Goggins, a retired Navy SEAL and current ultra-endurance athlete, whose videos and talks inspired me to get in shape and start training during law school. On the mental health side, I strongly recommend Sam Harris‘ meditation app “Waking Up,” which has become the most valuable 10-15 minutes of my day.

What is the proudest moment of your career to date? 

I remember the joy I felt getting an offer to be a summer associate at McDermott in 2012 and I maintain that sense of immense pride every day that I get to practice here as a member of an industry-leading health care team. As for individual moments, I feel proudest every year when I receive positive feedback from clients and guests that attend our Health Care Services Private Equity Symposium (HPE) in Miami, an event that I have helped organize since starting at McDermott and which has grown every year. It felt incredibly gratifying to hear one of our biggest clients say at this year’s event that HPE and the JPMorgan Health Care Conference have become the two highlights of their networking calendars.

Do you have any volunteer or pro bono work you focus on?

My pro bono work focuses on helping students and young people navigate education and challenges they may be facing in their lives. I lead our Miami office’s efforts with an after-school program called “All-Aboard” at Comstock Elementary School in Allapattah, Florida, where we organize and volunteer at events for the students. Recent events have included a back-to-school supply drive, a Halloween party and a toy drive/holiday party. This past school year we also donated spare computers to create a “McDermott Computer Lab” at the school. I also volunteer with Lawyers for Children America, where I mentor my pro bono client, a 14 year old foster child, and help him navigate through the foster system. I thank McDermott for encouraging us to contribute to these efforts.

Click here to learn more about Matt’s practice.