Seven associates from Goodwin share their views on what it takes to become a successful life sciences lawyer.
Chambers Associate: Which practice areas fall within the life sciences sector?
Stephanie Dusaban Gonzales, associate: One of the great things about Goodwin, is that we have a large and diverse practice. This includes general corporate to licensing and collaborations as well as more specialized groups such as regulatory, intellectual property, and tax. Overall, our life sciences sector encompasses a comprehensive number of practice areas to help our clients in their wide range of legal needs throughout their corporate lifecycle.
Daniel Hughes, associate: Life Sciences covers many types of practice areas within the industry (i.e. pharmaceutical, biotech, medical devices, medtech, healthcare services etc.) and within the legal practice (i.e. general corporate, M&A, venture capital, regulatory, privacy, intellectual property, etc.).
Heath Ingram, associate: There are number of practice areas that fall within the life sciences sector including, but not limited to Healthcare, FDA, IP, Licensing, Capital Markets, M&A, Corporate Governance, etc.
CA: Does Goodwin have a particular specialty in any of these?
Elizabeth Mulkey, associate: Absolutely. Goodwin’s life sciences team works cross-functionally to serve clients from early development of drugs, biologics, and medical devices through commercialization of approved products. As part of the life sciences regulatory team, I often work closely with colleagues on our corporate, healthcare regulatory, intellectual property, and privacy teams to help clients find creative solutions to issues that arise during product development. Goodwin’s comprehensive focus on the life sciences industry makes us uniquely suited to understanding the challenges our clients face.
Paresh Kumar, associate: Goodwin has deep expertise in the life sciences sector, which cuts across multiple legal practices and geographies. Given this expertise, Goodwin’s life science team has seen and navigated clients through a variety of complex issues. There is very little that our team has not seen before. Additionally, Goodwin’s life science team stays on top of current issues in an ever-evolving legal landscape.
Amarilice Young, associate: Absolutely, as a “life cycle” firm, Goodwin is distinct in that it is able to expertly advise early-stage companies (sometimes it is just one scientist in a basement!) all the way to “it” players in the industry with thousands of employees and a multi-national presence.
SDG: Goodwin has specialty in all areas of law to address the varied needs of our life sciences clients. We have legal experts in general corporate, licensing and collaborations, regulatory, intellectual property, and tax. We also have technical specialists in these particular areas, many of whom have advanced scientific degrees. Accordingly, Goodwin is able to serve our clients seamlessly to provide comprehensive advice to our clients.
DH: Goodwin has a broad and diverse team of lawyers devoted to the life sciences sector. This includes specialists spanning corporate, intellectual property, licensing, and regulatory practices who work collaboratively to provide comprehensive advice to life science companies.
HI: I am particular proud of Goodwin’s healthcare practice and the drug pricing expertise we have here.
CA: What do you enjoy least and most about your work?
PK: I most enjoy working with my impressive colleagues and having access to their wisdom and experience. Personally, I enjoy learning about and transacting innovative scientific technologies. It’s truly a privilege to have a practice that sits at the intersection of science, business, and law, especially within Goodwin’s life science business unit. On the flip side, sometimes it can be challenging managing high demand for our legal services.
AY: One of the best parts of being a corporate associate in the life sciences group is that every day is different! In a single day I might help a founder on a thorny question about how her founder shares vest, draft a letter of intent for a client to acquire a new business, remind a company that its charter prohibits it from its proposed course of action (and research alternatives), tackle a dispute about participation in a Board meeting, collaborate with specialists about a tricky tax concern and coach a junior associate to lead their first call about a set of disclosure schedules.
One of the most challenging aspects of my job is helping my clients navigate issues that are fundamentally both “legal” and “business” in nature. For example, putting myself in my client’s shoes so that I can arm them all the information they need to assess their appetite for risk (whether in a multi-million dollar merger agreement or a small vendor dispute) is one of the hardest (and most rewarding!) parts of the job.
EM: I enjoy the variety of projects I get the chance to work on every day. In one day, I may review regulatory correspondence to advise a client on their corporate disclosure, counsel a client on how to manage issues that have come to their attention as part of a clinical trial, and advise on potential regulatory pathways for a product a client is developing. I typically work with multiple clients each day, rather than spending my day on one or two matters. The clients I work with are, across the board, sophisticated and knowledgeable professionals who are dedicated to finding cures for patients, and I feel privileged to get to be part of their work. Sometimes our role as outside counsel involves managing crises or urgent issues, so there can be an element of unpredictability (but I think that’s part of what makes our job so interesting!)
SDG: There are two aspects I enjoy the most about work: the strategy and the people. As a patent attorney, I love working with clients on the cutting edge of science and leveraging my scientific background to help provide strategy advice. This is for clients in terms of their patent portfolio and informing their overall business strategy. I also love Goodwin’s collaborative environment and the people. I work with our legal experts in other practice areas to provide comprehensive legal advice to our clients. And while I enjoy the fast paced nature of the job, it can be stressful at times. Mostly because we want to make sure that we get it right for our clients and help them protect and meet the important deadlines to protect their valuable IP assets.
DH: I enjoy working directly with clients to advise them on how they can achieve their business goals. It is very rewarding to be able to help a client throughout its lifecycle. A significant number of times we are there when the company is formed and just an idea, all the way through to its successful IPO, sale or other successful exit event.
HI: I love helping life science and medical device companies develop their commercialization strategies as they look post-FDA approval. In particular, I enjoy helping life science companies set the price of their products, build out patient assistance programs, negotiate agreements with various entities in the supply chain, and help strategize for long term commercial success. I do not enjoy navigating the endless public policy fights and misinformation around the source of high drug prices.
CA: What are the differences between noncontentious and litigious life sciences work?
PK: I started out as a junior associate doing life science IP litigation and then transitioned to IP transactional practice. Based on my personal experience, litigation tends to have a more predictable work schedule and the day-to-day is more structured; whereas, transactional practice is less predictable and unstructured, with an increased emphasis on moving as quickly as possible. There are times where negotiations can become contentious. Also, writing motions, briefs, discovery requests and subpoenas is a different skill set than writing contracts or patents. I would encourage junior associates to pick whatever feels most intuitive to them.
EM: As a regulatory attorney, I am more frequently advising clients on non-litigious workstreams. To the extent there is another party involved, we are typically working toward a common goal, such as initiating a clinical trial evaluating multiple product candidates as part of a collaboration.
SDG: I consider noncontentious life sciences work more synonymous with transactional work. For example, trying to find a resolution whether it be terms of a license agreement or working with the patent office to get a patent allowed. This is different than litigious life sciences work where there are two opposing sides that are not aligned in the outcomes.
DH: The corporate side is mostly noncontentious and collaborative, except for negotiating terms in agreements.
HI: Litigation in the life sciences space can manifest in many different ways. One way contentious litigation plays out for me in life sciences work is in the 340B Drug Pricing Program. This is a controversial program that requires drug manufactures to provide steep discounts for their products to certain types of hospitals and other healthcare providers. I am often helping drug manufactures and healthcare providers navigate developments in the 340B program and stay on top of recent litigation. My work with helping newly commercial drug manufacturers set the list price of their drug is an example of non-litigious work in my area of life sciences. Helping life science companies navigate and comply with FDA and CMS regulations is difficult and sometimes contentious, but hopefully not litigious.
CA: Can you give us an idea of the clients you work with and why they need lawyers?
PK: I generally work with biopharmaceutical companies ranging from seed companies all the way to established public companies. My work is critical to a biopharmaceutical company’s most valuable asset, its intellectual property, and transacting it in a manner that creates value for our clients, while mitigating associated risks. These intellectual property transactions include a first foundation license, scientific collaborations along way, or managing service provider relationships through research, development, and commercialization of their products that essential to the company’s growth (and survival).
AY: I work with early-stage companies who may not have any lawyers on the payroll (in this capacity, Goodwin serves in a general counsel-like role) and with large, mature corporations (in this capacity, Goodwin serves as an advisor alongside in-house counsel). In each case, I see my role not just as a “deal lawyer,” but as a thought partner and strategic ally who can speak to issues life sciences companies may face at any stage of their development.
EM: Our life sciences regulatory team works with a broad range of clients whose activities are regulated by FDA. In addition to drug, biologic, and medical device developers, we work with product manufacturers, contract research and development organizations, and investors across the life sciences space. The needs of early-stage companies (who may not yet have an in-house legal team) are different from the needs of companies that have commercialized multiple approved products, and our team has experience counseling companies throughout their life cycle.
SDG: I work with early-stage to public life sciences companies in a wide range of technical areas ranging from antibody therapies and gene therapies to agriculture and synthetic DNA tools. Patent attorneys are needed to understand both the legal aspects but also the scientific details of an invention. We also help understand the patent landscape around their products and help navigate potentially blocking IP. Innovation in life sciences is driven by these companies and it’s rewarding to get to work and advise across this ecosystem.
DH: I work with a range of life sciences clients ranging from early-stage to public companies. Each client has their own unique set of needs from their lawyers. Early-stage companies can be the most engaging and interesting because your role is a lot of times both a lawyer and strategic business advisor. They need lawyers to help them follow the rules of the road as well as provide insight into the market and draw on our past experiences. Being a corporate lawyer in this industry requires you to wear a lot of hats and be knowledgeable in different practice areas besides corporate, such as FDA and healthcare regulatory, IP, employment, etc.
HI: I most often work with newly commercial drug and device companies as they navigate the final stages of the FDA approval process and are preparing their commercialization strategy for after they obtain FDA approval. These companies need lawyers like me to provide strategic regulatory advice on how to best set up their business model and support functions to comply with federal and state regulations. Strong legal counsel is needed to ensure these companies are appropriately modeling out how various business decision can implicate regulations that could have an impact on the company’s ultimate gross-to-net revenue.
CA: How does the work differ from more traditional areas of law such as finance?
PK: IP transactions can be an alternative source of funding compared to traditional financing models. The difference is that it requires expertise in intellectual property law and the ability to quickly grasp the scientific nature of the technology.
AY: There are lots of differences from more traditional areas of the law. One of the differences that most excites me is that in my practice, I have the regular opportunity to work with brilliant scientists. I have found that scientists in particular deeply value expertise. To me, that means they look to their lawyers as valued thought partners who can help them navigate through key inflection points in their business – whether that is their first equity raise, a unique patent dispute or anything in between!
EM: We serve our clients as advisors with subject matter expertise, and there are unique regulatory considerations for nearly all of the transactions and engagements our clients may enter into. As regulatory attorneys, we often interact directly with our clients’ clinical, quality, and regulatory leaders; our points of contact aren’t limited to the in-house legal team. Day-to-day regulatory counseling requires being able to issue spot the particular framework or legal obligations that may apply to a set of facts the client has provided, then help the client think through the best course of action (and whether other subject matter experts need to be consulted).
SDG: Patent law is a unique intersection of science and law. The work as a patent attorney is deeply intertwined with cutting edge science. A strong scientific backgrounds is necessary for understanding the technical details of a client’s invention and how patents held by third parties affect the ability of a client to market their products. Because the IP can be the strongest asset for a company, this results in interfacing with other practice groups that help commercialize the IP such as licensing and corporate.
DH: The work differs the most from traditional areas of law due to the science and regulatory factors that go into life sciences.
HI: My work is focused on providing regulatory advising to life science and medical device companies to help them get their products in the hands of patients. This is a very technical and specialized skill set different than general corporate law.
CA: Where does the life sciences sector intercede with politics?
PK: The life science sector is inherently political because it impacts our personal health and access to medicines. In the news, you can expect to regularly hear about (1) high costs of medication, (2) access to basic and life-saving medicines, (3) faith and religion colliding with science and medicine, particularly around the abortion pill (mifepristone), (4) the FDA’s role in approving safe and effective medicines, and (5) economics behind fueling science and innovation.
EM: We work with clients in a heavily regulated industry, and government authorities are frequently developing and implementing legislation and policies that can impact our clients’ current activities and future plans. In particular, our clients are closely attuned to how FDA balances objectives of promoting innovation while ensuring that products that are approved have sufficient clinical data to support approval. Our team stays up-to-date on legislation and FDA guidance that may be relevant to our clients—being knowledgeable about evolving policy is key to being an effective regulatory advisor.
SDG: Politics influences the life sciences sector such as the regulatory space, which can then in turn affect intellectual property. As patent attorneys, FDA guidelines or specific laws or acts can affect development and commercialization strategies for our life sciences clients.
DH: The intersection of life sciences and politics happens most frequently with the FDA approval process and with other regulatory bodies that regulate anti-trust and foreign investment that can affect M&A and financing transactions.
HI: There are many different ways the life sciences sector interceded with politics. The most common area that affects my practice is political fights around drug pricing.
CA: Are there any political developments that have affected the sector recently? Are there any on the horizon?
PK: Any changes to healthcare related laws, regulations or policies inevitably impacts the life sciences sector, in varying degrees, depending on the specific topic.
SDG: One political development that has been raised recently is the impact of regulatory laws on patent strategy. For example, the Inflation Reduction Act (“IRA”), in part, is designed to reduce prescription drug prices. Though not its intent, the IRA has implications for patent strategy for our life sciences clients. As such patent law is not an insular sector but interfaces with many different areas.
DH: The Covid pandemic really shined a light on the FDA, for better and for worse, where now more people are familiar and interested in the approval of drugs than ever before, which means that it will likely be a political topic of interest, especially in presidential elections, on how the executive branch should oversee and direct the agency for years to come.
HI: The recent passage of the Inflation Reduction Act of 2022 and its Medicare Drug Price Negotiation Program was the culmination of many years of political debate. The implementation of this program will also continue to be influenced by politics as well.
CA: What is the most interesting deal/case you have worked on?
PK: I’ve worked on a wide variety of interesting deals ranging from licensing breakthrough medical technologies out of academic labs, global vaccine supply contracts during the COVID-19 pandemic, and complex collaboration deals for next generation cell and gene therapies that have the potential to cure certain diseases.
AY: I worked on a fast-paced asset acquisition that involved four (four!) different sets of legal counsel, an intricately intertwined set of legal histories among the parties, a complex and unique set of definitive documents and an elaborate and involved diligence process. Needless to say, it was bespoke, hard work and fun to tackle with a grateful and inquisitive client and a motivated Goodwin team!
EM: Some of the most “interesting” issues I’ve worked on aren’t deals or cases that are publicly announced upon completion. I enjoy helping clients solve problems, which may mean conducting an internal compliance investigation, responding to issues raised during an FDA inspection, or helping resolve questions or concerns from FDA during product development.
SDG: The most interesting cases I work on are those with clients where l see them through their corporate lifecycle from start to finish. It is very rewarding to be counsel for a client at its beginning and then seeing them either go public or get acquired as they move forward to develop and commercialize life-saving technologies. The great thing about working at Goodwin, is that because we have a vast number of practice areas, we often get to see this happen.
DH: The most interesting deals are with clients that we’ve helped grow from formation onto a successful exit or success event, with the future potential to develop and commercialize life-saving technologies.
HI: I advised Biocon Biologics Ltd., in its agreement to acquire Viatris Inc.’s global biosimilars business for $3.335 billion.
CA: What was your role on the latest deal/case you worked on?
PK: As a senior associate, I work closely with a partner to manage the day-to-day tasks for each deal. This involves a mix of legal, analytical, project management, and leadership skills that apply both internally within our core legal team and externally with client teams. Also, I often lead and/or contribute to negotiations with the counterparty for each deal.
AY: As a senior associate, I like to think of myself as the deal “quarterback.” My role is to negotiate and draft the definitive documents, collaborate with Goodwin specialists, issue spot and anticipate client needs, delegate tasks to more junior members of the Goodwin team and (sometimes!) to keep spirits up when we are working hard late at night!
EM: My work varies from day to day, and my role changes depending on the type of project I’m working on for a client. When clients have regulatory questions about a proposed initiative, or concerns about something that has happened at the company, my role is typically to review and apply the relevant regulatory framework to the facts at hand, either through a call or through written correspondence to the client, and recommend potential courses of action. When I am working for a client that is looking to acquire or invest in a life sciences company, my role is typically to conduct diligence on the company, which may involve review of regulatory correspondence, clinical and preclinical materials, and operational and quality documentation, and identify key issues (along with reviewing transactional documents or any company filings being made in connection with the deal).
SDG: In my latest deal, I was senior associate leading the diligence of a potential asset for acquisition. This involved analysis of the potential asset and understanding the third party patent landscape and providing recommendations for carrying the potential asset forward.
DH: In my latest deal, I helped lead negotiations on the terms of a sale of a very early stage biotech client to a large pharmaceuticals company.
HI: led the legal analysis of all of the commercial, supply chain, and other agreements a drug manufacturer had in place to sell its drug products throughout the drug delivery ecosystem.
CA: How important is a scientific background to your work?
PK: The ability to quickly understand scientific concepts and develop fluency in the life science industry is a core competency for the life science IP transactions practice. A scientific background and industry knowledge allows one to readily understand clients’ concerns and advise accordingly. Many members of Goodwin’s life science IP team, including myself, have doctoral-level science degrees in addition to a law degree. It is also helpful to be a registered patent attorney with the United States patent office (which requires passing the patent bar exam) for our IP transactions practice, but not required.
AY: As a corporate associate in the life sciences group having a keen interest in what our clients do is essential, and enough to expertly advise start-up companies all the way to large, well-known public companies.
EM: Having a scientific background is helpful to working in life sciences, and our client base expects us to be conversant in the concepts and terminology of their industry. However, not having a background in science isn’t disqualifying, as long as you are committed to learning about the industry and asking the right questions to understand the disease states, patient needs, and key scientific concepts that guide the work our clients do.
SDG: A scientific background is essential for patent law. Patents are based on scientific discoveries and being able to understand the science and legal implications is important. Goodwin recognizes this and specifically recruits for this. I have a PhD in biomedical sciences from University of California San Diego, and most of my colleagues in our patent practice have advanced degrees as well. We want to ensure we’re bringing a deep scientific understanding to our legal excellence so that we can best understand and advise our clients.
DH: Having a scientific background could be helpful, but not a necessity for a corporate lawyer. The most important thing is to know exactly what your client does. Also, for general scientific education, there are plenty of tools and resources to draw from, including Goodwin’s helpful biology/chemistry trainings that help acclimate corporate lawyers without a science background.
HI: A scientific background is helpful to my work, but not necessary. It is more important for my area of life sciences law to understand the commercial healthcare ecosystem as a whole which is highly regulated and complex.