It may be hard to believe, but it's been a year since Faber Daeufer & Itrato's second Equal Justice Works fellow Madeline Middlebrooks began working to address the lead contamination water crisis in St. Louis Public Schools (SLPS). Through an initiative hosted by Great Rivers Environmental Law Center, Middlebrooks has been hard at work implementing a multi-dimensional strategy and advocating for the safety of school-aged children. With a focus on a predominantly African American area of the city, she has spent the past year investigating, coalition building and inspiring change in an area of the city where water contamination poses a serious health threat.
Faber Daeufer & Itrato PC recently added an innovative role to their corporate structure and welcomed a new firm member into the position. Jennifer Creamer has joined the firm as Client Relations Analyst, where she will help maximize client experiences. “My goals in this new position are to help assess where Faber wants to be in the future, and identify what it wants to accomplish,” said Creamer, “as well as determine how to achieve those goals. I also hope to be able to provide analytical insight into the firm’s operations, as it can be incredibly valuable for directing efforts moving forward.”
Faber Daeufer & Itrato recently took steps to neutralize the firm’s past and current carbon footprint. With its 2020 donation to Cool Effect, a nonprofit organization working to reduce carbon pollution worldwide, the firm successfully offset its carbon footprint dating back to its launch in 2003. Founded in 1998, Cool Effect is a globally recognized non-profit platform that works with corporations, organizations and individuals to reduce carbon pollution.
Carbon dioxide (CO2) occurs naturally in the Earth's atmosphere, but people and companies significantly increase these levels by consuming electricity, utilizing certain forms of transportation, manufacturing products and participating in deforestation. With a higher density than dry air, CO2 acts like a greenhouse around the earth, warming the planet’s surface. As these carbon levels rise, the earth experiences substantial climate changes. Cool Effect works to reverse these negative consequences one carbon footprint at a time.
Faber Daeufer & Itrato proudly announces the promotion of Gina Wu to Counsel where she will be taking a project management and/or supervisory role in various large-scale transactional projects for clients. Wu’s recent accomplishments include supporting one of the firm’s international clients on R&D activities globally, which includes putting clinical trial agreements and service agreements in place to cover several investigational products and trials in various phases – ranging from a single U.S. site Phase 1 study to a Phase 3 multicenter study with over 120 sites globally. Her recent work also includes an increasing number of manufacturing and supply chain related agreements.
Faber Daeufer & Itrato proudly announces the promotion of Lily Vakili to Principal. Vakili advises clients in the practice areas of Industry Collaborations, Licensing and Supply Chain Documentation. Recent transactions include representation of a large investor syndicate in the negotiation of a clinical development and manufacturing agreement for an exclusively in-licensed respiratory disease drug product and advising a Boston-based subsidiary of a large international biopharmaceutical company in CMC-related documentation for the development of a pipeline of cancer immunotherapies.
As Faber Daeufer & Itrato’s first two-year Equal Justice Works (EJW) fellowship comes to an end, recipient Jen Rasay joined the firm’s latest quarterly meeting to share some of the amazing successes achieved during her project. Working with the National Center for Law and Economic Justice (NCLEJ) in New York City, Rasay’s efforts challenged work requirements that impede access to public Medicaid benefits through advocacy, impact litigation and community-based organizing.
Faber Daeufer & Itrato recently announced the establishment of the firm’s Equity, Diversity and Inclusion Committee (“EDIC”) and EDIC Council. With the support and participation of senior management of the firm, the EDIC’s mission is to develop, issue and implement meaningful and sustainable equity, diversity and inclusion policies and business practices within the firm.
The EDIC Council consists of the EDIC chairperson, Principal Lily Vakili, Managing Principal Joe Faber, and Principal Ken Itrato, along with the chairs of three subcommittees: the Black Civil Rights Employee Education Subcommittee, Women’s Initiative Subcommittee, and Educational and Cultural Events Programming Subcommittee.
Faber Daeufer & Itrato recently held its 2020 Day of Service by revisiting a worthwhile cause serving the urgent needs of the most vulnerable people and places across the globe. The risks and necessary precautions of COVID-19 placed some limits on the firm’s Philanthropy Committee as they searched for this year’s activity, but they found the perfect fit with an initiative that Faber supported for a previous day of service.
Humanitarian OpenStreetMap Team (HOT) is an international organization using open mapping to further humanitarian actions and community development. Working with volunteers worldwide, the team creates and provides map data that reduces safety risks, transforms disaster management, and furthers Sustainable Development Goals.
Though the professionals of Faber Daeufer & Itrato are not able to gather for their annual holiday season dinners, they have found a way to celebrate together – even while apart. This year, the firm will partake in some delicious socially distanced dining, while giving back to businesses and communities hit hard by the pandemic. Each firm employee received a gift certificate to a minority-owned restaurant located within a minority neighborhood. While the principals hope that every employee will use the gift certificates to partake in some amazing meals, the purchases themselves provide an avenue for supporting small minority-owned businesses impacted by COVID-19.
Faber announces the establishment of an Equity, Diversity and Inclusion Committee (“EDIC”) and EDIC Council. With the support and participation of senior management of the firm, the EDIC’s mission is to develop, issue and implement meaningful and sustainable equity, diversity and inclusion policies and business practices within the firm. The EDIC is composed of three subcommittees: (i) a Black Civil Rights Employee Education Subcommittee, (ii) a Women’s Initiative Subcommittee and (iii) an Educational and Cultural Events Programming Subcommittee. The EDIC Council consists of the EDIC chairperson, Senior Counsel, Lily Vakili, Managing Principal, Joe Faber, Principal, Ken Itrato and the chairs of each subcommittee, Kori Kaufman, Haritha Ambros and Heather Centauro.
Faber Daeufer & Itrato congratulates Concerto Biosciences on winning the third Launch@LabShares competition, an innovative contest through LabShares Newton that awards an early-stage startup with a year of free research space. Faber co-sponsored the competition with DTWard PC, a biotech intellectual property law firm, and Safety Partners, an EHS and regulations guidance firm.“There were several strong applicants,” stated LabShares in their official announcement, “so the choice was a difficult one, and we are proud to be adding Concerto to our roster of member companies.”
Faber Daeufer & Itrato PC welcomes Katisha Brown as a new member of the firm’s contracts specialist team. “Like most of our team, Katisha brings extensive in-house experience in day-to-day R&D contracting for large and small biopharma companies,” said Linda DeGraw, Associate Director of Contracts Specialists at Faber. “She will be a terrific addition to our contracts specialist team, who seek to help the firm’s clients with a careful yet pragmatic perspective.”
Brown has helped draft, negotiate and administer a wide range of template-based agreements in support of biopharmaceutical R&D operations. Prior to her arrival at Faber, Brown served as a Senior Contracts Manager with Kintai Therapeutics, Inc. and an Associate Contract Manager at Momenta Pharmaceuticals, Inc.
Faber recently announced Madeline Middlebrooks as the recipient of their second two-year Faber Fellowship, which will begin in Fall 2020. A recent graduate of Sturm College of Law, University of Denver, Middlebrooks will implement a multi-dimensional legal and policy strategy to address the lead contamination water crisis in St. Louis Public Schools.
Following the success of their first fellowship with Jen Rasay, Faber decided to once again partner with Equal Justice Works (EJW) to provide this valuable opportunity. With a dedicated commitment to assisting new lawyers in their pursuit of equal justice, the EJW fellowship program is an innovative initiative that removes the financial barriers that often keep attorneys from pursuing public service careers. Having supported over 1700 attorneys with funding, training, and guidance to pursue their public interest dreams, EJW has established itself as the nation's largest provider of post-graduate legal fellowships.
Faber Daeufer & Itrato recently presented the second in a series of webinars discussing how COVID-19 is influencing drug development contracting strategies. Managing Principal Joe Faber opened the webinar with an overview of the topics to be covered. “Today’s focus is on some of the strategic choices drug development companies should make about their business relationships with CROs, clinical trial sites, and with other participants in the clinical trial ecosystem - all in order to deal with a sponsor’s goals and reacting to the disruptions caused by the pandemic around the suspension of enrollment, the continuing of studies and /or prompt relaunch or restart of studies.”
Gina Wu was the first to present. A member of the clinical development contracting team, Wu supports Faber’s clients sponsoring more complex global clinical studies. She explained that, while force majeure clauses had not generally been seen as a major issue before COVID, they are now popping up in agreements and being more heavily negotiated.
Faber Daeufer & Itrato recently launched its COVID-19 webinar series with the first in a series of informative presentations. Managing Principal Joe Faber began the webinar with a brief description of the firm’s goals in providing this information. “We recognize that drafting and negotiating contracts is just a part of the process for building or restructuring a business relationship, so lawyering at its best must be about counseling,” said Faber. “Particularly with the novel challenges presented by COVID-19, we may not have answers to every question, but we support our clients and their work to address unmet medical needs with our collective knowledge and experience and with our best judgement.”
He explained that the first webinar would look at some of the strategic choices that drug development companies should make about their business relationships with manufacturers, either at the RFP stage or later when a supply chain is already in place. “We’ll explore some of the key issues that arise when considering the portability of elements of the supply chain and some of the key issues that arise when considering the redundancy of elements within the supply chain.”
For the fifth consecutive year, Faber Daeufer & Itrato is partnering with deCordova Sculpture Park and Museum as a Corporate Patron supporting the museum and New-England based artists. deCordova provides a beautiful showcase for contemporary art with over 3,400 works in its collection and more than 60 sculptures in its 30-acre park.
Visitors and patrons of the museum have various options for viewing their unique art experiences, from the outdoor sculptures in the Sculpture Park to the contemporary pieces within the museum. Sculpture park exhibits are updated annually so visitors can experience something new each year. Indoor exhibitions change with the seasons, giving artists several opportunities to showcase their pieces.
On December 10, 2019, Joe Faber led a discussion around critical financing, licensing, and transactional challenges facing biotech start-ups as part of LabShares Newton’s “Lunch@LabShares” speaker series.
LabShares Newton is a turnkey, state-of-the-art lab and office space for life-science startups, located in Newton, Massachusetts. Fully permitted and professionally maintained, this innovative program offers a variety of support services and amenities to early-stage research companies at an affordable cost. Initially launching in October 2018, the highly coveted space opened at near capacity before recently expanding to accommodate up to 30 companies.
The average American emits 16.6 tonnes of CO₂ per year, but Faber Daeufer & Itrato is neutralizing its carbon footprint by supporting an innovative organization working to reduce these planet-warming emissions across the globe. Cool Effect is a nonprofit organization on a mission to reduce the carbon pollution that causes climate change. From wind energy to clean burning cookstoves, their initiatives make it easy for individuals and corporations to offset their carbon pollution and improve the lives of people around the world.
Faber Daeufer & Itrato proudly announces that the firm has assisted five of the innovative startups on the FireceBiotech 2019 “Fierce 15” list with their transactional representation needs.
Faber Daeufer & Itrato PC is pleased to announce that Justin Beegle has joined the firm as an associate, and will be supporting the firm’s clients in company formation, venture financing, and M&A. Prior to joining Faber, Beegle served as an associate attorney at Foley Hoag LLP, representing many of their clients in the life sciences and other emerging technologies.
Faber staff members recently spent a day of service empowering young adults to take charge of their lives by taking charge of a business. MoreThan Words is a nonprofit social enterprise that serves youth aged 15 to 24 who are in the foster care system, court-involved, homeless, or out of school. Through their bookselling enterprise, participants manage a retail business while also learning valuable life skills and gaining critical work experience.
LabShares Newton, a Faber sponsored biotech lab incubator, recently announced Savran Technologies as the winner of the first Launch@LabShares competition. “We are thrilled to be able to welcome Savran Technologies as a member of the LabShares community,” said Jeff Behrens, co-founder and CEO of LabShares Newton. “As our tenth member and first winner of our Launch@LabShares award, Savran was selected based on their exciting microfluidic technology, which focuses on whole cell isolation for both prenatal and oncology diagnostics.” Other finalists included Excelsior Genomics, an early stage biotech company focused on gene editing.
Faber Daeufer & Itrato principal Joe Faber recently delivered a guest lecture to about 40 graduate students in the Biomedical Engineering Seminar Series (HST 590) that is part of the Harvard-MIT Program in Health Sciences and Technology.
The HST Program is a unique collaboration that brings together Harvard Medical School, Harvard University, Harvard-affiliated teaching hospitals, the Massachusetts Institute of Technology, and local research centers to integrate science, medicine, and engineering to solve problems in human health, and is particularly appropriate for students who are planning multidisciplinary research careers in academic medicine.
The 15th annual Bio-Ball was recently held to benefit the athletes of Special Olympics Massachusetts. Athletes, volunteers, and bio-tech industry teams gathered in Cambridge, MA for a day of fun and fundraising. Continuing a decade-long tradition of giving back to the community, Faber served as a lead sponsor for the event.
Aspiring to the vanguard of legal technology, Faber Daeufer & Itrato PC has strengthened its capabilities further by adding two new members to its information technology department. “Putting the best-available computing resources in the hands of our employees has been a priority for firm management since the day I arrived,” said David Schrag, Senior Director of Information Technology. “Expanding the department will allow us to serve our clients better and faster while continuing to focus on core functions such as information security and high availability.”
With a continuing commitment to providing excellent counsel to emerging life sciences and technology clients, Faber Daeufer & Itrato PC is welcoming Haritha Ambros to its team of venture finance lawyers. “Haritha is a strong associate and we’re excited about the experience and perspectives she’ll add to our group,” says Faber principal Kurt Machemer. “She will be assisting clients on variety of venture finance and corporate organizational and transactional matters, and counseling clients on general governance.”
Affordable workspace can be difficult for biotechnology and life science startups to secure. But thanks to a generous co-sponsorship by Faber Daefuer & Itrato, one emerging company will receive a year’s worth of free access to an innovative workspace.
LabShares Newton has developed a state-of-the-art facility that is fully permitted and professionally maintained, offering a variety of support services and amenities to early-stage research companies at an affordable cost. Initially launching in October 2018, the coveted LabShares space opened at near capacity. In an effort to provide even greater assistance, they recently expanded the facility to accommodate up to 30 companies.
Faber Daeufer & Itrato principal Greg Ikonen recently shared his expertise as a speaker at the 2018 Licensing Executives Society (LES) conference, discussing the diverse perspectives that parties bring to technology license deals. “I was one of three speakers with substantial experience doing deals in the real world between larger and smaller partners,” Greg explained. “We talked about negotiation goals and strategies from the perspective of big, medium, and small parties, and shared some useful war stories.”
Faber staff members recently got their hands dirty when they donated their time and efforts to helping feed individuals in need throughout Greater Boston and Eastern Massachusetts. Gaining Ground is an organization that grows organic produce and distributes it for hunger relief. With help from volunteers of all ages and abilities, Gaining Ground’s produce goes straight from the farm to homeless shelters, food pantries, and various local meal programs.
Clinical trial professionals and in-house counsel from many emerging drug development companies in the Bay Area received valuable advice when they attended a seminar on “Optimizing Clinical Trial Agreements for Effective Trial Management” on May 9, 2018, sponsored by Faber Daeufer & Itrato PC and hosted by the California Life Sciences Association (CLSA). The half-day event in South San Francisco, designed to assist biotech professionals efficiently manage the clinical trial process and avoid common challenges, provided a rare opportunity for skilled advice and counsel, as well as highly useful peer involvement and information sharing.
Furthering efforts to expand its clinical trial agreement capabilities, Faber Daeufer & Itrato PC welcomed the addition of two new team members, each with extensive domestic and global clinical trial experience. Nirosha Sithirapathy and M. (Max) Masaya Seltzer recently joined the talented group of Faber lawyers, bringing highly skilled industry-side knowledge to the firm’s pharma, life science and emerging technologies clients.
“The firm is hiring and training more lawyers and contract specialists to support our clients’ clinical trial contracting needs for large, complex, multi-center, global clinical studies,” explained firm principal Sumy Daeufer. “Both Max and Nirosha have in-house legal experience directly relevant to clinical trial contracting. Max brings many years of experience handling clinical trial and other human research related contracts for the NYU School of Medicine, one of the premier institutions in the United States. Nirosha, who is based in the UK, brings European clinical contracting experience from her work with several contract research organizations.”
Faber staff members are consistently looking for worthy causes that need hands-on volunteers to achieve their philanthropic goals. So, when Patricia Wolfe saw a feature story on the not-for-profit organization Wine To Water, she wasted no time bringing the new service idea to the firm.
“My husband and I were having dinner at a restaurant and there was a video on the television monitor about Wine To Water and how they were constructing clean water systems in South America out of clay,” explained Wolfe. “I couldn’t really hear the report, but I looked into the organization later. At Faber, we try to do two or three days of philanthropic service each year. I found out that Wine To Water provides tiny, portable water filters to people in need and they look for companies to sponsor their builds.”
The WAVE/Pfizer Collaboration
In 2015, WAVE Life Sciences was a small biotech company seeking its first big research and development collaboration deal. It had developed a novel technology platform for the discovery and development of new oligonucleotide therapeutics for a wide range of diseases, and was advancing lead candidates in several of its key therapeutic areas. WAVE had identified a promising collaboration opportunity: a multi-program, option-based drug discovery, development and commercialization deal with Pfizer. This deal would combine WAVE’s proprietary oligonucleotide platform with Pfizer’s liver targeting technology, and leverage Pfizer’s drug development and marketing expertise. Pfizer would provide R&D funding, and would have options to acquire exclusive worldwide license rights to therapeutics for several liver-related disorders.
We get it. Our clients’ days are filled with pharmacokinetic testing, enrolling global clinical trials and pursuing financing and strategic transactions. Email encryption and Transport Layer Security (TLS) probably don’t rank at the top of their agendas. Faber Daeufer & Itrato’s team of lawyers and contracts specialists are well-known for providing our clients an extraordinary approach to counseling on all of the contracts and transactions that support scientific development and propel growth. But more recently, as we’ve made substantial investments in improving our own cybersecurity, we’ve become proactive in helping our clients address cybersecurity threats when we recognize that their security measures should be improved.
Focus Is on Real World Dynamics
Mark J. Cooper, Of Counsel with Faber Daeufer & Itrato, recently co-taught the “Contract Basics” segment of BIO’s Business Development Fundamentals course, held during the trade association’s June 17-19 conference in San Diego. He collaborated with Pauline Jen Ryan, of Red Sky Partners, on the four-hour workshop, which offered real world perspectives on how to structure and negotiate life science business deals.
Extraordinary Team of Seasoned In-House Lawyers Targets Complex Pharma Collaborations
Mark J. Cooper has joined Faber’s New York office, further expanding the firm’s extraordinary team of senior lawyers focused on complex licensing and collaboration agreements for the life sciences. He recently served as Vice President and Assistant General Counsel for Pfizer’s Business Transactions Group.
“We now have five very senior lawyers leading our team that helps clients structure and negotiate the most sophisticated technology licensing and R&D collaborations with Big Pharma,” says principal Joe Faber. “Even compared with mega law firms, this represents a rare assemblage of top talent with this focus. And, like Mark, each of the other senior lawyers in this practice has experience leading in-house legal departments in the industry or, in some cases, serving as CEO or CBO of emerging biotechnology companies.”
This past fall, Faber launched a major initiative to build capability in the San Francisco market, opening a new office and hiring senior talent. “Given the firm’s focus on the life sciences industry, a lot of our clients are located in California, and we see significant growth opportunities,” explains Greg Ikonen, who recently joined the firm and is leading its Bay Area office.
In fall 2016, Robert A. Aboud, a principal with Faber Daeufer & Itrato who leads the firm’s Philadelphia office, spoke about the unique traits and challenges of gene therapy and cell-based therapy deals at CBI’s Life Sciences Summit on M&A and Strategic Alliances in Cambridge, Massachusetts.
In “Gene Therapy Deals: Case Studies and Lessons Learned,” Rob shared insights and strategies for addressing the complex issues associated with such deals in order to drive commercialization while capturing adequate revenue from the intellectual property. In particular, he examined the legal and business issues surrounding what he termed the “patchwork IP” of key program assets throughout the deal’s life cycle. He also highlighted special considerations related to the “blurry line” between the IP for platform technology and the actual therapeutic product. And he discussed the challenges for ensuring consistent manufacturing supply and clinical trial support without undue reliance upon, and financial obligations to, university investigators, tech transfer offices and to third party IP holders.
During 2016, Faber further strengthened its professional lineup in key disciplines...
Faber recently opened new offices in the Philadelphia mainline suburbs in Radnor, Pennsylvania, an area that is home to many world class pharmaceutical and biotech companies, and is a hotbed of biotech innovation for the region.
Faber has been a geographically dispersed firm since inception, taking advantage of cloud technologies such as secure online backup.
On September 27, 2015, Faber held its first annual firm-wide Day of Service, partnering with the Boston Cares Bed Project.
Working from anywhere in the world and under any conditions are two critical factors in providing great service to a global client base.
Faber is expanding once again to accommodate growth. Starting with six employees about twelve years ago, the firm has grown to over 30.