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.
Event speakers from Faber included Isabelle DeBear (the Founding Director of Faber’s unique Contracts Specialists team), Jon Linden (a Principal at Faber who helps supervise the firm’s large team of lawyers and Contracts Specialists handling clinical trial agreements and related clinical development matters), and Greg Ikonen (a Principal at Faber who leads the firm’s new San Francisco office and helps lead the firm’s complex transactional practice). They led discussions about creating clinical trial agreements that address study priorities while appropriately addressing liability allocation, IP rights and other essential contract terms. They additionally provided advice on leveraging the capabilities of a CRO by establishing an efficient contracting process and special considerations for ex-US studies, including complying with the EU’s new General Data Protection Regulation (GDPR).
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.”
For the third consecutive year, Faber Daeufer & Itrato has chosen to be a Corporate Patron of the deCordova Sculpture Park and Museum in Lincoln, Massachusetts. With over 3,400 works in its collection and more than 60 sculptures in its 30-acre park, the museum is a showcase for contemporary New England art.
“We’re proud that our financial contribution will support deCordova’s mission to cultivate emerging local talent and offer programming that enhances public involvement with the arts,” says Joe Faber, a principal with the firm. “Our sponsorship gives us an opportunity to display beautiful samples from the museum’s collection in our Waltham office, serving as a consistent reminder of our commitment to the community.”
Faber joined with many clients and friends in the Boston-area biotech community to score big with the 2018 Bio-Ball tournament, the wildly-popular annual fundraiser for Special Olympics Massachusetts, raising a record $360,000. Approximately 650 athletes and spectators turned out for the event, which took place at the Cambridge Rindge and Latin School on March 24. For more than a decade, Faber has been the lead sponsor for the event, providing in aggregate over $150,000 in financial support, and also has regularly fielded its own team of committed volunteers to help organizers from Special Olympics Massachusetts ensure the event runs smoothly.
The “CEO Free Throw Contest” opened a day of enthusiastic, good-natured rivalry, as executives from each of the 16 participating biotech companies teamed with a Special Olympics athlete to show off their shooting skills. A red “Unified Ball,” symbolizing social inclusion, was thrown by the Special Olympians, as the crowd went wild.
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.
Faber lawyers and contract specialists have been working with 3 of the dynamic companies on this year’s list – and 1/3 of the companies listed in the past five years or their scientific founders.
On September 26, 2017, FierceBiotech released their eagerly-anticipated annual
“Fierce 15” list – “The FierceBiotech Fierce 15 is a hunt for the biggest ideas in biotech, the most daring characters in biopharma, and entrepreneurs doing things that haven't been done before. Fifteen privately held drug developers or platform biotechs with the potential to have a huge impact on the treatment of human diseases. The Fierce 15 celebrates the spirit of being "fierce"--championing innovation and creativity, even in the face of intense competition--and has recognized a number of distinguished biotechs over the years.”
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.
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 who leads the 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.
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.