Before co-founding The Bracken Group, Liz held positions at Sanofi, Novo Nordisk, Bracco, Kyowa Hakko Kirin, and Taiho Oncology. She is an accomplished drug development strategist and a seasoned regulatory leader with a strong track record of delivering IND, NDA, and MAA submissions in multiple therapeutic areas. She has developed and implemented numerous effective global regulatory strategies and submissions, enabling the earliest possible approvals of Phase I through Phase III applications. Liz started her career with the USDA’s Food Safety Inspection Service (FSIS) and Animal and Plant Health Inspection Service (APHIS) Divisions.
Regulatory IND and NDA submission strategy and execution, US agent and primary contact for sponsors, regulatory strategy in various therapeutic areas including oncology; exceptional cross-functional leader, bridging disciplinary and organizational boundaries to deliver innovative solutions.
Concierge-style consulting with the patient and caregiver in mind. The Bracken Group can help sponsors successfully navigate the regulatory pathway to achieve submission and approval of their products.
Carriage driving and spending time with her pair of Cleveland Bay mares.
The Black Forest in Germany or anywhere in the foothills of the Alpine mountains.
Along with her work at TBG, Lisa served as Vice President, Regulatory Affairs and Quality Assurance at Xennials Therapeutics, a Chicago-based biotech start-up. She is an accomplished global regulatory affairs professional, bringing a depth of experience in leading strategic regulatory pathways for drug and biologic products from pre-clinical through post-marketing stages. Lisa was previously Director of Regulatory Affairs at Immunocore, where she helped drive strategic regulatory approaches for lead product candidates to initiate clinical trials and maximize the probability of registrational success.
Oncology, orphan indications, IND submissions, advertising and promotion review, label development.
It’s a small, tight-knit group that really supports one another.
Gardening, reading, running, spending time with family.
The Florida Keys (it’s like being in the Caribbean but with all the conveniences of the US).
Katie has a bachelor’s degree in Business Management and Marketing. She started her career on the product management side of the Medical Device industry. She found her passion in meeting new professionals and being able to use her skills to help them with their marketing needs and so pivoted to TBG in 2019. When not attending networking events or tackling marketing projects, Katie enthusiastically manages the Dan Diaz Biotech Breakfast Club. She also enjoys being part of the Women in Bio Membership Committee. She also enjoys volunteering and fundraising for the ALS Association, competitively riding horses, and pet sitting. Katie lives with her family outside of Doylestown, Pennsylvania.
Business development, marketing.
I love working for a company that supports me in my professional development along with personal growth. When I am attending community events, such as my networking group to help raise awareness for the ALS Association, at least one TBG consultant is there, if not everyone. This team supports each individual person for who they are professionally and personally and they help us every step of the way to learn as much as we can.
Riding horses and hiking new trails.
Jim is a scientist, entrepreneur, executive, and business development specialist who has co-founded and helped lead multiple bio-pharma and bio-tech companies, including Tarsa Therapeutics, Herborium Inc., and Unigene Labs, where he oversaw the entire spectrum of drug development activities, including pharmacology and preclinical activities, CMC, clinical Phase I-III, as well as US and international regulatory strategies. Jim is a co-author on several manufacturing and formulation patents and has been featured in journal articles on novel therapeutic peptides and their clinical utility. He has executed numerous feasibility and licensing deals within the pharmaceutical industry, working frequently with investment bankers, venture capitalists, and brokers.
Drug development and strategic planning, pharmacology and toxicology, due diligence, peptide-based therapeutics, musculoskeletal diseases, cardiovascular disease, and atherosclerosis.
Playing golf and basketball, attending/watching sporting events.
Ireland – not because of the beer, but because of the people.
Monica has 20 years’ experience in the biotech/pharmaceutical industry. Following years in an academic practice, she has held positions of increasing responsibility at Novartis, Incyte, Mesoblast and Immune Pharmaceuticals in clinical development, translational medicine, and strategic planning, as well as key business development roles. Her experience ranges across stages of development, from exploratory phase 1 through phase 3, in multiple therapeutic indications, and includes numerous IND files and NDA. Dr. Luchi is a rheumatologist with an adjunct appointment at the University of Pennsylvania.
Clinical Development, across phases of development; strategic planning; business development; Rheumatologist with interest in immunologically mediated conditions.
This is a group of individuals with deep expertise in drug development, each with extensive knowledge in one or more facets of the development process from discovery and manufacturing through registration and marketing. The group functions as a cohesive team which is driven by collective knowledge to problem solve and achieve objectives. The culture is collegial and inspirational.
Seeing and experiencing as much of the world as possible; skiing, scuba diving, hiking – pretty much anything active and outdoors.
So tough to choose just one!!! Camelback in Morocco? Hiking in Machu Pichu? Skiing Zermatt? Diving the Black Hole?
Chelsea has a master's degree in Political Science from the University of New Hampshire. She started her career in Regulatory Affairs for a Multi-Brand CPG company and has experience in FDA Drug and Device submissions, as well as FIFRA submissions and compliance. She comes to TBG with 6 years of experience in Regulatory Affairs. Chelsea lives with her husband and two dogs in a tiny house located in the White Mountains of New Hampshire.
Regulatory IND & NDA Submissions, ODD Submissions, OTC Drug Compliance, FIFRA Submissions & Compliance, Medical Device Submissions & Compliance.
TBG is a collaborative team that does not believe in a "one-size fits all" approach. TBG will tailor its strategy to fit each project and client, ensuring successful navigation of regulatory pathways.
Spending time outside in the White Mountains, NH with my dogs: Hiking, Mountain Biking, and Skiing.
Exploring new trails both on my feet and on two wheels. Some of my favorites so far have been in the Wind River Range Wyoming; Ton Sai, Thailand; and Bugaboo Provincial Park, British Columbia.
Colin is a co-founder and managing partner of The Bracken Group. He previously served as Senior Vice President of Medical Affairs at BioClinica and was instrumental in supporting the growth of the company from 35 to more than 1,800 people. He was an officer of the company for 5 of the years it was publicly traded on the NASDAQ. Colin started Bona Fide Ltd. (part of the Lunar Corporation) and has also worked at Syntex Pharmaceuticals (now part of Roche) and Procter & Gamble Pharmaceuticals. He has written more than 70 peer-reviewed scientific and medical publications and published 3 books, the latest entitled “Medical Imaging in Clinical Trials.” He holds 3 patents. He has presented at the FDA on several occasions and attended meetings on the development of guidance documents, including “Imaging in Clinical Trials” and discussions on progression-free survival in oncology. He has been an advisor on several safety boards and ad-coms. Colin is also a fellow of the Institute of Physics and Engineering in Medicine (FIPEM) and is a Chartered Scientist (CSci).
Medical imaging in clinical trials, clinical development strategy, osteoarthritis, radiopharmaceuticals, nuclear medicine, and DXA.
Integrity and transparency are core to the company ethos. As a consultant, you only have your reputation and company reputation to stand on and that is a key facet of The Bracken Group. Everyone who joins the team is not only steeped in an area of expertise, but subscribes to this same underlying philosophy and mode of working.
Flying and all things aviation; kayaking, cycling, and hiking.
Colin as traveled to more than 40 countries, but some favorite memories include feeding a baby elephant in a Thailand rain forest, bungy jumping in New Zealand, and standing on the Arctic Circle in Finland.
Nick is a highly experienced, results-oriented executive with a strong track record of team building, strategic planning, and tactical execution in fast-paced organizations in medical devices, pharma, and biotech. Over his extensive and varied global career, he has held leadership positions with Smith & Nephew, Merck and Merial, and many others. Nick was also the Founder, Chairman, and President & CEO of Topaz Pharmaceuticals, the Founder and Managing Partner of Humanitas Consulting, President and CEO of Reliefband Technologies, and Partner at Alten Calsoft Labs.
Strategy, biotechnology, pharmaceuticals, and medical devices, human and animal health, as well as entrepreneurship and start-up-to-growth-stage companies.
The Bracken Group consistently provides its clients with certain intangible activities that fulfill very particular defined needs—quickly, quietly, and with incredible efficiency.
SCUBA diving, protecting the oceanic environment, activities involving aircraft and cars, reading (history, sci-fi, biographies), and computer science.
London, England. (“Maybe It’s Because I’m a Londoner!”)
Dani recently graduated with an MBA from Trinity College Dublin, located in Dublin, Ireland. Prior to joining The Bracken Group, she spent 3 years working in the commercial real estate industry in San Francisco, with a focus on hospitality assets. She earned a bachelor’s degree in Hotel and Restaurant Administration and a minor in Real Estate Finance from Cornell University.
Due diligence, corporate strategy, real estate and hospitality finance, social enterprise, market research, accounts receivable, and project management.
TBG has fostered a uniquely well-balanced, authentic, and supportive culture. All of the partners are extremely accessible and willing to take time to speak with you about anything, personal or professional.
Horseback riding and horsemanship, jigsaw puzzles, cooking, and hanging with her dog, Rocco.
Ireland, for the greenery, castles and distilleries; and San Francisco for the down-to-earth city vibes, as well as the beautiful hiking.
Brad is a recognized expert with more than 20 years of experience in clinical imaging studies and regulatory consulting. Brad was most recently Vice President of Imaging and Clinical Development at ImaginAb, where he was responsible for the development and clinical testing for novel PET tracers. While working with multiple medical device startups, his responsibilities included software and hardware development, Quality Systems Regulations (QSR), 510k submissions and clinical testing. Brad began his career at Pfizer, working across several therapeutic areas over 10 years. He has published more than 50 journal articles and has coauthored four patents.
The study design, protocol development, and study documentation of clinical trials, medical imaging for drug development, due diligence, investment management, and statistics and data management.
Working with The Bracken Group represents a chance to work with a team of creative thinkers to allow for a broader perspective when problem-solving.
Skiing, snowshoeing, hiking, and jogging.
We accept only the best from ourselves and for our clients, so naturally we choose our partners carefully.
At TBG, we’re always happy to connect with like-minded professionals who might have an interest in joining us. If that’s you, please reach out.
We would be delighted to hear from you and discuss our consulting services. Please call +1 215 648 1208 to chat with us directly. Or write to us using the form provided here. We look forward to collaborating with you.